7 Steps of CAPA Management
A safety and quality system for a cannabis facility should include preventive and basic corrective action in management procedures to resolve any non-conformances. For example, let’s say an internal audit of your entire cannabis safety and quality system is complete. At the end of the audit, you notice several deficiencies and immediately take action to correct the issues. Two weeks later, the same issues are popping up again. Once again, you correct them… or at least you think you do. A month later—the same issues happen again! The culprit? Not following a well-designed CAPA Management program.
What is CAPA Management?
CAPA refers to two distinct procedures: one for documented “Corrective Actions” in management and another for “Preventive Actions.” These procedures outline how your organization identifies and resolves existing or potential non-conformances.
Corrective Action – Action is taken to eliminate the cause of a non-conformance or other undesirable situation, to prevent a recurrence.
Preventive Action – Action is taken to prevent the occurrence of a non-conformance before it happens, usually as a result of a risk assessment.
Is CAPA Management a requirement of CSQ?
Yes. The requirements for CAPA Management can be found under section 1.8 Risk Management and Corrective Actions in the CSQ Standards.
The 7 Steps of CAPA Management
1. Identify
Before you can solve the problem, you need to identify and define it. This should include a detailed description of the problem, how the problem was found, and any evidence that supports the identification of the problem at hand.
2. Evaluate
After you have identified the problem, you should evaluate the severity and implications of the problem. What risk does it pose to the company, employees, or consumers? In your evaluation, you should clearly state the potential impact in regard to consumer safety, employee health and safety, product quality, cost, and brand reputation.
3. Investigate
Next, you investigate the who, what, when, where, and why. Who caused the problem? What caused the problem? When did the problem occur? Where in the facility, process, or supply chain did the problem occur? Why did the problem occur?
4. Analyze
After your investigation is complete, you can begin to analyze the evidence gathered from your investigation to determine the root cause of the problem. There are several methods for determining a root cause of a non-conformance, such as the 5 Whys Method or the Fishbone Diagram.
5. Plan
Once a root cause has been determined, it’s time to develop an action plan to correct and/or prevent the problem from occurring in the future. Your corrective action or preventive action plan should include any actions to be completed, such as changes to processes and procedures and/or employee training.
6. Implement
Now that you have a detailed action plan, it is time to implement the tasks described in the plan. Be sure to document each action taken to show evidence that the problem was corrected to ensure it does not occur in the future.
7. Verify
The last step is verifying the effectiveness of the implemented corrective or preventive action plan. Did the action plan have the desired effect? Has the problem occurred again? If the problem has reoccurred, start the process over and adjust your action plan accordingly.
In Conclusion
By rigorously following the Seven Steps of CAPA Management, you will ensure any non-conformances or other undesirable situations are documented, corrected, and effectively prevented from happening again. This method of approach creates a CAPA system that allows you to trend non-conformance data for continuous operational improvements.
