Cl. 4.15 Limited Shelf Life materials

R

RRamamurthy

#1
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?



------------------
Ram
Bangalore, India
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
--> ...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.
 
L

Leslie Garon

#3
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.
 
D

Don Winton

#4
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
 
R

RRamamurthy

#5
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


------------------
Ram
Bangalore, India
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
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 shit 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).]
 
R

RRamamurthy

#7
"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


------------------
Ram
Bangalore, India
 
D

Don Winton

#8
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).]
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Yes, Don, I do as well. I may not consider an internal document 'published' per se, but I would accept that.

BUT - I must admit I have not yet had a problem with shelf life issues. One client has material with a shelf life of 6 months designated by the manufacturer (adhesive) which that client keeps refrigerated and has extended the shelf life to about 1.5 years. They can show through warranty and other failure data that this is not a problem.

RRamamurthy wrote:
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%!
Most of my clients have materials storage indoors in a somewhat controlled environment (AC in summer, heat in winter). I have no idea what to tell you other than to talk with the quality manager of an ISO registered firm in India and see how they approached it.

You will, I predict, have to be quite aggressive here. If it was me, I would define every material which is time sensitive and write a document defining the company policy and directions for each. I would document the reason(s) for your 'classifications' and be ready to back that up with engineering, warranty and nonconformance data.

Obviously you are in an 'impossible' situation. I would get together with your registrar and go through the situation and your solution. Reality is reality. If they give you a problem and cite you (write a nonconformance) during an audit, appeal the write-up. There must be some other ISO registered companies in India which use time sensitive materials - find out which registrar one of them is using. And ask them how they handle their situation.

I'm sorry I personally cannot recommend anything else when:
...just throwing out recalcitrant supplier is not easy enough here, where we are still at a sellers' market stage in many products.
as I have not, with any of my clients, had a problem with shelf life. In fact, it is generally not an issue because material is typically used well before shelf life becomes an issue.

An example is a former client which used a special paint which had a shelf life of 4 months. They used the paint within 2 to 3 weeks of receipt so the only issue was ensuring Materials Management folks strictly followed their First-In-First-Out (FIFO) system and that Receiving folks adequately checked lot dates and such.
 
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