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Term
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Definition
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510 (k)
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A Pre-market submission required by FDA for certain medical devices as specified in the Code of Federal Regulations. (Title 21 CFR Part 807 Subpart E) (510(k) refers to the section in The Federal Food, Drug, and Cosmetic Act).
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80-20
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A term referring to the Pareto principle. The principle suggests that most effects come from relatively few causes; that is 80% of the effects come from 20% of the possible causes.
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Acceptable Quality Level (AQL)
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In a continuing series of lots, at quality level that, for the purpose of sampling inspection, is the limit of the satisfactory process average.
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Acceptance Sampling Plan
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A specific plan that indicates the sample sizes and the associated acceptance or non-acceptance criteria to be used. In attributes sampling, for example, there are single, double, multiple, sequential, chain and skip-lot sampling plans. In variables sampling, there are single, double and sequential sampling plans.
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Acceptance Sampling
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Inspection of a sample from a lot to decide whether to accept or not accept that lot. There are two types: attributes sampling and variables sampling. In attributes sampling, the presence or absence of a characteristic is noted in each of the units inspected. In variables sampling, the numerical magnitude of a characteristic is measured and recorded for each inspected unit; this involves reference to a continuous scale of some kind.
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Accreditation Criteria
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Set of requirements that are used by an accreditation body, to be fulfilled by an M&E Body in order to be accredited.
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Accreditation
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Certification by a duly recognized body of the facilities, capability, objectivity, competence, and integrity of an agency, service, or operational group or individual to provide the specific service or operation needed. For example, The Registrar Accreditation Board accredits those organizations that register companies to the ISO 9000 series standards.
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Accredited Laboratory
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Laboratory that has been reviewed and approved by a nationally recognized accreditation body.
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Accuracy of Measurement
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The closeness of the agreement between the result of a measurement and the (conventional) true value of the measurand.
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Accuracy
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A difference (bias) between the average of the readings from a measurement system and a corresponding benchmark or master.
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Addendum
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An update to existing product documentation which describes a new product or information that should be in the manual; the information will be incorporated into the next revision of the product documentation. This is a temporary document.
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Adjustment
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The operation intended to bring a measuring instrument into a state of performance and freedom from bias suitable for its use. .
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Advance Shipment Notification
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Notification from a company to its customer, via electronic media in the customer's format.
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Advisory Notice
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A notice issued to provide information or advise on what action should be taken in the use, modification, disposal, or return of a medical device.
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Analysis of Means (ANOM)
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A statistical procedure for troubleshooting industrial processes and analyzing the results of experimental designs with factors at fixed levels. It provides a graphical display of data.
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Analysis of Variance (ANOVA)
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A basic statistical technique for analyzing experimental data. It subdivides the total variation of a data set into meaningful component parts associated with specific sources of variance in order to test a hypothesis on the parameters of the model or to estimate variance components. There are three models: fixed, random and mixed.
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Analysis
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This encompasses the spectrum of activities from measurement, processing, ordering, characterization rating and presentation of data in a form fit for the purpose intended together with assessment.
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ANSI
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American National Standards Institute
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Apostille
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A form of internationally recognized notarization. The apostille ensures that public documents issued in one signatory country will be recognized as valid in another signatory country. Under the Hague Convention, signatory countries (including the United States) agreed to mutually recognize each other's "public documents" so long as such documents are authenticated by an apostille.
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Appraisal
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A form of the quality system audit, normally conducted to examine the total quality program effectiveness and implementation. An appraisal is usually conducted by a third party and reported to the highest levels of management.
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AQAP
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Allied Quality Assurance Publication
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ASM
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American Society of Metals
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ASME
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American Society for Mechanical Engineers
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ASQ
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American Society for Quality
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Assessment
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Another term for the quality audit sometimes used to indicate a less formal means of measuring and reporting than the normal audit. An assessment is usually limited in scope.
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ASTM
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American Society for Testing and Materials
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Attribute Data
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Qualitative data that has two responses (i.e., Pass/Fail, Fastener Present/Missing) and can be counted. Other examples are characteristics that are inherently measurable (i.e., could be treated as variables) but the results are recorded in a simple Yes/No or Go/No-Go fashion.
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Audit Client
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Person or organization requesting an audit.
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Audit Conclusion
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Outcome of an audit decided by the audit team after consideration of all the audit findings.
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Audit Criteria
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Set of policies, procedures or requirements against which collected audit evidence is compared.
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Audit Evidence
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Records, verified statements of fact or other information relevant to the audit.
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Audit Findings
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Results of the evaluation of the collected audit evidence against audit criteria.
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Audit Program Management
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Organization or function within an organization, given the responsibility to plan and carry out a programmed series of quality system audits.
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Audit Program
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The documented methods used to plan and perform audits.
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Audit Scope
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Extent and range of a given audit.
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Audit Standard
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A description of essential audit characteristics, reflecting current thought and practice.
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Audit Team
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One or more auditors conducting an audit, one of whom is appointed as leader.
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Audit
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An independent, structured and documented evaluation of the adequacy and implementation of an activity to specified requirements. An audit may examine any portion of the management control spectrum, including financial, environmental and quality aspects of business and government.
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Auditee
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An organization being audited.
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Auditor
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A person who is qualified and authorized to perform all or part of an audit.
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Authentication (see also Legalization and Consularization):
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An "authentication" is a governmental act by which a designated public official certifies to the genuineness of the signature, the seal, and the position of the official who has executed, issued, or certified a copy of a document. Foreign countries often require "official" documents to be "authenticated" before such documents will be accepted in the foreign jurisdiction.
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Authorized Representative
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The designated entity (person, business or organization) established in a European state representing our company.
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Availability
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The ability of a product to be in a state to perform its designated function under stated conditions at a given time.
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Average Chart
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A control chart in which the sub-group average, X-bar, is used to evaluate the stability of the process level.
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Average Outgoing Quality (AOQ)
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The expected average quality level of outgoing product for a given value of incoming product quality.
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Average Outgoing Quality Limit (AOQL)
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The maximum average outgoing quality over all possible levels of incoming quality for a given acceptance sampling plan and disposal specification.
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Baseline
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A formally approved version of a configuration item, regardless of media, formally designated and fixed at a specific time during the configuration item's life cycle.
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Batch
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An identifiable collection of products, or quantity of material, of a single type, grade, class, size or composition produced in the same facility under essentially the same conditions and at essentially the same time.
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Benchmarking
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An improvement process in which a company measures its performance against that of best-in-class companies, determines how those companies achieved their performance levels, and uses the information to improve its own performance. The subjects that can be benchmarked include strategies, operations, processes and procedures.
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Bias (of a Measuring Instrument)
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Systematic error of the indication of a measuring instrument.
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Big Q, Little Q
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A term used to contrast the difference between managing for quality in all business processes and products (Big Q) and managing for quality in a limited capacity - traditionally in only factory products and processes (little Q)
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Bill of Material (BOM)
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A list of components used to make the product assembly or kit. The BOM defines the configuration of an item or product, and identifies quantities and materials required.
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Biocompatibility Approval
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An approval issued for a device or device biocompatibility family (typically disposables). The Biocompatibility testing results are issued by the appropriate external Laboratory. Any change in intended use, product or manufacturing materials, or sterilization method may require additional biocompatibility evaluations approvals. Biocompatibility approvals are based upon:
Actual test results based on samples submitted for evaluation.
Test data already on file.
Biocompatibility data supplied by the manufacturer or supplier.
Biocompatibility data available from literature review.
A combination of any or all of the above.
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Biocompatibility Product Family
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A group of products for which a reference product has been selected and issued a biocompatibility approval by the Laboratory. The reference product from the family must contain all materials and components, and be subjected to the processes, manufacturing materials and sterilization method, as the products included in the family.
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Biocompatibility
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Biocompatibility evaluations are conducted by characterization of the interaction of devices or materials with body processes or tissues. Biocompatibility is the absence of toxic or adverse reaction of the devices or device materials used in our products with these body processes or tissues. Examples of toxic or adverse reactions can include local effects, effects on specific target organs, effects on the maintenance and integrity of nucleic acids; reactions with blood and other body fluids; effects upon the haemostasis of the living system or impacts on the immune system. These effects can be a result of the materials themselves, material interactions or effects due to inherent contaminants or the by-products of materials due to their contact with the living system through the intended use of the product.
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Blemish
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An imperfection that is severe enough to be noticed but should not cause any real impairment with respect to intended normal or reasonably foreseeable use.
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Block Diagram
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A diagram that shows the operation, interrelationships and interdependencies of components in a system. Boxes, or blocks (hence the name), represent the components; connecting lines between the blocks represent interfaces. There are two types of block diagrams:
Functional block diagram - which shows a system's subsystems and lower-level products, their inter-relationships, and interfaces with other systems.
Reliability block diagram - which is similar to the functional block diagram, except that it is modified to emphasize those aspects influencing reliability.
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Body Contact Duration
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These categories should be used to describe the duration of contact of the device. Note: with multiple exposures to a device, the decision into which category a device is placed should take into account the potential cumulative effect, bearing in mind the period of time over which these exposures occur.
Limited Exposure: Devices whose single or multiple use or contact is likely to be up to 24 hours.
Prolonged Exposure: Devices whose single multiple or long-term use or contact is likely to exceed 24 hours, but not 30 days.
Permanent Exposure: Devices whose single multiple or long-term use or contact exceeds 30 days. Under the European Medical Device Directive (EC 93/42/EEC annex ix), duration is defined as:
Transient - Normally intended for continuous use for less than 60 minutes
Short Term - Normally intended for continuous use for not more than 30 days
Long Term - Normally intended for continuous use for more than 30 days
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Body Contact
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Any substance, piece, part, or assembly that directly or indirectly touches any portion of the body during routine use of the device. These categories should be used to describe the intended use of the device. For the purpose of clarification, definitions and examples for the various types of body contact are as follows:
Non-contact Devices: Do not contact the patient's body directly or indirectly, such as in-vitro diagnostic devices.
Surface devices
Skin: Contact intact skin only, such as electrodes and external prostheses, fixation tapes, compression bandages and monitors.
Mucosal Membranes: Contact intact mucosal surfaces, such as urinary catheters, intravaginal and intraintestinal devices (stomach tubes, sigmoidoscopes); endotracheal tubes, bronchoscopes, and dental prostheses.
Breached or Compromised Surfaces: Contact breached or otherwise compromised body surfaces, such as wound dressings or healing devices and occlusive patches, for ulcers, burns, and granulation tissue.
External Communicating Devices
Blood Path, Indirect: Contact the blood path at one point and serve as a conduit for fluid entry into the vascular system, such as solution administration sets, transfer sets and blood administration sets.
Tissue/Bone/Dentin: Contact tissue and tissue fluid, bone or pump/dentin systems (this includes tissue fluids and subcutaneous spaces), such as iaparoscopes arthroscopes, drainage systems, dental cements, dental filing materials and skin staples.
Circulating Blood: Contact circulating blood, such as intravascular catheters, dialysis tubing, oxygenators, extracoporeal oxygenator tubing and accessories, dialyzers, dialysis tubing and accessories, hemoabsorbants and immunoabsorbants.
Implant Devices
Tissue/Bone: Devices principally contacting bone; such as orthopedic pins, plates, replacement joints, bone prostheses, and intraosseous devices.
Blood: Principally contacting blood, such as permanent pacemaker electrodes, heart valves, vascular grafts, etc.
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Box Plot
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A graphic representation of a frequency distribution of a set of data; for each group is drawn a rectangle with upper and lower limits representing the interquartile range, horizontal line within the rectangle representing the median, and vertical tails ("whiskers") extending above and below the rectangle representing the minimum and maximum values.
