Design and Development Process - Does one size fit all?

O

orangeisenergy

#1
Hello Covers,
I am tasked with updating our D&D process to better reflect all the different ways that we can do D&D activities. We currently have a "one size fits all" process, which is too robust for most of our activities. We manufacture IVDD tests. Some of these are for clinical, but most are veterinary or environmental. But we do all our activities to the ISO standard (for clinical). Many of our new tests are variations of our current tests, but according to our current process, they have to follow all the steps of our D&D process. I would like to edit our process to allow for a less paperwork intensive D&D process for a variation on a current product (i.e. use the groundwork of the base product, and carry out product specific testing and validation - but the design groundwork is already there from the similar product), but can't figure out how to get this across properly, or if it is appropriate. Have any of you done or seen a D&D process in this manner?
Also with our ISO 13485 certified QMS, could we do things differently for our products not covered under our ISO certification scope (i.e. veterinary & environmental products)-i.e. simplify process for this division of products - as long as it is clearly defined in our QMS?

I appreciate the feedback!
 
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dsanabria

Quite Involved in Discussions
#2
Hello Covers,
I am tasked with updating our D&D process to better reflect all the different ways that we can do D&D activities. We currently have a "one size fits all" process, which is too robust for most of our activities. We manufacture IVDD tests. Some of these are for clinical, but most are veterinary or environmental. But we do all our activities to the ISO standard (for clinical). Many of our new tests are variations of our current tests, but according to our current process, they have to follow all the steps of our D&D process. I would like to edit our process to allow for a less paperwork intensive D&D process for a variation on a current product (i.e. use the groundwork of the base product, and carry out product specific testing and validation - but the design groundwork is already there from the similar product), but can't figure out how to get this across properly, or if it is appropriate. Have any of you done or seen a D&D process in this manner?
Also with our ISO 13485 certified QMS, could we do things differently for our products not covered under our ISO certification scope (i.e. veterinary & environmental products)-i.e. simplify process for this division of products - as long as it is clearly defined in our QMS?

I appreciate the feedback!
So... your frustration is the engineering is following the established process?

Why would you like to take a short cut and and short change the process....

confused:confused::nope::confused::nope:
 

pkost

Trusted Information Resource
#3
Why would you like to take a short cut and and short change the process....

confused
sounds entirely reasonable to me - the quality system is there to support the business, not constrain and bind it with artificial requirements that bring little benefit.

If there is a perception that the work is unnecessary there is a very real risk that the people following the procedure will become disheartened and either work less effectively or start to ignore procedures.

If the part of the work has already been completed why should it be started on again? On the face of it, it would appear sensible to enable existing data and documentation to be used if it is relevant and if the approach is compliant with regulations

It sounds like OP has seen an opportunity to improve the system; provided it is properly evaluated by all relevant stakeholders I can't see any issue
 

somashekar

Staff member
Super Moderator
#4
13485 or plain 9001., the steps of D&D process are same.
Planning >> Inputs >> Outputs >> Review >> Verification >> Validation >> Change control.
Learning and outputs from earlier designs or similar designs are a great inputs to the D&D process. Your D&D procedure (documented since 13485) can be such that it fits all your D&D needs.
 

yodon

Staff member
Super Moderator
#5
If I understand, you have a "core" system which is fully documented. You want to essentially create a variant of this system. Much of the original documentation is still appropriate.

Presuming everything is in Doc Control (and properly controlled), there shouldn't be any reason you can't reference the baseline set in the variant. You should be able to fully specify / document the variant system through a combination of referencing the baseline materials + the variant-specific materials.

You could have a pretty simple Development Plan for the variant system that structures this approach.

The only thing I could think of that might hinder this would be if different customers were involved; i.e., customer 1 pays for the baseline system and customer 2 wants the variant. Customer 1 probably wouldn't be too happy to learn they paid for the bulk of the work on customer 2's product.
 

kreid

Involved In Discussions
#6
I agree with Yodon

You can legitimately tailor your processes, and there are various ways of doing so:
  • Describe the differences if approach in a project/product plan
  • You could have a QMS document that details the differences in approach for each type of product
  • Create markers in your processes - e.g. after each paragraph have something like (A, B, C) - this means that the paragraph applies to all three types of product. You would use a key to explain what this means.
 
O

orangeisenergy

#7
So... your frustration is the engineering is following the established process?

