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Application of Clause 8.3 Design and Development to the Wholesale Trade

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Pyrules, Mar 23, 2016.

  1. Pyrules

    Pyrules New Member

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    Dear All,

    We are involved in the wholesale trade.

    Our operating process basically involves the following:

    Customer Enquiry > Quotation to Customer > Acceptance of Quotation > Purchasing > Packing > Delivery

    We would like to enquire if Clause 8.3 Design and Development of the new ISO 9001:2015 is applicable to the above activities and to the wholesale trade in general?

    Many thanks in advance for the valuable comments and insights.

    Thanks & Regards
    pyrules
     
  2. James A Shell

    James A Shell Member

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    You are a "stockist" if you were in the aerospace world. You may have some minimal configuration activity like packaging and labeling but you pretty much just send the customers what they want. You have no responsibility for downstream performance or functionality.

    In my opinion you don't design the product.

    You may however be designing a service. If you have a customer agreement that calls for repackaging, or inventory control services or other supply chain activities you are "developing" a service package that meets customer requirements which are established by agreement and may have to be validated somehow.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If you do not own the specifications of the product you sell, then you may exclude the design and development requirements from your QMS.
     
  4. Pyrules

    Pyrules New Member

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    Dear James & Andy, many thanks for your replies and insight on the applicability of this clause to our operations. We will take note and proceed accordingly.
     
  5. James A Shell

    James A Shell Member

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    I can actually think of a couple of cases where an overreaching auditor may give you some grief. This would be in a case where you are handling some material like adhesive or goop of some type that are perishable in some way. The same may be said for medical supplies, or other items that are storage sensitive.

    If your agreement with a customer tells you "store these materials in accordance with manufacturers recommendations" then you are completely off the hook. They are taking responsibility for determining the storage conditions so as to preserve functionality. Same as if they said "store between 50 and 90 F. You would have to provide objective evidence that you did what they told you but you have no design responsibility whatsoever since they determined the conditions.

    But if your agreement says " store so as to prevent deterioration" you may be vulnerable because you determined the storage conditions and it might affect the functionality of the product.

    If the product is "sledgehammers" it is a different story than for something more technically complicated.

    To inoculate a distributor from liability, I have seen it put on the blanket terms of sale or in the order acknowledgement "materials are stored and shipped in standard warehouse conditions for this area and the buyer or manufacturer are responsible for all verification and validation activities" you are off the hook. You make it clear to a buyer what is going to happen and it is on them to determine if that is good enough.

    The business reason for any of this is to shift the liability of something going wrong to somewhere other than you. If there is a problem like corrosion or oxidation or static discharge or moisture or any of a dozen things, and there is some big field recall situation, someone may come back on you and say "you didn't store it properly" and then it would be up to you to convince a jury that you did.

    You will have to make that determination and avoid risk by passing the liability elsewhere if you feel like you need to.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Is this reality? For "off the shelf" products, such as adhesives etc, the customer of the distributor rarely (IME) states such stuff. In any case, we've deviated from the scope of the discussion, which is design and development in a wholesaler...
     
  7. tony s

    tony s Well-Known Member

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    In determining whether design and development requirements are applicable or not applicable to your products/services you may consider the following questions:
    1. who is/are your customer/s?
    2. what do they buy from you? products? services?
    3. who develops the product or service?
    4. who has the overall responsibility for setting and modifying the characteristics of the product or service?
    If the answer to questions 3 and 4 resulted to being your organization, them claim of non-applicability or exclusion is not permissible.
     
  8. Padym

    Padym Active Member

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    In my industry, we have the customer who provides the requirement of having their Intranet portal build on Microsoft Sharepoint platform. So the customer actually provides the idea of the design of how they would like to see their Internet page (like home, layout or ) and based on this our internal developer team develops the design of the page and eventually develops it with customer agreement.

    So please clarify in this scenario will the design and development clause applicable? Here the design already exist in customer thinking / mind and we understand that and build it.
     
  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It is one thing to conceptualize a portal, and quite another to construct it and make it function correctly, securely and smoothly. Certainly the first stage is to gather customer requirements and preferences. From there the customer does not know how to make it run. The customer might have no idea whether to use HTML, PHP, SQL etc. Developers have stages in which they take the customer's descriptions, make the portal, test the portal, have the customer test a beta version, perform further adjustments and then deploy. There are resources involved, validation, communication, records of changes, planned teamwork in many cases and final customer approval.
     
  10. tony s

    tony s Well-Known Member

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    If ISO 9000:2015 defines DESIGN AND DEVELOPMENT as "set of processes that transform requirements for an object into more detailed requirements for that object", I believe ISO 9001:2015 clause 8.3 is applicable to your organization.

    An OBJECT is defined as "entity; item; anything perceivable or conceivable" with examples like product, service, process, person, organization, system, resource and Note that: objects can be material, non-material or imagined.
     

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