Quality Assurance for Innovation Projects
I know I may be shot at dawn for saying this, but it appears to me that the regulatory environments that preside over quality in the medical device and the food sectors are in serious danger of producing precisely the opposite effect to that intended.
Back in the eighties, when Quality Assurance was being recognised as a key business process, when BS5750 morphed into ISO9000, the drive was for consistency, repeatability. The name of the game was conformance.
Without going into the pros and cons of these quality systems, many organisations took them in the intended spirit and Quality Assurance became the vehicle to really drive improvements in standards. And largely, it worked, with manufacturing quality standards actually going through a revolution.
Of course, it was also recognised by many more ‘savvy’ business manager that ISO 9000 simply required you to define your process, and then demonstrate that you followed it. There was no absolute standard of quality or best practice. So the less detail specified, the less conformance was required.
Unfortunately, that’s where we are now with the regulatory authorities. Because these august and vital institutions want to audit adherence to your own quality systems, it would be foolhardy for any organisation to make these systems any more exacting than absolutely necessary. So the QA system is invariably designed to ensure straightforward compliance rather than process excellence.
The problem with this is that organisations have actually lost one of their most important control mechanisms, relying excessively on individual experience and tribal knowledge to define processes rather than risk documenting them.
I see this as a potential opportunity.