MCT Beginning T 43

1. 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

2. The implementation of the audit program requires:

• Its approval by top management
• Its communication to the concerned parties
• Audit plans to be followed
• Audit follow-up

3. 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

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

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

5. The extent of the audit program, among other things, depends on:

• Process complexity
• Risks identified
• Follow-up of previous audits
• Commercial policy
• Essential characteristics of products