A novel audit model for assessing quality in non-regulated research

Abstract

The need for Quality standards in non-regulated research is a matter of considerable current debate. Whilst a number of such guidelines have been developed over recent years, their successful implementation remains a challenge to all. In order to assess whether research standards are indeed improving on the bench following the instigation of such a quality system, a question posed by both senior management and scientists alike, an independent compliance programme is required. However, given the lack of predicate rules, naivety to audit process and general sensitivity to external scrutiny within the scientific ranks, then work in this 'Grey Area' generates high exposure for the conventional GLP, GCP or GMP auditor. We have developed, tried, and tested a highly effective, novel audit model for assessing the quality of non-regulated research. This simple system can be applied successfully irrespective of scientific discipline or field. Whilst common principles will always apply during any quality system audit, the refinements and idiosyncrasies we describe here will, as we have found, help underpin success. Our intentional assumption is that this is a first time endeavour for the quality professional. Copyright © 2009 John Wiley & Sons, Ltd.