audit nonconformances and findings

  1. W

    Minor Audit Nonconformance Against Determining the scope of QMS

    I need help understanding this nonconformance that my organization was written up for in our IATF audit. I do not know how to answer this corrective action because I don't agree with it but disputing it didn't work so now I have to figure out what it is that the external auditor wants. Here's...
  2. A

    Interesting Read Human Factors as Root Cause

    any suggestions on how to describe human factors as a root cause for a non-conformity without is sounding like "operator error"
  3. P

    Received a minor for not having good measureables/goals. Need help with KPIs.

    "Top Management shall ensure that quality objectives to meet customer requirements are defined, established and maintained for relevant functions, processes and levels throughout the Organization. " So I recieved a minor on this clause. I need to get some measureables & goals together for...
  4. S

    GM/VP softgrading internal audit finding - need feedback from an audit guru!

    Hello, I need a question answered by an auditing guru- we a a contract manufacturer, that performs our QMS internal audits under AS9100D, ISO 13485:2016, ISO 9001:2015 QMS guidelines. One of the auditors noted a nonconformance finding, but our GM/VP overruled this nonconformance finding and...
  5. D

    Product Obsolescence Management

    Our auditor(s) the past two years have really harped on how do we manage product obsolescence. Last year, I didn't have an answer, so they wrote that up as part of our Prevention of Counterfeit system. They encouraged me to join Gidep, and to beef up our Counterfeit Prevention system, which we...
  6. J

    IATF 16949 registration - Major Nonconformance Finding

    Last year was our re-registration year, as we prepared for that audit our Lead Auditor reminded us that we could lose our certification. We had some majors and the auditor came back 2 months later, looked at our corrective actions, closed out the majors, and updated our registration. As we...
  7. D

    Root Cause on Non-Conformity Against Quality Manual

    Hi all, I'm struggling to come up with a root cause on a non-conformity brought up during our ISO9001:2015 upgrade audit. I am new to the company and have taken on the position which was left vacant by my predecessor for 4-6 months. I initially said that the errors were caused by an...
  8. M

    Vernier Calibrations & more

    Hi, We recently had an ISO 13485 2016 change audit. The NB auditor pointed out that we should increase the calibration frequency of verniers that we use daily from once in a year to once every quarter . There was no proper justification given . He just stated that for daily use instruments...
  9. Q

    Is it a NC, if a clause is not declared as non applicable?

    Hello everybody Please give some input on this issue: Im in a reselling company, measurement devices are not needed nor used. I have scheduled an internal audit for the next week. we are declaring with no applicability 8.3 and 8.5.1.f, but I wonder if I should declare 7.5.1 as...
  10. pziemlewicz

    Interesting Read Addressing Human Factors in Corrective Action

    In a recent AS9100D audit, I received one minor NCN: Need to better document how we're reviewing/addressing human factors within the corrective action process. Does anyone have a suggestion of something that works? Has someone seen a customer corrective action request form with an area to...
  11. regork

    ISO 13485:2016 Registration - NC on full cycle of internal audits

    Help, FYI, etc; During our registration audit to ISO 13485:2016 of a medical device software manufacturer we got a minor ding for not completing a full audit cycle on our processes based on the ISO 13485 2016 revision of the standard. Instead of doing the audits, we developed a comprehensive...
  12. A

    CAR from 3rd party AS9100D auditor - Root cause dilemma

    Short explanation. Had transition AS9100D audit, finished last Friday. We had not audited to the new standard. Received a minor nonconformance for not auditing to the new standard. Internal CA issued for me to address. I am the audit coordinator. Last year, January thru May, our Quality...
  13. Sidney Vianna

    Top 10 Major and minor NC's during IATF 16949:2016 Audits

    The IATF has made available some documents from a recent event in London, concerning the transition process @ their website. One of the documents made available presents the top 10 Major and Minor NC's during the transition audits. The document is available @...
  14. S

    Corrective Action from Internal Audits not performed

    We did not complete all of our planned audits for the previous audit cycle. There were several issues, but it mainly came down to we had too many planned for the manpower we have performing the audits. Our auditor is now telling me that part of the corrective action plan is that all of those...
  15. Q

    NC if word "development" stated in Policy?

    Hi guys Could you give some advice on the next issue: If a defined non applicability of 8.3 (design and development) , really dont apply 8.3 Can I include the word "development" in the quality policy to emphasize that even if we dont do 8.3 , we "develop" the product, something like...
  16. G

    Web based tool for benchmarking audit findings

    This may be an older thread, but possibly even more relevant with the requirement to benchmark in the 2015 version of ISO 9001. I’ve been working on a free web-based tool that enables users (management system professionals) to record audit findings which are then sanitised to be shared...
  17. N

    Responding to NADCAP nonconformance - Control of External Documents

    Hi All, we need to respond to a nonconformace "NADCAP" control of External Documents. my boss didn't take the time to read the nadcap checklist for the requirements, he thought that the checklist were optional (tool to assist) rather than actual requirements. "inadequate knowledge"...
  18. M

    IATF 16949 Clause 8.3.5.2 sub-clause (l) - Process maintainability requirements

    Hi Friends, we recently concluded our IATF 16949 audit. During the audit, we received an observation for not having Data for Reliability and Maintainability for Manufacturing process design output as per Clause 8.3.5.2 sub-clause (l). We were under the impression that it is the MTBF and MTTR...
  19. Q

    Minor non-conformance for not controlling local regulation laws?

    Hello everyone. An external auditor auditing compliance with 9001 2015, raised me a minor nc for not referencing anywhere into my qms other standards apart from Iso 9001. The point is, in my policy I state " complying with legal and statutory reglamentation " just to say that if I'm...
  20. Q

    Should I initiate CAPA for a nonconformance not recorded?

    Hi everybody, From the perspective of an auditor: If a have certification audit with external people (in short) And internally I have an nc, and I Know about it. Could I carry out an internal audit, identify the nc and raise the CA of this known nc? This way if the external audit, detect the...
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