NADCAP AC7108 and Supplements - Audit Observation

[Randy Stewart]

We received an "Observation" written under AC7108 'C' para 5.4.4.2. "Are SAT's perfromed upon installation and are periodic tests performed Biweekly thereafter unless a different interval is specified by AMS 2750 or customer requirements".
Our oven is used for Embrittlement Relief only and under AMS 2750 para 3.4.1.2.5 it states "If a furnace is used only for embrittlement relief, the frequency may be reduced to semiannually (for SAT's).
We have stated that we use the oven for only ER, we do the SAT's semiannually. I am on my 3rd go around trying to get this OBSERVATION closed.
I believe they are going to make us do the biweekly SAT's or get out of the Temper Etch business.
Any suggestions?

 

[Benjamin28]

Re: NADCAP AC7108 and Supplements

It seems pretty straightforward to me that the applicable section of AMS 2750 satisfies the NADCAP checklist requirement in this instance.

What reason are they giving for rejecting your request to void the "observation"?

Was the oven identified for embrittlement relief only?

I am also curious, is this observation from PRI or from a client audit?

 

[BradM]

Re: NADCAP AC7108 and Supplements

We received an "Observation" written under AC7108 'C' para 5.4.4.2. "Are SAT's perfromed upon installation and are periodic tests performed Biweekly thereafter unless a different interval is specified by AMS 2750 or customer requirements".
Our oven is used for Embrittlement Relief only and under AMS 2750 para 3.4.1.2.5 it states "If a furnace is used only for embrittlement relief, the frequency may be reduced to semiannually (for SAT's).
We have stated that we use the oven for only ER, we do the SAT's semiannually. I am on my 3rd go around trying to get this OBSERVATION closed.
I believe they are going to make us do the biweekly SAT's or get out of the Temper Etch business.
Any suggestions?

Challenge them.

Randy, are you saying the System Accuracy Test is the SAT? What kind of monitoring equipment do you have installed? I would think if you have monitoring equipment recording high/low/ average?

How long have you been performing uniformity surveys and have you established consistency in them? Have you made any major (minor) equipment changes?

 

[Randy Stewart]

We have not had any equipment changes, have not had a calibration, Accuracy or Uniformity failure in 3+ years. We have written preventive maintenance procedures, digital controllers, a chart/graph recorder, high temp shut downs, 1 sensor for 1 work zone, etc. etc.
The other part that gets me is, that if we didn't do passivation AC7108 wouldn't be applicable. We would have to be in compliance with AC7108/2 for the Temper Etch only (no findings from the auditor un 7108/2). However, since we do passivation AC7108 comes into play. But here is the catch, this oven has nothing to do with the passivation process!!!
I'm at a loss.
We experienced another issue with the "signed employee evaluation". They rejected our response so we called to see what was acceptable and where the requirement was for the signed eval. We were told that there is no requirement but that they wouldn't accept anything less! Go figure.

 

[Randy Stewart]

BTW, Benjamin. It was from the PRI Chem Process audit.

 

[Benjamin28]

We were told that there is no requirement but that they wouldn't accept anything less!

That response is ridiculous, PRI does not make the rules here, they audit to the standards set forth by consensus representation from primes within the industry. I would rock the ship on this one and try to speak with someone higher up in PRI, if there is no requirement the item should be a recommendation at best.

As to your original response, it should be accepted as closed or voided based on the data you've provided, again I would take this up with someone higher up in PRI. At the very least I would be on the phone with their staff engineer to get a better idea of what he/she expects.

This is straight from their site, so don't be timid in contacting them.

"In addition, please contact your Staff Engineer because open communication is key to success in Nadcap. The Staff Engineer may be able to give you recommendations for what can be submitted now or at a later date"

 

[andygr]

The one fall back PRI stands with for grey areas is that they are not making you go thru the audit your customers are. It is the same customers that create the questions and guidance given to the auditors and staff engineers to use.
The Chem group has just started to use "observations" and I do not see any procedure that covers this use in eauditnet currently published by PRI. At best the observations should only be identifed in the cover letter and if the staff engineer thinks they are actualy a finding make it formal by putting them into eauditnet with his justification. Clarification issues such as this should be covered in a discussion forum available on eauditnet that not all groups at PRI use for what ever reason.
But I am not in charge of shuch things so we deal with the hand we are delt.

