Relocation of Equipment - Equipment Validation template wanted

D

dbazinet

We are an AS9100, ISO 9001, ISO 13485 registered electronics contract manufacturer of circuit board assemblies. I am looking for an equipment validation template that can be used to validate a piece of equipment after picking up that piece of equipment and moving it to a new location. Does anyone have a template that I can download? Thanks.
 
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Y

yodon

Leader
Super Moderator
Was the system in a validated state before? If so, can the original validation protocols be used - at least as a basis to start (you may be able to make risk-justified decisions to do a subset of the effort).

Do you have anything like a validation master plan? That would possibly drive what all you need to do.
 
S

scooterbaby

Registered
This may help - IQ required if moving Equipment or if the Equipment is new, Sounds logical since the only thing that you need to verify is the installation at a new location.
 
D

dsanabria

Quite Involved in Discussions
dbazinet said:
We are an AS9100, ISO 9001, ISO 13485 registered electronics contract manufacturer of circuit board assemblies. I am looking for an equipment validation template that can be used to validate a piece of equipment after picking up that piece of equipment and moving it to a new location. Does anyone have a template that I can download? Thanks.
Click to expand...

First start with AS9102 - First Article Inspection Report - once you move an equipment from location, you are required to perform one per AS9102 - if it is flown down to you.

Next - find out what else your customer requires when relocation an equipment.

Third check out the standard on software - AS9115 - not sure if it applies (deliverable software.

Finally: http://www.sae.org/servlets/registr...HGeneral&PAGE=getSCMHBOOK&vgenNum=184&scmhs=2

Chapter 7.1

Start with those and then come back to the cove.
 
somashekar

somashekar

Leader
Admin
dbazinet said:
We are an AS9100, ISO 9001, ISO 13485 registered electronics contract manufacturer of circuit board assemblies. I am looking for an equipment validation template that can be used to validate a piece of equipment after picking up that piece of equipment and moving it to a new location. Does anyone have a template that I can download? Thanks.
Click to expand...
Please use the same templates that you used during the first location of the equipment ...
 
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