AS9100 7.5.2 Special Processes - Clean Room Apply?

L

littleRoot

#1
Hello,

I'm hoping someone can help me clarify if a clean room would be considered a special process? One of our customers is requiring us to have a clean room for their parts, so we are looking into this. So if we end up having a clean room, it would only be for this one particular customer and it is per their requirements. With that said, would putting in the Clean Room be a special process under 7.5.2? Again, this will only be used for the one customer that is requesting we have this in place. You're feedback is much appreciated. Thank you.

-Chantal
 
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Big Jim

Super Moderator
#2
A clean room in and of itself is not a special process. It is possible that some sort of special process takes place in a clean room though (although that isn't likely).
 

dsanabria

Quite Involved in Discussions
#3
Hello,

I'm hoping someone can help me clarify if a clean room would be considered a special process? One of our customers is requiring us to have a clean room for their parts, so we are looking into this. So if we end up having a clean room, it would only be for this one particular customer and it is per their requirements. With that said, would putting in the Clean Room be a special process under 7.5.2? Again, this will only be used for the one customer that is requesting we have this in place. You're feedback is much appreciated. Thank you.

-Chantal
Here is what you need to be aware

" AS9100C 7.5.2 The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered."

So "Big Jim" statement are correct if you comply with the paragraph above.
 
#4
Hello,

I'm hoping someone can help me clarify if a clean room would be considered a special process? One of our customers is requiring us to have a clean room for their parts, so we are looking into this. So if we end up having a clean room, it would only be for this one particular customer and it is per their requirements. With that said, would putting in the Clean Room be a special process under 7.5.2? Again, this will only be used for the one customer that is requesting we have this in place. You're feedback is much appreciated. Thank you.

-Chantal
A clean room isn't a process (special or otherwise). What goes on inside may be a special process. I worked at a place where we bonded (glued) parts which needed to be kept ultra clean before assembly, so we installed a clean room to reduce dust.
 

Big Jim

Super Moderator
#5
A clean room isn't a process (special or otherwise). What goes on inside may be a special process. I worked at a place where we bonded (glued) parts which needed to be kept ultra clean before assembly, so we installed a clean room to reduce dust.
Good example.
 

somashekar

Staff member
Super Moderator
#6
And when the clean room you have and you claim to be per the ISO classification, which is a work environment that is defined (By your customer and further by yourself) ... then you must have an ongoing validation that the clean room meets the claimed class.
 

Big Jim

Super Moderator
#7
And when the clean room you have and you claim to be per the ISO classification, which is a work environment that is defined (By your customer and further by yourself) ... then you must have an ongoing validation that the clean room meets the claimed class.
I believe that would be verification, not validation.
 

John Broomfield

Staff member
Super Moderator
#9
Hello,

I'm hoping someone can help me clarify if a clean room would be considered a special process? One of our customers is requiring us to have a clean room for their parts, so we are looking into this. So if we end up having a clean room, it would only be for this one particular customer and it is per their requirements. With that said, would putting in the Clean Room be a special process under 7.5.2? Again, this will only be used for the one customer that is requesting we have this in place. You're feedback is much appreciated. Thank you.

-Chantal
Chantal,

Is the work that goes on in this clean room resulting in products that can be verified with no possibility of hidden or latent defects?

If so, the clean room must be verified as meeting the requirements before use and monitored during use.

If not, the process itself including the special environmental conditions provided by the clean room must be validated (and re-validated as required) under 7.5.2. You can then run the special process with the specified process monitoring and with minimal checks on the conformity of its products.

A room is a facility not a process. A process may include a facility such as a clean room.

Best to think of process as a fancy word for work that applies resources and controls to turn input into output.

John
 
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