Quality Assurance, system safety

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,... 

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. 

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. 

The HACCP program is a quality assurance system used all around the world to ensure the quality and safety of food. The system works on the concept that prevention is better than cure. The original HACCP concept for food safety was developed at Pillsbury in the 1960s. HACCP was first conceived when Pills-... 

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. 

The safety of the medication system is the primary concern of every hospital pharmacist. Recently published reports of the incidence, causes, and cost of injury resulting from medication errors have led many hospitals to critically evaluate their quality assurance systems (Bates et al., 1996, 1997 Classen et al., 1997 Kohn, Corrigan, and Donaldson, 1999 Leape et al., 1991, 1995 Poon et al., 2006 Stelfox, et al., 2006). Written incident reports were once the standard for gathering information about medication misadventures. This method is now believed to lack sufficient completeness and reliability for identifying weaknesses in a medication system (Classen et al., 1991 Cullen et al., 1995 Leape, 1994, 2002 Leape et al., 1995). 

The second component of a successful clinical manufacturing program is appropriate quality assurance systems for the production of cell or viral banks, raw materials, in-process materials, and final product. Much has been written about the production and testing of cell and viral banks for use in manufacturing. Both FDA guidelines and other reference information are available (http // www.fda.gov.cber/guidelines.htm http //www.ich.org, http //www. emea.eu.int). The production of AAV vector batches for use in clinical trials should use qualified cell, viral, and/or plasmid banks as appropriate. Documentation on the source materials for these banks is also crucial in assuring the quality and safety of the clinical trial materials. 

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. 

The design and construction of isolators should be carried out in an appropriate quality-assured way because the devices are frequently complex and require a high level of documentation to comply with both safety and good quality requirements. ISO 9000 compliant or similar quality assurance systems provide an appropriate management environment in which to design and build systems destined for quality or safety critical applications. 

Without a quality assurance system, organizations risk sourcing substandard, counterfeit or contaminated pharmaceutical products, leading to complaints about products and product recalls, wastage of money and serious health risks to patients. Such problems affect the credibility of procurement agencies, cause financial losses and put patients safety in danger. Background... 

Medicinal products must be fit for their intended use, comply with the requirements of Market Authorization and not place patients at risk because of inadequate safety, quality or efficacy. These objectives are easy to state, but to achieve them requires a comprehensively designed and correctly implemented system of quality assurance. It is important that this is documented and its effectiveness monitored. Records must be kept that are open to inspection by validating bodies, and there must also be procedures for selfinspection and quality audit that allow appraisal of the quality assurance system. Management must be adequately trained and their responsibilities minutely defined. Two key posts are the Heads of Production and of Quality Control. These posts are required by the guidelines to be independent of one another. 

States should establish and maintain effective national safety and quality assurance systems to protect consumer health and to prevent commercial fraud. 

Limitations in the Soviet manufacturing capacity for specialist equipment such as electronics and control, and the lack of a comprehensive quality assurance system, linked to the pressure to design and build plant that could be manufactured, constructed and commissioned quickly, led to a design which, in both concept and detail, has features which impaired ultimate plant safety. Among the features of the design which appear to be questionable, some of which contributed to the initiation and development of the accident at the Chernobyl 4 reactor, the following merit noting ... 

Any good quality-assurance system should also assess the quality of performance in practice as well as in theory. With no currently available, effective, non-destructive test, critical areas or components may only be assessed for voids (acoustic methods are useful here) and, where possible, proof loaded. Other than this, test coupons or parts need to accompany the components themselves through the assembly process so that appropriate, systematic destructive tests may be carried out. A check-list for safety critical items is given in Table 6.1. 

HACCP is not designed to be a complete quality assurance system it is designed to be the part of the QA system that is focused on food safety (microbiological, chemical and physical). Record-keeping and display are vital to the process. Regular audits are also essential to ensure that the process is operating as required. HACCP works best when TQM is the basis of the company s quality philosophy (MFSC/NFPA, 1992). An overview of how TQM may be applied within the food industry is provided by Fulks (1991). 

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... 

Introduction Review and audit processes are used in the chemical process industry to evaluate, examine, and verify the design of process equipment, operating procedures, and management systems. These processes assure compliance with company standards and guidelines as well as government regulations. Reviews and audits can encompass the areas of process and personnel safety, environmental and industrial hygiene protection, quality assurance, maintenance procedures, and so on. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

Figure 15.4 shows a procedure for the refilling of returnable containers with a chemical of assured quality. (This will require some combination of documentation, sampling and analysis to ensure that the chemical is of the correct type, and in the intended condition.) This is applicable to drums and plastic containers, and bottles, but some modifications are necessary for pressure systems, i.e. gas cylinders, covered by the Pressure Systems Safety Regulations 2000 including ... 

While quality was formerly achieved by inspection of final products, it is accomplished now by prevention through controlling critical steps in the production processes along the agri-food chain. Hazard analysis critical control points (HACCP) represent a typical example of such a preventive approach. Although this concept was developed primarily to assure food safety, the basic principle is also applicable to assuring non-safety quality attributes such as color, flavor, and nutritional value. " This section translates the HACCP principles into a critical quality control point (CQP) concept that can be part of a system to assure food quality. 

The concept of risk assessment requires a profound understanding of food dynamics and technological conditions that may impact the risk levels of certain hazardous compounds. It requires that scientific information and data are collected to underpin conclusions about risk levels. Risk assessment can be used to scientifically underpin the selection of hazards that must be covered by a quality or safety assurance system (e.g., HACCP) that will improve the reliability of the system. 

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