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Tim Egloff

Quality Insider

Is PLM-Based CAPA Your Best Strategy?

PLM can address all CAPA control points

Published: Wednesday, November 21, 2012 - 12:08

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 to ISO 9001, the international standard for quality management systems, or regulated through the Food and Drug Administration’s (FDA) Code of Federal Regulations (CFR), a key safety or quality practice that has been well documented typically concerns conforming to a standard’s requirement or a corrective and preventive action (CAPA) for a nonconformance.

If a nonconformance has been identified or a consumer has filed a complaint, it’s in the manufacturer’s best interest (and the public’s, in many cases) to correct the issue as quickly as possible. This means identifying any potentially affected product, finding the root cause, and making the correction. Preventive actions on the other hand, are designed to monitor trends and evaluate risks in order to prevent nonconformances and identify areas for improvement. Whether for correction or prevention, an effective improvement process has a positive effect on customer satisfaction, company reputation, and financial performance. In other words, a corrective and preventive process has enterprise value.

However, the number of medical device firms cited by the FDA for deficient CAPA systems is increasing. In 2010, 81 percent of the 89 warning letters sent by the FDA cited CAPA deficiencies. To see the reasons for the increase, review the FDA’s website for Title 21, Subchapter H, Part 820, specifically the subparts defined as controls: for design, documents, purchasing, production and process, and labeling and packaging. The controls govern many areas. For example, subpart G for production and process controls covers equipment, facilities, maintenance, personnel, manufacturing material and more. With compliance to so many requirements, complexity is often a barrier to effective execution and very likely a major contributor to the FDA citations for CAPA discrepancies.

The FDA has increased its focus on CAPA processes, and many manufacturers are discovering that segregated information, inconsistent processes, and inadequate documentation require rework, which increases time to closure and raises the risk of improper validation and closure. 

As manufacturers consider their options, many are turning to their life-cycle data model and for good reason: Their product life-cycle management (PLM) domain covers the control points for a comprehensive CAPA solution. Product life-cycle management covers the processes involved in the collective efforts of all disciplines required to take a product from idea or concept through design, engineering, manufacturing, sales, and service to the product’s end of life. 

ProductCenter Product Lifecycle Management (PLM) software helps to ensure missing or inaccurate data is never a problem and that complete, up-to-date documents can be presented to the FDA at a moment’s notice. It is also used so production is driven by current information, eliminating noncompliance and possibly devastating consequences.

A fully implemented PLM solution relationship to product quality

All product decisions start with requirements. Whether for localized, targeted demographics or for global consumers, these requirements define the intended use for the product, its subsequent design, and the desired quality and product performance.

There are quality characteristics which must be engineered to fit the desired outcome in relation to the features, functions, materials, purpose, and useful life of the product. These engineered elements are used to define the requirements for process selection based on feature types and their decomposition for machine tools and fixtures as well as the related layout, operations, and inspection equipment required to build the desired quality at a specified rate. Regardless of the operational model (i.e., built-to-order, engineered-to-order, outsourced), this capacity and capability must be planned, defined, and executed with the full understanding of a product’s quality requirements.

I don’t think that anyone would argue that these things can all be managed in a PLM solution, but let’s take this a few steps farther because the product life cycle doesn’t stop here. 

Can we manage as-built production results within the PLM system? Yes. Can we manage maintenance, repair, and overhaul requirements, documents, service requests and their results in the PLM system? Yes. What about the order, sales, and consumer histories used for a formal solution to an issue? They are: configuration management with traceability to ownership is a core capability of a fully implemented PLM solution. 

To cover the control points of a comprehensive CAPA solution, we must touch each of the following:
• Design
• Production and process
• Records/documents including labeling and packaging
• Materials and purchasing
• Facilities and equipment

Does your PLM implementation cover these CAPA control points? It certainly can, however, your specific implementation may fall short if it is restricted to basic product data management. While this will require additional system integrations; those things that lead to the underlying challenges I’ve mentioned above, this is a great place to start.

It may be argued that the control points listed aren’t complete (I wouldn’t presume to know explicitly that every distinct control point is represented), but if you examine the purpose and intent of a complete PLM solution, you can see that an overwhelming majority of these factors are part of a product’s life cycle.

Yet, the benefits of a PLM-based solution go further. Not only are the control points connected, but the domain discipline knowledge and expertise responsible for product quality and safety is demonstrably found in this domain. This means that business operations involved in all aspects of bringing a product to market can be coordinated and synchronized with issue and CAPA management activities for the entire enterprise. This delivers more consistent results, faster identification of root cause and reduces repeat issue situations.

If I haven’t convinced you of the value of using the PLM platform for your issue and CAPA management processes, remember one thing; prevention is the antecedent to correction. In all cases, it is preferable to prevent than to correct and when you get right down to it, PLM is essentially the ultimate preventive solution for all product quality and safety concerns.

Discuss

About The Author

Tim Egloff’s picture

Tim Egloff

Tim Egloff is a marketing manager for the Tecnomatix brand in Siemens PLM Software. He is responsible for the quality management solution set, which is an integrated set of applications to Teamcenter’s life-cycle platform. Egloff has spent half of his 20-year career focused on the digital manufacturing domain, supporting business process consulting and marketing of the transformation between information technology and manufacturing engineering.