MCT Beginning T 43

1. A process creates, among other things:

• Added value
• Potential nuisances
• Quality
• Continual improvement

1. 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

1. The first edition of ISO 22716 appeared in:

• 2007
• 2008
• 2009

2. The 7 principles of quality management include:

• The quality approach
• The process approach
• Improvement
• Customer focus
• The quality policy
• Risk-based thinking

2. The process mapping allows us, among other things, to:

• Identify the beneficiary
• Identify the interactions
• Plan
• Control inspection means
• Obtain a global vision

2. The records related to the audits, among other things, contain the:

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

3. The acronym ANSM stands for:

• National Agency for the Safety of Medicines and Public Health
• National Drug Safety Agency
• National Drug Safety Association

3. The audit report often contains:

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

3. The process approach, among other things:

• Relies on process management
• Allows roles and responsibilites to be clarified
• Ensures document control
• Allows reducing costs, delays and waste

4. A process is determined, among other things, by its:

• Inputs
• Strategy
• Purpose
• Owner

4. 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

4. The latest version of Cosmetic Regulation EC 1223/2009 entered into force in:

• 2009
• 2013
• 2015

5. Improving the audit program takes into account the:

• Rate of implementation of the audit plan
• Percentage of trained persons as internal auditors
• Trends of audits
• Proper application of procedures

5. ISO stands for:

• International Standard Organization
• International Organization for Standardization
• International Superior Organization

5. The sell and purchase processes are:

• Management processes
• Realization processes
• Support processes