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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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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 #25  
Old 16th February 2017, 02:50 AM
Gopinath.v

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

guys...i need procedure & records for Identification of Risks and Opportunities

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  Post Number #26  
Old 17th February 2017, 02:43 PM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,219
Re: Is Identification of Risks and Opportunities required for QMS Processes?

Quote:
In Reply to Parent Post by Gopinath.v View Post

guys...i need procedure & records for Identification of Risks and Opportunities
What do you have in mind? Can you tell us a little more about your organization?
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  Post Number #27  
Old 17th February 2017, 02:48 PM
QAMTY

 
 
Total Posts: 478
Re: Is Identification of Risks and Opportunities required for QMS Processes?

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
  Post Number #28  
Old 17th February 2017, 08:45 PM
QAMTY

 
 
Total Posts: 478
Re: Is Identification of Risks and Opportunities required for QMS Processes?

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.
  Post Number #29  
Old 17th February 2017, 11:59 PM
Gopinath.v

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

I'm in car seat manufacturing org.
I need Sample document like..procedure for identifying the risk & records & format as well .
  Post Number #30  
Old 18th February 2017, 10:46 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,021
Re: Is Identification of Risks and Opportunities required for QMS Processes?

Quote:
In Reply to Parent Post by Gopinath.v View Post

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.
  Post Number #31  
Old 18th July 2017, 07:31 AM
morteza

 
 
Total Posts: 162
Re: Is Identification of Risks and Opportunities required for QMS Processes?

Quote:
In Reply to Parent Post by MVladimir View Post

This is one of ununderstandable topic of 9001:2015. ISO TC 176 does not provide the clear explanation about that. ISO/TC 176/SC 2/N1289 THE PROCESS APPROACH IN ISO 9001:2015 only states:
"These three concepts together form an integral part of the ISO 9001:2015 standard. Risks that may impact on objectives and results must be addressed by the management system. Risk-based thinking is used throughout the process approach to:
Decide how risk (positive or negative) is addressed in establishing the processes to improve process outputs and prevent undesirable results
Define the extent of process planning and controls needed (based on risk)
improve the effectiveness of the quality management system
maintain and manage a system that inherently addresses risk and meets objectives."
Very general and poor explanation indeed!
I personally use and suggest you the following approach:
Initially, take into consideration the requirement of 4.4.1 f. "The organization shall ... address the risks and opportunities as determined in accordance with the requirements of 6.1";
Following this statement, cl.6.1 "Actions to Address Risks and Opportunities" is a starting point in the risk-based thinking and the main purpose here is to determine the risks and opportunities that need to be addressed in QMS at a whole.
After risks determined the organization shall integrate and implement the actions into its quality management system processes (cl. 6.1.2). In the other words - divide risks between processes.
Therefore, for some processes risks will be relevant, but for others - irrelevant.
My conclusion - there is not any DIRECT requirements in 9001:2015 to identify risks and opportunities for ALL QMS processes.

Any opinions will be appreciated!
Dear all,

I searched much on this topic after my initial post. I believe that MVladimir is right.

Based on clause 6.1.1, the organization shall determine its risks and opportunities (e.g. emerge of new competitors). Based on clause 6.1.2, the organization shall plan actions to address the determined risks (reduction of product price). These action shall implement through QMS processes,(reduction waste in production process, providing raw material with lower price by supply process, etc.) as it has been referred in clause 6.1.2 and has been stated in clause 4.4.1 f).

Totally, I think ISO 9001:2015 does not require to determine risks and opportunities for any processes. It requires to determine risks that effect on organizational objectives, and plan treatment actions and implement them through processes.

What are your idea, friends?
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