MCT Beginning T 42

1. The objectives of an audit program are influenced by:

• Quality procedures
• Expectations of top management
• QMS requirements
• Applicable regulatory requirements
• Risks identified

2. 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

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 records related to the audits, among other things, contain the:

• Audit plan
• Audit report
• Audit procedure
• Evaluation of auditor competence
• Audit team members

5. 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