Abstract
AbstractThis article builds on concepts described in two earlier articles on principles in Quality Assurance (QA) 1, 2. The first of these papers described a simple approach to rationalizing QA activities based on simplicity, efficiency and effectiveness 1. The second article described how the GLP regulations could be ‘deconstructed’ and incorporated into an organization's quality systems to help a company ‘live GLP’ rather than just ‘comply with GLP’ 2. This third part puts the first two papers in a wider perspective by setting out a model for effective QA, to help in the design and implementation of a QA program as well as the organization, management and leadership of the QA Unit. QA personnel should not be viewed as just data‐checkers or ‘rubber stampers’; we must strive to make a positive impact on our company and the wider consumer community through partnership in the assurance of safe and effective products. This paper describes a simple scheme to help us make this impact. Copyright © 2010 John Wiley & Sons, Ltd.
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