When does an organization need to open a CAPA? (Identifying and Measuring Inputs to CAPA)

by: William McQuillan Jr. CAPA Subject Matter Expert

Many organizations and training programs interpret CFR 820 Subpart J and emphasize having appropriate inputs to facilitate knowing when to open a CAPA by “analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems…” What this statement means to one’s organization is that further guidance related to how to set thresholds for CAPA inputs may be required.

From a fundamental perspective, inputs to CAPA may be summarized as follows:

• Complaints and other post market data identified by reviewing:

o Customer complaints

o Clinical study deviations observed for released product

o Post market surveillance data

• Nonconformances indentified by reviewing:

o Process control data

o Process validation

o Computer system validation

o Environmental monitoring

o Control sterilization monitoring

o Control laboratory investigations

o Quality system issues

o Near miss situations identified

• Audit Observations by Reviewing:

o Internal regulatory compliance audit observations and trends

o External audit observations

The question that I have often heard is, “How do I determine my thresholds from these inputs?” The answer: For nonconformances and complaints, most of the thresholds will be extracted directly from your organizations design history files and risk documentation by product for known issues (e.g., production and process control data reviewing validated ranges versus operational ranges to define action limits). For new issues, further risk assessment must be completed. It is strongly recommended that the risk management program be incorporated from an analysis perspective with the nonconformance process.

For audit observations, the more appropriate approach for defining business risk should be evaluated and documented by the regulatory compliance team members within your organization. Their area of expertise will facilitate the interpretation of the GXP expectations and definitions of the risk classifications for quality system-related issues.

Since CAPA focuses on the systematic investigation of deviations in an attempt to prevent their recurrence (for corrective action), or prevent from occurrence (for preventive action), these are the most important sources of information required to ensure that your business is focusing on the known critical process areas. These sources should be reviewed holistically to ensure that all related inputs identified are confirmed to be related or unrelated to issues that are being assessed for escalation to CAPA. Additionally, to ensure that the CAPA process is efficiently and effectively initiating files, product and quality system risk must be incorporated into the data reviews that will ultimately analyze CAPA inputs. There are numerous examples of risk classifications. The chart below is one that I have used in the past.

In conclusion, understanding the customer, compliance and business risks will facilitate documenting the rationale for determining whether to open a CAPA. The initial evaluations will also facilitate the setting of effectiveness criteria at the closure of CAPAs.

ABOUT THE AUTHOR

This is Will McQuillan’s first blog in a 13-part series on CAPA Implementation. Will McQuillan is a CAPA Subject Matter Expert, and former Global Manager Change Document and Record Management at Cordis, a Johnson & Johnson Company

He welcomes your feedback. His next blog, “CAPA Scope Guide” will be published on October 24, 2009. Will’s CAPA-related topics he will publish on In the coming weeks include the following:

➢CAPA Scope Guide

➢Measurement Tools

➢Investigation Tools

➢CAPA Owner Guidance

➢How to Present at Reviews

➢CAPA Investigation Documentation

➢Scope Verification

➢Implementing Change

➢Staying on Track

➢Managing Obstacles

➢Effectiveness Criteria Selection

➢Tools for File Closure

Will can be contacted at wmcquill@yahoo.com or at 510-207-0575.