Quality Culture

Today, culture is on my mind.  We hear much talk on the subject, but I personally dislike the way we often use the term in the abstract when applied to GXP organizations.  Culture does not have to be an abstract concept; simply unable to be measured.  I find senior leadership may at times use culture as a distraction by treating it as something that is felt rather than realized.  Treating culture as abstract feeling dilutes its significance and can be used an excuse not to focus on tangible results that may actually realize the defining nature of culture: summarized as ‘purpose and meaning in labor’.  When we humans find purpose and meaning in work, only then can a common aim among various departments be realized – typically safe and effective medicines.  We achieve purpose and meaning in labor by ensuring any action required by an operator or analyst has a reason behind it, and that reason is because it in some way impacts a patient.

Developing SOPs that ensure tasks are meaningful is not easy. The easier route is volume - simply do everything, which will inevitably also include the meaningful tasks. Inspections will come and go without much disruption, but so will valuable employees… For these organizations that focus on volume rather than meaning, culture must be spoken of in the abstract, because it will never be realized. Volume is the enemy of quality culture… Luckily, a clear roadmap to eliminate unnecessary tasks has been published by the regulators years ago!

A simple and tangible roadmap to culture is sketched out below: it’s not too difficult – so get onboard!

Pete