MCT Beginning T 43

1. The audit procedure contains, at minimum, instructions on how to:

• Plan the audits
• Conduct the audits
• Ensure auditor competence
• Assign the responsibility for managing the audit program to a qualified person

2. The results of the process internal audit:

• Are management review outputs
• Are management review inputs
• Allow GMP improvement opportunities to be found
• Are verifiable evidences

3. Traps to be avoided by an auditor:

• Sharing advice or opinions
• Careful listening
• Keeping people waiting for you
• Discretion
• Reading the audit questionnaire spep by step
• Neglecting the work place at the expense of the documentation

4. The audit report often contains:

• Audit findings
• Auditor opinions
• Audit conclusions
• Auditor proposals
• Identified good practices

5. An internal audit is initiated, for example:

• When it is scheduled in the audit program
• Following the request of a department manager
• After a dysfunction in an activity
• Following a major evolution of a process