Right or wrong as with any interaction with anyone the aproach you take will always infuance the outcome. I would start by taking an objective look at how your responses to the staff engineer might have been taken or misunderstood.

All that said you have the right and can ask that the staff engineer to present your views to the task group for review and concurance of accepting what you have provided or voiding the entry. You can do this by email but I like to have such a request documented in eauditnet for all to see but the down side is it burns a round of response.

Remember you can voice your opinon in person the week after next if you are in Pittsburg at their meeting.

 

[Randy Stewart]

Remember you can voice your opinon in person the week after next if you are in Pittsburg at their meeting.

Funny you mention this, I'm on vacation that week and my son just came in from Iraq on Sunday. He's in New Castle PA, which is about 45 minutes from Pittsburg! I thought about stopping in.
What all started this was that AC7108 has been revised and mentions the biweekly SATs, whereas AC7108/2 in the section for Temper Etch only requires the semiannual SAT. We contacted a Staff Engineer with the auditor and he told the auditor to make it an observation. After our initial response was rejected with this response: "While a formal response, with all required topics, is not required for an indicated observation, sufficient information is needed to understand how checklist requirements are met. Please address this concern for how the performance of SATs twice a year meets the requirements of checklist item 5.4.4.2 of AC7108".
We contacted the review staff eng and was told he needed more information. We sent: "Auditor is seeking to apply AC7108 to Supplier's embrittlement relief oven. This oven is covered under AC7108/2 PRI staff engineer agreed that supplier's oven is audited to AC7108/2. The auditor did not fully understand the application of AMS 2750 to embrittlement relief ovens and wrote an incorrect observation.
To Which we received the reply: ". . . the scope of the 7108/2 document defaults to the requirements of 7108 when questions are repeated on the /2 sheet. With this clarification in mind please readdress this NCR in the required format and identify what will be done to address the checklist item designated for the this NCR item 5.4.4.2."

So now we have an NCR and not an Observation.

 

[ISAN16]

I received a minor NCR on PRI audit, and the auditor ask a lot on this.

Finding: No evidence of calibration on tape test roller utilized for wet tape test. Tape test roller not listed in calibration recall system.

Immediate Corrective Action Taken (Containment Actions):
-Labelled the batch number and manufacturing/expiry date at the tape #250 based on vendor Certificate of conformance (CoC).
-Rescreen all in-house consumable materials used at lab/prod/chemical store for any traceability and shelf life control needed Other consumable material reviewed against AC7108 rev F to identify any miss out of the shelf life control or tracebility.
No further consumable material is found miss out to label the shelf life or not
traceable to physical material. Up to date, only material tape #250 was missed out.

Root Cause of Nonconformance:
Internal procedure, SOP-D-04, for MIL spec consumable material shelf life control did not clearly identify items to be recorded and control. Do not aware the shelf life control and physical part tracebility are needed for Mil spec consumable material apart of the chemicals.

Impact of all Identified Causes and the Root Cause:
No impact. The NCR concerns recording of certain material traceability and shelf ? life control. Vendor?s CoC has shown acceptable adhesion strength and date of manufacturer (DOB) and is valid to use.

Action Taken to Prevent Recurrence:
Internal procedure, SOP-D-04, to include Mil spec consumable material shelf life control to be properly control and ensure the physical part is traceable to certified document.
Training provided on shelf life control to the lab/QA/Chemical store person incharge.

Objective Evidence Attached:
Attached the photo of tape 250 with traceable to batch number and shelf life control.
Attached the training record of the shelf life control.
Attached the SOP-D-04 to include Mil spec consumable material.
Attached the tape CoC.


This is the reply from PRI auditor.
Action to prevent recurrence:
- Training of present employees is not on its own a systemic fix. How will your system ensure that future rolls of tape, potentially labelled by new employees, are labelled per the example attached?

My question is can I answer by doc con the label format? please open discussion and advise is needed as I still new in this area.