Documenting Expiration Date Extension for a specific lot

[rlangeZMC]

Hi Everyone,

I'm trying to figure out a better way to document expiration date extensions. Currently we use our Nonconforming Material form but it's not really a nonconforming material. How does everyone else document this process? Its own separate form and system? Thank you in advance!

 

[Al Rosen]

I would consider it non conforming since it's past it's expiration date. Why create an additional form? On the NC form you can describe the testing/inspection procedure required to verify it still meets specifications.

 

[rlangeZMC]

I would consider it non conforming since it's past it's expiration date. Why create an additional form? On the NC form you can describe the testing/inspection procedure required to verify it still meets specifications.

Hi Al. Thanks for your response! Not all times is the product already expired. Sometimes it still has months before it expires but maybe a customer requests a further expiration extension, etc. I see what you're saying though, if it's already expired, it's nonconforming. Maybe we should just add the option to the form we currently use. I guess I was thinking it's throwing off our trending and it would be nice to separate it.

 

[John Predmore]

Use-as-is is commonly seen as one disposition on the NC form, and that category would apply when expired product is deemed usable. To separate non-conforming and defective data in your trend charts, tally the disposition codes. You may still want to monitor trends of expired or nearly expired product, even when it is ultimately used-as-is, because better control over shelf life is appropriate continual improvement.

Another possibility for nearly-expired product is to retest and/or recertify product with an extended expiration date. Maybe your NC form has a disposition checkbox for rework (I propose that retest or recertify is a form of rework). This is not the same as the first scenario, because the firm is taking an action (or making a decision and taking a risk) to make non-conforming product usable. Different industries have precise definitions when product is repaired versus remanufactured versus reworked. I won't get into those definitions here. I use the term rework in the generic inclusive sense.

 

[Eredhel]

How do you currently mark or document the shelf life before extending it?

 

[rlangeZMC]

How do you currently mark or document the shelf life before extending it?

We have a paper Batch Production Record where the product's expiration is documented. That is approved/released and left alone unless we want to extend. In that case, we would fill out a nonconforming material report and attach to the original BPR. We just thought there might be a better way.

 

[Eredhel]

Do you physically mark the material with a shelf life or just reference it's heat lot number or similar to a trace sheet of some kind?

 

[rlangeZMC]

Use-as-is is commonly seen as one disposition on the NC form, and that category would apply when expired product is deemed usable. To separate non-conforming and defective data in your trend charts, tally the disposition codes. You may still want to monitor trends of expired or nearly expired product, even when it is ultimately used-as-is, because better control over shelf life is appropriate continual improvement.

Thanks John! I appreciate your input!

 

[rlangeZMC]

Do you physically mark the material with a shelf life or just reference it's heat lot number or similar to a trace sheet of some kind?

It depends on the product but usually, yes, we have a label on the product with an expiration date so the nonconforming form allowing us to document the relabeling process, updating the COA, etc.

 

[Eredhel]

Are you proactively extending shelf life prior to expiration?