3 Ways to Improve CAPA Metrics

The ability to identify a nonconformance and execute a corrective action/preventive action (CAPA) quickly depends a lot on how you’ve set up your CAPA management system metrics in the first place. When executed correctly, a CAPA management system can provide your company with the ability to recognize and correct risks before they create bigger problems. But there are a few things to do to make sure your CAPA management system benefits, instead of hinders, the manufacturing process.

1. Make Sure CAPA Metrics Are Compliant

This may be obvious. However, compliance should be the first thing considered when calibrating your CAPA metrics. Do your parameters meet the standards and regulations you need to follow to sell a product in a particular market? Below is a list of standards and regulatory requirements medical device companies must meet for CAPA by geographical region.

United States

• 21 CFR 820.100 Corrective and Preventive Action

Europe

• ISO 13485 8.5.2 Corrective Action
• ISO 13485 8.5.3 Preventive Action
• MDD 93/42/EEC Annex II 3.1

Canada

• CMDR SOR/98-282 Section 57
• MDD 93/42/EEC Annex II 3.1

Japan

• JPAL Ministerial No. 169 Article 63
• JPAL Ministerial No. 169 Article 64

Once you determine what regulations or standards are applicable, it is important to ensure those specific requirements are addressed and executed accordingly, to be fully compliant. Being fully compliant, however, is not enough to be successful. The regulations and standards define requirements that specify "what" to do but they do not specify "how." That is up to you. Your success with CAPA management is dependent on the "how" of CAPA metrics to truly be effective in improving your company or organization.

2. Focus CAPA Metrics on the Riskiest Nonconformances

To make a positive impact, a CAPA management system should be designed so CAPA projects address the most pressing issues and do so in a way that creates the most value. The overall CAPA design and the workflows within should be aimed at streamlining issue prioritization and investigations. Ask yourself, “Do these CAPA metrics help me pinpoint known areas of high-risk, so I can appropriately escalate to a CAPA?”

What does "appropriately escalate" mean? Shouldn’t all identified nonconformances be escalated into CAPA? The answer is no. Doing so could cause the CAPA management system to be overwhelmed without properly addressing the most significant nonconformance. It is important to understand that each nonconformance will be corrected. However, only those identified as "high risk" or the result of "out of control" process conditions should be required to be escalated and formally addressed through a CAPA management system. This system is designed to uncover the root cause of the issue and take corrective action to prevent the recurrence of the issue.

3. Use CAPA Metrics That Reveal Trends

Your metrics should not only pinpoint high-risk situations, but they should also help you see larger nonconformance trends and patterns. An appropriate trending process can identify the "common cause" variations for nonconformance reduction leading to significant return on the time and effort invested in a CAPA project. Your CAPA management system should be the place for you to collect timely data and extrapolate from your CAPA metrics where and how you can improve.

Though nonconformance and deviations are usually human driven, your CAPA management system and metrics don’t have to be. See how MasterControl’s CAPA software solution can help you connect data channels and streamline the CAPA process throughout the entire product lifecycle.