Shelf-Life

[Mike S.]

Preservation of product is a MUCH better element to relate for shelf life. Although it is different standard, that is where AS9100D plugs it in. It isn't near as much of a stretch.

That doesn't mean you could not find other places to apply it. Control of Production would be another example.

I disagree.

This thread is ISO9001, not AS9100, so we cannot assume the OP is aware of AS9100 additions which do not apply to him/her.

In ISO9001 section 8.5.4 is after the product has been made, and clearly speaks to preservation of outputs (identification, handling, contamination control, packaging, storage, transmission or transportation, and protection). The shelf life of an input isn't addressed in 8.5.4.

8.4.1 and 8.4.2 clearly cover control of externally provided inputs.

 

[Tagin]

I'm going to argue that 8.5.1 is also where shelf life for production raw materials belongs.

While I agree that 8.4 can control how much remaining shelf life a purchased material must have at the time of purchase, it does not control monitoring of that remaining shelf life while the raw material sits in our building waiting to be used, or in-between processes. I also agree that 8.5.4 specifies outputs, rather than raw material inputs. But in the OPs case, "The left over mixed ink is stored and reused..." so an output of this process is a raw material for some later process.

Specifically, 8.5.1b ("availability and use of suitable monitoring and measuring resources") and 8.5.1c ("implementation of monitoring and measurement activities at appropriate stages") would seem to apply to tracking and acting upon shelf life expiration dates, whether it be for purchased raw materials, or 'subassemblies' such as the mixed ink.

As to the OP's question ("Can I state that we have identified expired ink as an internal risk but not to the degree that it would impact the product and require mitigation (based on there being no customer complaints or internal scrap caused by expired ink) and include this in our risk analysis process?"), I would say 'Yes...but', where the 'but' is three parts:

1. Is the data (lack of customer complaints or scrap) based on known expired ink? If you don't know if the ink was expired at the time it was used, then you don't really know if your data is good evidence of the lack of impact of expired ink.
2. Any potential concern over latent nonconformances, which the customer may not experience now, but could experience over the next months/years. E.g., the product for the customer is fine until 2 years go by and then the ink starts to peel off, etc. due to the ink being expired at the time of production. So, I would include in any risk analysis any evidence you have of no latent issues due to the ink (e.g., "there have been no ink-related nonconformances even after the product has been in the field for 5 years").
3. I presume you already have some kind of controls in your processes to prevent 'bad ink' (whatever that means) from being used? E.g., ink that has hardened, separated, etc., is somehow already detected and prevented from being used?

 

[Big Jim]

I disagree.

This thread is ISO9001, not AS9100, so we cannot assume the OP is aware of AS9100 additions which do not apply to him/her.

In ISO9001 section 8.5.4 is after the product has been made, and clearly speaks to preservation of outputs (identification, handling, contamination control, packaging, storage, transmission or transportation, and protection). The shelf life of an input isn't addressed in 8.5.4.

8.4.1 and 8.4.2 clearly cover control of externally provided inputs.

I respectively disagree for the simple fact that outputs are significantly controlled by their inputs.

Perhaps this is another weakness in the 2015 revision of the standard. 2008 did include constituent components.

Again, I point out that it could be addressed in many other clauses, but it is most pointedly address in preservation of product.

 

[Mike S.]

Quite often you can get an applications engineer from the mfr on the line and if you explain your circumstances to them they will give you advice on how to test and/or do risk analysis on "expired" product. As with most pharmaceuticals, the "expiration date" of many products like ink and adhesives have little relationship to whether or not the performance is degraded.

 

[Big Jim]

Quite often you can get an applications engineer from the mfr on the line and if you explain your circumstances to them they will give you advice on how to test and/or do risk analysis on "expired" product. As with most pharmaceuticals, the "expiration date" of many products like ink and adhesives have little relationship to whether or not the performance is degraded.

True

 

[dramman]

If managing shelf life makes sense and is important to quality you should establish a process. That does not mean you must follow manufacturers shelf life recommendations. Those could be inputs into establishing your own shelf life limits. It is always possible you see longer effective shelf life due to your processes and storage conditions.

I have a similar situation with a molding material. The manufacturer stated 4-6 weeks shelf life. We can routinely stretch that several months through storage conditions processing parameters. We also find their estimate is very conservative. When asked what shelf life means, they stated that is the time frame they will guarantee moldability performance. It is not necessarily the true shelf life.