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Monthly Meetings

Implementing an Effective Corrective/Preventive Action (CAPA)
Process for Improved Quality Systems Performance
Presentation/Best Practices discussion

Friday, April 23rd, 2010 at MKS Instruments, Wilmington, MA

Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process. Regulatory compliance requires organizations to capture all corrective action issues and track their corrective action process to completion. About 30% to 50% of all 483 citations in FDA regulated industries are related to problems with Corrective Action & Preventive Action (CAPA) processes. The corrective action process also forms the core of various quality management disciplines such as Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) or TOPS-8D or ISO 9000.

Repeat CAPA investigations are arguably one of the largest areas of concern for managers and customers today. Despite many firms executing the recommended corrective actions based on corrective action SOPs, repeat investigations throughout the industry have accounted for as many as 40% of all open investigations- or 1 in every 4. What's going wrong? Why is this happening to so many of us?

The adoption of CAPA systems will become widespread because of their enabling role in mitigating significant business risks and driving quality as an integrated part of the manufacturing process. As a result, companies are no longer buying a stand alone CAPA system; they want their CAPA solution to be an integrated part of a compliance and quality solution.

Join industry experts for a CAPA workshop that explores new ways of solving problems and correcting their causes. The meeting will focus on problem solving techniques that expedite the identification of the root cause and facilitates effective solutions.
Join us as we discuss this important topic and hear how some of our member companies are addressing this critical process!

AGENDA:
12-12:45 Lunch at MKS Instruments Corp.

12:45-2:30 Presentation/Discussion

2:30-3:30 Roundtable discussion

3:30-3:45 New business/Next meeting agenda

Meeting Location:
MKS Instruments Corporation
90 Industrial Way, Wilmington, MA

The MKS facility is located right off Exit 38 of Rt 93


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