The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
UL - Underwriters Laboratories - Health Sciences
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?


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

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 9001:2015, risk based thinking (rbt), risk management and analysis
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 28th July 2017, 12:09 PM
QAMTY

 
 
Total Posts: 479
Question ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

Hi all

Regarding of documented evidences in 6.1, I donīt see any specific
information required.

Would it be needed to have only a list of identified and treated risks, also to have the evidences of the follow-up and actions plans? Additional, evidences of a swot and list of interested parties.

But I wonder if is needed, say, an evidence of a brainstorming session
with employees when determining risk? and also a sheet/format for every risk detected en each process, where risk is evaluated (the impact, the responsibles, due dates for actions,etc) including sign off of them?.

Please give some feedback

Thanks

Sponsored Links
  Post Number #2  
Old 2nd August 2017, 06:34 PM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,021
Re: ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

I am sorry for the delay in answering this question.

Evidence can be in the form of physical changes, such as 5S to reduce the risk of product damage. It can be a checklist that helps people avoid missing tasks or steps in transaction-based processes. It can be documented in SWOT, in tables, in FMEA, in a short statement within controlled procedures, but none of these types of documentation are specifically required.

I always advise the simple approach if it is possible. The main difficulty with that may be in how you can express effectiveness of actions taken, which is an input in Management Review. That can be a chart, a number or a statement but it should be something that can be verified through documentation and/or talking with people and/or the auditor's physical observations.
Thank You to Jen Kirley for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 3rd August 2017, 12:22 AM
QAMTY

 
 
Total Posts: 479
Re: ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

Thanks you so much Jen

I really appreciate your help
  Post Number #4  
Old 3rd August 2017, 11:09 PM
bpritts

 
 
Total Posts: 247
Re: ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

As Jen states there are MANY possible considerations and actions on risk. Too many of our QA colleagues seem to think that we invented risk management in 2015! That's just nonsense. Our whole field has been based on managing risks. So, some other examples:

- Any time you do an inspection, you presumably do so because you perceive a risk of nonconformance. (If you were certain that a process was perfect, why would you do inspections? But we know that processes, and people, aren't perfect... there's risk!) How did you decide when to do inspections, and how many? That involved risk based thinking... I hope!

- Anything you do involving STATISTICS probably involves risk. A process capability study measures the risk of producing nonconforming product. Ongoing SPC process control is intended to assess the risk of processes going astray. The entire field of statistics was invented to help assess risk!

- Any time you audit a process, you are considering risk. If you "knew" that processes were always executed 100% correctly why would you audit them?

Same extends to supplier audits.

- When you calibrate/confirm a gauge, you should be considering risk. Why do you decide to do the calibration every 90 days/ 365 days/ 1 day/ etc. Hopefully you have considered the risk of the gauge/ measurement device going wrong, as well as the cost of checking it and the cost of reaction if bad parts have been accepted.

I hope that these everyday examples help illustrate the point. Good QA has always been about managing risk!

Brad
Thank You to bpritts for your informative Post and/or Attachment!
  Post Number #5  
Old 4th August 2017, 04:07 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,254
Re: ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

Please note that the 6.1 is leading you back to 4.1 and 4.2.

This means that its reflecting back on your context and needs and expectations of your organizations's interested parties.

If you have not done this well, you will not be able to focus on the actions to address the risks and opportunities. This is more at a macro level and not just the stuff of product failure risk, calibration risk and such.

Risks that address your business continuity, new technology challenges, changing market and demands, competition, need for diversification and its associated risks, Investment risks .....and more.

Unless your leadership (the management) gets down to discussing these with the executing professionals after a clear understanding of the business process and QMS requirement, most will simply be addressing the risks around what processes and products you see in and around you.
Thank You to somashekar for your informative Post and/or Attachment!
  Post Number #6  
Old 4th August 2017, 12:10 PM
Paul Simpson's Avatar
Paul Simpson

 
 
Total Posts: 1,813
Re: ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

Quote:
In Reply to Parent Post by QAMTY View Post

Hi all

Regarding of documented evidences in 6.1, I donīt see any specific
information required.

Would it be needed to have only a list of identified and treated risks, also to have the evidences of the follow-up and actions plans? Additional, evidences of a swot and list of interested parties.

But I wonder if is needed, say, an evidence of a brainstorming session
with employees when determining risk? and also a sheet/format for every risk detected en each process, where risk is evaluated (the impact, the responsibles, due dates for actions,etc) including sign off of them?.

Please give some feedback

Thanks
As others have said. How you address planning is up to you and depends on how the organization currently works. As somashekar the results of your internal and external context assessment (perhaps the PESTLE and / or SWOT analysis) will generate a list of issues you want to manage.

Similarly your list of process risks and opportunities (4.4.1 f)may generate some evidence of risk and opportunity management.

So long as your organization is happy you have adequately looked at risk your 3rd party CB should also be happy.
Thank You to Paul Simpson for your informative Post and/or Attachment!
  Post Number #7  
Old 23rd August 2017, 08:33 PM
zucccchini

 
 
Total Posts: 4
BIG Smile Re: ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

Well guys, here is how I am going to approach this risk thing and it may even cover some other little 'shalls' the powers that be have thrown in there. I internal Audit a AS9100 manufacturing (machine shop). I have since retired actually working there but they call me in to do their internals. Long time ago I suggested that they really needed a history paper among the CAD/CAM programs, inspection notes, etc. for reoccurring job. At that time it simply helped the setup people and operator to realize ahead of time the problems that they may run into.

This thing has become invaluable now. It lists the RISKS over time for that job, includes tooling issues, machine issues, hard to find gauges, etc, mistakes made that caused scrap. On top of that it qualifies as addressing loss of learned experience. No starting a new learning curve if someone leaves that always ran that job. It did not walk out the door with him/her.

As far as addressing risks on the outside to the business in general, that would fall into the Planning 6. But that 'job history paper' certainly helped our production side address those issues.
  Post Number #8  
Old 30th August 2017, 05:00 PM
xxxxxxl

 
 
Total Posts: 1
Re: ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed?

I have been wondering if Opportunities need to be addressed separately to risks. Some identified risks due reveal opportunities, but sometimes opportunities originate from places other than risk assessment, business plans, or management review outputs.

Thoughts?
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
Internal Audit During the Transition Period from ISO9001:2008 to ISO9001:2015 delanga25 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4 3rd May 2017 08:07 AM
Risk Impact - Risk Assessment Sample/Method per ISO 9001:2015 QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1 19th January 2017 07:45 AM
ISO9001:2015 and ISO14001:2015 Readiness/Self Evaluation Checklists wanted starupdk ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1 13th January 2017 05:56 PM
Process Map Transition from ISO9001:2008 to ISO9001:2015 cbhigdon3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0 2nd November 2016 10:20 AM
Has anyone made an ISO9001:2015 vs. ISO9001:2008 Matrix andrewg ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32 7th November 2014 06:30 AM



The time now is 03:06 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 
 


NOTE: This forum uses "Cookies"