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

Evidence-based decision making is an ISO quality principle requiring data analysis to reduce uncertainty and improve outcomes.

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

Recurring deviations signal a systemic issue; root cause analysis addresses the underlying cause rather than treating symptoms.

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

A compliance gate is a formal checkpoint verifying all regulatory and quality criteria are satisfied before a change proceeds.

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

Control chart specification limits define the acceptable upper and lower boundaries for process variation.

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

GMP regulations require all manufacturing changes to be documented in an approved change control record before implementation.

(CCA) Certified Change Agent Practice Test