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Brainstorming
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A technique that teams use to generate ideas on a particular subject. Each person in the team is asked to think creatively and write down as many ideas as possible. The ideas are not discussed or reviewed until after the brainstorming session.
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Brochure
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A brochure has similar information to a sell sheet, but is usually a four to six page piece of literature.
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C
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Control
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Calibration Record
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A record of calibration of inspection, measuring and test equipment. Such record includes equipment identification, location, frequency of calibration checks, calibration dates, individuals performing the calibration and actual calibration values.
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Calibration Standard
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The traceable standard of the highest accuracy order in a calibration system, which establishes the basic accuracy values for that system. Calibration standards are traceable to national or international standards.
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Calibration
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The comparison of a measurement instrument or system of unverified accuracy to a measurement instrument or system of a known accuracy to detect any variation from the required performance specification.
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Capability
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Ability of an organization, system or process to realize a product that fulfills the requirements for that product.
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Catalog Number
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Number and/or letter combination assigned by Marketing to uniquely identify product sales catalog model numbers or finished goods.
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Catalog
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A catalog is a multi-page comprehensive listing and review of products in a group or all product lines.
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Cause(s) Of Failure
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For each failure mode, the possible causes of the failure.
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Cause-and-Effect Diagram
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A tool for analyzing process dispersion. It is also referred to as the Ishikawa diagram, after the developer Kaoru Ishikawa, and the fishbone diagram, because the complete diagram resembles a fish skeleton. The diagram illustrates the main causes and sub-causes leading to an effect (symptom). The cause-and-effect diagram is one of the seven tools of quality.
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CE Certification
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A certification identification number given to a manufacturer upon a successful assessment procedure performed by a Notified Body of the manufacturer's quality assurance system.
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CE Mark
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A mark, granted to a manufacturer's product by a Notified Body, which indicates that the product conforms to the provisions of the Medical Device Directive.
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Certificate for Foreign Government (CFG)
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Most countries outside of the European Community require written certification that a US firm or it's approved devices are in compliance with FDA regulations and meet the requirements of 801(e)(1) of the FD&C Act. FDA will provide a notarized CFG upon request. Instructions for obtaining a Certificate for Foreign Government or Certificate for Exportability are available through Facts-On-Demand (FOD), an automatic fax back system. Dial 800-899-0381 on a touch-tone phone. Follow the prompts to request a document. Enter the document number (#865), or request via e-mail at dsmica@cdrh.fda.gov.
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Certificate of Compliance (C of C)
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A written statement issued by the supplier or subcontractor which references the applicable contract and certifies that the items, or material referenced, have been inspected and tested to the required specifications and was found to comply to those requirements.
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Certificate of Conformance (C of C)
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See Certificate of Compliance
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Certification
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(of auditors and lead auditors). The act of determining, verifying and attesting to the qualifications of a person to perform effective audits in accordance with applicable requirements. Certification may be internal (by the person's employer) or external (by a professional society such as the American Society for Quality Control or the Institute of Internal Auditors).
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CGSB
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Canadian General Standards Board
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Characteristic
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Any distinct property or attribute of an item, process or service that can be described and measured to determine conformance or nonconformance to specified requirements.
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Check Sheet
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A simple data-recording device. The check sheet is custom-designed by the user, which allows him or her to readily interpret the results. The check sheet is one of the seven tools of quality. Check sheets are often confused with data sheets and checklists.
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Check Standard
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Measuring equipment, product or other objects serving to collect a data base for the control of a measurement process, by being measured by that process.
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Checklist
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A tool used to ensure that all important steps or actions in an operation have been taken and lists items that are important or relevant to an issue or situation. Checklists are often confused with check sheets and data sheets.
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Client
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The person or organization requesting or sponsoring an audit. Typically, the client is the person within the quality group who is in charge of the audit program.
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Clinical Studies
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Physician testing requiring an Investigational Device Exemption (IDE). The requirements differ depending on the risk to the patient. There are two degrees of patient risks: Significant Risk Device and Non-Significant Risk Device. If the device is intended for clinical investigation, the following wording must be present on the labeling: per Federal Law, "Caution - Investigational Device." Limited by Federal (or United State) Law To Investigational Use," per the EU, Annex 1, 13.3h, "Exclusively For Clinical Investigations".
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CMI
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Certified Mechanical Inspector
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Code
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A systematic collection of regulations (i.e., The Canadian Criminal Code).
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Compatibility Evaluation
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The final assessment of biocompatibility of a finished device or device components, processed and sterilized and based on the intended use and duration of contact of the product. If the product is shown to be biocompatible for its intended use, a final biocompatibility approval will be issued by the Laboratory.
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Compatibility
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Ability of entities to be used together under specific conditions to fulfill relevant requirements.
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Competence
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Application of knowledge, skills and behaviors in performance.
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Competent Authority
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The individual government regulatory authority in the various countries of the EC.
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Complaint Records
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Documents and data pertaining to any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.
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Complaint
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Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.
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Compliance
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Meeting specified requirements, whether in a specification, contract, regulation or standard.
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Component Level Traceability
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A level of traceability which provides for tracing the manufacturing history of a specific finished device back to sub-assemblies, components and raw materials which were used in the manufacture of the product, to the degree specified in the record of traceability decision document.
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Component
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Any substance, piece, part or assembly, used during manufacturing of the product that is incorporated into the finished product.
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Computer-Aided Design (CAD)
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Computer system capabilities that automate the creation and editing of geometry, dimensions and other drafting annotations, which allow a user to define the shape and physical characteristics of an object.
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Computer-Aided Engineering (CAE)
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Use of computer technology to aid in the engineering process.
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Concession
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Authorization to use or release a product that does not conform to specified requirements.
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Concurrent Validation
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The application of the validation during the initiation of production for sale in order to establish a validated state.
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Configuration Audit (CA)
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Examination to determine whether a configuration item conforms to its configuration documents.
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Configuration Baseline
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Configuration of a product, formally established at a specific point in time, which serves as reference for further activities.
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Configuration Board (CB)
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Group of technical and administrative experts with the assigned authority and responsibility to make decisions on the configurations and its management. (This group is frequently known as the configuration control board (CCB).)
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Configuration Control (CC)
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Activities comprising the control of changes to a configuration item after formal establishment of its configuration documents.
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Configuration Documents
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Documents that define the requirements, design, build/production and verification for a configuration item.
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Configuration Identification
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Activities comprising determination of the product structure, selection of configuration items, documenting the configuration item's physical and functional characteristics including interfaces and subsequent changes, and allocating identification characters or numbers to the configuration items and their documents.
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Configuration Item (CI)
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Aggregation of hardware, software, processed materials, services, or any of its discrete portions, that is designated for configuration management and treated as a single entity in the configuration management process.
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Configuration Management (CM)
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Technical and organizational activities comprising: configuration identification; configuration control; configuration status accounting, configuration auditing.
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Configuration Management Plan (CMP)
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Document setting out the organization and procedures for the configuration management of a specific product or project.
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Configuration Status Accounting
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Formalized recording and reporting of the established configuration documents, the status of proposed changes and the status of the implementation of approved changes.
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Configuration
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Functional and physical characteristics of a product as defined in technical documents and achieved in the product.
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Confirmation
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The agreement of data obtained from two or more different sources.
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Conformance
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When the inputs and outputs of a process meet specific and measurable requirements.
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Conformity
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Fulfillment of a requirement.
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Construction
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The erection, installation, fabrication and assembly of items involving civil, mechanical and electrical work at the permanent site of the facility or plant by the party performing the work.
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Consularization
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Consularization means that the foreign consul with jurisdiction over the region where the notary operates is certifying to the consulate's home government that the notarization is valid (i.e. that the notary exists and is authorized under the appropriate foreign government's rules). Consularization is basically authenticating or legalizing a document, however it is a consulate that performs the certification or authentication - not a government authority at the county, state, or federal level.
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Contingency Plan
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Plan to overcome unexpected situations (utility interruptions, labor shortages or key equipment failure) in order to maintain product supply.
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Continuous Improvement Plan/Program
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Plan or program for the optimization of characteristics and parameters of a product or process at a target value.
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Continuous Improvement
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The ongoing improvement of products, services or processes through incremental and breakthrough improvements.
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Contract Manufacturer
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A manufacturer that manufactures a product according to a Purchase Specification or builds to our drawings. The product is designed by us and labeled as our product or becomes part, component or subassembly of a product labeled as ours.
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Contract Review
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Systematic activities carried out by the supplier before signing the contract to ensure that requirements for quality are adequately define, free from ambiguity, documented and can be realized by the supplier.
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Contract
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Agreed requirements between a supplier and customer transmitted by any means.
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Contractor
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A term used to designate an individual or organization on whom specific contract requirements are imposed.
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Contractual Documents
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Those documents, which have or will be produced, issued, received, referenced or maintained by the company, which specify contractual requirements and commitments between the company and its customers or suppliers. Contractual documents include, but are not limited to:
Company and customer purchase orders.
Contract or purchase order requirements.
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Contractual Requirement
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See Specified Requirements
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Control Chart
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A chart with upper and lower control limits on which values of a statistical measure for a series of samples or subgroups are plotted. The chart frequently shows a central line to help detect a trend of plotted values toward either control limit.
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Control of Measurement Processes
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Monitoring and analysis of data from a measurement process, together with corrective actions, intended to maintain the process of measurement continuously within a specification.
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Control Plan
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Documented descriptions of the systems for controlling parts and processes produced by suppliers to provide control of all characteristics important for quality and engineering requirements.
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Controlled Document
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Documents for which there are provisions for ensuring removal and/or disposal from the Quality System, when that documentation has become out of date.
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Conventional True Value (of a quantity)
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Value attributed to a particular quantity and accepted, sometimes by convention, as having an uncertainty appropriate for a given purpose.
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Correction Factor
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Numerical factor by which the uncorrected result of a measurement is multiplied to compensate for systematic error.
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Correction
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Action taken to eliminate a detected nonconformity.
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Corrective Action Committee
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A standing committee composed of Vice Presidents or other senior level employees from the Legal, Manufacturing, Marketing, Quality and Regulatory Affairs Departments, authorized to investigate and make a final determination to initiate one or more remedial, corrective or preventive actions.
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Corrective Action Plan
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Document specifying actions to be implemented for correcting a process or part quality issue, with responsibilities and target date assigned.
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Corrective Action Request (CAR)
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A document requesting corrective action of a condition adverse to quality. A formal notification issued to a supplier, subcontractor or department when they have failed to comply with quality requirements specified by the contract or as detailed in the quality manual, procedures or inspection and test plans and are considered as system breakdowns.
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Corrective Action System
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The collection of procedures requiring analysis, investigation, solution and recording of various real or perceived product or service problems, as reported by in-house or outside customers.
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Corrective Action
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Action taken to eliminate the causes of an existing undesirable condition, in order to minimize or prevent its recurrence. The implementation of solutions resulting in the reduction or elimination of an identified problem.
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Cost Improvement Project/Process Change
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A modification to an existing product that does not include a new or unique feature and/or change in performance; or, that does not result in an expanded labeling claim or indication for use.
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Cost of Conformity
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Cost to fulfill all of the stated and implied needs of customers in the absence of failure of the existing process.
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Cost of Nonconformity
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Cost incurred due to failure of the existing process.
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Cost of Poor Quality
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The costs associated with providing poor-quality products or services. There are four categories of costs: internal failure costs (costs associated with defects found before the customer receives the product or service); external failure costs (costs associated with defects found after the customer receives the product or service); appraisal costs (costs incurred to determine the degree of conformance to quality requirements) and prevention costs (costs incurred to keep failure and appraisal costs to a minimum).
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Cost of Quality
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A term coined by Philip Crosby referring to the cost of poor quality.
