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Risk Management Implementation for ISO 9001:2015
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Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
Risk Management Implementation for ISO 9001:2015
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iso 9001 - quality management systems, iso 9001:2015, organizational knowledge, risk management and analysis
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  Post Number #25  
Old 9th June 2016, 03:15 PM
LUV-d-4UM

 
 
Total Posts: 754
Re: Risk Management Implementation for ISO 9001:2015

Just today our TS auditor told us that her recommendation for Risk Based Thinking is FMEA and elaborated why. I told her in front of the management she's auditing that the standard does not require FMEA.
Thanks to LUV-d-4UM for your informative Post and/or Attachment!

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  Post Number #26  
Old 9th June 2016, 03:55 PM
dsanabria

 
 
Total Posts: 1,179
Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by LUV-d-4UM View Post

Just today our TS auditor told us that her recommendation for Risk Based Thinking is FMEA and elaborated why. I told her in front of the management she's auditing that the standard does not require FMEA.
..and she said... (you left out the rest of the conversation).
Thanks to dsanabria for your informative Post and/or Attachment!
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  Post Number #27  
Old 9th June 2016, 04:00 PM
Big Jim

 
 
Total Posts: 2,803
Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by LUV-d-4UM View Post

Just today our TS auditor told us that her recommendation for Risk Based Thinking is FMEA and elaborated why. I told her in front of the management she's auditing that the standard does not require FMEA.
It may not be required but for some companies it would be very useful. For others it would be a huge pain in the neck.
Thanks to Big Jim for your informative Post and/or Attachment!
  Post Number #28  
Old 9th June 2016, 05:56 PM
Zearl

 
 
Total Posts: 10
Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by Big Jim View Post

It may not be required but for some companies it would be very useful. For others it would be a huge pain in the neck.
Agree. But I am afraid we will see auditors all across the board on risk, as the standard is very vague on the subject. It seems with every new revision, the more ambiguous. As a result, there is too much interpretation by the auditors at times.
Thanks to Zearl for your informative Post and/or Attachment!
  Post Number #29  
Old 13th June 2016, 04:22 PM
Zearl

 
 
Total Posts: 10
Re: Risk Management Implementation for ISO 9001:2015

Quote:
In Reply to Parent Post by LUV-d-4UM View Post

Just today our TS auditor told us that her recommendation for Risk Based Thinking is FMEA and elaborated why. I told her in front of the management she's auditing that the standard does not require FMEA.
Show her Annex A, Section A.4 fourth paragraph.
Thank You to Zearl for your informative Post and/or Attachment!
  Post Number #30  
Old 19th June 2016, 03:55 PM
tqmexpert

 
 
Total Posts: 3
Re: Risk Management Implementation for ISO 9001:2015

to John R. Broomfield

Good point, but here is the guideline for you...

You must use your head...
for each potential risk component you must ask...
"Is the risk artifact ACCEPTABLE OR NOT, in order to ensure
that this particular QMS process can work out as planned?"

By answering this question you find the right answers
to put into your QMS Contingency Plan, which you should develop
to summarize your risk findings plus mitigation strategies.
If you really know your QMS processes well,
you will have no probelm with all the "holistic" risk assessment,
but make sure you apply it to all potential risk factors, like geographical risk,
process risk, pruduct risk, people risk, etc...well, that is what "risk based thinking" is all about...FMEA cannot cover it all and does not suit always 100%.

Hope that helps.
Thanks to tqmexpert for your informative Post and/or Attachment!
  Post Number #31  
Old 19th June 2016, 04:36 PM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,021
Re: Risk Management Implementation for ISO 9001:2015

I have seen a huge amount of discussion, concern and misinformation about risk-based thinking and ISO 9001:2015 (and related standards that use it as their core requirements).

Some people have tried to claim FMEAs will be required. That is not true. Indeed, ISO TC 176/SC2 has published a white paper on RBT to help clarify FMEAs are not required.

The FMEA's format has tended to be suited for manufacturing widgets, but I have seen its format adapted to help IT groups perform their risk control systems. Environmental and safety managers have been making Aspects and Impacts and Risk-Hazard Analyses for years, using an adapted FMEA format.

For that reason it seems sensible for some to suggest such a format might be helpful, especially for those of us who are accustomed to seeing it for product. That is why I made an adaptation of the FMEA for managing risks in processes. The fact that it somewhat resembles an FMEA is due to the usefulness of the FMEA for sorting information. That is all. Please see attached. I hope this helps!
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: xlsm Risk Based Planner.xlsm (463.5 KB, 765 views)

Last edited by Jen Kirley; 19th June 2016 at 04:41 PM.
Thank You to Jen Kirley for your informative Post and/or Attachment!
  Post Number #32  
Old 19th June 2016, 05:04 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,220
Re: Risk Management Implementation for ISO 9001:2015

Here are some thoughts regarding Risk Management.

ISO 9001:2015 does not require this effort to be documented.

Top Management (Managers/Process Owners) will likely be interviewed regarding how this has been considered and implemented in the processes they own or manage.

What's the risk associated with Managers contradicting each other during audits? (I've often experienced this!! ). My recommendation? Develop a risk matrix.

It represents "lessons learned." It helps to retain knowledge. And it should be part of "organizational knowledge."

Comments folks?
Thank You to Stijloor for your informative Post and/or Attachment!
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