Elsmar Cove Quality DiscussionsHow the addition of "Risk" will affect ISO 9001:2015The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
How the addition of "Risk" will affect ISO 9001:2015
UL - Underwriters Laboratories - Health Sciences
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

How the addition of "Risk" will affect ISO 9001:2015 - Page 9


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
iso 31000 - risk management, iso 9001 - quality management systems, iso 9001:2015, risk based thinking (rbt), risk management and analysis
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 2 votes, 5.00 average. Display Modes
  Post Number #65  
Old 30th December 2014, 01:11 PM
Colin's Avatar
Colin

 
 
Total Posts: 1,508
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Jennifer Kirley View Post

To see any real improvement, registrars will need to do a better job of training their auditors to assess how clients are using the process approach. Good luck with that.

<snip> So RBT would be about the business and its continued viability instead of just getting the certificate. <snip>
I agree with on both of these points Jennifer - in fact my previous post is intended to say just that - al organisations take risk into account almost every day - especially the small ones, or they don't survive.

The fun part will be how we get to audit this stuff
Thanks to Colin for your informative Post and/or Attachment!

Sponsored Links
  Post Number #66  
Old 30th December 2014, 01:23 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,211
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Colin View Post

all organisations take risk into account almost every day - especially the small ones, or they don't survive.
That being the case, what is the need/relevance of a QMS standard having requirements of questionable implementability and auditability for RBT? in other words, if everyone does, all the time, what is the point of a requirement being written to that effect?

Quote:
In Reply to Parent Post by Colin View Post

The fun part will be how we get to audit this stuff
Some auditors will misuse this to attempt to wander outside of the scope of the audit they are contracted to perform. ISO 9001:2015 will STILL be a QMS standard. Any auditor who thinks s/he has a mandate to assess any type of business risk because of ISO 9001:2015 will have to be shown otherwise.

The DIS clearly scopes it in 6.1.2:
Quote:
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
As for the concrete life jacket example, over 20 years ago I debunked that myth.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #67  
Old 30th December 2014, 02:22 PM
drgnrider's Avatar
drgnrider

 
 
Total Posts: 167
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Jennifer Kirley View Post

Disaster plans are a tough subject, and expecting suppliers to have disaster plans are especially tough I am sure. How to deal with risk of lost material stream in tornado alley? Second source? Semiconductor grappled with this with silicone shortages. Not everything can be solved, but recognizing and addressing what we can could mean being employed next week.
Not asking any of our suppliers for a detailed disaster plan, just have they looked into the issue? What is the general overview, how does it affect us? A rough plan is better than scrambling after the event happens. With our workload, a slow-down will be better than a stoppage! Either way, I won't be the one explaining up the chain as to why we delayed millions of dollars in product.


Quote:
In Reply to Parent Post by Jennifer Kirley View Post

Human performance is the toughest yet. IT people can set up daily mirror backups and weekly backups for the less-savvy computer users.
I have our password-protected documents on a controlled-access server, backed-up nightly and the back-ups stored a few thousand miles away. I've had managers complain they cannot revise their procedure on-line or copy a newer revision to the server... I tell them it's working then, send it to me.


Quote:
In Reply to Parent Post by Jennifer Kirley View Post

I'm not sure what to do with the bomb threat thing though, except to question how badly I need that person should the origin ever be found out. At least, even a fake bomb threat can count as a drill.
At 5:30am, I don't think management getting awakened at home, the three law-enforcement agencies, bomb dogs from 3-hours away, city and county highway departments closing a busy highway, or the bomb squad from 2-hours away were too appreciative of the "drill". But, as you mentioned, it counted and management did make some changes to the process.... so not a total loss.
Thanks to drgnrider for your informative Post and/or Attachment!
  Post Number #68  
Old 31st December 2014, 01:40 AM
Colin's Avatar
Colin

 
 
Total Posts: 1,508
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Sidney Vianna View Post

That being the case, what is the need/relevance of a QMS standard having requirements of questionable implementability and auditability for RBT? in other words, if everyone does, all the time, what is the point of a requirement being written to that effect?

Some auditors will misuse this to attempt to wander outside of the scope of the audit they are contracted to perform. ISO 9001:2015 will STILL be a QMS standard. Any auditor who thinks s/he has a mandate to assess any type of business risk because of ISO 9001:2015 will have to be shown otherwise.

