by: Steve Gompertz, QRx Partner
I had an interesting discussion recently during a client audit on something I see often in CAPA procedures: Verification of Effectiveness (VOE) planning occurring after completion of the action plan. The reason for this might be a misinterpretation of the list of requirements in ISO 13485 8.5.2 and 8.5.3 as a sequence of events. In those lists, reviewing effectiveness is listed last. That in no way is meant to imply that it occurs last.
VOE as Part of Action Planning
The correct time for planning VOE is while coming up with the corrective action plan. In many ways, it’s similar to writing test protocols—where you wouldn’t conduct a test without first defining measurable acceptance criteria. Think about it:
Would you accept a test report where the acceptance criteria were defined after the test was performed? Neither would regulatory bodies.
Similarly, both ISO 13485 7.3.4 and 21 CFR Part 820.30(d) require identification of acceptance criteria for Design Outputs. No one would approve a design without knowing how its performance will be verified.
Just as test plans define measurable success upfront, CAPA actions should include clearly defined VOE criteria from the beginning.
Value in Identifying Actions
Beyond logic, defining VOE during action planning provides real value. It serves as a litmus test for the clarity and validity of your action plan.
If you can’t identify how to verify the effectiveness of an action or plan, you likely haven’t defined it in clear, measurable terms.
Avoid vague words like improve, better, more, less, etc.
Hopefully, the investigation produced data that can be used as the basis for VOE.
Example: problem = lots of scrap, investigation = 70% first pass yield, VOE = 99.999% first pass yield
Without baseline data , defining VOE becomes nearly impossible.
How Much VOE?
CAPA’s typically address a single systemic problem, or maybe several related problems. However, the investigation often uncovers multiple Root Causes and/or the need for multiple Corrective or Preventive Actions.
So, if your plan encompasses four Actions, do you need VOE for each action or for the plan as a whole?
Since the intent is to address the root cause(s), it would make sense to establish VOE for each root cause.
Sometimes multiple actions are required to address one or more root causes.
Basing the VOE on the number of actions may not make sense.
But, in keeping with the idea that actions must be defined with measurable outcomes, those outcomes should be defined in terms of their degree of contribution to addressing the entire root cause or causes they apply to.
For example, in the first pass yield issue noted earlier, if the plan includes three actions, each should indicate how much they improve yield and together they need to add up to the overall VOE goal.
This approach ensures that every action has a measurable impact and aligns with solving the root cause effectively.
Overall VOE Value
As with all QMS requirements, VOE isn’t just something to check off a list. As noted above, it serves to ensure that the actions being taken have not only worked but as a predictor of whether they will work. The latter is what supports defining VOE as part of action planning rather than after completion of the actions. No one wants VOE to fail as it represents wasted resources. See VOE as a tool for avoiding failure first, and then as a means for demonstrating success.
One last challenge: you are monitoring VOE success rate as one of your CAPA metrics, right?
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