Quality assurance system

The assessor should establish what percentages of key tollers do have an ISO 9000 series quality assurance system or other. Check whether the purchasing function has copies of certification including scope of certification. 

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. 

The text especially covers testing requirements and an introduction to quality assurance systems and application of ISO 9001. 

Prior to the publication of ISO 9000, several nations had developed national quality system standards, with many used only in the procurement of military equipment. With the emergence of the NATO Quality Control System standards in 1973, the Quality Panel of the UK Society of Motor Manufacturers set out to develop an equivalent standard for non-military applications. The result was BS 4891, which was published in 1972. In 1974 this was followed by BS 5179 with the title Operation and Evaluation of Quality Assurance Systems. However, BS 5179 was intended only as a guide and it was not until 1979, with the publication of BS 5750, that major purchasers in the UK had a standard that could be invoked in contracts. A certification scheme was eventually established in 1983, following the UK government s white paper on competitiveness ... 

Planned changes should be documented as part of a formal change monitoring process (for example via a quality assurance system). Unplanned changes should be identified during the accident investigation process. 

All surveyors need a database of technical information, which should include reports of accidents or of defects that could lead to accidents derived from other sources. He also needs a regular supply of technical documentation from his head office that keeps him abreast of technical developments. If his company operates an effective quality assurance system, they will periodically check that he is keeping these data properly and they may control the indexing of them. 

The alternative is hexane, which because of the explosion hazard requires a more expensive type of extractor construction. After the extraction the product is dull gray. The continuos sheet is slit to the final width according to customer requirements, searched by fully automatic detectors for any pinholes, wound into rolls of about 1 m diameter (corresponding to a length of 900-1000 m), and packed for shipping. Such a continuous production process is excellently suited for supervision by modern quality assurance systems, such as statistical process control (SPC). Figures 7-9 give a schematic picture of the production process for microporous polyethylene separators. 

The final element which regulations address is quality. Safety and fitness for purpose, as discussed above, are two of the characteristics that you would associate with a quality product. However, these characteristics alone would not describe a quality product. For any product or service to be considered quality you would also expect it to be reliable and consistent. Additionally in the context of medical products, quality means a requirement to demonstrate conformance to agreed specifications or applicable standards for content, purity and stability. Many organisations, from manufacturers to service providers, voluntarily apply quality assurance systems in order to more effectively meet their customers needs on a consistent basis. However,... 

Quality assurance system - maintain an effective pharmaceutical QA system... 

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

Figure 11.6 Pharmaceutical quality assurance system principles.

Despite extensive development and a rigorous adherence to procedures, one cannot guarantee absolutely that a medicine will never fail under the harsh abuses of real-life usage. A proper quality assurance system must include procedures for monitoring in-use performance and for responding to customer complaints. These must be followed up in great detail in order to decide whether one s carefully constructed schemes for product safety require modification, to prevent the incident recurring. 

Understanding quality perception. The starting point of a CQP-based quality assurance system should be the clear understanding of which product attributes are considered important and contribute to the quality perceptions of target consumers. This will help focus the system to control and assure only those attributes that are critical for quality perception. Decision-supporting tools can be found in the areas of consumer research, sensory studies, and new product design. 

Obviously, GMP requirements, especially extensive personnel training, calibration, qualification and validation, enhanced documentation, extensive cleaning and sanitation, and sharpened in-process control must considerably influence process organization and output. All these GMP-related activities are costly and time consuming, and will result in decreased productivity and increased production costs. On the other hand, a quality assurance system contributes to consistent production with a lower number of rejected batches and complaints. 

Huppatz, C., Munnoch, S. A., Worgan, T., Merritt, T. D., Dalton, C., Kelly, P. M., and Durrheim, D. N. (2008). A norovirus outbreak associated with consumption of NSW oysters Implications for quality assurance systems. Commun. Dis. Intell. 32, 88-91. 

The issue of anthelmintic use in poultry production is covered in Chapter 12 and quality assurance systems based on hazard analysis by critical control point (HACCP) systems are described in detail by van Elzakker et al. (2004) and in Chapters 22 and 23 and are therefore not addressed here. 

The trend towards larger flock sizes, while often perceived as undesirable from an animal welfare point of view, coincided with more professional practices being introduced into the organic poultry industry, especially with respect to food safety and HACCP based quality assurance systems. However, it did result in a decrease in time spent on individual animals and their welfare. 

To improve the ability to establish best practice with respect to manure use and prevention of pathogen transfer (especially on farms which are converting to organic farm management), a hazard analysis critical control point (HACCP)-based quality assurance system has been proposed (Haward and Leifert, 1999). This proposed four main critical control points (CCPs) (see Table 19.4). 

A good image for compost can be built up with assured quality and a quality label. Germany, Denmark, the Netherland, and Belgium have developed a composting system which is very important for the quality assurance. Elements of the quality assurance system are quality assurance of European composting and digestion plants (in ECN 2008) ... 

United Kingdom Quality assurance system in introduction ... 

Although a united compost quality system of the European Union does not exist, the European Compost Network (ECN), as an initiative of the ORBIT Association developed a Quality Assurance System providing the necessary background information and documentation to build up a European Quality Assurance System (ECN-QAS). Product definitions and characterizations of this system are shown in Table 12.7. 

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