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Where to report other kind of nc's?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Jul 7, 2017.

  1. Qualmx

    Qualmx Well-Known Member

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    Please feedback as how to manage non conformities.

    Now, I have one method and want to improve it..

    I have a NCR format according to 8.3 control of non conformity product, but is specifically used for product, onto it we apply dispositions.

    Recently I was reported other kind of nonconformities:

    - Operator fail to follow procedures.

    - Lack of competence.

    - People fails at filling out records, etc.

    For events mentioned previously.

    Which format do you think it is more recommended to raise non conformities of this type?

    1 In the current format, considering it is just for product?
    but adjusting it, mentioning that are included other issues, although some
    of them will not have applied dispositions like if it were product?
    Here a correction (disposition) will apply o maybe to be escalated to a CA.

    2 To raise a CAR , mentioning the other different issues in it?
    from here, a correction or full corrective action will apply.


    What is practical to be followed?

    Thanks
     
  2. hogheavenfarm

    hogheavenfarm Well-Known Member

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    I use a NCR for product and (outsourced) services, for the rest I use a CAR, as you point out, NCR is better suited for product, the CAR has a wider scope. Set this up however it works best for you. I suppose they could be combined, but the methods in researching them may be different, so maybe that is not the best course of action. Here, any employee can raise a CAR, but the quality department issues NCR's. CAR's can often be handled by the Production team better anyway.
     
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day Qualmx.
    My recommendation is as follows. An NC is an NC. They all likely require corrective action. For that reason I recommend that the Scope of your 8.3 (now 10.2 in 2015 version) be reviewed and be applicable to any NC (safety, product ng, process out of spec, etc..etc..). This will prevent you from having redundant and fragmented methods. The logging of an NC should then segue into a corresponding corrective action...followed by review.

    I would also caution in regards to cause vs affect and whether or not disposition applies. For example, if a cause (contributor) is "operator fails to follow procedures", then what is the disposition of his/her output? If the "...procedure" is how to produce parts, then the output (part) disposition needs to be determined. I would suggest that disposition always applies, and caution against having different approaches to "different" NC.

    On a different topic, I notice that the associate is often referred to....

    - Operator fail to follow procedures.
    - Lack of competence.
    - People fails at filling out records, etc.


    It is a frequent problem in industry, where the associate is defined as a cause. This is inherently wrong (and possibly not what you are inferring. If you are not inferring this, then please accept my apology) and removes the focus from where it belongs...leadership. Poor associate performance/behavior begs us to examine the vetting process, the training process, the associate development process, etc... Please consider this as well.

    Hope this helps.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I don't agree! I agree that an NC is an NC, and as with product NCs, many times they are "fixed" - i.e. repaired/replaced etc., that is corrected. For QMS ncs they can have correction too. Corrective action in response to NCs is an external view of the QMS and isn't always applicable.
     
    Last edited: Jul 8, 2017
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  5. Qualmx

    Qualmx Well-Known Member

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    Thank to all
    But Andy,what about what format to use for those ncs, which are not product? What is better ,the ncr or the car format?
     
  6. MCW8888

    MCW8888 Well-Known Member

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    The better format, from my point of view, is the Internal Audit Corrective Action format.
     
  7. Qualmx

    Qualmx Well-Known Member

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    Thanks mcw8888, I have just one format for all the Corrective actions (internal and external, for nonconformance reports,etc.
    is this format what you mean?
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why write a CAR when one isn't needed? All that needs to be reported is that there's been a non-conformity. If you go writing CARs, as I said before, this REQUIRES you to do a full blown corrective action - which isn't appropriate. This is where the external audit process has corrupted things - especially internal audits. We see it every day. CAR tracking burdened with piddly, nit-picky issues which should have been CORRECTED and NOT entered into a Corrective Action system. We also see a lack of management support because we keep forcing them to do too much when the simplest action would be just fine.

