OQ, PQ Requirement for Aerospace? Recently purchased CNC

[Document Dame]

Greetings all,

My company recently purchased a CNC and a friend told me we need to have Operational Qualification and Performance Qualification or it would be a problem for us during our AS9100D transition audit.


I know OQ, PQ is a requirement in the medical field, but is it required in the aerospace field too?

Thanks!

 

[Coury Ferguson]

Re: OQ, PQ requirement for Aerospace?

If I understand your question:

Yes I believe...you would be required to perform a First Article Inspection using AS9102, to validate and verify the results of the CNC.

Just my opinion.

 

[howste]

Greetings all,

My company recently purchased a CNC and a friend told me we need to have Operational Qualification and Performance Qualification or it would be a problem for us during our AS9100D transition audit.


I know OQ, PQ is a requirement in the medical field, but is it required in the aerospace field too?

Thanks!

The relevant AS9100 requirements are in 8.5.1.1 and 8.5.1.3:

8.5.1.1 Control of Equipment, Tools, and Software Programs

Equipment, tools, and software programs used to automate, control, monitor, or measure production processes shall be validated prior to final release for production and shall be maintained.

8.5.1.3 Production Process Verification

The organization shall implement production process verification activities to ensure the production process is able to produce products that meet requirements.

NOTE: These activities can include risk assessments, capacity studies, capability studies, and control plans.

The organization shall use a representative item from the first production run of a new part or assembly to verify that the production processes, production documentation, and tooling are able to produce parts and assemblies that meet requirements. This activity shall be repeated when changes occur that invalidate the original results (e.g., engineering changes, production process changes, tooling changes).

NOTE: This activity can be referred to as First Article Inspection (FAI).
The organization shall retain documented information on the results of production process verification.

AS9100 doesn't specifically require First Articles to AS9102. You should verify if your customers require FAI per the AS9102 requirements.

 

[Document Dame]

Thank you folks for the information.

I apologize for my delayed reply, but a broken hip slowed me down a little.

 

[howste]

Thank you folks for the information.

I apologize for my delayed reply, but a broken hip slowed me down a little.

Ouch! I hope you heal up quickly.

 

[Eredhel]

We're also a CNC shop with AS9100. The AS9102 first article is not an AS9100 requirement, it's a guidance in its Annex. But it can often be customer driven. I think you'll find most AS9102 requirements will be part driven, not machine driven. But until you have customers requiring it you don't need to. If an auditor requires it have them "show you the shall". We verify with First Part Inspections and our own internal First Articles, that meets the standard but is not an AS9102 FAIR.