Quality assurance Subject

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

System Evaluation Subject Management Data Quality Assurance Treatment Dispensing Handling Unexpected Events Data Transformation... 

However, since the data used in this study are subject to the limitations and uncertainties cited above, the results of this analysis represent only a very rough approximation of the national frequency distribution of indoor radon levels. EPA s national survey will seek to more accurately characterize this distribution through use of a larger sample size, a statistically based survey design, and consistent, quality assured sample collection and measurement procedures. 

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. 

Events develop too rapidly at the start of an incident to make use of anything other than immediately available resources and methods. Every stage of the process needs to be subject to rigorous quality assurance. Meticulous care and documentation is essential if any investigation is to be useful in bringing malefactors to justice. 

Normally, the study subject is informed both verbally and in the ICF that certain other individuals besides the investigator site staff wiU view his or her medical records. In clinical studies sponsored by pharmaceutical companies or institutions, the monitoring and quality assurance (QA) personnel from the sponsors and CROs, and inspectors from a regulatory agency wiU review the medical records of the study subject. 

Because of the potential legal consequences on the suspect(s) and the subjects involved, forensic analyses require high quality standards and have to be subjected to extensive quality assurance and rigid quality control programs. For example, the enforcement of laws establishing a sanction based on the presence/concentration of a substance in blood (e.g., cocaine in a driver s blood) requires that the substance is correctly identified and reliably determined with acceptable precision and accuracy. 

Quality assurance unit records are exempt from routine FDA inspection and copying authority on the theory that such records are more likely to be complete and candid if they are exempt from review by the FDA. This exemption extends only to records of QA inspection and audit findings and records of corrective actions recommended and taken. All other QA records are subject to inspection and cop5dng by FDA. 

During a validation process, the products and processes are subjected to testing at extreme conditions of in-process limits and their performance is evaluated against the acceptance criteria. The parameters of different pharmaceutical operations are varied and product properties are recorded and evaluated (Figure 3). When it is found that adjustment is required, necessary actions are taken in consultation with R D personnel. Generally, validation data of three production scale batches are compared to generate a high level of quality assurance. 

Analytical method validation forms the first level of QA in the laboratory. Analytical quality assurance (AQA) is the complete set of measures a laboratory must undertake to ensure that it is able to achieve high-quality data continuously. Besides the use of validation and/or standardized methods, these measures are effective IQC procedures (use of reference materials, control charts, etc.), with participation in proficiency testing schemes and accreditation to an international standard, normally ISO/IEC 17025 [4]. Method validation and the different aspects of QA form the subject of Section 8.2.3. 

We five in the age of quality. Quality is measured, analyzed, and discussed. The simplest product and the most trivial service come from quality-assured organizations. Conspicuously embracing quality is the standard of the age. Even university faculty are now subject to quality audits of their teaching. Some of these new-found enthusiasms may be more appropriate than others, but I have no doubt that proper attention to quality is vital for analytical chemistry. Analytical measurements affect every facet of our modern, first-world fives. Health, food, forensics, and general trade require measurements that often involve chemical analysis, which must be accurately conducted for informed decisions to be made. A sign of improvement in developing countries is often a nation s ability to measure important aspects of the lives of its citizens, such as cleanliness of water and food. 

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 ... 

There are some existing texts that cover the material in this book, but I have tried to take a holistic view of quality assurance at a level that interested and competent laboratory scientists might learn from. I am continually surprised that methods to achieve quality, whether they consist of calculating a measurement uncertainty, documenting metrological traceability, or the proper use of a certified reference material, are still the subject of intense academic debate. As such, this book runs the risk of being quickly out of date. To avoid this, I have flagged areas that are in a state of flux, and I believe the principles behind the material presented in this book will stand the test of time. 

Recently, the topic of method development for both routine and non-routine analyses has been the subject of two EURACHEM documents The Fitness for Purpose of Analytical Methods and Quality Assurance for Research and Development and Non-routine Analysis as part of the VAM (Valid Analytical Measurements) programme. These guides provide information and a bibliography for ISO publications. 

In the seventh edition, quality assurance was moved from the back of the book into Chapter 5 to emphasize the increasing importance attached to this subject and to link it closely to statistics and calibration. 

Taking quality assurance in a wide sense, it is necessary to consider specifications, the relevance of test methods, the accuracy of test methods and the statistically based control schemes which make up the discipline of the quality engineer. This is a specialised subject that happens to involve testing and it is not appropriate to consider here quality assurance of the production of rubber products. 

The BSI was formed in 1901 and has now developed to the point where it covers an astonishing range of subjects from virtually all branches of industry. Apart from its main function of producing standards, it also operates a quality assurance division which operates BSI s certification and assessment schemes and a comprehensive test house. 

This approach to validation is the clearest example of validation being a QA tool. It appears that this approach will rarely be used for validation today, however, because it s very unlikely that any existing product hasn t been subjected to the PV process. The technique may only be justifiable if it is used for the audit of a validated process. With retrospective validation, the generated data already exist, but must be documented in a manner that clearly demonstrates that the existing process is under control. Quality assurance must first outline a plan for the validation effort, however, which would include the following items ... 

The purpose of quality control or quality assurance in the citrus industry is to help provide for the production of a uniform, high quality and commercially acceptable product. For most of the major qualitative characteristics, standardized, accurate and simple methods have been developed, and high and low limits have been carefully been established. Some of these include Brix, acid, color, recoverable oil, and free and suspended pulp. For each of these criteria, a simple and rapid assay has been developed and good correlation exists between the objective assay results and the subjective quality evaluations. 

Quality Assurance Section representatives periodically attend staff meetings of each section that does work subject to the GLP regulations to discuss quality assurance concerns. It has been much easier to get compliance by discussing problems than to simply make recommendations in audit reports. 

The audit was divided into two parts (1) General QA Practices and (2) Data Audit. A questionnaire as used by EPA s Office of Pesticide Programs, Quality Assurance Office, for Internal Audits, was employed. A copy of the completed questionnaire is(not) attached. From discussions, based on the questionnaire and observations made during inspection of the facilities and from a data audit, a subjective summary regarding... 

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