#107 – ERM IN ISO IS ENHANCED RISK MANAGEMENT – GREG HUTCHINS

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Greg Hutchins pixISO maintains risk has implicitly been a part of the standard since the ISO 9001:2015 revision.  How?  In the new standard, ‘preventive action’ has evolved to ‘actions to address risk and opportunities.’  This changes the Corrective Action – Preventive Action (CAPA) model.  In the past, Preventive Action was implemented as a result of Corrective Action specifically to prevent the recurrence of the nonconformity. Continue reading

#106 – ‘FUTURE OF QUALITY: RISK®’ IS NOT NEW CONCEPT – GREG HUTCHINS

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Greg Hutchins pixIn 2000, I wrote Risk Management: Is It the Future of Quality Management? for ASQ’s Quality Progress.  We’ve been evangelizing this concept a long time.

Why do I bring this up?

We’ve been evangelizing the mantra for 15 years.  We felt so strongly that we have a  have a registered trademark on the Future of Quality: Risk® Continue reading

#105 – WHAT IS RISK BASED THINKING? – GREG HUTCHINS

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Greg Hutchins pixWhat is Risk Based Thinking (RBT)?

We get this question weekly and sometimes daily it seems.

Why?  ISO has not defined Risk Based Thinking?  And, this is a hugely important question because ISO has elevated RBT to the same level as PDCA and Process in the Final Draft International Standard (FDIS) of ISO 9001:2015. Continue reading