Aim

To ensure audits are properly undertaken

Description

Preparing the audit meeting:

• The auditors will arrange to meet the auditee (the researcher(s)) and the project leader at least 3 weeks in advance.
• The researcher will be sent a message including:

• Confirmation of the meeting;
• Estimated length of meeting;
• Who the auditors are;
• Request to complete the self-evaluation;
• Request to send the following in preparation of the audit: The completed self-evaluation, research protocol or project description and any (draft) articles relevant to the audit;
• Any point(s) the auditee wishes the auditors to focus on in particular.

• The Quality Officer or co-ordinating KC member will send the documents associated with the project, as well as the audit maual with the audit questions to the auditor(s).

Auditor guidelines:

• The audit manual should be used to prepare the audit;
• Consult with your co-auditor about the approach to take regarding the audit prior to the actual audit. Determine a number of focus points on the basis of the completed self-evaluation. Agree how the tasks are to be divided: Who will lead the audit, who will draft the report. Determine which guidelines are not applicable to the project.
• Bring the Manual and the self-evaluation completed by the researcher along to the audit.

Audit
Opening
Explain the purpose of the audit and ask whether this is clear to the auditee. If the purpose is not clear to the auditee, then ensure that the aim is further elucidated. Explain what will happen to the information obtained. Ensure that the atmosphere is relaxed/open by asking the auditee some general, open questions, for instance, by asking how the research is progressing.

Discussion
Select a question from the questionnaire that preferably links in to what the auditee has discussed during the opening. Go over things if issues are not totally clear. Ensure that all questions on your list are answered. Check whether what the auditee is saying is substantiated by the documentation. Make notes.
Talk to the project leader/mentor afterwards and do not forget the questions for the project leader. If this does not immediately follow the meeting, or is discussed during the meeting with the auditee, then it should be discussed shortly thereafter.

Avoid:

• Suggestive questions or questions that already contain the answer;
• Questions with multiple parts;
• The use of either/or questions.
• Third parties
• There may be points involving third parties that may have an influence on the project. Examples of third parties: Service providers internal or external to the VUmc, advisors, other knowledge institutes, etc. If this is the case, then contact the third party, and be prepared to listen to all sides of the argument. Only allow third parties to read those parts of the draft report and definitive version that are applicable to them.

 
Conclusion
This is an important aspect of the audit. The auditee should be made aware of the strong and weak points of his or her research and be offered as much assistance as possible in order to improve the completion of the project.
Discuss the audit in private with your co-auditor. Briefly summarise the audit for the auditee(s). Describe the strong and weak points. Ask the auditee whether he/she agrees with your findings. Discuss any potential actions with the auditee that may need to be taken following the audit findings. Ask the auditee for his or her opinion of the audit. Thank the auditee for the meeting.

Evaluate the audit with the co-auditor. The aim is to learn from the audit. Pay particular attention to the following:

• How did the discussion go?
• Were all questions answered sufficiently?
• Did we wander from path that was set out, and if so, when and what was the cause of this?
• What struck us in particular during the meeting?
• Which questions seemed particularly effective?
• Which areas did we have to explore in more depth?

Report
Draw up a draft report based on the guidelines and notes, and provide a timeline for any potential recommendations as well. Use the standard template for this. Send the draft to the auditee and ask for comments. Also ask whether the auditees intend to undertake any potential actions as a result of the recommendations. This should be done as quickly as possible, and no later than 10 working days after the audit. Revise the commentary if necessary. E-mail the definitive report to the Quality Officer, who will ask the researcher and project leader to sign the report and who will ensure that the signed report is forwarded to the KC, as well as archived.

Follow-up
The results of one or multiple audits will be discussed by the Quality Committee. The conclusions and potential advice of multiple audits will be reported anonymously to the board.
If actions have been planned following an audit, a follow-up audit may be undertaken to review whether the actions have been effective. The Quality Officer will contact the researcher and project leader a number of months after the audit has been concluded in order to evaluate the audit and particularly the recommendations made.

Audit  :    Independent investigation into the progress (of part of a) research project based on guidelines in the EMGO+ Quality Handbook.
Auditor: Person conducting an audit.
Auditee:     Individual being audited.
KC:            Quality committee (in Dutch: Kwaliteits Commissie (KC))

V1.2: 1 Jan 2010: English translation
V1.1:  16 Aug 2005: Procedures adjusted based on the new procedures with self-evaluation by the researcher, dealing with third parties.