Why would you like to take a short cut and and short change the process....

confused:confused::nope::confused::nope:
:cool: Well the problem is that the D&D department doesn't follow the currently written procedure- hence the nonconformance that spurred a CA, which is why I am evaluating our process. They say they don't follow it because it is confusing and "too much work" and "unnecessary" as they see it. And as a newly hired QMS Manager, I agree that it is confusing, cumbersome and overly indepth for the simple products we make (for the most part).
Another issue is that we make things other than medical devices, and D&D activities are centered on these other products. So, D&D argues that since what they are designing isn't even a medical device, so they shouldn't have to follow that procedure based on 13485 (specific standard for medical device manufacturing). My rebuttal is that we have to comply to our QMS in all that we do, as it is our QMS that gets ISO13485 certified. This is another reason I would like to update the process, and what Yodon & Kried said makes sense to me. Also, we do very little D&D to customer specifications, so hopefully won't have the issue Yodon mentioned.

To re-ask the 2nd part of my original question: "With our ISO 13485 certified QMS, could we do things differently for our products not covered under our ISO certification scope (i.e. veterinary & environmental products, or other ancillary equipment)-i.e. simplify process for this division of products - as long as it is clearly defined in our QMS?" aka, what if I write a D&D process specifically for products that are not medical devices - not even close to medical devices- and it doesn't comply with 13485, would that be okay?? Feel free to rip me a new one for thinking this... :popcorn:
 

somashekar

Staff member
Super Moderator
#8
Have you got the ISO 9001 certificate from your CB who have issued you the ISO 13485 ?
Ask them for your ISO 9001 certificate as well.
Your procedure can detail how you handle medical devices D&D and other products D&D within your procedure.
Giving all freedom to your D&D department, define with them what stages constitute your stages of D&D and determine what such records that will constitute D&D records.
 

John Broomfield

Staff member
Super Moderator
#9
:cool: Well the problem is that the D&D department doesn't follow the currently written procedure- hence the nonconformance that spurred a CA, which is why I am evaluating our process. They say they don't follow it because it is confusing and "too much work" and "unnecessary" as they see it. And as a newly hired QMS Manager, I agree that it is confusing, cumbersome and overly indepth for the simple products we make (for the most part).
Another issue is that we make things other than medical devices, and D&D activities are centered on these other products. So, D&D argues that since what they are designing isn't even a medical device, so they shouldn't have to follow that procedure based on 13485 (specific standard for medical device manufacturing). My rebuttal is that we have to comply to our QMS in all that we do, as it is our QMS that gets ISO13485 certified. This is another reason I would like to update the process, and what Yodon & Kried said makes sense to me. Also, we do very little D&D to customer specifications, so hopefully won't have the issue Yodon mentioned.

To re-ask the 2nd part of my original question: "With our ISO 13485 certified QMS, could we do things differently for our products not covered under our ISO certification scope (i.e. veterinary & environmental products, or other ancillary equipment)-i.e. simplify process for this division of products - as long as it is clearly defined in our QMS?" aka, what if I write a D&D process specifically for products that are not medical devices - not even close to medical devices- and it doesn't comply with 13485, would that be okay?? Feel free to rip me a new one for thinking this... :popcorn:
orangeisenergy,

From what you say your project team is failing to plan per 7.1 before designing per 7.3. Both management system standards provide for getting the design process and its procedures right before you use them.

Pushing all designs through the same boiler plate procedures without regard for the complexity of the product or process being designed would probably be a nonconformity to clause 7.1.

Realizing this and with your organization's desire for continual learning and improvement you probably design and develop several processss for the design of your services, products and processes. And you'll probably have a choice of two or three design procedures for each new or modified product.

Writing an all encompassing set of design procedures and calling this the design process to follow seems to have gotten you where you now find yourself. Naturally, you'd engage the design teams in determining what their suite of design procedures should require them to do to control their design processes.

Also, please remind them, process is the work itself and procedure is the way the work is carried out.

John
 
O

orangeisenergy

#10
Have you got the ISO 9001 certificate from your CB who have issued you the ISO 13485 ?
Ask them for your ISO 9001 certificate as well.
Your procedure can detail how you handle medical devices D&D and other products D&D within your procedure.
Giving all freedom to your D&D department, define with them what stages constitute your stages of D&D and determine what such records that will constitute D&D records.
I was under the impression that getting ISO 9001 (even though we have ISO 13485) would cost extra money and extra audit time. Am I mistaken?
 
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