Iterative design and production for custom made products

James

Involved In Discussions
#1
Hi

I'm setting up a new QMS for low risk custom made class 1 devices (with a Health Institution Exemption) and struggling with how to reflect processes where we have products that are iteratively designed and produced, or purposefully reworked. This could be because:

1: The specifier (a rehab engineer) needs to test the product at numerous points during manufacture to check it will work for the patient. The Rehab Engineer will be much better placed to understand characteristics necessary for successful manufacture better than the technician who is building it. Such characteristics cannot be easily documented on a prescription (specification form).

or

2: The patient is rapidly deteriorating; for example they have Motor Neurone Disease, so the requirements of the custom made communication aid have changed since the patient was first assessed (and the device specified)

Any thoughts?

James
 
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Nadaabo

Starting to get Involved
#2
I'm not an expert, but my thoughts are as follows:

I'm assuming the changes have to be done on the fly, they have to happen fast and don't need to be re-validated/ verified, etc.

I would suggest using a "prototype" process that allows for:
- Modifications to take place from existing designs,
- Shows how the configuration and traceability and validation is accomplished,
- How it will be documented and the documents retained.

Or
It could be controlled with a concession or deviation due to an NC?
- The product is technically non-conforming to original specs,
- The reason/ Cause of the NC is what you mentioned above (The specifier (a rehab engineer) needs to test the product at numerous points , or requirements need to be temporarily modified based on patient's needs.)
- Correction would be the alternate design or modification to the equipment.
- Long term solution is not applicable. modified for this condition.

I hope this helps :)
 

James

Involved In Discussions
#4
Thanks for the suggestions.

I'm thinking device and design 'base files' will be a good starting point from a previous forum post. I think I just need to work through a process for 'custom made to bespoke requirements', indicating which base file the custom design relates to, and the designer can define check points, at which progress can be signed off / custom made design changes recorded for the next stage if required.

Risk will be assessed and mitigated for any custimisation, again using the risk parameters defined in the 'base file' risk management plan.

Cheers

James
 
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