Category Archives: Tips&Tools@Risk™

#48 – WHAT DOES ISO ‘RISK BASED THINKING’ REALLY MEAN? – T. DAN NELSON

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T. Dan NelsonISO is promoting ‘Risk-Based Thinking’ in all of its standards – even ISO 9001:2015 its flagship Quality Management System standard.  What does this really mean for companies?

IRISK AS PART OF QUALITY
Risk is recognized (finally?) as being part of quality management—which is nothing new.  Risk is involved with every activity in life—some will likely knee-jerk react with an over-blown response to the inclusion of risk-based thinking among ISO 9001 requirements.  To clearly comply with the requirement to apply ‘risk-based thinking’, some companies will no doubt be tempted to raise a ‘Risk Management’ process and maybe even hire a ‘Risk Manager,’ even though neither is necessary to implement ‘risk-based thinking’ or to comply with requirements to apply ‘risk-based thinking.’ Continue reading →

#47 – AS 9101 E – BEST YET – T. DAN NELSON

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T. Dan NelsonAS9101 is the audit companion to AS9100.  A sector scheme of ISO 9001, AS9100 is used in the aerospace and defense industries.  Certifying bodies (CBs) use AS9101 as a guide for auditors using AS9100. AS9101E, released just this month, seems to offer a vast improvement over all previous versions of AS9101.

Revision E removes the temptation to use AS9101 as stage 2 audit criteria, while at the same time further promoting a process approach to auditing, being clear about the importance of stage 1 auditing. Continue reading →

#47 – FMEA IN THE KITCHEN – CARLOS E. Z. KRAHEMBUHL

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CarlosFailure mode and effects analysis FMEA is an important tool for identifying the potential failures in design or manufacturing.  It started in 1940s by the U.S. Military and was further developed by the aerospace and automobile industries. The FMEA approach facilitates the improvements when potential issues are found. Continue reading →

#47 – WHY ERM FAILS? – MARY DRISCOLL/KRISTINA NARVAEZ

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mary_driscollAPQC’s Mary Driscoll recently spoke to Kristina Narvaez, President & CEO of ERM Strategies, about enterprise risk management (ERM).  In the interview below, Kristina talks about several factors that tend to undermine ERM programs.

Mary Driscoll (photo): What are the essential components of an effective ERM program?

Kristina Narvaez:  First off, I have yet to find the perfect ERM program.  Some organizations have been more successful at implementing their programs than others. So, let’s consider why. Continue reading →

#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.
Continue reading →