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.

Does Section 8 (Operation) apply to self funded R&D and Product Development?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by xrat86, Oct 6, 2020.

  1. xrat86

    xrat86 Member

    Joined:
    Mar 31, 2017
    Messages:
    32
    Likes Received:
    5
    Trophy Points:
    7
    Greetings,
    RE: Applicability of Section 8 to internal R&D and self directed & funded Product Development?

    We are in the throws of a recertification audit and the topic of 'Product Development' came up. The auditor observed that we do not have the necessary (per section 8) evidence related to product development. We do have a robust process for the products that we delivery to our customers that are engineered to their specific requirements (Application Engineering). The auditor has no negative comment about that (yet...).

    Am I off my rocker to contend that Section 8 is N/A to self funded R&D and Product Development for the following -
    1. The effort(s) is/are entirely self directed and funded
    2. Section 8.2.3.1 states - "..shall conduct a review before committing to supply products and services to a customer.."
    2.1 - If we are at a low TRL, there is no commitment to provide; and therefore everything after this is N/A

    I do understand that at some point it all applies, maybe when we contract a third party test facility for testing (as is customary in this industry).

    Can i play in my sandbox until then?;)
     
  2. 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 @xrat86 ;
    Please help us (me) understand...


    1- What do you mean by "self directed and funded"?
    2- Is your organization design responsible?...(or does your organization simply deliver an output with a design that the customer controls?)
    3- You state that this is a "recertification audit". This begs the question....how has your organization handled this previously? (i.e. why is it just
    NOW a problem?)

    Thanks in advance for helping me understand the situation.
     
    xrat86 and Andy Nichols like this.
  3. Eric Twiname

    Eric Twiname Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    329
    Likes Received:
    230
    Trophy Points:
    42
    Location:
    Northeast USA
    Play in your sandbox, and cover it under design control by using very high level and all-encompassing language.

    Do you care if it is successful?
    Have you defined what "success" means?
    Do you care if it's just paying for stuff regardless of what the employees do? (like goofing off online instead of working)
    Do you care if a product ever results from this effort?

    Whether or not it is for a customer directly...you're still doing product development...so treat it that way...in the sandbox or not.
    If it's a 6month "can this even work?" feasibility project...call it that in your design control system and give a monthly update.
    If it isn't worth giving a monthly update...why are you spending money on it?

    My two cents...the approach above is cheaper and easier than trying to defend it to an auditor, win or lose. K.I.S.S.
     
    xrat86 likes this.
  4. xrat86

    xrat86 Member

    Joined:
    Mar 31, 2017
    Messages:
    32
    Likes Received:
    5
    Trophy Points:
    7
    1- What do you mean by "self directed and funded"? - Any effort(s) in this regard are funded by my company, NOT a customer. At best the effort is kicked off due to customers asking us "if we can" or "can you". We decide when and where to use our funds to develop items / products that we will then sell (or not) in the future.

    2- Is your organization design responsible?...(or does your organization simply deliver an output with a design that the customer controls?) Yes, we are design responsible. We meet customer requirements, with what are essentially industry accepted and proven bits (the main items provided), with ancillary / auxiliary items customer specific. The collection of 'proven bits' are the items that we would spend our money to develop. Think like maybe a tool box, we have all the standard 6 point sockets, 1/2" drive. They are industry standard, that is the main product. We can sell you a pink one with rubber coating, red one with flames. That is application engineering IMHO. My inquiry is referring to the development of 6 point sockets that are 1/4" drive to capture more market share. We decide whether or not to do that.

    3- You state that this is a "recertification audit". This begs the question....how has your organization handled this previously? (i.e. why is it just
    NOW a problem?) No auditor has pulled this thread before beyond our application engineering efforts
     
  5. 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
    Understood:
    Based on what / how I understand it, I do not see how any part of product design does not apply to your organization. Does your scope (4.3) show any exclusion? (not sure how your organization can site any exclusions since your organization is design responsible).
    I also see no reason why "self directed" and/or "self funded" would have any bearing on the decision (i.e. it does not have any bearing on the decision).

