Quality Management Systems and Medical Device Manufacturers

Many manufacturers have established quality management systems in their organizations, but an impressive new book geared specifically to medical-device companies entitled Excellence Beyond Compliance: Establishing a Medical Device Quality System and authored by William I. White was published this past June.

This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. I recently spoke with William I. White and had a chance to ask him a few questions. Here are those questions with William's complete answers: 

What are the common obstacles medical device manufacturers face when developing a quality management system (QMS)?

It is an unfortunate truth that the QMS itself may provide obstacles between the employee who wants to do the right thing and the ultimate goal of effective compliance. Ironically, one of the most common sources of obstacles is excessive zeal in compliance. Sometimes this happens through a succession of audits.  Each audit may identify nonconformities.The nonconformities may lead to new procedures, but don’t always lead to revision or elimination of the old procedures, and then procedures are in place that may be inconsistent.  Some companies make it easier to create new procedures than to revise old procedures; this leads readily to a profusion of inconsistent requirements. In addition, a company finds itself with serious compliance problems and then brings in experts to ensure that it has procedures covering all aspects of compliance. In this situation, the primary motivation of the experts (understandably) is to ensure that compliance issues are fully addressed in the resulting procedures.  If the company is not a full partner in preparing these procedures and simply accepts blindly what the experts dictate, the result can be procedures so complex that they confuse employees more than they help them. In short, if not managed well, the complexity that is to some degree required by worldwide regulatory requirements can lead to confusion among employees who are struggling to do their best with an overpowering workload.

How can they overcome these problems?

The actions of people are ultimately what decide whether a quality system accomplishes its goals, and those actions depend upon documentation that is understandable and straightforward. People want to do the right thing, but if they have to struggle to figure out what they are supposed to do, they will lose patience and do whatever seems sensible (which may or may not correspond with the documentation). The most critical aspect is that employees must be able to determine readily those procedures that are applicable to their work. A well-planned documentation system can make this possible.

What do those who work for medical-device manufacturers think of William's perspective? How has your QMS been affected by compliance issues?