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7.4.1 - Purchasing process, difficulty with CAR

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Testbloke, Jun 23, 2016.

  1. Testbloke

    Testbloke New Member

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    I have a minor non-conformity under section 7.4.1, "The company shall ensure that purchased product conforms to specified purchase requirements"
    We build pretty much everything from scratch (raw materials), therefore all material purchased is off the shelf items. We are therefore taking the material with the manufactureres / suppliers stated specification and not forcing our specificatio on them.
    Orders can be placed through email, phone or credit card.
    I really appreciate advise on conforming to this clause ...
     
  2. hogheavenfarm

    hogheavenfarm Well-Known Member

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    Even off the shelf items like hardware may have specific requirements. If I order fasteners (screws) can they be aluminum? Stainless steel? What length? What head side or countersink? What we do here for these items is bring the PO (copy) to receiving and check the PO against the packing slip. We check off count, type, material, etc. and then stamp the PO "received", then I scan it into the job file. This confirms that our 'specifications' were met. The part may be entirely wrong, but if it is what we ordered, then conformance was made to the PO.
     
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  3. RoxaneB

    RoxaneB Moderator Staff Member

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    Hi, Testbloke...

    Are there components, items, and/or raw materials that you purchase which are critical to ensure what your organization creates conforms to the customer's requirements? Even if you're buying them off the shelf, you may require that they are certain colour or a specific type of material or a range of physical/chemical properties or delivered exactly when required because perhaps you're a just-in-time organization. From there, it's establishing processes that ensure purchased product actually conforms to these requirements (e.g., inspection, failure rates during production (although, this is a bit reactionary), etc.).

    For example, if you're using raw materials such as scrap steel, perhaps you'll want it to be of a certain size (i.e., nothing larger than a"xb") or you're buying a chemical component so you want certificates from your vendors stipulating that the material is of the composition you require.
     
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  4. Testbloke

    Testbloke New Member

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    Thank you for your advice. I have always previously worked in sub contract electronics so there always were customer specific requirements that would then be impressed upon suppliers. In this employment, we supply wedding albums and other products to professional photographers, therefore the judgement of what is good or not really has to be policed by oursleves. Previously we had all the T&C's as part of purchase orders which were physically printed and posted to suppliers. As we often source material using credit cards or over the phone from various suppliers this becomes tricky. I am wondering if I can use a supplier survey to poll all suppliers on an (annual?) basis rather than on a per purchase basis?
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    I'm not sure how a supplier survey would help in this particular area. If you're providing products to professional photographers, it really isn't only your criteria that determines pass/fail regarding items. You could ask your customers if the albums and other items are meeting their needs, beyond whatever alterations (if any) your organization does to them. That could help determine your criteria.
     
  6. tony s

    tony s Well-Known Member

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    Hi Testbloke. Can you provide the statement of nonconformity as noted down in the report?
     
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  7. Testbloke

    Testbloke New Member

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    Description
    No evidence could be presented which verified that suppliers are evaluated and selected using identified criteria
    Requirements
    Purchasing process The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).

    My submitted action plan taking some of the advice here is two fold :-
    1) Supplier surveys
    2) A new system to have a digital list of all open purchase orders at goods in which the person recieving the goods can then verify the correct material has been delivered against the purchase order. When he then closes the item on the new system this is then noted as acceptance as the material being approved against original order, if rejected this is also then noted and CAPA can be taken.
     
  8. tony s

    tony s Well-Known Member

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    7.4.1 requires an organization to have controls on: (1st) the purchased product and (2nd) the supplier. Since the "description" of the NC is about the absence of evidence on evaluation and selection of suppliers against specified criteria, the 2nd purchasing control is the auditor's concern.

    Controls for selection (could also be for evaluation) can include securing quotations from suppliers, perform some canvassing or comparative analysis using cost and delivery date as criteria. If the suppliers can provide swatches or sample materials, you can use them also as part of the quality criteria. If you have a regular supplier for a certain material, you may need ensure that they are consistently providing you the supplied products as per your set of criteria such as quality, cost and delivery. You may need to devise a simple monitoring form to record your supplier's performance for all the orders they have served for a given period (e.g. quarterly, semi-annually).

