Are you familiar with the CAPA process? Having a Corrective and Preventive Action (CAPA) process is a mandatory requirement of most Quality Management Systems standards. If used correctly, CAPA is a powerful tool that helps to identify and eliminate non-conformance causes. If not used correctly, real challenges and inefficiencies can be created.
Let’s look at the three most common CAPA mistakes I’ve seen over the years.
Mistake 1: Opening a CAPA for every single issue
It sounds ridiculous but I’ve seen a CAPA created for a typo! Small issues such as minor cosmetic problems, failed components and typos do not need a CAPA.
When you open a CAPA for every single issue you lose sight of what is actually important and you end up fighting the symptom instead of the disease. For example, a CAPA was initiated for a non-conforming product; the root cause was documented as resistor R15 failed. The Corrective Action recorded for this issue was to replace the component. When I asked how this could be considered a Corrective Action, the justification was: “We replace the component, and it will not happen again”. The third-party auditor noted this and the company ended up with a non-conformance due to the ineffective CAPA process.
The CAPA process should not be used as a tool to document manufacturing issues but rather should be used as a tool to identify and fix systematic process issues. Before opening a CAPA, statistical analysis should be done to determine which of the problems require attention. Is it a single occurrence or a system failure? It is important to perform analysis of data prior to initiating a CAPA, to ensure you can prioritise the issues and fix the real problem – not just the symptoms.
There are some cases where you should initiate a CAPA for a single issue, however, this is rare and usually relates to a potential safety issue or is the result of an adverse event.
Mistake 2: Re-train as a Corrective Action
Almost every company I have worked with makes this mistake! They repeatedly identify the root cause of a problem as a ‘training issue’. This is usually documented as the preferred and straightforward solution to human mistakes in a process, where personal attention to detail and employee memory is relied upon, rather than addressing the actual process.
Using CAPA to deal with human mistakes may seem a simple solution, but regulators do not see it that way. This is something that every auditor looks out for when auditing CAPA process. When corrective action is initiated for training issues, the auditor will ask to see previous training records to verify what the training method was and how you evaluated the effectiveness of the training. If you keep training your employees but they continue to make mistakes it can be concluded that either your training method is not effective or there is a problem with that specific process which needs to be addressed.
Let’s face it, unless you fully automate a process, there will always be the possibility of human error. In the case where mistakes cannot be tolerated, this should be addressed at the process level; continuous re-training of your employees will not solve the problem. I would also recommend documenting in your CAPA procedure that for minor mistakes, such as document typos, that corrective action is not applicable; these issues should be addressed by correction only.
Mistake 3: Corrective Action presented as a Preventive Action
I see this mistake happening over and over during audits: the auditor asks to see Preventive Actions and the company replies that Corrective Action is, in fact, a Preventive Action. When this happens, the auditor issues a non-conformance for compliance with clause 8.5.3 Preventive Actions.
Let me reconfirm for you what Preventive Action is: preventive action is an action you perform to prevent potential non-conformance from occurring in the first place. This means that if your action is the result of an existing non-conformance, this is not a preventive action.
The following are examples of preventive actions:
- Risk assessment – this is an assessment of potential problems and their mitigations.
- Routine Quality meeting – This is where you discuss and document potential issues and how you are going to resolve them.
If used correctly, the CAPA system can significantly improve a company’s performance. When used incorrectly they can cause time-wasting and non-compliance. So before opening a CAPA think about exactly what you’re trying to achieve. Are you solving a problem or just creating an administrative workload?