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Practical guide to scan for Risks in all QMS systems without missing any
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Practical guide to scan for Risks in all QMS systems without missing any
Practical guide to scan for Risks in all QMS systems without missing any
Practical guide to scan for Risks in all QMS systems without missing any
Practical guide to scan for Risks in all QMS systems without missing any
Practical guide to scan for Risks in all QMS systems without missing any
Practical guide to scan for Risks in all QMS systems without missing any
Practical guide to scan for Risks in all QMS systems without missing any
Practical guide to scan for Risks in all QMS systems without missing any
Practical guide to scan for Risks in all QMS systems without missing any
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Practical guide to scan for Risks in all QMS systems without missing any


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  Post Number #1  
Old 2nd September 2017, 12:51 PM
QAMTY

 
 
Total Posts: 476
Question Practical guide to scan for Risks in all QMS systems without missing any

Hi all

In trying to detect risks, I thought it would be enough to analize processes shown in the general process map.
Considering that normally main processes are there.

Now I see that there is some difficulty because it is supposed that processes are documented in procedures, but there may exist requirements which are not in documents, moreover that now some documents are not needed.

What will ve a practical guide to scan risk in all the system without missing them?
Could you provide a guide?
Should we check every clause?

Thanks

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  Post Number #2  
Old 3rd September 2017, 08:24 AM
Office350

 
 
Total Posts: 2
Re: Practical guide to scan for Risks in all QMS systems without missing any

Good morning.

The 3rd party auditor who just conducted our re-certification audit told us to use the FMEA form for everything when assessing risk. Of course, he then advised us to use a FMEA of the FMEA, to have a plan in case we did forget something in the original FMEA; sort of like a 'Plan B', if you will.
Thanks to Office350 for your informative Post and/or Attachment!
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  Post Number #3  
Old 4th September 2017, 08:14 AM
ousgg

 
 
Total Posts: 10
I Say... Re: Practical guide to scan for Risks in all QMS systems without missing any

A couple of things to consider here:
1) There is no obligation on you to encapsulate ALL relevant risks in your risk-management approach. An auditor cannot write you a nonconformity for a risk you have omitted from your system, providing your system has some structure and consistency. It is emphatically NOT an auditor's job to try to identify risks you have missed by nitpicking and/or using their own arcane knowledge - keep your eyes open for this sort of practice, because it's worryingly common.

1b) My advice - start with Top Management. Discuss what the major risks to the business are. Get those properly documented and associate them with action plans. Make sure Top Management communicate this to middle management. This alone should be enough to make you compliant to the requirements, but you can then talk to middle management about how their departments/processes contribute to this risk and identify deeper causes and risks. Some areas will be more fruitful for drilling into than others.

2) Using FMEA for everything is a terrible idea. The inputs to an FMEA need to be structured, otherwise you end up with a free-for-all that is no help to anyone. I recommend you only use FMEAs where they were intended: in product designs and for individual clearly-defined granulated processes (ie - ones with a process flow chart).

2b) My advice - break down Risk Management by business process. In my QMS, Risk Management is part of each process design, and can take different forms depending on the process - some do FMEAs, some do a simpler risk assessment, some just do SWOT. The Risk Management for our despatch department, for example, is simply a list of contingency delivery plans. I have one show-off process owner who has done fault-tree analysis, but then his process is entirely driven by data, so it makes sense in context. You will probably already have a top-level business contingency plan which can slot quite neatly into this structure and might also overall guidance for the process-level documents if it is comprehensive enough.
Thank You to ousgg for your informative Post and/or Attachment!
  Post Number #4  
Old 4th September 2017, 09:13 AM
dsanabria

 
 
Total Posts: 1,175
Re: Practical guide to scan for Risks in all QMS systems without missing any

Quote:
In Reply to Parent Post by QAMTY View Post

Hi all

In trying to detect risks, I thought it would be enough to analize processes shown in the general process map.
Considering that normally main processes are there.

Now I see that there is some difficulty because it is supposed that processes are documented in procedures, but there may exist requirements which are not in documents, moreover that now some documents are not needed.

