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Clarification of Section 8.4-Control of Externally Provided Processes

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by mojojojo78, Aug 15, 2022.

  1. mojojojo78

    mojojojo78 Member

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    Hello all,
    I just joined a couple weeks ago and introduced myself in the introductions. Here is my first question.
    It is in regards to section 8.4 - Control of externally provided processes, products and services.
    We buy some components for our product that are specifically made to our criteria, so it they technically can't be considered dock to stock. We do some sort of receiving inspection whether visually or actually measuring the components.
    Does section 8.4 state anywhere that the vendor needs to provide some sort of inspection report?
    8.4.2 C2 states that the organization shall take into consideration the effectiveness of the controls applied by the external provider. What exactly is that referring to?
    I have gone over section 8.4 multiple times and cannot find anything that says the vendor needs to provide anything. Its up to us the organization to make sure that the product conforms to our standards.
    Am I correct in my understanding or am I missing something.
    Thank you.
     
  2. Miner

    Miner Moderator Staff Member

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    No. You are correct. Your organization specifies the controls. If your supplier's controls are highly effective, you could go to dock to stock. If your supplier's controls are ineffective, then you need tighter internal controls to compensate. Bottom line, your organization decides what controls are required. The auditor should only check on whether these controls appear to be effective based on number of nonconformances and where they are found.
     
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  3. Qualmx

    Qualmx Well-Known Member

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    I dont see in the standard about some sort of inspection report.

    In 8.4.2 C2 here, it refers to an external providers evaluation, that is one type
    of control, other could be by mean of contracts, or Purchase orders.
     
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  4. mojojojo78

    mojojojo78 Member

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    Thanks Miner and Qualmx for the reply. I didn't see anything either in all of section 8.4 about any kind of inspection being required by an external provider.
    Am I also correct in the wording of the ISO where it says that the organization shall take into consideration... meaning that we don't need proof but that their is some type of control on their end? This could be in operating procedures or if they are ISO certified. Is that safe to assume?
     
    Last edited: Aug 15, 2022
  5. Miner

    Miner Moderator Staff Member

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    You do not need inspection reports if that is what you meant, but you should have evidence that they have controls in place. You could verify this by obtaining a copy of their control plan, performing an on-site or virtual audit, etc.
     
  6. mojojojo78

    mojojojo78 Member

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    That is what my understanding was Miner. Our quality manager is misunderstanding something.
    On a different note but same subject, section 8.5 is for the organizations manufacturing and services provided. Not any outside services. We make like 90% of the components in house and we do provide some services in regard to our product. So section 8.5 applies to us not any external providers because 8.4 applies to them. Is this correct?
     
  7. Miner

    Miner Moderator Staff Member

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    Yes. 8.4 applies to your suppliers, subcontractors, outside services, etc., and 8.5 applies to your organization.
     
  8. mojojojo78

    mojojojo78 Member

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    Thank you all. This is helping out a lot.
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agree with the above. If you go into a burger joint and order a burger, you can often get it made just the way you want it - type of cheese, onions, no pickle and so on. You don’t ask for an inspection report. Experience, however, shows that when ordering a breakfast sandwich from McDonalds, even when asking for, and confirming “no cheese”, the inspection ticket had “no cheese” on it but the sandwich HAD cheese in it. It will depend what you order and the supplier’s capability to meet that. I don’t order anything off their menu, and then I take out what I don’t want when I get it…
     
    Last edited: Aug 16, 2022
  10. tony s

    tony s Well-Known Member

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    Having an ISO certificate, even operating procedures, does not guarantee quality of the supplied products. The "proof of the pudding" can be demonstrated better by the results of the receiving inspection of your organization. The incoming quality of the supplied products can be compared against the committed or agreed upon outgoing quality.

