The Quality Assurance Programme

One obvious presupposition for the competent and efficient work of Quality Assurance is the expertise and experience of Quality Assurance personnel that is necessary to fulfil their responsibilities. Like any other, this expertise cannot be got out of the blue, but it has to be acquired through training and experience. Thus, it is the duty of management to ensure that there is a documented training programme for the Quality Assurance 

However, the whole of this training and experience should not simply cover the Quality Assurance work only, but the Quality Assurance personnel should also be, or become, familiar with the test procedures, standards and systems operated at the test facility. This familiarity with test systems and test procedures should be extensive enough to allow the individual inspector to choose the most suitable approach to the inspection of the study part he is monitoring, to ask the most pertinent questions, and to judge the importance of any deviations from study plan or from SQPs. Qn the other hand, it is certainly not necessary that Quality Assurance personnel should possess highly expert knowledge in the conduct of the tests and in the properties of the test systems they have to monitor, since the Quality Assurance inspector is expected neither to perform a scientific evaluation of a study nor to judge the validity of the scientific procedures that are used. 

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

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-Q5 Assessment of the Implementation of the Quality Assurance Programme (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 ... 

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... 

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. 

Suffice it to say here, that the compiling of the Quality Assurance Programme with the respective SOPs, and the validation policies and validation efforts for the IT applications should certainly be one, preferably two, steps ahead of the other implementation efforts. 

Validation is an integral part of current good manufacturing practice it is, therefore, also an element of the quality assurance programme associated with a particular product or process. 

A principal section of a safety report should be devoted to the description of the quality assurance programmes of the plant owner and of its contractors during the design, construction, testing and operation of the plant. The methods for the implementation of the quality assurance functions should also be described. 

Inspection and test procedures should be developed to ensure that the requirements of paras 502(a) and 502(b) are satisfied. Compliance should be documented as part of the quality assurance programme (see para. 310). 

IV.6. In the review of the earlier edition of Appendix IV the section headed Control of Use and Care of Packages was removed, and more appropriate parts of the quality assurance programme elements were revised to cover the important issues. This significant change brings this edition of the appendix more into harmony with the accepted quality assurance standards in use worldwide. 

IV. 17. The quality assurance programme should be subject to regular review by the management relative to the activities for which they have responsibility. Measures should be included to remedy any deficiencies discovered or to introduce any improvements recommended. 

IV. 18. The quality assurance programme should be prescribed in a document describing the structure and overall composition of the qnality progranune. The document should include or make reference to the necessary procedures and/or instructions, and describe the way in which they combine to form the overall quality programme. The programme should cover all activities of the company related to the safe transport of radioactive materials and compliance with the IAEA Regulations. 

IV.20. All constituent parts of the quality assurance programme developed and maintained by the company should be systematically produced in the form of appropriate written documents. 

IV.21. Documentation of the quality assurance programme should be structured so that it is appropriate to the size and complexity of the company and the work it performs, and is readily understood by users. 

IV.22. Provision should be made by the company management for periodic review and evaluation of the quality assurance programme. These reviews should ensure that the quality assurance programme continues to be effective and appropriate to the... 

V.70. Documented procedures should ensure that internal audits are carried out on a regular basis to verify compliance with all aspects of the quality assurance programme and to confirm its continuing effectiveness. Similarly, when conducting external audits, to verify the quality arrangements of suppliers, they should be planned and carried out in accordance with written procedures. Audits should be conducted by qualified persons selected for their independence from the activity under audit. 

A quality assurance programme is required to be established and implemented to cover items, services and processes that affect safety and are within the scope of this Safety Guide (Ref. [1], paras 3.14-3.16). The quality assurance programme is required to be implemented to ensure that data collection, data processing, studies, analyses and qualification, code validation (software) and verification, and other activities necessary to meet the recommendations of this Safety Guide are performed correctly [11,12]. 

More specifically, the quality assurance programme should cover ... 

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