#46 – RISK MANAGEMENT & ISO 9001:2015 – GREG HUTCHINS

AmCon Presentation1

 

Bio:

Greg Hutchins PE and CERM (503.233.101 & GregH@QualityPlusEngineering.com)  is the founder of:

CERMAcademy.com
800Compete.com
QualityPlusEngineering.com

WorkingIt.com

He is the evangelist behind Future of Quality: Risk®.  He is currently working on the Future of Work and machine learning projects.

He is a frequent speaker and expert on Supply Chain Risk Management and cyber security.  His current books available on all platform are shown below:

#46 – FICTIONAL RISKS – UMBERTO TUNESI

Umberto Tunesi pixOddly enough, though it is often said that imagination – or fiction – can never match reality.

Arts – generally speaking, such as literature, poetry, music, painting, sculpture, and so on – often anticipate real risks or thoroughly analyze them.

Why is it so?

Artists, be they writers or musicians or painters, etc., are not trained risk assessors, let alone risk managers.  However, if not all but certainly some of them have a – let me say -‘sense of risk’ that’s uncommon, and often superior even to risk’s experts. Continue reading

#46 – PLANNING … MORE IMPORTANT THAN THE PLAN? – MALCOLM PEART

Malcom Peart pixWhy do we say “planning is more important than the plan” and yet oftentimes a plan, if there is one is created, is copied from a, hopefully, similar previous project.  This ‘plan’ is then thrust upon the Project Team and in one fell swoop this ‘plan’ becomes sacrosanct with little or no buy-in from the Project and blind acceptance by almost all participants.

And again, how often is the plan flawed, inappropriate and eventually ignored only to be replaced by a series of workarounds that allow a muddling through until a real plan eventually emerges (hopefully).  We know that action without a plan is a nightmare, but if a plan is flawed nobody has time to think, let alone dream about effective action.
Continue reading

#46 – A BRIGHT FUTURE FOR QUALITY PROFESSIONALS – T. DAN NELSON

T. Dan NelsonPDCA ON DISPLAY
When we see an athlete perform at the Olympics, we are looking at someone who has become intimately familiar with plan-do-check-act (PDCA) in its simplest form.

Each Olympian has measured every possible aspect of his or her ability to perform.  Each has done everything in his or her power to improve in an effort to be the best.  It’s not only the drive to win that makes them winners, it’s the effective application of PDCA.  To win, they can’t just want to be better, they need to be better.  Every Olympic event is PDCA in action and under pressure to deliver. Continue reading

#46 – AVOIDING REMEDIATION WITH A GOOD QMS – WALT MURRAY

WALT MURRAYMany companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic document management system (EDMS) approach that is typically post mortem.

This is risky business at two critical levels.  First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes.  Secondly, the response will need to have a litany of justifications for a retrospective systematic approach.  This is like trying to perform process validation on pre-existing production of unqualified products: it’s bad business! Continue reading