What constitutes design under 9001?

KarenA01

Involved In Discussions
#1
I am trying to understand what constitutes design under 9001.

We got 9001 certified with a design exclusion as we have been doing contract fermentations (no not beer! ;) )...

But now we are considering developing our own product where we clone an organism, ferment to produce an enzyme, partially purify it and sell it as technical grade...
We may only (but not necessarily?) sell it only to one customer that we do contract fermentations for.

Unlike what we do for contract manufacturing we would own the whole production process for this enzyme ( but this would not be a novel product or use novel technology and others already sell it commercially)

An argument has been made that since the target enzyme is a known commercial product produced by others, we would be manufacturing to specs already in the market place and it is not a novel enzyme , we are not doing development but rather only working out manufacturability, and so could keep our design exclusion...

Is that likely the case? We are a small company and don't want to slow down such development work.

We will also be going for 13485 (we can do contract manufacturing of biologics that could go into diagnostic kits and vaccines) but we would only be a "component" manufacturer providing crude product that get purified etc by customers that use it in those products. I am assuming that if we did a product of our own it would only be under 9001 and not 13485... I assume we could do that?


Thanks for any feedback

-Karen
 
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Sidney Vianna

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Leader
Admin
#3
But now we are considering developing our own product where we clone an organism, ferment to produce an enzyme, partially purify it and sell it as technical grade...
It seems that you answered your own question with this sentence. One can reach the same final product in a million different ways. If you are developing an unique path to reach the end product, you are designing it.

If you are really interested in a formal definition of the term design in the context of the ISO 9000 family of documents, you can find it at the ISO Online Browsing Platform. I copied the definition below.

Screenshot 2022-08-31 090715.png
 

KarenA01

Involved In Discussions
#4
Creating a new enzyme from scratch or changing the characteristics to meet a different need might be design
That's not what we are doing. I'm not a biologist but if I understand what is being proposed is that using standard DNA cloning technology to insert the genes to produce the enzyme into an organize which then can be gown to produce a lot of the target enzyme.

The enzyme to be produced is not novel and should have the same characteristics as that on the market now (which is produced basically the same way by other companies though some details may differ) ... all we would be doing is optimizing production and the purification.

As A chemist I would call that development but I have been told that it is manufacturability, not design (though I am unclear on the difference)

Thanks,
-Karen
 

KarenA01

Involved In Discussions
#5
It seems that you answered your own question with this sentence. One can reach the same final product in a million different ways. If you are developing an unique path to reach the end product, you are designing it.
As I said in post after yours we are basically planning to do the same way everybody else (and is in the literature)....

Personally I think of it as development, but upper management is hoping not to have to worry about design/development documentation under the standard... The person that would be in-charge of the development is a VERY freewheeling R&D type person who's documentation instincts and skills are not strong.

So if there is a way we can legitimately keep our design exclusion, the CEO will be significantly happier...

Thanks
-Karen
 

Sidney Vianna

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#6
So if there is a way we can legitimately keep our design exclusion, the CEO will be significantly happier...
Cutting to the chase. You just need to convince your certification body that such exclusion is justified. If they agree with you, voilà, mission accomplished. If they don’t agree with you, you can shop around for a CB that is more flexible and understanding. With hundreds of CB’s out there eager to sign new clients, there is no shortage of options.
 

KarenA01

Involved In Discussions
#7
Cutting to the chase. You just need to convince your certification body that such exclusion is justified. If they agree with you, voilà, mission accomplished.
I think we will need our consultant to do that... I'm am not a standards expert (heck I'm an R&D analytical chemist that got tossed into being the head (and now only person) in QA...

As i said I would call it development, and I'm not a great tap dancer or poltician !!!

BTW as a chemist I find things being so "squishy" about something major like this, that it depends on certification body or specific auditors a bit disconcerting... Who is to say the next auditor won't bring it up!

Thanks,
-Karen
 

Randy

Super Moderator
#8
Read the attached ISO document and maybe get a copy of ISO 9000:2015 to help (as Sidney said)...In this world we either are fed a meal of fish by people that feel sorry for us or we can learn to catch the fish ourselves and eat when we want.

Who is to say the next auditor won't bring it up!
Nobody can say for sure, everything is always subject to sampling and no 2 samples are ever the same...Ever!
 

Attachments

John Broomfield

Leader
Super Moderator
#9
I think we will need our consultant to do that... I'm am not a standards expert (heck I'm an R&D analytical chemist that got tossed into being the head (and now only person) in QA...

As i said I would call it development, and I'm not a great tap dancer or poltician !!!

BTW as a chemist I find things being so "squishy" about something major like this, that it depends on certification body or specific auditors a bit disconcerting... Who is to say the next auditor won't bring it up!

Thanks,
-Karen
Karen,

You and your colleagues need to defend your own system during the audit. Relying on your consultant to do this suggests your organization’s system is not ready for certification.

Don’t forget that you also design your service to satisfy your customer’s needs (needs are unspecified requirements BTW).

So, design is a process that translates customer/user needs into specified requirements for a service, product or a process.

Best wishes,

John
 

Al Rosen

Leader
Super Moderator
#10
That's not what we are doing. I'm not a biologist but if I understand what is being proposed is that using standard DNA cloning technology to insert the genes to produce the enzyme into an organize which then can be gown to produce a lot of the target enzyme.

The enzyme to be produced is not novel and should have the same characteristics as that on the market now (which is produced basically the same way by other companies though some details may differ) ... all we would be doing is optimizing production and the purification.

As A chemist I would call that development but I have been told that it is manufacturability, not design (though I am unclear on the difference)

Thanks,
-Karen
Sounds to me like process development, not product development.
 
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