Wednesday, September 4, 2013

Ownership Responsibility for the Pharmaceutical Quality Management System: Setting New Expectations

In Texas we have an expression: If it's left to two people to water the horse, the horse will go thirsty.

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.

John Snyder
The QA Pharm

The QA Pharm is a service of John Snyder & Company, Inc.

John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.

Contact us at john@john-snyder.com.