Design Review Checklist Format Example wanted

S

Sentinel

#1
I'm looking at introducing a Design Review Checklist into the Company. I want to keep it fairly simple.

Does anybody use these? Are they a good idea? Has anybody got a format I could look at to start me in the right direction please?

Any help much appreciated.

Thanks
 
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yodon

Staff member
Super Moderator
#3
Re: Design Review Checklist

At a very generic level, you would confirm things like:

* Does the design fully 'consume' the requirements?
* Is the design verifiable?
* Is the design unambiguous?

Going too much further, I think you need to get into the design specifics (hardware, software, etc.).
 
G

Groo3

#4
Oh ya, but we don't like to do these in a simple way :notme:. Our R&D group is offsite; they use a Microsoft Project template to take a marketing concept and review the feasability (lab trials that basically cover ISO 9001 requirements for 7.3.1 through 7.3.3, and where appropriate, 7.3.7), they also work with a phase-gate software to provide appropriate information for the gate-keepers.
Note - SteveK's D&D flow-chart is comparable to an abbreviated version of our R&D's Microsoft Project template.​

Once the R&D feasability is established, our corporate R&D management (one of the gate-keepers) reviews and determines whether or not to proceed with further development. If the green light is given to proceed, our site will become involved in the process at the scale up phase (pilot plant runs are done on a small scale, this basically covers 7.3.4 + 7.3.5, and where appropriate, 7.3.7), this phase is where we verify the design concept and complete site design review checklists... Once checklists are completed and another gate-approval made, we validate (7.3.6) in full scale production. After that is the final handoff from R&D to the site. After final handoff, 7.3.7 is managed via our management of change process.​


As for the content on your checklists, these will depend on the complexity of your site and products, as well as the departments that have a stake in your manufacturing?
  • Procurement? are there established suppliers? or do new suppliers need to be qualified? are they capable of supplying the material / quality needed? what about c of a's / samples / MSDS's, etc.​
  • Finance? how much will it cost to make the intended product? how much are the raws? do we require safety stock? etc.​
  • Quality? are target specifications established for the intended product? what about technical data sheets for the intended product?​
  • IT (computer)? are all electronic systems updated to allow the manufacture of the product? at each stage of the process? are unique product codes established? etc.​
  • Manufacturing? is the needed equipment already in place to make the intended product? is the process capable?​
  • Lab? are test methods established for the products / raws? are specifications available? what is the test method capability?​
  • Maintenance / Engineering? is new equipment involved? are appropriate controls available for the equipment? etc.​
  • EHS? What are the hazards / potential risks associated with the intended product? raw materials? process? Are MSDS's available for the products / raws? etc.​
  • Personnel? Will training need to be provided? probably if it is a new process, probably not if it is similar to existing processes...​
I would like to keep our process fairly simple too, but for us, the other departments involved in the process seem to keep adding items to the checklists... :2cents:
 
S

Sentinel

#5
Thanks very much for the responses. I now have some ideas on putting a checklist together.
 
S

Sentinel

#7
Thanks shocked.

Looks like a good form that could be tweaked to suit our business. A good front end document to enable a decision to be made as to the feasibility of a new product.
 
A

alexfeile318 - 2010

#8
Re: Design Review Checklist

Hi Sentinal,

Not got a check list but do have a D & D Flow Chart (attached) which may help. Obviously it referes to my documentation/references.

Steve
Hi, steve,

I took a look at your flow chart.

I wonder if the whole product development process shall be cut into several phases. And I find there is no apperant design input in your flow chart, which i think is against regulation.

If you have time, i'd like to disscus this with you in details.

Alex:D
 

SteveK

Trusted Information Resource
#9
Re: Design Review Checklist

Hi, steve,

I took a look at your flow chart.

I wonder if the whole product development process shall be cut into several phases. And I find there is no apparent design input in your flow chart, which i think is against regulation.

If you have time, I'd like to discuss this with you in details.

Alex:D
Hi Alex,

The design and development SOP covers all the design phases i.e.

Product realization
Assessment
Planning
D & D Inputs
D & D outputs
D & D review
D & D V & V
etc

So they all have to be covered - so it is basically a tick box exercise within a tick box chart.

Thanks for the concern. It has been tested out by a recent Technical File submission for a product (substantial) variant to our NB which was accepted.

Steve
 
K

kalyani.tanu

#10
Re: Design Plan format example wanted

Hi,
I want to prepare a design plan for medical device equipment design & development

Kalyani
 
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