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Count Chart (C Chart)
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A control chart for evaluating the stability of a process in terms of the count of events of a given classification occurring in a sample.
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CQA
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Certified Quality Auditor
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CQE
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Certified Quality Engineer
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CQT
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Certified Quality Technician
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CRE
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Certified Reliability Engineer
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Criteria for Workmanship
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Established standards, such as workmanship examples or documented descriptions, which define the required output of a process.
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Critical Control Point
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Step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
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Critical Defects
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Those type of defects that could prevent the use or operation of an end item or which could pose a hazard to users.
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CSA
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Canadian Standards Association
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Current Controls
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Controls which exist to prevent the cause(s) of failure from occurring or which are intended to detect the cause(s) of failure.
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Customer - Supplier Partnership
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A long-term relationship between a buyer and a supplier characterized by teamwork and mutual confidence. The supplier is considered an extension of the buyer's organization. The partnership is based on several commitments. The buyer provides long-term contracts and uses fewer supplies. The suppler implements quality assurance processes so that incoming inspection can be minimized. The supplier also helps the buyer reduce costs and improve product and process designs.
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Customer Contact
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Company representative responsible for the primary interface with a customer. May be specified by contact.
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Customer Dissatisfaction
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Customer's opinion of the degree to which a transaction has failed to meet the customer's needs and expectations.
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Customer Satisfaction
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Customer's opinion of the degree to which a transaction has met the customer's needs and expectations.
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Customer Supplied Material
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Components, hardware or supplies provided by a customer for incorporation into product to meet the customer's requirement.
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Customer
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Organization or person that receives a product.
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CWB
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Canadian Welding Bureau
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D
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Demerit
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Date Code Level Traceability
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A level of traceability which provides for tracing the manufacturing history of a product back to the month and year (date code) in which the that product was manufactured so that, at a minimum, reports from the field can be addressed to a specific month and year of manufacture.
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Date Code
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Alphanumeric code used to identify the month and year of manufacture of a product.
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Defect
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A product's or service's non-fulfillment of an intended requirement or reasonable expectation for use, including safety considerations. There are four classes of defects:
Class 1: Very Serious. Leads directly to severe injury or catastrophic economic loss.
Class 2: Serious. Leads directly to significant injury or significant economic loss.
Class 3: Major. Is related to major problems with respect to intended normal or reasonably foreseeable use.
Class 4: Minor. Is related to minor problems with respect to intended normal or reasonably foreseeable use.
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Degree of Demonstration
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Extent to which evidence is produced to provide confidence that specified requirements is fulfilled.
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Demerit Chart (D chart)
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A control chart for evaluating a process in terms of a demerit (or quality score), i.e. a weighted sum of counts of various classified nonconformities.
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Dependability Plan
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A document setting out the specific dependability practices, resources and sequence of activities relevant to a particular product, contract or project.
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Dependability Program
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The organizational structure, responsibilities, procedures, processes and resources used for managing dependability.
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Dependability
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The degree to which a product is operable and capable of performing its required function at any randomly chosen time during its specified operating time, provided that the product is available at the start of that period. Non-operation related influences are not included.
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Design and Development
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Set of processes that transform requirements into specified characteristics and into the specification of the product realization process.
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Design Control Records
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Documents and data which are contained in product Design History Files.
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Design Dossier
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A submission prepared to demonstrate that a Class III device conforms to the relevant provisions of the Medical Device Directive. A design dossier is submitted for review and approval by the Notified Body in order to obtain an EC Design Examination Certificate and approval to CE mark and sell a device.
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Design for Assembly (DFA) Design for Manufacture (DFM)
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Simultaneous engineering process designed to optimize the relationship between design function, manufacturability and ease of assembly.
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Design History File
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A DHF is a compilation of documents which describes the design history of a Finished Device. Also called a Project Master File.
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Design of Experiments (DOE)
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A branch of applied statistics dealing with planning, conducting, analyzing and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters.
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Design Record
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Engineering requirements, typically contained in various formats.
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Design Review
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Documented, comprehensive and systematic examination of a design to evaluate its capability to fulfill the requirements for quality, identify problems, if any, and propose the development of solutions.
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Design Validation Studies (Human Use Only)
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To establish by objective evidence that device specifications conform with user needs and intended uses. These are finished devices that are released to selected physicians for human use.
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Design-responsible Suppliers
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Suppliers with authority to establish a new, or change an existing product specification for product delivered to a customer.
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Desktop Publishing
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Use of the computer to design and format the layout for manuals, labeling, literature and artwork.
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Detection
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The identification, at a stated level of probability, of the presence of a phenomenon with certain characteristics.
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Development
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Software life cycle process that comprises the activities of requirements analysis, design, coding, integration, testing, installation and support for acceptance of software products.
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Deviation Permit
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Authorization to depart from the originally specified requirements of a product prior to realization, for a limited quantity of product or period of time, and for a specific use. .
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Deviation
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Permission in writing and in advance of manufacture, to deviate from specified requirements for a given number of units, or for a specified period of time.
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Device Classification
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The category that a device is placed under (Class I, I Exempt (IE), II, II Exempt (IIE), III in the US; Class I, II, III, IV in Canada; Class I, IIa, IIb, and Class III for EU) for the purpose of identifying the pre and post market regulatory requirements for marketing the device.
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Device History Records (DHR)
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A compilation of records containing the production history of a finished device, which shall include repair history.
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Device Master Record (DMR)
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A compilation of records containing the procedures and specifications for a finished device.
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DGQA
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Director General Quality Assurance
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Direct Mail Literature
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Direct mail literature is a promotional/information piece mailed directly to a segment of the medical population.
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Direct object
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The object being acted upon by the action verb.
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DIS
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Draft International Standard
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Disposition of Nonconformity
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Action to be taken to deal with an existing nonconforming entity in order to resolve the nonconformity.
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Disposition
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The action to determine how a nonconformance is to be resolved.
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DND
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Department of National Defense
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Document Control
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The activity which ensures that the preparation, review, approval, issuance, retrieval, storage and destruction of documentation within the Company is performed to provide receipts with only approved documentation of the latest issue and which is readily accessible within all departments and locations where it applies.
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Document Revision Level
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An alpha or numeric designation, assigned sequentially, of the number of updates to which the document has been subjected.
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Document
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information and its support medium.
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Documentable Changes
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Changes to Canadian Class III-IV product labeling, materials, software versions or performance specs, which are not significant, but must be reported annually during license renewal.
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Documentation
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Form of information used in defining process requirements. (For example, quality manual, operator instructions, control plans, graphics, pictorials).
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Documented
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Recorded in writing, signed, dated, retained (e.g., checklists, corrective action reports, minutes of meetings, correspondence, etc.),
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DOT
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Department of Transportation
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Drift
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The slow variation with time of a metrological characteristic of a measuring instrument.
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DRN
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Drawing Review Notice
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DSS
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Department of Supplies and Services
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Due Care
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Approach taken by the supplier at the time the product was designed or manufactured, to realize a product that is reasonably safe for its intended and foreseeable uses by those who might use, might be expected to use, or might be endangered by the product.
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EC Design Examination Certificate
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A certificate issued by the Notified Body upon reviewing and approving a design dossier for a specific device or group of devices. The certificate certifies that the devices conform to the relevant provisions of the Medical Device Directive.
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EC
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European Community
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ECN Approval Matrix
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Identifies the approvals required for a specific type of ECN change.
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ECN Log
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A Master Log for the assignment and tracking of ECNs.
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ECN Originator
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The person requesting a change or initiation of a new document through an Engineering Change Notice.
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ECN
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Engineering Change Notice
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Edge of Failure
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Those process input settings which begin to produce unacceptable outputs. See also process window.
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EEA
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European Economic Area
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Effectiveness
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Measure of the extent to which planned activities are realized and planned results achieved.
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Effects of Failure
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The outcome of the occurrence of a failure mode of a product, process and/or customer.
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Efficiency
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Relationship between the result achieved and the resources used.
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Employee Involvement
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A practice within an organization, whereby employees regularly participate in making decisions on how their work areas operate, including making suggestions for improvement, planning, goal setting, and monitoring performance.
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Empowerment
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A condition whereby employees have the authority to make decisions and take action in their work areas without prior approval. For example, an operator can stop a production process if he detects a problem, or a customer service representative can send out a replacement product if a customer calls with a problem.
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Engineering Approved Authorization
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Written customer authorization that is required whenever the product or process varies from those currently customer-approved.
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Engineering Document
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Those documents, which have been or will be prepared, produced, issued, controlled, referenced or maintained by the company's engineering department. Engineering documents are used to transmit technically related information to other company departments involved in producing, procuring or controlling products. Engineering documents include, but are not limited to:
Drawings
Bills of material
Product and process specifications
Special instructions
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Entity
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That which can be individually described and considered. An entity may be, for example: an activity or a process, a product, an organization, a system or a person, or any combination thereof.
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Equipment
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Collective term to include discrete items used in design, manufacture and verification of product(s).
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Error (of indication) of a Measuring Instrument
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Indication of a measuring instrument minus a true value of the corresponding input quantity.
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Error of Measurement (absolute)
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The result of a measurement minus the true value of the measurand.
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Error
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Occurs, when any act, through ignorance, deficiency or accident, departs from or fails to achieve what should be accomplished. Any output that does not meet the individual or the customer's expectations.
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European Harmonized Standard
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A technical specification adopted in a mandate from the European Commission, by either CEN or CENELEC in accordance with EC council directives.
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Evaluation
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The act of examining a process or group to some standard and forming certain conclusions as a result.
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EVS
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European Vigilance System.
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Examination
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A measurement of goods or services to determine conformance to some specified requirement.
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Excellence
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Providing products and/or services noticeably superior to all the competition and having this recognized by the customer and the competition.
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Executive Responsibility
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Responsibility for profit and loss.
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External Audits
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Quality audits conducted by the company on major supplier and subcontractor quality programs.
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External Customer
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A person or organization who receives a product, a service or information, but is not part of the organization supplying it.
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External Standards
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Documents prepared and issued by private and public bodies that contain requirements and procedures associated with the design, manufacture, testing and packaging of devices or processes used in the device industry. These documents include scientific, technical, industry or product-specific, professional and regulatory standards. Organizations publishing voluntary standards include the European Committee for Standardization (CEN), European Committee for Electromechanical Standardization (CENELEC), International Standards Organization (ISO), American National Standards Institute (ANSI), American Society for Testing and Materials (ASTM), British Standards Institute (BSI). Regulatory (or mandatory) standards are published by government agencies Such as the U.S. Food and Drug Administration (FDA) and the U.K. Medical Devices Agency (MDA).
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FACI
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First Article Configuration Inspection
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FAI
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First Article Inspection
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Failure Mode Analysis (FMA)
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A procedure to determine which malfunction symptoms appears immediately before or after a failure of a critical parameter in a system. After all possible causes are listed for each symptom, the product is designed to eliminate the problems.
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Failure Mode and Effects Analysis (FMEA)
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A systematic analytical technique whereby a design and/or process is studied in detail by reviewing schematics, engineering drawings, etc. to identify and prioritize potential faults or weaknesses so as to determine their effects on product performance at the finished device or sub assembly levels.
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Failure Mode and Effects Analysis (FMEA)
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Systematized group of activities to:
Recognize and evaluate the potential failure of a product/process and its effects.
Identify actions which could eliminate or reduce the chance of the potential failure occurring.
Document the process.
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Failure Mode Effects Analysis
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A procedure in which each potential failure mode in every sub item of an item is analyzed to determine its effects on other sub-items and on the required function of the item.