What will ve a practical guide to scan risk in all the system without missing them?
Could you provide a guide?
Should we check every clause?

Thanks
Go to AIQG website (International Aerospace Quality Group) and open the link for Supply Chain Management Handbook and go to section 7.3 Risk Assessment.

Supply Chain Management Handbook - Terms of Use
Thanks to dsanabria for your informative Post and/or Attachment!
  Post Number #5  
Old 4th September 2017, 11:54 AM
Big Jim

 
 
Total Posts: 2,803
Re: Practical guide to scan for Risks in all QMS systems without missing any

Quote:
In Reply to Parent Post by QAMTY View Post

In trying to detect risks, I thought it would be enough to analize processes shown in the general process map.
Considering that normally main processes are there.

Now I see that there is some difficulty because it is supposed that processes are documented in procedures, but there may exist requirements which are not in documents, moreover that now some documents are not needed.

What will ve a practical guide to scan risk in all the system without missing them?
Could you provide a guide?
Should we check every clause?
The short answer is that you are overthinking it. Risk is so diverse and so permeated into everything we do that you could never in your lifetime list it all.
Thank You to Big Jim for your informative Post and/or Attachment!
  Post Number #6  
Old 4th September 2017, 11:57 AM
Big Jim

 
 
Total Posts: 2,803
Re: Practical guide to scan for Risks in all QMS systems without missing any

Quote:
In Reply to Parent Post by Office350 View Post

Good morning.

The 3rd party auditor who just conducted our re-certification audit told us to use the FMEA form for everything when assessing risk. Of course, he then advised us to use a FMEA of the FMEA, to have a plan in case we did forget something in the original FMEA; sort of like a 'Plan B', if you will.
Gross example of overthinking it. In this case overthinking solutions. This is even worse than turning every instance of a nonconformance into a corrective action.
Thank You to Big Jim for your informative Post and/or Attachment!
  Post Number #7  
Old 4th September 2017, 12:00 PM
Big Jim

 
 
Total Posts: 2,803
Re: Practical guide to scan for Risks in all QMS systems without missing any

Quote:
In Reply to Parent Post by ousgg View Post

A couple of things to consider here:

1) There is no obligation on you to encapsulate ALL relevant risks in your risk-management approach. An auditor cannot write you a nonconformity for a risk you have omitted from your system, providing your system has some structure and consistency. It is emphatically NOT an auditor's job to try to identify risks you have missed by nitpicking and/or using their own arcane knowledge - keep your eyes open for this sort of practice, because it's worryingly common.

1b) My advice - start with Top Management. Discuss what the major risks to the business are. Get those properly documented and associate them with action plans. Make sure Top Management communicate this to middle management. This alone should be enough to make you compliant to the requirements, but you can then talk to middle management about how their departments/processes contribute to this risk and identify deeper causes and risks. Some areas will be more fruitful for drilling into than others.
Excellent advise
Thank You to Big Jim for your informative Post and/or Attachment!
  Post Number #8  
Old 4th September 2017, 12:05 PM
Big Jim

 
 
Total Posts: 2,803
Re: Practical guide to scan for Risks in all QMS systems without missing any

Quote:
In Reply to Parent Post by ousgg View Post


2b) My advice - break down Risk Management by business process. In my QMS, Risk Management is part of each process design, and can take different forms depending on the process - some do FMEAs, some do a simpler risk assessment, some just do SWOT. The Risk Management for our despatch department, for example, is simply a list of contingency delivery plans. I have one show-off process owner who has done fault-tree analysis, but then his process is entirely driven by data, so it makes sense in context. You will probably already have a top-level business contingency plan which can slot quite neatly into this structure and might also overall guidance for the process-level documents if it is comprehensive enough.
Even this could be overthinking.

To quote Randy, it isn't rocket science.

Use any of the tools (SWOT, FEMA, etc) when appropriate. Trying to come up with a heavy duty response for every instance every time isn't just impracticle, it is a terrible waste of time and leads to not only ineffeciency but to inadequate answers for the ones that matter.

Last edited by Big Jim; 4th September 2017 at 12:06 PM. Reason: typo
Thanks to Big Jim for your informative Post and/or Attachment!
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