10 CAPA Tips for the Medical Device Industry

CAPA Systems,
FDA & European Regulations
The CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements (ISO 13485, 8.5.2) is one of the most important elements of a Quality Management System (QMS).

It is essential to develop a system the right way to assure QMS effectiveness and minimize irregular findings on regulatory audits.

Consider the 10 tips to help implement an effective CAPA process:

1. Use IMDRF guidelines and FDA resources for regulatory compliance

Use recommended guidelines from industry experts such as those in the International Medical Device Regulators Forum (IMDRF and formerly known as GHTF) to implement an effective CAPA system that will help reach compliance to both U.S. FDA and EU medical devices regulations.

These guidelines provide a framework to understand a CAPA system better and give examples of implementation. By following an approved guideline, a better CAPA system can be developed.

2. Centralize CAPA system for better control

Make a universal system to trace all issues from different sources in one list. One might also develop a custom-made CAPA software application and clearly distinguish the source from which each particular CAPA is initiated.

These methods will allow easy monitoring and traceability of each CAPA status.

3. Define coding system for corrective actions / CAPA forms

Make a universal coding system and assign unique IDs for each CAPA record to allow easy tracking. This is essential to have better traceability among several CAPAs.

4. CAPA and Risk Management

Be sure to implement risk management within the first stage of a CAPA process. Using a risk management process allows you to perform a root cause analysis and Corrective action only for those issues which require it.

Define risk criteria where critical issues (safety-relevant or systematic failures) require all phases of the CAPA process. For most minor cases, only corrections will be necessary.

5. Clearly distinguish causes from symptoms

Sometimes, the first description of the issue is not clear enough and does not represent a failure. Carry out an additional investigation to clarify an issue and define a clear problem statement.

Use questions such as Who, When, Why, How, How much, and How often to gather additional information and clearly define the problem and cause. This is an essential step to get near the root cause.

6. Containment actions

Be careful not to miss containment actions. Select all products or forms which might be affected by the issue. Isolate them and mention them on the CAPA record.

It’s imperative to take care of products that might be affected when determined that a complete production lot is defective. This often happens after an investigation into a customer or consumer complaints.

7. Root cause analysis

Use an appropriate method for root cause analysis. In some cases, it is enough to use something simple such as the 5 Whys technique. Starting from the problem statement and asking why several times, one can often identify the root cause. It’s essential to keep in mind that a person should not be the root cause; it is a system failure, product design failure, lack of training, or other common root cause factor.

For more complex issues, Cause and Effect diagrams often referred to as an Ishikawa or fishbone diagram, can be used.

8. Corrective actions

Once you determine the root cause, you need to prevent the same issue’s recurrence at the beginning of the process. Corrective action is required here.

Preventive action cannot be performed because the problem has already occurred. By its nature, preventive action cannot follow nonconformity.

9. Preventive actions

Preventive actions should be used to prevent the occurrence of nonconformity. You may encounter situations that have not caused nonconformity but may do so in the future. Such cases may call for preventive action.

For example, production or acceptance testing trend data indicates that control limits are being approached, and a revision of product or production (process, equipment, or facilities) requirements may be necessary.

10. Verification of CAPA effectiveness

Every good CAPA process should have a built-in effectiveness checking mechanism to verify and validate that the CAPA system works. Data tracking is a mandatory component of CAPA so that the organization can ensure that all CAPA-related information can be confirmed, monitored, measured, and, if necessary, corrected.

A common way to check effectiveness is to search similar issues at the place of occurrence, at internal audits, or any other convenient method depending on the type of CAPA.

CAPA Helps Resolve Organizational Issues

Corrective action isn’t just for regulatory compliance; it can also be a critical aspect of resolving an organization’s issues. CAPA records provide detailed information about past issues that might resurface, eliminating the need for guesswork or redundant efforts that use up valuable time and resources.

Corrective action is just one aspect of a QMS that will provide long-term value for your organization if implemented correctly and effectively.

GxP-CC has extensive experience in helping companies develop a lean CAPA methodology that improves their products while reducing risks.

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