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1. Origins and rationale of ISO 9001
• Complex systems and processes make it impossible for any particular worker to control the quality of a job. This created the need for quality management systems.
2. ISO 9001:2015 clause 6.1, Actions to Address Risks and Opportunities and its relationship to Context of the Organization and Needs and Expectations of Interested Parties
3. Scope of risk: internal, supply chain, and external
4. What is risk?
• Application of General Carl von Clausewitz's friction to the workplace—a principle later described by Tom Peters.
5. Risk = np, not just p
• The FMEA occurrence rating focus on p (the chance that an individual part will suffer a failure).
• The Army's Risk Management Process recognizes that risk entails not just p but also n, the number of times we are exposed to the risk.
• The only way to reduce np to zero is to make the failure or mistake impossible.
6. Overview of hazard identification and risk assessment (HIRA)
7. Supply chain risks
• A supply chain failure will shut down a world class factory just as quickly as it will shut down a bad one.
8. Changing technology and new distribution channels as sources of risks and opportunties
9. Self-made risks; how the EpiPen controversy encouraged competitors to step in to "give the people what they want."