On the 3nd Wednesday of each month, we invite you to join us for dinner to engage with a local quality practitioner at the Biltmore Hotel. View previous dinner presentations: navigate to the top tool bar, click on “RESOURCES” > “DOCUMENTS” (Documents for Members) > “Dinner Meeting Presentations”, select year, then month.
“Implementing Effective Corrective and Preventive Actions (CAPA)“
The CAPA process has been an integral part of a quality management system, until the recent revision of ISO 9001 where the preventive action has been substituted by risk assessment. Now, the challenge is how to use the risk assessment to initiate a preventive action. What happens to driving continuous improvement? Interestingly, ISO 13485:2016 still maintains the CAPA process.
The presentation will include understanding the problem, process management approach, differences between corrective and preventive actions, an anatomy of a problem, the Ishikawa root cause analysis, and effective implementation of remedial actions. After the presentation, attendees will have more confidence in addressing CAPAs correctly.
- September Meeting – To be announced
Quality and Risk Management.pdf
ISO 9001:2015 is promoting "Risk Based Thnking" similar to Other Standards, but does not call for particular tools to be used. The Organzation is required to take action to address Risks and Opportunities.
Dr. Flaig will provide a historical overview of risk assessment and management in business and engineering. He will discuss current risk management initiatives such as ISO 9001:2015. Additionally he will analyze some of the deficiencies in current risk assessment tools such as Risk Registers and FMEA and suggest better methods
|Date:||February 23, 2016|