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Audits always are reliable?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Apr 4, 2019.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi everybody
    I was wondering, how reliable an audit can be?
    The way an auditor audits, is , show me this document, give me a phisical evidence,etc.
    However as a result of the audit, he or she only deliver a report, not samples of evidences, I mean a package of evidences, PDFs, photos,etc.
    And how many times we have had discussion about some NC, because not always we have sufficient object evidences to fight the NC .
    What is the right and effective method to audit regarding to show evidences when delivering the final report?
    Thanks
     
  2. Richard Billings

    Richard Billings Active Member

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    An audit is only a snap-shot in time. If auditor identifies a NC he must provide you with the evidence of non- conformance immediately. NC should only be issued when there is repeat issues, although a single issue can result in a NC depending on seriousness of finding.
     
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  3. tony s

    tony s Well-Known Member

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    If auditors stick to the guidelines given by ISO 19011:2018 section 6.4.8 and annex A.18, I believe, the audit findings will be reliable.
     
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  4. Qualmx

    Qualmx Well-Known Member

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    Bu
    But where specifically is mentioned that is required or not to add in an Audit report a package of evidences?:are sometimes needed?
    Thanks
     
  5. Richard Billings

    Richard Billings Active Member

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    Qualmx,
    Auditors notes should be kept as quality records (documented information) and kept on file, in paper or scanned in, for at least one audit cycle. That's how we ensure evidence is available. In our reports we give an overview of the process findings.
     
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  6. tony s

    tony s Well-Known Member

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    ISO 19011 is a guideline document, so, it is not mandatory. You can refer to sections:
    • 6.5 Preparing and distributing audit report (specifically on 6.5.1g);
    • A.18.2 Recording conformities
    • A.18.3 Recording nonconformities
    For CB auditors, it is a requirement by ISO/IEC 17021-1:2015 (at section 9.4.5.3) as stated below:
    "A finding of nonconformity shall be recorded against a specific requirement, and shall contain a clear statement of the nonconformity, identifying in detail the objective evidence on which the nonconformity is based".

    You can also refer to ISO/IEC 17021-1 section 9.4.8.2k, which specifies:
    The audit report shall provide an accurate, concise and clear record of the audit to enable an informed certification decision to be made and shall include or refer to the following:
    k) audit findings (see 9.4.5), reference to evidence and conclusions, consistent with the requirements of the type of audit";
     
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  7. Qualmx

    Qualmx Well-Known Member

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    Thank
    Thanks, Tonys
    But Is it usual fue example,
    I detected in an auditee Is using a document with old revision Is a NC .
    I could write up the NC based on ISO Clause .
    But Is sufficient justo to write up that, document xxxx round with Rev. 3 while in the systematic Is the Rev. 5.
    Or should I get a copy of the document, or a Photo as evidence?
    And as a part of audit report deliver such evidences?
    What Is usual and
    Do exist these type of audits?
    Thanks
     
  8. Richard Billings

    Richard Billings Active Member

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    Qualmx,
    How many documents were sampled and how many out-dated docs were actually in use? For example did you find a single wrong rev in a sample of 25 or was it a single wrong rev in a sample of 5? This may make a difference in your decision to raise it as a non-conformance. Your NC process probably requires root-cause-analysis, corrective action, corrective action verification, etcetera. It will take lots of time and effort to close the NC.

    In my opinion if it was only a one-off finding I would ask them to obtain the latest rev, check what the chages are, and verify if the change had any impact on the process being audited. I would also record it in the audit report with a brief explanation of why it was not raised to NC status. You won't be 'cheating' but you will certainly gain the respect of everyone involved. Too often we auditor's are labelled as 'nit-pickers', 'never give us a break', 'real PRs'.

    Bottom line is you found it, verified that is a one-off, had the problem corrected, and reported it i your audit report.
     
  9. Richard Billings

    Richard Billings Active Member

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    Too much info could be the problem. The operative words being 'could be' the problem. An inspection of PO records would confirm it. There are many variables to consider.
     
  10. Qualmx

    Qualmx Well-Known Member

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    Suppose were 6, the Point Is do we need to keep Photos (documents oudated) o voice recording in the case of interview as evidences?
     
  11. Richard Billings

    Richard Billings Active Member

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    You need evidence to support your audit results. We call it the. 'audit trail'. In my report I would simply state:

    'A random sample of documents was selected to ensure they were of current release per Master List ABC. The sample consisted of 10 Work Instructions, 10'Wiring Schematics, 5 Quality Plans, and 10 Assembly Drawings. One assembly drawing (AD1478)) was found to be the wrong revision (R4 s/b R5. The process manager contacted Engineering and it was determined that the Rev chage had no impact on the assembly process. Correction was immediate. No NC was raised due to the prompt intervention of Engineering."

    Your audit notes should list the numbers of each drawing/instruction in your sample.
     
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  12. tony s

    tony s Well-Known Member

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    Could be against 7.5.3.1a. If you are challenging the "suitability for use". An "old" version may no longer suitable. But to make your finding solid, look for additional evidence on whether the use of the old version led to adverse result/s. This will help you also on addressing clause 10.2.1a.2 (i.e. deal with the consequences).
     

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