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Adding Value prior to signing EASA Form 1

S

spvdj

#1
#1
We have recently received a NCR from an EASA Part 21G audit from the CAA because we could not clearly demonstrate we were 'adding value' to issuing an EASA Form 1 for the release of a part that we buy in from an approved supplier who are not EASA Part 21G approved. When we receive the item, apart from checking it is not damaged we perform no further test or inspection before releasing it to our customer with an EASA Form 1 release. The NCR was raised against 21.A.165. Has anyone else come across this previously and it so, how do you address this. I was unable to see where it is stated within the regulations. Thanks in advance
 
QMS for Medical Device Companies
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K

Koray

Registered
#2
#2
I would like to ask what is the scope of your Production Organizaston in Production Organizastion Exposition? You should demonstrate the checks you performed before issue a form 1.
 
A

Al Rosen

Staff member
Super Moderator
#3
#3
21.A.165 Obligations of the holder
The holder of a production organisation approval shall:

(c) 1. determine that each completed aircraft conforms to the type design and is in condition for safe operation prior to submitting statements of conformity to the competent authority; or

2. determine that other products, parts or appliances are complete and conform to the approved design data and are in a condition for safe operation before issuing an EASA Form 1 to certify conformity to approved design data and condition for safe operation;
Click to expand...
According to this you're required to verify that the product meets the design data. You need to have records of the inspections/tests performed to verify this.
 
S

spvdj

#4
#4
Al - Are you saying then that we need to perform 100% inspection of all dimensions and/or test of the parts received at the point of Goods receipt to meet the requirements. I am not aware of any organisation who does this
 
A

Al Rosen

Staff member
Super Moderator
#5
#5
spvdj said:
Al - Are you saying then that we need to perform 100% inspection of all dimensions and/or test of the parts received at the point of Goods receipt to meet the requirements. I am not aware of any organisation who does this
Click to expand...
I never said 100% inspection, but you must perform some inspection verify the parts meet the design data. Sample inspection using a C=0 plan of at least critical dimensions.
 
K

Koray

Registered
#6
#6
Actually i have encountered a presentation which may related to this topic. It includes the checks to verify the parts meet design data. Here is the some of it;
"To enable the certifying staff to exercise their responsibilities adequately an effective release to service procedure should include the following checks either directly or by confirming that they have been addressed within the overall business management system.
- That the subject part number(s) is covered by current POA scope​
- That the subject part number(s) is covered by a DOA/POA arrangement​
- That the subject part number(s) is permitted for direct delivery to end users if applicable Contract / Purchase Order requirements​
- That the subject part number(s) are in compliance with the applicable production documents and applicable design data​
- That the applicable design data is approved (e.g. via TC/STC/ETSO or minor change) for airworthiness purposes or will be subject to such an approval for conformity purposes​
- Completeness of all specified and executed production operations Approval and execution of concessions - those concessions that affect fit, form or function shall be stated in block 13 of the EASA Form 1​
- Valid change status (modification, amendment,…)​
- That the part (and packaging where applicable) are appropriately identified​
- Compliance with applicable airworthiness directives​
- Compliance with specified storage terms and conditions (life limited items/time controls are respected)​
- Completeness of specified tests and available test records​
- Visual inspection for damage, corrosion, leaks, etc. "​
 
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