Risk and Change

Concurrent Session

M34 - Risk-Based Thinking and the Supplier Audit

Monday, April 30
3:00 PM - 4:00 PM
Location: WSCC Ballroom 6C

Level: Intermediate

Division: Audit Division

Conducting a successful supplier audit can help identify, assess, and mitigate organizational risk, while meeting the requirements of ISO 9001:2015 clause 8.4. Supplier auditing tips, tools, and techniques along with practical application of various risk assessment tools will be shared. Risk-based thinking as it applies to the supplier audit program will be discussed throughout the session. Attendees will also learn how to select an audit team and conduct a risk-based supplier audit.

Learning Objectives:

Lance B. Coleman

ASQ CQE/SSGB/CQA/CBA, Exemplar Global QMS-PA

Senior Quality Systems Engineer
Natus Medical
Kent, Washington

Lance B. Coleman is a Senior Quality Systems Engineer for Natus Medical in Seattle where he manages the CAPA and internal audit programs. He has over 20 years of leadership experience in the areas of quality engineering, Lean implementation, quality and risk management in the Medical Device, Aerospace and other regulated industries. He has a degree in Electrical Engineering Technology from the Southern Polytechnical University in Marietta, GA and is an American Society for Quality Senior Member as well as, Certified Quality Engineer, Quality Auditor, Biomedical Auditor and Six Sigma Green Belt,. He is also an Exemplar Global Principal QMS Auditor. Lance is the author of three books – “Managing Organizational Risk Using the Supplier Audit Program (Quality Press 2018), “Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement and Data Analysis (Quality Press 2015)” and “The Customer Driven Organization: Employing the Kano Model (Productivity Press 2014)” and as well as, many articles on quality, Lean implementation and risk management. He is 2018 ASQ Lean Enterprise Division Chair and 2016-2018 TAG 302 Chair. Lance is also an instructor for the ASQ FMEA and Certified Quality Auditor Preparatory courses. He has presented, trained and consulted throughout the United States and abroad.

Presentation(s):

Send Email for Lance Coleman

Kristen Wagner

B.S Materials Science and Engineering

Sr Supplier Quality Engineer
VISION EASE
Ramsey, Minnesota

Kristen Wagner is a Senior Supplier Quality Engineer at VISION EASE, a recognized leading manufacturer of quality ophthalmic lenses, where she manages the supplier audit program. Kristen has a B.S. in Materials Science and Engineering from the University of Minnesota - Twin Cities. Over the past three years, Kristen has worked on implementing supplier development best practices including re-energizing a supplier assessment program, helping drive improvement and mitigate organizational risk, as a result of these efforts. Kristen is responsible for supplier auditor training in addition to serving as lead auditor for both domestic and international supplier audits.

Presentation(s):

Send Email for Kristen Wagner

Colin Gray

ASQ

Presentation(s):

Send Email for Colin Gray


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M34 - Risk-Based Thinking and the Supplier Audit

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