Definition of "Sensitive Products" Clause 8.5.4 (c) in AS9100 Rev. D

#1
We were recently given a minor nonconformance from a customer against clause 8.5.4(c). The auditor interprets the "special handling and storage of sensitive products" as chemicals (such as epoxy or adhesive). In my 13 years of AS9100 auditing, it has always been audited as product, such as ESD sensitive parts and components.

I am curious what others think the interpretation of "sensitive product" is from AS9100 D.
 
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Al Rosen

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#2
We were recently given a minor nonconformance from a customer against clause 8.5.4(c). The auditor interprets the "special handling and storage of sensitive products" as chemicals (such as epoxy or adhesive). In my 13 years of AS9100 auditing, it has always been audited as product, such as ESD sensitive parts and components.
I am curious what others think the interpretation of "sensitive product" is from AS9100 D.
Chemicals and epoxy would be addressed under 8.5.4 e. shelf life control and stock rotation or 8.5.4 f special handling and storage for hazardous materials.

What was the actual non conformance statement?
 

outdoorsNW

Quite Involved in Discussions
#3
Without more details about your situation, adhesives may fall under special handling and storage.
What do the products' directions say?

Some adhesives need to be stored at cool to cold temps. A few adhesives give temperature vs. storage life data. Where I work, we refrigerate some adhesives (such as some Loctite), and we have some epoxy tubes that must be stored at -40. Others are stored at normal room temperature.

Many adhesives have expiration dates. Common wood glue often only performs at full strength for a year [often you have to look at the mg website to find this out], although for less demanding applications this may not matter, since often the wood will split before the glue fails.

If you do not have one already, you likely need an instruction in a process to check the storage temperature and expiration date (opened and unopened) for each new adhesive type and act accordingly.
 

Marc

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#5
In my 13 years of AS9100 auditing, it has always been audited as product, such as ESD sensitive parts and components.
Be happy you didn't have a critical auditor for 13 years. But now that it has come to the surface...

Just to add slightly to what @outdoorsNW and @Sidney Vianna stated:

During the design phase, all parts, supplements and materials need should be defined. Part of the Design Output is Receiving/Receiving Inspection and Storage controls. Products like those Sidney and outdoors cited are great. Sometimes, also, there are products, usually a chemical, can not be frozen so it has to be stored in a heated area.

In many industries, such as aerospace, the design outputs for materials are important with respect to maintenance. O-rings were mentioned here. Depending on the use case, many times various o-rings and seals have to be replaced after a certain number of flight hours. This is very common where the seals come into contact with chemicals such as aviation fuels, various hydraulic fluids, etc.

My intention with this post is just to point out that as Design Outputs, storage requirements should already be well defined.

Thoughts about Shelf Life: Search results for query: shelf life and site:elsmar.com shelf life at DuckDuckGo
 
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