Medical Device Design Quality Plan

T

tami longsdorf

#1
I am a design quality engineer working on a new product development project. We are currently working on putting together the development plan which defines all the project design deliverables for the DHF. One deliverable of this includes the quality strategy for the project. The basis of this document is defined as a plan to assure all required documents, etc to show the design was completed in compliance with our QMS. This is a very broad description of what this document should contain. I am looking for advice on what information should be included in this document and to what level of detail.

Thanks!
 
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Wes Bucey

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#2
I'm curious. Is it part of your plan/process to collaborate with the production people who will manufacture the item? Such collaboration usually results in a Control Plan subscribed to by designer, producer, and often even the purchaser, to assure the production will include in-process and final inspections with instruments and techniques agreed by all parties to prevent "interpretation errors" from creeping into the process and ensure the entire process from design to finished product is as efficient as possible.to help prevent nonconforming material from reaching the end user.

Sometimes, the designers are part of the FMEA (Failure Mode & Evaluation Analysis) and sign off on the equivalent of PPAP (Production Part Approval Process) to assure the product as made meets the designer's concept and requirements. The FMEA and PPAP help prevent or elminate manufacturing glitches BEFORE they occur.
 
T

tami longsdorf

#3
Yes, various members of production are on the design team. There is a manufacturing program leader assigned who will be responsible for overseeing the operational requirements and developing the supply chain plan.
 
M

MIREGMGR

#4
If I may ask, which regulatory systems will the product be subject to? What will the product's classification/categorization be under each of those systems? What does your team regard as the most difficult design challenge in regard to customer satisfaction, clinical safety and effectiveness, and market success?

The nature of an effective design control system depends on what the product project is about.
 
T

tami longsdorf

#5
The regulatory path for the device is yet to be determined. Either CDER or CDRH. It is a class II combination device.
 
A

Antimony

#6
I am a design quality engineer working on a new product development project. We are currently working on putting together the development plan which defines all the project design deliverables for the DHF. One deliverable of this includes the quality strategy for the project. The basis of this document is defined as a plan to assure all required documents, etc to show the design was completed in compliance with our QMS. This is a very broad description of what this document should contain. I am looking for advice on what information should be included in this document and to what level of detail.

Thanks!
It's best to keep the plan as pragmatically 'value add' as possible within the context of your corporation's process and knowledge-base maturity levels. Dependent upon these key drivers, such a plan can take significantly different form - and provide drastically different value add potentials. For example, if the corporation's DNA is major-league in the areas of continuous improvement, diligence, process discipline, achieving design excellence, and the design effort has a mix of contributors with gaps in their personal bodies-of-knowledge and experience, then it is appropriate and desirable to frame the plan with details which will assist in optimizing results for design activities and work products. Conversely, if the corporate vision for the preceding operational attributes is low / dim, then it may be more appropriate to itemize the required tasks in a simplistic form, along with their relationship to other tasks, work-products, and project execution control points. In either case, it is both reasonable and appropriate to delineate tasks and deliverables in a framework like this:

* TASK / ACTIVITY
> Inputs
> Processing Criteria / Requirements
> Outputs (Deliverables)

SIDE NOTE: The human race has a much higher propensity to make significant and meaningful change for improvement in an environment of desperation rather than inspiration.

Regards & Peace Out
 
E

engr.post

#7
This doesn't seem completely coherent? In other words the strategy for managing quality already exists - it is the QMS.

What does the QMS already say? The company's interpretation of ISO13485 still includes design processes? In this development plan write anything/phrase, e.g. 'following ISO13485 and our QMS a project specific (document) quality plan XXX is developed with involvement from A,B,C,D,E and released for use'. Ask the others to contribute (new) relevant codes and standards their designing with ref towards. Do they know of any they are normally using? Use and utilise quality tools to assist your role in this.
 
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