    Qualmx - why are you so worried about the "format"? Simply report what was found, who found it it, and deliver it to the process owner. We spend far too long worrying about forms and filling them out instead of telling management, in simple terms, why they need to take action (or have their people take the initiative)
     
  9. Qualmx

    Qualmx Well-Known Member

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    Thanks Andy
    Well, maybe I didnt explain it in detail.
    When I raise a CAR, I use my format,into it,there are two sections, one for correction and other for the full analysis (fishbone,8D).
    When the nc is minor,we just do a correction,when is major we develop the analysis to find the root cause.
    For correction,I only verify action was done,for full analysis,I check the effectiveness.
    Realy the root question is , for that type of ncs,what format is better,the Ncr format (product) or Car format.
    Thanks
    .
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I guess you can do what you want, but in my world, an NC is an NC. To complete a CAR then treat it like an NC and have it corrected is, IMHO, one of the many reasons why non-quality people get frustrated with the Quality people. We aren't consistent - or even appropriate - in our approach. Keep it simple.
     
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  11. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I once worked with an Environmental Engineer who insisted on having his own NC Tracking log, separate from the Internal Audit tracking system. He wanted to identify, address and follow through on small issues before they became big issues.

    I eventually became convinced and never changed my mind - he was right. I attached a version of the tracking log he used, with his permission, in the resources page. The intent is to stop the one-size-fits-all problem of typical NC applications and tools. By adding flexibility to the process (based on severity, response can be a 3W - who does what, when, 5Y - or some other type of root cause analysis, or an 8D - or some other type of project). The tool also takes note of areas having the most issues, counts types of issues etc. so you can learn from it.

    I hope this helps!
     
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  12. Qualmx

    Qualmx Well-Known Member

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    Thanks Jennifer,
    But the method (format/document) to raising the nc´s was only one ? NCR for everything (products, competence, people attitude) or were managed in several documents?
    Or some ncs required to ask a direct CAR?

    In my RAC format I consider corrections in two steps, one section is just for containment and other for full corrective action (fishbone,8d), so in anyway when I fiend NC´s, I raise the RAC for both.
    Could yoy please expain it?

    Thanks
     
  13. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The tool was meant to be adaptable to your needs. Categories (product preservation, product traceability, process design, communication, documentation, equipment, materials not available/incorrect etc) can be assigned, as well as types of issues (Competence, attitude, etc) in Root Cause type. As many as eight Root Cause types can be assigned.

    It is true the tool does not have templates for the 3W, fishbone method, 5Y method etc.). Should I include forms for that in the Tracking Log? As I recall the Tracking Log already has a form for a CA Project.

    The forms used are less important than we learn from our mistakes and improve processes so costly mistakes do not recur.
     
  14. Nick1

    Nick1 Member

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    Hi Qualmx,

    Why don't you just call them all NC's. An NC can be anything that is doesn't conform to something: be it the law, company policy or customer expectations.
    I always try to be as consistent with the NC's as possible and just apply some kind of identifier for the type of NC. You can create a bunch of type like: Product, System (not working according to the system), law you name it. With respect to the correction, you almost always perform a certain correction to fix it. Fix the product, tell the person to follow the procedure, and change the way you work to follow the low. On top of that you might perform a corrective action to prevent it from happing in the future: Change production process, training people, hire a specialist for the laws and regulations.

    You can just use NC's for all the incidents/issues as long as you use some kind of identifier to make it easier for yourself to find a certain type.

    good luck
     
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  15. Qualmx

    Qualmx Well-Known Member

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    Thanks to all.

    Hey Nick, I agree with you, I think the most important thing, it is to detect it and report it.
    For that I use a document (format) with 2 sections, section 1 for product and services, I´ll register product NC´s, and applying dispositions like
    rework, scrap, etc.
    In section 2, I named System NC´s , in here, I register all the nc´s mentioned before (people, laws, lack of competence, etc)
    and normally the disposition is: modify documents, formats, give some training (correction).
    If I consider that nc´s from section1 and 2, deserve a Corrective action, then I raise a CAR
    Because my original format for the product NC´s. cover only 8.3, then I modified in order to cover ncs´s from all the sources.
    That way I use same format and dont create a new one for that.
    By the way, the addressing of the special nc´s, where clause do they fall in? I suppose in 8.5.2 (9001 2008), compared
    to 8.3 which covers non conformance product.

    Thanks for your time
     

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