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Failure Mode Effects and Criticality Analysis (FMECA)
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A procedure that is performed after a failure mode effect analysis to classify each potential failure effect according to its severity and probability of occurrence.
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Failure Mode
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The inability of a product or process to perform its designed intent. It answers the question of how something failed to meet the specification/requirement.
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Familiarization
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Acquainting people with the responsibilities, policies and objectives of the Company's Quality Program.
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FAT
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Factory Acceptance Test
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Fault Tree Analysis
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A systematic way of prospectively examining a design for possible ways in which failure can occur. The analysis considers the possible direct proximate causes that could lead to the event and seeks their origins. Once this is accomplished, ways to avoid these origins and causes must be identified. It is conducted to anticipate, resolve, or monitor potential problems.
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FDA-482
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Notice of Inspection form presented by FDA at the start of an inspection, which identifies the reason for FDA's visit to a facility.
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FDA-483
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Notice of Inspectional Observations form presented at the conclusion of an inspection identifying any deficiencies observed during the course of the inspection.
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FDA-484
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Form used by FDA to document receipt of samples obtained during an inspection.
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Feasibility
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Assessment of the suitability of a particular design, material or process for production, while conforming to all engineering requirements at the required statistical process capability and at specified volumes.
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Final Inspection
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The last point in the production cycle where the examination, measurement and testing of product characteristics can be performed to determine acceptability.
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Final Product
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A product, in its final form, or "as used" state (i.e., as distributed for human use). This includes all manufacturing processes, assembly, packaging, and sterilization methods, if applicable.
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Finding
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An audit conclusion, which identifies a condition having a significant adverse effect on the quality of the goods or services produced. An audit finding is normally accompanied by several specific examples of the observed condition.
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Finite Element Analysis (FEA)
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Technique for modeling a complex structure.
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First In First Out (FIFO)
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Inventory management ensuring that the first material received is the first material used.
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Fitness for Use
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A term used to indicate that a product or service fits the customer's defined purpose for that product or service.
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Flowchart
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A graphical representation of the steps in a process drawn to better understand that process. The flowchart is one of the seven tools of Quality.
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Fluid Path
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That portion of a medical device through which fluids are transported into or out of the body.
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FMEA Leader/Originator
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The Project Leader or designate is responsible for leading the FMEA Team in developing the FMEA, generation and approval of the necessary documentation, as well as ensuring that the documents are filed in the Design History File for the product/project.
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FMEA Team
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At a minimum, the team should consist of representatives from Manufacturing, Product Development Engineering, Marketing, Regulatory Affairs, Quality Control and Quality Engineering. Note: when a supplier's component is involved, representatives from the supplier are also recommended. When specific qualifications are not represented on the FMEA team, participation and/or review of the FMEA may be required by members outside of the team, such as clinical, etc.
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Follow-up Audit
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Verifies that some corrective action has been accomplished as scheduled, and determines that the action was effective in preventing or minimizing recurrence.
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For Cause
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Type of inspection carried out by FDA to investigate a specific issue pertaining to a product complaint, Medical Device Report (MDR), recall, or other similar situation.
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Functional Verification
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Testing to ensure the part conforms to all engineering performance and material requirements, specified by the customer and supplier.
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Gantt Chart
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A type of bar chart used in process planning and control to display planned work and finished work in relation to time.
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Gauge Repeatability and Reproducibility (GR & R)
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The evaluation of a gauging instrument's accuracy by determining whether the measurements taken with it are repeatable (i.e., there is close agreement among a number of consecutive measurements of the output for the same value of the input under the same operating conditions) and reproducible (i.e., there is close agreement among repeated measurements of the output for the same value of input made under the same operating conditions over a period of time).
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Geometric Dimensioning and Tolerancing (GDT)
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A method to minimize production costs by showing the dimension and tolerancing on a drawing while considering the functions or relationships of part features.
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Go/No-Go
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State of a unit or product. Two parameters are possible: go (conforms to specification) and no-go (does not conform to specification).
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Good Manufacturing Practices
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Combination of manufacturing and quality procedures aimed at ensuring that products are consistently manufactured to their specification.
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Grade
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Category or rank given to different quality requirements for products, processes or systems having the same functional use.
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Guideline
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Document stating recommendations or suggestions.
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Guidelines
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Methods which are considered good practice, but which are not mandatory. Generally, the term should denotes a guideline and the term shall denotes a mandatory requirement.
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Hague Convention Participants
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The 1961 Hague Convention abolished the requirement of foreign embassy legalization or consularization for CFGs. The Convention provides for the simplified certification of notarized documents (CFGs) by member countries. The US became a participating member in 1981. A list of member nations is provided in Section 7. Briefly, a notarized CFG received from FDA requires Maryland County authentication followed by an apostille authentication by the Maryland Secretary of State before it can be sent directly to the participating/requesting country (no authentication by the US Secretary of State is required, and no foreign embassy consularization is required as is the case with non-participating members). If the country where the document will be used is not a party to the Convention, then the time-consuming process of obtaining a series of certifications known as the "chain authentication method" must be completed. This authentication process requires that authorities attest to the validity of a succession of seals beginning with the initial CFG notarized at FDA and ending with the seal of the foreign embassy or consulate in the United States.
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Hardware
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Tangible, discrete product with distinctive form.
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Hazard Analysis
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Process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and; therefore, should be addressed in the HACCP plan.
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Histogram
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A graphic summary of variations in a set of data. The pictorial nature of the histogram lets people see patterns that are difficult to see in a simple table of numbers. The histogram is one of the seven tools of quality.
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Hold Point
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Point, defined in an appropriate document, beyond which an activity must not proceed without the approval of a designated organization or authority.
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IA
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Inspection Authority
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IEC
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International Electrotechnical Commission
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Incident (Definition for Vigilance reporting)
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Any alleged malfunction or deterioration in the characteristics and/or performance of a medical device, as well as any alleged inadequacy in the labeling or instructions for use, which might lead or might have led to the death of a patient or user or to a serious deterioration in his or her state of health.
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In-Control Process
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A process in which the statistical measure being evaluated is in a state of statistical control (i.e., the variations among the observed sampling results can be attributed to a constant system of chance causes).
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Independent
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Not directly responsible for the quality, cost, and/or production of goods and services being examined.
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Industry/Economic Sector
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A grouping of suppliers whose offerings meet similar customer needs and/or whose customers are closely interrelated in the marketplace.
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Influence Quantity
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A quantity which is not the subject of the measurement, but which influences the value of the measurand or the indication of the measuring instrument.
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Infrastructure
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Organization system or permanent facilities and equipment of an organization.
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Injury
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An act or event that damages or that is detrimental to the health of a patient or health care personnel.
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In-Process Inspection
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Those inspections and tests which are required to be performed at specific points throughout the production cycle.
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Inspection and Test Point
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A location or stage in the production cycle where inspection and testing are performed by personnel, whose responsibility it is to determine the acceptability of products or services and to record inspection and test data.
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Inspection and Test Status
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A system of tags, tape, stamped impressions or signatures associated with or affixed to a product, item, its container, or an inspection report that indicates the quality status of the product, item or service.
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Inspection by Attributes
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An inspection whereby either the unit of product is classified simply as defective or non-defective, or the number of defects in the unit of product is counted with respect to a given requirement or set of requirements.
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Inspection
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Measuring, examining, testing or gauging one or more characteristics of a product or service and comparing the results which specified requirements to determine whether conformity is achieved for each characteristic.
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Inspection, Measuring and Test Equipment Installation Qualification (IQ)
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Equipment used to measure, gauge, test, inspect or otherwise examine items to determine compliance with specifications. Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer's approved specification and that the recommendations of the supplier of the equipment are suitably considered.
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Instruction Sheet/Package Insert
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A brief document accompanying a product which instructs users in the basic operation and maintenance of the product.
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Interchangeability
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Ability of an entity to be used in place of another, without modification, to fulfill the same requirements.
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Interested Party
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Person or group having an interest in the performance or success .of an organization.
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Interface
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Physical or functional interaction at the boundary between configuration items.
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Internal Audits
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Quality audits conducted within the company against established Quality Assurance procedures and on company products.
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Internal Customer
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The recipient (person or department) of another person's or department's output (product, service or information) within an organization.
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International (Measurement) Standard
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A standard recognized by an international agreement to serve internationally as the basis for fixing the value of all other standards of the quantity concerned.
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International Format
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Approved formats for manuals/labeling incorporating any number of foreign languages, most often 5 total: English, French, German, Italian and Spanish. Literature could be in any foreign language.
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Investigation
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A systematic assessment of a Complaint to determine the facts and the root cause.
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ISO 9000 Family
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All those International Standards produced by the technical committee ISO/TC 176.
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ISO 9000 Series Standards
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A set of five individual but related international standards of quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system. The standards, initially published in 1987, are not specific for any particular industry, product, or service. The standards were developed by the International Organization for Standardization (ISO), a specialized international agency for standardization composed of the national standard bodies of 91 countries.
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ISO
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International Organization for Standardization
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Item
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That which can be individually described and considered.
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ITP
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Inspection and Test Plan
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Job Instruction
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Description of work conducted in one function in a company, (e.g., set-up, inspection, rework, operator) and considered to be level three quality system documentation.
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JUSE
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Japanese Union of Scientists and Engineers
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Justification
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The means by which something is demonstrated or proven to be just, right or valid.
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Kaizen
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A Japanese term that means gradual unending improvement by doing little things better and setting and achieving increasingly higher standards.
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Labeling
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Any printed material which provides information for identification and safe and effective use of a product or which makes product claims.
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Laboratory Scope
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Quality record containing the following:
Specific tests, evaluations and calibrations that a laboratory is qualified to perform.
List of the equipment which it uses to perform the above
List of methods and standards to which it performs the above.
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Laboratory
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Test facility that may include chemical, metallurgical, dimensional, physical, electrical, reliability testing or test validation.
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Last-Off-Part Comparison
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Comparison of the last part made in a production run with a part from the next production run to verify that the quality level of the new parts is at least as acceptable as that of the previous run.
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Layout Inspection
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Complete measurement of all part dimensions shown on the design record.
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Lead Auditor
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A person who is qualified and authorized to manage and direct an audit.
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Leadership
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An essential part of a quality improvement effort. Organization leaders must establish a vision, communicate that vision to those in the organization, and provide the tools and knowledge necessary to accomplish the vision.
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Legalization
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Official documents that are issued in one country and will be used in another country, need to be legalized or authenticated by the appropriate authorities in the issuing country as proof that the document was issued by a competent official, i.e. proof that the certificate is genuine and not fraudulent.
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Life Cycle Model
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A framework containing the processes, activities, and tasks involved in the development, operation and maintenance of a software product, spanning the life of the system from the definition of its requirements to the termination of its use.
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Limits of Permissible Error of a Measuring Equipment Maximum Permissible Errors (of a Measuring Instrument)
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The extreme values of an error permitted by specifications, regulations, etc. for given measuring equipment and its intended use.
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Line Extension
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The addition of a product offering within a product family which is accomplished by deleting, or adding, or changing component(s), and results in a new product model/catalog numbers but without substantial change in product principle of operation, features/benefits, indications for use, performance or labeling claims. The original product model(s) remain in existence.
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Lot Identification Number
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A unique number assigned to product when received or during manufacturing and used as appropriate for traceability purposes.
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Lot
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A defined quantity of product accumulated under conditions that are considered uniform for sampling purposes.
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Lower Control Limit (LCL)
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Control limits for points below the central line in a control chart.
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Maintainability
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The probability that a given maintenance action for an item under given usage conditions can be performed within a stated time interval when the maintenance is performed under stated conditions using stated procedures and resources. Maintainability has two categories:
Serviceability (the use of conducting scheduled inspections and servicing)
Repairability (the ease of restoring service after a failure)
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Maintenance
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Action taken to ensure material remains fit for its intended use.
