Cl. 4.15 Limited Shelf Life materials

We face difficulties in specifying the Shelf-life period of materials subject to deterioration in time upon storage.

1. Manufacturers or their agents do not always help by providing this information even after requests.
2. Even when it is provided it is not not always unequivocal and straight.
3. It is not always always verifyable from published sources.

Can anybody help by suggesting any public source from where one can easily obtain this inforamtion in a collated form - like a handbook? Is this info available in the Net?



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Ram
Bangalore, India

[Marc]

--> ...1. Manufacturers or their agents do not always help by
--> providing this information even after requests.

If a manufacturer does not specify shelf life, I assume there is none (or it is good for at least a year at room temperature and 'nominal' humidity).

--> 2. Even when
--> it is provided it is not not always unequivocal and straight.

I would have to see an example to see the verbiage they use. If it is verbal and not part of the 'product specification', then I would not consider it as significant anyway.

--> 3. It is not always always verifyable from published sources.

I would think that a designed validation test would / could provide the information but you will have to post an example of the product we are talking about.

I know of no 'One Source' to go to for such information. I always go directly to the manufacturer. If they can't give the information I need, I would contact purchasing and seek a more responsible source for the material. If your suppliers are playing games with you, you could end up with a lot of problems in the future.

Ram,

I am in agreement with Marc, but here's another avenue you could take:

Go to your engineers to define longevity of solvents, adhesives etc..... that the manufacturer hasn't specified but your company has set requirements. They can put their druthers (preferences) on the print. Now you have documentation.

Another way is sloppy but would also work. make a list including the material name, expiration period and some sort of approval. this method works as long as the item has a date code (if missing, you need to put one on it).

Generally speaking, If the manufacturer doesn't recommend an expiration perios and neither do your engineers, then don't worry about it. this also goes for storage and safety conditions.

[Don Winton]

I am in aggreement with Leslie and Marc. If the manufacturer does not supply the information, supply it yourself and be sure it is "assessed at appropriate intervals."

Or, if "deterioration" is not a concern, state such and document.

Regards,
Don

As regards sample of manufacturer's recommendation, here is one:
"The shelf life is normally one year, so long as due care is taken in the storage of the material, as regards temperature, humidity and ventilation"!
And the manufacturer often does not give the date of manufacture, we only have the date of receipt of material in the store. We have no means of knowing whether the life is already expired!

As regards our engineers certifying the shelf life, this is not acceptable to the auditors, unless backed up by published sources. And I think, rightly so.

Ram


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Ram
Bangalore, India

[Marc]

As regards sample of manufacturer's recommendation, here is one:
"The shelf life is normally one year, so long as due care is taken in the storage of the material, as regards temperature, humidity and ventilation"!

This means if stored at 'room ambient temperature and humidity'. Typically this is like in the area of 60 degrees F to 85 degrees F and 30% to 80% humidity.

And the manufacturer often does not give the date of manufacture, we only have the date of receipt of material in the store. We have no means of knowing whether the life is already expired!

I'm going back to where purchasing has to work with suppliers to ensure this is evident. I mean, the bottom line is if they don't even provide information on when it was made you have a real problem.

As regards our engineers certifying the shelf life, this is not acceptable to the auditors, unless backed up by published sources. And I think, rightly so.

Umm, well, OK. But I can think of no published source which could give a shelf life for a company's product. You may be able to get some generalities, but hey - you have no idea what additives they may put in that is 'their special ingredient' - so, shelf life of comparable products or a class of products is, at best, a guess.

Make your suppliers get their **** together or find other suppliers.

Last comments:

You do identify materials when they are received and 'start' your shelf life from that point.

Run a report and be ready to show you have no nonconformances due to failure of a product which has been tracked to a root cause of expired shelf life. You may need evidence that this is not a problem.

[This message has been edited by Marc Smith (edited 01-03-99).]

"This means if stored at 'room ambient temperature and humidity'. Typically this is like in the area of 60 degrees F to 85 degrees F and 30% to 80% humidity."

Sir, that may be typical in the US. here in India, it may vary from 45 C to 10 C, with humiduty from 40% to as high as 100% !

And just throwing out recalcitrant supplier is not easy enough here, where we are still at a sellers' market stage in many products.

Do other readers have similar problems as mine as regards defining shelf life?

Can we not start building up a list of generic materials and their shelf life period under specified conditions?

Ram


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Ram
Bangalore, India

[Don Winton]

As regards our engineers certifying the shelf life, this is not acceptable to the auditors, unless backed up by published sources. And I think, rightly so

Am I the only one who has a problem with this? Cannot published sources be internal?

Regards,
Don

[This message has been edited by Don Winton (edited 01-09-99).]

[This message has been edited by Don Winton (edited 01-09-99).]