Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

That old chestnut that is 8.3 Design & Development

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Steve Morris, Apr 14, 2021.

  1. Steve Morris

    Steve Morris Member

    Joined:
    Apr 14, 2021
    Messages:
    5
    Likes Received:
    3
    Trophy Points:
    2
    Hi all,

    Having searched various forums etc, and not finding a definitive answer, I though a quick post here might help in my quest!

    We are a distributor of comercial products, such as adhesives, sealants, tapes and 'O' rings into industrial customers. We successfully transitioned to ISO9001:2015 in 2019, however at our most recent surveillance audit, it was pointed out that our claimed exclusion from clause 8.3 was no longer valid, as we must have some design input into the service we offer.

    I am struggling to see how I can appease the auditor/certification body and include 8.3 somehow into the QMS. Basically, we purchase product from the manufacturer(s), which is to their specification and sell on to our customers against their purchase order. The only other process that we sometimes carry out is to repack the material (adhesive/sealants) into smaller containers.

    I would appreciate any guidance on this matter to help me resolve this problem.

    Steve
     
  2. Rustle

    Rustle Member

    Joined:
    Jun 23, 2020
    Messages:
    29
    Likes Received:
    4
    Trophy Points:
    2
    Location:
    Scotchland
    Hi Steve, your auditor might just be picking up on your use of the word 'exclusion' as you should now be stating it is 'not applicable'. I'm guessing you are in the UK where a number of CB's now appear to not accept that design can be excluded. You can argue with the auditor (I think you're correct, design isn't applicable) or simply include a very short overview of how you manage design to keep them happy.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    4,149
    Likes Received:
    2,099
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Clearly, the individual CB auditor is incompetent.
    You don't. What I'd offer you is that a) you should not engage with the (incompetent) audit. b) you should write and complain to the CB about the lack of competency of their audit and tell them you don't want them to return, ever and c) that you are considering withholding payment for the audit based on the auditor being incompetent! (OK so the last is not going to happen).

    Depending on the outcome of a) above, you can move your certification, without charge, to a more in-control CB who takes care to avoid such basic silliness as this.
     
  4. Steve Morris

    Steve Morris Member

    Joined:
    Apr 14, 2021
    Messages:
    5
    Likes Received:
    3
    Trophy Points:
    2
    Thanks for the replies.

    You are correct, the company is in the UK. A little more information about the problem.

    We have been fortunate to have the same auditor for a number of years, who has always been fair in his audits. The CB, who he works for was taken over by a larger organisation 2 years ago and it is this 'new' CB that has instructed their auditors to raise the issue of 8.3 not (in their eyes) being met.

    I am loathed to simply produce a procedure on what I think is a misreading of the ISO clause. Mind you, I don't think ISO have helped in leaving this open to interpretation.
     
  5. Miner

    Miner Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    437
    Likes Received:
    332
    Trophy Points:
    62
    Location:
    Greater Milwaukee USA
    I completely agree with the previous responses, but want to ask a clarifying question that might change perspectives. Do your customers always order a specific SKU (catalog number) that you then provide to them, or do you ever recommend a product based on your customers' needs? The latter scenario could be construed as providing some design input.
     
  6. Steve Morris

    Steve Morris Member

    Joined:
    Apr 14, 2021
    Messages:
    5
    Likes Received:
    3
    Trophy Points:
    2
    Hi @Miner That's an interesting point as we have advised on the suitability of a product for a particular use, however, I would have thought that was covered by our Product Realisation process flow chart and have never considered it as having design implications for us.

    However, as always I stand to be corrected and learn from others
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    4,149
    Likes Received:
    2,099
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Steve: As a "veteran" of the Certification World for some 30 years (LRQA and NQA etc) distributors have never been subject to the design requirements. The clue - if these hapless auditors had half a brain cell to muster into life - is the wording in your contractual agreements with your customers. Is the word "design" ever in an RFQ or PO? I'll go out on a limb here and say "NO".

