Full development quality assurance

Quality issues related to analytical measurements have been described in full detail in several books [1-3] and highlighted several principles, e.g. validation of methods, quality assurance protocols incorporating the use of CRMs, independent assessment of method performance by participation in proficiency testing schemes, and accreditation. Method performance studies also represent a very important aspect to evaluate the state-of-the-art of a particular type of analysis at the development stage e.g. for testing the applicability of a standard method) or to improve the quality of measurements, e.g. prior to the certification of reference materials. 

The criteria 1 to 8 may be reduced, especially those requiring full application of lEC 60880. Quality assurance shall divide the development and the modification phases of the software safety life cycle into specified activities. These activities shall include all what is necessary to achieve the required software quality, to verify that this quality is achieved, and to provide objective evidence to that effect. ... 

In combination with full-spectrum multivariate analysis methods and developments in fibre-optic technology NIR has gained great importance especially for chemical quality assurance but also for automatic reaction process confiol of polymers, in a rational and economical manner [272,278]. Although multiple component quantitations are now routinely being performed, NIRS is not an easy to use technique. Each specific application needs to be calibrated. The complex relation between chemical and physical structure of polymers can easily lead to misinterpretations by uncritical use. Clearly, NIRS is not a technique suitable for analysis of competitor products beyond the training set. 

Clause 7 in lEC 61508 part 3 describes a full software safety life cycle model with 6 phases exactly as previously described for the hardware life cycle. Details of activities in each phase are specified and described in detail. These detail clauses provide very firm rules for the software developer and provide the basis of a quality assurance program for a new product. 

The general process of sample transformation into data is the same at every environmental laboratory. The differences are primarily in the manner various tasks are performed by laboratory personnel. To assure the quality of produced data, every laboratory must develop, implement, and maintain a quality system that is documented in the Laboratory QA Manual. The implementation of specific tasks related to sample management, analysis, and quality system, which may be different at different laboratories, is addressed through a set of laboratory s own SOPs. A full service laboratory has dozens of SOPs, describing every laboratory procedure and task from sample receiving to invoicing. The SOPs are updated as necessary and undergo internal review and approval. 

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