The DIS clearly scopes it in 6.1.2:

As for the concrete life jacket example, over 20 years ago I debunked that myth.
I can't disagree with your point Sidney, my only thought is that it is a further attempt to encourage organisations to have a single system for running their business rather than that which we often see now where there seems to be a system for running the business and one for achieving certification.

This should be helped by the inclusion of statements such as "... relevant to its purpose and its strategic direction ..." (4.1).

As for wandering out of scope, do auditors need further encouragement?
Thanks to Colin for your informative Post and/or Attachment!
  Post Number #69  
Old 31st December 2014, 01:52 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,317
Re: How the addition of "Risk" will affect ISO 9001:2015

If by logical questioning, common sense approach, trail of interacting processes based on established procedures, when a non conforming situation can be potentially seen, and the auditee agrees on same, a NC can be written up on RBT application ...
Thanks to somashekar for your informative Post and/or Attachment!
  Post Number #70  
Old 31st December 2014, 04:27 AM
Colin's Avatar
Colin

 
 
Total Posts: 1,508
Re: How the addition of "Risk" will affect ISO 9001:2015

I don't want to be looking for evidence of a nonconformity for a lack of RBT, I want to see evidence that the organisation have included RBT as part of their operations.

Does having a business plan, or at least a SWOT analysis, meet the requirement? Or are we going to see an item on the management review agenda called Risk, just so that someone can point to it and say "we have addressed RBT" - I truly hope not.
Thank You to Colin for your informative Post and/or Attachment!
  Post Number #71  
Old 31st December 2014, 01:16 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,211
Re: How the addition of "Risk" will affect ISO 9001:2015

Colin, as must of us know, the TC 176 SC2 has released a paper on ISO 9001:2015 and Risk.

As usually happens with the "papers" issued by that body, the document does very little, in my estimation, to clarify "acceptable approaches" on "dealing with RBT". The silly example of RBT when crossing a road does not assist people to extrapolate and abstract it to a business setting. A wasted opportunity to truly help the ISO 9001 users community. When will they learn to develop papers that are useful?

I do know for a fact that some high level TC176 members are voyeurs of this space and some of our lengthy discussions at The Cove about the inadequacy of the preventive action text led to it's removal from the 5th Edition of ISO 9001. I wished they had consulted with some of the knowledgeable people here before adding RBT as a requirement.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #72  
Old 31st December 2014, 03:40 PM
WCHorn's Avatar
WCHorn

 
 
Total Posts: 198
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Sidney Vianna View Post

That being the case, what is the need/relevance of a QMS standard having requirements of questionable implementability and auditability for RBT? in other words, if everyone does, all the time, what is the point of a requirement being written to that effect?
Your rhetorical questions made me think, Sydney. I believe that any business that wings it is successful because of pure luck and likely to fail. Successful businesses use RBT all the time; it's the best path to success. Having read the paper TC176 issued on the subject, to me RBT is just a modified statement of the preventive action requirement.

Training operators and supervisors on RBT will be worth the effort, though, to at least make clear how the risks they might take affect the business. Adding written procedures and forms would be overkill, though, in my opinion. That would be like requiring a procedure for breathing.

It should be more like asking folks how their work affects the company's quality policy. If the auditor asks about RBT and gets a coherent response, will auditors be satisfied? Am I being too shallow on the topic?
Thank You to WCHorn for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
"Partial Design" Designation and Applicable ISO 9001:2015 Exemptions MichelleMcR ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13 25th October 2017 10:14 AM
What can be considered a "Post Delivery Activity" (ISO 9001:2015 Clause 8.5) kcoryell1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12 29th September 2017 01:57 PM
Easy Way of "Implementing" Risk in ISO 9001 2015 QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7 3rd April 2017 01:50 AM
Including the Word "Risk" into the Quality Policy (ISO 9001:2015)? QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4 15th February 2017 04:26 PM
ISO 9001:2015 4.4.1 - Providing Evidence of QMS Processes "Shalls" ogghall ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9 3rd October 2016 02:02 AM



The time now is 11:49 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"

The Elsmar Cove is currently owned by the Marc Smith Retirement Trust and operated by Law-Nutz Wyoming©2018