5 Steps to Ensuring CAPA Compliance

A Corrective and Preventive Action (CAPA) system is a roadmap of processes regulators expect manufacturers to follow to identify and solve compliance problems. As such, they're a critical point of focus during FDA inspections and quality system audits.

More than just a mandated requirement, CAPA systems are the means by which manufacturers can improve their quality system to mitigate risks and avoid quality-related issues in the future.

An effective and compliant CAPA system requires a strong set of data in order to detect problems, find and implement solutions, and document findings and subsequent changes.

Since FDA investigators, auditors, and executive management all rely on CAPA documentation for reviewing compliance issues, we've summarized the the five essential steps to ensuring your CAPA system is both compliant and effective.

1. Implement a CAPA Process and Document CAPA Procedures

It may seem like an obvious first step, but failing to show a CAPA process or establish and document CAPA procedures are among the most common compliance issued cited by the FDA.

In fact, inadequately established CAPA procedures were the most common types of Form 483 observations for device manufacturers in 2016. (Update: inadequate CAPA procedures has continued to be the top-cited inspectional observation into 2019.)

For smaller firms, failing to establish a CAPA system often results from a lack of knowledge around FDA and EU requirements or a product's questionable regulatory status.

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For larger firms with mature quality systems, the problem can center around contract manufacturers or failing to integrate new sites into the quality system. Any new partnership with a contract manufacturer or company acquisition should be conducted after careful due diligence to identify lapses and implement the appropriate procedures.

Following an agreement or new facility integration, sites should be thoroughly reviewed by an experienced quality system auditor to ensure CAPA compliance.

2. Use Statistical Methodologies to Analyze Quality Data and Identify Quality Problems

Current regulations mandate particular types of quality data to be analyzed:

  • Process data
  • Work operations data
  • Concessions
  • Complaints
  • Returned product
  • Quality audit reports
  • Quality records
  • Service records

When choosing the quality data to review, it's important to include both internal and external data sources. FDA has cited companies for lack of attentiveness in regards to quality data on manufacturing processes and nonconformances.

Complaints, in particular, deserve special attention. As a primary indicator of problems with distributed products, they should be analyzed through the lens of your CAPA system. The FDA has clearly stated that it views complaints as a CAPA data source.

CAPA logs play an important role during during an investigation. Since most investigators and auditors judge the quality system by reviewing a firm's CAPA log, it's important to record all changes to methods and procedures in this document.

A single quality issue may spawn multiple CAPAs in order to implement the necessary changes. It's important to evaluate the number of CAPAs generated and review that information for quality assurance.

3. Investigate and Identify the Root Causes of Quality Problems

The causes of quality problems should be immediately investigated once detected. FDA investigators aren't just looking for identified problems, but also detailed investigations to determine root causes.

Manufacturers should have a systematic, organized methodology for conducting root cause investigations — a documented investigation procedure implemented when problems arise.

Root cause investigations should be conducted by trained and experienced investigators and include a flexible CAPA closure target dating method that takes risk into consideration.

A typical CAPA investigation should be comprised of the following general steps:

  1. State the problem clearly and completely
  2. Invest the appropriate time and effort to implement the documented investigation procedure conduct a thorough evaluation
  3. Document the investigation process as it's conducted
  4. Analyze the root cause of the issue and identify all actions needed to correct and prevent recurrence

Read Also: 3 Key Elements of a Successful CAPA System

To ensure your investigation is thorough and complete, be sure to avoid the following common mistakes.

  • Using training as a cure-all solution: Training-only solutions rarely satisfy the FDA without a compelling rationale.
  • Jumping to root causes without investigating: Regulators are also weary of root causes that aren't backed by an investigation. Even if the cause of a problem appears to be clear, investigation procedures should still be carried out and communicated. Failing to test assumptions can have severe consequences that impact both product quality and regulatory compliance.

4. Verify or Validate CAPAs for Effectiveness and Prevent Possible Adverse Impact on Finished Products

Once a CAPA investigation is complete, any corrective or preventive actions must be validated to ensure the actions solved the problems without creating new ones.

Any changes to the production process that were made to address an issue should also be seen as a new source for potential problems.

5. Implement and Record Changes in Methods and Procedures as Part of Actions Taken and Disseminate Those Records to Management and Quality Assurance Personnel

Any changes to methods and procedures must be reviewed by management and quality assurance professionals before being solidified in writing.

Regulators underscore the importance of management review in its "QSIT Manual" by instructing investigators to look at the review schedule to determine if management reviews are sufficiently frequent enough to keep management "informed of ongoing quality issues and problems."

If management is unaware of quality issues, it's a clear indicator to investigators that quality control is not being reviewed as frequently as it should.

But more frequent management reviews are not, by themselves, enough. To ensure management is involved in implementing and validating CAPA procedures, these reviews must all include detailed information regarding findings.

It's advised to include a follow-up report for all CAPA issues that not only documents the investigation, but lists the actions implemented and the validation of those actions.

A CAPA system can truly be called "robust and effective" when it includes procedures for analyzing quality data, offers a thorough investigatory procedure, validates the effectiveness of actions taken, records changes in methods and procedures, and communicates that information to those involved in maintaining a compliant state.


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Topics: FDA Form 483, FDA Compliance, CAPA