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Volume 9 · Issue 1· January 2004

Contents

Page 22…

What Does It Take to Manufacture in a Regulated Sector?

James W. Kolka writes that, although the QSR was written to provide the equivalent requirements of ISO 9001:1994 without adopting its verbatim language, it nevertheless was written as if FDA intended these manufacturers to conform with Subclause 6.2.2, Competence, Awareness and Training. The QSR requirements hold Top Management of a medical device manufacturer accountable for providing adequate resources to its production operations, including the assignment of trained personnel for the management of those operations, the performance of work and assessment activities. Kolka explores FDA’s requirements regarding employee competence and discusses some recent cases where FDA cited the lack of adequate employee training and competence. He advocates the importance of employee assessments for certain types of work and assessments of the outcomes of training.