Importance of quality assurance

The importance of quality assurance of chemical measurements not only for global trade but also for a global society has been characterized in a statement by Paul de Bi re, one of the foremimers concerned about analytical results and their use in widespread applications ... 

The importance of quality assurance in any industry is widely acknowledged. More stringent customer expectations with regard to quality, together with the realisation that continued improvements in quality are often necessary for a company to sustain good economic performance, mean that some level of quality assurance is mandatory for all those associated with adhesive bonding operations. The use of technical specifications and quality control procedures go some way towards fulfilling the requirements of a quality system, and these measures are outlined here. 

It is obvious that in any system where quantitative measures are used, accurate measurements are essenti. Allen points out that absolute accuracy is more important for research and development functions whilst for process control, the important criterion is reproducibility or precision. However, modem developments place extra demands on production processes. The increasing importance of Quality Assurance requires knowledge of measurement systems and an ability to trace back the attribution of accuracy to an acceptable standard. 

Using Control Charts for Quality Assurance Control charts play an important role in a performance-based program of quality assurance because they provide an easily interpreted picture of the statistical state of an analytical system. Quality assessment samples such as blanks, standards, and spike recoveries can be monitored with property control charts. A precision control chart can be used to monitor duplicate samples. 

The Kerridge-Bongard model of information is of great importance in quality assurance, in particular for the assessment of interlaboratory studies. Examples of the information-theoretical evaluation of analytical results within the context of interlaboratory comparisons have been given by Danzer et al. [1987, 2001], Wienke et al. [1991] and Danzer [1993]. 

Safety is important in any chemical laboratory but is not normally considered a formal part of quality assurance procedures, unless the lack of safety also imperils the quality of the work. The relevance of safety is based on it being part of good operating practice within a laboratory and this in turn needs to be optimized in order to produce good quality results. Many of the chemicals used, and some of the samples encountered in a laboratory, are dangerous and certain rules should be followed to ensure that they can be handled safely. Most countries have a list of substances which have to be controlled carefully and the maximum level to which workers can be exposed. 

Table 12.4 shows the status of quality assurance of European composting and digestion plants. This is very important for the classification of compost and digestion quality (Table 12.5). 

Stability of calibrants and analytes is another frequently overlooked aspect of quality assurance, which is particularly relevant to surfactants. This aspect is discussed in Chapter 4.4. Very few intercalibration studies have been performed for the surfactant types of analytes (cf. Chapter 4.5). Currently, no certified reference material is available for surfactants. The European Commission has recently tendered for production of a reference material with certified surfactant concentrations [2]. We can conclude that quality assurance in quantitative surfactant analysis is still in its infancy when compared to analysis of PCB or chlorinated dioxins. Notwithstanding this, several important achievements have been made during recent years regarding improvement of the accuracy and reliability of qualitative analysis of surfactants, which will be the subject of the following chapters. 

Because of the status of the CAC described above, the work that it has carried out in the area of laboratory quality assurance must be carefully considered. One of the CAC Committees, the Codex Committee on Methods of Analysis and Sampling (CCMAS), has developed criteria for assessing the competence of testing laboratories involved in the official import and export control of foods. These were recommended by the Committee at its 21st Session in March 19979 and adopted by the Codex Alimentarius Commission at its 22nd Session in June 1997 10 they mirror the EU recommendations for laboratory quality standards and methods of analysis. The guidelines provide a framework for the implementation of quality assurance measures to ensure the competence of testing laboratories involved in the import and export control of foods. They are intended to assist countries in then-fair trade in foodstuffs and to protect consumers. 

If they are incorporated in, say, management systems of quality assurance and occupational safety and environmental protection on a corporate level, guiding principles assume an important function for orientation, especially in the case of persistent knowledge inadequacies about the effects of substances. 

There are a number of quality assurance checks that should be considered before identifying the final list of causal factors. It is important to test for sufficiency of the information when compiling a sequence diagram. This test for sufficiency may be performed by asking one or more of the following questions, when comparing two adjoining facts in the sequence of events ... 

Authentication of genuine flavours is an important topic in view of quality assurance in the food industry and in consumer protection as well. Both isotope discrimination as well as enantioselectivity during biosynthesis may serve as inherent parameters of authenticity, provided that appropriate analytical methods and concise data from authentic samples are available. 

An element of quality assurance ensuring that all tests and measurements used to control and monitor the process or to test the product are capable of producing results that are accurate and precise to the extent dictated by importance of the measurement. 

One must also stress the importance of quality considerations during compounding and full adherence to current good manufacturing practices while producing parenteral products. Personnel responsible for the process design and scale-up of the equipment must assure proper documentation... 

Equipment qualification is an essential part of quality assuring the analytical data on which our knowledge of the sample rests. The importance of this data to information iceberg is illustrated in Figure 6. There are several approaches commonly employed. 

This is where the concept of Quality Assurance (QA) comes in and I can assure you, nothing is more important within the concept of GLPs than QA. As good as you are, tie QA Unit has the responsibility of double checking your procedures and your results and... 

He is a practitioner with valuable experience in tackling real challenges and dealing with real-life problems. In this book, he illuminates the role of quality assurance, and shows the importance of integrating the validation activities into the system life cycle within a structured top-down approach. 

As mentioned earlier, the complete analytical process involves sampling, sample preservation, sample preparation, and finally, analysis. The purpose of quality assurance (QA) and quality control (QC) is to monitor, measure, and keep the systematic and random errors under control. QA/QC measures are necessary during sampling, sample preparation, and analysis. It has been stated that sample preparation is usually the major source of variability in a measurement process. Consequently, the QA/QC during this step is of utmost importance. The discussion here centers on QC during sample preparation. 

No one doubts the crucial operational dependence of computer systems on their software, and the importance of professionally developed software is widely appreciated. GMP regulatory authorities hold pharmaceutical and healthcare companies accountable for the suitabihty of computer systems, including software, and expect them to take all reasonable steps to ensure that it [software] has been produced in accordance with a system of Quality Assurance. " One GMP regulatory authority is quoted as stating that there is no room in the pharmaceutical industry for magic boxes. ... 

Non-GxP aspects of the system are important to the project from a business perspective. These elements of the system would normally be tested in a similar manner to GxP aspects to demonstrate the consistent application of Quality Assurance principles across the full functionality of the system and in the execution of the project. 

Information on good agricultural practices of many important medicinal plant species is either not available or meager. This information is important in view of quality assurance and safety of the products derived from medicinal plant species. The WHO has developed guidelines for good agricultural and collection practices however, there is a need to develop country specific guidelines for such practices. 

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