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10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by

Male Scientist Using Medical ToolsThe 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 in order to assure QMS effectiveness and minimize the occurrence of 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 which will help reach compliance to both U.S. FDA and EU medical devices regulations.

These guidelines provide a framework to better understand a CAPA system 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 CAPA process. For most minor issues, 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 has occurred. 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 in order 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 which might be affected when it has been determined that a complete production lot is defective. This often happens after investigation into 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 important 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 root cause, you need to prevent recurrence of the same issue noticed at the beginning of the process. Corrective action is needed 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 occurrence of nonconformity. You may encounter situations that have not actually caused nonconformity, but may do so in the future. Such situations 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 is working. 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 issues within an organization. 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 it is implemented correctly and effectively.

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

Find out how GxP-CC can assist you by contacting us today!

About this author:

Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

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