CCA CCA Quality & Compliance 2

Question 1

Which quality management principle emphasizes that decisions should be based on analysis of data and information rather than intuition alone?

Accepted Answer

Evidence-based decision making

Answer

Customer focus

Answer

Relationship management

Answer

Leadership commitment

Question 2

A change agent notices that a compliance audit found recurring deviations in the same process. What is the BEST quality response?

Accepted Answer

Conduct root cause analysis to identify the systemic failure

Answer

Issue corrective action reports for each deviation separately

Answer

Increase audit frequency to catch more deviations

Answer

Retrain employees on the procedure immediately

Question 3

In change management, a 'compliance gate' serves what primary function?

Accepted Answer

Ensuring regulatory and quality requirements are met before advancing a change

Answer

Slowing down change implementation to allow more stakeholder input

Answer

Documenting lessons learned after change completion

Answer

Assigning accountability for change ownership

Question 4

Which document type establishes the acceptable range of variation for a process output in a quality management system?

Accepted Answer

Control chart specification limits

Answer

Standard Operating Procedure (SOP)

Answer

Change request form

Answer

Risk register

Question 5

A pharmaceutical company is implementing a change to a manufacturing process. Under GMP compliance, which action is mandatory BEFORE implementation?

Accepted Answer

Completing a validated change control record and receiving approval

Answer

Notifying all employees via email

Answer

Updating the marketing materials

Answer

Informing the distribution network

Question 6

What does 'validation' mean in the context of quality and compliance for a changed process?

Accepted Answer

Confirming through documented evidence that the process consistently produces the intended result

Answer

Getting stakeholder sign-off on the change plan

Answer

Reviewing the change for budget approval

Answer

Testing the change in a single pilot location

Question 7

Which quality concept describes the ongoing, incremental improvement of processes, products, and services over time?

Accepted Answer

Continuous improvement (Kaizen)

Answer

Six Sigma

Answer

Business process reengineering

Answer

Total productive maintenance