| 14 Points | W. Edward Deming's 14 management practices to help companies increase their quality and productivity 1. Create constancy of purpose for improving products and services 2. Adopt the new philosophy 3. Cease dependence on inspection to achieve quality 4. End the practice of awarding business on price alone; instead, minimize total cost by working with a single supplier 5. Improve constantly and forever every process for planning, production, and service 6. Institute training on the job 7. Adopt and institute leadership 8. Drive out fear 9. Break down barriers between staff areas 10. Eliminate slogans, exhortations, and targets for the work force 11. Eliminate numerical quotas for the work force and numerical goals for management 12. Remove barriers that rob people of pride of workmanship and eliminate the annual rating or merit system 13. Institute a vigorous program of education and self-improvement for everyone 14. Put everybody in the company to work to accomplish the transformation. |
| 80-20 | A term referring to the Pareto principle, which was first defined by J. M. Juran in 1950. The principle suggests that most effects come from relatively few causes, that is, 80% of the effects come from 20% of the possible causes. |
| Acceptable quality level (AQL) | When a continuing series of lots is considered, a quality level that, for the purposes of sampling inspection, is the limit of a satisfactory process average |
| acceptance criteria | The criteria that a system or component must satisfy in order to be accepted by a user, customer, or other authorized entity. |
| Acceptance sampling | Inspection of a sample from a lot to decide whether to accept or not accept that lot. There are two typeso Attributes sampling and variable 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. |
| Acceptance sampling plan | A specific plan that indicates the sampling 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. (For detailed descriptions of these plans, see the standard ANSI/ISO/ASQC 3534-2, Statistics--Vocabulary and Symbols--Statistical Quality Control.) |
| acceptance testing | Formal testing conducted to determine whether or not a system satisfies its acceptance criteria and to enable the customer to determine whether or not to accept the system. |
| Accreditation | 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(s) or operation(s) needed. [ ANSI / ASQ A3 ] |
| Accredited Registrars | Qualified organizations certified by a national body (e.g., the Registrar Accreditation Board in the U. S.) to perform audits to the QS-9000 and to register the audited facility as meeting these requirements for a given commodity. [ QS-9000 ] |
| ACSI | The American Customer Satisfaction Index, released for the first time in October 1994, is a new economic indicator, a cross-industry measure of the satisfaction of U.S. household customers with the quality of the goods and services available to them--both those goods and services produced within the United States and those provided as imports from foreign firms that have substantial market shares or dollar sales. The ACSI is co-sponsored by the University of Michigan Business School and ASQC. |
| AIAG | Automotive Industry Action Group |
| American Society for Quality (ASQ) | A society of individual and organizational members dedicated to the ongoing development, advancement, and promotion of quality concepts, principles, and technologies. The Society serves more than 130,000 individuals and 1000 corporate members in the United States and 63 other countries. |
| An organization can establish partnering agreements with its unions, suppliers, customers, local businesses, and / or educational institutions. "Cooperation" differs from partnering in that the relationship is less formal, either by choice or due to the fact that the parties involved are not part of the formal organization. | |
| Analysis of means (ANOM) | 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. Ellis R. Ott developed the procedure in 1967 because he observed that non statisticians had difficulty understanding analysis of variance. Analysis of means is easier for quality practitioners to use because it is an extension of the control chart. In 1973, Edward G. Schilling further extended the concept, enabling analysis of means to be used with non normal distributions and attributes data where the normal approximation to the binomial distribution does not apply. This is referred to as analysis of means for treatment effects. |
| ANSI | American National Standards Institute |
| AQL | Acceptable level |
| AS9100 | Quality system requirements for suppliers to the aerospace industry (previously known as AS9000). |
| ASQ | American Society for Quality |
| Assessment | An evaluation process including a document review, an on-site audit and an analysis and report. (see Quality audit ) [ QS-9000 ] |
| Assignable cause | See Special cause |
| ASTM | American Society for Testing and Materials |
| Attributes | An inherent characteristic of a product, program, or service such as its cost, color, function, duration, etc. |
| Attributes | Qualitative data that can be counted for recording and analysis. Examples include characteristics such as the presence of a required label and the installation of all required fasteners. [ M. Brassard ] |
| audit | An independent examination of a work product or set of work products to assess compliance with specifications, standards, contractual agreements, or other criteria. |
| Audit | An onsite verification activity used to determine the effective implementation of a supplier's documented quality system. [ QS-9000 ] |
| Audit | Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. [ ISO 9000:2000 ] |
| Audit client | Organization or person requesting an audit. [ ISO 9000:2000 ] |
| Audit conclusion | Outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings. [ ISO 9000:2000 ] |
| Audit criteria | Set of policies, procedures or requirements used as a reference (while conducting an audit). [ ISO 9000:2000 ] |
| Audit evidence | Records, statements of fact or other information which are relevant to the audit criteria and verifiable. [ ISO 9000:2000 ] |
| Audit Findings | Result of an audit. |
| Audit findings | Results of the evaluation of the collected audit evidence against audit criteria. [ ISO 9000:2000 ] |
| Audit program | Set of one or more audits planned for a specific time frame and directed towards a specific purpose. [ ISO 9000:2000 ] |
| Audit Scope | The extent and boundaries of an audit. |
| Audit team | One or more auditors conducting an audit. [ ISO 9000:2000 ] |
| Auditee | Organization being audited. [ ISO 9000:2000 ] |
| Auditor | Person with the competence to conduct an audit. [ ISO 9000:2000 ] |
| Availability | the ability of a product to be in a state to perform its designated function under stated conditions at a given time. Availability can be expressed by the ratioo uptime divided by (uptime + downtime) being when the product is operative (in active use and in standby state) and downtime being when the product is inoperative time (while under repair, awaiting spare parts, and so on). |
| Availability | The ability of an item to perform its designated function when required for use. [ ANSI / ASQ A3 ] |
| Average chart | A control chart in which the subgroup average, X-bar, is used to evaluate the stability of the process level. |
| Average or mean | The most common expression of the centering of a distribution . It is calculated by totaling the observed values and dividing by the number of observations. [ M. Brassard ] |
| Average outgoing quality (AOQ) | the expected average quality level of outgoing product for a given value of incoming product quality. |
| Average outgoing quality limit (AOQL) | The maximum average outgoing quality over all possible levels of incoming quality for a given acceptance sampling plan and disposal specification. |
| baseline | A work product (e.g., a plan or specification) or a set of configuration items (software components and/or software documents) that has been formally reviewed and agreed upon, that thereafter serves as the basis for future development, and that can be changed only through established change control procedures. and |
| Benchmark Data | The results of an investigation to determine how competitors and/or best-in-class companies achieve their level of performance. [ APQP Reference Manual, guidance for QS-9000 ] |
| Benchmarking | An improvement process in which an organization compares its performance against "best-in-class" organization, determines how those organizations achieved their performance levels, and uses information to improve its own performance. The subjects that can be benchmarked include |
| Big Q, little Q | 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). |
| Bimodal Distribution | A distribution with two identifiable curves within it, indicating a mixing of two populations such as different shifts, machines, workers, etc. [ M. Brassard ] |
| Blemish | 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. See also "defect","imperfection",and "nonconformity". |
| Block diagram | 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 diagramso a functional block diagram, which shows a system's subsystems and lower-level products, their interrelationships, and interfaces with other systems; and a reliability block diagram, which is similar to the functional block diagram except that it is modified to emphasize those aspects influencing reliability. |
