Streamline your quality system with risk assessment

January 2, 2014 3:11 pm Published by

Corrective action and preventive action (CAPA) is a hallmark of quality management. Depending on the organization, a QA manager can be inundated with CAPAs in varying degrees of severity in the order they were created.

Problem is, managers have to sift through them to investigate which ones are critical or immediately correctable, creating a potential bottleneck. How do you differentiate between non-critical and essential?

A whitepaper from quality software maker ETQ makes the case for risk assessment. This is not new to the quality industry. Risk has been prominent in such standards as ISO 13485:2003, ISO 14971 and others.

With risk assessment as part of the CAPA process, you can extract critical events as they are recorded and automatically initiate an investigation for a CAPA.

As events come into the system, the whitepaper explains, whether it’s a complaint, nonconformance, audit or any other event, the initial form includes a risk table with information such as severity, frequency or pre-defined risk elements.

Based on the risk table results, the event can either be immediately corrected within the process or investigated. With that in hand, companies can prioritize resources that have the most critical impact and risk to an organization rather than taking a reactive approach to what is overdue. It’s an objective way to measure the impact of CAPAs – and reduce stress.

Contact Beth for your copy of the whitepaper and for our take on it.


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This post was written by Roy D'Ardenne