Documented Rework Procedure - ISO 13485 Requirements

ISO 13485 calls for a documented procedure for rework in the control of non conforming products..... What is expected here ?
a) To have a documented procedure and address in it how a non conforming product undergoes rework ..... OR
b) Have several documented procedures for rework as and when non conforming products are identified, or simply said, several rework instructions matching several work instructions.
But over here rework instructions can only be made after the analysis of the non conformance and hence rework instructions cannot be decided in advance like a work instruction.
Would an auditor corelate the data of rework on non conforming products to established rework procedures even when the nonconformance is minor in nature and few in number ?
Further does it mean to state that documented work instructions are mandatory as here is a call for documented procedure for rework ?
And finally would my work instruction itself become a rework instruction if I can refer to any such depending upon the analysis..........

would like to see responses with examples of good practices in rework.

Re: Documented procedure for Rework

Rework instructions can provided on a nonconformance report or any other document. There just has to evidence of approval and has to follow your documented procedure for NC Product. Within your own procedure, you should define what a rework is.

The area where some companies have issues is that they do not document the determination of any adverse effect of the rework prior to performing the rework.

Re: Documented procedure for Rework

DannyK said:

The area where some companies have issues is that they do not document the determination of any adverse effect of the rework prior to performing the rework.

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Where could / would / should this be documented? I am trying to implement the rework instruction activity within my company. Currently, rework instructions, an approved and controlled document, are referenced on the traveler that goes with the assembly. For example, a circuit board - if a component is found in inspection to be installed incorrectly with regards to polarity, the rework instructions are referenced to perform the necessary rework. I take it I'm missing the determination of adverse effects portion of the requirement.

Couldn't this determination be noted on the traveler? For this instance, would the inspector finding the nonconformity do the determination? (I fear there is no guarantee they are qualified to determine such.) Any other suggestions? The way our system works, any nonconformities found on an in-process assembly are recorded on the traveler.

Any input on this would be appreciated as I'm at wits end right now.

Re: Documented procedure for Rework

RCW said:

Couldn't this determination be noted on the traveler? For this instance, would the inspector finding the nonconformity do the determination? (I fear there is no guarantee they are qualified to determine such.) Any other suggestions? The way our system works, any nonconformities found on an in-process assembly are recorded on the traveler.

Any input on this would be appreciated as I'm at wits end right now.

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Wouldn't such determination be part of pFMEA? The NC found in process will be recorded on the traveler.

Re: Documented procedure for Rework

treesei said:

Wouldn't such determination be part of pFMEA?

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A pFMEA is not available for the parts in question. In fact, pFMEAs do not exist for many of the medical devices we build.

treesei said:

The NC found in process will be recorded on the traveler.

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Correct. The nonconforming condition is already recorded on the traveler. The operator performing the rework initials and dates the traveler. Then the inspector inspecting the rework initials and dates the traveler upon sucessful completion of rework. If this or a new nonconformity exists, then the whole process is repeated.