“Who Owns the Quality System: Everybody, Somebody or Nobody?” via PharmPro brings up an excellent point – the tragedy of the commons – if quality is everyone’s responsibility, then no one is really taking any responsibility. The author is correct that this happens quite often. And in most pharma companies, management is adamant that quality IS everyone’s responsibility.
As with many things, the best answer is somewhere in the middle. Defining “champions” or subject matter experts for every piece of the quality system is both useful and necessary. From the practical need to determine who will conduct training on an SOP for the staff to the more general compliance need of ensuring that a procedure is at all times meeting the applicable regulations and best practice, it is essential that some named person knows they are responsible.
That said, the users of a system don’t get to sit idly by and complain if a procedure is inefficient or known to be out of compliance. Every person that lays eyes on a procedure or uses a form or performs any function in a GxP environment has a responsibility to speak up and take action when changes are needed. Management must encourage this ongoing process to ensure the drugs they manufacture have the required safety, identity, purity, potency and quality
The question “who is responsible for quality?” is particularly relevant in today’s world. This highlights the need for detailed contracts and quality agreements with your CRO, CMO and consultants. It is paramount that the sponsor understands his or her role in ensuring the quality of clinical trial materials. This is not something they can fully delegate to a contractor, nor can the CRO or CMO get away with saying “the sponsor told us to”.
Parties must be named, but aspects of the overall quality responsibility are still shared. As with commercial products, clear definition of quality responsibilities is essential during clinical trials and everyone involved must speak up if problems are noted.