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Use CAPA to Improve Defect Reporting

by The Tip Doctor

August 15, 2011

The following tip is taken from the SCM Expert article “Improve Defect Reporting by Using CAPA to Track Incidents” by Vineet Pandey, published in June 2011.

In today’s competitive environment, a majority of industries are facing increasing pressure from regulatory bodies, big players in their respective industries, the latest customer mandates, and internal quality initiatives to take a proactive and automated approach for managing non-conformity, process deviations, and critical observations in relation to the defined quality procedures across their supply chains.

Corrective action and preventive action (CAPA) is one such process that has become a formal requirement by regulatory authorities for categorizing the various types of issues a company may encounter. The CAPA process I describe is based on the define, measure, analyze, improve, and control (DMAIC) framework, which can improve supply chain performance considerably by containing critical-to-quality problems, including:

•    Nonconformity incidents, which are deviations from processes and procedures that get detected during audits (audits can be conducted internally or by external regulatory bodies)

•    Process-related incidents resulting from an internal or external audit at a supplier premise

•    Complaints from customers

CAPA can help organizations identify, record, investigate, and resolve nonconformity issues across the supply chain. Apart from resolving incidents within the organization with regards to process inconsistencies reported by customers or any other internal process issue, the CAPA process based on the DMAIC framework can also help assess supplier process compliance during delivery of goods and services.

The CAPA process requires companies to document the issues, monitor the progress and impact of the actions taken, and implement the findings to prevent reoccurrence of the major cause of the complaint and to improve process quality. Companies can then use these findings to conduct largely error-free operations and to make more consistent decisions, resulting in higher quality and more reliable supply chain operations. You can apply CAPA to any industry.

For instance, companies can initiate CAPA with an investigation to identify the root cause of the nonconformance. Root cause analysis centers on ascertaining the source of a problem, defect, or nonconformity, by identifying the reasons for a product failure or inconsistency in process operations. From there, you implement corrective or preventive action to address the issue. CAPA can identify various solutions to reported incidents or nonconformities (e.g., new training, redesigned business processes, or added risk management steps). A software solution that automates the process can be instrumental in managing and tracking a corrective and preventive process.

To learn more about implementing CAPA using an SAP system, check out Vineet’s full article in SCM Expert.

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