Common Goals
Production is the economic engine of the plant. Quality is the patient representative (with ultimate authority) who acts as a coach, guiding production to achieve the highest quality product at the lowest price – maximizing both profit and reputation. The best coach is one who provides guidance and direction to achieve the common goal, in our case achieving this goal while working within the regulatory framework. Any activity introduced by the coach that is not aligned with the common goal nor required within the regulatory framework should be avoided. When approached objectively, the two departments should align more often than not. The problems arise when there is no clear understanding of risk acceptance within the Quality Unit - any risk identified during discussions is viewed as a regulatory noncompliance (gap), when in fact this is often not the case. QA is uncomfortable with risk, then attempts risk mitigation (which is not risk reduction) via additional procedural controls. Technical and engineering controls are typically the only the means for risk reduction, but are not always feasible. I would argue that in the majority of such instances, the best mitigation (when reduction is not possible) is a focus on simplification of the workflow rather than adding procedural steps that do little to achieve the common goal.
One massive source of quality problems (as we well know) come from mistakes - therefore we must focus on a reduction in mistakes through process excellence as “plan A” when risky (usually manual) operations are identified. Adding procedural controls (e.g., witnessing/verification) often increases the chances for mistakes (due to limited resources), inadvertently introducing quality problems despite good intentions.
To my QA friends & colleagues: before you roll out the next phase of your DI journey as an action item resulting from the new EU GMP framework – make sure your processes and mindset around risk mitigation are aligned with the principles of process excellence and a reduction in mistakes, otherwise the common goal may be difficult to achieve!
Pete