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Major Defects
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Those type of defects that could result in an item's failure or which would reduce or limit an item's usability.
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Malfunction
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The failure of a device to meet its performance specifications or labeling claims, or otherwise perform as intended. Performance specifications shall include all claims made in the labeling of the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.
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Management Commitment
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When management realizes the importance of an activity or subject and provides the required resources to improve all affected functions within the organization.
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Management Participation
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When management embraces quality as their first priority now and in the future. When they start to set the example of error free performance, they help and expect their employees and themselves to perform error free.
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Management Representative
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An appointed member of management who, irrespective of other responsibilities, shall have defined authority and responsibility for ensuring that the requirements of the Quality System are effectively established and maintained. The Management Representative is also responsible for reporting on the performance of the Quality System to top management.
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Management Review
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Formal evaluation by top management of the status and adequacy of the quality system in relation to quality policy and objectives.
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Management System
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System to establish policy and objectives and to achieve those objectives.
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Management
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Coordinated activities to direct and control an organization.
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Manuals
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Will cover domestic and multi-language operating and maintenance manuals, service manuals, user and technical manuals, instructions sheets, instructions for use, package inserts, addendums, and any other forms considered to fulfill the requirements of providing adequate instructions for use. Production of manuals is the responsibility of the Document Control Department.
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Manufacturer
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The natural or legal person with responsibility for the design, manufacture, packaging and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
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Manufacturing Material
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Any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacture.
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Manufacturing Records
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Documents and data which relate to products released for normal production.
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Manufacturing
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The production, fabrication and assembly of items on the premises of the party performing the work.
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Market Withdrawal
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The removal or correction of a distributed product, which would not be subject to legal action by the appropriate regulatory authorities and involves no violations. Examples of this are normal stock rotation practices and routine equipment adjustments and repairs.
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Marketing variation specification
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Detailed description of "Special Order" product to be made.
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Master Validation Number
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A number assigned by Quality Assurance at the plant which serves to link all validation activity under one MVP. Each validation element should reference the applicable MVP.
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Master Validation Plan (MVP)
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A master validation plan is a site specific and complete overview of all the validation activity planned for a proposed product project or change to existing product/process/facility system.
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Material Requirements Planning (MRP)
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A set of techniques that uses bill of material data, inventory data, and the master production schedule to calculate requirements for materials. It makes recommendations to release replenishment orders for material. Further, because it is time-phased, it makes recommendations to reschedule open orders, when due dates and need dates are not in phase. Time-phased MRP begins with the items listed on the master production schedule and determines (1) the quantity for all components and materials required to fabricate those items and (2) the date that the components and materials are required. Time-phased MRP is accomplished by exploding the bill of material, adjusting for inventory quantities on hand or on order, and offsetting the net requirement by the appropriate lead times.
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Material Review Board (MRB)
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The designated body made of cross-functional disciplines, i.e., engineering, QA, manufacturing/purchasing, which evaluates and dispositions non conforming material according to established procedures.
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Material
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Any synthetic or natural polymer, metal, alloy, ceramic, fabric, or other nonviable substance, including tissue rendered nonviable used as a medical device or any part thereof.
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Maximum Permissible Error of Measuring Equipment
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Extreme values of an error permitted by specifications, regulations, etc. for given measuring equipment and its intended use.
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MDR
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Medical Device Report. A report that a marketed device (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
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Mean Time Between Failures (MTBF)
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The average time interval between failures for repairable product for a defined unit of measure (e.g., operating hours, cycles, miles).
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Measurand
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A quantity subjected to measurement
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Measurement Control System
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Set of operations necessary to achieve metrological confirmation and continuous control of measurement processes.
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Measurement Equipment
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All instruments used for measuring vibration, including transducers, amplifiers, filters and data acquisition units.
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Measurement Procedure
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Set of operations, described specifically, used in the performance of particular measurements according to a given method.
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Measurement Process
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Set of interrelated resources, activities, and influences which produce a measurement.
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Measurement
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Set of operations having the object of determining the value of a quantity.
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Measuring and Evaluation Body
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(M & E Body) An organization the purpose of which is to supply vibration measuring and evaluation.
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Measuring Equipment
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Instrument, measurement, standard, reference material and/or auxiliary apparatus necessary to implement a measurement process for carrying out a specified and defined measurement.
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Measuring Instrument
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A device intended to make a measurement, alone or in conjunction with supplementary equipment.
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Medical Device Directive (MDD)
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The NOD (93/42/EEC) is a directive within the European Union (EU), which defines the requirements a company must meet in order to apply the CE Mark to its medical devices and hence be sold within the European Union (EU).
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Medical Device
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Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
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Metrological Characteristic
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Distinguishing feature, which may influence the measurement.
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Metrological Confirmation
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Set of operations required to ensure that measuring equipment is in a state of compliance with the requirements for its intended use.
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Metrological Requirement
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Requirement for a metrological characteristic.
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MIL
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Military
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Minor Defects
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Those types of defects that do not significantly reduce an item's usability.
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Mistake-Proofing
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Use of process or design features to prevent manufacture of non conforming product.
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Model for Quality Assurance
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Standardized or selected set of quality system requirements combined to satisfy the quality assurance needs of a given situation.
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Modified Product
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Any existing product which has been altered by significant manufacturing process change; by addition of claims, new uses, or alterations in design, including changes in materials or material vendor; by a change in packaging materials or design; or by a change in sterilization parameters or method, which would result in a change in form, fit or function of a device, including biocompatibility.
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MPR
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Methods to Prevent Recurrence
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MQR
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Acronym used to describe Material Quality Record.
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MRO
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Material required for operations.
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MRR
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Material Review Report
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Multidisciplinary Approach (Cross-Functional Approach)
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Activity where a group of individuals is consulted to complete a task or activity that seeks to have all relevant knowledge and skills available to the decision making process.
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n
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Sample Size
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NAR
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Nonconformance Analysis Report
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National (Measurement) Standard
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A standard recognized by an official national decision to serve, in a country, as the basis for fixing the value of all other standards of the quantity concerned.
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NATO
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North Atlantic Treaty Organization
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NCR
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Nonconformance Report
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Near Incident
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Any alleged Malfunction or deterioration in the characteristics and/or performance of a medical device, as well as any alleged inadequacy in the labeling or instructions for use, which might lead to the death or serious deterioration in the state of health of a patient or user if the incident occurred again.
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New Device
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New catalog number, including line extensions and devices marketed under an OEM arrangement.
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New Product
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A product, which does not exist in form within the current product line; or, a modification to an existing product that includes a new or unique feature and/or change in performance; or, that results in an expanded labeling claim or indication for use.
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Newsletter
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An informal publication containing articles and news items of interest mainly to the medical industry.
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NIST
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National Institute of Standards and Technology
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Nonconformance
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A deficiency in characteristic, documentation or procedure which renders the quality of a product or service unacceptable, or indeterminate or not according to specified requirements. Examples of nonconformance are: physical defects, test failures, inadequate documentation, deviations from prescribed processing or from any other part of the program. The non-fulfillment of a specified requirement.
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Non-conforming Product Report
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Any document designed to indicate non-conforming status of associated product.
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Nonconformity
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Non-fulfillment of a requirement.
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Nondestructive Examination (NDE)
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See nondestructive testing. (American)
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Nondestructive Testing (NDT)
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Inspection methods used that permit evaluation of materials and products without destroying their usefulness. (Canadian) Examples of nondestructive testing are: Visual inspection, Radiography, Ultrasonic examination, Magnetic particle testing, Penetrant testing, Eddy current testing, Acoustic emission testing, Ferrite determination.
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Notarization
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The Notary Public or Notary certifies the identity of the signer. Notarization is intended to deter fraud. The impartial witness (Notary) ensures that the signer of a document is who they say they are and that the person signed the document willingly. Notarization does not prove that information or statements on a document are true or accurate. The signer is responsible for the content of the documents.
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Notified Body
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A regulatory body chosen by a European Union Member State Competent Authority to carry out conformity assessment tasks required per Article 11 of the Medical Device Directive. These tasks include auditing device manufacturers' quality systems and reviewing/approving technical files and design dossiers to determine if the devices conform to the relevant provisions of the Medical Device Directive.
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NRC
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National Research Council
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Objective Evidence
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Qualitative or quantitative information, records or statements of fact that are based on observation, measurement, or test and which can be verified.
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Observation Report (OR)
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A formal notification issued to a supplier, subcontractor or department when minor infractions are noted in the product, service or documentation.
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Observation
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An audit conclusion, which identifies a quality system weakness, either in definition or implementation. An audit observation identifies a condition which is not yet causing a serious degradation of quality.
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Occurrence
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A score reflecting an assessment of the frequency of the failure mode as projected to occur as a result of a specific cause.
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Offered Product
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Product submitted to a customer external to the offering organization.
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Operating and Maintenance/ User Manual/Instructions for Use:
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A document accompanying a commercial product which instructs users in the operation and maintenance of the product.
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Operating Characteristic Curve (OCC)
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A graph used to determine the probability of accepting lots as a function of the lot's or processes' quality level when using various sampling plans. There are three types:
Type A curves - which give the probability of acceptance for an individual lot coming from finite production (will not continue in the future).
Type B curves - which give the probability of acceptance for lots coming from a continuous process
Type C curves - which, for a continuous sampling plan, give the long¬ run percentage of product accepted during the sampling phase.
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Operational Performance
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Overall performance results of a business, measured against defined objectives that is sometimes expressed in terms of functional performance.
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Operational Qualification (OQ) Organization
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Establishing by objective evidence process control limits and action levels which result in product that meets are predetermined requirements. Group of people and facilities with an orderly arrangement of responsibilities, authorities and relationships.
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Organizational Structure
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Orderly arrangement of responsibilities, authorities and relationships between people.
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Original Equipment Manufacturer (OEM)
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A manufacturer that manufactures a product according to a Purchase Specification. The product is designed by the OEM and labeled as our product. We can request that the device be customized to meet our purchase specification. However, the OEM is responsible for determining if the proposed change is acceptable.
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Out of Spec
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A term used to indicate that a unit does not meet a given specification.
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Out-of-Control Process
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A process in which the statistical measure being evaluated is not in a state of statistical control (i.e., the variations among the observed sampling results can be attributed to a constant system of chance causes).
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P
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Percent
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Pareto chart
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A graphical tool for ranking causes from most significant to least significant. It is based on the Pareto principle, which was first defined by J.M. Juran in 1959. The principle, named after 19`h -century economist Vilfredo Pareto, suggests that most effects come from relatively few causes; that is, 80% of the effects come from 20% of the possible causes. The Pareto Chart is one of the seven tools of Quality.
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Percent chart (P Chart)
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A control chart for evaluating the stability of a process in terms of the percent of the total number of units in a sample in which an event of a given classification occurs. The percent chart is also referred to as a proportion chart.
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PERT
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Program Evaluation and Review Technique
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Phase
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Defined segment work.
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Pilot Work Order (PWO)
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A Pilot Work Order provides instructions to build product for a specific intended use, using approved and issued specifications at alpha and numeric revision level, and/or approved deviations.
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Plan-Do-Check-Act-Cycle (PDCA)
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A four-step process for quality improvement. In the first step (plan), a plan to effect improvement is developed. In the second step (do), the plan is carried out, preferably on a small scale. In the third step (check), the effects of the plan are observed. In the last step, (act), the results are studied to determine what was learned and what can be predicted. The plan-do-check act cycle is sometimes referred to as the Shewhart cycle (because Walter A. Shewhart discussed the concept in his book, "Statistical Method From the Viewpoint of Quality Control") and as the Deming cycle (because W. Edwards Deming introduced the concept in Japan, the Japanese subsequently called it the Deming cycle).
