• Zuned Khalifa

What's your Quality System do for you?

The FDA defines a quality system as “the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility”. The culture and needs of each individual company is always unique yet quality systems may share frameworks due to the same set of regulatory requirements and standards. While actually working within a quality system is the gold standard in identifying its strengths and weaknesses, I have found interviews to be an excellent vantage point into how an organization and its leadership sees the quality system. Though some of my thoughts below are now colored by hindsight, I think there is still value in sharing some experiences.

“Quality Systems lets a company go fast!” During a recent interview, I found myself speaking to another director. Excited, he discussed how he viewed quality systems. In his mind, the quality system’s role is to ensure that the company had identified its key processes and provided guidance to its employees in how to tackle important situations. In his mind, flexible approaches that could adapt to and address challenges were paramount. Work instructions and procedures weren’t written solely for regulatory purposes but for practical application. This kept things on track and moving forward without undue delay.

“In your opinion, do you put quality into the product or quality into the system?” A few years ago, I found myself in the office of a director interviewing for a quality role in his group within a medical device company. We had just wrapped up the interview and were chatting casually when he leaned back in his chair after a moment, grinned and then fired away with this gem. Only by having organized, well-established processes can quality trickle into the product. It became evident that the director truly tried to instill the importance of having strong processes drive his team. I later found that this director’s approach was to focus on customer feedback to drive improvements.

“The quality system needs to support the business” I was interviewing for a position within a biopharma company with a recently appointed director. We had a great conversation and, as he had only recently joined the company, he was very open about my questions regarding challenges in the department. The key challenge, he stated, was that the quality system he inherited often found its processes at odds with the business units it was meant to support. It often led to necessary items such as CAPAs and internal audits to be considered burdensome. Teams would often create their own rapid internal process to monitor key areas and then a delayed “quality” process. The overall result was a system with inefficient, redundant and often token activities. As a result, one of his key priorities was to find ways to streamline and engage employees in the quality system. Having established and purposeful processes is a basic need in a quality system. I find the examples above interesting as I think they demonstrate that multiple organizations tug at this thread in different ways. I’d be very interested in hearing opinions from my quality colleagues.

Originally posted on LinkedIn.

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