Quality assurance programm

The automotive sector s quality assurance standard QS 9000 (1998) suggests a concurrent high level model, as opposed to the sequential model from BS 7000 (1997). This is shown in Figure 5.7. The automotive industry in particular has embraced the use of concurrent engineering models for product development, and this is reflected in the standards which facilitate their quality assurance programmes. A concurrent industrial model from the automotive sector will be discussed later. 

DTI 1992 Quality Assurance Programme 1992-1996. Federal Ministry of Research and Technology, Genuany. London DTI Translation No. 0219-92, DTI. 

The management of an analytical chemistry laboratory involves a number of different but related operations. Analysts will be concerned with the development and routine application of analytical methods under optimum conditions. Instruments have to be set up to operate efficiently, reproducibly and reliably, sometimes over long periods and for a variety of analyses. Results will need to be recorded and presented so that the maximum information may be extracted from them. Repetitive analysis under identical conditions is often required, for instance, in quality assurance programmes. Hence a large number of results will need to be collated and interpreted so that conclusions may be drawn from their overall pattern. The progress of samples through a laboratory needs to be logged and results presented, stored, transmitted and retrieved in an ordered manner. Computers and microprocessors can contribute to these operations in a variety of ways. 

In a quality assurance programme, the control with a mean value of 10.5 mg and a standard deviation of 0.1 mg was analysed with a batch of test samples and gave a result of 10.0 mg. Which of the following actions should be taken ... 

The laboratoiy should have a documented Quality Assurance Programme, carried out by designated individual(s), to assure that the activities perfonned are in compliance with the principles of GLP. The QA personnel must conduct inspections to determine if all of the laboratory activities are conducted in accordance with the principals of GLP and defined SOPs. These personnel... 

The inspection is performed according to the quality assurance programme and is based on the audit plan. There can be three types of audit ... 

A quality assurance programme for Chemical Leasing projects has to be based... 

Ruijter GJG, Boer M, Weykamp CW, de Vries R, van den Berg I, Janssens-Puister J, Niezen-Koning K, Wevers RA, Poorthuis BJHM, van Diggelen OP (2005) External quality assurance programme for enzymatic analysis of lysosomal storage diseases a pilot study. J Inherit Metab Dis 28 979-990... 

Ensure that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice. 

Ensure for a multi-site study that clear lines of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel. 

Safety Series No, 50-SG-Ql Establishing and Implementing a Quality Assurance Programme (1996). Safety Series No. 50-SG-QI0 Quality Assurance in Design (1996). 

Validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use. These principles are as follows ... 

Medicines Quality Assurance Programme Quality Assurance Safety Medicines World Health Organization 20, av. Appia CH-1211 Geneva 27... 

Already the Consensus Document on Quality Assurance (OECD No. 4, 1999) had recognised that these two possibilities would not sufficiently describe the real-life inspection activities of a Quality Assurance unit, and the revised GLP Principles have acknowledged this extended view of inspection types. Inspections dealing with the conduct of, and the activities within, a study are now further subdivided into two different types, so that there are finally three types of inspections, which are just named in the OECD Principles, are described in the OECD Consensus Document on Short-Term Studies (OECD No. 7,1999), and which have to be further specified by Quality Assurance Programme Standard Operating Procedures. These three types are ... 

As a final point to this section on inspections, it should be kept in mind that - as it is the case for any other operative procedures covered by the GLP Principles - the Quality Assurance Programme of inspections (and audits) should be subject to management verification. Management has to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice which means that the Quality Assurance has to provide management with periodic reports on its activities, not only for single studies as already detailed above, but for the totality of its... 

Quality Assurance Programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice. 

The Quality Assurance Programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures. 

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