    Similarly, if the auditor understood the reason why the "4. Context of the Organization" was added to the standard, specifically the "needs and expectations of interested parties", the function of design would have been discussed and become the foundation of the scope (also section 4). The ONLY place in my experience of when you provide technical support to clients on the application or appropriateness of a product you supply, is in the sales-related processes. And they aren't "design" the way the standard applies it.

    If your CB's management don't understand this - and they clearly don't - I'd be pulling my cert and heading for one which does!
     
    Last edited: Apr 14, 2021
    John C. Abnet and tony s like this.
  8. Steve Morris

    Steve Morris Member

    Joined:
    Apr 14, 2021
    Messages:
    5
    Likes Received:
    3
    Trophy Points:
    2
    Andy,
    I appreciate your input as a veteran and actually used your posts for inspiration when working towards the transition to 9001:2015 with COTO being one success after creating a COTO log which is in effect an exercise in FMEA.

    I started developing management systems in 1996 when working with a tier 1 automotive supplier who was 'ordered' to get certification to ISO14001. I actually didn't have any QM responsibility apart from auditing until 2012 when circumstances 'colluded' against me .

    So, I am still learning and really appreciate people like yourself who take the time to support others.

    The next audit isn't until November so I might use the time to arm myself with the argument against and see what happens then.
     
    Andy Nichols likes this.
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    4,149
    Likes Received:
    2,099
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Many thanks! It's a pleasure.
    As much as I like the thought of this - I couldn't in all sincerity counsel you to adopt the approach. Might I suggest it would be fruitful to research CB options, review which ones Certify competitors or similar stockists (a thought might be to look at who certifies to AS6081 which is specifically FOR distributors) and review resumes and even interview around this topic of scope... By the next audit, it should be plain sailing.
     
  10. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,242
    Likes Received:
    936
    Trophy Points:
    112
    Location:
    Laguna Philippines
    Your product/service is what the customers buy from you. They only buy the products that you bought from the manufacturers who are the one responsible for the products design. If you repack the products into smaller containers, you are not transforming the products.

    According to the Auditing Practices Group Guidance (which CB auditors should follow):

    "Product and service design and development is the set of processes for transforming requirements for the products and services (for example specifications, statutory requirements and specific or implied customer requirements) into specified product/ service characteristics (“distinguishing features of the product”)".

    As a distributor, you don't transform the products. The repacking is just a process in your organization to organize your shipment to your customers as per your customers' purchase order. On the same APG Guidance, this statement is specified:

    "ISO 9001 clause 8.3 refers only to design and development of products and services. In some organizations it can be beneficial, but not required, to apply the same methodology to design and development of processes".

    I hope this can help in arming your organization for the November surveillance. See link about the APG Guidance.
     
    John C. Abnet likes this.
  11. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    548
    Likes Received:
    389
    Trophy Points:
    62
    Location:
    Upper Midwest- USA
    Good day @Rustle ;
    I respectfully, strongly disagree. This is a slippery slope and only serves to pollute the management system with erroneous documentation and/or verbiage, which frustrates and confuses the organization. Remember, it is not solely @Steve Morris 's management system. It is a management system for the organization, which includes the individuals that don't even yet work there. The teams see right through "fluff" and things that are simply an attempt to "tick a box".

    As you/all have seen me council here numerous times...."never do anything for the auditor. Do ONLY what benefits the organization, and then do it in a manner which meets the requirements of the standard".

    Hope this helps...

    Be well.
     
    Andy Nichols likes this.
  12. Rustle

    Rustle Member

    Joined:
    Jun 23, 2020
    Messages:
    29
    Likes Received:
    4
    Trophy Points:
    2
    Location:
    Scotchland
    I would suggest spending 10 minutes documenting how design is managed isn't an erroneous act and would benefit the organisation if it saves spending hours responding to non-conformances raised because they are not meeting the requirements of the standard
     
  13. NISHITH NEEMA

    NISHITH NEEMA Member

    Joined:
    Sep 15, 2020
    Messages:
    15
    Likes Received:
    2
    Trophy Points:
    2
    I am struggling to see how I can appease the auditor/certification body and include 8.3 somehow into the QMS. Basically, we purchase product from the manufacturer(s), which is to their specification and sell on to our customers against their purchase order. The only other process that we sometimes carry out is to repack the material (adhesive/sealants) into smaller containers.

