CCA CCA Quality & Compliance 3 — Questions and Answers
Question 1: When assessing compliance risk for a change initiative, a change agent should FIRST:
- Draft the implementation timeline
- Identify applicable regulations and standards that govern the change (Correct answer)
- Assign team members to compliance tasks
- Communicate the change to stakeholders
Correct 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.
Question 2: A CAPA (Corrective and Preventive Action) plan differs from a simple corrective action in that it also:
- Involves executive leadership approval
- Addresses prevention of recurrence in addition to fixing the current issue (Correct answer)
- Must be completed within 30 days
- Requires external audit verification
Correct 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).
Question 3: In ISO 9001:2015, which clause specifically addresses 'Management Review' of the quality management system?
- Clause 6
- Clause 9.3 (Correct answer)
- Clause 7.1
- Clause 8.4
Correct answer: Clause 9.3
ISO 9001:2015 Clause 9.3 covers management review, requiring top management to periodically evaluate the QMS.
Question 4: A change agent discovers that a quality procedure was updated but employees are still following the old version. This is BEST described as:
- A training gap
- A document control failure (Correct answer)
- A leadership alignment issue
- A communication breakdown only
Correct answer: A document control failure
Document control ensures current versions are accessible and obsolete versions are withdrawn; failure here causes version misalignment.
Question 5: The 'Plan-Do-Check-Act' (PDCA) cycle is most useful in quality management because it:
- Provides a legal framework for compliance activities
- Creates a structured iterative approach to implementing and verifying improvements (Correct answer)
- Replaces the need for risk assessments
- Defines roles for the quality team
Correct 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.
Question 6: Which metric is MOST useful for measuring process capability in a quality-focused change initiative?
- Employee satisfaction score
- Cpk (process capability index) (Correct answer)
- Net Promoter Score
- Budget variance percentage
Correct answer: Cpk (process capability index)
Cpk measures how well a process performs relative to its specification limits, indicating whether it reliably meets requirements.
Question 7: When a change agent encounters resistance to a new compliance requirement, the MOST effective initial approach is to:
- Enforce the requirement through disciplinary action
- Explain the rationale and business impact of the compliance requirement (Correct answer)
- Escalate to senior management immediately
- Delay implementation until resistance subsides
Correct 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.
CCA CCA Quality & Compliance 3
When assessing compliance risk for a change initiative, a change agent should FIRST: