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Risk Assessment Help Needed

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by doooo79, Apr 3, 2017.

  1. doooo79

    doooo79 Member

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    Good day

    in my company we are shifting from ISO 9001 ( 2008 to 2015 ) , i am little bit confused for some points

    now after changing the main processes to the new format that includes the risk and opportunities ( minimum 3 in each process ) so for the total processes it may reach 30-40 risk , on the other hand we already finished the strategic SWOT analysis and PESTLE for the company , my question , shall i consolidate all these risks and opportunities( for processes and for the company ) in one SWOT analysis with one risk assessment table ?

    as this from my point of view will be too much complicated and confusing

    thanks
     
  2. tony s

    tony s Well-Known Member

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    For what purpose? IMHO the intention of the standard for promoting the RBT concept is to make it an integral part of any organization's planning process.

    SWOT analysis is usually utilized for high level planning (e.g. strategic planning) where strategic directions are established and subsequently supported by measurable objectives. This kind of approach can satisfy the requirements in Clause 6.1.1 and 5.1.1b.

    Risks and opportunities on processes can be determined using planning tools for operational level like FMEA, Risk Matrices, HACCP, etc. These tools can help organizations to determine appropriate controls to address risks on processes. This approach can satisfy clauses 6.1.2 and 4.4.1f.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm totally confused! As Tony comments, the new standard promotes Risk Based Thinking, that's all...
     
  4. doooo79

    doooo79 Member

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    Is there any complete process includes risk and opportunities ( as an example ) for example sales process .
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Have you considered involving your own (sales) people in identifying risk in a sales process? Taking what someone else has done, without a lot of background information is not - IMHO - a good idea. As with many things to do with implementing ISO 9001 requirements, using what someone else has done, without knowing things like their culture, their risk tolerance, their maturity with regard to their QMS, risks etc., you may not get much from the example. Worse, you might use it, wholesale, and it may not fit. It's of most benefit to you to involve the people who are in the Sales process and maybe some from down stream from Sales. Don't overlook that one of the (original) "Quality Management Principles" which underpins ISO 9001 is "Involvement of People"...
     
  6. doooo79

    doooo79 Member

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    Andy , you are a moderator in a support forum so you have to help any one needs support, who told you that i want to take what someone has done , i am not copy pasting dear , i need to know what is the required flow for process and what is the best format that can help us to finalize documents in proper way , by the way in our company we are helding management meeting daily to finalize this issue and we are brain storming and already we took a training for all depayhow to implement, but during execution of the system , we have some points needs elaboration, thays why i am asking you
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What are these points? We can probably help answer those. You only asked for an example of a sales process...
     
  8. doooo79

    doooo79 Member

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    The points are , the minimum requirements for a process to be comolying to 2015 edition, of course it is written in too many sites , courses and training material , but to see it implemented in one of any process as an example will elaborate more
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Your training didn't discuss this? I'd ask for my money back!
     
  10. doooo79

    doooo79 Member

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    if each question i will ask , you will answer with a question , we will reach to an endless discussion

    my respectable moderator , didn't you hear before that a student took a lesson in school and after that he is asking points in the same lesson for another teacher or colleague or father or anyone , who told you that if i have a training i must understand 100% !!

    if you can answer me it is ok , if you cant just say it

    and please take a training to be a moderator of a support forum
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    OK, so let me help you. Your thread is entitled "Risk Assessment help needed". Then your most recent post states:
    Please clarify what you would like to know. I have been asking questions because I cannot tell what it is you are actually seeking to answer and I am clarifying. I'll ignore your comments about my abilities as a moderator for now...

    Please rephrase your question...
     
  12. tony s

    tony s Well-Known Member

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    Let me share an approach for applying the RBT concept in an organization's QMS...
    As I have explained in my previous post, RBT is primarily intended to be utilized during any organization's PLANNING process. There are at least two types of planning (i.e. strategic and operational) as explained by ISO/TC 176 on their RBT presentation (see below - I also attached their presentation for your reference).

    upload_2017-4-6_7-51-51.png

    RBT role on Strategic Planning can be demonstrated by using tools like the SWOT Analysis. The output of SWOT will establish the STRATEGIC DIRECTIONS of an organization. See example below (RBT concept is demonstrated by determining the Opportunities and Threats):

    upload_2017-4-6_8-56-26.png

    The strategic directions are then supported by measurable objectives and plan of actions. It is good to note that during Strategic Planning, we deal with high-level risks and opportunities (i.e. "strategic level" as indicated in the SWOT). This approach satisfies the requirements in in Clause 6.1.1 and 5.1.1b.

    For process-level risks and opportunities, we usually address them during Operational Planning. I'll post an approach in demonstrating RBT concept for Operational Planning later. (I just have to report for work first).;)
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

    Last edited: Apr 6, 2017
  13. doooo79

    doooo79 Member

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    Many many thanks , I really appreciate your supporting reply , i will be waiting for the 2nd part of the reply regarding operational risks .
    Thanks
     
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  14. tony s

    tony s Well-Known Member

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    Okay for the 2nd part.

    The role of RBT concept for Operational Planning can be demonstrated by using operational tools like FMEA, HACCP or Risk Matrices. Unlike with risks and opportunities identified using the SWOT during the Strategic Planning, process-level risks and opportunities are dealt with using these operational tools. The intention of accomplishing these tools is to determine the controls that need to be installed to address risks/opportunities for each individual process. An example is given below (my apologies for not using the Sales process):

    upload_2017-4-6_12-53-57.png

    I devised my own tool above (using FMEA as template). I did not include columns that assign numbers for determining the level of risks/opportunities like the RPN (risk priority number) or S/O/D (severity, occurrence & detection) columns of FMEA since there's no requirement to determine the risk level. ISO 9001 only requires an organization to "determine risks and opportunities that need to be addressed". You can make your own tool also.

    The items on the Actions column should become part of the controls that you will need to integrate into your processes. If you have documented procedures, you should indicate them. This approach can satisfy the requirements in clauses 6.1.2 and 4.4.1f.
     
  15. doooo79

    doooo79 Member

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    many thanks , that's what i was searching for

    appreciate your supportive spirit and good listening
     

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