Quality Escapes Procedure (requirement for FAR 21.137 (n)) needed

J

James2170

#1
I am looking to see if anyone has a Quality Escapes Procedure (requirement for FAR 21.137 (n)- A procedure for identifying appropriate corrective action for products that have been released from the quality system.

Thanks for your help.
 
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#2
I am looking to see if anyone has a Quality Escapes Procedure (requirement for FAR 21.137 (n)- A procedure for identifying appropriate corrective action for products that have been released from the quality system.

Thanks for your help.
I'll assume you already have an established quality system which includes a corrective action procedure, MRB and your inspection system?

Generally the MIDO is looking for an FAA approved procedure or work instruction tied to your quality system that describes the following.

1- Written notification to the FAA that product(s) have escaped your quality system- A Self Disclosure will do under the VDRP FAA Order 2150.3B and AC 00-58B. (The FAA will usually issue you an EIR anyhow)

2- Reinspect process, purge/quarantine current stock of affected product and process for MRB the affected product to ensure airworthiness

3- Notification to supplier or SCAR to the supplier if they caused the escape and have notified you (You still have to manage the process if the supplier's products went through your quality system and made it fielded A/C)

4- Corrective action to fielded A/C and to product in-house (follows your MRB process)

5- RRCA

Note that if an OEM which is typically the TC holder notifies you of an escape, then it's should be their responsibility to manage the FAA notification process. In this case, it makes it much easier to manage as the OEM will likely be doing most of the leg work.

This should get you headed in the right direction.
 
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