Non-Conformance and Deviations

#1
This is my first time posting on this site, so apologies if this is not 100% clear.

I am currently looking at updating our NCR form and associated procedure. Currently we also have a deviation form, which is typically used in the event of unplanned deviations.
For each deviation raised, a NCR is also raised, creating 2 forms, 2 numbers and multiple paperwork.

Could it be possible to remove unplanned deviations and instead incorporate this into part of the NCR form, and then subsequently using the deviation form only if this is planned?

Secondly, if unplanned deviations are part of the NCR form, can this include all product that is effected by the raised deviation or would a separate NCR need to be raised for each product effected?

Any help would be much appreciated.
 
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#2
Welcome to the Cove. There are a few related terms--"Deviation," "waiver" and "concession." In order, and in general usage, the first is used when asking a customer for permission to ship nonconforming material, or to allow further processing of NC material. The second term is used when it's known prior to production that a specification won't or can't be met, and permission is sought from the customer to proceed. The third term describes the first two--a deviation and a waiver are types of concessions. Given this context, I'm not sure what you mean by "unplanned deviation." It sounds like the definition of "deviation" I gave above, in which case "unplanned" is redundant.

The general progression is to document the NC, then ask the customer for permission to ship, with the permission being in writing. You don't necessarily need a separate deviation form; you just describe the condition for the customer and ask for permission. Documenting the disposition of the NC material, no matter what the disposition is, should be a normal part of the process of handling NC material.
 

indubioush

Quite Involved in Discussions
#3
It is possible to have one process and one form for dispositioning nonconforming material/product that results from planned deviations, unplanned deviations, and any other material/product issues.

You can have one record that is used to disposition all lots that have the same or similar nonconformity. You just need to ensure you are listing the quantities for each lot.

To clarify planned vs unplanned deviation, for medical device, deviation means any temporary change to a currently approved production process. For example, let's say your label printing equipment stopped working and you now need to use a label printer that has not undergone qualification activities. If you know of the situation prior to starting the printing, it is a planned deviation. If the equipment stops working while you are printing, and you have to use the other printer to finish the rest of the labels, it is an unplanned deviation.
 
#4
It is possible to have one process and one form for dispositioning nonconforming material/product that results from planned deviations, unplanned deviations, and any other material/product issues.

You can have one record that is used to disposition all lots that have the same or similar nonconformity. You just need to ensure you are listing the quantities for each lot.
In this one form, would you recommend this be a separate entity to the associated non-conformance report or that the disposition is included as a part of the non-conformance report?
 

indubioush

Quite Involved in Discussions
#5
In this one form, would you recommend this be a separate entity to the associated non-conformance report or that the disposition is included as a part of the non-conformance report?
The final report for the nonconforming product/material needs to include everything required from ISO 13485. I have seen nonconforming product forms have two or three forms that are filled out and then put together to make the final report. It really doesn't matter how you document everything, as long as it is all then in the final report. Hope that helps.
 
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