Quality assurance inspection systems

The structural integrity of the reactor coolant system support components is ensured by quality assurance inspections in accordance with Section III of the ASME Code during fabrication. The non-integral supports are procured by individual equipment specifications which impose appropriate quality assurance requirements commensurate with the respective component s functions. 

As the safety and quality of industrial components, equipments and constructions is correlated with the inspection sensitivity and this is influenced in radiography by the film system class, a continuous supervision of the film systems on the market seems to be urgently necessary. To support the confidence of the film users in the film properties specified by the film manufacturers such a system for quality assurance for industrial x-ray films is proposed by some manufacturers and BAM. This system will be open to all manufacturers, distributers and users of x-ray films. It will deal with all film systems inclusive those which are not specified by a manufacturer as for instance mixed systems. The system for quality assurance will be based... 

To operate the MPI or LPI equipment at stable and reprodncable inspection conditions modern units are equipped with a monitoring and control system called "Quality Assurance Package" (termed QAP). The QAP System is ba.sed on an industrial PC with a bus system and field sensors. It ensures that process parameters important for the reproducability of the MPI or LPI are controlled an held between defined limits by a central computer system. It can be adapted to any old system, as well as integrated into new systems. 

Any quality or performance deviations of the equipment are printed out, the system allows fully automated operator free inspection and quality assurance documentation. 

This section covers only the tests that are essential on a completed motor, irrespective of the manufacturing procedure and stage quality checks. If ISO 9000 guidelines are assimilated, practised and enforced by a manufacturer so that a customer s trust is obtained, a final pre-despatch inspection by the customer may not be necessary. The customer, having gained confidence in the practices and Quality Assurance Systems of the manufacturer, may issue an authorization to the manufacturer to despatch the material under their own inspection certificate, rather than an inspection by the customer. We discuss below the test requirements procedure and the acceptance norms prescribed by various national and international standards for such machines and adopted by various manufacturers. 

Quality systems. Model for quality assurance in linal inspection test 1400.3/1994 BS EN ISO 9003/1994 900.3/1994... 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

There is a procedure for Self-Inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the Quality Assurance system. 

During the inspection, the inspector should proceed with particular emphasis on the critical points. This system guarantees that the internal quality assurance is oriented to the risks associated with the particular type of production. It is a preventive approach. The employees who identify with the organic objective , who are involved in the process and assume responsibility for it, are more careful, because they understand the sense of quality assurance and do not feel that it is an additional burden, impractical, bothersome, a mere formality and bureaucratic. 

The first and foremost element for GMP is the quality system. This can be divided into Quality Assurance (QA) and Quality Control (QC). QA is a total system approach. It sets out the compliance policies and procedures for all facets of drug manufacturing. QC is the practical extension of QA. The role of QC is concerned with inspection and testing of the manufacturing environment, raw materials, in-process intermediates, and finished products. 

For products in Classes Ila, lib and III, and AIMDs, examination and certification by a notified body of a specimen product (t)q)e examination Aimex III of the MDD) coupled with a varying degree (partially restricted by product class) of product or production quality assurance (MDD Annexes IV, V and VI), which ensures that the manufacturing process produces products that conform to the certified t)q)e and might involve a quality system for manufacture and final inspection (Annex V), or a quahty system for final inspection and testing (Annex VI). 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

ISO 9001 1994, Quality System — Model for Quality Assurance in Design, Development, Production, Installation, and Servicing ISO 9001 2000, Quality Management System Requirements. Design, Manufacture, and Final Product Inspection and Testing. 

ISO 9003 1994, Quality System — Model for Quality Assurance in Final Inspection and Test... 

Since 1998, all medical devices marketed in Europe (EEA) must bear the CE mark, which signifies conformity to the essential requirements of the MDD. The MDD harmonized the European requirements along with device certification and the inspection procedures for manufacturers to ensure the highest degree of safety and product quality of the medical devices throughout the EC. Most important was the requirement for a full quality assurance system (Annex II of the MDD, 93/42/EEC), which included design controls for new medical device products. This was in line with the ISO 9000 series of standards established for quality systems by the International Organization for Standardization. 

Quality Assurance is the system of monitoring, inspecting, and auditing which assures that the work is documented and conducted according to protocol and the laboratories standard operating procedures from the conception of a study to the review of the final report. 

Concepts like quality, safety, and efficacy should be taken into consideration during process development, since it is not enough to inspect and test only the final product. Good Manufacturing Practice (GMP), as well as quality assurance systems are essential to guarantee safety, quality, and economic feasibility during the whole process and therefore to obtain a marketing license. 

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