| Brainstorming | 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. |
| BS | British Standard |
| BSI | British Standards Institution |
| C Chart | Count Chart |
| CAI | Computer aided inspection |
| Calibration | 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. |
| Capability | The total range of inherent variation in a stable process. (See Process Capability ) [ QS-9000 ] |
| Capability | Ability of an organization, system or process to realize a product that will fulfill the requirements for that product. [ ISO 9000:2000 ] |
| CASCO | ISO Committee on Conformity Assessments |
| Cause-and-Effect diagram | A tool for analyzing process dispersion. It is also referred to as the Ishikawa diagram, because Kaoru Ishikawa developed it, and the fishbone diagram, because the complete diagram resembles a fish skeleton. The diagram illustrates the main causes and subcauses leading to an effect (symptom). The cause-and-effect diagram is one of the seven tools of quality. |
| CC | Critical characteristic |
| CE Mark | European Union product safety certification symbol: |
| CEN | European Committee for Standardization |
| CENELEC | European Committee for Electro-technical Standardization |
| CEO | Chief Executive Officer |
| Certificate of compliance | A document signed by an authorized party affirming that the supplier of a product or service has met the requirements of the relevant specifications , contract, or regulation. [ ANSI / ASQ A3 ] |
| Certificate of conformance (Certificate of conformity) | A document signed by an authorized party affirming that a product or service has met the requirements of the relevant specifications , contract, or regulation. [ ANSI / ASQ A3 ] |
| Certification | The procedure and action by a duly authorized body of determining, verifying , and attesting in writing to the qualifications of personnel, processes , procedures, or items in accordance with applicable requirements. [ ANSI / ASQ A3 ] |
| Characteristic | Distinguishing feature [ ISO 9000:2000 ] |
| Checklist | A tool used to ensure that all important steps or actions in an operation have been taken. Checklists contain items that are important or relevant to an issue or situation. Checklists are often confused with check sheets and data sheets (see individual entries). |
| CIM | Computer Integrated Manufacturing |
| CMM | Capability Maturity Model |
| Collier, Simon (deceased) | an ASQ president who led the Society during a critical growth period in 1952-53. His term was marked by numerous milestone events, including a membership increase of 22% and the formation of 11 new sections and the first divisions. Collier, an ASQC Honorary member, was a chemist who began his career at the National Bureau of Standards (now the National Institute of Standards and Technology). Later he worked at Johns-Manville Corporation, where he produced a quality training film used by more than 300 companies. |
| Common Cause | A source of variation that is always present as part of the random variation inherent in the process itself. Its origin can usually be traced to an element of the system which only management can correct. [ M. Brassard ] |
| Common Causes | Causes of variation that are inherent in a process over time. They affect every outcome of the process and everyone working in the process (see also "special causes"). |
| Company Culture | A system of values, beliefs, and behaviors inherent in a company. To optimize business performance, top management must define and create the necessary culture. |
| Competence | Demonstrated ability to apply knowledge skills. [ ISO 9000:2000 ] |
| completeness | The degree to which a software product provides necessary and sufficient information and/or capability to satisfy user needs. |
| compliance | To be in agreement. |
| Compliance | An affirmative indication or judgment that the supplier of a product or service has met the requirements of the relevant specifications , contract, or regulation; also the state of meeting the requirements. [ ANSI / ASQ A3 ] |
| Component | Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. [ FDA QSR ] |
| Concession | See Waiver |
| Concession | Permission to use or release a product that does not conform to specified requirements. [ ISO 9000:2000 ] |
| configuration control board (CCB) | A group of people responsible for evaluating and approving or disapproving proposed changes to configuration items, and for ensuring implementation of approved changes. Depending on the size and character of the software project, the CCB may be comprised of one person (e.g., the project manager) or a number of people representing different areas of the project. The role of the CCB is to take a global view, that is, to assess the impact of the change beyond the individual configuration item. How will the change impact performance? How will the change modify the customer's perception of the software? How will the change affect quality and reliability? |
| configuration item | A unit, or aggregation of units, of software, data, or documentation that is designated for configuration management and treated as a single entity in the configuration management process. Tools used in the creation of a configuration item (e.g., compilers) may also be treated as configuration items. |
| configuration management | A discipline that applies technical and administrative direction and surveillance over the lifecycle of items to: identify and document the functional and physical characteristics of configuration items; control changes to configuration items and their related documentation; record and report information needed to manage configuration items effectively, including the status of proposed changes and implementation status of approved changes; audit configuration items to verify conformance to specifications, interface control documents, and other contractual requirements. The four key elements of configuration management are: configuration identification, configuration control, configuration status accounting, auditing. [Crosstalk, U.S. Air Force Software Technology Support Center, January 1995] |
| conformance | Similarity in form or content. |
| Conformance | An affirmative indicator or judgment that a product, program, or service has met the agreed-upon requirements of * A customer, or * A relevant specification, contract, or regulation. |
| Conformance | An affirmative indication or judgment that a product or service has met the requirements of the relevant specifications , contract, or regulation; also the state of meeting the requirements. [ ANSI / ASQ A3 ] |
| Conformity | The fulfilling by an item or service of specification requirements. [ ANSI / ASQ A3 ] |
| Conformity | Fulfillment of a requirement. [ ISO 9000:2000 ] |
| consistency | The degree of uniformity, standardization, and freedom from contradiction among the documents or parts of a system or component. |
| Continual Improvement | The recurring activity to increase the ability to fulfill requirements. |
| Continual improvement | Recurring activity to increase the ability to fulfill requirements. [ ISO 9000:2000 ] |
| Continuous improvement | The ongoing improvement of programs, services, or processes through incremental and breakthrough improvements. |
| Control Chart | A chart with upper and lower control limits on which values of some 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. |
| Control Chart | A graphic representation of a characteristic of a process , showing plotted values of some statistic gathered from that characteristic, and one or two control limits. [ M. Brassard ] |
| Control Limit | A line (or lines) on a control chart used as a basis for judging the significance of the variation from subgroup to subgroup. Variation beyond a control limit is evidence that special causes are affecting the process . Control limits are calculated from process data and are not to be confused with engineering specifications . [ M. Brassard ] |
| Control Plans | Written descriptions of the systems for controlling parts and processes. [ QS-9000 ] |
| convention | Standards employed to prescribe a disciplined uniform approach to achieving consistency in a software product, for example, uniform patterns or forms for arranging data, text, or graphics. |
| Correction | Action to eliminate a detected nonconformity. [ ISO 9000:2000 ] |
| Corrective Action | The implementation of solutions resulting in the reduction or elimination of an identified problem. |
| Corrective action | Action to eliminate the cause of a detected nonconformity or other undesirable situation. [ ISO 9000:2000 ] |
| Corrective Action Plan | A plan for correcting a process or part quality issue. [ QS-9000 ] |
| correctness | The degree to which a software product agrees with any applicable specifications, other project documentation, and applicable standards. |
| Cost of poor quality | The costs associated with providing poor-quality products or services. There are four categories of costso 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). |
| Cost of quality (COQ) | a term coined by Philip Crosby referring to the cost of poor quality. |
| Count chart | 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. |
| Count-per-unit chart | A control chart for evaluating the stability of a process in terms of the average count of events of a given classification per unit occurring in a sample. \ |
