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We'll need a sample, sir...

Discussion in 'ISO 19011 - Auditing Management Systems Guidelines' started by Andy Nichols, May 10, 2022.

  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's common for auditors to explain that "the audit is a sample, blah, blah, blah..."

    For internal audits, is this true? If the audit scope and audit criteria are specific to an incident management wish to evaluate the QMS against (did we follow the process or not?) then doesn't the whole "sample" caveat fly out the window?
     
  2. Bev D

    Bev D Moderator Staff Member

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    At least random sample. I think internal audit should rarely use random samples but should use targeted samples to truly assess the system. The company shouldn’t ‘have a fair shot’ at passing an internal audit.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed!
     
  4. John C. Abnet

    John C. Abnet Well-Known Member

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    @Andy Nichols , when I'm performing an internal audit for a client...I certainly let them know that I will be "sampling" because obviously I can not/will not see every instance...every record of evidence...etc.etc... So my answer is "no"....sampling would still apply.
    (even when I was working for an organization and performing or having my teams perform internal audits...although we could/would look specifically at trouble/risk areas...even then it was difficult [impossible??] to ensure all was seen/reviewed.)

    Be well.
     
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So, is the issue that I'm misinterpreting the term "sample"? As a concrete example: A company doesn't suspend production for the 2 weeks when the (experienced) line workers head out on annual vacation. Instead, the company recruits some people to back fill and, during the same timeframe, product quality fails - rejects soar, quality costs spiral. With inexperienced people making product these results might be predictable, but management are left with a dilemma:

    Did these temporary people receive training? Was the process followed? Or, was the process followed, but the result was ineffective? Management need to know so that actions may be planned and taken. In taking "samples" of temporary workforce induction and whatever training was (or wasn't conducted - according to the documented QMS process) the auditor should ONLY keep to those people which were part of the temporary workforce. I don't take that as "sampling". Am I being too restrictive in my application? If 10 people were hired in, then should I look at all 10? If 40, is 10 representative?
     
  6. Bev D

    Bev D Moderator Staff Member

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    If we believe that investigations into events count as internal audits (and I believe that this is the most important and effective form of internal audit) then I think what you are really thinking of is the term random and not sample. Granted many people including auditors are really thinking of random samples when they say sample. When performing internal audits that are investigatory we need to take directed samples. How many is dependent on the situation. We will rarely look at 100% of the process event unless it is a rarely used process.

    In your example it may be sufficient to look at only a portion of the temporary employees but it may be just as easy - and more telling - to look at all of them. I would also say that you would probably have to look at some of the full time employee to determine if it was the training or the on-the-job experience or their ‘natural’ skill level or perhaps even how the supervisor manages the different type of employees. Comparison of good results to bad results is essential in an investigation…
     
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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I hope that that's what ISO 9001, 9.2.2 is alluding to when it requires the "importance" of the process and "changes affecting..."

    I believe you've hit the nail of the proverbial head. I'll research ISO 19011 with that in mind.

    Thanks, Bev!