Informational Is Identification of Risks and Opportunities required for QMS Processes?

Mike S.

Happy to be Alive
Trusted Information Resource
#21
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.
 
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Kronos147

Trusted Information Resource
#22
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​
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#24
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?").

:2cents:
.
 

Attachments

Q

QAMTY

#27
As stijloor said, For identifications of risk and opportunities, it is good to know, what your business is.
Formats and procedures may be different.

Regards
 
Q

QAMTY

#28
Risk in finance and HR, of course, exist, how do you address the risk of not having enough resources to buy raw material, equipment, payroll,etc.
 
G

Gopinath.v

#29
I'm in car seat manufacturing org.
I need Sample document like..procedure for identifying the risk & records & format as well .
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#30
I'm in car seat manufacturing org.
I need Sample document like..procedure for identifying the risk & records & format as well .
Identifying risks and opportunities is not meant to be a standalone process, which makes sense because a procedure could actually limit or constrain the activities enough to impact the results.

If you are automotive, are you doing FMEA for your processes and products? That is an excellent risk method. But FMEA is not needed or required for other processes.

Another good thread on this subject can be found here: Confusion about Risks for Processes in ISO 9001:2015. I also attached a Risk Based Planner in that thread, in case it helps. I am not going to just provide the link now - please read the thread.

To be clear, the Planner's first tab has hyperlinks to other good sources that address risk in various ways.
 
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