CCA Quality & Compliance Flashcards
7 cards from real CCA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 CCA Quality & Compliance flashcards as text
Which quality management principle emphasizes that decisions should be based on analysis of data and information rather than intuition alone?
Answer: Evidence-based decision making
Evidence-based decision making is an ISO quality principle requiring data analysis to reduce uncertainty and improve outcomes.
A change agent notices that a compliance audit found recurring deviations in the same process. What is the BEST quality response?
Answer: Conduct root cause analysis to identify the systemic failure
Recurring deviations signal a systemic issue; root cause analysis addresses the underlying cause rather than treating symptoms.
In change management, a 'compliance gate' serves what primary function?
Answer: Ensuring regulatory and quality requirements are met before advancing a change
A compliance gate is a formal checkpoint verifying all regulatory and quality criteria are satisfied before a change proceeds.
Which document type establishes the acceptable range of variation for a process output in a quality management system?
Answer: Control chart specification limits
Control chart specification limits define the acceptable upper and lower boundaries for process variation.
A pharmaceutical company is implementing a change to a manufacturing process. Under GMP compliance, which action is mandatory BEFORE implementation?
Answer: Completing a validated change control record and receiving approval
GMP regulations require all manufacturing changes to be documented in an approved change control record before implementation.
What does 'validation' mean in the context of quality and compliance for a changed process?
Answer: Confirming through documented evidence that the process consistently produces the intended result
Validation is documented evidence that a process reliably and reproducibly achieves its specified requirements.
Which quality concept describes the ongoing, incremental improvement of processes, products, and services over time?
Answer: Continuous improvement (Kaizen)
Kaizen, or continuous improvement, focuses on small, ongoing positive changes involving all employees.