    Clause 8.4.2 supports the principle of "relationship management". It gives some guidance on how much control should organizations exert for their external providers - hence the phrase "take into consideration". The amount of control should be commensurate with the effectiveness of the controls employed by the suppliers. Over-control can cause the operations to slow down if the acceptance criteria are too tight that could also turn-off first-rate suppliers. Under-control, on the other hand, will compromise the quality of the organization's products/services.
     
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  11. mojojojo78

    mojojojo78 Member

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    This is the issue we are running into now. Our quality manager is misinterpreting this entire section and wants all outside vendors to supply inspection reports. We have lost a few vendors because they did not want to comply. We do inspection when we receive parts from our vendors, so to myself and the receiving department it didn't make sense to require inspection from the vendor. It also causes parts to be late to our manufacturing or assembly departments. The items are put on hold till the inspection reports are received.
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why are you inspecting things? I’m inclined to agree with the QM. Maybe not the way they are approaching it - but inspecting stuff is adding cost and your suppliers should have inspected it before shipping to you. Why can’t they send their results?
    If you have lost suppliers over this issue, they were likely the wrong ones to deal with.

    Are the inspection reports part of the PO agreement? If not, why not?
     
  13. tony s

    tony s Well-Known Member

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    If I order a burger and specifically ask for "no cheese", I will not just bite it the moment it gets to my table. Control on the supplier depends on what an organization orders (as I read above). @mojojojo78 mentioned in the original post:
    It's just normal that some form of caveat emptor is applied. If suppliers can afford to lose their business with your organization, that doesn't mean they are no good suppliers.

    Sorting or 100% inspection is not as dependable as inspection by sampling. If you do sorting, then you're doing what you paid for the supplier to do. Sampling inspection can put more pressure to suppliers to ensure all the supplied products conform to the acceptance criteria. Strike a balance with your supplier. It would be beneficial to both your organization and your supplier if the supplier feels they work "with you" and not "for you".
     
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  14. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day all (and welcome @mojojojo78 .)

    I think we all may be overlooking the fact that @mojojojo78 never said their external providers (suppliers) are sending bad products or causing them problems. Lack of problems is in itself evidence that the organization did "...take into consideration the effectiveness of the controls..."

    IF receiving inspection is determined necessary to prevent bad product from being introduced, then that data tells your organization it needs to work with ('encourage';) ) their supplier to improve the process controls NOT to send inspection reports.

    Inspection is never a tenable , effective, cost effective solution. (I had a customer once that had an entire room of metal file cabinets FULL of supplier inspection reports. No, that customer did NOT review or respond to those reports....they just stored them. Senseless work for both them AND their suppliers).
    Remember, tasting the soup is NOT value added. Tasting the soup (or in @Andy Nichols analogy...the breakfast sandwich) is Cost of Quality.

    Problems caused by your suppliers? Help them/cause them to develop/improve their process.
    Team effort that will be time well spent investing in your product and supplier relationship.

    Get the process right and STOP. TASTING. THE. SOUP.

    Hope this helps.
    Be well.
     
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  15. mojojojo78

    mojojojo78 Member

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    Thanks for all the replies. Just to clarify, 99% of the time our parts are to spec. When we do get out of spec. parts we immediately work with our vendor to remedy the situation.
    We do inspection here because when we were first getting ISO certified, we were told that we had to do inspection at receiving.
    This is basically what happens here. Our QM basically told me that as long as we have the paperwork we are fine, even if it is incorrect. We have to have it because in our SOP's we state that. We are trying to change that because it has caused more problems than it is worth. But we are getting a lot of kick back from the QM.
    A lot of our vendors charge extra to send an inspection report.
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    we were told that we had to do inspection at receiving.

    All too common, sadly. Made worse by someone with responsibility not actually opening up the standard and reading what it requires!

    Figure out what its costing. Use that plus the overwhelming evidence of no quality issues (if its true) to show the VP Finance where you can save a cool mil. An inspector inspecting something and filling out a form must be worth $500-$1K a pop