Ink and Label Shelf Life and Internal Concessions for Expired Stock

[Rjack]

In our quest to gain ISO 9001:2000 certification I have run into this obstacle.

We are a company that prints folding cartons and pressure sensitive labels with approximately 50 employees.

Our raw materials used are basically ink and a substrate to print on.

The substrate that we use for pressure sensitive labels comes from a large international company. We use several different kinds. All of their data sheets state:

Shelf Life:
One year when stored at 72°F at 50%RH

The material identification includes the production date.

The problem is that we have material on hand (and probably always will have from time to time) that has surpassed the shelf life date. Purchasing substrates always leaves you with some on hand and it’s too expensive to throw away. The material always checks out to be ok and we have always used it in production. Basically if the ink adheres to the substrate and the adhesive is sufficient that’s all there is to it. Naturally we will not use any bad material in our jobs.

The auditors have seen the data sheet and have seen the material. Of course they say that the material should not be used (its nonconforming since it’s shelf life has expired).

The auditors say that in order to use the material that we should write an “internal concession”.

Try as I might, I have been unable to find any information relative to an “internal concession” for this purpose.

My questions to the forum are:

1. Do we need to have these data sheets on file (so as to prevent even messing with this)?
2. What is an “internal concession” and how do you go about it?
3. Are there other ways that someone might know of to handle this problem?

Naturally we do not want to create additional procedures, extra forms, more records, etc. to work around a problem that we feel does not exist in the first place.

We have talked to the supplier about this and they say that the shelf life is to primarily reduce any quality claims to a manageable time frame. They will not put this in writing.

We also do not want to broach the topic with our customers as you can imagine what a can of worms that would open up.

If anyone has any examples of “internal concessions” that might help please email them to my home office:

Thanks in advance for your help.

John Jewell

 

[tomvehoski]

I have never heard the phrase "internal concession", but my guess is that they mean to write it up as a nonconformance and then disposition it as acceptable for use. Much as you would do with a part that did not meet custemer requirements, but they decided was OK to take.

Options I could see are:

1. Everytime you have a old lot identify it as a nonconformance. Define in your procedure who can authorize its use. Keep records of the disposition with test results showing the material still functions properly.

2. State in your procedures that expiratoin dates can be extended by 1 year (or whatever timeframe you feel is safe) without the need for going through #1 above.

3. State in your procedures that expiration dates don't matter since functional testing is performed.


I would probably use #1 if I felt there was a chance that recently expired material could be a problem. If you know that material is actually good for five years past the date, go with #2 or #3.

Hope this helps,

Tom

 

[David Hartman]

Tom stated, I have never heard the phrase "internal concession", but my guess is that they mean to write it up as a nonconformance and then disposition it as acceptable for use. Much as you would do with a part that did not meet custemer requirements, but they decided was OK to take.

Ditto!

Just as I hit the reply button I noticed that Tom had already responded. In reading his response, I find that he stated basically the same thoughts that I had.

I have dealt with shelf-life requirements many times in this fashion in a past life. Just define in your documentation that it will be treated as "nonconforming" product, and will be dispositioned by testing for continued suitability, re-dated, and re-issued (upon passing the suitability testing).

 

[Mike S.]

Tom pretty much nailed it IMO, as usual.

Internal concessions or "waivers" are not too unusual and are often performed by a MRB (Material Review Board). Here is what we do: If, for example, a shelf life date has expired, but we wanna use the stuff, we do a functional test. If the product functions okay, we record the test method and data on a MRB form, and the MRB members, which always includes a QA person and an engineer with knowledge of the area in question, signs it off. We allow this (by written procedure) as long as there are no customer specifications being broken. In other words, the MRB can "overrule" or "wiave" internal requirements, vendor "use-by" dates, etc. but cannot overrule a customer requirement. Only the customer can waive their own requirements, and it must be done in writing. At least, that's how it is supposed to work. On occasion I kinda recall "executive powers" were used... but that's another story.

 

[Claes Gefvenberg]

Let me guess: 7.5.5?

/Claes

 

[RosieA]

In a company where I once worked, there were large quantities of materials with a shelf life used. We had a short work instruction on how to extend the shelf life of certain materials. (In this case, epoxies)

At the point of expiration, a test was run by a manufacturing engineer and if the product performed as it should, the shelf life was extended by 3 months. A variance was written and kept on file with the test results attached.

It was a small company, and the process was not considered to be overdone. In fact, it kept us from the costs associated with having to dispose of materials that were still useable.

The "internal concession" was the variance. (We "varied" from the documented process and provided the reason why)

 

[Al Dyer]

I will have to disagree with not notifying the customer. Shelf lifes are for a reason. This type of situation should already have been handled under some type of APQP/Product Realization process and material costed out adequately.

If the horse is out of the barn then it's a company call. How would you appreciate a supplier of yours selling you outdated material? Sometimes it realy does come down to the material end application.

Never throw it away though, it's amazing what a customer will do when they are low on stock?

Al...

 

[Mike S.]

I disagree, Al. Sometimes a customer places a large PO, so you order enough stuff to do the job, then the customer cancels part of the order or delays (extends) delivery times. Just because something goes past the shelf-life date does not mean it is no good. It is not like it works with 100% efficiency on the day before it expires then won't work at all the day after. If the epoxy or whatever passes all functional tests, why not use it? Mfr's. usually state them conservatively and not always for performance reasons. I've seen stuff with lots of time left on the exp. date (essentially new) fail and stuff a few months past the date work great, well exceeding spec's. Do what works and is sensible! JMO.

 

[Al Dyer]

Mike,

We are not far apart. We all know that if it 1 week/month before expiration that the product in 99% sure to function. I'm sure we have all made decisions in our careers to send such product because we have the experience internally as well as experience with the customer use of the product to make such a decision.

I guess because I was in a business of gaskets, and adhesives that there is a built in sense of adhesive failure. An believe me, the cost of adhesive is materials is almost a straight line progression, you get what you pay for.

Someone like a 3M will sell a material at a certain price, usually higher than others like Adchem. But we as suppliers have to decide if the higher proces for a 3M is what will make the customer happy. Many times in the adhesive industry there will be a callout for a specific supplier and material.

One thing that does get under my skin is when a production manager or an engineer trying to make the decision over the complaints of someone more atuned to the aspect of quality just to make production numbers.

Hands raised, How many "quality" people have been held up on a Friday night because production hit the numbers but they need to be 100% inspected!!!

Al...

 

[Mike S.]

pancreas said:

One thing that does get under my skin is when a production manager or an engineer trying to make the decision over the complaints of someone more atuned to the aspect of quality just to make production numbers.

Hands raised, How many "quality" people have been held up on a Friday night because production hit the numbers but they need to be 100% inspected!!!

Al...

I would never make the recommendation to ship something -- or sign-off on it -- unless I saw the test data and was sure it would work, whether the ingrediant in question was within expiration date or not. Heck, I often did the test myself to make sure if it was an iffy situation.

As for your question: