Are the IQ OQ & PQ procedures applicable to the aerospace industry?

DuncanGibbons

Involved In Discussions
#1
Is Installation, Operational and Performance Qualification applicable to the aerospace industry or are there different procedures required when installing new manufacturing systems?

Thanks
 
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DuncanGibbons

Involved In Discussions
#3
The Aerospace Industry, in general, relies on First Article Inspection type methodology. And special processes also need to be validated in-house and, as a rule of thumb, go through Nadcap approval.
Hi Sidney, thanks for the reply.

The methodology I am currently working on is a "roadmap" to certification, if you will, for special processes such as additive manufacturing.

From my understanding is that FAI is more for certification of the process (design specific process). As for Nadacap, the audit criteria for AC7110/14 (the additive manufacturing certification) makes little to no mention of machine installation or operational qualification. It is also very focused on process qualification and auxiliary and environmental factors.

I am therefore developing a certification process that goes deeper than the FAI and Nadcap. Below is a high-level roadmap I am theorizing:

Facility qualification -> FAT at machine OEM -> SAT at customer facility -> Installation qualification -> Operational qualification -> Performance qualification (whereby requirements of MMPDS are met statistically) -> AS9100D certification -> Nadcap accreditation -> Process qualification (including FAI for specific design) -> and so forth.

From my understanding of the IQ OQ PQ process as per the medical industry, it aims as the machine specifically, with only the PQ process delving more toward the process.

Would this be an acceptable method for addressing machinery within the aerospace industry?
 

DuncanGibbons

Involved In Discussions
#4
The Nadcap audit criteria just state that there need to be documented procedures for equipment qualification. I'm presuming the IQ OQ PQ procedures could be classified as equipment qualification?
 

Ajit Basrur

Staff member
Admin
#6
The IQ, OQ and PQ are just concepts and could be applied across other segments as well. I have used it in the Consumer&Electronics, Automotive, and Packaging, As long as you could satisfy the specific aerospace requirements, you could definitely use the IQ, OQ and PQ to strengthen the process. I am not an aerospace expert but expressing my thoughts from a quality systems perspective.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
Informational:

IQ OQ PQ comes in three stages:

IQ - installation qualification
OQ - operational qualification and
PQ - performance qualification

IQ - Verify the equipment is installed correctly, training, utilities, could include DoE for new unfamiliar processes, SOPs, risk analysis, preliminary control plans etc etc

OQ - Testing "worst case parameters" - basically define the worst case settings for the particular process and ensure it still gives acceptable results - i.e. for an ultrasonic cleaner it could be lowest temperature, lowest frequency and lowest solvent concentration.

PQ - This ensures the process is repeatable - to do this you would have to define a statistically relevant number of production runs of typical batch / lot sizes. Although often I used the "three batch rule" - running 3 batches of the largest & smallest parts in a product range. The 3 batch rule isn't recognised officially anywhere as far as I know. This is all done under normal manufacturing conditions - i.e. no special inspection - everything as it would be in full production.
 
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