I had lunch with a couple of colleagues other day and we were comparing notes on some of the challenges we encountered in Quality Management when working in the regulated industry. As it turned out, we share one very common challenge where we’ve been engaged to assist an organization in addressing adverse inspection or audit findings. We’ve all at one point encountered an executive officer from that company say “Just get all the documents done as quickly as possible and get it in the system” or similar words to that effect.
That phrase alone speaks volumes on how misguided some organizations are on what Quality Management is about. In such organizations, many of the executive team mistakenly believes that Quality Management is all about the volume of paper it generates and do not appreciate what the documents represent to their business. They see it as a necessary evil for conducting business in a regulated industry. Those beliefs and values percolates down through the organization and often result in the hiring and appointment of Quality Managers who are powerless to create a quality culture – Paper Tigers. These quality groups often approach deploying Quality Management Systems with a “box checker” mentality. By that I mean they try to embed in their quality programs, each element and tool from a checklist without attempting to understand the philosophy, integrate the systems or facilitate culture change. In these instances, quality is managed in a reactive ‘catch-as-catch-can” mode. Its easy to identify the “WHAT” of these elements, a quick web-search will direct you to any number of websites, literally an alphabet soup of abbreviations! For the regulated industry they include; ICH, FDA, EMEA, HPFB, etc. and for industry standards; ISO, PICs, ASTM, ISPE, etc. It is more challenging to know the “HOW” in implementing these elements with an integrated approach.
A more insidious result of such a dysfunctional approach to Quality Management is a never-ending cycle of quality processes. In this scenario, the Quality Manager is unable to impress on executive management the benefits and importance of embracing a quality culture. The Quality Manager’s role is boxed into a very defined space delineated by the operations directly affecting the production process and the quality processes that are specifically mandated by the applicable regulations. Within the organization, the quality processes are viewed as excessive, generates too much paper, and unnecessarily costly. As a result the quality processes are ineffectively deployed, poorly understood and unsupported. The Quality Unit focuses on the execution of the processes like so many hamsters on their wheels but none of these are linked to the larger objective of increasing efficiency, reducing and eliminating scraps, preventing process drifts, identifying and correcting sources of errors etc. Some common symptoms are; Quality Manual and Policies are not signed or read by executive management, personnel training programs cover only what is mandated for the industry, high rate of product returns and complaints, high rate of reworks or rejects, repeated adverse audit and inspection findings, and an understaffed quality unit. In one particularly egregious instance, where I had alerted the organization that a product did not conform to the manufacturing specifications and that there was no data to support its ability to meet its intended function in the field, I was asked if I’d approve the release of that batch if the Vice President and Director issued a memo indicating that they acknowledged my concerns with regard to that batch! Sadly such organizations do not reap the benefits from the cost of all the effort in implementing a Quality Unit and deploying a Quality Management System. This is akin to; buying a cannon, loading the cannon, aiming the cannon…aiming the cannon…..aiming the cannon… aiming the cannon…