QA - A Doctrine?

If there is one thing the pharmaceutical industry is not short of it is paper. Literal mountains of guidance exist covering thousands of topics with millions of words. But do we need more? Despite the guidance available non compliance is a persistent issue.

I have been reflecting on how people I admire in the industry do have a set of core values they embody on a daily basis. And it extends to a level of understanding that is both more in depth and more applied than core QRM principle where the management of risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient. At the same time it could be more succinctly expressed than all the regulations and all the guidance already published. Ask anyone to read the orange guide cover to cover to see the definition of a chore.

Do we need a further compass? A succinct guiding philosophy and set of principles of Quality Assurance (QA) that exists not as a mandatory regulatory compliance activity but as an ethical obligation and a strategic imperative.

I occasionally get left contemplating that something could exist at an intermediate level. A shared way of working that is both easily accessible for everyone engaged in pharmaceutical manufacture and a useful set of guiding principles. Something that would defining and emphasizing the purpose of QA and how it shapes everything we do and must do to operate in this space.