CCA CCA Quality & Compliance 5

Question 1

A supplier fails a quality audit. Under a robust supplier quality management program, the NEXT step is:

Accepted Answer

Issue a supplier corrective action request (SCAR) and define a remediation timeline

Answer

A SCAR formally notifies the supplier of the deficiency and requires documented corrective actions within a defined timeframe.

Question 2

The concept of 'quality at the source' in change management means:

Accepted Answer

Each person is responsible for the quality of their own work rather than relying on end-of-line inspection

Answer

Quality at the source embeds accountability into each process step, preventing defects from passing downstream.

Question 3

When documenting a change for compliance purposes, which principle ensures the record is trustworthy and defensible?

Accepted Answer

ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate)

Answer

ALCOA+ defines the data integrity principles required for compliance records to be considered complete and trustworthy.

Question 4

A change agent reviewing a process change identifies a potential failure mode that could affect product safety. The BEST quality tool to analyze this risk systematically is:

Accepted Answer

Failure Mode and Effects Analysis (FMEA)

Answer

FMEA systematically identifies potential failure modes, their causes, effects, and risk priority to guide preventive actions.

Question 5

In the context of organizational change, 'embedding compliance' means:

Accepted Answer

Integrating compliance requirements into standard workflows so they become routine rather than exceptions

Answer

Embedding compliance means making regulatory requirements a natural part of daily processes rather than an additional burden.

(CCA) Certified Change Agent Practice Test

(CCA) Certified Change Agent Practice Test

CCA CCA Quality & Compliance 5