Quality control definition

As stated above the Surveyor s role will include an assessment of the yard s quality control department including the suppliers of any contracted NDE services. The Surveyor will look for the employment of qualified personnel, the availability of adequate inspection procedures and the presentation of definitive NDE reports. 

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. ... 

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],... 

For purposes of quality control, any cell preparation used in the screen (see below) needs to have a definitive or consensus diagnosis and grading determined by histological examination. Furthermore, tumor cell preparations must be at least 80% tumor cells (as determined by cytopathological examination), whereas normal cell preparations must be devoid of any tumor cells. Cell viability, determined by trypan-blue exclusion, must be a minimum of 70%, and the signal-to-noise ratios for a predetermined cell cluster concentration must be at least threefold. 

Presently there is no definitive text in HPLC that specifically addresses the needs of the busy pharmaceutical scientist on the pivotal subject of pharmaceutical analysis. This handbook strives to offer a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. The Handbook of Pharmaceutical Analysis by HPLC can be broadly classified into six major sections ... 

We would like to thank all of the authors for their valuable efforts in making this book serve as a definitive reference source on CE for laboratory analysts, researchers, managers/ executives in industry, academia, and government who are engaged in various phases of analytical research and development or in quality control. 

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. 

A prerequisite for any quality control is the definition of how the characteristics of a specific raw material, an intermediate product or a final product of a manufacturing process should be described. This means that all characteristics for every single product have to be defined in adequate standards and specifications so that the results obtained can be compared with these data. Numerous standards and specifications have been established in more or less official specification collections, for example pharmacopoeias, the aforementioned ISO or DIN standards, standards of the Essential Oil Association or the American Spice Trade Organization (ASTA). 

There are many reasons for the need to validate analytical procedures. Among them are regulatory requirements, good science, and quality control requirements. The Code of Federal Regulations (CFR) 311.165c explicitly states that the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Of course, as scientists, we would want to apply good science to demonstrate that the analytical method used had demonstrated accuracy, sensitivity, specificity, and reproducibility. Finally management of the quality control unit would definitely want to ensure that the analytical methods that the department uses to release its products are properly validated for its intended use so the product will be safe for human use. 

It is important to issue a common understanding on the topics of method validation, traceability, and uncertainty of measurements. Here, the interrelationships between method validation, traceability, and MU of results will be elucidated. Throughout the landscape of guidelines and standards, the most relevant information is selected, compiled, and summarized. Great importance is attached to the different method performance parameters and their definitions, ways of expression, and approaches for practical assessment. We discuss the role of method validation within QA as well as the topics of standardization, internal and external quality control (IQC and EQC, respectively), and accreditation and the links between these different aspects. 

A number of issues were addressed in the general sessions that were common to all six of the proposed protocols. These included definitions of each of the sample media, limitations of the protocols, guidelines for the fractionation of samples found to be toxic in the Salmonella assay, and analytical quality control considerations. 

This observation has become an important contributor to the development of rapid, automatic scanning of outer tissues of grains (primarily bran tissues) which contribute both strong color and taste characteristics to grain products such as wheat flour. The ability to measure both the concentration and distribution of such components is paramount to quality control in bakeries, and to definition of raw materials. An example of the systems necessary for routine analysis is included in a following section. 

The present sensor could easily discriminate between some kinds of commercial drinks such as coffee, beer and aqueous ionic drinks (Figure 11) [22], Since the standard deviations were 2 mV at maximum in this experimental condition, these three output patterns are definitely different. If the data are accumulated in the computer, any food can be easily discriminated. Furthermore, the taste quality can also be described quantitatively by the method mentioned below. In biological systems, patterns of frequency of nerve excitation may be fed into the brain, and then foods are distinguished and their tastes are recognized [4-8]. Thus, the quality control of foods becomes possible using the taste sensor, which has a mechanism of information processing similar to biological systems. 

Precise definition of the host-protection epitope(s) of the Taenia and Echinococcus vaccine antigens would be valuable if it were to lead to the development of a synthetic vaccine or provide reagents to assist with quality control of vaccine production. Identification of a limited number of host-protective fragments may allow the recombinant antigen to be replaced by synthetic peptides. This would have significant advantages in the production... 

EOQC (1980) European Organization for Quality Control, 4th European Seminar (1980) Validation of Manufacturing Processes (Geneva) [5] Definitions, installation and operational qualification, development and manufacturing phase, responsibilities and organization, use of historical data, change control and revalidation... 

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. 

We are working with the Food Quality Control Department of the Ministry of Health to study the contamination of OCPs and PCBs in local fish and chickens. This project is in line with our current effort to assess the health risk arising from consumption of food contaminated with POP chemicals. The health risk assessment of POPs through dietary intakes project involved analyses of OCPs and PCBs in various foodstuff, initially raw materials which will be extended to cooked food. Unfortunately, we do not currently have the capability to analyze PCDD/PCDF in our laboratory but there are two high resolution mass spectrometers in the country that are capable of analyzing PCDD/PCDF. National and international collaborations will definitely improve the country capacity to monitor POPs not only those listed in the Stockholm Convention but other toxic chemicals found in the environment. 

The results of the analysis were compared with the mean values, and acceptable ranges of the commer--cial quality-control products provided by the manufactures. However, a definition of the acceptable ranges is not given. The mean values of the concentrations of NA and DA determined using the three modified HPLC methods agree well with the means and fall within the acceptable ranges of both control samples. 

A quality audit has been defined as A systematic, independent examination of a manufacturer s quality system that is performed at defined intervals and sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives 21 CFR 820.2 (t). Another definition is Quality Audit A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives (International Organization for Standardization/American Society for Quality Control). 

The quality control of the main enological parameters of commercially available wines, according to EC regulation (EC No. 822,1987), is almost nonexistent in the literature (Nogueira and Nascimento, 1999). The physicochemical and sensorial parameters must also be definitely controlled as a strategy to confirm the authenticity and to prevent or detect possible adulterations (Nogueira and Nascimento, 1999), which contributes to increase consumer confidence. Nogueira and Nascimento (1999) were... 

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