The best laid CAPA plans

Don't give me problems, give me solutions!! Have you heard this in your work environment? I have. We have to understand a problem, the cause of the problem before we can begin identifying solutions.

Well, good news! In my previous blogs, I've written about writing a good problem statement and I've also introduced the 5 Why's and Cause and Effect Diagram root cause analysis tools. So now that we have a good problem statement and understand our root cause(s), we can begin planning actions to address the cause(s) of the problem.

In the Quality world, we are wanting to identify the corrective actions and where needed any preventive actions. This is often called a CAPA plan.

Beware of CAPA plans, whatever you decide to do, make sure you are not creating new problems with your new solution. Mitigate this by engaging a cross-functional team to help in CAPA planning or by performing an FMEA on the CAPA plan to identify things that can go wrong with your plan.

We want to identify the best permanent actions to correct the root cause(s), address any systemic issues in CAPA plan.

Write a CAPA plan in a table with Action / Owner / Due Date.

Some tips:

• Verify that the actions will not affect product performance, safety or where applicable, regulatory requirements. (bring in regulatory affairs, design engineers or environmental health and safety folks as needed).

• Consider opportunities for error-proofing (also referred to as Poka Yoke in the Lean Manufacturing world)

• Review and update your process failure mode effects analysis (pFMEA) if applicable

• Review and update your process control plans if applicable

• Be sure to assign an owner and due date to the identified actions

• If the issue is not isolated, for example to one production line or one specific area, consider more systemic actions in form of preventive actions

There are a few tools to help you on your way with CAPA planning. Brainstorming is a good tool. Failure Mode Effects Analysis (FMEA) is a great way to identify potential ways things go wrong and mitigations to ensure they don't. For several options, the pugh matrix can help with an objective assessment of potential paths. And finally, for more complex issues, a Design of Experiments (DOE) may be the way to go.

For this blog, to get you started, I recommend simple brainstorming on potential actions, with a good cross-functional team...a conference room and a whiteboard. Work through potential actions, get aligned, then take a picture to paste or write down the plan in your problem-solving tool with action, owner and due date. Once your CAPA plan is complete, check that the plan answers the root cause(s) identified earlier. Then, execute the CAPA plan.