Category Archives: ISO9001:2015@Risk™ – Greg Hutchins

#39 -ISO PROCESS PLANNING & PROCESS AUDITING – JULIUS HEIN

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Julius HeinThe International Standard Organization (ISO) has always known that there is a definite relationship between Process Planning and Process Auditing. They connected those two activities in ISO 9001:2000. The manufacturers, of course, had to plan the Process Flow for a product from “Input” to “Output”. In general, the Internal and Third Party Auditors did not audit the Process Flow as directed in ISO 9001:2000 and ISO 9001:2008. The Auditors audited mainly for compliance with the Standard.
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#38 – WHY IS PDCA SO PAINFUL? – T. DAN NELSON

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T. Dan Nelson - Screen Shot 2013-09-06 at 8.16.28 PMThe short answer: the standard has been widely misinterpreted and misapplied. A lack of understanding how to approach quality management vis-à-vis ISO 9001 has stymied proper use of the standard. As a result, many ISO 9001-certified organizations (I dare say most) have adopted a poor approach to quality management in the name of ISO 9001 certification. No wonder they don’t like it.

What tool produces good results when it is used contrary to its manufacturer’s instructions? Misusing a tool often produces undesirable results. Before discarding a tool as being useless, it might be worth the effort to ensure that it is being used properly. After all, misusing a tool can also be costly in many ways. Continue reading →

#37 – A CURVE ‘BACK’ TO THE PROCESS APPROACH – T. DAN NELSON

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MEET BOB’S MACHINET. Dan Nelson - Screen Shot 2013-09-06 at 8.16.28 PM
Bob’s Machine was operating successfully before ISO 9001 came along.  Bob was introduced to ISO 9001 when it appeared among his largest customer’s supplier requirements.  Although the requirements of ISO 9001 were unclear, the requirement to become ISO 9001 certified needed no clarification.

Bob’s objective became to ‘get certified.’  Unknown to Bob, what the standard requires is a demonstrably effective quality management system (QMS).  To ‘get certified,’ Bob needed to sensibly document the system of processes currently operating to output product.  To Bob, those processes were (in order of appearance): Sales, Purchasing, Receiving, Production, and Shipping. Continue reading →

#37 – ISO 9001:2015 NEW TAG LINE: ‘RISK BASED THINKING’ – GREG HUTCHINS

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Greg Hutchins pixISO tackles ISO 9001 (2015) risk with a new tag line:

‘Risk based thinking.’

Not bad!  The new ISO 9001 tag line is similar to ours.  Q+E CERM tagline is Risk Based Problem Solving and Risk Based Decision Making.

ISO is coming to terms with risk and quality.  ISO recognizes that all ISO 9001 stakeholders are NOT ready for risk.  Many countries voted down the Committee Draft, while two-thirds or so approved it. Hence, ‘risk based thinking.’ Continue reading →