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Deming’s 14 Principles
Background Recent changes in regulatory requirements for clinical trials pose considerable challenges for the clinical research community. The clinical research Quality Assurance (QA) profession as a whole has not historically utilised quality management tools, and QA professionals may have little to no formal training in continuous improvement methods, to be aware of their value in assessing and improving the impact and value of the QA department to any organisation. This article will present Deming’s 14 Principles for Management, paraphrasing them to demonstrate how easily they can apply to the clinical trial project management, Contract Research Organisation (CRO) and clinical department management.
Deming’s 14 Principles
Dr. William Edwards Deming is known as the father of the Japanese post-war industrial revival and was regarded by many as the leading quality guru in the United States. Deming created 14 Principles for Management that summarised his business philosophy. The principles became a basis for transformation of industry. The 14 principles apply anywhere, from small organisations to large ones, to the service industry as well as to manufacturing. They apply to any division within a company.

2. Adopt the New Philosophy
Management should actually adopt the ‘quality philosophy’, rather than merely expect the workforce to do so. When the new clinical trial project is thoroughly planned and the quality matters are carefully embedded into it by the study management, while creating the atmosphere of striving for the best performance, it will penetrate into the study team at all levels, both in-house and at sites. When the management looks forward, not at the competitors, but at the customers, that will be the moment of major change.

3. Cease Dependence on Inspection
Quality does not come from inspection; mass…...

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