Quality assurance, definition

Quality assurance Definition of supplemental indicators, such as specific pollutants, for example to identify causes and sources of impairments and targeting appropriate source controls Development maintain and review of Quality Management Plans and Quality Assurance Project Plans according to EPA policy, in relation with an appropriate level of data quality for an efficient decision... 

Quality assurance definition of, 1967 in electronic production, 431-432 poka-yoke for, 548 TQM, 552... 

The ISO definition states that quality assurance is all those planned and systematic actions necessary to provide adequate confidence that an entity will fulfill requirements for quality. Both customers and managers have a need for quality assurance as they are not in a position to oversee operations for themselves. They need to place trust in the producing operations, thus avoiding constant intervention. 

Although I have defined terms such as quality control and quality assurance in this chapter, what is important is not the definition but the deeds which it imbues. Whether we call the set of principles I have listed under the heading Quality assurance, Quality Assurance, Quality Improvement or Quality Control makes no difference since it does not change the set of principles. We often seem to invent a term then decide what it means rather than invent or discover a set of principles and think of a suitable name which conveys exactly what we intend without confusing people. Instead of saying Quality control is. .. or TQM is. .. to which there will be many propositions, we should be asking What should we call this group of principles so that we can communicate with each other more efficiently As Shakespeare once said That which we call a rose/By any other name would smell as sweet. ... 

Although there are many similar definitions for traceability, the essence of trace-ability is an unbroken pathway to the definition of the accepted units used to express the measurement result and a measurement process in which quality assurance is an integral component. 

Briefly, the quality management system is a combination of quality management, quality control and quality assurance. Quality assurance and quality control are components of the laboratory s quality management system. There is often confusion over the meaning of quality control and quality assurance and regrettably they are often used interchangeably. This is possibly because some quality control and quality assurance actions are interrelated. The definition of the terms can be found in the International Organization for Standardization (ISO) Standard, ISO 9000 2005 [2],... 

Computerized System Requirements and Electronic Records Increasingly, computerized systems and electronic records are part of a laboratory s operations. However, records may be held in both paper and electronic format and the quality assurance required depends to some extent on the format of the definitive document. Because of space requirements involved with paper records and ease of retrieval of electronic records, the latter are gaining in popularity. The same requirements that we have for paper records, e.g. change control, readability and archiving, will still apply to electronic records. For this to be achieved, new procedures may have to be developed. 

Although a united compost quality system of the European Union does not exist, the European Compost Network (ECN), as an initiative of the ORBIT Association developed a Quality Assurance System providing the necessary background information and documentation to build up a European Quality Assurance System (ECN-QAS). Product definitions and characterizations of this system are shown in Table 12.7. 

Quality assurance is defined by Donaobedian as all actions taken to establish, protect, promote, and improve the quality of health care (Donobedian 2003). He describes quality of care as an attribute of a system (structure), a set of organized activities (process), and an outcome that results from both. The definitions are described in Table 3.1. It should be noted that the efficacy of a drug (the ability for improvement under the most favourable circumstances) is included in the structure and that the effectiveness of a dmg (real improvement in the care) is included in the process. 

The management system for process definition documentation should ensure that the contents of the process documentation package are accurate and complete. A suitable review and quality assurance program should be implemented for the process documentation. This may involve a hierarchical review process, and/or using external experts in a review capacity. 

The definitions are for those words and phrases that the reader encounters in the regulations. Examples include quality assurance unit, raw data, reference substance, sponsor, study, study director, test substance, test system, testing facility. See Box 7.4 for these definitions. 

The quality assurance unit (QAU) performs the quality assurance audit. This task is ongoing throughout the study and is the reason for the existence of the QAU. The QAU is the person (see definition of "person" in Box 7.4) designated to perform the quality assurance duties. Thus, the QAU inspects the study to assure integrity and that problems are brought to the attention of the study director. This unit also determines if unauthorized deviations from protocols and SOPs occurred and reviews the final report for accuracy. 

Two important definitions are those of quality control and quality assurance. The former relates to operational techniques and activities, whereas the latter ensures that systematic actions are in place which enable confidence that the results meet the required level of quality, such as accuracy and precision. The concept of total quality control extends to areas such as management style and reduction of waste. 

Definitions of quality assurance and statistics Part 11 - Basic definitions of quality assurance Part 18 - Definitions regarding certification of results of quality tests/quality test certificates 8/95 7/87... 

The FDA established a GLP review task team to identify provisions in the regulations that could be amended or deleted, and this team recommended revisions to 36 GLP provisions. Recommendations were issued as a proposed rule on October 29, 1984 [15]. The proposal made various changes to definitions to reduce the amount of paperwork required for nonclinical laboratory studies and to clarify earlier GLP provisions. Similar clarifications were made to the provisions, delineating the definition and function of the study director and quality assurance unit. 

MIL-STD-105 — Sampling Procedures and Tables for inspection by Attributes MIL-STD-109 — Quality Assurance Terms and Definitions... 

Method validation is a term used for the suite of procedures to which an analytical method is subjected to provide objective evidence that the method, if used in the manner specified, will produce results that conform to the statement of the method validation parameters. Like many aspects quality assurance, method validation is of a relative nature. As with the concept of fitness for purpose, a method is validated for a particular use under particular circumstances. If those circumstances vary, then the method would need to be re-validated at least for the differences. Common sense should be used, and the analysts should use his or her skill and experience to decide what aspects of a method require validation and to what extent. The goal of satisfying client requirements is prominent in most published definitions of method validation, some of which are listed below ... 

Numerous definitions and criteria of quality have been published (JL, jD and in some areas, e.g. Florida, wide ranging guidelines have been adopted and laws enacted for the sole purpose of maintaining quality levels. Extensive advances have been made in quality control or quality assurance programs (8) yet many difficult and complex problems remain as intrinsic components of the industry. Thus as the impetus for quality improvement has evolved, it has become a widely recognized fact that certain technological advances were required before qualitative progress could be realized. 

The International Standards Organization (ISO) definition of audit is Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. The bottom-line goal of the software developer audit process is to allow you to assess the developer s quality assurance (QA) system. 

If the laboratory investigation does not provide a definitive cause for the OOS result, a formal investigation prescribed by a predefined written procedure should commence. The formal investigation should be conducted under the auspices of the quality assurance unit and encompass all other departments that could be implicated, such as production, process development, engineering, and maintenance. 

For the purposes of more clearly differentiating between the laboratory investigation phase and a subsequent formal investigation conducted outside the laboratory, the laboratory investigation will be referred to as phase I, while the formal quality assurance-coordinated investigation will be referred to as phase II. For the purposes of phase I v. phase II, there is a definite difference, in that QC personnel handles the laboratory functions, while quality assurance personnel monitors and coordinates the overall investigative process. 

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