Operational functions documented unit testing

Beyond the principle that quality is the responsibility of all personnel, there are specific responsibilities, which must be carried out by the quality unit. The challenge is to achieve a balance between executing the necessary activities and not allowing the abdication of other departments toward quality. The quality unit most often becomes a focal point for all quality related matters, functioning as a technical consultant in quality and compliance. It is imperative that the quality unit be independent of the manufacturing operations in order to achieve an objective perspective. Some of the basic quality responsibilities include review and approval of documents (specifications, test methods), written SOPs for all departments, records (batch records and log books), deviations and their investigations/resolutions, and finally the release of the product to market. 

Equipment calibration. This quality function for production consists of a viable calibration program for equipment that provides in-process test data or a measurable indication of the controlled process used. This activity is needed so that the manufacturing unit will know whether the equipment is operating consistendy during the time period covered by the calibration activity. This effort is also a continuing commitment of production to maintain its equipment as it was documented to perform during its installation qualification (IQ) and operational qualification (OQ) activities. 

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