QIS Quality Information System

QS-9000 A quality standard, based on ISO 9000, used by the American domestic automobile manufacturers to register their suppliers.

Qualification, installation. (FDA) Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer's recommendations are suitably considered.

Qualification, operational. (FDA) Establishing confidence that process equipment and subsystems are capable of consistently operating within established limits and tolerances.
qualification, process performance.(FDA) Establishing confidence that the process is effective and reproducible.

Qualification, product performance. (FDA) Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety.

Quality "Quality is conformance to specifications. "British Defence Industries Quality Assurance Panel "Quality is conformance to requirements." Philip Crosby "Quality is fitness for purpose." Dr Juran "Quality is synonymous with customer needs and expectations." R J Mortiboys "Quality is a predictable degree of uniformity and dependability, at low cost and suited to the market. "Dr Edward Deming "Quality is meeting the (stated) requirements of the customer- now and in the future." Mike Robinson "Quality is the total composite product and service characteristics of marketing, engineering, manufacturing and maintenance through which the product and service in use will meet the expectations by the customer." Armand Feigenbaum "Totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs." ISO 8402 : 1994. Quality The ability of a product, or service, to meet customer requirements, both stated and unstated

Quality Assurance All the planned and systematic activities implemented within the quality systems to provide adequate confidence the requirements for quality will be met.
quality assurance, software. (IEEE) (1) A planned and systematic pattern of all actions necessary to provide adequate confidence that an item or product conforms to established technical requirements. (2) A set of activities designed to evaluate the process by which products are developed or manufactured.

Quality assurance. (1) (ISO) The planned systematic activities necessary to ensure that a component, module, or system conforms to established technical requirements. (2) All actions that are taken to ensure that a development organization delivers products that meet performance requirements and adhere to standards and procedures. (3) The policy, procedures, and systematic actions established in an enterprise for the purpose of providing and maintaining some degree of confidence in data integrity and accuracy throughout the life cycle of the data, which includes input, update, manipulation, and output. (4) (QA) The actions, planned and performed, to provide confidence that all systems and components that influence the quality of the product are working as expected individually and collectively.

Quality Audit A systematic and independent examination to determine quality related activities are implemented effectively and comply with the quality systems and/or quality standards.

Quality Characteristics The characteristics of an output of a process that are important to the customer. Identification of quality characteristics requires knowledge of the customers needs and expectations.

Quality circles 1. Quality improvement teams or groups. 2. In Japan, groups of employees formed for the study of and sharing information regarding quality control issues and theory.

Quality Control The process by which actual product or service performance is measured and compared with a standard, and action is taken to eliminate any non-conformances

Quality Council A group of senior management within given operational units who plan, implement, facilitate, and monitor the QUALITY PROCESS.

Quality Function Deployment (QFD) A requirements identification analysis, flow down, and tracking technique. It focuses on quality and communication to translate customer needs into product and process design specifics. Also known as the "house of quality."
Quality function deployment (QFD) A technique used to translate customer requirements into appropriate goals for each stage of product or service development and output. The two approaches to quality function deployment are known as the House of Quality and the Matrix of Matrices.

Quality improvement A systematic approach to the processes of work that looks to remove waste, loss, rework, frustration, etc. in order to make the processes of work more effective, efficient, and appropriate.

Quality improvement team A group of employees that take on a project to improve a given process or design a new process within an organization.

Quality loss function An algebraic function that illustrates the loss of quality that occurs when a characteristic deviates from its target value. It is expressed often in monetary terms. Dr. Genichi Taguchi coined this term; his work suggests that quality losses vary as the square of the deviation from target.

Quality Management The planned actions taken to ensure the effective implementation of an organization's quality systems.

Quality Manual A document stating the quality policy and describing the quality systems of an organization.

Quality Planning Quality Planning is a structured process for defining the methods that will be used in the production of a specific product or family of products. Quality planning embodies the concepts of defect prevention and continuous improvement as contrasted with defect detection.

Quality Policy A statement and a genuine commitment from Top Management regarding their position relative to Quality Products and/or Services.

Quality Process A planned strategy that ensures all employees will be able to produce defect free work.

Quality Records Quality Records are the documented evidence that the supplier's processes were executed according to the quality system documentation and records results.
Quality System Organizational structure, procedures, processes and resources required to implement quality management.

Random Selecting a sample so each item in the population has an equal chance of being selected; lack of predictability; without pattern.

Random Sample One or more samples randomly selected from the universe (population).

