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Sunday, October 13, 2013

Partnership for Success: Laboratory Operations and Quality Assurance

A long while ago an employee told me, "QA forgot that we are working for the same company". His inference was that the Quality Assurance Unit was deliberately looking for faults within his department. GLP Compliance will be difficult to achieve if the Operations Group and the Quality Assurance Unit (QAU) do not understand and respect each other’s role.  Building an effective partnership involves investing time to train on the requirements that each area operates under.  Training the technical groups of GLP requirements by the QAU unit and educating the QAU on the   It should be the goal of the QAU and Ops Group to meet the GLP requirements on the front end rather than at the conclusion of the study. The technicians will become confused about data documentation when some pre-clinical studies are conducted GLP and others conducted [by design] Non-GLP. To that end Operations management must ensure that Standard operating procedures are adhered to, even when conducting non-GLP studies, so that data quality will remain consistently high.    Daily quality control inspection of the data by the Operations Group prevents voluminous QAU findings to correct at the conclusion of a study.  Tracking internal inaccuracies within the department will aid in preventing repeat errors.
technical subtleties by the Operations Group will ensure that each has full understanding of the required and feasible data documentation.

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