Control of Production Equipment, Tools and NC Programs: 7.5.1.3

[Lorenzo36]

Hello folks,
Ok, production equipment and tools are being validated, it's evident through my observations. Nonetheless, it's not being documented and there is no "documented procedure" as required per the standard (AS9100 7.5.1.3). I've been asked to help production create a procedure, however I would like to see (if ya'll don't mind) how some of ya'll addressed this section of the standard. As I wrote in a previous thread, AS9100 is new to me, most of my career has been in the Oil and Gas (ISO/PED/ASME/API, etc). Any help is much appreciated. Thanks in advance.

 

[Duke Okes]

Seems to me it wouldn't be any different regardless of the industry. Need:

- version/configuration control
- evaluation of condition and maintenance as required
- storage and protection
- ...

 

[Phil Fields]

Hello folks,
Ok, production equipment and tools are being validated, it's evident through my observations. Nonetheless, it's not being documented and there is no "documented procedure" as required per the standard (AS9100 7.5.1.3). I've been asked to help production create a procedure, however I would like to see (if ya'll don't mind) how some of ya'll addressed this section of the standard. As I wrote in a previous thread, AS9100 is new to me, most of my career has been in the Oil and Gas (ISO/PED/ASME/API, etc). Any help is much appreciated. Thanks in advance.

I am not familiar with your standard (AS9100), but what I would look at is:
What does the standard say to do, what are you doing, does it match the standard. Make any adjustments to meet the standard, then document what you are doing.

Phil

 

[Bob the QE]

I too am writing this procedure using the first article inspection as the validations tool (per the standard) so my question has to do with PM's. One reply identified the "storage and protection" to be addressed in the procedure, as does the standard. To what extent would you address this? We are an older precision machining company and I have found cabinets with tooling covered in dust and are told that we save that because "we may use it". I am concerned that this could be construed as not meeting this requirement under the "periodic preservation and storage checks" clause. Any need to worry?

 

[windsal]

per to standard, you need validate the equipment, tool or NC program can meet production requirement. This may via FAI, validation report, etc.

 

[Coury Ferguson]

Hello folks,
Ok, production equipment and tools are being validated, it's evident through my observations. Nonetheless, it's not being documented and there is no "documented procedure" as required per the standard (AS9100 7.5.1.3). I've been asked to help production create a procedure, however I would like to see (if ya'll don't mind) how some of ya'll addressed this section of the standard. As I wrote in a previous thread, AS9100 is new to me, most of my career has been in the Oil and Gas (ISO/PED/ASME/API, etc). Any help is much appreciated. Thanks in advance.

We just went through the Stage 2 Assessment for AS9100, and the procedure we have was acceptable.

My suggestion, is to document the controls, configuration management, validation and verification of the NC program.

Verification is usually accomplished by First Piece or First Article (two different concepts) inspections.

Write the procedure to reflect how you control the configuration of the product, what steps you take, and how you will validate and verify product meets its intended use (validate) and its conformance to drawings and specification (verification).

Just my opinion.

 

[RSantos]

Try this FDA process control document - especially the Installation Qualification/Operational Qualification parts. Lots of nice words to use in a procedure - just ignore the references to CFR 820. https://www.fda.gov/cdrh/qsr/04valid.html.

 

[RCW]

I'm assuming the equipment and tooling being referenced in this clause is big machinery - mills, lathes, solder machines. Hand tools such as pliers, cutters and such would not fall into this clause as requiring validation? Or does it depend?
Also what about crimpers for assemblying contacts on wires? Hand crimpers? Pneumatic crimpers? Or do I need to draw a line in the sand for smaller tooling?

Any comments or suggestions?

 

[RCW]

I'm assuming the equipment and tooling being referenced in this clause is big machinery - mills, lathes, solder machines. Hand tools such as pliers, cutters and such would not fall into this clause as requiring validation? Or does it depend?
Also what about crimpers for assemblying contacts on wires? Hand crimpers? Pneumatic crimpers? Or do I need to draw a line in the sand for smaller tooling?

Any comments or suggestions?

Never got a response on this one? Anybody?????

 

[dsanabria]

Hello folks,
Ok, production equipment and tools are being validated, it's evident through my observations. Nonetheless, it's not being documented and there is no "documented procedure" as required per the standard (AS9100 7.5.1.3).

This is what AS9100C states

"7.5.1.3 Control of Production Equipment, Tools and Software Programs
Production equipment, tools and software programs used to automate and control/monitor product realization processes, shall be validated prior to release for production and shall be maintained.

Storage requirements, including periodic preservation/condition checks, shall be defined for production equipment or tooling in storage."


Where did you read that a procedure is required?