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Dec 02, 2020 Robert Fenton

5 Fundamentals of the CAPA Quality Process

The CAPA (corrective and preventative actions) quality system consists of the specific improvements an organization makes to its processes to eliminate non-conformities. From the outset, getting the process right ensures that your life science organization has everything it needs to institute a comprehensive CAPA program.

But with so many CAPA quality process resources out there, it can be difficult to tell which resource offers the most comprehensive information related to process optimization.

As an industry-leading provider of quality management software, Qualio has first-hand experience orienting life science organizations toward sustained CAPA success.

The 5 Fundamentals of the CAPA Quality Process

CAPA management software is designed to simplify FDA requirements for corrective/preventative action processes.

To provide effective safeguards against regulatory risk, CAPA is generally a module within a comprehensive quality management system. If not, it's usually capable of integrating with management systems for audits, nonconformities, document management, change control, and other capabilities.

Unfortunately, the FDA offers minimal guidance on selecting a CAPA system. At a high level, the CAPA system must:

  • Include CAPA procedures which address quality system requirements
  • Facilitate data analysis to identify the sources of product quality concerns
  • Enable organizations to monitor trends for preventive action
  • Integrate with surrounding systems and QA processes to assure data quality
  • Facilitate statistical analysis and formal failure investigations
  • Allow organizations to validate the success of preventive or corrective actions

These requirements do not necessarily translate directly to software features. As such, an intimate understanding of the CAPA quality process is required.

1. Detection

The problem identification and CAPA detection phase requires an appropriate documentation of the issue at hand. The description should be complete, including who, what, when, where, why, and how many.

Moreover, a risk analysis should be performed based on compliance risk. The results of the risk analysis should inform the CAPA timeline. In most cases, low-risk issues do not carry the same sense of urgency as high-risk issues.

2. Investigation and Root Cause Determination

Next, quality management teams should commit to rapid investigation and root cause determination. There are several methods for conducting analysis including:

  • Brainstorming
  • Flowcharting
  • Fishbone Diagrams
  • Affinity Diagrams
  • Physics of Failure

Typically, root cause determination is aided by quality management systems. With end-to-end traceability, you can easily track every change and action from beginning to end with fully integrated, closed-loop quality processes.

RELATED READING: The 9 Core Elements of a Quality Management System

3. Proposed Corrections

In this next phase, correction and containment should be completed as soon as possible to prevent further disruption. Moreover, organizations should proactively review processes and procedures to identify broader issues. In the case of a product-related issue, field correction and/or recall may be required.

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4. Implementation

At this point, long-term corrective and preventative actions work to resolve or eliminate the cause of nonconformity. A corrective action is an action that eliminates the cause of a nonconformity. On the flipside, a preventative action is an action to eliminate the cause of potential nonconformity.

RELATED READING: 6 Signs Your Quality Management Process is Failing

5. Verification of Effectiveness

Finally, validate or verify corrective and preventative action effectiveness. Once a CAPA investigation is complete, determine if nonconformities have been resolved.

Moreover, determine if corrective and preventative actions haven't created new areas of inconsistencies. Any changes to the production process that were made to address an issue should also be seen as a new source of potential problems.

Finding the Best eQMS for Your Company

Unfortunately, quality management issues can have an immediate and significant impact on the success of your company. Failure to follow CAPA procedures and identify the root cause of compliance issues can cause repeatable problems at unavoidable costs.

What's more, ineffective complaint handling can jeopardize brand reputation and customer relationships. As a result, purchasing control breakdowns may be linked to unreliable input quality, and speeding through the validation will produce unfavorable results.

This is precisely why a quality management system is a necessity. By adopting the right solution during the startup or scale-up phase, you can build your organization a strong baseline for effective CAPA, supply chain management, and complaint handling.

Qualio is the first cloud-based quality management system designed for growing life sciences organizations. Schedule a demo today to learn more about how Qualio can help your organization bring better products to market faster.

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Published by Robert Fenton December 2, 2020