Lab Quality

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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