    Is there any part of the planning, inputs, controls, outputs of design and development that your organization is NOT wanting to control?
    I assume not. In other words, don't worry about what thread the auditor pulls or does not pull. Ensure that your organization and customer are properly protected by ensuring the aspects your organization is responsible for are properly addressed. I would assume your organization DOES already address these aspects, so be careful not to simply start writing additional procedures or requirements for your teams, but instead take a look at what is already done and then capture and/or ensure your organization takes credit for it.

    Hope this helps.
    Be well.
     
    xrat86 and Andy Nichols like this.
  6. Eric Twiname

    Eric Twiname Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    329
    Likes Received:
    230
    Trophy Points:
    42
    Location:
    Northeast USA
    Hoping not to step on John's toes...

    "We decide whether to do that."
    And you decided to do it.
    It's design you're doing...and belongs covered under design control.
     
    xrat86 likes this.
  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"
    R&D is, by definition, not product design as required by ISO 9001:2015 to be controlled. The nature of R&D is that it isn't a structured process. It's the input TO Design/Product Engineering & Development. Doesn't need to be in the scope of a QMS.
     
    xrat86 and John C. Abnet like this.
  8. 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
    @Andy Nichols is spot on.
    I was (am) speaking generically to '8.3 Design and development of products and services' and not necessarily to the unique aspects of R&D.

    Thanks Andy.
     
    xrat86 and Andy Nichols like this.
  9. Eric Twiname

    Eric Twiname Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    329
    Likes Received:
    230
    Trophy Points:
    42
    Location:
    Northeast USA
    I suppose you can call that R&D... I call it product development, which is the whole point of Design control, no?
     
    xrat86 likes this.
  10. 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"
    On re-reading this:

    "Recertification"? Do you mean after a number of years? Or did you JUST get certified? Whichever it is, the auditor is NOW making this comment? After issuing a certificate?

    What is your scope? I sense an auditor screw-up here. My previous comment may NOT be accurate. Typically, Research and Development are NOT in scope, per ISO 9001:2015. However, once a product/technology etc has been identified for proper (detailed) design and development and hence manufacturing and release to the market, ISO controls DO apply. What is described by the OP isn't "R&D" - regardless of who pays - that will be scope dependent...
     
    xrat86 likes this.
  11. xrat86

    xrat86 Member

    Joined:
    Mar 31, 2017
    Messages:
    32
    Likes Received:
    5
    Trophy Points:
    7
    Thanks everyone for your time and input.

    I mention that it is self funded due to the language in the standard, specifically 8.2.3.1 "..shall conduct a review before committing to supply products and services to a customer".
    Part of my hang up to fully digest this is the structure and numbering of the standard. I interpret it sequentially, so section 8.2.3.1 (in my eyes) is a prerequisite for the balance of the section. If i have no commitment and no (external) customer, then the section (and subsequent sections related to it) does not apply. I see that i may be too strict in that regard...

    Language and terminology may muddy the waters further. For us and using my socket example, determining the best grade of material, maybe forging process, coatings, etc we would consider R&D. They don't lead to a product directly, but help to identify technologies and processes that may be used.

    Lastly, yes we are being re certified, with a different more better registrar. Our previous one was negligent, in this and other areas. Caveat emptor.
     
  12. Eric Twiname

    Eric Twiname Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    329
    Likes Received:
    230
    Trophy Points:
    42
    Location:
    Northeast USA
    In my experience, this is one of the two 'mud-sources'...it's all in the terminology.

    I submit, though some may disagree, that the ONLY purpose for R&D in a for profit company is to develop and launch new products and services (including upgrading existing ones...upgrade = different = new).
    If it's "determining the best grade of material, maybe forging process, coatings, etc "...it is being done for the purpose of offering new products or services, else why are you spending money on it?

