Every quality management system (QMS) that is put in place to manage ISO or FDA requirements needs corrective and preventive action (CAPA) procedures.
In a well-functioning QMS, everyone has a clear set of criteria for determining which events to escalate into a CAPA system and which to handle through other procedures.
How a CAPA system works
A CAPA process should analyze customer complaints and non-conformances to identify how the problem can be corrected and prevented.
Corrective action is reactive and tends to happen only when a problem is discovered through a complaint or an audit.
Preventive action is proactive. It searches out non-conformances to prevent them from happening and leading to complaints.
Both actions can be implemented at the same time, but they can also be applied individually. It’s also possible for a complaint not to require CAPA action but some other solution.
FDA and ISO requirements for a CAPA system
Companies that need to comply with FDA regulations and ISO standards must have a CAPA process as part of their QMS. Without it, they may not comply with the necessary regulations and standards to keep manufacturing their products (especially medical devices).
The FDA’s Quality System Regulation 21 CFR 820.100 specifies the need for a CAPA subsystem as follows: “Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.”
It defines CAPA procedures as needing to include:
- analyzing processes
- investigating the cause of non-conformances
- identifying the action(s) needed to correct and prevent a recurrence
- verifying or validating the corrective and preventive action
- implementing and recording changes in methods and procedures
- information related to quality problems or non-conforming products is disseminated to those directly responsible
- submitting relevant information for management review.
The ISO 13485:2016 guidelines also specify the need for corrective and preventive actions in two separate clauses.
Clause 8.5.2 for corrective action requires your CAPA process to include:
- non-conformances
- causes of non-conformances
- need to prevent a recurrence
- planning and documenting
- corrective actions must not affect the product quality
- reviewing the effectiveness of the corrective action.
Clause 8.5.3 for preventive action requires the following to be included:
- potential non-conformances and their causes
- evaluating the need for preventive actions
- planning and documenting
- preventive actions must not affect the product quality
- reviewing the effectiveness of preventive action.
Common sources of CAPA events
Uncovering potential CAPA events is also an important step in the process. Neglecting any of these common sources of CAPA events could mean issues get overlooked and unresolved.
Customer complaints
Complaints from customers are one of the major sources of CAPA events. This doesn’t mean that every complaint is worthy of CAPA.
Audits
Audits often uncover quality issues and non-conformances that need CAPA to be resolved. These can be internal or external audits.
Non-conformances
Non-conformances can become apparent at any time in the manufacturing process, even during planning and design. Not all non-conformances will require CAPA.
Changes to procedures
When changes are implemented to procedures, it sometimes uncovers potential non-conformances or issues that could lead to non-conformances.
Why it’s necessary to decide which events to escalate
Without clear guidelines on when it’s appropriate to trigger CAPA for an event, it’s possible to end up with one of two extremes.
In the first, too many problems get escalated, resulting in a backlog of unnecessary CAPA processes. This is known in the industry as being “CAPA happy”.
The other outcome is that CAPA-worthy events get overlooked. This can lead to 483s and warning letters from the FDA.
Either way, the effectiveness of your CAPA system – and your entire QMS by extension – gets compromised.
What should trigger a CAPA?
To avoid over or underreacting to complaints or non-conformances there are considerations you can use to determine if a CAPA should be triggered.
Frequency
How often the problem occurs, especially if other measures have already been taken to prevent it, is an important factor. For example, if you keep getting complaints about the same product despite attempts to resolve it, a deeper investigation is needed.
Alternatives
Are there other solutions that might resolve the issue that are less time consuming and require fewer resources? Triggering CAPA unnecessarily can compromise the system and cost the company time and money.
Relevance
Gauging the relevance of an issue shouldn’t just be up to one person, especially someone who is not familiar with CAPA procedures. More than one person’s perspective can help. A dedicated CAPA administrator helps to evaluate potential CAPA instances.
Past occurrences
Anyone deciding on a CAPA process should be familiar with the system and can access the database of past CAPA processes for the same or a related problem. They can use past determinations and actions to help decide if CAPA is necessary, especially if it is a recurrence.
Verification
Use a system that verifies other actions that have been taken to try to rectify an issue. For example, if a complaint wasn’t properly dealt with, the issue might still be resolved by other means.
A cloud-based CAPA software solution
An important part of an effective CAPA system is accessible software that can track and record CAPA actions. Our quality management software includes a CAPA module that can be used independently or form part of a comprehensive cloud-based QMS.
The module helps ensure that the right corrective actions are implemented. It also automates workflows and notifications and provides real-time records for audits.
Our cloud-based system includes Complaints Management, Audit Management, Training, and Non-Conformance Management software.
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