This acknowledges that putting words in a procedure does not mean they will be put into action or be effective.
The responsibility of Quality Assurance is to ensure that an effective Managing the Quality Management System (QMS) is put in place procedurally, is in use behaviorally, and is in control measurably.
The responsibility of Management is to enable the QMS through accountability of each element of the QMS by an identified owner; to provide oversight through performance metrics; and to promote the QMS as a normal and valued part of the business---not to make the FDA happy or pass an inspection.
As I reflect on my pharmaceutical career and the many clients I have served over the years, the best results and most rewarding experiences were with those who embraced this concept.
My hope is for all my followers to use this simple graphic as a way to communicate a QMS implementation strategy.
I would be pleased to support your effort with details behind each of these points.
If you would like a high resolution image, please write to me at my personal email address: firstname.lastname@example.org. You have my permission to use freely.
The QA Pharm