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
A supplier fails a quality audit. Under a robust supplier quality management program, the NEXT step is:
Answer: Issue a supplier corrective action request (SCAR) and define a remediation timeline
A SCAR formally notifies the supplier of the deficiency and requires documented corrective actions within a defined timeframe.
The concept of 'quality at the source' in change management means:
Answer: Each person is responsible for the quality of their own work rather than relying on end-of-line inspection
Quality at the source embeds accountability into each process step, preventing defects from passing downstream.
When documenting a change for compliance purposes, which principle ensures the record is trustworthy and defensible?
Answer: ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate)
ALCOA+ defines the data integrity principles required for compliance records to be considered complete and trustworthy.
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:
Answer: Failure Mode and Effects Analysis (FMEA)
FMEA systematically identifies potential failure modes, their causes, effects, and risk priority to guide preventive actions.
In the context of organizational change, 'embedding compliance' means:
Answer: Integrating compliance requirements into standard workflows so they become routine rather than exceptions
Embedding compliance means making regulatory requirements a natural part of daily processes rather than an additional burden.
Which change management approach BEST supports sustained compliance after a major process change?
Answer: Reinforcement plan with follow-up audits, feedback loops, and ongoing coaching
Sustained compliance requires reinforcement mechanisms — audits, feedback, and coaching — to prevent regression to old behaviors.
A change agent learns that a process change created an unintended non-conformance with an environmental regulation. The FIRST action should be:
Answer: Halt or contain the non-conforming activity and report it through the appropriate compliance channel immediately
Regulatory non-conformances require immediate containment and escalation through compliance channels to limit liability and harm.