    I will not recommend you to initiate CAPA for every rejection on your orders. You can only do some correction such as replacement or return the supplied material.
     
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  9. James

    James Active Member

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    "No evidence could be presented which verified that suppliers are evaluated and selected using identified criteria"

    Is this the only written part of the actual non conformance? It sounds like the kind of thing we cover by having an Approved Vendor List. Although I may be over simplifying.
     
  10. Testbloke

    Testbloke New Member

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    For this actual non-conformance I think it could be covred by the approved vendor list however I amagine they will be digging deeper in this area during the full assessment so just trying to cover all the bases.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    An approved supplier list ISN'T indication of evaluation! That is HOW they got on the list (output), not the process of evaluation.
     
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  12. hogheavenfarm

    hogheavenfarm Well-Known Member

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    Our AVL is keyed to live inspection data from the supplier, so they are constantly 'evaluated' while they are supplying us. In addition, we schedule 'site visits' and PSI's to observe capability of some more critical suppliers. Making a list alone is not evidence of evaluation, as Andy points out, it is more in how the list is created and maintained. At any given time, I can tell you how a specific supplier is performing in terms of defects, percent of our product mix, OTD, and pull up the last site visit report as well as their quality system documentation and/or a current ISO cert. This info is available directly on the list for purchasing to view prior to ordered product.
     
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  13. James

    James Active Member

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    It looks to me like the wording of the NC is both the evaluation and the metrics for past performance. "...are evaluated and selected..."
     
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  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Suppose your raw material was wheat flour in a 5-pound bag. You purchase it from the corner grocery store.

    There may still be requirements besides this substance is finely ground wheat. Bleached or unbleached? Sifted or unsifted? Self rising flour or regular?

    Then you will probably want it to be free of clumps and insects, and to be available for purchase with reasonable shelf life remaining.

    These can all be evaluated under 7.4. The corner grocery store can be evaluated to reliably have plenty of shelf life left, bags not torn, and no moisture damage to their off-the-shelf product.

    So you see, we still have requirements and we expect them to be met upon purchase. Our job is to recognize those requirements and to recognize if our supplier is meeting our requirements. This can even be done with off-the-shelf materials.
     
  15. MCW8888

    MCW8888 Well-Known Member

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    Are there records of in-coming inspection of materials purchased (quantity, match the products vs requirement in PO).
     
  16. QualityNoob

    QualityNoob Member

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    My organization received a similar nonconformity during an audit. One fundamental question I have is whether I need to establish criteria for selection, evaluation and re-evaluation for ALL suppliers, or only those who supply a product or service that is subsequently incorporated into a product or service supplied by my organization, i.e. can I make a distinction between suppliers related to direct procurement and those related to indirect procurement?
     
  17. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    An example of indirect procurement: if you have an internal requirement that internally used office copy paper is to be (for example) 80 brightness or better and 25% or more recycled content, then you may have set yourself up for requirement to control the supplier in some way and ensure the paper meets the requirements. I would wonder why such strict requirements exist when they do not appear to be needed.

    Direct procurement is about that which gets incorporated into customer product. If you are producing printed materials and the customer requires the paper to be 80 brightness or better and 25% or more recycled content, then you once again have a need to control the supplier in some way and ensure the paper meets the requirements.

    One often-overlooked detail is critical services like calibration, and even maintenance performed on systems that maintain things like cleanliness controls. Services are often thought of as indirect procurement, but even though they are not physically incorporated into the product they can affect outcomes so the suppliers need to be controlled.
     
  18. QualityNoob

    QualityNoob Member

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    OK, so it sounds like you're saying that some but not all suppliers need to be taken into account when determining the criteria for selection, evaluation and re-evaluation, is that correct?
     
  19. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    That is correct. 7.4 is intended to protect the customer by regulating the raw materials and services that are used to produce product/services that conform to customer requirements.
     
  20. Raymond

    Raymond New Member

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    Hi hogheavenfarm,

    My company evaluate suppliers which raw materials and equipment are used to produce the product that conform to customer requirements.
    e.g product: bread, equipment: oven, I evaluate the supplier which sell the oven. Here is the thing I get confused, when I need to buy a temperature sensor for maintenance, the purchase department come up with several suppliers which meets with the specification, so, is it necessary to evaluate all these suppliers?
     

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