I have a similar question. Last year we purchased new ESD monitoring equipment for our warehouse and this year the auditor is stating that we need to have this vendor on the approved supplier list and that they don't meet our criteria because we don't have a quality questionnaire as per our required set up criteria. We didn't get that information when we set them up originally because we considered them a "non-aviation" vendor because we are only using them to procure the ESD monitoring equipment and not material we are selling to our customers. I assume she is saying that they need to be on the ASL because it is something that we use in our processing center and could affect the conformity of the part but we were viewing it the other way being that they aren't supplying us product that we are selling to our customers.
AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List?
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Does the auditor expect the manufacturer of the inspection, measuring and test equipment also to be in the ASL? For sure, calibration labs should be, but the manufacturers of the equipment?
What about the manufacturers of the production equipment you purchase? Equipment such as Solder Paste Screen Printer, Pick and Place Machine, Reflow Soldering Equipment, Solvent Cleaning Equipment, etc. Does she expect the manufacturers of those devices to be in the ASL? Ask her where does she draw the line....
If I were you, I would reach out to the CB Aerospace Technical Manager (or equivalent) and ask for a CB formal position on where the line is drawn in terms of "suppliers" that need to be approved. Otherwise, some misguided soul (and there are many in the auditing world) will expect your organization to list the ISP, the utility company you get electricity from, the external legal council firm, etc....to be in the ASL.
Look at the IAQG document what provides AS9100 clarifications @ https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf
One of the clarifications reads "...The 9100-series requirements in clause 8.4 are applied to the organization’s external providers that affect process, product, or service conformity. ..." If the auditor tries to reason that the ESD monitoring equipment should be on the list, then the manufacturer of the delivery truck that your company owns should be there too. There is no Risk Based Thinking without common sense.
What about the manufacturers of the production equipment you purchase? Equipment such as Solder Paste Screen Printer, Pick and Place Machine, Reflow Soldering Equipment, Solvent Cleaning Equipment, etc. Does she expect the manufacturers of those devices to be in the ASL? Ask her where does she draw the line....
If I were you, I would reach out to the CB Aerospace Technical Manager (or equivalent) and ask for a CB formal position on where the line is drawn in terms of "suppliers" that need to be approved. Otherwise, some misguided soul (and there are many in the auditing world) will expect your organization to list the ISP, the utility company you get electricity from, the external legal council firm, etc....to be in the ASL.
Look at the IAQG document what provides AS9100 clarifications @ https://www.sae.org/iaqg/projects/9100-2016_clarification_table.pdf
One of the clarifications reads "...The 9100-series requirements in clause 8.4 are applied to the organization’s external providers that affect process, product, or service conformity. ..." If the auditor tries to reason that the ESD monitoring equipment should be on the list, then the manufacturer of the delivery truck that your company owns should be there too. There is no Risk Based Thinking without common sense.
We are only a distributor approved to AS9120 so we don't have any production equipment. My boss did ask if we needed the same for our Air Conditioner repair guy because if the A/C goes down it could affect the "conformity" of the part as well and she said we wouldn't need to have him on our ASL so I don't know what her reasoning is. She dinged us last year for not having the ESD monitoring equipment calibrated and for taking an exclusion to 7.1.4 because we were assuming that it meant for any equipment that was used to inspect, measure or test and didn't think it included the equipment that is used to assure there is no electro-static shock to the material in the process of inspection (not that we use it for inspection, measuring or testing)
7.1.4 relates to the environment and if you handle ESD parts, the ESD monitoring equipment should be verified periodically. Look at ANSI/ESD S20.20 and JEDEC JESD625.
Agreed, if you are handling ESD sensitive parts you need to make sure you are handling them with appropriate care which may include proper grounding and maintenance of the grounding monitoring equipment.
What I think is at question here though is would that supplier have to be approved. For that I refer back to 8.4.1a:
"The organization shall determine the controls to be applied to externally provided processes, products, and services when: a) products and services from the external providers are intended for incorporation into the organization's own products . . . "
Based on that, I would say they probably would not need to be an approved supplier. That said, it would be a wise business practice to approve and monitor them, but it appears that the standard does not require it.
What I think is at question here though is would that supplier have to be approved. For that I refer back to 8.4.1a:
"The organization shall determine the controls to be applied to externally provided processes, products, and services when: a) products and services from the external providers are intended for incorporation into the organization's own products . . . "
Based on that, I would say they probably would not need to be an approved supplier. That said, it would be a wise business practice to approve and monitor them, but it appears that the standard does not require it.
Anyone who agrees that the manufacturer of ESD gear monitoring equipment must be in the ASL is on the slippery slope path. because, if that were the case, then the manufacturers of ALL and ANY production, transportation, servicing, etc. equipment should also be listed in the ASL (and all of the implications of that). A line must be drawn somewhere and hopefully before common sense and RBT fail to work.
The auditor in question is reporting a bogus NC just to tally up some nonconformities in her report and not be deemed a "soft grader".
The auditor in question is reporting a bogus NC just to tally up some nonconformities in her report and not be deemed a "soft grader".