| CQA | Certified Quality Auditor |
| CQE | Certified Quality Engineer |
| CQMgr | Certified quality manager |
| crash | The sudden and complete failure of a computer system or component. |
| CRE | Certified Reliability Engineer |
| Cumulative Sum Control Chart | A control chart on which the plotted value is the cumulative sum of deviations of successive samples from a target value. The ordinate of each plotted point represents the algebraic sum of the previous ordinate and the most recent deviations from the target. |
| Customer | Organization or person that receives a product. [ ISO 9000:2000 ] |
| Customer (external) | A person or organization who receives a product, service, or information, but is not part of the organization supplying it (also called a patient in the health care sector and a student in the education sector). |
| Customer (internal) | A person or unit who receives output (product, service, or information) from another person or unit within the same unit -or from another unit within the larger organization of which it is a part. |
| Customer Delight | The result of delivering a product of service that exceeds customer expectations. |
| Customer Satisfaction | The result of delivering a product or service that meets customer requirements. |
| Customer satisfaction | Customer's perception of the degree to which the customer's requirements have been fulfilled. [ ISO 9000:2000 ] |
| Customer Supplier Partnership | A long-term relationship between a buyer and 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 suppliers. The supplier 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. |
| Cycle time | The interval required to complete a task, or function, starting from the beginning of the first step until the completion of the last. |
| Data management | The process by which the reliability, timelines, and accessibility of an organization's database is assured. |
| Decision Matrix | A matrix used by teams to evaluate problems or possible solutions. After a matrix is drawn to evaluate possible solutions, for example, the team lists them in the far-left vertical column. Next, the team selects criteria to rate the possible solutions, writing them across the top row. Third, each possible solution is rated on a scale of 1 to 5 for each criterion and the rating recorded in the corresponding grid. Finally, the ratings of all the criteria for each possible solution a re added to determine its total score. The total score is then used to help decide which solution deserves the most attention. |
| Defect | 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 defectso 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; and Class 4, Minor, is related to minor problems with respect to intended normal or reasonably foreseeable use (see also blemish, imperfection, and nonconformity). |
| Defect | The non-fulfillment of intended usage requirements. [ ISO 8402 ] |
| Defect | Non-fulfillment of a requirement related to an intended or specified use. [ ISO 9000:2000 ] |
| defect (with respect to code) | Improper program conditions that are generally the result of an error or some combination of errors. |
| defect (with respect to software documentation) | Instances in which a document either: contains editorial mistakes that have not been corrected; is inconsistent with related specifications and documents; or, is not in compliance with applicable standards. |
| Deming Cycle | See "plan-do-check-act cycle" |
| Deming Prize | Award given annually to organizations that, according to the award guidelines, have successfully applied companywide quality control based on statistical quality control and will keep up with it in the future. Although the award is named in honor of W. Edwards Deming, its criteria are not specifically related to Deming's teachings. There are three separate divisions for the awardo the Deming Application Prize, the Deming Prize for Individuals, and the Deming Prize for Overseas Companies. The award process is overseen by the Deming Prize Committee of the Union of Japanese Scientists and Engineers in Tokyo. |
| Deming, W. Edwards (deceased) | a prominent consultant, teacher, and author on the subject of quality. After sharing his expertise in statistical quality control to help the U.S. war effort during World War II, the War Department sent Deming to Japan in 1946 to help that nation recover from its wartime losses. Deming published more than 200 works, including the well-known books Quality, Productivity, and Competitive Position and Out of the Crisis. Deming, who developed the 14 points for managing, is an ASQ Honorary member. |
| demonstration | A dynamic analysis technique that relies on observation of system or component behavior during execution, without need for post-execution analysis, to detect errors, violations of development standards, and other problems. |
| Dependability | The totality of characteristics related to the availability performance and its influencing factors: reliability, maintainability, and support. |
| Dependability | 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. (Nonoperation-related influences are not included.) Dependability can be expressed by the ratioo time available divided by (time available + time required) |
| Dependability | The state of being counted on or trusted. [ ANSI / ASQ A3 ] |
| Dependability | Collective term used to describe the availability performance and its influencing factors: reliability performance, maintainability performance and maintenance support performance. [ ISO 9000:2000 ] |
| Design and development | Set of processes that transforms requirements into specified characteristics or into the specification of a product, process or system. [ ISO 9000:2000 ] |
| Design Failure Mode and Effects Analysis (DFMEA) | An analytical technique used by a design responsible engineer/team as a means to assure, to the extent possible, that potential failure modes and, their associated causes/mechanisms have been considered and addressed. [ APQP Reference Manual, guidance for QS-9000 ] |
| Design for Manufacturability and Assembly | A simultaneous engineering process designed to optimize the relationship between design function, manufacturability, and ease of assembly. [ APQP Reference Manual, guidance for QS-9000 ] |
| Design input | The physical and performance requirements of a device that are used as a basis for device design. [ FDA QSR ] |
| Design Review | A proactive process to prevent problems and misunderstandings. [ APQP Reference Manual, guidance for QS-9000 ] |
| Design Review | A formal, documented , comprehensive, and systematic examination of a design to evaluate the design requirements and the capability of the design to meet these requirements and to identify problems and propose solutions. [ ANSI / ASQ A3 ] |
| Design review | A documented , comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. [ FDA QSR ] |
| Design Validation | Testing to ensure that product conforms to defined user needs and/or requirements. Design validation follows successful design verification and is normally performed on the final product under defined operating conditions. Multiple validations may be performed if there are different intended uses. [ APQP Reference Manual, guidance for QS-9000 ] |
| Design Validation | Establishing by objective evidence that device specifications conform with user needs and intended use(s). [ FDA QSR ] |
| Design Verification | Testing to ensure that all design outputs meet design input requirements. Design verification may include activities such as: • Design review • Performing alternate calculations • Understanding tests and demonstrations • Review of design stage documents before release [ APQP Reference Manual, guidance for QS-9000 ] |
| desk checking | A static analysis technique in which code listings, test results, or other documentation are visually examined, usually by the person who generated them, to identify errors, violations of development standards, or other problems. |
| Detection or inspection | A past-oriented strategy that attempts to identify unacceptable output after it has been produced and separate it from the good output. (See Prevention and Nonconforming ) [ M. Brassard ] |
| deviation | A departure from a specified requirement. |
| Deviation permit | Written authorization, prior to production or provision of a service, to depart from specified requirements for a specified quantity or for a specified time. [ ANSI / ASQ A3 ] |
| Deviation permit | Permission to depart from the originally specified requirements of a product prior to realization. [ ISO 9000:2000 ] |
| DFA | Design for assembly |
| DFM | Design for manufacturing |
| DFMEA | Design Failure Mode and Effects Analysis |
| Diagnostic journey and remedial journeyo A two-phase investigation used by teams to solve chronic quality problems. In the first phase, the diagnostic journey, the team journeys from the symptom of a chronic problem to its cause. In the second phase, the remedial journey, the team journeys from the cause to its remedy. | |
| DIN | Germany Standards Institute - Deutsches Institut fuer Normung |
| direct metric | A metric applied during development or during operations that represents a software quality factor. |
| discrepancy | Lack of agreement; a difference or inconsistency. [The American Heritage Dictionary] |
