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

[skits]

Hi, new poster to the forums...but longtime lurker (lol)...

I need some quick advice...we just had a customer audit and they are citing us because we have no procedures in place to check the shelf life of product...the problem is, we are a plastics manufacturer and our product basically has the shelf life of plutonium...as long as it is kept out of direct sunlight, it never expires or fades...do I need to write a procedure stating that we don't need a procedure???

I'm not sure how to handle it.

 

[SteelMaiden]

Do you have anything in your tier documents that states there is no shelf life issues, and that you will assess your storage areas to ensure the products condition is maintained? I was once in a similar situation, but I pointed out that we inventoried twice per year and that inventory included assessment of product condition (documented on the inventory sheets when nonconformances found) plus documented procedures for handling (hold, inspect and disposition) material that was found in between inventories.

 

[Jim Biz]

As this is posted under the 1994 versions - I can tell you "what we do here" today under 9002 for what its worth.

We store finished Metal Products.

We have included a separate procedure for "preservation" in all storage areas of the plant.

Basically what we do is a YES/No acceptable audit "AT RANDOM" locations in the written doc. (5-10 condition audits in random locations per month)

We keep the signed dated checksheets onfile to show evidence of the activity - we backed that up with a notation on final inspection docs. indicating that "If materials are found to be in unacceptable condition upon presentation for shipment - they will then be addressed as nonconformaig until appropriate rework (on our case pickle & oil wire bruch/ vibrating operations (cleanup) is completed.

Hope this helps!!

 

[skits]

Thanks!! This is a tremendous help for me. I've only been here a few months, and they basically had NO quality system here, so I'm starting from scratch (which is kind of a good thing, but it's awfully easy to overlook stuff, too).

skits


PS..
I just realized I posted this in the wrong forum. Doh!!

 

[CarolX]

what we did

Hello skits,

Thanks for your question. Trust me, there is never a dumb question...only ignorant people that won't ask for help.

We have the same issue here, no shelf life requirements. I added a one line statement in our quality manual that we did not use any limited shelf life items. The problem you could get into, and this is where I had a problem is what effect did our enviroment have on our materil. We maintain very little stock (we are a JIT sheet metal fabricator), but sheet metal is highly suspeptable (sp) to rust. So I added an inspection collum to our inventory sheet.

we are a plastics manufacturer and our product basically has the shelf life of plutonium

But can it deteriorate to the point of being unusable because iof enviromental conditions, i.e raw material stored in an un-airconditioned warehouse during a record heat wave???? I know I am talking worst case, but this is what you might run into.

Lots of luck and don't do to much of this

CarolX

 

[Al Dyer]

In reading through QS-9000 3rd edition there is a requirement for your situation. 4.15-4.15.3 (in italics i.e. ISO 1994) states that a procedure is required.

How detailed the procedure is can be your choice.

 

[Jim Biz]

Danger Will Robinson

Yep - as I read through ISO 9004:2000 guides there are "suttle" (sp?) differences between the 1994 version & the intent of what the committee is saying on this - Possibly Marc has an upgraded outlook or two on it.

For one difference in our place of business we have always interpreted the language to mean "product conditions only" - The way the new guide reads - the issues could also be expanded to packaging materials and marking label "conditions" as well.


if you are working toward/under the 9001:2000 section just let me know - I'll gladly move the thread.

I just realized I posted this in the wrong forum Doh!!

 

[skits]

Moving the thread is probably a good idea, thanks.

You guys have given me some terrific feedback today, I really appreciate it.

 

[gpainter]

Shelf life per say is an expiration date. Not knowing what type of plastics area you are in, what about moisture?

 

[skits]

We make mostly office furniture--chair bases and buckets that sort of thing. (the stuff you see in classrooms everywhere)...I've only been in this industry a few months, but from what I've heard and see, getting wet doesn't hurt the finished product at all. :/ I really liked the idea of tying it into our inventory program...we're going to try that out right away.