Technical terms of quality management: Q
Quality assurance instruction.
Qualität und Entwicklung in Praxen [Quality and Development in Practices]. German modular quality management system for doctor‘s offices that can be implemented one step at a time. It is used for the efficient and effective implementation of legal obligations in the individual practices. The Kassenärztliche Bundesvereinigung, together with employees from the national health medical organizations, doctors in private practice, psychotherapists, quality management experts, doctor‘s assistants and professional organizations, developed QEP.
Quality Management Center of the VDA, see VDA-QMC.
Quality Policy Deployment. See Management by policy.
Quality Steering Committee.
Fulfillment of the requirements for the current condition that is verified in a unit. (On the basis of DIN 55350-11)
Process to demonstrate the suitability to fulfill specified requirements. The term “qualified” indicates the corresponding status. Qualification can relate to people, products, processes or systems, e.g., auditor qualification process, material qualification process. (On the basis of ISO 9000:2015)
Values of a characteristic that are assigned to a scale without stipulated intervals. (On the basis of DIN 55350-12)
Characteristics that allow statements such as yes/no or good/poor.
Degree to which a set of inherent characteristics fulfills requirements. “Inherent” means “existing in a unit. The term “quality“ can be used in combination with adjectives such as “poor“, “good“ or “excellent“. (On the basis of ISO 9000:2015)
Part of quality management that is used to instill confidence that the quality requirements are fulfilled. (On the basis of ISO 9000:2015)
Quality assurance agreement
Contractual agreement between a supplier and its customer as a supplement to the purchase or supply agreements. A QAA contains agreements on the sequence organization and actions for quality assurance before, during and after production. For example, this includes the quality management system evaluation, system audits, first article inspections, evidence of process and machine capability, inspections, evidence, documents, complaint handling, guarantee regulations, handling technical changes and also product liability questions.
Quality audit finding
Quality audit report
Quality audit types
Suitability of an organization or parts of an organization to realize a product that will fulfill the quality requirement for this unit.
(DGQ Volume 11-04:2009)
Inherent characteristic of a product, process, or system that refers to a requirement. Inherent means “existing in a unit“, particularly when it involves a permanent characteristic. A characteristic that is assigned to a product, process, or system (e.g. the price or owner of a product) is not seen as a quality characteristic of that product, process, or system. (On the basis of ISO 9000:2015)
A small group (6 –10 employees) set up permanently in which employees in a hierarchical level who have a common basis of experience voluntarily get together at regular intervals. The objective is to analyze topics from the group‘s own work area and to develop and present suggestions for improvement under the direction of a trained moderator with the help of special techniques for problem-solving and creativity. The group, which is integrated into the organizational framework of the quality circle system, can also implement suggestions and check the results itself or through normal channels.
- Inspection of products by inspectors after completed manufacture. This term is often also used as a synonym for quality inspection, quality audit or quality management demonstration.
- Part of quality management focused on fulfilling quality requirements. (On the basis of ISO 9000:2015)
Quality control chart
The quality control chart is a quality tool (Q7) for monitoring and controlling a manufacturing process on a statistical basis. Process data (measured values or performance data) are collected over a longer time and graphically represented with the help of a control chart (form with coordinate system). The mean value, warning limits, action limits and tolerance limits are drawn in ahead of time. The plot of the data makes it possible to draw conclusions about the process capability.
Data regarding the quality of units. They provide information on the applied quality inspections, the general conditions that prevailed during the inspections, and possibly on the particular associated requirement while determining the quality. (On the basis of DIN 55350-11)
That part of the organizational structure that deals primarily with quality management activities. On the basis of the quality policy, the quality department specifies objectives and responsibilities in order to satisfy legitimate customer requirements. Its assignment is the planning, control, assurance and improvement while using all available resources, such as finances, personnel and equipment. In a certain sense, quality management is the task of all employees. In contrast, the quality department means those departments, locations and inspection bodies in which quality control activities predominate.
Unit that contributes to quality. (On the basis of DIN 55350-11)
Quality record that serves as evidence that the quality requirement placed on a product is fulfilled.
Quality Function Deployment
Method in quality management that is used to conceive, manufacture and sell products and services that are what the customer really wants. All departments are included in this process. Yoji Akao from Japan developed this method as a basic concept for quality planning. The QFD quality method is one of the methods that is used to prevent nonconformities. It is used during the product planning phase. QFD is often called the “voice of the customer“. This is because QFD‘s systematic approach does not end with the comparison of customer requirements and product characteristics. Instead, it continues through to the observation of process characteristics in line with the requirements.
Part of quality management that focuses on increasing the ability to fulfill quality requirements. The requirements can involve any aspect such as effectiveness, efficiency or traceability, (On the basis of ISO 9000:2015)
Relative or scaled characteristic value to assess quality; it is determined according to the selected performance measurement system.
Remark 1: As a rule, quality indicators are used to assess series manufacturing. (DGQ Volume 11-04:2009)
Inspection to determine the degree to which a unit fulfils the quality requirement. (On the basis of DIN 55350-17)
Proportion of nonconforming units or number of nonconformities in percent in relation to the lot or sampling unit. (On the basis of ISO 3534-2:2013)
Losses in processes and activities caused by the use of unsuitable resources, the failure to exhaust available resources, and the waste of available resources.
