Rework requirement in ISO 13485

Hi,

The medical device we manufacture requires very simple fix if it failure a final inspection, mainly replacing part. e.g. if there is a scratch on the cover the cover will be replaced; if a motor is not working, the motor will be replaced. There is no re-processing required.

Is a rework request, evaluation and approval required for such simple "rework"?

ganglai said:

Hi,

The medical device we manufacture requires very simple fix if it failure a final inspection, mainly replacing part. e.g. if there is a scratch on the cover the cover will be replaced; if a motor is not working, the motor will be replaced. There is no re-processing required.

Is a rework request, evaluation and approval required for such simple "rework"?

Click to expand...

If I am right, your question comes from the 13485, 8.3 last paragraph ...
You have your answers in your question and the rest the standard guides you.
Address the process of replacing cover, replacing motor within your risk management and assess risks and actions needed to cover the same.
Do you have a work instruction for this task that is approved ?
Then please have a work instruction for the rework process as well approved by the same authorized person who has approved the manufacturing work instruction. These work instructions will address and cover any actions that you have already identified in your rework risk management step.
The standard wants you to establish such a PDCA process for rework so as to always obtain the same safety and effectiveness as intended for the medical device, and keep records of such activities.
Such a discipline established will be useful for you whenever you are faced with rework challenge, that become more serious in nature. This is the intent of the standard ...

Thank you Somashekar.
We have a rework control procedure which details the review, approval process. Such replacing a cover has never gone through the rework documentation process. Production would just replace it.
Can it be justified such simply rework does not require the rework control process?

If your issued work instructions cover in sufficient detail the actions that need to be taken if a device fails final inspection, including (but not limited to) documentation of the fix, re-inspection + results and final approval as "pass" - there would be no "rework" as such. The fix will be an inherent part of the initial manufacture.

if, on the other hand, a unit or a batch are tagged as "finished", then (separately) inspected and found NC (where no detailed instructions are integrally prescribed for the necessary fix), they'd need to go through the formal rework process.

Routine, known, prescribed in detail = rework within the initial manufacture
Irregular, unexpected/uncommon, off-line = separate and formal rework process

Thank you Ronen for the practice solution.

ganglai said:

Hi,

The medical device we manufacture requires very simple fix if it failure a final inspection, mainly replacing part. e.g. if there is a scratch on the cover the cover will be replaced; if a motor is not working, the motor will be replaced. There is no re-processing required.

Is a rework request, evaluation and approval required for such simple "rework"?

Click to expand...

This is from FDA and I use it in a REWORK procedure (which complies with ISO 13485:2016:

Generally, routine reconditioning or repair prior to distribution is not considered reworking unless the activity would adversely affect the reliability, safety, or effectiveness of the device.

Routine replacement of defective parts would normally not be considered reworking, unless the structure of the supporting materials such as adhesives, epoxies, solders, etc., must be changed or modified.