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audit nonconformances and findings

  1. J

    Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting

    ISO auditing - Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting. Would you say this is true or false?
  2. Q

    Write down same nonconformity in several processes?

    Hi all Please share your opinion in this issue. Auditing a 9001 system. When auditing the responsible of the Management system (Coordinator) in the process management system, it was found that for Some documents, the responsible didn´t follow what the procedure stated. The procedure states...
  3. Q

    ISO 14001:2015 accredited but import most product - CB Raised minor NC on Life Cycle Perspective

    Hi, We import most of our product and do some small assembly here on site. The CB raised a minor non conformance that we had not done a lifestyle perspective and we needed to. This was what the CB wrote: "The organisation has not ensured that requirements that can lead to environmental impacts...
  4. D

    Management of NC after internal system audit

    Hello all, after our internal system audit we have obviously detected some NC. We have in 3 weeks time the official IATF audit and of course it's not possible at all to solve all of them. The responsible of the system is forcing the organization to close all them before the audit because this...
  5. G

    Timing allowed by IATF to close a Remote Site Minor Nonconformance

    Hi, Can anyone find for me documented information related to the timing allowed by IATF to close a remote site minor nc? I am being told that the RSL nc issued has to be assigned to the plant it supports and that the plant's last audit day starts the clock for the RSL. I cannot find anything...
  6. S

    Root cause analysis - The system of developing a work instruction is not effective

    Dear all Plz help me to analyze the root cause against nc got in IATF audit . The NC is ..the system of developing a work instruction is not effective. Incident was - parameter mentioned in wi was not same as defined in control plan.
  7. Z

    CQI-15 Welding System Assessment - Robotic Ultrasonic Foam onto Plastic "Weld" applicable?

    Hello. During our most recent IATF audit, our auditor found that we were not performing a yearly assessment according to CQI-15. This CQI is required by our customer, where applicable. Only problem is we don't have any traditional welding. We use robotic ultrasonic weld horns to adhere foam onto...
  8. B

    How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done.

    How to reply NCR on ineffectiveness of corrective action on Control Plan documentation during IATF external audit? This is repeated issue whereby some terminology mistake was done without proper review by internal team. This is argument on Product Characteristics and Process Characteristics was...
  9. XRAY_3121

    Design and Development Requirement - MDSAP Audit Finding

    Hi all, I work for a company that has no design and development files (they've been making same product with no changes for 50+ years - Lead aprons, dental xray film, etc.). We just had MDSAP audit under Annex II of MDD, so these files were expected. In my initial response I said we would...
  10. R

    Extension of product nonconformances - Construction project

    Hello, I work in construction project quality with various contracts being undertaken in parallel. Inevitably, NCR’s are raised and captured for elements of the works which are not in accordance with the contract. My question is that whilst I’d like to ensure NCR’s are closed in a timely...
  11. F

    AS9100 D - Verification of purchased product - Sheet metal and aluminum extrusion stock

    We purchase sheet metal and aluminum extrusion stock and we accept the material at incoming based on the supplier c of c. Our AS auditor says that does not satisfy the requirement of the standard. The auditor says our receiving or incoming inspector must review the materials composition sheet...
  12. I

    "We don't have enough resources" as an Audit Non-conformance Response

    I was taught during my ISO training that a response from an auditee that "we don't have the resources" to complete a quality related is in itself a non-conformance related to Resourcing and Planning for the QMS. Any input on this?
  13. XRAY_3121

    MDSAP Audit Findings - Document change orders

    I could really use some help from everyone on some audit findings. The first one is on document change orders. We were unable to produce all of the records requested (because the person responsible didn't complete them). They requested 3 DCO's and we only had 1. Yet this was marked as a...
  14. G

    Defect codes and process codes need to be controlled

    We have a Boeing contract for Air Force product. We recently had a Air Force audit and the QAS generated a finding stating, "NCR defect codes and process codes are not controlled." He advised us because we manufacturer/assemble critical safety items and have serialization requirements, the...
  15. R

    Major nonformance finding was given during a closing meeting of a ISO9001 certification audit

    Hi all, New to the forum. Looking for people's comments what immediate actions you would perform if a major conformance was given during a closing meeting of a ISO9001 certification audit? Thanks Raymond
  16. K

    Turtle diagram or process interaction chart - Making it easier for an auditor

    Hello, We recently were audited by our ISO 9001: 2015 CB, it was our surveillance 1 audit. The CB wrote finding: "the process for determining the management system processes was not effectively implemented in all cases". Objective evidence: "The inputs and outputs of each process are not...
  17. G

    Audit finding - Components being transferred inter-plant

    Hi All, I recently completed a course to become an internal auditor to ISO 13485. I also took part in my first audit for the medical device company I work for (I’m in training). During this audit I found components being transferred inter plant ( from one global site to another) but the SAP...
  18. J

    ISO 13485 Audit Nonconformance written against 6.3 Infrastructure

    NC was written - The Requirements for Infrastructure have not been fully documented because despite the fact that there is a governing procedure, the requirements themselves have not been clearly defined and documented. The building, hvac, security, pest control - is all handled by contract...
  19. M

    Issuing NCR for improper method statement submissions

    just wanted to know if you cna issue an NCR for document submittals which are not done propely , in my case our subcontractor had submitted various method statements for a construction project , whch were absolutely rubish nad was techncally not acceptable , showing a lack of knowledge fo the...
  20. J0anne

    90 Day Limit Imposed by NB to complete NCs raised at audit

    An EU auditor has given my client 90 days to complete NCs raised at audit. Does anyone know where the NB got their 90 day rule from? I am guessing it's one of their internal procedures? Although I can't see how it can be possible to apply. For example if a manufacturer needed a new...
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