audit nonconformances and findings

  1. 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...
  2. 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...
  3. I

    Audit Nonconformances - Can reported corrective actions be incomplete?

    If you receive non-conformances during an audit, then you need to report back within a certain time frame on the corrective actions. Do the corrective actions need to be completed when you report back or can they be in-process (i.e. ongoing)?
  4. I

    What if your root cause analysis is -- they just didn't do it?"

    If you have a situation where a non-conformance is issued and the real root cause is "they just didn't do it" what do you write? Training issue? Insufficient resources? (that would just lead to another non-conformance).
  5. J

    EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances

    Hello Everyone, I have a questions - We recently had a audit for ISO recertification and product registration. We had 10 minor conformities and the notified bodies informed us that we have demonstrated the capabilities needed to apply for Annex II conformity assessment route. So this will...
  6. PastorBee13

    IATF 16949 Audit Nonconformance Responses per - Format

    I have a couple non-conformances to respond to from our IATF 16949 audit a few weeks ago but I'm unsure of the best format to use for the responses. Fortunately, my auditor was kind enough to simply state a section of the rule book. Unfortunately, I only have the mini version of the standard...
  7. E

    Root Cause CAPAs from internal audit

    We recently upgraded our QMS to ISO 13485:2016. Prior to that we had an internal audit performed by a consultant. We have 5 minor non conformances relating specifically to the new 2016 standard. In our root cause analysis I would like to present the idea that we knew there was a risk in moving...
  8. W

    Closing of Stage 2 Audit Nonconformances

    Hi Group, So i am set to close out my NC's from my current Stage 2 ISO/AS9120B audit next week. Couple questions came up that I am hoping some experts like you all can shine some light on. 1. I have 7 MI & 1 MA NC's, since having a MA in contract review the auditor has to do a "on-site" audit...
  9. A

    What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list?

    what iso 9001:2015 clause could be used to write nonconforming for not updating licensed driver list?
  10. B

    IATF 16949 FAQ #7 Audit Finding - External Calibration Laboratory

    Hello! Long time lurker to this forum, decided it was finally time to get my feet wet by sharing a recent experience. IATF FAQ #7 for External Laboratory states: QUESTION 1: When can the equipment manufacturer be used to calibrate inspection and test equipment? If an accredited laboratory...
  11. B

    ISO 9001:2015 6.1.1 b - Enhance desirable effects - No opportunities were addressed

    Our CB Auditor issued a Minor Nonconformance stating "Risks identified show enhancement of desirable effects, and no opportunities were addressed." This was a recert audit. He is recommending us for recert, but the NC has to be addressed. Regarding opportunities, we just need to do a better...
  12. K

    Audit without a QA/RA Representative

    Due to some unfortunate circumstances our QA/RA manager had to leave last month. Unfortunately, we're due for an audit for ISO 13485:2016, in a few weeks and have yet to find a replacement (we're still going through interviews). The rest of the team can pick up much of the slack, but we've...
  13. S

    Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness

    I was recently given a noncompliance against ISO 13485: 2016, clause 6.2 Human resources because of the NOTE " The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided." I am a contract converter...
  14. A

    API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance

    Hello all! I have recently participated in my re-certification audit for API Q1 9th edition. The following was first deemed an Observation then later upgraded to a minor NC. The finding is listed below. Keep in mind that we have identified 22 separate processes that need to be audited annually...
  15. D

    Minor non-conformance for not receiving a CofC from a heat treater

    We have been ISO Certified for over 20 years and AS certified for 6. We have had the same Auditor for 5 years. During our most recent recertification we were issued a Minor non-conformance for not receiving a CofC from a heat treater- for the Rockwell hardness test - indicating the readings. We...
  16. A

    Where are the rules for when a repeat minor nonconformance becomes a major?

    Can someone answer a question I have had for some time? If a CB auditor issues a "minor" non-conformity and a year later at a subsequent visit discovers a similar "minor", (same clause or part of the QMS) the "minor" automatically becomes a "major"? I have reviewed the Rules and I can only find...
  17. R

    ISO 9001:2015 9.3 - Required inputs to the management review - Audit Nonconformance

    Good morning, just had our ISO audit and i had a CAT2 minor on Clause 9.3, The Non-Conformance was set as follows; Some of the required inputs to the management review are not always visible and/or included in the meeting minutes. Examples include the effectiveness of actions taken for risks and...
  18. P

    Major Finding Elevation - Do I elevate this minor finding to a major one?

    Do I elevate this minor finding to a major one ? There was an NCR written up against 8.5.4 C. in 2017 8.5.4.C special handling and storage for sensitive products. There was an ESD control and Nitrogen dry box issues on sensitive material. No expired shelf life material found. C/A and...
  19. K

    Which clause would best fit this Nonconformance? (Supplier Related)

    Hello! I am an internal auditor to an organization that is certified to ISO 9001:2015, IATF16949:2016, and AS9100D:2016. I wont go into the specifics, but, we test some of our supplier product through the use of a spectrometer. When covering receiving inspection for all three standards...
  20. S

    Adding Value prior to signing EASA Form 1

    We have recently received a NCR from an EASA Part 21G audit from the CAA because we could not clearly demonstrate we were 'adding value' to issuing an EASA Form 1 for the release of a part that we buy in from an approved supplier who are not EASA Part 21G approved. When we receive the item...
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