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Policy
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A management directive that provides a very clear prescribed method of action based on defining expected reaction to a specific condition. Usually these policy statements are written and provide direction for present and future activities.
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Positive Recall
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A method whereby a product can be released so that further work can proceed, provided that the product is identified as being subject to recall and can be removed, repaired, or reworked at a later stage if found to be unacceptable.
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Posters
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Posters can be flexible, mounted on various materials, or backlit, and are used to promote products or events at tradeshows, meetings, or other functions.
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Post-Market Surveillance (PMS)
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Any proactive method used to obtain or solicit, compile and evaluate feedback information regarding identity, quality, durability, reliability, safety, effectiveness and performance of marketed products, packaging and service as may be applicable. This information may come from such sources as users, practitioners, regulatory bodies, industry, trade journals, etc.
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Precision
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The closeness of agreement between independent test results under stipulated conditions.
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Predictive Maintenance
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Activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes to prevent disruption of production.
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Preferred Supplier
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A supplier, identified by the Supply Chain Department, which we will pursue a long term business relationship. Plant Purchasing will be required to initiate new business and migrating current business to Preferred Suppliers.
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Pre-Market Approval (PMA)
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A Pre-Market Approval Application required by FDA for most Class III devices.
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Premium Freight
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Charges incurred additional to contracted delivery and monitored as an indicator of potential supply problems and supplier efficiency.
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Pre-production Build
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Documents and data which relate to pre-production products not yet
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Pre-ship Repair Exchange
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The exchange of a defective customer unit with a new or refurbished unit that ships prior to receipt of the customer unit.
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Prevention vs. Detection
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A term used to contrast two types of quality activities. Prevention refers to those activities designed to prevent non-conformances in products and services. Detection refers to those activities designed to detect non conformances already in products and services. Another term used to describe this distinction is "designing in quality vs inspecting in quality.
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Preventive Action System
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A system used to eliminate, reduce the magnitude of, or reduce the likelihood of the effect of a potential nonconformity or its cause.
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Preventive Action
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Action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation.
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Preventive Maintenance
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Action taken to avoid causes of equipment failure and unplanned interruptions to production.
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Primary Packaging
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Any packaging material coming into contact with the finished product (e.g. trays, lids, covers, pouches, wraps etc.).
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Primary Production
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Production of foodstuffs that are supplied into a raw state.
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Problem Solving
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Disciplined process to analyze problems to determine and eliminate root causes.
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Problem
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An identified actual or potential product Nonconformity, Malfunction or deterioration in the characteristics and/or performance of a product, as well as any inadequacy in the labeling or instructions for use.
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Procedure
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Specified way to carry out an activity or a process.
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Process Audit
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The evaluation of a process operation against established instructions and standards. The process audit measures conformance of the processed item or activity to established standards. It also measures the effectiveness of process instructions. The audit is a check for adequacy and effectiveness of the process controls over the equipment and operators as established by procedures, work instructions and process specifications.
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Process Capability
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A statistical measure of the inherent process variability for a given characteristic. The most widely accepted formula for process capability is 6 sigma
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Process Change
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A change to a process which may improve the operation or performance characteristics, mode of manufacture, and/or quality level of the finished product or any of its sub-assemblies or components.
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Process Control
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The evaluation and controls established and maintained at appropriately located points in the manufacturing process to assure continuous quality of parts, components and assemblies.
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Process Definition
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The existence of sufficient specifications for procedures, materials, equipment, facilities, utilities, components and products to reproduce a specific manufacturing process.
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Process Flow Diagram (Process Flow Chart)
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Depiction of the flow of materials through the process; including any rework or repair operations.
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Process Input
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Any material, component, parameter setting, utility, environmental condition or human manipulation which can control or affect the output.
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Process Monitoring
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Carrying out independent, periodic verification of processes to confirm that all the parameters of those processes are maintained within the specification defined by the process procedures.
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Process Performance Qualification (PPQ)
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A series of testing, utilizing individual protocols, encompassing both individual processes and aggregate product analysis. Prerequisite to PPQ is equipment qualification (IQ & OQ) and creation of product/process specifications.
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Process Performance Qualification
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A portion of PPQ documentation which establishes that each individual process under study is in control and produces product to the desired specifications or process capability.
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Process Quality Audit
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An analysis of a process and appraisal of completeness and correctness of conditions with respect to some standard.
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Process Validation
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Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
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Process Window
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A range of process inputs which result in the manufacture of products meeting specification beyond which are "edge of failure." A subset of the window or the entire window may be made into the process specifications.
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Process
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System of activities which uses resources to transform inputs into outputs.
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Processed Materials
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Products (final or intermediate) prepared by transformations, consisting of solids, liquids, gases, or combination thereof, including particulate materials, ingots, filaments or sheet structures.
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Product (or Service)
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Output that an organization supplies to the purchaser.
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Product Audit
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The examination, inspection, or test of a product, which has been accepted previously for the characteristics being audited. Such an audit is a re inspection and retesting of the product, which has already been accepted, or a review of documented evidence of acceptance. It is an indicator of quality going to the customer. .
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Product Change
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A change to a product in order to improve manufacture, function, features or benefits, or cost without causing a change in labeling claims or the indication for use, or jeopardizing safety and effectiveness.
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Product Experience Report (PER)
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A form that is completed by or on behalf of a customer or distributor to document a complaint.
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Product Family
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A grouping of products that are similar in design, packaging and intended use that may be placed together in regard to establishment of a Technical File.
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Product Information Sheet
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A product information sheet is usually a one-sided page similar to a sell sheet but less detailed or comprehensive than a sell sheet.
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Product or Service Liability
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The obligation of a company to make restitution for loss related to personal injury, property damage, or other harm caused by its product or service.
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Product Performance Qualification
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Establishing confidence through appropriate testing that the finished product produced by a specified process(es) meets all release requirements for functionality and safety.
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Product Plan
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Document setting out which is required to meet the objective(s) of the project.
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Product Quality Audit
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A quantitative assessment of conformance to required product characteristics.
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Product Specification
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A specification that describes the general construction of a product in the form of an engineering drawing.
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Product
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Result of a process
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Production Equipment
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Equipment utilized to produce a product, including machinery, fixturing and tooling.
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Production Permit
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Written authorization to depart from the originally specified requirements for a product prior to its production.
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Products Excluded from Coverage under the MDD
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The following items are excluded from coverage under the MDD and, therefore, cannot be CE marked under the MDD:
In vitro diagnostic devices covered by EU Directive 98/79/EEC
active implantable devices covered by EU Directive 90/385/EEC
medicinal (pharmaceutical) products covered by EU Directive 65/65/EEC
personal protective equipment covered by EU Directive 89/686/EEC
cosmetics covered by EU Directive 76/768/EEC
products of human origin (e.g., blood products, materials derived from human tissue)
products of animal origin unless non-viable products with no stated medical purpose (e.g. hygiene tampons)
components or subassemblies which are not finished medical devices themselves
samples not intended for use
devices for sale and use exclusively outside the EC
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Program Audit
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See Quality Program Audit
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Progress Evaluation
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Assessment of outputs of project activities, carried out at appropriate points in the project life cycle across project processes, based on defined criteria for project processes and product.
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Project Management
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Set of organized activities designed to achieve goals and objectives related to a specific business opportunity and for which resources must be planned.
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Project Product
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That which is defined in the project product scope and delivered to the customer.
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Project Team
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Any cross-functional group assembled for the purpose of developing a product or process. The project team is defined for document approval purposes as one representative from each participating functional group. The project team members participate in or review the design and process FMEA(s) for new products.
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Project
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Unique process, consisting of a set of coordinated and controlled activities with start and finish dates, undertaken to achieve an objective conforming to specific requirements, including the constraints of time, cost and resources.
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Prospective Validation
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Validation conducted prior to the distribution of either a new product or product made under a revised manufacturing process where the revisions may affect the product's characteristics.
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Protocol
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An approved document that defines requirements, instructions and necessary documentation for conducting a validation or engineering study.
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Purchaser or Customer
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Customer in a contractual situation.
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Purchaser
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Customer in a contractual situation.
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Purchasing Requisitions
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A purchase requisition is a written or computerized request for the procurement of goods or services from a supplier.
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PWO Originator
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The Pilot Order Originator is responsible for the following: determining the need to produce a Pilot production build; providing all technical information necessary to define the product to be built including training and labeling; assuring the completeness and accuracy of the PWO Package and for assuring that the PWO Pilot package is returned to Manufacturing for filing when completed.
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Q90 Series
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Refers to ANSI/ASQ Q90 series of standards, which is the Americanized version of the ISO 9000 series standards. The United States adopted the ISO 9000 series as the ANSUASQ Q90 series in 1987.
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QA Acceptance Indicator
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Document issued by Quality Assurance personnel which substantiates the fact that the product is acceptable and approved for stocking and subsequent use or distribution.
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QAM
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Quality Assurance Manager
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QAPP
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Quality Assurance Program Procedure
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QEIT
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Quality Engineer In Training
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QMI
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Quality Management Institute
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QSIT
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Quality Systems Inspection Technique program used by FDA to inspect medical device manufacturers.
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Qualification "
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(Audit) combination of personal attributes, minimum education, training, work and audit experience, and competencies possessed by an auditor.
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Qualification Process
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Process of demonstrating whether an entity is capable of fulfilling specified requirements.
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Qualified Suppliers List (QSL)
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Listing of suppliers qualified and approved to supply material, products, and/or services to us.
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Qualified Suppliers
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Those suppliers providing product, material, and/or services for use in products, having a direct impact on products, (such as calibration services, test services, and clean rooms) who have successfully completed the qualification process and are on the Qualified Suppliers List (QSL).
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Qualified
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Status given to an entity when the capability of fulfilling specified requirements has been demonstrated.
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Quality (System) Survey
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An activity conducted prior to a contract award and used to evaluate the overall quality capability of a prospective supplier or contractor.
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Quality Assurance (QA)
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A management discipline consisting of a planned and systematic program covering all functions and actions necessary to provide adequate confidence that the end item or service will perform satisfactorily in actual operation, thereby assuring customer satisfaction.
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Quality Assurance Procedure (QAP)
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Directives issued by Quality Assurance for communicating the established methods for performing and administering the work relative to assuring and controlling the quality of the company's products.
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Quality Assurance Representative (QAR)
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The person who is appointed by the Customer to survey and verify the quality of the Company's work.
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Quality Assurance/Quality Control
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Two terms which have many interpretations because of the multiple definitions for the words "assurance" and "control". For example, "assurance" can mean the act of giving confidence, the state of being certain, or the act of making certain; "control" can mean an evaluation to indicate needed corrective responses, the act of guiding, or the state of a process in which the variability is attributable to a constant system of chance causes. One definition of quality assurance is: all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality. One definition for quality control is: the operational techniques and activities used to fulfill requirements for quality. Often, however, "quality assurance" and "quality control" are used interchangeably, referring to the actions performed to ensure the quality of a product, service or process.
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Quality Audit Observation
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Statement of fact made during a quality audit and substantiated by objective evidence.
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Quality Audit
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A systematic, independent examination and review to determine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve the objectives.
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Quality Auditor
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Person qualified to perform quality audits.
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Quality Characteristic
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Inherent characteristic of a product, process or system derived from a requirement.
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Quality Circles
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Quality improvement or self-improvement study groups composed of a small number of employees (IO or fewer) and their supervisor. Quality circles originated in Japan, where they are called quality control circles.
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Quality Control (QC)
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Part of quality management, focused on fulfilling quality requirements.
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Quality Control Records
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All inspection and test records that include data regarding both the conformance and non-conformance of products produced.