| Distribution | The population (universe) from which observations are drawn, categorized into cells, and form identifiable patterns. It is based on the concept of variation that states that anything measured repeatedly will arrive at different results. These results will fall into statistically predictable patterns. A bell-shaped curve (normal distribution) is an example of a distribution in which the greatest number of observations occur in the center with fewer and fewer observations falling evenly on either side of the average . [ M. Brassard ] |
| Document | Information and its supporting medium. A set of documents is often called documentation. [ ISO 9000:2000 ] |
| Documentation | Written material defining the process to be followed (e.g. test procedure, quality manual, operation sheets). [ QS-9000 ] |
| DOE | Design of Experiments |
| Durability | The probability that an item will continue to function at customer expectation levels, at the useful life without requiring overhaul or rebuild due to wearout. [ APQP Reference Manual, guidance for QS-9000 ] |
| EC | European Community |
| Effectiveness | Extent to which planned activities are realized and planned results achieved. [ ISO 9000:2000 ] |
| Efficacy | (see effectiveness) |
| efficiency | The degree to which a system or component performs its designated functions with minimum consumption of resources. |
| Efficiency | Relationship between the result achieved and the resources used. [ ISO 9000:2000 ] |
| EFTA | European Free Trade Association |
| Employee involvement | 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. |
| Empowerment | 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. |
| EN | European Standard |
| engineering change | In configuration management, an alteration in the configuration of a configuration item or other designated item after formal establishment of its configuration identification. |
| engineering change proposal (ECP) | In configuration management, a proposed engineering change and the documentation by which the change is described and suggested. |
| EQS | European Committee for Quality System Assessment and Certification |
| error (with respect to a calculation) | The difference between a computed, observed, or measured value or condition and the true, specified, or theoretically correct value or condition. |
| error (with respect to code) | A mistake resulting from human action. Examples include typographical mistakes or incorrect syntax . |
| Establish | Define, document (in writing or electronically), and implement. [ FDA QSR ] |
| ETSI | European Telecommunications Standards Institute |
| evaluation | appraisal |
| failure | A malfunction of a user's installation. A failure may result from a fault, incorrect installation, a communication line problem, hardware failure, etc. |
| fatal error | An error that results in the complete inability of a system or component to function. |
| fault | A program defect that is encountered in operation, either under test or in use. Faults result from defects, but not all defects cause faults (some are latent and never found). With widely used software, the defects may be found many times, resulting in duplicate or multiple faults per defect. |
| fault tolerance | The ability of a system or component to continue normal operation despite the presence of hardware or software faults. |
| Fishbone diagram | See "cause-and-effect diagram" |
| Fitness for use | A term used to indicate that a product or service fits the customer's defined purpose for that product or service. |
| flexibility | The ease with which a system or component can be modified for use in applications or environments other than those for which it was specifically designed. |
| Flowchart | A graphical representation of the steps in a process. Flowcharts are drawn to better understand processes. The flowchart is one of the seven tools of quality. |
| FMEA method (FMECA) | Failure Mode and Effect (and Criticality) Analysis, a powerful method of risk assessment and failure analysis for use in risk management and product liability control. (see Risk Analysis article |
| Force field analysis | A technique for analyzing the forces that aid or hinder an organization in reaching an objective. An arrow pointing to an objective is drawn down the middle of a piece of paper. The factors that will aid the objective's achievement, called the driving forces, are listed on the left side of the arrow. The factors that will hinder its achievement, called the restraining forces, are listed on the right side of the arrow. |
| Frequency distribution | A statistical table that presents a large volume of data in such a way that the central tendency (average /mean/median) and distribution are clearly displayed. [ M. Brassard ] |
| FTA | Fault Tree Analysis |
| function | A defined objective or characteristic action of a system or component. |
| Functional Verification | Testing to ensure the part conforms to all customer and supplier engineering performance and material requirements. [ QS-9000 ] |
| functionality | The degree to which a system or component provides the specified functions allocated to it. |
| Gantt chart | A type of bar chart used in process planning and control to display planned work and finished work in relation to time. |
| GD&T | Geometric Dimensioning and Tolerancing |
| Generally implied | Custom or common practice for the organization, its customers and other interested parties, that the need or expectation under consideration is implied. [ ISO 9000:2000 ] |
| GMP | Good Manufacturing Practice |
| GR&R | Gage Repeatability and Reproducibility |
| Grade | An indicator of category or rank related to features or characteristics that cover different sets of needs for products or services intended for the same functional use. [ ANSI / ASQ A3 ] |
| Grade | Category or rank given to different quality requirements for products, processes or systems having the same functional use. [ ISO 9000:2000 ] |
| Guideline | A document stating recommendations or suggestions. |
| Hardware | Tangible, discrete product with distinctive form. [ ANSI/ASQ Q9000-1 ] |
| Histogram | A graphic summary of variation 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. |
| Histogram | See Frequency distribution |
| Hoshin planning | Breakthrough planning. A Japanese strategic planning process in which a company develops up to four vision statements that indicate where the company should be in the next five years. Company goals and work plans are developed based on the vision statements. Periodic audits are then conducted to monitor progress. |
| IEC | International Electro-technical Commission |
| IEEE | Institute of Electrical and Electronic Engineers |
| Imperfection | A quality characteristic's departure from its intended level or state without any association to conformance to specification requirements or to the usability of a product or service (see also "blemish","defect", and "nonconformity"). |
| Improvement cycle | An action or series of actions (taken as a result of an organized and planned review) which make the process better. To ensure that continuos improvement becomes a way of life, all processes should provide for periodic improvement cycles. |
| independent verification and validation (IV&V) | Verification and validation performed by an organization that is technically, managerially, and financially independent of the development organization. |
| indicator | A device or variable that can be set to a prescribed state based on the results of a process or the occurrence of a specified condition. |
| Information | Meaningful data [ ISO 9000:2000 ] |
| Infrastructure (of an organization) | System of facilities, equipment and services needed for the operation of an organization. [ ISO 9000:2000 ] |
| inspection | A static analysis technique that relies on visual examination of development products to detect errors, violations of development standards, and other problems. |
| Inspection | Activities, such as measuring, examining, testing , gaging one or more characteristics of a product or service, and comparing these with specified requirements to determine conformity . [ ANSI / ASQ A3 ] |
| Inspection | Conformity evaluation by observation and judgement accompanied as appropriate by measurement, testing or gauging. [ ISO 9000:2000 ] |
| Instant pudding | A term used to illustrate an obstacle to achieving qualityo the supposition that quality and productivity improvement is achieved quickly through an affirmation of faith rather than through sufficient effort and education. W. Edwards Deming used this term, which was initially coined by James Bakken of Ford Motor Co., in his book Out of the Crisis. |
| integration testing | Testing in which software components, hardware components, or both are combined and tested to evaluate the interaction between them. |
| integrity | The degree to which a system or component prevents unauthorized access to, or modification of, computer programs or data. |
| Interested party | Person or group having an interest in the performance or success of an organization. [ ISO 9000:2000 ] |
| intermittent fault | A recurring temporary or unpredictable fault in a component. |
| interoperability | The ability of two or more systems or components to exchange information and to use the information that has been exchanged. |
| ISO | International Organization for Standards |
| ISO 14000 | International environmental management system standard administered by ISO |
| ISO 9000 | International Standard for Quality Systems |
