Recertification Process for Expired Shelf Life Materials

[sberg]

I would like to get an alternative perspective on a recertification process for expired shelf life materials. My intial thought is that I would handle the recertification by treating expired shelf life materials as non-conforming and sending them through the MRB. Anyone have any experiences with this?

If I decide to go that seperate route of a stand alone procedure then I am a bit hung up between where to place this procedure in the quality manual. I would assume that this would be placed under the umbrella of preservation of product? Any thoughts on this?

Thanks

 

[Ajit Basrur]

Can you provide more info which type of expired materials are you referring to ?

 

[Scott Catron]

I think it really depends on what sort of material we're talking about.

For chemicals or materials dependent on chemical stability, if there is sufficient stability data to support an extension, then a MRB could review the data and approve an extended shelf life. We've done this before on drug intermediates.

 

[sberg]

The type of materials would be heat shrink tubing and epoxies mainly.

 

[Al Rosen]

I would like to get an alternative perspective on a recertification process for expired shelf life materials. My intial thought is that I would handle the recertification by treating expired shelf life materials as non-conforming and sending them through the MRB. Anyone have any experiences with this?

If I decide to go that seperate route of a stand alone procedure then I am a bit hung up between where to place this procedure in the quality manual. I would assume that this would be placed under the umbrella of preservation of product? Any thoughts on this?

Thanks

I would address it in the Nonconforming material procedure. MRB is usually not qualified to determine if the material is still acceptable, but could decide to return it to the mfr for testing. I'm assuming it's chemicals, adhesives or rubber o-rings & gaskets.

 

[sberg]

Thanks for your insight into this.

 

[Scott Catron]

The type of materials would be heat shrink tubing and epoxies mainly.

Is there any data to suggest the shelf life could be extended?

And not to disagree with Al, but if the material is currently not nonconforming to specifications, it may not be wise to kick it into the NCM process - depends on one's system and how these things are reported. If it's more of a procedural change - a change in the shelf life - then it probably belongs in the change control system.

 

[Al Rosen]

A procedure for controlling the materials is neccesary, but once the expiration date has passed, it is nonconforming material in my opinion.

 

[sberg]

I think we would most likely scrap the materials. We are a small facility and do not have much of an ability to recertify things. But you still have to have the procedure. A statement that we will not use any materials that have expired doesn't seem to cut it with me.

 

[Al Rosen]

Here's a draft of a procedure that might need a little work.