Remark 1: Some examples of quality losses are: loss of customer satisfaction and missed opportunities to enhance the value for customers, the organization or society. (DGQ Volume 11-04:2009)
Coordinated activities to direct and control an organization with regard to quality. Normally this also includes establishing the quality policy and quality objectives, quality planning, quality control, quality assurance and quality improvement. (On the basis of ISO 9000:2015)
Quality management agreement
Agreement formally concluded between the customer or client and the supplier or contractor to stipulate the responsibilities for quality management jobs before and after the passing of risk.
(DGQ Volume 11-04:2009)
Quality management demonstration
Part of quality management intended to generate trust that the quality requirements can be fulfilled.
Quality management document
Quality management element
Quality management evaluation
Quality management leadership element
Management element in which the rules regarding management in implementing the policy are defined.
(DGQ Volume 11-04:2009)
Quality management principles
The seven principles of quality management systems are described in the ISO 9000:2015 standard. They constitute the basis for the standards on quality management systems in the ISO 9000 family:
a) Customer focus: Organizations depend on their customers. Consequently they should understand the customers‘ current and future needs, fulfill their requirements and strive to surpass the customer expectations.
b) Leadership: Managers ensure that the organization is aligned with its purpose. Managers are tasked with creating and maintaining an internal environment in which people can fully commit to achieving the organization‘s goals.
c) Involvement of people: People at all levels make an organization what it is. If they are fully included they can uses their abilities for the benefit of the organization.
d) Process approach: When activities and associated resources are controlled and managed as a process it is possible to achieve a desired result more efficiently.
e) Continual improvement: Continual improvement of the organization‘s overall performance is one of the organization‘s permanent objectives.
f) Factual approach to decision making: Effective decisions can be made if they are based on the analysis of data and information.
g) Mutually beneficial supplier relationships: An organization and its suppliers depend on one another. Relationships that benefit both parties increase the ability of both parties to create value. (On the basis of ISO 9000:2015).
You can find out more about this in the Quality management principles.
Quality management procedure instruction
Quality management representative
Representative of top management. Management member appointed by top management. He/she has the authority and responsibility to introduce and maintain a quality management system.
Quality management system
Management system used to direct and control an organization with regard to quality. (On the basis of ISO 9000:2015)
Document in which an organization‘s quality management system is defined and anchored. Quality manuals can vary in detail and format depending on an organization‘s size and complexity. (On the basis of ISO 9000:2015)
Quality manual record
Estimate acquired during an inspection by variables to describe the distribution of actual values with regard to a limiting value, limiting amount of deviation, limiting amount, or limiting quantile.
(DGQ Volume 11-04:2009)
Something regarding quality that is aimed for or to be attained. As a rule, quality objectives are based on the organization’s quality policy. They are usually specified for relevant functions and levels in the organization. (On the basis of ISO 9000:2015)
Document that specifies which procedures and associated resources are to be used by whom at which time for a particular project, product, process or contract. These procedures are based on quality management and product realization processes. Often a quality plan refers to parts of the quality manual or to procedure documents. The quality plan is normally also a result of quality planning. (On the basis of ISO 9000:2015)
Part of quality management. This part includes setting the quality objectives, necessary operational processes and related resources in order to reach the quality objectives. Preparing quality management plans can be a part of quality planning. (On the basis of ISO 9000:2015)
An organization‘s overall intentions and direction with regard to quality. This is formally expressed by top management. As a rule, the quality policy is consistent with the organization‘s overall policy and provides a framework for setting quality objectives. Quality management principles given in the ISO 9000 family can be consulted as a basis for the establishment of a quality policy. (On the basis of ISO 9000:2015)
Optimization of the quality capability. Quality promotion is a part of quality improvement. (On the basis of DIN 55350-11)
The “Q7“, also called the seven basic tools of quality, are a collection of quality tools. They were originally compiled to use in the quality circles of Kaoru Ishikawa. These are visualization aids. They are used to detect, understand and finally solve problems. In detail, these are: Inspection list, histogram, quality control chart, Pareto diagram, scatter diagram, brainstorming, and cause and effect diagram (Ishikawa diagram).
A process that is capable of realizing a unit that fulfills the quality requirements for this unit. (DGQ Volume 11-04:2009). The CP and CPK values are indicators used to review processes. The Cp value indicates the dispersion of a quantitative variable with respect to the specification limits. The Cpk value additionally takes the position of the limiting values into account. These indicators are defined in such a way that a process that is just barely usable is assigned a value of “1“.
Prevention, inspection and nonconformity costs that arise in the framework of quality management. These also include costs for quality audits conducted by customers and certifying bodies. (On the basis of DIN 55350-11)
Document that contains instructions for an activity in quality management, a quality requirement for a product, or results of quality inspections.
Points of a distribution function (values of a measuring scale) that describe the set relationships of all points (all measured values). A common quantile is the quartile that divides all points (values) into 4 uniform sets. For example, 25% of all points (measured values) lie below the 1st quartile, 75% lie above the 3rd quartile. The minimum quantile is the name for a specified characteristic value that describes a specified lower limiting proportion and an actual quantile is the name for a characteristic value that is established for a stipulated distribution proportion.
Values of a characteristic that are assigned to a scale with stipulated intervals. (On the basis of DIN 55350-12)
Measurable and countable data.