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

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?

 

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.

 

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.

 

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

 

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.

 

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.

 

@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.

 

I suppose you can call that R&D... I call it product development, which is the whole point of Design control, no?

 

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.

 

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

 

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!

 

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 .

 

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