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Verbal Evidence for ISO 9001:2015 audit

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Garry Chidgey, Jul 20, 2020.

  1. Garry Chidgey

    Garry Chidgey Member

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    Hi,

    Just wanted some opinions please with regards to verbal evidence.

    ISO details objective evidence as:

    Objective evidence, as defined in ISO 9000, is “data supporting the existence or verity of

    something. Objective evidence can be obtained through observation, measurement, test, or

    by other means. Objective evidence for the purpose of audit generally consists of records,

    statements of fact or other information which are relevant to the audit criteria and verifiable.“

    How can you prove something verbal as verifiable after an audit? For example, during an audit an employee was asked if he could identify the procedure required for purchasing items from external suppliers, something that this person had been doing, it was also part of their role. The employee could not identify the procedure or find it on the system. This was noted on the audit under clause 7.1.6. Organisational knowledge. Post audit, the employee has claimed that he doesn't remember being asked the question and that of course he knew the procedure and where to find it. The end result s that the employee now knows about the procedure and where it is and therefore the audit has served some of its purpose, but where does the auditor stand with regards to enforcing this as verifiable?

    Thanks,
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome, Garry:

    It's long been true (since the earliest ISO editions) that a few Certification Bodies have taken verbal evidence. Typically that means if a "process owner" (the Purchasing manager) says "We do x, y and z." that would be checked against what the people in purchasing, responsible for x, y and z actually do and say they do.

    The main thing any auditor should be looking for is the responsible person being able to demonstrate their competency in the process/activity...
     
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  3. Golfman25

    Golfman25 Well-Known Member

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    What's the point of being able to find the procedure? Why not just have him walk the auditor thru it? That would show the employee's understanding of the procedure which is probably more important.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Because, the documented procedure and what happens are often not the same. Also, awareness of the QMS documentation is an important feature of process control - knowing where to go for the answers, instead of asking the "go to" person is particularly important to avoid "mission creep". I'd ask what the point of writing things down is, if no-one needs to know about where to find it.
     
  5. Brian Buss

    Brian Buss New Member

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    A few comments:
    First, I would have written this as a lack of sufficient evidence of the employees competency. There is more to Competency than there is for demonstration of Organizational Knowledge.

    If an employee didn't know something at 9am, and suddenly knows it at the closing meeting at 4pm and disputes the finding, then under Competency you could have requested a training record showing that the employee had been trained to the latest Purchasing Procedure. If they scrambled to fix the finding between 9am and 4pm, chances are they won't document the training or they will show you a training record dated and time stamped at 10:30am, which just makes their attempt obvious.

    Second, Competency also requires that the organization determines what skills and competencies an employee should have, which is often in a skills matrix, job description, training matrix, so I start with these. It may not be the organization's expectation that an employee knows where the procedure is, but as soon as their job description, training matrix or skills matrix mentions that one of the job requirements is to "purchasing from external providers", then you can ask how this competency is established, and the procedure will probably come up, at which point knowing the procedure contents and location (and change awareness) becomes a firmer position for you as the auditor.

    The other option is to try and have the QA Manager or an observer with you during the audit, a third person, so its not "you say, they say" at the closing meeting. If you sense a possible finding, turn to the auditee and the observer and say, "I believe there may be a concern here, this buyer/operator/engineer etc is not aware of the location of the purchasing procedure. Do you agree that knowledge of this procedure would be part of their job responsibilities?"

    I've never had a client try and "sneak" a solution in to avoid a finding. That organizations got big cultural issues if they did attempt that.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It seems from what you've written, Brian, you are looking for a lot more than is actually required in the ISO 9001:2015 requirements. From what Garry explained, it was a simple case of not being aware of a QMS procedure and then, later, miraculously finding it. I see nothing which suggests that the employee isn't competent or, indeed, needs training - especially in a procedure. I've encountered a few people who can't make head or tail of a set of QMS documents, filed by some arcane numbering system "QOP-PUR-8.4-003 rev 3" and yet they do a bang-up job of buying good things from suppliers they know everything about, performance wise.
     
  7. tony s

    tony s Well-Known Member

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    Where in 7.1.6 that the issue of not knowing where to find the procedure was raised against? The employee may have been doing the job for so many years and have records to show that what they've purchased conform to all requirements. Then, ISO 9001 came, somebody documented what are being actually done by the employee. And just because this employee can't find the procedure, the auditor finds it against 7.1.6? It seems here the auditor, and not the employee, is the one with issues against organizational knowledge.
     
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