Need some help, folks. We were recently audited to the NQA-1-1989 standard as a supplier audit for a nuclear waste application. As we are not NQA-1 certified (registered or whatever) I do not have a copy of the standard so I asked the customer to make sure to quote the exact phrasology of the standard in their audit report so we could make sure our response to their corrective action requests would meet the standard. Needless to say, what I received in somewhat vague. Can anybody give me a better feel for what the standard says (show me the shall, to quote one of our illustrious members?) for the following?
1. Nonconformance: "XXXXX" software is not validated...there are no records of validation for the "XXXX" software used with the tensile testers.
Their quote from the standard says " NQA-1 Section 12 Determine the program has control measures for tools, gages, instruments, and other measuring and test equipment to be calibrated at specific intervals and adjusted to maintain accuracy within specified limits"
I read program as being our quality system not software program. Can you offer me any insights? My thoughts at the time of the audit as stated to the auditor were: The software was able to read the electrical current used in the calibration of the load cells and convert it into digital readout that could be comprehended by human beings and within the allowable variance of the appropriate ASTM requirements and traceable to NIST.
2. Nonconformance: "Suppliers are evaluated by the use of a mail-in questionnaire and/or ISO 9001:2000 certifications"
Their reference "NQA-1 Section 7 Control of purchased items and services The procurement of items and services shall be controlled to assure conformance with specified requirements. Such chontrol shall provide for the following as appropriate: Source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services upon delivery or completion."
They are telling me that because we do not perform actual audits to our calibration suppliers we are not in compliance with NQA-1. But, we select our suppliers using their registration/certification to ISO 9001:2000, NAVLAB, A2LA, 17025 or whatever other lab certification they hold. We can show that not a single customer complaint has been validated where the root cause of the problem was found to have been the failure to physically go to a supplier and audit them. They say that ISO and all the other certifications do not mean anything to the government, we as their supplier must be held responsible for ensuring for ourselves that our suppliers quality systems.
3. Nonconformance: Purchase orders do not reference quality program requirements or alternatively the supplier's quality manual or program.
Their reference: NQA-1-1989 Section 4 Procurement document control "Applicable design bases and other requirements necessary to assure adequate quality shall be included or referenced in documents for procurement of items and service. To the extent necessary, procuremnt documents shall require suppliers to have a quality assurance program consisten with the applicable requriements of NQA-1"
Once again, we have already approved our supplier based on their quality systems (and our other criteria) and know that they have a quality system (ISO) and lab accreditation (see number 2). We refer to the applicable ASTM specifications that work is to be performed to and NIST traceability requirements, and can show the auditor a copy of, or the Registrar and Certificate number to look up our calibration supplier's certs. I am confused, cuz this seems like redundant work, and just because I don't put it on my PO, doesn't mean that the supplier is going to perform their work outside of THEIR quality system. They even list their certs on the calibration certs we receive. I see this as "to the extent necessary" and since we already know their status....
If anyone can shed some light, or pound this through my thick skull, please jump in here. I just don't really understand where their reference to the standard really backs up their claim that we are in nonconformance? I am sure that I am missing something, and certainly we will change our documentation as needed to meet the customer's requirements if needed.
Thanks in advance, I know my friends at the Cove will set me on the right path.
1. Nonconformance: "XXXXX" software is not validated...there are no records of validation for the "XXXX" software used with the tensile testers.
Their quote from the standard says " NQA-1 Section 12 Determine the program has control measures for tools, gages, instruments, and other measuring and test equipment to be calibrated at specific intervals and adjusted to maintain accuracy within specified limits"
I read program as being our quality system not software program. Can you offer me any insights? My thoughts at the time of the audit as stated to the auditor were: The software was able to read the electrical current used in the calibration of the load cells and convert it into digital readout that could be comprehended by human beings and within the allowable variance of the appropriate ASTM requirements and traceable to NIST.
2. Nonconformance: "Suppliers are evaluated by the use of a mail-in questionnaire and/or ISO 9001:2000 certifications"
Their reference "NQA-1 Section 7 Control of purchased items and services The procurement of items and services shall be controlled to assure conformance with specified requirements. Such chontrol shall provide for the following as appropriate: Source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services upon delivery or completion."
They are telling me that because we do not perform actual audits to our calibration suppliers we are not in compliance with NQA-1. But, we select our suppliers using their registration/certification to ISO 9001:2000, NAVLAB, A2LA, 17025 or whatever other lab certification they hold. We can show that not a single customer complaint has been validated where the root cause of the problem was found to have been the failure to physically go to a supplier and audit them. They say that ISO and all the other certifications do not mean anything to the government, we as their supplier must be held responsible for ensuring for ourselves that our suppliers quality systems.
3. Nonconformance: Purchase orders do not reference quality program requirements or alternatively the supplier's quality manual or program.
Their reference: NQA-1-1989 Section 4 Procurement document control "Applicable design bases and other requirements necessary to assure adequate quality shall be included or referenced in documents for procurement of items and service. To the extent necessary, procuremnt documents shall require suppliers to have a quality assurance program consisten with the applicable requriements of NQA-1"
Once again, we have already approved our supplier based on their quality systems (and our other criteria) and know that they have a quality system (ISO) and lab accreditation (see number 2). We refer to the applicable ASTM specifications that work is to be performed to and NIST traceability requirements, and can show the auditor a copy of, or the Registrar and Certificate number to look up our calibration supplier's certs. I am confused, cuz this seems like redundant work, and just because I don't put it on my PO, doesn't mean that the supplier is going to perform their work outside of THEIR quality system. They even list their certs on the calibration certs we receive. I see this as "to the extent necessary" and since we already know their status....
If anyone can shed some light, or pound this through my thick skull, please jump in here. I just don't really understand where their reference to the standard really backs up their claim that we are in nonconformance? I am sure that I am missing something, and certainly we will change our documentation as needed to meet the customer's requirements if needed.
Thanks in advance, I know my friends at the Cove will set me on the right path.