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What is "Input"?

Discussion in 'ISO 19011 - Auditing Management Systems Guidelines' started by Andy Nichols, Apr 4, 2022.

  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can anyone shine a light on what are the inputs to an Internal Quality Audit process? I've read ISO 19011 and see that it refers to auditing as a process - which, by definition must include inputs - but the flow chart only speaks to establishing audit programme objectives, but what are the inputs? What's being transformed in planning the audits
     
  2. Miner

    Miner Moderator Staff Member

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    The standard(s) to which you will audit. The processes to be audited.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hmmmm. If we consider that a process transforms the inputs, what happens to the standard? The standards are requirements for the QMS, from what I understand, not for the internal audits...
     
  4. Miner

    Miner Moderator Staff Member

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    A specific requirement within the standard might be transformed into audit questions to be asked. Prior audit results might be used to assess risk and transformed into an audit frequency and/or audit sample size.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    To be perfectly honest, I'm really struggling with wrapping my head around this. I checked with ISO 19011 and it's avoided the whole issue. Instead it talks about the objectives of the audit programme, but since it's also defined an audit as a process where's the description of the inputs? Nowhere to be found, except in the improvement section! It's a bit late putting it there!
     
  6. pkfraser

    pkfraser Active Member

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    Andy

    Why do you stick with the old, flawed and unhelpful definition of a process?(!) Even ISO have given up on it.
    A process starts with a trigger event and tries to achieve an objective. Occasionally there may be something put into it from outside the process, but it is more likely that something(s) will be taken in to it by those working in the process (not that ISO have yet grasped the difference between "put in" and "take in"). Resources are probably of more concern - what is needed for the process to function effectively?

    And please save us from the need for "transformations"! Most times you want to preserve what you have, not transform it...
     
  7. Bev D

    Bev D Moderator Staff Member

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    This feels a bit like arguing how many angels can fit on the head of a pin…

    Most processes do transform inputs to outputs - certainly most manufacturing processes do. Outside of manufacturing the verb transform is a bit if a stretch but the process (actions taken and results expected) can be defined. Inputs or ‘initiating events’ can also be defined. e.g. The hiring process is initiated by the receipt of a request to hire / fill an open position. To state that we are transforming a human candidate into a human employee is a bit like stuffing someone into spanks to make them look thinner.

    A second thought: auditing a process is just like inspecting product for compliance to specifications. The only real transformation is when initiated when the thing being inspected is to determined to not be in compliance…

    A third thought: (third cup of coffee this AM!) If we can see no real transformation (in the classical definition of the word) we should be questioning whether or not the process is value-add (in the strict definition per ‘Lean’/TPS) or if it is really necessary.
     
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I totally get that, Peter. I understand your antipathy for transformation, however, in processing, something is done, effort (in some shape or form) is expended.

    I find it paradoxical that ISO 19011 provides ZERO guidance on what "triggers an audit programme to be initiated and what stuff is useful to take in/put in/gather up in that initiation. Indeed a quick word search shows that the word "input" only appears in the clause on improvement - shutting the stable door, methinks.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Totally Bev. Although apparently a pure academic exercise on my part, I'm researching how internal audit programmes get started and why they subsequently fail - and am concluding a number of things which don't pass the "sniff test" IMHO. Maybe Internal Audits, like a couple of other requirements in ISO 9001 aren't actually processes, for example. Maybe ISO 19011 is written by external auditors for external auditors because they haven't actually ever done a true internal audit (merely emulated the external kind - which is what they were taught in Lead Auditor class).

    I admit it, I have no life outside of pondering these things. Does that make me a sad case? :D
     
  10. pkfraser

    pkfraser Active Member

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    Folks
    Sorry, I am a bit distracted by the thought of Andy in Spanx...!
    Bev - I agree that something (raw material) is usually transformed in a manufacturing process, but this is where ISO went wrong when they tried to apply their logic to services, and worse when supposedly intelligent managers try to justify the definition. For example, in the process of storing goods awaiting delivery, the last thing the customer wants is for them to have been "transformed". I have seen "the passage of time" quoted as a transformation - all because the definition doesn't work.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    :eek:
     
  12. Bev D

    Bev D Moderator Staff Member

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    I understand your frustration. Not only does the suite of ISO standards poorly describe the purpose of internal auditing, most organizations simply default to the external audit model. Where the standards do describe internal auditing they tend to mimic external auditing as well. This yields to a huge amount of effort that yields little to no substantial improvement although it does increase the animosity of the rest of the organization towards QA due to the trivial nature of most ‘findings’/corrective actions. The two most egregious ‘requirements’ are the schedule and auditing for compliance.

