Quality systems philosophy

Philosophy of Quality Systems and Testing of Electrical Machines... 

Philosophy of quality systems and testing of electrical machines 11/247... 

Philosophy of quality systems Testing of electrical machines Procedure for testing Load test No-load test Tolerances in test results Certification of motors used in hazardous locations... 

Philosophy of quality systems Recommended tests Procedure for type tests Procedure for routine tests Procedure for field tests An introduction to earthquake engineering and testing methods... 

This book applies a systems philosophy to the preliminary process design and cost estimation of a plant. In doing so, it tries to keep in perspective all aspects of the design. There is always a tendency on the part of designers to get involved in specific details, and forget that their job is to produce a product of the desired quality and quantity, at the lowest price, in a safe facility. What is not needed is a technological masterpiece that is difficult to operate or costly to build. 

The objective of this guidance is to describe a quality systems model and demonstrate how and where the elements of this model can fit within the requirements of the CGMP regulations. The philosophy being put forward is that quality should be build into the product, and testing alone cannot be relied on to ensure product quality. 

Any difference in monitored values between the validated independent system and GEP/qualified control system wonld act as a trigger for investigation, in advance of any routine calibration or performance check of the validated system. Decisions about product quality must be driven by data generated from the validated independent system where an independent system philosophy is followed. The data nsed to snpport these decisions must be archived. 

A good model of a quality system is provided by the FDA s Quality System Regulations for medical devices.It is based on the ISO 9000 standard. These regulations are based on a modern, up-to-date philosophy of quality. They view quality as a total system. 

To obtain a realistic assessment, the method and detail of the purchaser s evaluation of a new supplier must be formalised, and the results documented. The opportunity must be taken to view the supplier under normal operating conditions, with the involvement of the relevant technical staff. Systems of working routines must be made available and the operation of quality systems defined. The supplier company should explain its organisation (line/functional disposition), its personnel training policy, and its philosophy and commitment to quality. 

The integrated systems facilitated a quality management philosophy based on quality circles, with direct feedback to production management on the outcome of a process, the quality status and the immediate handling of exceptions or deviations. 

The responsible pharmacist or QP may decide not to deliver the product because of lack of timely available quality control, although that may cause delay in the treatment of the patient. This scenario is not pleasant for the patient or for the medical institution or the hospital because it causes irritation and even a bad reputation. It is however not advisable to deliver insufficiently controlled medication to patients, which would be against the philosophy of quality systems. In case of individual preparations it is not against the law to deliver without analysis. The responsible pharmacist has to make a risk assessment on the basis of his clinical insight and product knowledge. 

Although different authorities have different systems of premarket review, they all apply a similar risk-management philosophy in which all medical devices must satisfy safety and performance, quality system, and labeling requirements. The degree of regulatory scrutiny increases with the potential risks of the medical device, as evidenced by the risk-based device classification system proposed by the GHTF. 

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