The One-Minute CAPA: Key Practices

• Implement a written problem investigation SOP. Provide training to all employees on determining root causes and on performing thorough problem investigations.

• In training classes, walk employees through a problem investigation, root-cause analysis determination, and proposal of possible actions. Explain the criteria for selecting a possible solution.

• Remember that the depth and intensity of an investigation (and the thoroughness of the CAPA activity) should always match the potential risk to patients.

• Review FDA inspection guides, such as the QSIT Guide, for suggestions for procedures. Share them with employees. Also read the preamble to the medical device QSR and applicable industry guidances.

• Ensure that a system is in place to verify the effectiveness of the CAPA activity. Ensure that it did not cause a worse problem.

• Review the data sources that were used to identify the problem in the first place to ensure that the problem is not repeating (reviewing current nonconformities and deviations is a good starting point).

• Check or confirm the status of any open CAPA items during internal audits.

• Review pertinent data sources periodically to see whether there are trends that need to be acted upon.

• Clarify the issues that must be brought immediately to senior management’s attention. Define who is responsible for bringing them to management’s attention.

• Any problem involving distributed product must be investigated with the utmost urgency—the problem may require a recall or notification to FDA.

• Try to determine all root causes.

• Do not confuse corrective action and preventive action. Implement solutions that not only correct the immediate problem but also prevent the problem or any related problems or issues from occurring again.

• Move toward being able to identify and take action on possible problems before they become real ones.