Repeat CAPA investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3.

What percentage of your quality system investigations are repeats?

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After reviewing many CAPA SOP’s there appears to be two primary directions companies go in to decide if they are going to initiate a CAPA:

1. An issue (nonconformance ect.) is identified and a root cause investigation is conducted. Based on the the investigation a decision is made to address the issue as a CAPA or not.

2. CAPA is initiated (based on risk) and the first action is to conduct a root cause investigation.

Based on your companies current flow process, which comes first; initiation of a CAPA or a root cause investigation?

GHTF has posted a proposed guidance document on Corrective and Preventive Action at http://www.ghtf.org/sg3/sg3-proposed.html The document is open for comment for 5 months.

Comments are to be sent to Egan Cobbold at Egan_Cobbold@hc-sc.gc.ca

Egan is the chair of SG3.

Please take the time to review and comment to help GHTF make a better document.

From the problem statement to root cause identification, corrective and preventive actions to effectiveness checking measures, many hours of preparation are needed to compile a strong CAPA project.

In your experience, what is the single item most companies forget to include or struggle with in their CAPA Projects?

Effectiveness Checking Measures
Documentation of Investigation
Identification of Root Cause
Corrective and Preventive Actions
Problem Statement

Repeat Corrective and Preventive Action (CAPA) investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action or preventive action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3. What’s going wrong? Why is this happening to so many of us?

According to an announcement issued this month, the FDA may now issue a Warning Letter “close-out letter” once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. The FDA may issue a close-out letter when, based on evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

This is a great incentive for manufacturers to quickly address and remediate their warning letter findings.

CAPA is a critical quality subsystem that, when executed correctly, can provide an organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency. Yet many organizations struggle with CAPA, from ongoing and repeat investigations to lack of management control.

A CAPA System itself must be compliant, effective and efficient. But how do we get there? What elements do you consider to be essential to creating a sound CAPA System?