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Product Design Project Checklist?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by RICHARD GALLAGHER, Dec 11, 2015.

  1. RICHARD GALLAGHER

    RICHARD GALLAGHER Member

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    Might anyone have sample templates for a robust project checklist for product design & release in a medical device manufacturing entity? Possibly something going thru the various stages thru final release?

    My present project site has a variety of disjointed checklists scattered throughout the existing protocols. We are planning on the introduction of a typical Control Plan format after their Pfmea. A good, inclusive staged "checklist" would be another good mechanism to foster a more standardized product design approach and level of review. We have a multi-facility development organization with Design resident at one location and Production Development at another. The present Engineering interfaces are less than well defined and have typically resulted in gaps along the project line. I hope to develop a detailed checklist of deliverables and interfaces to guide such product/project management.

    Any good ideas or sample checklists?
     
  2. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    I was never a "Checklist" fan so I tend to bury requirements in my procedures (my quirk). I model a phased (gated) design review where one phase builds on the next or can be independent of the other. This is extracted from my last review hence the words final or approved. Hope it gets the conversation going.


    1.1 For the Phase Review meeting at minimum the required information shall be:

    1.1.1 A Final use model on which the requirements and intended specifications are based

    1.1.2 A Finalized set of Product Requirements that the product was designed to meet.

    1.1.3 A Finalized set of Specifications that the product is required to meet

    1.1.4 Finalized BOM(s)

    1.1.5 An Approved 510K Authorization.

    1.1.6 Specifications of Commercial Off the Shelf (COTS) component anticipated for inclusion in the product

    1.1.7 A Validated Risk Management Assessment

    1.1.8 Validation documentation demonstrating the product works as intended

    1.1.9 Design Transfer Documentation​

    1.2 Other information may be developed for presentation at the review in order to better characterize the product if known. This may include:

    1.2.1 Current Market Review

    1.2.2 Preliminary costing estimates and Sales estimates

    1.2.3 A Post Market Surveillance Plan​
     
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  3. QAengineer13

    QAengineer13 Member

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    Jim , can you please provide me some recommendation as to for a NPI program , I need to conduct Design reviews, what would be the best way of going about it , Please advice.
     
  4. RICHARD GALLAGHER

    RICHARD GALLAGHER Member

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  5. RICHARD GALLAGHER

    RICHARD GALLAGHER Member

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    Jim, Thanks much for your input. This potential "checklist" will no doubt be lengthy!
     
  6. Sidney Vianna

    Sidney Vianna Well-Known Member

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    As a suggestion browse the ANSI/ASQ D1160:1995 document titled Formal Design Reviews. If you google it, you can even find it available online. It provides for a comprehensive cycle of product design reviews.
     
  7. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    Sorry for the delay QAengineer, with the holiday's I've been offline. Sidney's suggestion is probably the best, I saw it in the past but don't remember much of it other than "this looks interesting". Formal design reviews IMHO differ widely depending on what the product is (hardware vs. SW, Med Device vs. General product). My laundry list above is what is expected to be brought to the table at a Design Phase review hence Finalized which would move to Preliminary in the earlier phases. In either case what is presented and approved drives the stake in the ground to provide change control from or at least raise the question why the change moving forward.

    My key is that objective evidence is brought to the table that can prove the work was completed and that you have agreement at the end.
     
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  8. QAengineer13

    QAengineer13 Member

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    I have another question related to product design, our company is using a consulting firm to develop our new product, the challenge I have with the management is that the agreement with the consulting firm to document their progressive design work ( eg design description at stage gates) I see a huge value add for our firm if the consulting firm can give us output at stage gates before design transfer gate , so our firm can sustain it and also understand the development life cycle but the consulting firm doesn't see value...so any input /recommendation of how to handle this situation? May be have some doc as Project doc and the key o/p as design history file?
     
  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It is easy to understand why they would not see the value - it is not their system. Has the contract already been agreed on? If you are still negotiating it, you can write the stage approach into the requirements.

    Are you doing this for yourselves or because a standard requires it in design clauses? If it is for a standard, I am not sure the same requirements apply for outsourced design services. Wouldn't you just be purchasing their output?
     
  10. Ronen E

    Ronen E Well-Known Member

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    Hi,

    A client of mine is currently in a similar situation, as they've outsourced the design task to a consulting firm.

    I don't think it's a question of added value; rather, it's a question of engagement scope and project costs. If that requirement was not negotiated into the contract upfront, the consultant has probably not allowed for the extra work in their budget. If I was them I would expect my client to pay extra for the additional work and deliverables (the interim design documentation), if that wasn't initially included.

    In the case of my client, the D&D consultant is ISO 13485 certified, so the concepts of design control, design reviews and establishing a DHF during the development phase are already in their normal practice. During engagement we ensured that the deliverables from the D&D consultant would allow my client to establish a DHF in line with relevant regulatory requirements. The requirement was spelled out and accepted by the service provider before commencement.

    Cheers,
    Ronen.
     
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  11. QAengineer13

    QAengineer13 Member

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    Thank you Jenn & Ronen for your input.
     

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