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Confusion about Risks for Processes in ISO 9001:2015
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Confusion about Risks for Processes in ISO 9001:2015
Confusion about Risks for Processes in ISO 9001:2015
Confusion about Risks for Processes in ISO 9001:2015
Confusion about Risks for Processes in ISO 9001:2015
Confusion about Risks for Processes in ISO 9001:2015
Confusion about Risks for Processes in ISO 9001:2015
Confusion about Risks for Processes in ISO 9001:2015
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Confusion about Risks for Processes in ISO 9001:2015


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Some Related Topic Tags
iso 9001 - quality management systems, iso 9001:2015, processes (general), risk based thinking (rbt), risk management and analysis
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  Post Number #1  
Old 8th June 2016, 08:05 AM
armani

 
 
Total Posts: 123
Please Help! Confusion about Risks for Processes in ISO 9001:2015

I am very confused about "risks" in this new ISO standard. For what processes do I have to identify the risks (e.g. production process, suport processes)...any (non) exhaustive list of processess for which ISO 9001:2015 says I shall identify risks?
And do u have any risk identification example for a process (not for Purchasing, this is a frequent example)?

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  Post Number #2  
Old 8th June 2016, 11:25 AM
rob73's Avatar
rob73

 
 
Total Posts: 221
Re: Confusion about Risks for Processes in ISO 9001:2015

The fundamental change in ISO 9001 is to apply "risk based thinking" across the whole organisation, but this does not mean you need to do a full risk analysis on every process or procedure you use.
Have a good read of this discussion thread: Risk Management Implementation for ISO 9001:2015. It may help you.
Thanks to rob73 for your informative Post and/or Attachment!
  Post Number #3  
Old 9th June 2016, 01:30 AM
armani

 
 
Total Posts: 123
Re: Confusion about Risks for Processes in ISO 9001:2015

And the selected processes depends on what? I must have some criterie to choose those processes??
  Post Number #4  
Old 9th June 2016, 03:56 AM
rob73's Avatar
rob73

 
 
Total Posts: 221
Re: Confusion about Risks for Processes in ISO 9001:2015

the point is "risk based thinking" is applied across the WHOLE orgainsation. The first step is consideration of risks, it will be up to you to decide how deep you go, some will only need a "what if.....", others a more rigorous study.
  Post Number #5  
Old 13th June 2016, 09:45 AM
armani

 
 
Total Posts: 123
Re: Confusion about Risks for Processes in ISO 9001:2015

But the point is I have to identify risks for ALL processes (including communication, change process etc.)...for every process to the extent I determine, but for ALL! Am I right?
  Post Number #6  
Old 21st June 2016, 04:52 AM
rob73's Avatar
rob73

 
 
Total Posts: 221
Re: Confusion about Risks for Processes in ISO 9001:2015

Not sure if you have seen this in another thread, but it does explain how risk based thinking can be (and probably already is) implemented in a system.

http://asq.org/quality-progress/2016.../prove-it.html
Thank You to rob73 for your informative Post and/or Attachment!
  Post Number #7  
Old 21st June 2016, 09:31 AM
tony s's Avatar
tony s

 
 
Total Posts: 138
Re: Confusion about Risks for Processes in ISO 9001:2015

I'm afraid that we have to identify risks as specified by ISO 9001:2015 clause 4.4.1f which says:
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


Some examples of risks:
  • Human Resource - hiring of persons with derogatory character;
  • Documentation - use of obsolete documents for the current operation;
  • Finance - inaccurate billing;
  • Internal Audit - baseless audit findings;
  • Management Review - uncommitted top management;
  • Communication - incomplete data;
  • Inspection - good products judged as bad or vice versa;
  • Sales - forgot to bring product catalog
Thanks to tony s for your informative Post and/or Attachment!
  Post Number #8  
Old 21st June 2016, 10:47 AM
Kchnwtch

 
 
Total Posts: 40
Re: Confusion about Risks for Processes in ISO 9001:2015

Quote:
In Reply to Parent Post by tony s View Post

I'm afraid that we have to identify risks as specified by ISO 9001:2015 clause 4.4.1f which says:
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
"

Some examples of risks:
  • Human Resource - hiring of persons with derogatory character;
  • Documentation - use of obsolete documents for the current operation;
  • Finance - inaccurate billing;
  • Internal Audit - baseless audit findings;
  • Management Review - uncommitted top management;
  • Communication - incomplete data;
  • Inspection - good products judged as bad or vice versa;
  • Sales - forgot to bring product catalog
Well, 6.1 cites 4.1 and 4.2, which give specific lists of places to look for risks and opportunities -- to your interested parties (4.2) and your external and internal business operations (4.1) which it lists as things like legal, market, cultural, values, and performance.

I'm wondering if maybe your list might be a little overly specific. Most of these risks would already be addressed in your QMS documentation; for example, human resources probably has job descriptions, and ways to check an employee's job references; the finance department has a billing strategy, or probably a computer system that regulates billing; your internal audit staff has been trained not to waste time on baseless findings.

This list might be a good check of whether the systems you have in place would take care of these issues, but IMO they seem too small to be listed as risks for your QMS. What are the terrible ramifications if a salesperson forgets the catalog? They can drive back to the office and pick it up, and get back on their sales route, or they can refer a client to a web catalog. Putting the sales catalog online might well be an opportunity that would be worth investigating, but because it would be really beneficial to your customer--not just to make sure that one sales guy doesn't have to waste gas.

The CEO of my company is a really great worrier, and could make a list of the most infinitesimal of risks--he puts himself in a tailspin all the time when he thinks of them, and tends to trip up the workflow by interfering when he panics. I think the standard intends to set a larger sense of risk, and especially to direct the majority of risk-based thinking towards the customer and what the customer wants.
Thank You to Kchnwtch for your informative Post and/or Attachment!
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