Product Shelf Life - Plastics manufacturer - Cited for no system to address

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Shelf Life

I've always looked at shelf life issues in any implementation. Typically with a FIFO system it's not an issue, but each facility is different.

Take for example paint - in a QS audit back in 1995 the auditor was raising caine because of no 'shelf life' documentation that addressed the paint issue. The problem went away when we showed the system is FIFO and that there was no paint that wasn't used wthin 2 weeks of receipt - they ran pretty lean. Since the shelf life for the paint was a year or more it becaume a non-issue.

Ever since, even in ISO, I look at that possible issue to ensure it's addressed or not applicable. I have had clients which - when we looked - did in fact have a lot of 'chemicals' which were well past their stated shelf life. In one case - since the stuff was expensive and rarely used, we contacted the manufacturer and ended up with a letter that said the shelf life was stated only because it found many companies did not properly store the stuff - they'd put it in outside storage areas or in areas where the daily sun hit it, stuff like that. It said something along the lines of if properly stored, it's actual shelf life was at least triple what was stated on the container if not longer. The client stored the stuff in a climate controlled store room. We altered a procedure with a sentence - that employees were required to know (open eyes and look at label) whether or not what they were using was a 'shelf life' item and if it was 'out of date' that the supervisor would have to be contacted to determine whether it was a real issue or not.

Just to remind, there is also the internal issue. I had a client whose product can not be shipped if it's less than 45 degrees outside. They had always known this - and in fact prior to shipping they even checked the weather forcast prior to scheduling shipment. But nothing was documented - so we made up a poster for the shipping dock and 'trained' (although everyone already knew) to keep the ISO auditor happy.

Deal with shelf life as is appropriate for your specific business and processes / products. Typically this should be a Materials Management issue IMHO.
 
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dbaca0903

Re: Shelf Life

Deal with shelf life as is appropriate for your specific business and processes / products. Typically this should be a Materials Management issue IMHO.

This is an issue that I'm currently dealing with. We use a material that has a 'use by' date on it. But the material is stored according to the suppliers recommendations. We've been told that as long as its stored in the original container under refrigeration, it is good indefinitely. With all explaining I did with the auditor (presenting data that we've never received a complaint from a customer in over 14 years of using the material) we received a minor finding for having 'expired' material. At what point, if any, can we say that its a non-issue? I referenced your statement, because we've determined that shelf life isn't an issue for our specific process, but the auditor won't budge on the issue.
 

Marc

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Re: Shelf Life

What is the product/material? Who told you that the material would be good "indefinitely" if stored correctly (refrigerated)? If it was the manufacturer I would get that in writing.

If the manufacturer of a product stamps a "Use By" date on the container there is a reason. That doesn't mean it is of no value or is in some way "bad" within some time frame after the date, but there is a reason. I would contact the manufacturer and talk to them about the date they stamp on the product and ask what it is based upon.

Note that "no customer complaints" has nothing to do with shelf life. If I was going to try to defend the use of "expired" materials not having an effect on the final product, I'd look to my nonconformances history as a whole (internal and external).
 
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dbaca0903

Re: Shelf Life

Hi Marc, I appreciate the feedback. We are using a rubber material. We were told about 5 years ago that as long as it was kept cold (in raw form), the life is at a minimum of 5 times past the date on the container. The problem is that we didn't get the statement in writing. I'm sure we could get the supplier to give us a written statement. In my opinion, this would be better addressed in 'risk management'. knowledge of the product, experience of the people working with the material and also, no nonconformities while using the material, aren't we able to say that the 'risk' of sending nonconforming product to the customer is extremely low?

Im not saying that the material doesn't go bad, its more like the material is unworkable if maintained improperly. It would be impossible to work with. We have material (in a separate area for research purposes out of production) that is at least 7 years old, and it would still work just fine.
 

Marc

Fully vaccinated are you?
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Re: Shelf Life

I'm sure others will add their thoughts, but if I was auditing you and found a material with an expired stamped shelf life on it I would probably not write it up with what I know so far.

It would still be good to be able to show something from the manufacturer to back up the claim that if kept cold (in raw form), the life is at a minimum of 5 times past the date on the container.

My bet is Jim Wynne or one of the others here know more about rubber materials than I do. My assumption is that the "Use By" date is related to it curing during storage since you say the material is unworkable if maintained improperly.

As to risk management aspect, what you mention is on track.

Technically there is nothing in ISO 9001 which requires that a material be used by a "Use By" date. ISO 9001 only requires that you track/control materials with a shelf life. So - The auditor actually had no reason that I am aware of to write up a minor finding.

You say: "...knowledge of the product, experience of the people working with the material and also, no nonconformities while using the material...". I agree. I would add in external nonconformance history (customer returns, customer complaints and other customer feedback).
 
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dbaca0903

Re: Shelf Life

Im happy with your response. You referenced ISO 9001, is it the same for AS9100?

Your correct in your assumption that the use by date is related to the curing of the material. And this issue has been brought up in previous audits. However, in the past, the auditor came to the same conclusion as the audit progressed and didn't write it up.

Im still in the research phase of the corrective action process, and I have to present my plan to management (thats another battle for later discussion). I plan to get the supplier to send us a statement, but what if management wants to fight the finding. Do we have any defense? I don't see the auditor reversing himself, but would going the risk management route be acceptable?
 

Marc

Fully vaccinated are you?
Leader
Re: Shelf Life

I can't tell you with regard to AS9100. This thread that you added onto is an old thread which was posted in the ISO 9001 forum which is why I *assumed* you were in an ISO 9001 scenario.

I have moved the thread to the AS9100 forum and left a pointer to it in the ISO 9001 forum. One of the folks more familiar with AS9100 will hopefully add to this.
 
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dbaca0903

Re: Shelf Life

Thanks Marc, I appreciate the back and forth. Like I mentioned, I'm in the research phase, and looking all over for different points of view. :thanx:
 
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