AS9100 Shelf Life Extension or Exemption

wephraim

Registered
Our organization has implemented a shelf life control program and has done well with maintaining our consumables within that program but occasionally we run into situations where consumables have expired that could easily be argued aren't process/product critical.

A few examples could include isopropyl alcohol or bagging sealant tape.

My question is, what is a common or acceptable method to either exempt or extend an item from its shelf life?

Obviously we wouldn't want to do this to a consumable or item that is incorporated into the product, but rather something that supports the process.

Within the world of AS9100, is this just a bad idea or something worth pursuing?

Thanks in advance for any insight or input!
 

John Predmore

Trusted Information Resource
If it is "easy" to argue these certain items aren't critical when expired, then why have expiration dates on them?

My suggestion is if you have a Material Review Board who dispositions non-conforming product, expand the scope of the MRB to include disposition of raw materials in inventory which are found to be non-conforming.

Sometimes the manufacturer of a purchased material, isopropyl alcohol for example, will put an expiration date on the bottle, but that might be geared to a particular user of the chemical, pharmaceutical use, let's say, which is more stringent than what your requirements are. If you are using IPA as a cleaning solvent, you don't care about minor changes in pH or viscosity over time. Maybe you are saying your workers are trained to always check the label and not use any chemical or item past the expiration date.

For a permanent solution on each item, blacken-out the expiration date on the manufacturer's label upon receipt, or put your own Does-not-expire label over theirs.
 

Mike S.

Happy to be Alive
Trusted Information Resource
Each situation is different with different risks.

For example, if you use IPA in an application where its shelf life, potency, etc. is critical (say as a sterilizing agent in a medical application) and as a glass cleaner in the front office, you could easily say the office IPA "does not expire" but you'd need to ensure that it NEVER made it to the medical use area. Maybe in such case the juice isn't worth the squeeze.

If you never use IPA in a critical application, as John said, delete any expiration info and just use it till it's gone.

Even if it is a process critical item, I have extended shelf life via testing based on the manufacturer's input. We had a written process to follow and created records.
 

John Predmore

Trusted Information Resource
As a follow-up to what @Mike S. said, the MRB in my factory will sometimes "repurpose" non-conforming material (such as expired IPA). Finding an acceptable alternative use is more cost-effective than discarding raw materials. Examples of re-purposing a raw material would be for training operators, for machine try-out experiments, or in the case of IPA, as a cleaning solution. Of course, in these circumstances, the MRB and the quality department must give serious thought to preventing any possibility of non-conforming or expired material accidentally finding its way into a critical product situation.

Some practical ways to reduce risk of misuse would be to issue a different internal inventory numbers for non-critical chemicals (e.g. IPA when used as window cleaner), color a clear liquid with dye so it no longer appears clear, change the packaging so the cleaning fluid IPA is in spray bottles which will never be accidentally confused with the gallon bottles the IPA is originally delivered in. Depending on the item and the proposed alternative use, I have drilled holes in repurposed items to guarantee they will never accidently be used in a critical product application. That does not work with bottles of IPA however.
 

audacious

Registered
You could technically test the expired material to see if it's still good. For example aerospace adhesives comes with minimum lap shear strength requirement, so you could re-test and see if material is still good and use the material accordingly.
 
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