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Risk Management Integration into the Business
Mark Durivage, ASQ Fellow, CBA, RAC, CTBSManaging Principal Consultant
Quality Systems Compliance LLC
ASQ Biomedical DivisionMay 31-June 1, 2017 1
May 31-June 1, 2017 ASQ Biomedical Division 2
✓Define Risk✓Discuss the Risk Management Process✓Define Risk-Based Thinking✓Explore Risk Tools
RISK
ASQ Biomedical DivisionMay 31-June 1, 2017 3
Definitions and Background
May 31-June 1, 2017 ASQ Biomedical Division 4
➢ ISO 9000:2015 Quality management systems —Fundamentals and vocabulary
➢ ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach
➢ ISO 9001:2015 Quality management systems —Requirements
➢ ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
➢ ANSI/AAMI/ISO 14971:2007 Medical devices—Application of risk management to medical devices
ICH Q9: Quality Risk Management
ASQ Biomedical Division ICH Harmonized Tripartite Guideline. ICH Q9: Quality Risk Management June 2006 http://www.ich.org
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Risk Management
Process
Risk-Benefit Analysis
ASQ Biomedical Division
Risk-Based Thinking
May 31-June 1, 2017 ASQ Biomedical Division 9
✓Design and development activities✓Inspection activities (incoming, in-process,
and release)✓Commissioning and validation activities✓Supplier management✓Audits findings (Internal and External)✓Corrective and Preventive Action (CAPA)✓Nonconformances✓Complaints
Risk Tools
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➢ Failure Mode and Effects (FMEA) Analysis ➢ Strengths, Weaknesses, Opportunities, and Threats (SWOT) Analysis➢ Political, Economic, Social, and Technological (PEST) Analysis➢ Hazard Analysis and Critical Control Points (HACCP)➢ Force Field (FF) Analysis➢ Fault Tree Analysis (FTA)➢ Hazard Operability (HAZOP) Analysis➢ Preliminary Hazard (PHA) Analysis
Failure Mode and Effects (FMEA) Analysis
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Perform FMEA (user, design, process)
FMEA determines the risk
Risk indicates the actions
Strengths, Weaknesses, Opportunities, and Threats (SWOT) Analysis
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Political, Economic, Social, and Technological (PEST) Analysis
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Hazard Analysis and Critical Control Points (HACCP)
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Force Field (FF) Analysis
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Fault Tree Analysis
(FTA)
Hazard Operability (HAZOP) Analysis
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Preliminary Hazard (PHA)
Analysis
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May 31-June 1, 2017 ASQ Biomedical Division 19
May 31-June 1, 2017 ASQ Biomedical Division 20
➢ Use risk management tools that are appropriate to your organizations expertise
➢ Start with simple risk management tools and explore the use of other tools as appropriate.
➢ Proceduralize the risk management tools your organization utilizes.
➢ Use a risk-based statistical rationale➢ Keep apprised of current industry
trends➢ Document you plan, actions, and
results
Questions
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Contact Info
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https://www.linkedin.com/in/markdurivage
