As someone with many years of experience working in and around FDA-regulated manufacturing operations, a recent LinkedIn post (March 2018) entitled “Why QUALITY Needs to STOP Working on COMPLIANCE” has really rankled me. Unfortunately, this is not the first time this topic has been discussed. There are frequent speakers these days berating “compliance” in favor of “quality.”
Despite how de rigueur it has become to embrace this premise, I remain unconvinced.
In fact, a discussion about Quality and Compliance is not a competition or an either/or proposition. I believe strongly that it’s a dangerous message to refer to compliance as a non-value-added activity (an expense as the article referenced above stated) while referring to quality as some abstract panacea that magically occurs from some creative or innovative activity that is not being done because of the focus on “the bad compliance activities.”
I submit that this characterization is a gross oversimplification.
Quality vs. Compliance in the FDA-regulated industry
What IS QUALITY if not the activity that ensures conformance to defined requirements and expectations? What IS COMPLIANCE if not the activity that ensures conformance to defined requirements and expectations? The only difference is that, with respect to Quality, it’s patient, customer, and market-centric requirements and expectations that ensure therapeutic and commercial success.
With respect to Compliance, it’s third-party regulator and NGO requirements and expectations that are in place to ensure a baseline-level of performance, for quality – whether the company wants to or not. My long experience has been that those organizations that do the best jobs with defining quality requirements and expectations – and driving relentlessly to meeting them consistently – are the same organizations that achieve the best outcomes with compliance.
Unification
In my opinion, the focus for FDA-regulated industry shouldn’t be on devaluing one discipline versus the other. On the contrary, the focus should be on doing rigorous definition of the requirements and expectations for both Quality and Compliance; aligning these efforts where commonality of approach exists; and ensuring sufficient systems, practices, and people exist to consistently carry out the activities that achieve both sets of requirements and expectations.
Quality is important. Compliance is important. Let’s stop bashing compliance. Let’s focus on doing both disciplines better.
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