    This a matter of defining the scope of audit before certification
    To start, there are three considerations to be included when determining the scope:
    1. External and internal issues that are relevant to the purpose of the organization, the strategic direction, and the ability to achieve intended results.
    2. Requirements of relevant interested parties.The product and service of the organization
    3. In addition, the scope is to include any requirements of the ISO 9001 standard that can be applied, and if a requirement is determined to not apply, the organization will not use this as a reason for not ensuring conformity of product and service. The scope is to state the products and services covered by the QMS, and justification for any instances where the ISO 9001 standard cannot be applied.
    You can go ahead with this this.
    Best wishes
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    4,149
    Likes Received:
    2,099
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    If only it were that simple. What happens when the actual CB management don't understand when "design" should appear in the scope? How about the IAF-member accredited CB which insists a tool making company is design responsible, maintains that company's certification with the word "design" in the scope, yet the QMS has no design process, they don't implement any of the 8.3 requirements, there are no designers on staff and the customers' contracts never mentioned doing design work as a line item?
     
  15. NISHITH NEEMA

    NISHITH NEEMA Member

    Joined:
    Sep 15, 2020
    Messages:
    15
    Likes Received:
    2
    Trophy Points:
    2
    Thanks Mr. Andy for clarification.
    The engineering design process is a common series of steps that engineers use in creating functional products and processes, The engineering design process is a common series of steps that engineers use in creating functional products and processes. So it is possible that a tool making company has out sourced its design function and it reverts back for any modification etc. and provide customer satisfaction.
    The organization can only decide that a requirement is not applicable if its decision will not affect its ability or responsibility to ensure the conformity of products and services and the enhancement of customer satisfaction.
     
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    4,149
    Likes Received:
    2,099
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Once again, if only it were that simple. There are far too many CBs and their auditors who have practiced this decision making - often because they don't understand what "design" is, partly because the more processes IN scope, especially Design, the more they can charge for the audit.
     
    tony s likes this.
  17. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,242
    Likes Received:
    936
    Trophy Points:
    112
    Location:
    Laguna Philippines
    If your organization has been satisfying your customers and other interested parties with your products/services without the need to go through the controls mentioned in 8.3, then any CB auditor insisting the applicability of 8.3 doesn't understand the intention of the standard. The standard explicitly mentioned in clause 4.3:

    "Conformity to this International Standard may only be claimed if the requirements determined as not
    being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its
    products and services and the enhancement of customer satisfaction
    ".

    Does the organization of @Steve Morris and their customers/interested parties affected by the absence of the controls in 8.3?
     
  18. Leonid

    Leonid Well-Known Member

    Joined:
    Jan 4, 2016
    Messages:
    164
    Likes Received:
    30
    Trophy Points:
    27
    Location:
    Moscow
    @Steve Morris: Strength of the containers seems to be important for preservation of conformity of the materials during transportation. Are the containers just purchased somewhere or designed and fabricated by your company or outsourse?
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    4,149
    Likes Received:
    2,099
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Let's not overlook that the 8.3 requirements are for product, not the packaging it come in...
     
  20. Leonid

    Leonid Well-Known Member

    Joined:
    Jan 4, 2016
    Messages:
    164
    Likes Received:
    30
    Trophy Points:
    27
    Location:
    Moscow
    The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services (8.3.1).
    Subsequent provision of products shall preserve the outputs to the extent necessary to ensure conformity to requirements during transportation (8.5.4). If the organization fabricated the containers itself then the design activity per 8.3 should take place.
     

Share This Page