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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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risk management and analysis
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  Post Number #9  
Old 4th September 2017, 02:41 PM
QAMTY

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

Thanks dsanabria, office35o and Big Jim I appreciate your feedback

Specially referring to what dsanabria suggested, I read briefly such documents, and they are very complete, but consider risk as a formal management,

I wanted to have a simple guide to follow considering how the 2015 version considers the risk, not a really risk management.

Trying to have some guides, I got the next information, have in consideration that I already have 2008.

This is an extracted info from the ISO/IAF document (Auditing Practices Group) regarding to Risk auditing.

what an auditor should look,
In Italic (between rows), is shown what I have planned to do.

An auditor should act in accordance with the following steps and collect objective evidence as follows:

What inputs are used by the organization for risk and opportunity determination?

These inputs should include the following:

_ analysis of external and internal issues

By using SWOT, I got the risks and opportunities and will be registered
with its analysis and treatments in List of risks.
The weaknesses will need some attention, some actions plans, will be carried out.
For sure, some output issues from SWOT will be inputs for the quality objectives.


_ the strategic direction of the organization.

For the strategic direction, I think is a term which expect too much, IŽll make it simple, for that , I will show actions derived from the SWOT analysis and maybe
A piece of paper where I have written the vision, mission of my business.
In this point, I think the auditor will not expect to see complex business analysis, at least in my business ( 30 employees) steel parts manufacturing.



_ interested parties, related to its QMS, and their requirements, also
related to the QMS.

Ok, will be considered what will be detected

_ the scope of QMS of the organization.

Ok, will be considered

_ the processes of the organization.
Is Ok, inviting to owners of all the processes including the top management
I think is good idea that all process owners, participate in detecting risk and opportunities in each process, this way would more effective.

Thanks again

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  Post Number #10  
Old 11th September 2017, 04:16 PM
Joe Cruse's Avatar
Joe Cruse

 
 
Total Posts: 275
Re: Practical guide to scan for Risks in all QMS systems without missing any

Quote:
In Reply to Parent Post by ousgg View Post

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.
I'm not seeing the "shall" to put together a list of EVERY possible permutation of risk and write that list into your QMS, and definitely not the registrar auditor's job to go out and find all the risks you didn't formally define. To me, your system should be built with the structure and consistency that allows for your business to define, assess, and address the risks to your processes/QMS, AS they get identified. It's not supposed to be a one-time, catch-all list that you build up and add to the QMS for an auditor to see and approve of or get an NC on you from, for failing to document a specific risk that THEY see.
As part of your ongoing, regular QMS/process planning (production planning, etc) you'd generally go through the risks associated as a general course, and if you (or your internal auditors, or an NC incident, etc) identify another risk, well, that's all part of improvement, isn't it?
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  Post Number #11  
Old 11th September 2017, 08:27 PM
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Total Posts: 476
Re: Practical guide to scan for Risks in all QMS systems without missing any

Thanks Joe

In your point of view, regarding risk and opportunities, what will be the best option to detect the risks ans opps.?

In the case that ISO 2008 version is implemented and certified?
Would it be to have meetings with Top management and asking him how he complies every ISO clause regarding Risks and Opp?.

After that, to follow with responsibles of processes, with the same question?
All picked-up risk and opportunities it would be documented.

On the other hand, in respect to your comment.

I was thinking to put an effort in order to detect in a short time all the risk existing into our processes.

The fastest we detect the risk, the minimum possibilities to have non conformances.

Ok I know, I may miss some risk, ok, that wouldnŽt deserve a NC.

But if we have an audit, and a non conformance in a process is found because was not well planned regarding a risk, would it be a nc against 6.1?

Please feed back, sorry for a lot of questions.

Thanks
  Post Number #12  
Old 11th September 2017, 11:32 PM
QAMTY

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

Joe I forgot to say something
form the standard:

6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:......
Says and Determine the risks and opportunities, at planning, for me having 2008, already have been planned but not considered risks, so my task it is to determine them but you say "and address the risks to your processes/QMS, AS they get identified", dont you think that "as they get identified" it may take too long, if it is not put an immediate effort to do that?

That is the point in my mind, immediate tasks to determine them as soon as possible.

Hope it is clear.

Thanks
  Post Number #13  
Old 12th September 2017, 12:33 AM
Randy's Avatar
Randy

 
 
Total Posts: 8,571
Re: Practical guide to scan for Risks in all QMS systems without missing any

You'll never find all opportunities and risks so get it out of your head that you can.

Business is fluid, organizations are fluid, situations are fluid, people are fluid and as such there is no such thing as all. Anybody tells you different should be buying lottery tickets.

You're expending your most valuable and finite resource, your time, in quest of the Holy Grail and fighting windmills.
Thank You to Randy for your informative Post and/or Attachment!
  Post Number #14  
Old 12th September 2017, 08:19 AM
Joe Cruse's Avatar
Joe Cruse

 
 
Total Posts: 275
Re: Practical guide to scan for Risks in all QMS systems without missing any

I'm with Randy; it appears that you have it in mind that EVERY risk must be tracked down, then written on the "risk list" for your registrar to look at, and then addressed. You have the "tail wagging the dog", so to speak.

Your top managers, including top management and especially the managers responsible for your core processes, have already identified the risks (negative and positive) associated with the process under their control. They see it every day in operating. Some of them are likely negligible and may not be worth spending a lot of time on (running out of staples or other office supplies from one supplier, for example-easily mitigated), whereas others could either put a dead stop on the process, or lead it to non-conformance. You can probably bet that your managers have identified these risks, and are active in mitigating them. These are ones you need to be able to effectively show top management AND a registrar auditor that your system is identifying and addressing. You don't HAVE to have a list to do this; it's up to you how you show you are meeting the standard. Most risks that have been identified in your core processes have likely been addressed by your management and process owners, and that is built into your QMS already, possibly in work instructions.
Thanks to Joe Cruse for your informative Post and/or Attachment!
  Post Number #15  
Old 12th September 2017, 08:42 AM
QAMTY

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

Thanks Randy and Joe

Very helpful your comments.I really appreciate your time for feeding us back.
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