Temperature Cycling Process - Continual Improvement and ISO 13485

[somashekar]

We have temperature cycling as a process in the medical sensor cable assembly and we have been doing this over several years. The data from this has been no failures.
The processes involved in the cable assembly are also validated and I have faced no customer complaints or any early failure feedbacks.
Under this background and based on our data and other technical judgements, could we eliminate this temperature cycling process, there by bring in improvement on energy and throughput time ?

 

[DannyK]

Re: Continual improvement and ISO 13485 ?

If you have no technical or customer requirements to perform the temperature cycling, you can probably remove it.

Make sure you update your risk management process and re-assess the risks involved.

 

[Marc]

Re: Continual improvement and ISO 13485 ?

We have temperature cycling as a process in the medical sensor cable assembly...

Do you have any idea why you started doing temperature cycling in the first place?

 

[somashekar]

Re: Continual improvement and ISO 13485 ?

Do you have any idea why you started doing temperature cycling in the first place?

This was started as a reliability test for the solder joints of cable conductors on the devices.

 

[Marc]

Re: Continual improvement and ISO 13485 ?

OK - Yeah, I've been down that road. Typically if you've had a few years of no failures/returns you can point to that as evidence that your soldering process is robust and temperature cycling isn't buying you anything. Do be sure it's not a documented requirement before you drop it, though. I've see times where temperature cycling or thermal shock never produced failures, but the equipment was high reliability and it was required on 100% of product by the contract regardless of whether it induced failures or not.

 

[hitesh]

Re: Continual improvement and ISO 13485 ?

You might want to check your design input requirements. For example,if solder joint reliability shall be intact for the product life cycle, before you remove thermal cycling requirement, Enough products must have passed through product life cycle to consider product confirmity data as a rationale to remove thermal cycling.

 

[Marc]

Re: Continual improvement and ISO 13485 ?

True, and let's not forget data from field returns. That is a data aspect which has to be considered.