Incorporating Risk Management into Process Improvement

CBS Newsman Eric Sevareid once said, “The chief cause of problems is solutions.” Every organization engages in process improvement activities, but too often, these activities also have unintended negative consequences. A small mistake can cost a company millions of dollars and hundreds of jobs, should a recall or lawsuit follow. One cannot stop or eliminate this risk entirely. One can only hope to manage it.

With all the improvement projects being implemented, the probability of unintended negative consequences as a result of these projects has increased significantly. Failure Mode and Effects Analysis (FMEA) is a structured technique to analyze a process to determine and prioritize shortcomings and opportunities for improvement. When used properly, this technique identifies and evaluates the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting that failure to determine and manage the overall risks and minimize future problems.

Incorporating risk management into the improvement process can eliminate, or at least minimize unintended negative consequences that might result from these solutions. This talk will focus on how to use risk management techniques when developing and implementing process improvements.

Participants should have some previous experience with process improvements or risk management, but otherwise, this talk is applicable to all levels, especially management, as it covers underlying principles in a simplified format. (These are often overlooked in other basic and intermediate how to courses.)

Areas Covered in the Session :
Steps for constructing an FMEA, including assigning quantified values to risks for analysis and prioritization
Benefits of Risk Management combined with FMEA
Strategies to mitigate and reduce risks
Techniques for communicating failure risk to those responsible for future process improvements
Common mistakes in developing and using FMEAs and how to avoid them

Who Will Benefit:
QA Managers
Technical Supervisors
Manufacturing Managers
Process Improvements Teams
Department Managers
Process Owners
Design Engineering Teams
Teams responsible for developing FMEAs or implementing process improvements
Executives responsible for the risk management program

Tony DeMarinis has BS degrees in Biology & Microbiology and a MS in Quality Management. He is currently an independent Consultant specializing in Sterilization, Quality Systems, Auditing, and other Quality Management issues in the medical device and pharmaceutical industries. Previously, Tony was Director of QA/RA at Tunstall Americas for electronic monitoring devices, Quality Manager at Sealed Air for medical packaging, Quality Systems Manager at Davol for implants and surgical devices, Director of Quality Assurance at Scott Laboratories for in-vitro diagnostics and Sr. Microbiologist at the National Cancer Institute.

He is recognized as a Fellow by the American Society for Quality, and he is a Certified Quality Auditor, BioMedical Auditor, Six Sigma Black Belt, Pharmaceutical GMP Professional and Manager for Quality and Organizational Excellence. He also teaches the refresher courses for the CQA and CMQ/OE certification programs through the local ASQ sections. Tony has over 25 years’ experience using quality management techniques and value added auditing including the use of Failure Investigation and Root Cause Analysis to improve processes and products.

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  • Presentation Handout in .pdf format
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