    I have suggested to various QA departments that we would be better served if:
    We initiated audits based solely on not meeting productivity or quality goals. In other words, utilize the Pareto principle to go after the processes that will yield the most substantial results.
    Corrective actions should be based on the effect to productivity and quality. (No more CAs because someone didn’t initial a line on a form…).
    Group audits with real experts should count as “audits”. An example of this is the work done under the auspices of Toyota Production System that draws out the process, identifies wastes, uses actual data and initiates actions to increase the value-add (reduce the waste) of the process.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Paradoxically - considering the ultra-low profile that the document has, especially compared to ISO 19011 (which one might reasonably expect to provide guidance) - ISO/TC 9002 has details. Hooray for THAT committee!
     
  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I agree with Bev:
    Input for auditing is information that the auditor intakes (personal observation, review of documented information, interviews). Transformation is the analysis (comparing to requirements) and the output is the reporting/resulting feedback, including nonconformities (if any).

    We usually think of processes involving tactile things but in this case it's not; doesn't make it less of a process. We could fill out a turtle diagram with its factors.
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sorry, don't agree. I'm asking about the input(s) to the audit programme, not to the activities of auditing. Internal auditors don't decide what to audit. Yes, they should sit down with documents etc. before their audit assignment, but who decides what the audit programme (one or more audits) is going to consider regarding scopes, criteria, timing, duration, auditor assignments and so on.

    This is why Lead Auditor training is failing organizations when they send someone to get trained. The whole thing is predicated on a 3rd party audit - which by definition isn't an internal audit. Even Exemplar Global don't understand that, and their Lead Auditor course content is littered with references to 3rd party auditing (probably less than 10% of people going to such training will ever become a 3rd party auditor.)
     
    Last edited: Apr 8, 2022
  16. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Andy, your original post asked about the process, not the program. A series of planned audits are execution of process that combine to make a program.

    The input for an audit program are interested party requests and requirements, top management needs and requests, results of previous audits and process performance. Just like the standards state. These inputs are transformed into audit planning, which can be annual (and usually is) but also include on-demand audits for verifying effectiveness of actions (which I hardly ever see happening). The further inputs of the audit program include the results of the process audits themselves, which then are transformed into data for top management.

    This has nothing to do with Lead Auditor training as I have seen it delivered, since a manager of an audit program doesn't necessarily need Lead Auditor training (though in my view it wouldn't hurt) if he/she is not doing the audits. It could be the QA Manager or the Management Rep.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So to be clear, the programme isn't planned? Only the audits?

    Which ones? Where?

    I'm expressing my experience, based on 16 years of teaching an IRCA and RABQSA (now Exemplar Global) Lead Auditor course, plus very recently accessing the latest course content requirements. Add to that the countless client engagements where I assist clients who need to help resolve an issue/upgrade their system/do an audit etc. There's a common theme. CBs who run their version of Lead Auditor training. You cannot ignore it's an external model used by a majority of people who ONLY do internal audits. There is NO training or qualification on Audit Programme Management available.

    It's been the single most popular form of auditor training and it is at the very foundation of why internal audits aren't implemented with any benefit to the organization beyond keeping a certificate on the wall.
     
  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Andy,

    Certainly an audit program is planned, but your original question was about process. I'm responding to what's on the screen.

    9.2.1 of ISO 9001 says internal audits are to be conducted to provide information on ... (there's the output) whether the management system conforms to the requirements of the standard and the organization's requirements. The same language appears in ISO 14001, RC 14001, and ISO 45001. 45001 adds "including the OH&S policy and OH&S objectives." Added is the requirement to provide information on whether the management system is effectively implemented and maintained.

    All of the above mentioned standards ask for the management systems to understand the needs and expectations of interested parties (4.2) and all ask that program planning (the program that includes audits) include results of previous audits (9.2.2) etc. I won't quote the entire clause for you; I know you don't need it.

    I wasn't in your classes. But I want to add that I was not clear enough in describing what wasn't included in the classes: data reporting methodology for top management. That task usually falls to the process manager. The Lead Auditor classes I went to did include long and short range planning, but the main focus was on managing audits not the audit program. Managing the program would potentially need another day.

    I didn't take Internal Auditor training.

    If it's true that 90% of Lead Auditor class graduates do the audits inside their organizations, I wonder what portion of those are the program managers?
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    An individual audit with a defined scope, criteria, purpose, is a part of the (bigger) audit process, which includes audit programme planning. Hence my question about "the audit process". To consider the only process is an actual audit assignment, is going to be (indeed it causes) a problem. I've wager that the vast majority of audit processes (big picture) don't include what the inputs to the programme are, and (arbitrarily) begin (frequently the same way as a CB audit does) with the planning for the individual audit. How can that be effective?

    While people seem to think that an individual audit is the audit process, and the audit programme is some disembodied activity separated from the audits, is what confirms for me that auditor training has created this gulf in understanding. Sadly, even ISO 19011 doesn't really help. (probably because the writers went to LA training...)
     
    Last edited: Apr 8, 2022
  20. pkfraser

    pkfraser Active Member

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    Jennifer
    This is a good example of where I struggle - what is changed into a different form? Nothing has changed, even if something has been created.