Are manufacturing processes/procedures considered Design Output-ISO 13485

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BishDamo

#1
Hi all,
I'm trying to create an SOP for new product development and am having difficulty with one particular aspect. Prior to verifying the design, the design outputs will need to be documented (e.g. engineering prints), right? But do the manufacturing processes need to be specified at this stage/ are they part of the "design output" as well? Does it really matter how product for design verification is made, or is it enough to just provide evidence that product used for design verification conforms with the design prints? I'm really not gone on the idea of having to tie down (unproven/ unvalidated) manufacturing processes so early in the product development process.

I couldn't find any previous threads on this, so if anybody has any thoughts I'd really appreciate. I'm working to section 7.3 of ISO 13485, but assume its the same considerations as with ISO 9001.
Thanks,
Damien
 
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#2
Re: Are manufacturing processes/procedures considered Design Output

Hi all,
I'm trying to create an SOP for new product development and am having difficulty with one particular aspect. Prior to verifying the design, the design outputs will need to be documented (e.g. engineering prints), right? But do the manufacturing processes need to be specified at this stage/ are they part of the "design output" as well? Does it really matter how product for design verification is made, or is it enough to just provide evidence that product used for design verification conforms with the design prints? I'm really not gone on the idea of having to tie down (unproven/ unvalidated) manufacturing processes so early in the product development process.

I couldn't find any previous threads on this, so if anybody has any thoughts I'd really appreciate. I'm working to section 7.3 of ISO 13485, but assume its the same considerations as with ISO 9001.
Thanks,
Damien

Welcome to the Cove, Damien!

What you're asking is dependent on the type of development process your organization uses. Actually, it's also dependent on your organization's culture!

A conventional design process only considers the product design and not the manufacturing processes. Unfortuately, the design tends to be 'thrown over the wall' to Production and, unless the Designers are very experienced, all kinds of problems occur......

More 'enlightened' organizations use 'concurrent engineering' - what is known in the auto-industry as 'Advanced Product Quality Planning' - which requires that a cross-functional team colaborate and consider not only product but the manufacturing process - if you're familiar with the original Land Rover Discovery, it's a great example of concurrent engineering. indeed, often even Field service requirements are also designed in.

There are many other tools that can be used, again dependent on your design process, including 'Design for Manufacturability', 'Design for Assembly' etc., etc. The concurrent process also has process validation steps, because it's cheaper to catch issues earlier rather than in production.

If you let us know what your current process steps include.
 
Last edited:

Ajit Basrur

Staff member
Admin
#3
Re: Are manufacturing processes/procedures considered Design Output

Hi all,
I'm trying to create an SOP for new product development and am having difficulty with one particular aspect. Prior to verifying the design, the design outputs will need to be documented (e.g. engineering prints), right? But do the manufacturing processes need to be specified at this stage/ are they part of the "design output" as well? Does it really matter how product for design verification is made, or is it enough to just provide evidence that product used for design verification conforms with the design prints? I'm really not gone on the idea of having to tie down (unproven/ unvalidated) manufacturing processes so early in the product development process.

I couldn't find any previous threads on this, so if anybody has any thoughts I'd really appreciate. I'm working to section 7.3 of ISO 13485, but assume its the same considerations as with ISO 9001.
Thanks,
Damien
Hi Damien,

If you are referring "Design Output" from ISO 13485 perspective, I would recommend you to refer ISO/TS 14969 - "Medical devices — Quality management systems — Guidance on the application of ISO 13485:2003"
 

harry

Super Moderator
#4
Re: Are manufacturing processes/procedures considered Design Output

There are many other tools that can be used, again dependent on your design process, including 'Design for Manufacurability', 'Design for Assembly' etc., etc. The concurrent process also has process validation steps, because it's cheaper to catch issues earlier rather than in production.
Andy had given a very good explanation on the above. In the construction industry, we called it design for 'buildability'. You will be surprised that many designs that come out of the Designers office are not economical to construct because that do not take into account materials, dimensions & sizes, etc available in the market and thus result in high wastages and poor economics. Regular meetings during the design stage (inputs & verification) will help to overcome these problems.
 
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Duke Okes

#5
Re: Are manufacturing processes/procedures considered Design Output

For ISO/TSD 16949 Design & Development (7.3) must be applied to both product design and process design. Design output would definitely apply to process documentation in this case.
 

Big Jim

Super Moderator
#6
Re: Are manufacturing processes/procedures considered Design Output

Under ISO it could go either way. It is very common to have engineering activity after the design that is strictly involved with how to make the product. In that case, it would not be part of design output.

It is also common to consider how something is to be made during design and in that case specifiec details about how to make it would be included as output to design. In these cases it is common to have detailed work instructions.
 
B

BishDamo

#7
Re: Are manufacturing processes/procedures considered Design Output

Under ISO it could go either way. It is very common to have engineering activity after the design that is strictly involved with how to make the product. In that case, it would not be part of design output.

It is also common to consider how something is to be made during design and in that case specifiec details about how to make it would be included as output to design. In these cases it is common to have detailed work instructions.
Thanks all - I looked up TR14969 and it also points to the benefits of design for manufacture/buildability. However, a concurrent engineering approach isn't really affordable for a small start-up like ours. I do understand that this is what we should be doing and would be cheaper & better in the long-run, but at the moment our very existence depends on our ability to obtain approval for the design. For us, getting approval for the design is such a priority, that final manufacture almost certainly will use different processes than for the original design verification.

Based on Jim's response, I'm wondering if it's acceptable to simply inspect design verification units to the design prints. If this would meet the requirements of 9001/13485, could anyone tell me how they would have done this in the past - 100% inspection or would you treat it similar to a first-article? Obviously I'd have traceability on how we built the units here, but I'd prefer not to have to consider the manufacturing process/procedures as part of the "design" (because then changes to these procedures would have to be treated as potential design changes).
 
#8
Re: Are manufacturing processes/procedures considered Design Output

I'm interested to know what data you are using to back your claim that you can't afford to do concurrent engineering?

My experience in the Design function tells me that you can't afford not to do this! Do you know how much time/effort is expended working on changes to designs that the customer isn't paying for? Especially those design changes requested by the supplier or manufacturing folks? I believe that if you look hard enough you'll find a story other than what you're thinking is true.
 
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JaneB

#9
Re: Are manufacturing processes/procedures considered Design Output

Do you know how much time/effort is expended working on changes to designs that the customer isn't paying for?
Oh so very, very true.

Not something that anyone can afford to ignore!

I'm sure it's just one of the reasons that 7.3 talks about design and development (not just design) and has so many specific requirements, including the need to plan, and for review, including 'representatives of functions concerned'.

A design can be lovely - and completely impractical.

I remember one architect-designed gorgeous building... which had all the electrical power sockets designed as being installed into glass windows. Totally, utterly impossible, and caused no end of difficulty at the build stage!
 
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BishDamo

#10
Re: Are manufacturing processes/procedures considered Design Output

Thanks everyone for the input. I'm well sold on to the benefits of concurrent engineering/ DFM. I also found the attached very convincing in making up my mind on this - see last paragraph in point #20, page 8.
 

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