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In Reply to Parent Post by Quality_Steve
During an internal audit, is it necessary to follow the process or should I just be looking at results of the process?
My thinking is that I should follow them through the process to see if what they are doing matches what is documented, not to catch them doing it wrong, but so, I can improve the documentation to allow for the variation in doing it right, therefore, "maintaining" the system.
It seems to me that only looking at process results is more indicative of a system audit and doesn't really help to improve the processes.
Thanks for your input.
Steve
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Hi, Steve. I take it when you say 'follow the process' you mean compare it with the documented procedure? Please correct me if I am wrong. I am also assuming this is an internal audit of your own system - again please correct me if this is not the case.
But in answer to the question - Yes - as part of your internal audit you should be looking at the procedure being used to see that people are complying. I'll pick up the 'why do this' below.
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In Reply to Parent Post by John Broomfield
ssz102,
If management want obedience to procedures then they must require it and continuously show their commitment to their requirement by what they do.
Management may say "ISO 9001 says that you must obey our procedures" but that has been untrue since the year 2000.
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Where did this come from? Let me just quote a few requirements of ISO 9001 (2008 edition) to put this particular urban myth to bed - for once and for all (as if that will happen!

) Compliance with procedures is still a significant part of the quality management systems standard.
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4.2.1 d d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
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So this requires the organisation to establish what documents are needed to control its processes. If the organisation decides it needs a documented procedure then it comes under this requirement.
... and then in the section on management representative it says the organisation's top management appoint one of their managers to:
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5.5.2 a a) ensuring that processes needed for the quality management system are established, implemented and maintained,
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So here the top team are allowed to delegate the responsibility to someone to put these procedures in place.
... and a bit of repetition here:
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7.1 In planning product realization, the organization shall determine the following, as appropriate:
b) the need to establish processes and documents, and to provide resources specific to the product;
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So when planning all the 'doing' bits the company has to make sure that everything necessary is in place.
... and a bit more duplication:
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7.5.1 The organization shall plan and carry out production and service provision under controlled conditions.
Controlled conditions shall include, as applicable,
b) the availability of work instructions, as necessary,
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So again if the organisation decides they are necessary then documents should be in place to control how work is done.
... and finally the role of audit:
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8.2.2 The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
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... now IMHO that is compliance auditing. It is not the full role of an internal audit but it is part of it and it can be extremely significant where procedures need to be strictly adhered to.
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In Reply to Parent Post by John Broomfield
Auditors do not do repeat the role of management. Such auditing would be a waste. Such auditing would not be independent, impartial and objective. Such auditing makes the system depend on its auditors.
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A lot depends on what you intent is here, John. You are of course right that auditing does not repeat management's supervisory role but it does provide an independent view of whether the organisation is following procedures that top management downwards feel are necessary.
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In Reply to Parent Post by John Broomfield
Such auditing stops managers from continuously demonstrating their personal commitment to requirements. Instead they say "the auditor says you must obey our procedures".
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How does compliance auditing do this?
If you have weak management they might play the 'auditor' card but that shouldn't stop an auditor evaluating compliance. To the extent that the organisation determines it needs procedures the audit has to determine that people are following them. If there is a finding that says 'Procedures not being followed' then the organisation has three (or even more) choices:
- Re-enforce the procedure
- Change the procedure to reflect what people are doing
- Delete the procedure
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In Reply to Parent Post by John Broomfield
Auditors independently, objectively and impartially gather and evaluate evidence of how well the management system (this includes what the managers say and do) enables the employees to determine the requirements and monitor their meeting of the requirements and make improvements as and when required.
Have I have interpreted your post correctly?
John
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... and the first stage of determining this is to see if they are working to any procedures for the processes they work in.
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In Reply to Parent Post by John Broomfield
Steve,
Ask the people operating the process how they know it is working effectively (4.1) and what they do on finding that the process is failing to fulfill its objectives (4.1).
Ask the people operating the process how they monitor conformity to their procedures (8.2.3) and what they do on finding that the procedure needs to be changed (8.2.3).
Auditees should already be improving their processes without the help of the auditors. If not find out why managers are not seeking information on where the system needs to be improved so the system is improved without relying on the auditors.
Focus on how well the management system (includes leadership) helps the employees to determine and fulfill requirements; including the requirement for continual improvement.
Do not allow auditors to become the only people enforcing the procedures and driving improvements. In a mature management system no more that 20% of the CARs should come from audit.
John
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All of the above is fine, John and I don't disagree with it but (as in the title of the thread) - one of the prime reasons for an audit is to establish:
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8.2.2 ... whether the quality management system ... conforms to the planned arrangements ...
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