| ISO 9000 series standards | A set of five individual but related international standards on 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 to 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 standards bodies of 91 countries. |
| ITR | Internal Test Report. The mechanism by which defects, faults, failures, and other types of problems, are reported and tracked on the RFMP project. |
| JIS | Japan Industrial Standards |
| JUSE | Japanese Union of Scientists and Engineers |
| Just-in-time manufacturing (JIT) | An optimal material requirement planning system for a manufacturing process in which there is little or no manufacturing material inventory on hand at the manufacturing site and little or no incoming inspection. |
| Kaizen | a Japanese term that means gradual unending improvement by doing little things better and setting and achieving increasingly higher standards. The term was made famous by Masaaki Imai in his book, Kaizeno The Key to Japan's Competitive Success. |
| Kaizen | Taken from the Japanese words kai and zen, where kai means change and zen means good. The popular meaning is continual improvement of all areas of a company not just quality. [ APQP Reference Manual, guidance for QS-9000 ] |
| LCL | Lower control limit (see Control limit ) |
| Leadership | 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. |
| Lot or batch | One or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. [ FDA QSR ] |
| LSL | Lower specification limit (see Specification ) |
| maintainability | The ease with which a software system or component can be modified to correct faults, improve performance or other attributes, or adapt to a changed environment. |
| Maintainability | The probability that a failed system can be made operable in a specified interval or downtime. [ APQP Reference Manual, guidance for QS-9000 ] |
| Maintainability | Ability of an item under stated conditions of use to be retained in, or restored to, within a given period of time, a specified state in which it can perform its required functions when maintenance is performed under stated conditions and while using prescribed procedures and resources. [ ANSI / ASQ A3 ] |
| Malcolm Baldrige National Quality Award (MBNQA) | An award established by Congress in 1987 to raise awareness of quality management and to recognize U.S. companies that have implemented successful quality management systems. Two awards may be given annually in each of three categorieso manufacturing company, service company, and small business. The award is named after the late Secretary of Commerce Malcolm Baldrige, a proponent of quality management. The U.S. Commerce Department's National Institute of Standards and Technology manages the award, and ASQC administers it. |
| Management | Coordinated activities to direct and control an organization. [ ISO 9000:2000 ] |
| Management System | The set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives. |
| Management system | System to establish policy and objectives and to achieve those objectives. [ ISO 9000:2000 ] |
| MBNQA | Malcolm Baldrige National Quality Award |
| Measurement | The set of operations to determine the value of a quantity. |
| Measurement control system | Set of interrelated or interacting elements necessary to achieve metrological confirmation and continual control of measurement processes. [ ISO 9000:2000 ] |
| Measurement process | Set of operations to determine the value of a quantity. [ ISO 9000:2000 ] |
| Measuring equipment | Measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process. [ ISO 9000:2000 ] |
| metric | A quantitative measure of the degree to which a system, component or process possesses a given attribute. |
| Metrological characteristic | Distinguishing feature which can influence the results of measurement. [ ISO 9000:2000 ] |
| Metrological confirmation | Set of operations required to ensure that measuring equipment conforms to the requirements for its intended use. [ ISO 9000:2000 ] |
| Metrological function | Function with organizational responsibility for defining and implementing the measurement control system. [ ISO 9000:2000 ] |
| mistake | A human action that produces an incorrect result. |
| MRB | Material review board |
| MSA | Measurement System Analysis |
| MTBF | Mean time between failures |
| NACCB | National Accreditation Council for Certification Bodies (UK) |
| NDT | Nondestructive testing |
| NIST | National Institute of Science and Technology |
| Nominal group technique | a technique similar to brainstorming, used by teams to generate ideas on a particular subject. Team members are asked to silently come up with as many ideas as possible, writing them down. Each member is them asked to share one idea, which is recorded. After all the ideas are recorded, they are discussed and prioritized by the group. |
| Nonconformance | Product or material which does not conform to the customer requirements or specifications. [ QS-9000 ] |
| Nonconformities | Specific occurrences of a condition that does not conform to specifications or other inspection standards; sometimes called discrepancies or defects [ M. Brassard ] |
| Nonconformity | the nonfulfillment of a specified requirement (see also "blemish","defect", and "imperfection"). |
| Nonconformity | A process which does not conform to a quality system requirement. [ QS-9000 ] |
| Nonconformity | Non-fulfillment of a requirement. [ ISO 9000:2000 ] |
| Normal Distribution | See Distribution |
| Numerical reliability | The probability that an item will perform a required function under stated conditions for a stated period of time. (See MTBF ) [ ANSI / ASQ A3 ] |
| Objective evidence | Data supporting the existence or verity of something, [ ISO 9000:2000 ] |
| Organization | Group of people and facilities with an arrangement of responsibilities, authorities and relationships. [ ISO 9000:2000 ] |
| Organizational structure | Arrangement of responsibilities, authorities and relationships between people. [ ISO 9000:2000 ] |
| Pareto chart | 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 1950. The principle, named after 19th-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. |
| Partnering | The establishment of a long-term relationship between two parties characterized by teamwork and mutual trust, enabling both parties to focus on the needs of a mutual customer. Partners have risks well as benefits. |
| Parts Per Million (PPM) | PPM is a way of stating the performance of a process in terms of actual or projected defective material. [ QS-9000 ] |
| pass/fail criteria | Decision rules used to determine whether a software item or a software feature passes or fails a test. |
| PCR | Problem/Change Report |
| performance | The degree to which a system or component accomplishes its designated functions within given constraints, such as speed, accuracy, or memory usage. |
| Performance standard | A goal against which actual performance is measured. |
| PFMEA | Process Failure Mode and Effects Analysis |
| Plan-do-check-act cycle | 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. |
| Population | The universe of data under investigation from which a sample will be taken. [ M. Brassard ] |
| portability | The ease with which a system or component can be transferred from one hardware or software environment to another. |
| practices | Requirements employed to prescribe a disciplined uniform approach to the software development process. |
| predictive metric | A metric applied during development and used to predict the values of a software quality factor. |
| Prevention | A future-oriented strategy that improves by directing analysis and action toward correcting the production process . Prevention is consistent with a philosophy of never-ending improvement. [ M. Brassard ] |
| Preventive action | Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. [ ISO 9000:2000 ] |
| preventive maintenance | Maintenance performed for the purpose of preventing problems before they occur. |
| problem | A user-encountered difficulty. Problems may result from failures, misuse, or misunderstanding. Problems are human events, as opposed to failures, which are system events. |
| Procedure | Specified way to carry out an activity or a process. [ ISO 9000:2000 ] |
| Procedure process | A description of the logical sequence of activities to perform a procedure. Covers what, when, where, and by whom. |
| Procedure purpose | The reason for the procedure. It is important to know the objective of the document and why the reader should follow the process. |
| Procedure records | The information and data saved during the process for use in other processes and as proof of compliance to requirements. |
| Procedure references | A list of related documents mentioned in the Process section. |
| Procedure responsibilities | The roles and authority for process users and process managers organized by job titles. |
| Procedure scope | The boundaries of the procedure. It describes which activities are covered and the applicability of the document to functional areas. |
| Process | A particular method of doing something, generally involving a number of steps or operations. |
| Process | The combination of people, machine and equipment, raw materials, methods, and environment that produces a given product or service. [ M. Brassard ] |
| Process | Set of interrelated or interacting activities which transforms inputs into outputs. [ ISO 9000:2000 ] |
