Assessor Resource
FDFPH4006A
Respond to non-conformance
Assessment tool
Version 1.0
Issue Date: May 2024
This unit can apply to people working in a supervisory or line management production role. They would typically work as part of a team responsible for investigating causes and controls to prevent recurrence of non-conformance. Typical applications of this unit would include responding to deviation and incident reporting results and may include participation in responding to customer complaints, product recalls and audit findings. Responding to non-conformance is typically within the parameters of established policies, plans and procedures.
This unit of competency covers the skills and knowledge required to respond to non-conformance within level of authority and consistent with legal requirements within the pharmaceutical sector.
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