Issue Management and CAPA

By Tim Egloff

Every manufacturer must conform to some level of product safety and quality whether driven by consumer desires, competitive pressures or government regulations.  To this end, quality practices have become a business imperative for all industries.  Whether your company is certified under ISO 9001 guidelines or regulated through the FDA’s Code of Federal Regulations (CFR), corrective and preventative actions or CAPA, is a requirement which has been well documented.

The reasons are clear.  If a non-conformance has been identified or a consumer has filed a complaint, it is in the best interest of the manufacturer and the public in many cases, to contain and correct the issue as quickly as possible.  This means identifying any potentially impacted product and finding and fixing the root cause to eliminate any further discrepancies.  Preventative actions on the other hand, are designed to monitor trends and evaluate risks in order to prevent non-conformances and identify areas for improvement.  Whether for correction or prevention, an effective process has a positive impact to financial performance, customer satisfaction and company reputation.In other words, a corrective and preventative process has enterprise value.

Yet, the FDA’s published data from 2010 shows that of 89 Warning Letters to Medical Device firms, 81 or 91% of all letters cited some sort of corrective and preventative action deficiency.  (View the PDF here).  2011 citations for CAPA appear to be rising as well.  It’s not hard to see why.  Even a cursory review of the FDA’s website for Title 21, Subchapter H, Part 820 (found here), shows a number of specific sections defined as Controls.  Design controls, document controls, production and process controls and others.  Just look into that last one and you’ll see further touch points such as equipment, facilities and maintenance just to name a few.  With so many touch point requirements, complexity is often the barrier to effective execution and very likely a major contributor to the FDA citations for CAPA discrepancies.

While the FDA increases its focus and attention on CAPA processes, many manufacturers are finding that segregated information, inconsistent processes and inadequate documentation are the underlying challenges which increase time to closure, require rework and raise the risk of improper validation and closure.

As manufacturers consider their options, many are turning to their lifecycle data model and for good reason: when fully implemented, their PLM domain covers the control points of an effective CAPA solution.

Something to consider as you seek to elevate CAPA to enterprise value.

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This article first appeared on the Siemens Digital Industries Software blog at