CAPA is dead, Root Cause killed it.

What does fixed look like?

Looking for “Root Cause” is like searching for the Holy Grail when all you really need is a sleeve of Solo cups.

Continuous Improvement methodology teaches us that there is no perfect solution. So, why do we spend so much time seeking the perfect problem?

Overly narrowing the problem space significantly reduces the solution space.

This leads to a cut and paste approach to applying “fixes” that are easily verified so that your CAPA program appears compliant but have very little positive impact on daily operations. All of this leads to sub-optimal processes, demotivating cross-functional support and reinforces leadership’s opinion that the Quality Department is just regulatory necessity with zero return on investment.

I think it’s time for a new approach. One that looks at all potential causes and confirms the contributing factors that lead to the systemic problem (all problems are systemic) as a feeder into brainstorming solutions. Teams can generate a lot more good ideas if they have a broader understanding of the problem, the system they live in and given the freedom to explore even outlandish ideas. I recommend ranking of impact/effort analysis of proposed solutions should occur the day after your brainstorming. It reduces the desire to eliminate good ideas and provides some time for reflection.

Also, if anyone says, “We don’t want to boil the ocean” during your brainstorming session they need to leave the room for 15 minutes for an attitude adjustment. Increase the punishment by 5 minutes for each infraction.