Shelf-Life

QC-Mike

Registered
I am creating a Preservation procedure (plastic manufacturing) and my original draft included shelf life inspections for our screen printing ink.

I've tracked down all TDS sheets for the ink we use and found they can vary from 6 months to 3 years. I then went to the ink storage rooms to get a look myself and found the following:

  • Roughly 50% of our raw ink was past the manufacturers shelf life date with some being 1-3 years past shelf life dates.
  • We color match ink by mixing different containers of ink with varying expiration dates.
    • The left over mixed ink is stored and reused, however, we only label mixed containers with a color id number.
    • I understand we could request a deviation when expired ink is used and submit for re-test, etc. but we have 100s of ink containers that would require this deviation.
Feedback from the top has suggested that tracking ink shelf life would be nearly impossible with our available resources.

So I was thinking, can I remove the requirement for shelf life and still be compliant with ISO 9001:2015? 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?
 

Big Jim

Admin
To start with, shelf life is not a specified requirement is ISO 9001:2015. Sure, many assume it is a requirement under 8.5.4 Preservation of Product.

It is specified in AS9100D in a list of "when applicable in accordance with specifications and applicable statutory and regulatory requirements"

It may also be a customer requirement for their orders.

That said it would be considered a "best practice" by many organizations to do something to handle shelf life.

I call on several printing shops including screen printing. Most don't do anything about ink shelf life with the belief that as long as it has not thickened or hardened it is OK to use. Others take the approach that an appropriate shelf life is one year after it is received and record on the container the received date and the expiry date. Some also believe shelf life can be re-evaluated if it has expired depending on its physical condition.

So there is no need to try to claim it as an exclusion, as it isn't a requirement in ISO 9001:2015.

Figure out what works for you.
 

Mike S.

Happy to be Alive
Trusted Information Resource
The key from a practical as well as ISO 9001 standard compliance perspective is does the age and handling of the ink matter? Jim is right that "shelf-life" is not mentioned directly in ISO 9001 but that doesn't mean you can ignore it if it could affect product quality. 8.4.1 - 8.4.2 applies.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
The listed shelf life may not represent the actual shelf life. Companies would prefer customers not hoard products for years and years avoiding new purchases so stating a 3-year shelf life on a product with 5 years of shelf life is not illegal.
 

Miner

Forum Moderator
Leader
Admin
The key from a practical as well as ISO 9001 standard compliance perspective is does the age and handling of the ink matter?
You might contact the supplier and ask how the shelf life was determined. Sometimes, it is because they only tested it up to a year and do not want to be responsible for it past that point. If you have successfully used older product, I would document the results and specify your own shelf life. You may want to add a new shelf life label with the new date, or some method of controlling it. You did not mention your application, so you need to consider any additional requirements that may exist beyond printability and appearance such as adhesion or wear on a label.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
We had a similar issue with a roll of adhesive material. The supplier claimed 3-year shelf life. When we went to use it we found it had expired so we dug into the product specifications. We also used a risk analysis to determine if it wasn't as adhesive as originally purchased what would the risk be? The supplier claimed a 3 year shelf life of a certain peel force from stainless steel. it turns out we needed about half that and after 5 years it was acceptable for our use.
 

Miner

Forum Moderator
Leader
Admin
A former company that I worked at built one order per year for a customer that used a special high temperature bearing grease that was no longer made and long past its documented shelf life. We probably had a 10-year supply of it since it was not a high usage item. We just repeated the relevant design qualification test each year when we ran the order.
 

Big Jim

Admin
The key from a practical as well as ISO 9001 standard compliance perspective is does the age and handling of the ink matter? Jim is right that "shelf-life" is not mentioned directly in ISO 9001 but that doesn't mean you can ignore it if it could affect product quality. 8.4.1 - 8.4.2 applies.

8.4.1 and 8.4.2? Please explain how those elements dealing with purchasing apply.
 

Mike S.

Happy to be Alive
Trusted Information Resource
8.4.1 and 8.4.2? Please explain how those elements dealing with purchasing apply.
If shelf life of a purchased product can affect your product's quality, or a customer requires that you only use purchased product with X amount of shelf life remaining, you had darn well better consider it and control it.

Please explain why you don't think 8.4.1 or 8.4.2 applies.
 

Big Jim

Admin
If shelf life of a purchased product can affect your product's quality, or a customer requires that you only use purchased product with X amount of shelf life remaining, you had darn well better consider it and control it.

Please explain why you don't think 8.4.1 or 8.4.2 applies.

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.
 
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