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Quality Costs
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The combined cost of conformance and non-conformance to specified requirements.
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Quality Documents
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Those documents which have or will be prepared, produced, issued or maintained by the Quality Assurance department. Quality documents are used to control, document, analyze and ensure product quality compliance to company standards and contract requirements. Quality documents include, but are not limited to:
Quality program manual
Quality assurance procedures
Inspection forms
Inspection reports
Calibration Records
Nonconformance Reports
Audit Reports
Inspection Instructions
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Quality Engineering
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The analysis of a manufacturing system at all stages to maximize the quality of the process itself and the products it produces.
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Quality Evaluation
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Systematic examination of the extent to which an entity is capable of fulfilling specified requirements.
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Quality Function Deployment (QFD)
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A structural method in which customer requirements are translated into appropriate technical requirements for each stage of product development and production. The QFD process is often referred to as listening to the voice of the customer.
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Quality Function
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The entire collection of activities through which we achieve fitness for use, no matter where these activities are performed.
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Quality Improvement
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Part of quality management, focused on increasing effectiveness and efficiency.
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Quality Loop
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Conceptual model of interacting activities that influence quality at the various stages ranging from the identification of needs to the assessment of whether these needs have been satisfied.
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Quality Losses
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Losses caused by not realizing the potential of resources in processes and activities.
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Quality Management System
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System to establish a quality policy and quality objectives and to achieve those objectives.
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Quality Management
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Coordinated activities to direct and control an organization with regard to quality.
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Quality Manual
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Document specifying the quality management system of an organization.
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Quality Objective
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Something sought, or aimed for, related to quality.
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Quality Plan
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Document specifying the quality management system elements and the resources to be applied in a specific case.
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Quality Planning
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Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives.
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Quality Policy
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Overall intentions and direction of an organization related to quality as formally expressed by top management.
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Quality Program Audit
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The documented activity performed to verify, by examination and evaluation of objective evidence, that applicable elements of the quality program have been developed, documented and effectively implemented in accordance with specified requirements.
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Quality Program
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The documented plans, organizational structure, and activities that are implemented to control the conformance of a product or service to specified requirements and to provide evidence of such conformances.
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Quality Records
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Design, pre-production build, manufacturing and quality system documents and data generated by the quality system which furnish objective evidence of activities performed or results achieved. Quality Records may be retained in a variety of formats, including for example paper, electronic data, or microfilm. Quality record categories and their retention periods have been defined on the Records Retention Schedule.
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Quality Requirement
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Requirement for inherent characteristics of a product, process or system.
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Quality Surveillance
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Continual monitoring and verification of the status of an entity and analysis of records to ensure that specified requirements are being fulfilled.
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Quality System Audit
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A structured activity performed to verify that one or more portions of a quality program are appropriate and being implemented effectively in accordance with agreed-to standards of performance.
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Quality System Certificate
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A certificate issued by the Notified Body upon auditing and approving the quality system of a device manufacturer. The certificate certifies that the quality system conforms to the relevant provisions of the Medical Device Directive.
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Quality System Records
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Documents and data generated as a result of the functioning of the quality system which are not directly related to a product or a specific lot of a product.
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Quality System Regulations (QSR)
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Quality System requirements mandated by the FDA that companies must meet in order for medical devices to be placed on the market in the United States.
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Quality System Review
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A formal evaluation by top management of the status and adequacy of the quality system in relation to quality policy and new objectives resulting from changing circumstances.
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Quality System
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The organizational structure, responsibilities, procedures, processes and resources needed for implementing quality management.
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Quality Trilogy
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A three-pronged approach to managing for quality. The three legs are quality planning (developing the products and processes required to meet customer needs); quality control (meeting product and process goals); and quality improvement (achieving unprecedented levels of performance).
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Quality
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Ability of a set of inherent qualifications of a product, system or process to fulfill requirements of customers and other interested parties.
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Quality-Related Costs
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Those costs incurred in ensuring and assuring satisfactory quality, as well as the losses incurred when satisfactory quality is not achieved.
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Quarantine Area
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Quarantine Area is a designated, identified, and controlled area for temporary storage of suspect material (may be nonconforming) or nonconforming material. The Quarantine Area may be permanent (examples - - a room, locker, cabinet or cage) or temporary (examples a table, cabinet, or portion of a floor).
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Quarantine
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The setting aside of items (raw material, WIP, finished goods, etc.) from availability for use or sales until all necessary screening has been performed.
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R
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Range
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RAB
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Registrar Accreditation Board
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RAM
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Reliability/Availability/Maintainability
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Random Sampling
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A commonly used sampling technique in which sample units are selected in such a manner that all combinations of n units under consideration have an equal chance of being selected as the sample.
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Range Chart
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A control chart in which the sub-group range, R, is used to evaluate the stability of the variability within a process.
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Ranging Study (RS):
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Any activity designed to establish and process window and subsequent process specifications This may occur during process development when developing a new product.
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Rationale
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Written justification for any decision to deviate from or to eliminate a required process.
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Reaction Plan
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Set of actions specified by a control plan, or other quality system documentation, to be initiated when nonconforming product or process instability is identified.
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Recall
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The removal or correction of a marketed product that violates the applicable regulations of the markets in which we distribute our products and against which the appropriate regulatory authorities would initiate legal action or seizure.
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Receiving Document
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Document issued by personnel involved in receiving product into the facility and which substantiates the fact that such product was received.
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Recognition
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Having someone else acknowledge the individual's or group's worth. It is something everyone wants, needs and strives to attain. Studies show that people classify recognition as one of the things they value most.
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Recommended Actions/Target Date
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When used in a FMEA, recommended actions are changes that will be put in place at a later date, in order to reduce the Risk Priority Number.
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Record
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Document stating results achieved or providing evidence of activities performed.
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Records
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released for normal production, which are in the design and testing stage.
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Reference Conditions
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Conditions of use for a measuring instrument prescribed for performance testing, or to ensure valid inter-comparison of results of measurements.
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Reference Material
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A material or substance one or more properties of which are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials.
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Registration Accreditation Board
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A board that evaluates the competency and reliability of registrars (organizations that assess and register companies to the appropriate ISO 9000 series standards). The registrar Accreditation Board, formed in 1989 by ASQ, is governed by a board of directors from industry, academia and quality management consulting firms.
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Registration to Standards
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A process in which an accredited, independent third-party organization conducts an on-site audit of a company's operations against the requirements of the standard to which the company wants to be registered. Upon successful completion of the audit, the company receives a certificate indicating that it has met the standard requirements.
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Re-grade
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Alteration of the grade of a nonconforming product in order to make it conformant with requirements differing from the initial ones.
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Regression Testing
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Testing to determine that changes made in order to correct defects have not introduced additional defects.
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Regulatory Authority
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The Federal, Provincial, Territorial or Municipal agency having the lawful right and power to interpret the law and exercise authority.
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Release
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Authorization to proceed to the next page of a process.
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Reliability
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The probability of a product performing its intended function under stated conditions without failure for a given period of time.
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Remark
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A finding that a requirement has not been adequately implemented, including isolated occurrences that are not likely to result in a deficiency of the quality system or the shipment of nonconforming product.
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Remedial Action
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Any Advisory Notice, Corrective Action, Market Withdrawal, Preventive Action, Recall, Removal or Stock Recovery.
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Remote Location
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Location that supports sites and at which non-production processes occur.
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Removal
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The physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
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Repair Exchange (REX)
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The exchange of a defective customer unit with a new or refurbished unit.
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Repair
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Action taken on a nonconforming product to make it acceptable for the intended usage.
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Repeatability and Reproducibility Studies
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Technique to assess potential variation in measurement due to either intrinsic variability in the measurement device or variation which can arise from operator use and used to assess the inherent accuracy of measurement devices.
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Replication
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Copying a software product from one medium to another.
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Requestor/Sponsor
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Any person who submits a request for biocompatibility evaluation is considered the sponsor of the material or product to be evaluated.
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Requirement
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Need or expectation that is stated, customarily implied or obligatory.
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Requirements for quality
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Expression of the needs or their translation into a set of quantitatively or qualitatively stated requirements for the characteristics of an entity to enable its realization and examination.
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Requirements of Society
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Obligations resulting from laws, regulations, rules, codes, statutes and other considerations.
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Resolution (of a Displaying Device)
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Smallest difference between indications of a displaying device that can be meaningfully distinguished.
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Resolution (of an Indicating Device)
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A quantitative expression of the ability of an indicating device to permit distinguishing meaningfully between immediately adjacent values of the quantity indicated.
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Responsible Individuals/Completion Date
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For each recommended action a responsible individual is assigned a target date for completion of the recommended action.
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Retrospective Validation
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Validation of a process for a product already in distribution based on accumulated production, testing and control data.
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Review
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Activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject matter to achieve established objectives.
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Rework
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Action taken on a nonconforming product to make it conform to the requirements.
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Risk Analysis
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The investigation of available information to identify hazards and to estimate risks.
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Risk Management
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The systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk.
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Risk Priority Number (RPN)
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RPN=Potential Effect(s) of Failure x Potential Causes of Failure x Current Controls.
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Risk
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The probable rate of occurrence of hazards causing harm and the degree of severity of the harm.
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Root Cause
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The causal factors that, if corrected, would prevent reoccurrence of the same or similar nonconformance. Root causes can be systemic or local. Local: a specific deficiency that, if corrected, would prevent reoccurrence of the same nonconformance. Systemic: a deficiency in a management system, that, if corrected, would prevent reoccurrence of a class on nonconformance.
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Run
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An uninterrupted set of production separated from another by a shutdown and set-up of equipment.
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SAE
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Society of Automotive Engineers
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Safety
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State in which the risk of harm (to persons) or damage is limited to an acceptable level.
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Sample Standard Deviation Chart
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A control chart in which the subgroup standard deviation, s, is used to evaluate the stability of the variability within a process.
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Sampling Inspection
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A determination of the probable quality of all items in a given group on the basis of examining the quality characteristics of a selected segment of that group.
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SCAR
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Supplier Corrective Action Request
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Scatter Diagram
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A graphical technique to analyze the relationship between two variables. Two sets of data are plotted on a graph, with the y axis being used for the variable to be predicted and the x axis being used for the variable to make the prediction. The graph will show possible relationships (although two variables might appear to be related, they might not be. Those who know most about the variables must make that evaluation). The scatter diagram is one of the seven tools of quality.
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SCC
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Standards Council of Canada
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Scope of Products Covered under the NOD
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The MDD covers all medical devices and essential accessories defined as: "Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of –
diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment or alleviation of or compensation for an injury or handicap;
investigation, replacement or modification of the anatomy or of a physiological process;
control of conception and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
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Scrap
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Action taken on a nonconforming product to preclude its originally intended usage.
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Secondary Production
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Food stuffs supplied that have undergone a manufacturing process and manufacture that have altered the taste, color or form of the primary production foodstuff.
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Self-Inspection
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Inspection of the work by the performer of that work, according to specified rules.
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Sell Sheet
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A sell sheet is usually a single sheet, describing the features, benefits, specifications, and ordering information for a product.
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Serial Number Level Traceability
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A level of traceability which facilitates tracing the manufacturing history of a specific product via a serial number applied to the product.
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Serial Number
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A unique letter and/or number set which identifies a specific product.
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Service Delivery
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Those supplier activities necessary to provide the service.
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Service
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Intangible product that is the result of at least one activity performed at the interface between the supplier and the customer.
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Service/Technical Manual
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A document which usually includes the same information as an Operating and Maintenance Manual/Instructions for Use and includes information to instruct qualified technicians in servicing the product.
