CCA CCA Quality & Compliance 3

Question 1

When assessing compliance risk for a change initiative, a change agent should FIRST:

Accepted Answer

Identify applicable regulations and standards that govern the change

Answer

Draft the implementation timeline

Answer

Assign team members to compliance tasks

Answer

Communicate the change to stakeholders

Question 2

A CAPA (Corrective and Preventive Action) plan differs from a simple corrective action in that it also:

Accepted Answer

Addresses prevention of recurrence in addition to fixing the current issue

Answer

Involves executive leadership approval

Answer

Must be completed within 30 days

Answer

Requires external audit verification

Question 3

In ISO 9001:2015, which clause specifically addresses 'Management Review' of the quality management system?

Accepted Answer

Clause 9.3

Answer

Clause 6

Answer

Clause 7.1

Answer

Clause 8.4

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:

Accepted Answer

A document control failure

Answer

A training gap

Answer

A leadership alignment issue

Answer

A communication breakdown only

Question 5

The 'Plan-Do-Check-Act' (PDCA) cycle is most useful in quality management because it:

Accepted Answer

Creates a structured iterative approach to implementing and verifying improvements

Answer

Provides a legal framework for compliance activities

Answer

Replaces the need for risk assessments

Answer

Defines roles for the quality team

Question 6

Which metric is MOST useful for measuring process capability in a quality-focused change initiative?

Accepted Answer

Cpk (process capability index)

Answer

Employee satisfaction score

Answer

Net Promoter Score

Answer

Budget variance percentage

Question 7

When a change agent encounters resistance to a new compliance requirement, the MOST effective initial approach is to:

Accepted Answer

Explain the rationale and business impact of the compliance requirement

Answer

Enforce the requirement through disciplinary action

Answer

Escalate to senior management immediately

Answer

Delay implementation until resistance subsides