Our quarter horses are well-watered because of established roles and responsibilities around the ranch. But I am no longer surprised that in the pharma industry it's not that easy to point to who is responsible for what when it comes to the details of the quality management system.
I typically get one of two responses to the question, "Who owns the [fill in the blank] system?" Whether it is Training and Qualification, Deviation and CAPA, Document Management, Complaint Handling--or whatever-- it's the same:
- Ultimately it is the Head of Quality, or
- What do you mean "own" (or responsible) exactly?
Sure, the Head of Quality has the ultimate functional responsibility, and in the sense of the Park Doctrine, the CEO has the penultimate responsibility. But that is a neither practical or effective.
I published an article that discusses the importance of identifying clear ownership at the operational level for each element of the quality management system and the benefits to the business when new expectations are set.
Follow this link to read the article on IVT Network--> Ownership Responsibility
I hope you find this article beneficial. Write to me, or post a comment to this blog and tell me what you think.
The QA Pharm
