Choosing the Right Solution for Issue Management and CAPA

January 1, 2015


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, RC - PLM for Medical Devices

Siemens PLM Software’s Teamcenter® software solution for Issue Management and Corrective and Preventive Actions (CAPA) provides an enterprise-wide solution for capturing various forms of complaints, defects and non-conformances providing a formal process to systematically investigate, analyze and resolve these issues while streamlining the definition of measures to prevent future reoccurrences and reporting the results in a simple, intuitive user experience.

In today’s competitive environment, companies are challenged to reduce product and operating costs while improving on product quality to help distinguish them in the marketplace. Every effort must be made to improve efficiencies among teams which may be distributed across the globe. 

The Teamcenter Issue Management and CAPA solution provides closed-loop issue resolution built on an enterprise-scalable foundation for identifying, analyzing and sharing critical product quality data across your enterprise. Now your design, manufacturing and quality improvement teams can share the same views of the information they need to directly impact Six Sigma and Lean initiatives. CAPA provides visibility into critical product quality characteristics, failures/ non-conformances, and resolutions to these issues for smarter decisions across the global, extended enterprise. 

Impact the cost of quality

Built on your PLM foundation, Issue Management and CAPA can interrogate the full spectrum of control points including design, production and process, documents, materials, facilities and equipment. This broad information domain allows your CAPA teams to find and validate root causes faster without delays of searching other systems for critical data or additional risk that can be introduced through manual processes. 

Automated workflows streamline the effort of communicating and managing your CAPA process across the extended enterprise. Correlating issues to deliverables and capturing their root causes and resolutions helps to mitigate the risk of rework and improve consistency of execution. This closes the loop between issue capture and final resolution for a final impact on your cost of quality. 

Any result of a corrective or preventive process must be able to demonstrate control through objective measurement of an implemented action. With Teamcenter sophisticated trace links, all deliverables, analysis, documentation and validation results are neatly retrievable for internal or external audits providing added value for engineering and manufacturing teams working on new product programs.

When CAPA activities result in engineering or manufacturing change requests, each change is managed and documented through formal workflows which maintain the associativity of the entire CAPA investigation. This assures complete documentation throughout the entire process and supports your ability to deliver investigations within consistent processes.

Simple user experience

The Teamcenter user experience supports a wide range of users and the CAPA solution adds to this suite with an extremely simple web-based user interface dedicated to the issue definition and resolution process. The CAPA user interface has been tuned to be very efficient to meet the needs of quality users participating in the issue identification and resolution processes.

Issues and corrective actions and preventable actions

The corrective and prevention process is managed by a CAPA business object. The CAPA object and process manages the resolution of the issue, independent of the issue itself. The advantages of different objects include:

1. Shielding the corrective measures from the issue, if that is desired by your company; 
2. Resolving multiple issues/complaints by a single CAPA, reducing the need to replicate information or duplicate efforts; and 
3. Addressing a single issue with multiple resolutions, each managed by a separate CAPA business object.

Teamcenter CAPA provides management for both issue and CAPA processes. You may choose to use only one or both, depending upon your business needs.

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Adapted from a white paper from Siemens PLM Software.