Random Sampling The process of selecting units for a sample of size, so that all units have an equal chance of being selected as the sample.

Random Variable A variable which can assume any value from a set of possible values.

Random Variations Variations in data which result from causes which cannot be pinpointed or controlled.

Range The difference between the highest and lowest values in a set of values or "subgroup."

Range Control Chart Control chart in which the range of the subgroup is used to track the instantaneous variation within a process, i.e. the variation in the process at any one time, when many input factors would not have time to vary enough to make a detectable difference. Range charts are usually paired with average charts for complete analysis.

Ranks Values assigned to items in a sample to determine their relative occurrence in a population.

Record. (1) (ISO) a group of related data elements treated as a unit. [A data element (field) is a component of a record, a record is a component of a file (database)].

Registered Suppliers Registered Suppliers are suppliers who have received third party registration to a specific quality system standard for the commodity supplied.

Regrade Action taken on non-conforming product that changes the classification, or category of the product for use in alternative applications. Cannot be done without customer approval/direction. [Also see Repair/Rework]

Regression analysis A statistical technique used to determine the best mathematical expression to describe the relationship between a response and independent variables.

Regression analysis and testing. (IEEE) A software V&V task to determine the extent of V&V analysis and testing that must be repeated when changes are made to any previously examined software products. See: testing, regression.

Relations Diagram method is a technique developed to clarify intertwined causal relationships in a complex situation in order to find an appropriate solution. It is typically represented graphically as squared ellipses (concepts) connected by directed lines (arrowheads show direction). The directed lines represent causal relations between the concepts.

Release. (IEEE) The formal notification and distribution of an approved version. See: version.

Reliability assessment. (ANSI/IEEE) The process of determining the achieved level of reliability for an existing system or system component.

Reliability The probability of a product or service successfully doing its job under given conditions.

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.

Reliability. (IEEE) The ability of a system or component to perform its required functions under stated conditions for a specified period of time. See: software reliability.

Repair Action taken on non-conforming product so that the product will fulfill the intended usage, although the product may not
conform to the original requirements. [Also see Regrade/Rework]

Replication Observations made under identical test conditions.

Representative Sample A sample which accurately reflects a specific condition or set of conditions within the universe.

Requirement. (IEEE) (1) A condition or capability needed by a user to solve a problem or achieve an objective (2) A condition or capability that must be met or possessed by a system or system component to satisfy a contract, standard. specification, or other formally imposed documents. (3) A documented representation of a condition or capability as in (1) or (2). See: design requirement, functional requirement, implementation requirement, interface requirement, performance requirement, physical requirement.

Requirements analysis. (IEEE) (1) The process of studying user needs to arrive at a definition of a system, hardware, or software requirements. (2) The process of studying and refining system, hardware, or software requirements. See: prototyping, software engineering.

Requirements phase. (IEEE) The period of time in the software life cycle during which the requirements, such as functional and performance capabilities for a software product, are defined and documented.

Resources-those items necessary for a team to understand a problem and implement solutions; also, the time to work on solutions, access to manufacturing engineers, etc.
revalidation. Relative to software changes, revalidation means validating the change itself, assessing the nature of the change to determine potential ripple effects, and performing the necessary regression testing.

Review. (IEEE) A 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 review, design review, formal qualification review, requirements review, test readiness review. Contrast with audit, inspection. See: static analysis.

Rework Action taken on non-conforming product so that it will meet the specified requirements.

RFP Request For Proposal

RFQ Request For Quotation

Risk assessment. (DOD) A comprehensive evaluation of the risk and its associated impact.

Risk The possibility of loss, injury, disadvantage or destruction. Apply this definition to the issues of program management and you have the starting point for successful risk management

Risk. (IEEE) A measure of the probability and severity of undesired effects. Often taken as the simple product of probability and consequence.

Robust design An approach to the planning of new products and services that harnesses Taguchi methods.

Robust The ability of a product or service to function appropriately regardless of external conditions and other uncontrollable factors.

Root Cause Analysis Using one or more various tools to determine the root cause of a specific failure.

Root Cause The lowest level cause of a failure, or variation in a product, component, or process .

RPN Risk Priority Number (ref: FMEA)

Run 1) SPC: A consecutive number of points consistently increasing or decreasing. 2) Production: The production of a specified number of sequential units.

Run chart Also known as a line chart, or line graph. A chart that plots data over time, allowing you to identify trends and anomalies.