Re: AS9100 clause 7.5.1.1
In regards to AS9100 clause 7.5.1.1 states in part 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 capable of producing parts and assemblies that meet requirements.
The question I have is that we received a minor non-conformance as we do not do First Article Inspections. We build custom support tooling for the airspace industry and nothing is mass produced nor do we build anything that is a fly away part. The type of tool's we build are drill jigs, layup mandrels, Assembly jigs, work platforms etc. Is it necessary for us to do a first article inspection??
We currently do 100% inspection and also collect material certs for all jobs build and any special processes are only given to suppliers on our approved vendor list and we flow down all requirements.
I am just trying to see if I have a leg to stand on as I do not feel based on the type of tooling we do that this is needed and this is more geared to production runs. My major concern is loosing jobs due to the additional cost associated with this.
Any help would greatly be appreciated.
You are caught in the middle of a somewhat controversial and often misunderstood requirement.
What is awkward is that many believe that 7.5.1.1 means that you have to adhere to the requirements of AS9102 which is specifically about first article inspection. Just for your own enlightenment, you should get a copy and read it so you understand what is required when you do have a customer that requires first article per AS9102. It would also be wise to see what is there so you understand the connotation that rides along with the term "First Article".
Please note that AS9100C does not require that you adhere to AS9102. Instead it provides its own definition of first article, a definition that falls way short of what is in AS9102.
For convenience sake, many companies use the forms provided with AS9102, but this is not a requirement of AS9100C. Sometimes it is a customer requirement though. Some auditors seem to believe that if they don't see those forms, or at least something very similar, that you are not practicing first article and are not adhering to the requirements of clause 7.5.1.1, while it is possible that you may be doing so.
Clause 7.5.1.1 does not require that you have a written procedure for the topic, nor does it have a requirement for maintaining records. It doesn't even require that you call this activity "first article". A very difficult thing for many auditors to get over is the mistaken belief from days long past that they need to see some sort of paperwork for every clause to prove that you are living to it. That is not true, and when you don't have any such documentation for clauses that don't need it, the auditor needs to determine your actual practice from observation and interview. Did this happen? Did the auditor simply see the lack of paperwork or did he attempt to determine your actual practice of meeting clause 7.5.1.1?
Can you demonstrate, from the records you do keep, including what is needed for clause 8.2.4 (monitoring and measurement of product), and from your actual practice, that you do perform something that meets the requirements of 7.5.1.1?
If you haven't truly thought it through so your intent to meet 7.5.1.1 is either weak or nonexistent, this could be a legitimate nonconformance. If you have thought it through, and you do meet the requirement use a representative sample of the first production run (a sample of one of a production run is 100% inspection is it not?) to verify that the process, documentation, and tooling are capable of making the part to specification, then you have met the requirement of 7.5.1.1.
Pay attention to the note at the end of 7.5.1.1: This ACTIVITY is often referred to as first article inspection" (emphasis added). ACTIVITY, not SET OF DOCUMENTATION. May I repeat that this activity doesn't need to be called "first inspection".
So if you believe you met the requirement then protest the finding. If you believe that you may not have thought it through well enough to claim that you have met the requirement, accept it, resolve it, and move on with life.