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Corrective and Preventive Action (CAPA) -Part 2: Preventive Actions and Verification

2/22/2021  By Kristine McDonald

 

Corrective and Preventive Action (CAPA) -Part 2: Preventive Actions and Verification

Last month I introduced the use of a Corrective and Preventive Action (CAPA) program to work to find a root cause by using a 5-Why technique, but that is just the start of a CAPA. The next step after a root cause is discovered is to prevent the issue from reoccurring by instituting actions that are effective. Done correctly, a CAPA will extend beyond the specific failure to other possible failures with the same or similar root cause. To ensure the preventive actions are effective, a verification step is necessary. Verification periods should be set to appropriately assess the preventive actions have successfully prevented the root cause of the issue from reoccurring.

Using a diverse team is not only necessary in coming to a true root cause but to also find effective preventive actions. It is too easy for us to look at solutions from our work perspective only and not view other preventive actions from other points of view. Having outside input allows us to truly assess the root cause and actions to prevent it from reoccurring.

A diverse team has been assembled, the root cause has been determined through the 5-Why technique, now it is time to develop and assign preventive actions. Preventive actions must correct the processes or develop processes that will truly prevent reoccurrence. Rarely is re-training an employee an effective preventive action. This is because a failure is more about processes not being sufficient to prevent the root cause from happening. Employees will change and if the training is the only prevention, ensuring that training is complete needs to be corrected in the process. Create actions that will make the reoccurrence of the root cause virtually impossible.

Most CAPAs will have multiple preventive actions. Remember, these are actions that will permanently correct the issue, not just “band-aid” it. If there are structural or equipment failures, what preventive maintenance issues have been overlooked? If personnel have made “human-errors” in blending, what safeguards can be put into place to prevent “human-errors” from happening, e.g. physically removing supplies from an area or placing locks on supply areas.

The last step in creating preventive actions is to ask the question, “Will these preventive actions truly prevent the root cause issue from reoccurring?” If the answer is “yes”, move to completing the actions. If the answer is “no” or “maybe”, work to find other actions that will change that answer to “yes”. This may include ensuring all root causes have been directly addressed with a preventive action or to add to the actions. Ensuring the preventive actions will be effective will make the CAPA successful, put the work in at this stage.

Once the preventive action plan is created, do the actions. Ensure all actions are complete and that they are appropriate to the CAPA they were created for. Then determine, with the team, an appropriate duration for the verification stage. The verification stage must be a sufficient amount of time to allow for the issue that caused the CAPA in the first place, or something similar to occur to prove that the preventive actions were effective in preventing a reoccurrence of said issue. This time frame may be a few weeks, a few months, or even a year. This is a valuable step as it will allow for evidence that the CAPA was effective.

Should the Verification stage fail, meaning the issue was not prevented by the preventive actions, it is back to the drawing board. Solutions may include re-assessing the preventive actions, re-assessing the root cause, adding additional persons to the team, or starting over from scratch. If the verification is effective, the CAPA can be closed successfully.

Don’t forget to ensure others that may experience this type of issue and were not directly involved in the CAPA are informed as it may be useful in preventing issues before they have occurred in their area. Tree Top conducts a monthly Structured Communication with our facilities and other departments to communicate quality metrics and CAPAs that are opened each month. This allows for transparency through our organization on the improvements that are happening through our CAPA program.