audit nonconformances and findings

  1. 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...
  2. 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...
  3. 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...
  4. 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...
  5. 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...
  6. 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...
  7. 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...
  8. 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...
  9. 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...
  10. 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...
  11. 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"
  12. 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...
  13. 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...
  14. 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...
  15. 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...
  16. 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...
  17. 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...
  18. 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...
  19. 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...
  20. 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...
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