Hello, Ms. Robitaille. Thanks for the article. It seems companies whose QMSs consist of clause-by-clause or 6 procedures only could now be applying RBT together with the process approach to establish effective QMSs. It's never too soon to do that, certainly. 

It seems more than being too onerous for smaller companies, "system FMEAs" or other risk assessment tools wouldn't be appropriate in many smaller companies. It might not be appropriate in some medium-sized, or even large companies, either. If an organization is managing risk successfully without such tools, ISO 9001 will not require that they start using such tools. (If risk assessment/analysis tools ARE needed, that's determined by management's application of RBT, not by management's applicaiton of ISO.)

The risk being entertained in a quality environment is a particular kind of risk: risk to achieving quality objectives. A QMS is established to systemically address this kind of risk. THAT's what a QMS is FOR. 

To say that ISO 9001:2015 will require additional risk assessment tools (beyond any that might already be in place), I believe, is mistaken. Rather, I believe it underscores the importance for auditors to find evidence of conformity where it exists and as it is presented, instead of expecting management to develop uneccessary routines to provide them with the evidence they think they need.

Rather than developing "system-level FMEAs" because it might look good to an auditor, how about we expect the auditor to recognize the effective application of RBT evidenced by our process-based management system with just the right amount of controls needed for our situation, and just the right amount of documentation needed to view and operate the system effectively, and just the right training to assure consistent performance, and in the effective actions we've taken to address risks and opportunities relvant to our ability to achieve our qualtiy objectives. 

Do we assume that auditors can't see the forest through the trees, so best practice is to riddle the forest with signs clearly pointing to each instantiation of RBT? We would hardly be able to see the forest through the signs! Rather than putting signs in the forest, or painting the trees with RBT, how about we expect the auditors to be able to recognize each tree as naturally being part of the (RBT) forest?

Rather than pointing auditors to FMEAs and managment review as evience of RBT, how about we point them to the architechture of the system, the documentation describing the system, the process controls in place, and the action log? Evidence of RBT is present in each of these; effective RBT would result in each of these being appropriate for the circumstances. 

Denise accidentally lets the truth slip out:

"All the wringing of hands and ongoing debate will not hurry the process or change the outcome."

In short, ISO 9001 users, there's nothing you can do, so shut up. Take your passive position and accept the inevitable. This, of course, is against every rule and law governing the development of international trade standards. It is against every ISO and ANSI mandate demands that the TAG engage with users, listen to them, and adopt consensus-based positions. It's also a violation of WTO regulations, which is eventually going to bite ISO and ANSI back. Then pieces like this will point out those responsible for some very severe deficiencies in the standards making process.

Through its Annex SL mandate to TC 176, ISO proved it was not interested in consensus. The TMB, with its 15 nonelected permanent members, has trumped consensus by demanding specific content in standards, not merely structure. Now we watch as opportunistic would-be consultants. TC 176'ers and Quality Digest regulars reboot all of history, tell us "it was about risk all along" and claim sudden, retroactive mastery in "risk based thinking" even though such a thing has never before existed, in either the risk management or the quality management professions. If the TMB tomorrow invented dinosaur-driven flying cars, the same people would suddenly claim to be experts in this, too. 

Through its crony-driven leadership structure, the US TAG has squandered the nation's good will and interest in ISO 9001, failing utterly to meet the needs of major industries such as aerospace, automotive, medical devices and others. The US TAG leadership is obsessed with self-promotion over performance, and will kowtow to the TMB's unelected leadership if that means they can sell books and give keynote speeches. Meanwhile, US industry is considering abandoning ISO 9001 altogether, and returning to an era of endless 2nd party standards, contradictory customer audits, and passing on impossible costs to suppliers, and thus consumers.

Rather than arrogantly denigrating negative feedback as "hand wringing", Ms Robitaille should prove the management mastery she claims, and show how she can LEAD. She can start by listening to the overwhelming message that the US is sending to her and her TC 176 cronies, that RBT is a joke, that 9001:2015 is a disaster, and they should start from scratch. The 2015 deadline is a fiction, an arbitrary line in the sand that is no more a permanent thing than a snowflake. 

But Ms Robitaille isn't a leader, is she? She's a messenger, dutifully carrying the word of her masters, without so much as an ounce of critical thought. If she has to insult those who eventually have to buy her product, so be it. Geneva will be happy, and she will keep getting published.

At least this article goes on the pile of evidence that ANSI and the US TAG aren't interested in what anyone thinks, so when the heat gets turned up, we will know who to depose.