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audit nonconformances and findings

  1. F

    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...
  2. 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?
  3. 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...
  4. 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...
  5. 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
  6. 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...
  7. 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...
  8. 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...
  9. 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...
  10. 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...
  11. 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)?
  12. 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).
  13. 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...
  14. 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...
  15. Ed Panek

    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...
  16. 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...
  17. 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?
  18. 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...
  19. 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...
  20. 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...
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