Shelf Life Control and Identification of items that do not have Shelf Life

[Mark_QM]

I work for an electronics manufacturer in the defense industry and we've been ISO 9001:2008 certified for several years. We have a shelf life program that has worked quite well to control our flux, solder, adhesives and we've had very few findings during internal and external audits.

We have also found that it's made life easier during both internal and external audits to label items that do not have a shelf life (such as cleaners, alcohol, water, and basically anything that is in a jar, can or bottle) with "indefinite" so that it's easy for an auditor to determine if an item has a shelf life requirement or not. This practice of labeling non-shelf life items has not been documented in our shelf life procedure.

Yesterday during an external ISO 9001:2008 audit the external auditor found that a solder we use in a selective solder machine was not labeled with a shelf life or as "indefinite". Initial thinking was that the solder must have a shelf life as most hand solders do. Further research found that the solder has no flux and therefore no shelf life (per the manufacturer's data sheet).

Now the auditor has discovered that our "indefinite" labeling practice is undocumented and is advising us to label this non-shelf life solder as "indefinite" and to document this practice.

Here's my thinking on the issue:

While this may make sense from a consistency point of view I don't see any requirement for us to label non-shelf life items as "indefinite".

Even though the "indefinite" labeling practice has been working well for us, I don't believe there's a requirement to document every practice.

I'm concerned that if we document this "indefinite" labeling practice that in the future we could have audit findings for not having an item labeled as "indefinite" and we would then be spending more resources on a non-required practice.


What do you think -
- should we label the non-shelf life solder as "indefinite"?
- should we document the "indefinite" practice?

 

[Jen Kirley]

Re: Shelf Life Control and id of items that do not have shelf life

Good morning,

If this is all she found to point to I am thinking you are in good shape.

Was this an OFI? If so, I would say I considered it and decided to not add this reference to the defined process, especially if you continue to practice FIFO even with indefinite items.

That said, if there are whole categories of items (that could include solid core solder) with indefinite shelf life you might be able to simply list them in your documented procedure and be done with it. I suppose she would then expect then to be labeled but I would be focusing on more value-added subjects instead.

 

[Mallya]

I will suggest you can establish shelf life based on research try to google you can get publication which you can use as a source to establish shelf life; include and monitor in your register and beef up with FIFO practice

Rgs

Ben

 

[Ajit Basrur]

Mark QM,

I am attaching a perfect procedure for you - http://www.digikey.com/Web Export/S.../kester-wp-solder-shelf-life.pdf?redirected=1

 

[Mark_QM]

Thanks for the input everyone!

There were no findings as a result of the audit, just some recommendations, including to label items consistently (with "indefinite" labels).

We won't be striving to label everything with indefinite - that would be crazy as there are thousands of items on the manufacturing floor that could fall under that scope. :mg:

I think that we'll word our Shelf Life procedure such that items without a shelf life are not required to have a shelf life label.

Thanks!

 

[Falcon419]

Hi Mark,
Great idea to label product that is also not impacted by shelf-life. Would you be willing to share your shelf-life procedure?