Quality system principles

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

Basic requirements applicable to all management systems Management responsibility Quality system principles... 

Management Responsibility [Quality System Principles These two requirements are fundamental to any quality-based management system and must be the first to be installed. 

The Standard considers that an effective quality system should comprise management responsibility quality system principles quality system audits quality/cost considerations raw material quality control inspection and testing control of non-conforming product handling, storage, packaging and delivery after sales service quality documentation and records personnel training product safety and liability and statistical data/analyses. 

Organization Level Principle Process Focus Basic Team Structure Performance Issue Focus Typical Quality System Focus Ideal Quality System Focus... 

A system is an ordered set of ideas, principles, and theories or a chain of operations that produces specific results to be a chain of operations, the operations need to work together in a regular relationship. A quality system is not a random collection of procedures (which many quality systems are) and therefore quality systems, like air conditioning systems, need to be designed. All the components need to fit together, the inputs and outputs need to be connected, sensors need to feed information to processes which cause changes in performance and all parts need to work together to achieve a common purpose i.e. to ensure that products conform to specified requirements. You may in fact already have a kind of quality system in place. You may have rules and methods which your staff follow in order to ensure product conforms to customer requirements, but they may not be documented. Even if some are documented, unless they reflect a chain of operations that produces consistent results, they cannot be considered to be a system. 

The principles outlined in the standard can be applied to any creative activity and while the standard primarily addresses the design of automotive products for onward sale to customers, the principles can be applied to internal systems such as an information technology system, an inventory control system, and even the quality system. 

We will eliminate all duplication of effort within our PSM and ESH systems by integrating the elements, programs, and management processes wherever possible. We will achieve this integration by using Quality Management principles to design new systems. We will measure our improvement in terms of fewer resources, quicker response to new demands and improved PSM and ESH performance. 

Figure 11.6 Pharmaceutical quality assurance system principles.

From the consumer s perspective, cost is an important characteristic of the food and the best buy is the product that is considered to have the best ratio of quality and price. So consumers should welcome any measure that will improve quality at no extra cost or reduce the cost at no reduction in quality. In principle, using a CCP-based system at the level of a supply chain is supposed to do just that, since it will ensure that the controls are taking place at the steps where they can be implemented most effectively, thus eliminating superfluous double or triple testing of the same thing, or unnecessary waste when food is discarded because its safety is uncertain. 

If both the farms and the dairy are covered by a reliable control system, the everyday monitoring will take place at the optimal CCP at the farm and analysis of milk samples at the dairy will only be needed at low frequency for verification of the system (Principle 6). This will ensure that there are no antibiotic residues in the milk sold by the dairy, with minimal expenses for control. In fact, the most expensive item will be the cost of the unannounced inspections at the farms to monitor the integrity of the system. However, if not all the farms are covered by a sufficiently good control system, the dairy will have to add the extra costs of its own independent system, in order to be able to take responsibility for this quality aspect. So the main benefit of a supply chain-based system is that it provides full control at the lowest cost. The main drawback is that the more entities that are involved, the greater is the risk that one of them will experience a system failure and this can have disastrous consequences for all those other entities that rely on the defaulting entity for their product control. 

The Quality System Program (QSP) shall follow the Quality System description of this Chapter, which applies to all Parts of this Code following the principles of the appropriate ANSI/ ASQC Q9000 series standards. The program may require amendments or revisions to include specific project and jurisdictional requirements for hydrogen installations. 

Good Laboratory Practice is a quality system that is tailored to the needs of the modem laboratories. Its principles are very close to the principles of the modem quality management systems like ISO 9000 and ISO 17025. However, GLP is specific to the non-clinical health and environmental safety studies, it covers physical and chemical test systems, and gives emphasis to biological test systems. It is of utmost importance to note that GLP principles were set out by the Organization for Economic Cooperation and Development (OECD) and after being modified they were adopted by the Emopean Union and are now the Commission Directive 1999/11/EC. 

The Government of India has established the National GLP Compliance Monitoring Authority (India GLP), adopting the OECD quality system of the principles of GLP, for inspection, monitoring, and accreditation of test facilities in India for conducting nonclinical and environmental safety studies. Currently, India enjoys the full member status of OECD for GLP. India is a member of the OECD Test Guidelines program. 

GUIDING PRINCIPLES Encourage new technological advances State-of-the-art pharmaceutical science Risk-based approaches focus industry and agency attention on critical areas Eacilitate industry application of modern quality management Enhanced quality systems approaches into the agency s business processes... 

Life cycle management and change control provide a mechanism for continuous improvement. To support continuous improvement through change control a quality system would need to be based on principles of manufacturing science and risk-management. The proposed ICH QIO guidance is an opportunity to accomplish this task. 

Process analytical technology is consistent with the quality systems approach in that it is based on science and engineering principles for assessing and mitigating risks related to poor product and process quality. In the PAT guidance, the FDA indicates that the desired state for pharmaceutical manufacturing may be characterized as follows ... 

Accreditation to ISO/IEC 17025 or GLP is becoming a standard approach to creating a quality system (chapter 9). Note that accreditation, as such, is not part of the VAM principles, but it is one of alternative quality systems (see chapter 1). Like any quality system, accreditation only fulfills its purpose if implemented properly. Some laboratories have done the minimum to achieve accreditation, and then take the view that having paid for their accreditation payment of the annual fee will then suffice. This practice is evidenced when accredited laboratories perform no better in testing rounds than experienced laboratories without accreditation (see chapter 5). 

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