| Process Capability | The measured, built-in reproducibility (consistency) of the product turned out by the process . Such a determination is made using statistical methods, not wishful thinking. The statistically determined pattern or distribution can only then be compared to specification limits to decide if a process can consistently deliver product within those parameters. [ M. Brassard ] |
| Process Failure Mode and Effects Analysis (PFMEA) | An analytical technique used by a manufacturing responsible engineer/team as a means to assure that, to the extent possible, potential failure modes and their associated causes/mechanisms have been considered and addressed. [ APQP Reference Manual, guidance for QS-9000 ] |
| Process quality audit | An analysis of elements of a process and appraisal of completeness, correctness of conditions, and probable effectiveness. [ ANSI / ASQ A3 ] |
| Process validation | Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. [ FDA QSR ] |
| Product | Result of a process. (May be services, software, hardware or processed materials, or a combination thereof.) [ ISO 9000:2000 ] |
| Product liability or Service liability | A generic term used to describe the onus on a producer or others to make restitution for loss related to personal injury, property damage, or other harm caused by a product or service. [ ANSI / ASQ A3 ] |
| Product or service liability | 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. |
| Product quality audit | A quantitative assessment of conformance to required product characteristics. [ ANSI / ASQ A3 ] |
| Project | 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. [ ISO 9000:2000 ] |
| QEM | Quality Engineering Memorandum. Summarizes issues found during specific activities defined in the Quality Engineering Plan for a project. |
| QFD | Quality Function Deployment |
| QMS | Quality Management System (see Quality system ) |
| QS-9000 | Quality system requirements for suppliers to Daimler Chrysler, Ford and General Motors |
| QSR | Quality System Requirements |
| Qualification process | Process to demonstrate the ability to fulfill specified requirements. [ ISO 9000:2000 ] |
| quality | The degree to which a system, component, or process meets specified requirements. |
| Quality | A subjective term for which each person has his or her own definition. In technical usage, quality can have two meaningso 1) the characteristics of a product or service that bear on its ability to satisfy stated or implied needs and 2) a product or service free of deficiencies. |
| Quality | The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. [ ANSI / ASQ A3 ] |
| Quality | The totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance. [ FDA QSR ] |
| Quality | Degree to which a set of inherent (existing) characteristics fulfils requirements. [ ISO 9000:2000 ] |
| Quality assessment | The operational techniques and activities used to evaluate the quality of processes, practices, programs, and services. |
| quality assurance | A planned program consisting of: all actions necessary to provide adequate confidence that an item or product conforms to established technical requirements; and, activities designed to evaluate the process by which products are developed or manufactured. |
| Quality assurance | All those planned or systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for . [ ANSI / ASQ A3 ] |
| Quality assurance | Part of quality management focused on providing confidence that quality requirements will be fulfilled. [ ISO 9000:2000 ] |
| Quality assurance/quality control | Two terms that 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. (For a detailed discussion on the multiple definitions, see ANSI/ISO/ASQC A3534-2, Statistics--Vocabulary and Symbols--Statistical Quality Control.) One definition of quality assurance iso 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 iso the operational techniques and activities used to fulfill requirements for quality. Often, however, "quality assurance"and "quality control"are used interchange |
| quality attribute | A feature or characteristic that affects an item's quality. |
| Quality audit | 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. |
| Quality audit | (also quality assessment, or conformity assessment) A systematic and independent examination and evaluation to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. (se Quality system audit ) [ ANSI / ASQ A3 ] |
| Quality characteristic | Inherent characteristic of a product, process or system related to a requirement. [ ISO 9000:2000 ] |
| Quality circles | Quality improvement or self-improvement study groups composed of a small number of employees--10 or fewer--and their supervisor. Quality circles originated in Japan, where they are called quality control circles. |
| Quality control | The operational techniques and activities used to ensure that that quality standards are met. |
| Quality control | The operational techniques and the activities used to fulfill requirements of . [ ANSI / ASQ A3 ] |
| Quality control | Part of quality management focused on fulfilling quality requirements. [ ISO 9000:2000 ] |
| Quality engineering | That branch of engineering which deals with the principles and practice of product and service quality assurance and control . [ ANSI / ASQ A3 ] |
| Quality Engineering Plan | The document describing the plan for accomplishing independent system testing and quality assurance activities for a given project, within specified resources. |
| quality factor | Synonymous with quality attribute; however, in a hierarchy of quality attributes, higher level attributes may be called quality factors, lower level attributes called quality attributes. |
| Quality improvement | Part of quality management focused on increasing the ability to fulfill quality requirements. [ ISO 9000:2000 ] |
| Quality loop; Quality spiral | Conceptual model of interacting activities that influence the of a product or service in the various stages ranging from the identification of needs to the assessment of whether these needs have been satisfied. [ ANSI / ASQ A3 ] |
| Quality management | The aspect of the overall business management function that determines and implements the quality policy . [ ANSI / ASQ A3 ] |
| Quality management | Coordinated activities to direct and control an organization with regard to quality. [ ISO 9000:2000 ] |
| Quality management system | Management system to direct and control an organization with regard to quality. [ ISO 9000:2000 ] |
| Quality manual | Document specifying the quality management system of an organization. [ ISO 9000:2000 ] |
| Quality measure | A quantitative measure of the features and characteristics of a product or service. [ ANSI / ASQ A3 ] |
| quality metric | A quantitative measure of the degree to which an item possesses a given quality attribute. |
| Quality Objective | Something sought, or aimed for, related to quality. The objectives are generally based on the quality policy of an organization and specified for relevant functions and levels in the organization. [9] |
| Quality Plan | A document setting out the specific quality practices, resources, and activities relevant to a particular product, process , service, contract, or project. [ ANSI / ASQ A3 ] |
| Quality plan | Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract. [ ISO 9000:2000 ] |
| Quality plan audit | See Quality system audit |
| Quality Planning | A structured process for defining the methods (i.e., measurements, tests) that will be used in the production of a specific product or family of products (i.e., parts, materials). (See Quality Plan ) [ QS-9000 ] |
| Quality planning | Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives. [ ISO 9000:2000 ] |
| Quality policy | Overall intentions and direction of an organization related to quality as formally expressed by top management. [ ISO 9000:2000 ] |
| Quality Surveillance | The frequent or constant monitoring and verification of the status of an entity and analysis of records to ensure specified requirements are being fulfilled. |
| Quality surveillance | The continuing monitoring and verification of the status of procedures, methods, conditions, products, processes , and services, and analysis of records in relation to stated references to ensure that requirements for are being met. [ ANSI / ASQ A3 ] |
| Quality system | The organizational structure, responsibilities, procedures, processes , and resources for implementing quality management . [ ANSI / ASQ A3 ] |
| Quality system audit | A documented activity performed to verify , by examination and evaluation of objective evidence, that applicable elements of the quality system are suitable and have been developed, documented, and effectively implemented in accordance with specified requirements. [ ANSI / ASQ A3 ] |
| Quality system review | A formal evaluation by management of the status and adequacy of the quality system in relation to quality policy and/or new objectives resulting from changing circumstances. [ ANSI / ASQ A3 ] |
| Quality trilogy | 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). |
| Quality values | The principles and beliefs that guide an organization and its people toward the accomplishment of its vision, mission, and quality goals. Examples might be "meeting our customers' needs is always our first priority" or "we build quality widgets, at a profit if we can, at a loss if we must, but always quality widgets." |
