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6.3 QMS Planning of changes ?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by jaltangerel, Jan 4, 2018.

  1. jaltangerel

    jaltangerel Member

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    What is this mean in clause 6.3 "When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner " ?

    is it a changes of procedures and work instructions?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, but not only those. If your organization makes a change to, say, the sales process because they are going to use a software tool, like SalesForce etc. planning for the change will also include software support, training of users, changes to methods, equipment and so on.
     
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  3. Qualmx

    Qualmx Well-Known Member

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    Any change who may impact negatively your qms, must be planned adequatelly.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Any change - including improvements - must be planned.
     
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  5. Golfman25

    Golfman25 Well-Known Member

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    What does that even mean? What is a "planned manner?" Seriously, who does things without at least a minimal plan? What level of planning?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Unsophisticated organizations in emerging economies who want to supply a global marketplace...
     
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  7. The PPAP Assassin

    The PPAP Assassin Active Member

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    All you should need to do is show proof of any changes that impact the QMS. For instance, meeting sign in sheets, minutes, ect..
     
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  8. jaltangerel

    jaltangerel Member

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    Very helpful me. Thanks all.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I wouldn't suggest this at all. Section 6 is pretty clear about what has to be considered in planning changes. In fact there's a list. Showing someone lists of names from meetings is almost inconsequential. What's needed is a) a plan and b) measureable results once the change has been implemented.
     
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  10. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    6.3 does include change planning aspects that are expected, but I want to add that personnel changes should also be planned. Reorganizations, promotions, downsizing etc. all can leave responsibilities untended unless the responsibilities are reassigned and personnel prepared to successfully accomplish their new tasks on time.
     
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  11. The PPAP Assassin

    The PPAP Assassin Active Member

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    I wouldn't suggest this either.. You cant pretend like every company is the same. Each company has there own way of dealing with changes.

    Changes to the QMS can come from CAR's. Most of them do here. An error has occurred, the CAR calls for a change in the QMS.

    "Changes shall be carried out in a planned manner."

    We have had several documented meetings about changes that happen that take into account requirements a.) b.) c.) and d.)

    All of which can be proved with objective evidence..

    Thanks for you opinion, Andy.
     
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  12. tony s

    tony s Well-Known Member

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    Just want to share this form if you need to record changes for improvement.
     

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

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  13. jaltangerel

    jaltangerel Member

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    Thanks Tony s
     
  14. Charles Van

    Charles Van New Member

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    Hi All,

    I am currently going through the Transition from ISO 9001:2008 to 2015 version.
    I am going to review most of our processes and update Process Maps and Flowcharts since we want to keep our Quality Manual for our clients (we are manufacturing and importing industrial instrumentation products for major private companies as well as some public ones).

    I find the Template above very interesting and applicable in my company, but is that part of the ISO Requirements ?
    Both Part 6.1 and 8.1 (criterias) mention that the Risks should be considered, but nothing about the fact it should be kept and documented.

    Can someone confirm that point since i'll start updating everything soon ?

    Thank you

    Charles
     
  15. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Welcome Charles!

    Although it is true there are no specific requirements to document risk considerations, it seems to me that not documenting them would present challenges in including (9.3.2e) the effectiveness of actions taken to address risks and opportunities.

    ISO 9001 is not meant as a recipe to be followed to the letter; it is better to place your greater focus on making your system robust and effective. Chances are very good that if you have done so, you will find you are conforming (completely or mostly) to the revised standard, and few gaps will be left, if any.
     
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  16. Charles Van

    Charles Van New Member

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    Hi Jennifer,

    Thank you for the quick answer.

    So technically, it's not necessary to document them, if that can clearly be explained to the Auditor who will come to do the 2015 Audit, when he sees "Rev.02" on a document for example ?
    But showing that this has been documented will help proving we comply with the Standard, meaning we weighted the possible risks and expected benefits that these changes could bring, is that the point you are making ?

    Thanks

    Charles
     
  17. David Bradley

    David Bradley Active Member

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    One of my clients had an issue with a outsourced process. The quality was acceptable, but the turn around was excessive (in my client's) opinion. So, they decided to bring the process (powder coating) in house. This was a rather dynamic shift in their operations. They had no process similar to powder coating. You can imagine the planning that was required to acquire all the necessary equipment, materials and most importantly.... competence! That is an extreme example, but a fairly clear one.
     
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  18. Charles Van

    Charles Van New Member

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    Hi David,

    Very good Example indeed.
    To situate the company I work for, we manufacture in House and do assembly, as well as import finished goods, as the volume of the products sold increased a lot since the 80's, and we now have offices in Latin America, US, Dubai, Shanghai, but the ISO is for Our Toronto Head office only ( Toronto site has manufacturing and assembly )

    So for the control of External Providers, we have controls already (Audit of Supplier and Sub-Vendors, QC reports, PPAP process etc ...)

    I am more concerned about for example doing slight changes to the Process Maps and Quality Manual, in order to add points of control / monitoring where there is currently none or not enough
    (for example Work Order Completion Rate / week ; Delayed Work Orders Rate / Week etc .. ) Basically where I find the control not extensive enough.
    Not sure if I should actually document that using the Template Tony S. provides above.

    We are going to change drastically the way we operate our Work Orders, so this will obviously fall under his template which I find very appropriate for it as we can list the cost, improvements and
    issues we should/would encounter.

    To sum up, for small changes and more points of controls on Internal Processes we are familiar with, is this a need to document it ?

    Sorry for the long message, thanks again for the help.
     
  19. tony s

    tony s Well-Known Member

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    The form was actually a generic template for documenting any improvement initiatives that will necessitate changes. Other documented information can support the requirements of 6.3. If there will be changes like the example given by David Bradley, honestly my template is not adequate to document the plans, tests, results, training records, etc. to demonstrate that changes are "carried out in a planned manner". However, the template can serve as a good tool for documenting small to relatively substantial changes on any organization's process, resource, product or service.

    Since 6.3 mentioned 4.4 in its statement, retaining of documented information to demonstrate carrying out of changes in a "planned manner" is actually a requirement specified in 4.4.2b - "To the extent necessary, the organization shall...retain documented information to have confidence that the processes are being carried out as planned."
     
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  20. Charles Van

    Charles Van New Member

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    Hi Tony,

    Thanks for the reply.
    Well noted, I am going to use this template for a few changes happening in our processes actually.
    Already found that Monitoring activities are not in our process maps for example, and we are lacking of some points of controls In my opinion,
    so i'm currently reviewing various means of monitoring and I am willing to add these to the Process Maps / SOP / FlowCharts.

    We are not planning major changes for the Audit, more of slightly updating some processes (using tablets instead of paper for our workshop).
    So your form is particularly applicable there, thanks for the answers.

    Charles
     
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