Internal audit

An internal audit could be divided into three phases: the preparation, the execution, including communication and behaviour and finally the writing of a good report.

The information below is based on the discussion during the workshop on internal audit.

Preparation of an audit

  • Preparation beforehand is very important
  • The audit plan should be flexible to permit changes
  • Define the method of audit:
    • horizontal: This examines one element in a process on more than one item. It is a detailed check of a particular aspect of the documentation and implementation of the quality management system or examination processes.
    • vertical: This examines more than one element in a process, on one item. It is a detailed check that all elements associated with a chosen examination (test) are implemented. In any single audit, one or a number of examinations that have recently passed through the laboratory are randomly selected.
  • The audit plan should include:
    • audit objectives and scope
    • identification of the individuals or organisation having significant direct responsibilities regarding the objectives and scope
    • identification of reference documents (SOPs, standards, ...)
    • identification of audit team members
    • date and expected time – duration
  • Working documents like checklists and observation forms are required to facilitate the auditor's investigations and to document and report the results. Working documents should be designed so that they do not restrict additional audit activities or investigations, which may become necessary as a result of information gathered during the audit.
  • Make the distinction between you as the auditor and you in your normal function (e.g. quality manager)
  • Involve as many people as possible in the implementation and execution of your quality system. The better they know, the less they fear
  • Knowledge of standards, quality manual is necessary

Execution of an audit: communication and behavior

Communication

  • Describe what you see
  • Ask question after question, deeper and deeper
  • Use simple straight forward questions
  • Start with and use mostly open questions
  • Avoid "why" questions, they often trigger defensive reactions – preferably use questions that start with 'how'
  • The use of words like 'maybe', 'a little bit, 'could', etc. could have miscellaneous effects. On the one hand they make your message less direct and non-threatening. On the other hand they may give the impression that you're not sure about yourself.
  • Do not raise your voice and stay calm, especially when something is wrong
  • Do not forget to give positive feedback as well
  • Give constructive feedback
  • Teaching, tell what is missing
  • Integrate suggestions
  • Find the right argument to change habits
  • Focus on solutions, improvements which are possible
  • Explain why improvement is needed. Could be a small problem now, but explain the consequences for later.
  • Important is that you mention when something is not conform the procedure. Auditee should have already during the audit an idea that not everything was perfect.
  • Write down during the audit for the report later on

Effective behaviors

  • Work together: "we"
  • Good eye contact
  • Structure the process
  • Empathy
  • Explain that it is about the procedure, not the person
  • Be professional, do not blame. You audit the system, not the person
  • Give explanations and arguments for rules
  • Give positive feedback as well
  • Make auditee feel comfortable - be friendly, gentle polite but not too formal
  • Be firm, do not hide or minimize when something is wrong
  • Adapt to behavior of auditee
  • Find the balance between confrontation and empathy
  • Stay objective, independent

Non effective behaviors

  • Interrupting auditee
  • No eye contact
  • sloppy or aggressive body language
  • No records of observations
  • No communication, no information -> worries the auditee
  • Not enough preparation
  • Too many questions -> disruptive
  • No monitoring of body language auditee
  • Not taking into account the bad timing for the auditee
  • Leaning over, take a chair
  • Answer own questions
  • Too superficial

End of the audit: round off, follow up, criteria for a good report

Round off, follow-up

  • Positive summary at the end
  • Reporting within well defined time limits
  • Audit leads to corrective actions within certain time limits (action plan)
  • Examination of the action plan
  • Follow-up by:
    • documented proof or
    • scheduling a additional audit

Criteria for a good report

  • Clear definition of major/minor points
  • Easy to read, clear, keep simple
  • User-friendly
  • Use a clear template
  • Well structured: order based on norm, order based on topic
  • A person who was not present should be able to get all info from the report
  • Precise:
    • How? What?
    • Procedure
    • Equipment
    • Documentation
  • Audit checklist/clear cross-references to norm(s)extra box with norms
  • Short info/summary at the beginning
  • Summary of major/minor points at the end/beginning
  • Mention standard, version
  • Signature of auditor
  • Deadline for validation of action
  • Explain why something should be improved
  • Do not avoid difficult issues
  • Do not apportion blame
  • Mention positive points

Example of a good report

Further reading and related documents:

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