So we just had a NADCAP audit for Fusion Welding. We got a Minor NCR due to a small oversight on our part and 2 previous auditors. It has to do with a requirement for our customer, Honeywell, in the NADCAP handbook, stating "Within the US, Laboratories must be accredited to AC7110/13. Outside of the US, either AC7110/13 OR NATIONALLY GRANTED ACCREDITATIONS (via government endorsed programs) which specifically cover weld evaluations are acceptable."
We have been using an AWS Certified Facility (Earlbeck Gasses and Technology) for our testing, and have been since the early 80's/90's for all of our testing and when this was brought up by two previous auditors, we looked at it and only paid attention to part of the second sentence, with that being "either AC7110/13 OR NATIONALLY GRANTED ACCREDITATIONS" and the auditors accepted that reasoning. The latest auditor pointed out the first part of the sentence "Outside of the US," and thus issued a Minor NCR (understandable).
The Audit Reviewer kicked back our response ( see below) with "Misinterpretation cannot be used as a root cause. The requirement is clear that Honeywell requires labs to have AC7110/13. The root cause must explain why the company's quality system failed to ensure this requirement was met before outsourcing work to this lab. Once the root cause is known it must be addressed with a permanent corrective action."
Any help on answering this would be appreciated.
Below are our responses:
1.Immediate Corrective Action Taken (Containment Actions)
Stopped production welding in process and re-evaluated requirements. Spoke with management and decided the best course of action would be to requalify all active PQRs and WPQs and archive inactive documents. During requalification of all active PQRs and WPQs, all test plates shall be sent out to Laboratory Testing Inc. 2331 Topaz Drive Hatfield, PA 19440. LTI is a NADCAP accredited facility certified for both nondestructive and materials testing, to include AC7110/13.
2.Root Cause of Nonconformance
Misinterpretation of Checklist Requirement - After interviewing the Quality Manager, the previous NADCAP auditors had seen the destructive testing being performed by Earlbeck Gases and Technologies as sufficient based their AWS accreditations and their status as our Honeywell SCA. The requirement appears to have been interpreted somewhat liberally to this point. Here is what I believe to be the culprit. Reference all caps section of requirement below:
"Within the US, Laboratories must be accredited to AC7110/13. Outside of the US, either AC7110/13 OR NATIONALLY GRANTED ACCREDITATIONS (via government endorsed programs) which specifically cover weld evaluations are acceptable."
I believe this had been deemed acceptable in past audits by way of leaning on the nationally granted accreditations mentioned (American Welding Society), but that is not an allowable substitution as we are operating in CONUS. Moving forward all qualification test plates shall be processed to the "Within the US" requirement of AC7110/13 accreditation.
3.Impact of all Identified Causes and the Root Cause
No product impact, as these tests have been performed and documented as they had been prior to NADCAP accreditation. The facility performing and evaluating these tests is an accredited AWS testing facility, and the evaluations are being performed by Certified Weld Inspectors accredited by AWS as well.
4.Action Taken to Prevent Recurrence
Added "All mechanical / destructive testing of test plates shall be performed by a NADCAP AC7110/13 approved facility." to QP-0720-01, Welder Qualification under section 5.1.2, bullet 5.
Updated qualification test plate routing docs to include AC7110/13 requirement.
Updated PO notes to Earlbeck to flow down requirement of testing to AC7110/13
5.Objective Evidence Attached
Document Change Request for additions to QP-0720-01, Welder Qualification
Laboratory Testing Inc NADCAP Certificate for Materials Testing Lab Approval to AC7110/13
MATERIAL PO - MATERIAL PURCHASED FOR REQUALIFICATION OF WELD PROCESSES
We have been using an AWS Certified Facility (Earlbeck Gasses and Technology) for our testing, and have been since the early 80's/90's for all of our testing and when this was brought up by two previous auditors, we looked at it and only paid attention to part of the second sentence, with that being "either AC7110/13 OR NATIONALLY GRANTED ACCREDITATIONS" and the auditors accepted that reasoning. The latest auditor pointed out the first part of the sentence "Outside of the US," and thus issued a Minor NCR (understandable).
The Audit Reviewer kicked back our response ( see below) with "Misinterpretation cannot be used as a root cause. The requirement is clear that Honeywell requires labs to have AC7110/13. The root cause must explain why the company's quality system failed to ensure this requirement was met before outsourcing work to this lab. Once the root cause is known it must be addressed with a permanent corrective action."
Any help on answering this would be appreciated.
Below are our responses:
1.Immediate Corrective Action Taken (Containment Actions)
Stopped production welding in process and re-evaluated requirements. Spoke with management and decided the best course of action would be to requalify all active PQRs and WPQs and archive inactive documents. During requalification of all active PQRs and WPQs, all test plates shall be sent out to Laboratory Testing Inc. 2331 Topaz Drive Hatfield, PA 19440. LTI is a NADCAP accredited facility certified for both nondestructive and materials testing, to include AC7110/13.
2.Root Cause of Nonconformance
Misinterpretation of Checklist Requirement - After interviewing the Quality Manager, the previous NADCAP auditors had seen the destructive testing being performed by Earlbeck Gases and Technologies as sufficient based their AWS accreditations and their status as our Honeywell SCA. The requirement appears to have been interpreted somewhat liberally to this point. Here is what I believe to be the culprit. Reference all caps section of requirement below:
"Within the US, Laboratories must be accredited to AC7110/13. Outside of the US, either AC7110/13 OR NATIONALLY GRANTED ACCREDITATIONS (via government endorsed programs) which specifically cover weld evaluations are acceptable."
I believe this had been deemed acceptable in past audits by way of leaning on the nationally granted accreditations mentioned (American Welding Society), but that is not an allowable substitution as we are operating in CONUS. Moving forward all qualification test plates shall be processed to the "Within the US" requirement of AC7110/13 accreditation.
3.Impact of all Identified Causes and the Root Cause
No product impact, as these tests have been performed and documented as they had been prior to NADCAP accreditation. The facility performing and evaluating these tests is an accredited AWS testing facility, and the evaluations are being performed by Certified Weld Inspectors accredited by AWS as well.
4.Action Taken to Prevent Recurrence
Added "All mechanical / destructive testing of test plates shall be performed by a NADCAP AC7110/13 approved facility." to QP-0720-01, Welder Qualification under section 5.1.2, bullet 5.
Updated qualification test plate routing docs to include AC7110/13 requirement.
Updated PO notes to Earlbeck to flow down requirement of testing to AC7110/13
5.Objective Evidence Attached
Document Change Request for additions to QP-0720-01, Welder Qualification
Laboratory Testing Inc NADCAP Certificate for Materials Testing Lab Approval to AC7110/13
MATERIAL PO - MATERIAL PURCHASED FOR REQUALIFICATION OF WELD PROCESSES
