IN SHORT
How do you know whether a GMP control still adds value?
A useful control has a visible purpose: people can explain which risk it prevents, detects or reduces, who owns it, how independence is protected where needed and what evidence shows that it works.
What this means in practice
Review mature controls by purpose, ownership and effectiveness rather than by habit. If the reason for a control can no longer be explained, re-evaluate it instead of automatically adding another signature or review step.
GMP & quality systemsThere is one type of control I have always had mixed feelings about: the second-person check.
Not because I do not believe in independent verification. Quite the opposite. One of the strengths of GMP is precisely that critical activities are not simply left to one individual without any form of independent challenge or oversight.
What makes me uncomfortable is something else.
When one person performs a task and another person checks it, there is a risk that responsibility becomes less clear rather than more clear. The first person may unconsciously think that the second will catch anything that was missed, while the second may approach the check with the assumption that the first person has already done the work carefully.
Instead of creating two fully attentive layers, we can end up creating two partially shared ones.
Controls accumulate faster than their purpose is revisited
This is where mature GMP systems can become complicated over time.
A deviation happens, so an additional check is introduced. An inspector asks a question, so another review step is added. A near miss occurs, so a second signature appears. A temporary monitoring activity is increased because, at that moment, it makes sense to increase detectability while the underlying issue is being addressed.
Each of those decisions may be entirely rational when it is made.
Years later, however, the control often remains while the reason behind it becomes less visible.
Ask why something is done and the answer may be, “because the SOP requires it”, or “because QA wants it”. Neither of those answers actually explains the control. They only explain where the requirement currently sits.
Start with the risk the control is meant to manage
The more useful question is: what risk is this control supposed to prevent, detect or reduce?
Once that is clear, we can ask whether the control still does what we think it does.
Does the person performing the activity clearly own the correctness of that activity?
The department that owns the process should also own the logic of the controls around it. QA should challenge and verify that logic, and the QP should be able to rely on the system as a whole.
When those responsibilities are clear, independent checks strengthen the system. When they are not, an additional signature can sometimes create the appearance of control without necessarily creating more control.
Review purpose, ownership and effectiveness
That is why reviewing established controls should not simply be an exercise in asking what we can remove.
Sometimes the conclusion will be that a control remains entirely justified. Sometimes it may need to be strengthened. Sometimes it may need to be redesigned or reduced.
The important part is that we still understand why it is there.
A mature quality system should not only be capable of adding controls when experience shows that something can go wrong. It should also be capable of revisiting those controls when the process, the risk or the surrounding system has changed.
Because if nobody can explain what a control is intended to achieve, who owns it and why it still adds value, the problem may not be that we have too few controls.
It may be that we have stopped understanding the ones we already have.
What am I missing? How often do we check not only whether a control is being performed, but whether its purpose, ownership and independence are still clear?
