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
When assessing compliance risk for a change initiative, a change agent should FIRST:
Answer: Identify applicable regulations and standards that govern the change
Identifying applicable regulations and standards is the foundational step before any risk assessment or planning can occur.
A CAPA (Corrective and Preventive Action) plan differs from a simple corrective action in that it also:
Answer: Addresses prevention of recurrence in addition to fixing the current issue
CAPA combines corrective action (fixing the current problem) with preventive action (stopping it from recurring).
In ISO 9001:2015, which clause specifically addresses 'Management Review' of the quality management system?
Answer: Clause 9.3
ISO 9001:2015 Clause 9.3 covers management review, requiring top management to periodically evaluate the QMS.
A change agent discovers that a quality procedure was updated but employees are still following the old version. This is BEST described as:
Answer: A document control failure
Document control ensures current versions are accessible and obsolete versions are withdrawn; failure here causes version misalignment.
The 'Plan-Do-Check-Act' (PDCA) cycle is most useful in quality management because it:
Answer: Creates a structured iterative approach to implementing and verifying improvements
PDCA provides a repeatable, iterative framework that tests changes and verifies results before full implementation.
Which metric is MOST useful for measuring process capability in a quality-focused change initiative?
Answer: Cpk (process capability index)
Cpk measures how well a process performs relative to its specification limits, indicating whether it reliably meets requirements.
When a change agent encounters resistance to a new compliance requirement, the MOST effective initial approach is to:
Answer: Explain the rationale and business impact of the compliance requirement
Explaining the 'why' behind compliance requirements builds understanding and buy-in, reducing resistance more sustainably than enforcement.