| RAB | Registrar Accreditation Board (U.S.) |
| random failure | A failure whose occurrence is unpredictable except in a probabilistic or statistical sense. |
| Range | A measure of the variation in a set of data. It is calculated by subtracting the lowest value in the data set from the highest value in that same set. [ M. Brassard ] |
| Reaction Plan | The action specified by a Control Plan when nonconforming product or process instability is identified. [ QS-9000 ] |
| Realization (as used in ISO 9000:2000) | The carrying out of an action or process to completion. [dictionary] |
| Record | Document stating results achieved or providing evidence of activities performed. [ ISO 9000:2000 ] |
| Registrar | A third party organization that conducts independent audits of a company’s quality system to ensure it complies with requirements. |
| Registrar | A company that conducts quality system assessments to the Quality System Requirements. [ QS-9000 ] |
| Registration | When a quality system complies with the ISO 9001 standard, the registrar issues a certificate of registration and places the company’s name in a directory of registered firms. |
| Regrade | Alteration of the grade of a nonconforming product in order to make it conform to requirements differing from the original ones. [ ISO 9000:2000 ] |
| regression testing | Selective retesting of a system or component to verify that modifications have not caused unintended effects and that the system or component still complies with its specified requirements. |
| Relative quality | Degree of excellence of a product or service. [ ANSI / ASQ A3 ] |
| Release | Permission to proceed to the next stage of a process. [ ISO 9000:2000 ] |
| reliability | The ability of a system or component to perform its required functions under stated conditions for a specified period of time. |
| Reliability | The probability that an item will continue to function at customer expectation levels at a measurement point, under specified environmental and duty cycle conditions. [ APQP Reference Manual, guidance for QS-9000 ] |
| Reliability | The ability of an item to perform a required function under stated conditions. [ ANSI / ASQ A3 ] |
| Reliability engineering | That engineering function dealing with the principles and practices related to the design, specification , assessment, and achievement of product or system reliability requirements and involving aspects of prediction, evaluation, production, and demonstration. [ ANSI / ASQ A3 ] |
| Repair | Action taken on nonconforming product so that the product will fulfill the intended usage although the product may not conform to the original requirements. [ QS-9000 ] |
| Repair | Action on a nonconforming product to make it acceptable for the intended use. [ ISO 9000:2000 ] |
| reproducible | The characteristic of being able to generate the same results from a given process. |
| requirement | A condition or capability that must be met or possessed by a software component to satisfy a contract, standard, specification, or other formally imposed document. |
| Requirement | Need or expectation that is stated, generally implied or obligatory. [ ISO 9000:2000 ] |
| reusability | The degree to which a software module or other work product can be used in more than one computer program or software system. |
| review | Process or meeting during which a work product, or set of work products, is presented to project personnel, managers, users, customers, or other interested parties for comment or approval. Types include code, design, formal qualification, requirements, and test readiness reviews. |
| Review | Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives. [ ISO 9000:2000 ] |
| Rework | Action taken on a nonconforming product so that it will fulfill the specified requirements before it is released for distribution. [ FDA QSR ] |
| Rework | Action on a nonconforming product to make it conform to the requirements. [ ISO 9000:2000 ] |
| Right the first time | A term used to convey the concept that it is beneficial and more cost-effective to take the necessary steps up front to ensure a product or service meets its requirements than to provide a product or service that will need rework or not meet customer's needs. In other words, an organization should engage in defect prevention rather than defect detection. |
| Root cause | The original cause or reason for a condition. The root cause of a condition is that cause which, if eliminated, guarantees the condition will not recur. |
| Runs | The patterns in a Control Chart within which a number of points line up on only one side of the central line. [ M. Brassard ] |
| RvC | Raad voor de Certificatie (Dutch Council for Certification) |
| SAE | Society of Automotive Engineers |
| Sample | One or more individual events or measurements selected from the output of a process for purposes of identifying characteristics and performance of the whole. [ M. Brassard ] |
| SCC | Standards Council of Canada |
| Scope | The scope of registration defines the company sites, product lines, and operations covered by an ISO 9001 certificate. |
| Scrap | Action on a nonconforming product to preclude its originally intended use. [ ISO 9000:2000 ] |
| SEI | Software Engineering Institute of Carnegie-Mellon University |
| Service | An intangible product that is the result of at least one activity performed at the interface between the supplier and the customer. |
| Seven tools of quality | 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 (see individual entries). |
| Sigma () | The Greek letter used to designate the estimated standard deviation . [ M. Brassard ] |
| Simulation | The practice of mimicking some or all of the behavior of one system with a different, dissimilar system. [ APQP Reference Manual, guidance for QS-9000 ] |
| Simultaneous Engineering | A way of simultaneously designing products, and the processes for manufacturing those products, through the use of cross-functional teams to assure manufacturability and to reduce cycle time. [ APQP Reference Manual, guidance for QS-9000 ] |
| Six Sigma | Quality process, developed at Motorola, focused on reducing defects to a six sigma level (3.4 defects per million parts ; 0.00034%), for all practical purposes zero defects. |
| SMWT | Self-managed work teams |
| software | Computer programs, procedures, and possibly associated documentation and data pertaining to the operation of a computer system. |
| Software | An intellectual creation consisting of information expressed through supporting medium. [ ANSI/ASQ Q9000-1 ] |
| software element | Any part of software which can be described as a single entity for some purpose. |
| software work product | Any artifact created as part of defining, maintaining, or using a software process, including process descriptions, plans, procedures, computer programs, and associated documentation, which may or may not be intended for delivery to the customer or end user. |
| SPC | Statistical Process Control (see below) |
| Special Cause | A source of variation that is intermittent, unpredictable, unstable; sometimes called an assignable cause. [ M. Brassard ] |
| Specification | The document that prescribes the requirements with which the product or service has to conform . [ ANSI / ASQ A3 ] |
| Specification | The engineering requirement for judging acceptability of a particular characteristic. Chosen with respect to functional or customer requirements for the product, a specification may or may not be consistent with the demonstrated capability of the process (if it is not, out-of-specification parts are certain to be made). A specification should never be confused with a control limit . [ M. Brassard ] |
| Specification | Document stating requirements [ ISO 9000:2000 ] |
| specification change notice (SCN) | A document used in configuration management to propose, transmit, and record changes to a specification. |
| SPI | software process improvement |
| SQC | Statistical Quality Control (see below) |
| Stakeholder | An individual or group of individuals with a common interest in the performance of the supplier organization and the environment in which it operates. [ ANSI/ASQ Q9000-1 ] |
| standard | Mandatory requirements employed and enforced to prescribe a disciplined uniform approach to software development. |
| Standard Deviation | A measure of the spread of the process output or the spread of a sampling statistic from the process (e.g., of subgroup averages ), denoted by the Greek letter (sigma ) for the estimated standard deviation. See Sigma [ M. Brassard ] |
| Statistical Control | The condition describing a process from which all special causes have been removed, evidenced on a control chart by the absence of points beyond the control limits and by the absence of non-random patterns or trends within the control limits. [ M. Brassard ] |
| Statistical Process Control | The application of statistical techniques to the control of processes . [ ANSI / ASQ A3 ] |
| Statistical Process Control | The use of statistical techniques such as Control Charts to analyze a process or its output to take appropriate actions to achieve and maintain a state of statistical control and to improve the capability of the process. [ M. Brassard ] |
| Statistical Quality Control | The application of statistical techniques to the control of . [ ANSI / ASQ A3 ] |