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Seven Tools of Quality
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Tools that help organizations understand their processes in order to improve them. The tools are the cause-and-effect diagram, check sheet, control chart, flowchart, histogram, Pareto chart and scatter diagram.
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Severity
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A score reflecting an assessment of the seriousness of the effect of the failure mode to the next assembly, the product or the customer.
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Significant Change:
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Any change to fit, form, or function to a currently marketed device that could affect the safety or effectiveness of the device. Such changes may include modifications in the design, packaging or sterilization processes, approved indications for use, or marketing authorizations.
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Simple Random Sampling
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In statistics, a simple random sample from a population is a sample chosen randomly, in which each member of the population has the same probability of being chosen. In small populations such sampling is typically done "without replacement", i.e., one deliberately avoids choosing any member of the population more than once.
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Site
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Supplier or subcontractor location at which value-added production processes occur.
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Six-Sigma Quality
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A term used to indicate that a process is generally well within specifications, i.e., that the specification range is +/- 6 standard deviations. The term is usually associated with Motorola, which named one of its key operational initiatives, "Six Sigma Quality".
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Software Item
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Any identifiable part of a software product.
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Software Product
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The set of computer programs procedures, and possibly associated documentation and data.
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Software Validation Plan
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The collection of activities for conducting the software validation study.
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Software Validation Report
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A documentation package summarizing the outcome of the software validation study, including the validation plan, test results and review/approval signoff.
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Software Validation
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Confirmation by examination and provision of objective evidence that the particular requirements and performance of the software meets its intended use.
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Source Control Drawing (SCD)
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A drawing for a critical part procured from a specific supplier where the part has been validated for use in a specific finished device(s) or application. Source Controlled parts may be purchased only from the specified supplier as indicated on the procurement drawing
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Special Characteristics
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Product or process characteristics subject to variation, which may affect safety or compliance with regulations, fit, function, performance or subsequent processing of product; are detailed within the product realization process; and require particular attention in verification activities. (e.g., inspection and testing, product and process audit).
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Special order
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A product made, at the request of a customer consisting generally of existing validated components. Special order product are generally minor changes to catalogue product.
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Special Process
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A process where product quality cannot be verified through subsequent test or inspection.
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Special Processes (inspection)
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An inspection requiring either specialized inspection skills, inspection techniques, or both.
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Special Processes (production)
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A production process is a special process when subsequent inspections required to establish conformance are either impossible or undesirable.
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Specification
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A document that states the requirements to which a given product or service must conform.
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Specified Measuring Range
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The set of values for measurand for which the error of a measuring instrument is intended to lie within specified limits.
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Specified Requirements
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(1)Product requirements prescribed by the customer and agreed by the supplier. (2)Requirements prescribed by the supplier that are perceived as satisfying a market need.
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SQI
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Supplier Quality Index
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Stability
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The ability of a measuring instrument to maintain constant in the performance of the supplier organization and the environment which it operates.
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Stakeholder
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An individual or group of individuals with a common interest in the performance of the supplier organization and the environment, which it operates.
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Standard
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A material measure, measuring instrument, reference material or system intended to define, realize, conserve or reproduce a unit or one or more values of a quantity in order to transmit them to other measuring instruments by comparison.
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Statistical Process Control (SPC)
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The application of statistical techniques to control a process. Often the term "statistical quality control" is used interchangeably with "statistical process control".
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Statistical Quality Control (SQC)
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The application of statistical techniques to control quality. Often the term "statistical process control" is used interchangeably with "statistical quality control", although statistical quality control includes acceptance sampling as well as statistical process control.
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Stock Recovery
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The removal or correction of a product that has not been marketed or that has not left our direct control, i.e., the product is located on our premises and no portion of the lot has been released for sale or use.
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Storage
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The process of storing material in order to preserve it for its intended use.
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Stratified Random Sampling
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A sampling procedure for which the population is first divided into strata or subgroups based on designated criteria and then the sample is drawn, either proportionately or disproportionately, from each subgroup.
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Subcontract
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A contract between a supplier and a sub-supplier.
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Subcontractor Development
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Activities designed to improve the fundamental quality system performance of the subcontractor.
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Subcontractor
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Organization which provides, to a supplier: production or service parts of materials; heat treating, painting, plating, or other finishing services, other customer-specified products.
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Supplier Quality Assurance
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Confidence that a supplier's product or service will fulfill it's customer's needs. This confidence is achieved by creating a relationship between the customer and supplier that ensures the product will be fit for use with minimal corrective action and inspection. According to J. M. Juran, there are nine primary activities needed:
Define product and program quality requirements
Evaluate alternative suppliers.
Select suppliers
Conduct joint quality planning.
Cooperate with the supplier during the execution of the contract.
Obtain proof of conformance to requirements.
Certify qualified suppliers.
Conduct quality improvement programs as required.
Create and use supplier quality ratings.
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Supplier
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Organization or person that provides a product.
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Supply Chain
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A set of inter-related processes that accepts inputs from suppliers, adds values to these inputs and products outputs for customers.
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Surveillance
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The continuing evaluation, analysis, and verification of a supplier's records, methods, procedures, product, and services, to assure that requirements are met.
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System
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Set of interrelated or interacting elements.
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Systematic Random Sampling
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In an audit context, a method of drawing a sample in which the first item is chosen at random and then every kth item thereafter is chosen, where k is the number of times in the population divided by the required sample size, until the full sample has been drawn.
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Systems
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A group of inter-related and interacting processes or components designed to achieve a predetermined objective. A system includes the controls required to minimize variables and provide feedback to the individual processes that it controls.
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TC
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Technical Committee
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Technical Expert
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(Audit) person who provides specific knowledge or expertise with respect to a particular subject field to be audited.
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Technical File
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This is a compiled set of documents that identifies a product family's specifications and verifies the design of a Class I, II(a), and II(b) device. The Notified Body reviews technical files during surveillance. Class III devices require a more extensive set of documents called a Design Dossier.
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Temporary Deviation/Changes
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These are commercially released devices that require temporary change in order to generate supportive documentation, needed to justify making the change permanent and/or a one time only event. Lot release may also be dependent on a bench test report, depending on the change.
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Tender
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The written requirements of products or services specified as required by the Customer and released to suppliers for evaluation and bid submission.
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Test
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Technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specified procedure.
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Text Node
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An electronic prompt, most often found in the title block of an electronic drawing, used by a CAD operator/drafter to enter specific text (such as "Drawing Title," "Date," "Material," etc) into the relevant part of the title block. It allows the CAD operator/drafter to add or edit appropriate text and may also allow editing the size of the text.
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Tool/Tooling
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Part-specific machinery or equipment, which is used to transform or check material.
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Top Management Commitment
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Participation of the highest-level officials in their organization's quality improvement efforts. Their participation includes, establishing and serving on a quality committee; establishing quality policies and goals; deploying those goals to lower levels of the organization; providing the resources and training that the lower levels need to achieve the goals; participation in quality improvement teams; reviewing progress organization-wide; recognizing those who have performed well; and revising the current reward system to reflect the importance of achieving the quality goals.
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Top Management
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Person or group of people who direct and control an organization at the highest level.
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Top Quality Control (TQC)
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The application of measurements and control systems to the total process (from development to obsolescence) to minimize the possibility of the customer not being satisfied with the provided product and/or services.
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Top Quality Management
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A term jointly coined in 1985 by the Naval Air Systems Command to describe its Japanese-style management approach to quality improvement. Since then, total quality management (TQM) has taken on many meanings. Simply put, TQM is a management approach to long-term success through customer satisfaction. TQM is based on the participation of all members of an organization in improving processes, products, services and the culture they work in. TQM benefits all organization members and society.
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Total Quality Management (TQM)
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Management approach of an organization, centered on quality, based on the participation of all its members and aiming at long-term success through customer satisfaction, and benefits to all members of the organization and to society.
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Total Quality Process
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An activity that focuses management and support group attention on the myriad of processes in all parts of the business to insure that they are both effect and efficient. This activity includes business, service and manufacturing processes.
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Total Quality
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Providing all employees with the tools, training, desire and feedback that will allow them to understand customer expectations and continuously improve their output and quality of work-life.
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Traceability
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(General) ability to trace the history, application or location of that which is under consideration.
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Training
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A continuous program of learning to gain knowledge and improve one's ability in any subject, art or profession. Developing skills and attitudes through self-teaching, working on the job, workshop seminars or formal classroom instruction.
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Trending
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Analysis of Complaints, Incidents, Problems and Repair data to determine if a pattern exists which requires the taking of Corrective/Preventative Action.
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True Value (of a Quantity)
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Value consistent with the definition of a given particular quantity.
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Type Test
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Tests or series of tests directed towards approval of a design conducted to determine that it is capable of meeting the requirements of the product specification.
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ULC
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Underwriters Laboratory Council
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Uncertainty of Measurement
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Result of the evaluation aimed at characterizing the range within which the true value of a measurand is estimated to lie, generally with a given likelihood.
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Upper Control Limit (UCL)
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Control limit for points above the central like in a control chart.
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Use-as-is
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The disposition of an item to allow its further processing without rework or repair being performed as it is determined to be suitable for its intended purpose.
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Validated State
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A condition where documented evidence of rocess definition, capability and control justifies the continuance of production of medical devices.
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Validation
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Confirmation and provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.
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Value-Adding Process
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Those activities that transform an input into a customer-usable output. The customer can be internal or external to the organization.
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Variation of Released Product (Special Order)
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These are products, which are varied to meet the needs of a specific customer that are not "substantially different" from the existing device. Lot release is dependent on routine inspection and any additional test and inspection instructions.
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Variation
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A change in data, a characteristic, or a function that is caused by one of four factors: special causes, common causes, tampering or structural variation.
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Verification Record
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A record of an inspection, measuring or test equipment capability. Such record includes a manufacturer's certification and/or on-site checks and/or capability studies.
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Verification
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The act of reviewing, inspecting, testing, checking, auditing or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
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Vibration Receiver
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All structures or elements of structures responded by the vibration energy emitted by an inside or outside source.
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Vibration Source
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A simple (like one machine) or multiple (like rail or road traffic) element emitting vibration energy in its environment.
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Waiver
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Written authorization to use or release a product which does not conform to the specified requirements. Permission in writing to accept for use, a completed but nonconforming item(s) either "as is" or upon completion of approved repairs.
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Warranty/Repairs
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Returned product from customers that may or may not be under a warranty period and are in need of repair to a stage that meets functional specifications.
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Witness Testing
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Testing of a product in the presence of the customer's representative or a third party. The description and the duration of production elements producing vibration used in series to manufacture a product.
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Work Description and Inspection and Test Plan (WDITP)
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A document describing the various production, inspection and test stages and their sequence.
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Work Environment
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Set of conditions under which a person operates.
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Work Instructions
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Detailed manufacturing procedures. These procedures describe work to be performed during activities which affect product or service quality.
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Work Order Packet
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Typically this includes a Work Order, Manufacturing Outline, Prints and/or procedures [Manufacturing Procedure (MP), Quality Control Inspection Instructions (QCII or QCP) and Standard Test Methods (STM)] and a Router to track parts.
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Work Order
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Documentation package issued by Materials personnel to facilitate the flow of product through the facility for all stages of manufacture, inspection and stocking to result in completion of product.
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Workmanship
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The quality imparted to a product or material during fabrication.
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World Class Quality
|
A term used to indicate a standard of excellence: the best of the best.
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World Class
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Providing the customer with more value for the dollar than the competition provides.
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Worst Case
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Those conditions within normal parameters most likely to give failure. For processing purposes, "worst case" means those values of normal operating parameters most likely to cause process failure. For product purposes, "worst case" means those values of specifications most likely to cause process failure.
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X-Bar Chart
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Average chart.
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