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How to Avoid Risky CAPA Decisions

In my travels I work with large and small companies, and all of these firms have difficulties with the corrective and preventive action (CAPA) process. For the life of me, I can’t figure out why. Then again, what other process touches each and every part of the QS Regulation and the 13485 Standard? What other process deals with all of the negatives dealt out by inadequacies and inconsistencies in the entire Quality Management System (QMS)? How positive a “spin” can you put on complaints, non-conformances, adverse events, audit findings, defective products, process failures and medical device reporting? The CAPA process requires tenacious process owners with documented follow-up and follow-through. In this age of instant gratification, this process touches the very fiber of your company’s core competencies and must be dealt with methodically. You can’t dial up improvement by running your finger across a screen. 

The “action” part of corrective and preventive sometimes takes months to fix, and then a fair amount of time to determine whether the fix really works. Companies now and again lose track of their CAPAs, and generally have trouble dealing with and remembering long-term initiatives. It can become a monster that just won’t obey. Fire-fighting companies tend to deal in the “here and now” and wouldn’t (or couldn’t) plan a free lunch, no less a long-term corrective action. This is a generalization, but here goes—companies with successful process controls usually have a better handle on facilitating the CAPA process than companies that have to solve a multitude of problems all day and every day (to “make it work”). The latter of these companies are so in-tune with solving brand new, daily problems on the run that CAPA initiatives lasting more than three days cause consternation, undertones of “this is taking too long” and the inability to focus on long-term goals.

Making every defective a long, drawn-out corrective action is not the answer. Handling systemically-driven issues by making them just corrections is not the answer, either. There needs to be a common denominator that helps with the decision-making as to how far you have to go when confronted with a defective situation. Risk management fits the bill because it tends to use quantitative results and statements to make decisions, rather than “hip shots,” and it touches every square inch of the quality management system…like CAPA. What a coincidence. Reducing uncertainties by using a risk management approach is the forerunner to quality improvement, successful corrective action and, when you really “get good at this game,” preventive action, as well. Yes, you can prevent defective issues by using risk-based planning and applying just the right amount of planning, i.e., reduce the costs involved with resource-intensive CAPAs that should simply be “just” a correction.

Defined Examples
Correction eliminates the problem, e.g., a quick fix such as “rework of non-conforming devices”

Corrective action eliminates the root cause of the problem, e.g., usually a systemic issue such as “the machine qualification was not achieved when the injection molding machine was rebuilt and caused defective devices to be manufactured”

Preventive Action is taking proactive steps to ensure that a potential nonconformity does not occur, e.g. “every time a machine is rebuilt, a machine qualification is strongly considered using a formally-issued go/no-go decision chart based upon risk management.” (We should check all of the machines that have had recent changes.)

Quality Review Board is a group of cross-functionally-related process owners who meet periodically to discuss and make decisions about non-conformances whether they are product- and/or process-based.

The Seven Steps in the CAPA Process
There are seven steps that must be taken when performing a full-blown corrective action, whereas a correction commonly involves only steps one, two and three:

  1. Define the problem. Make sure the problem is a real problem and not a perceived problem.
  2. Define the scope. Make sure you understand the extensiveness of the problem.
  3. Take Containment Actions. Make a correction to stop the problem immediately while you look for and correct the ultimate cause.
  4. Find the Root Cause. Try to identify the underlying problem, not just the one on the surface. Ask the five “whys.”
  5. Document a Corrective Action Plan. Decide what steps are needed to eliminate the root cause of the problem.
  6. Implement the Corrective Action. This is as simple as following through on your plan and enabling a systemic action.
  7. Verify that the plan worked. After you have put corrective action in place, wait a suitable amount of time to make sure that the problem doesn’t recur. If it does, you need to ask if you determined the actual root cause.


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