| STR | Software Trouble Report a formal report stating a limitation of the system under test. An STR is generated by the TDRB and is based on a TIF. |
| Stratification | The process of classifying data into subgroups based on characteristics or categories. [ M. Brassard ] |
| Supplier | Organization or person that provides a product. [ ISO 9000:2000 ] |
| Supplier quality assurance | Confidence that a supplier's product or service will fulfill its customers' 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 neededo 1) define product and program quality requirements, 2) evaluate alternative suppliers, 3) select suppliers, 4) conduct joint quality planning, 5) cooperate with the supplier during the execution of the contract, 6) obtain proof of conformance to requirements, 7) certify qualified suppliers, 8) conduct quality improvement programs as required, and 9) create and use supplier quality ratings. |
| System | A set of well-defined and well-designed processes for meeting the organization's quality and performance requirements. |
| System | Set of interrelated or interacting elements. [ ISO 9000:2000 ] |
| system testing | Testing conducted on a complete, integrated system to evaluate the system's compliance with its specified requirements. |
| TDRB | Test Data Review Board, a panel composed of various government and civilian witnesses and evaluators of a formal qualification test. |
| Technical expert (in an audit) | Person who provides specific knowledge of or expertise on the subject to be audited. [ ISO 9000:2000 ] |
| Test | Determination of one or more characteristics according to a procedure. [ ISO 9000:2000 ] |
| test case | A set of test inputs, execution conditions, and expected results developed for a particular objective such as to exercise a particular program path or to verify compliance with a specific requirement. |
| test class | A generalization describing the type of test represented by one or more test cases. |
| test criteria | The criteria that a system or component must meet in order to pass a given test. |
| test procedure | Documentation specifying a sequence of actions for the execution of a test. |
| testability | The degree to which the specification of a requirement, or the implementation of a system or component, facilitates the establishment of test criteria and performance of tests to determine whether those criteria have been met. |
| Testing | A means of determining the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating actions and conditions. [ ANSI / ASQ A3 ] |
| TGA | Germany Association for Accreditation |
| TIF | Test Incident Form a form used by the sponsor's test witnesses during official tests to record notes regarding unexpected software or hardware occurrences. A TIF does not constitute a formal report. TIFs are reviewed by a panel (generally, the TDRB) to determine if the issue is significant. If so, the TIF is used to create an STR. |
| TL 9000 | Quality system requirements for suppliers to the telecommunications industry |
| Top management | Person or group of people who directs and controls an organization at the highest level. [ ISO 9000:2000 ] |
| Top-management commitment | 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, participating in quality improvement teams, reviewing progress organizationwide; recognizing those who have performed well, and revising the current reward system to reflect the importance of achieving the quality goals. |
| Total quality management (TQM) | A term initially coined 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. The methods for implementing this approach are found in the teachings of such quality leaders as Philip B. Crosby, W. Edwards Deming, Armand V. Feigenbaum, Kaoru Ishikawa, and J. M. Juran. |
| TPM | Total productive maintenance |
| TQM | Total quality management |
| traceability | The degree to which a relationship can be established between two or more products of the development process, especially products having a predecessor-successor or master-subordinate relationship to one another; for example the degree to which the requirements and design of a given software component match. |
| Traceability | Ability to trace the history, application or location of that which is under consideration. [ ISO 9000:2000 ] |
| TRR | Test Readiness Review - A review conducted to evaluate preliminary test results for one or more configuration items; to verify that the test procedures for each configuration item are complete, comply with the test plans and descriptions and satisfy test requirements; and to verify that a project is prepared to proceed to formal testing of the configuration items. |
| U chart | count per unit chart |
| UCL | Upper control limit (see Control limit ) |
| unit testing | Testing of individual hardware or software units or groups of related units. |
| usability | The ease with which a user can learn to operate, prepare inputs for, and interpret outputs of a system or component. |
| USL | Upper specification limit (see Specification ) |
| validation | The process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements. |
| Validation | Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. [ FDA QSR ] |
| Validation | Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. [ ISO 9000:2000 ] |
| Value-adding process | Those activities that transform an input into a customer-usable output. The customer can be internal or external to the organization. |
| Variables | Those characteristics of a part that can be measured. Examples are length in millimeters, resistance in ohms, closing effort of a door in kilograms, and the torque of a nut in foot pounds. (See Attributes ) [ M. Brassard ] |
| Variation | The inevitable difference among individual outputs of a process . The sources of variation can be grouped into two major classes: Common Causes and Special Causes . [ M. Brassard ] |
| verification | The process of evaluating a system or component to determine whether the products of a given development phase satisfy the conditions imposed at the start of that phase. |
| Verification | The act of reviewing, inspecting , testing , checking, auditing, or otherwise establishing and documenting whether items, processes , services, or documents conform to specified requirements . [ ANSI / ASQ A3 ] |
| Verification | Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. [ FDA QSR ] |
| Verification | Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. [ ISO 9000:2000 ] |
| Vital few, useful many | A term used by J. M. Juran to describe his use of the Pareto principle, which he first defined in 1950. (The principal was used much earlier in economics and inventory control methodologies.) The principle suggests that most effects come from relatively few causes; that is, 80% of the effects come from 20% of the possible causes. The 20% of the possible causes are referred to as the "vital few"; the remaining causes are referred to as the "useful many." When Juran first defined this principle, he referred to the remaining causes as the "trivial many", but realizing that no problems are trivial in quality assurance, he changed it to "useful many". |
| Voice of the Customer | Customer feedback both positive and negative; including likes, dislikes, problems and suggestions. [ APQP Reference Manual, guidance for QS-9000 ] |
| Voice of the Process | Statistical data that is feedback to the people in the process to make decisions about the process stability and/or capability as a tool for continual improvement. See Statistical Process Control ) [ APQP Reference Manual, guidance for QS-9000 ] |
| waiver | A written authorization to accept a configuration item or other designated item which, during production or after having been submitted for inspection, is found to depart from specified requirements, but is nevertheless considered suitable for use as is or after rework by an approved method. |
| Waiver | Written authorization to use or release a quantity of material, components , or stores already manufactured but not conforming to the specified requirements . [ ANSI / ASQ A3 ] |
| walkthrough | A static analysis technique in which a designer or programmer leads members of the development team and other interested parties through a segment of documentation or code, and the participants ask questions and make comments about possible errors, violation of development standards, and other problems. This term is often used interchangeably with the more general term "review"; i.e., a walkthrough can be considered a type of review. |
| Work environment | Set of conditions under which work is performed. [ ISO 9000:2000 ] |
| Workforce | The union and non-union employees of an organization, as well as the labor union(s) where applicable. The term "workforce" is generally used to describe non-management employees, unless otherwise indicated. |
| Zero defects | A performance standard developed by Philip B. Crosby to address a dual attitude in the workplaceo people are willing to accept imperfection in some areas, while, in other areas, they expect the number of defects to be zero. This dual attitude had developed because of the conditioning that people are human and humans make mistakes. However, the zero defects methodology states that, if people commit themselves to watching details and avoiding errors, they can move closer to the goal of zero. |
| Zero Defects | The quality concept of zero tolerance for defects (see Six Sigma ) |
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