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Is Identification of Risks and Opportunities required for QMS Processes?
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Is Identification of Risks and Opportunities required for QMS Processes?
Is Identification of Risks and Opportunities required for QMS Processes?
Is Identification of Risks and Opportunities required for QMS Processes?
Is Identification of Risks and Opportunities required for QMS Processes?
Is Identification of Risks and Opportunities required for QMS Processes?
Is Identification of Risks and Opportunities required for QMS Processes?
Is Identification of Risks and Opportunities required for QMS Processes?
Is Identification of Risks and Opportunities required for QMS Processes?
Is Identification of Risks and Opportunities required for QMS Processes?
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Some Related Topic Tags
interpretations, iso 9001 - quality management systems, iso 9001:2015, qms (quality management system), risk based thinking (rbt), risk management and analysis
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  Post Number #17  
Old 29th January 2017, 04:59 PM
MVladimir

 
 
Total Posts: 97
Re: Is Identification of Risks and Opportunities required for QMS Processes?

I found our discussion as very effective! Thanks for everybody involved! The final Sidney's statement will help to find right direction as to RBT implementation.

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  Post Number #18  
Old 31st January 2017, 08:50 AM
armani

 
 
Total Posts: 115
Re: Is Identification of Risks and Opportunities required for QMS Processes?

Maybe it's just me, but it seems like this post hasn;t reached any conclusion regarding the requirement to identify risks and opportunities for any QMS processes or requirement to identify risks and opportunities for all QMS processes.
In my opinion, ISO doesn't impose this requirement, neither for "any process" nor for "all processes" - 4.4.1f and 6.1 are too vague....it's a question of interpretation.
Any other opinions?

Last edited by armani; 31st January 2017 at 09:15 AM.
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  Post Number #19  
Old 31st January 2017, 09:07 AM
Mike S.

 
 
Total Posts: 2,143
Re: Is Identification of Risks and Opportunities required for QMS Processes?

There are some very vague areas of the standard, but with respect to your question, 4.4.1.f and 6.1 is not that vague, IMO.

In addition, FWIW, I was told by an auditor and trainer who is part of TC176 that auditors will put a great deal of focus on the risks and opportunities associated with your key processes. YMMV.
  Post Number #20  
Old 31st January 2017, 09:16 AM
armani

 
 
Total Posts: 115
Re: Is Identification of Risks and Opportunities required for QMS Processes?

Then, where 4.4.1 and 6.1 says about requirements to identify risks for processes??....I repeat, for processes, not resulting from 4.1 and 4.2?? and much more, for ALL processes?
  Post Number #21  
Old 31st January 2017, 10:32 AM
Mike S.

 
 
Total Posts: 2,143
Re: Is Identification of Risks and Opportunities required for QMS Processes?

4.4.1 The organization's quality management system shall also address customer and applicable statutory and regulatory quality management system requirements. The organization shall determine the processes needed for the quality management system and their application throughout
the organization, and shall: f) address the risks and opportunities as determined in accordance with the requirements of 6.1 ;

So, do you need to identify risks associated with running out of plastic forks in the employee lunchroom? Probably not.

Do you need to identify risks associated with running out of raw material for the #1 product produced in your manufacturing area? Probably so.

You determine what is important.
Thank You to Mike S. for your informative Post and/or Attachment!
  Post Number #22  
Old 31st January 2017, 02:09 PM
Kronos147

 
 
Total Posts: 259
Re: Is Identification of Risks and Opportunities required for QMS Processes?

Quote:
In Reply to Parent Post by armani View Post

Maybe it's just me, but it seems like this post hasn;t reached any conclusion regarding the requirement to identify risks and opportunities for any QMS processes or requirement to identify risks and opportunities for all QMS processes.
In my opinion, ISO doesn't impose this requirement, neither for "any process" nor for "all processes" - 4.4.1f and 6.1 are too vague....it's a question of interpretation.
Any other opinions?
The conclusion is:
Maybe you can sell an auditor that top level risk and opportunities are all that is important. However, how effective will the system\process be?

Who knows better than the process owner about the risks and opportunities?

Risk Based Thinking is a thread in ISO 9001\AS9100. Have you reviewed it as such?
Risks and Opportunities: 0.3.3 Risk-based Thinking, 0.1 General, 4.4.1 (f) QMS and its Processes, 5.1.2 (b) Customer Focus, 6.1.1, 6.1.2 Planning: Actions to Address Risks and Opportunities, 8.3.3 (e) Design and Development Inputs, 8.3.6 (d) Design and Development Changes, 8.4.2 Type and Extent of Control, 9.3.1 (e) Management Review: General, 10.2.1 Nonconformity and Corrective Action, A.4 Risk-based Thinking

Last edited by Kronos147; 31st January 2017 at 02:09 PM. Reason: typo
  Post Number #23  
Old 31st January 2017, 03:10 PM
randomname

 
 
Total Posts: 84
Re: Is Identification of Risks and Opportunities required for QMS Processes?

I always get a kick out of seeing how much energy organizations put into trying to avoid doing things that are actually in their own self interest.
Thank You to randomname for your informative Post and/or Attachment!
  Post Number #24  
Old 31st January 2017, 03:55 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,940
Yin Yang Re: Is Identification of Risks and Opportunities required for QMS Processes?

Quote:
In Reply to Parent Post by randomname View Post

I always get a kick out of seeing how much energy organizations put into trying to avoid doing things that are actually in their own self interest.
@randonname - I do as well.

I realize this is a thread asking if identification of risks and opportunities is a "requirement", but I come back to my experience as I close in on my 70's and about 30 years of consulting. This is stuff companies should be doing anyway and most of them are. Identification of risks and opportunities is just standard for any business to succeed and to stay in business long term. And no one needs an MBA to know this. I know some small business owners none of them which are ISO anything, much less have an MBA, that know and do this.

My guess is the original poster who started this thread does so in his/her company whether they recognize it or not. I believe it really comes down to being ready for what auditors may ask with regard to identifying risks and opportunities.

In my early ISO 9001 consulting days back in the early 1990's one of the things I would get companies to do is get t-shirts for every employee (including top management) so when the auditor(s) arrived everyone would be wearing them (at least on the first day of the audit). It really got everyone involved and even excited about being audited. I used to have a collection of t-shirts from different companies but have, over the years, gotten rid of the. One of the early ones had the company name and logo on the front, and on the back in big letters it said: "I'm Ready! Audit me!" The auditors got a bit of a kick out of the t-shirts. I also would have wallet cards such as the attached printed with the company quality policy on the front (remember when ISO 9001 auditors would ask employees if they knew the company quality policy and "What does it mean to you?").


.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: doc QA Policy Card-Back.doc (28.0 KB, 265 views)
Thank You to Marc for your informative Post and/or Attachment!
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