    That's my thinking behind my above statement that it belongs covered under 8.3.
    Perhaps you "consider" 8.3.2.a-j as required and decide that no documentation, no communication, no customer involvement, no specifically designed authority need be in place "Joe's smart, just let him fiddle with this in his spare time...he'll come to us if there's something to report". Fine, so be it...you've now covered the Design and development of products and services under 8.3...off you go.
    If, instead, you want more control of the project than that...8.3 walks through things to consider...

    Either way, I'd have a really hard time believing that R&D in a for profit enterprise is not "Design and Development", and would not contest a finding in that area. (Especially since it's so easy to just handle it under 8.3).
    HTH
     
    xrat86 likes this.
  13. 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"
    Yeah, a common problem with the standard. Don't read it like a book. ISO cares not which comes first - the chicken or the egg. That's why it's dangerous to read clauses in isolation. In section 4 it speaks to the ORGANIZATION determining the "sequence and interaction of the processes of the QMS". You get to decide chicken or egg. Design first, then customer contract or customer contract then design...(the requirements still play, regardless of any money changing hands
     
    Last edited: Oct 7, 2020
    John C. Abnet and xrat86 like this.
  14. xrat86

    xrat86 Member

    Joined:
    Mar 31, 2017
    Messages:
    32
    Likes Received:
    5
    Trophy Points:
    7
    Thought I would update all on this - we did get a minor NC for not having evidence that we are following the same processes for our development efforts as we do for our products that we do deliver (application engineering). We have a list of those efforts and some order to the chaos, but in the end we need to correct the linearity problem with our water fowl (LOL). I was ready to argue my points, proven moot based on the education I got here. Thanks again, you saved me from making a fool out of myself.

    Have a great weekend!
     
    Last edited: Oct 9, 2020
    Andy Nichols likes this.
  15. 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"
    Would you share what was written (exactly)? You don't HAVE to follow the SAME process... The NC may be invalid. An NC may be appropriate, but only if accurately worded.
     
  16. xrat86

    xrat86 Member

    Joined:
    Mar 31, 2017
    Messages:
    32
    Likes Received:
    5
    Trophy Points:
    7
    Apologizes for the delayed response, I was called out of the office for a business trip (one of the many hats I wear). Thanks for your interest in this.

    Specifically it was 8.2.4 – “The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, the requirements for products and services are changed”

    Objective Evidence – “Found no evidence of revision control or communication of changes when requirements for products and services were changed”

    This only applied to our R&D type efforts. Our Application Engineering that interfaces directly with the customer(s) is good to go here. We have already developed a solution for this, we have an Engineering Projects list that was very high level and not much info. We are expanding that to enable us to better communicate, especially requirements as mentioned above. The specific example that was most discussed was an interface between a mechanical and electrical system. The mechanical group had one type of bulkhead connector and the electrical group had another. Kind of a minor point I contended, but valid. In the end, I think the improvements will help us a company be more efficient and effective. The bonus is that it will make an auditor happy, assuming that is possible .
     
    Andy Nichols likes this.
  17. 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"
    I'd take this as a bit of a stretch, TBH. In R & D you don't HAVE a "product". But if you find benefit, have at it.
     
    xrat86 likes this.
  18. Eric Twiname

    Eric Twiname Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    329
    Likes Received:
    230
    Trophy Points:
    42
    Location:
    Northeast USA
    I'd have an issue with "revision control" in development...but doesn't the target of development evolve? (Always did in every project I've ever seen).

    Methinks that you likely have "communication of changes when requirements ___changed."
    Something like " The chrome plating should be 0.030" minimum, not the original 0.025" min."
    I'll bet you already communicate stuff like that...it's just that no evidence was shown to the auditor.

    I went through that kind of thing in my first "get audited"... I didn't know what the guy was asking for, so I didn't show it. I had it, it was simple... I just didn't know why he was asking for such an obvious thing and got confused.

    HTH
     

Share This Page