Risk and Change

Concurrent Session

W16 - ABC's of Implementing Risk-Based Thinking

Wednesday, May 2
9:30 AM - 10:30 AM
Location: WSCC Ballroom 6C

Level: Intermediate

Whether your new product is a hybrid vehicle, ketchup bottle or a molecular assay to detect a disease, the use of risk-based thinking is critical to designing products and processes that deliver the maximum benefits at the lowest risk to both the customer and the company designing and manufacturing the product. Every company uses risk-based thinking. If you ever ask the “what’s is the risk of doing …” before you do it, you are using risk-based thinking. The objective of this presentation is to provide insights on how implement risk-based thinking effectively and efficiently.
The concept of risk-based thinking has been implicit in previous ISO 9001, ISO 13485 and ISO/TS 16949 Standards. The new ISO 9001:2015, ISO 13485:2016 and IATF 16949:2016 Standards require evidence of its use. The presentation will explain what the three Standards’ risk-based thinking requirements are and show a method compliant with all three standards on how to apply risk-based thinking from definition of customer requirements through delivery, installation and usage of the product. It is expected that the majority if not all the attendees can use the example discussed as a template.

Learning Objectives:

Richard Harpster

PE, Michigan

Harpco Systems
Wixom, Michigan

Richard Harpster is president of Harpco Systems Inc. which he founded in 1987. Harpco Systems specializes in providing software, training and consulting for Risked Based Product Lifecycle Management (RBPLM™). Over the past 24 years Richard has helped numerous companies implement improved design and manufacturing systems on a wide variety of products from automotive components to molecular assays to detect diseases such as Prostate Cancer and HIV. He is a recognized expert in the application of Failure Mode and Effects Analysis and invented several new concepts including the linking of Design FMEAs to Process FMEAs which became an automotive industry standard in 2008, eighteen years after he first introduced the concept to Ford Motor Company Climate Control Division. His latest inventions in the field of RBPLM™ include Requirements Risk Assessment™ (RRA™), Multiple Integrated Cause Analysis (MICA™) and Rapid Integrated Problem Solving (RIPS®). He has published several papers on the topic of RBPLM™.

Prior to starting Harpco Systems, Richard spent 14 years at Ford Motor in a wide variety of positions including Senior Design Engineer, Superintendent of Plant Maintenance and Plant Manager. His education includes a B.S.E.E. from Penn State University, M.S.E.E from the University Of Detroit and an M.B.A. from Eastern Michigan University. Richard is a registered professional engineer in the State of Michigan.


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Edward Cook


Director, Supplier Quality Management
ICU Medical
Chicago, Illinois

 Director, Supplier Quality Management, ICU Medical, formerly Hospira, a Pfizer Company, since January 2013, where his responsibility is to manage global SQ program for both medical devices and pharmaceutical operations. He holds these certifications: ASQ-Six Sigma BB, CMQ/OE, CQE, CQA, Exemplar Global Principal QMS Auditor. Ed also helped to develop the new ASQ-CSQP certification, and is an Instructor for the Preparation Course. With over 20 years of manufacturing quality experience, he has served in various roles in and out of the medical field, including Plant QA Head for Husqvarna Outdoor Products; Head of QA/RA for Facet Technologies and Director of Quality, Molding Operations for Avail Medical Products as well as QA Manager roles at several other companies


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W16 - ABC's of Implementing Risk-Based Thinking


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