Unit of competency Outline

Date retreived
22/07/2026 6:47 AM AWST

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Respond to non-conformance

Respond to non-conformance

Unit of competency
National Code
FBPPHM4006
State Code
OAN30
TGA Status
Current
DTWD Status
Approved
Current Release Number
1.00
Current Release Date
18/12/2018
View on TGA
State Implementation and Classification
Approved Date
18/04/2019
Field of Education
080317 - Quality Management
Original Release Date
18/04/2019
Nominal Hours
60
Description
This unit of competency describes the skills and knowledge required to identify and respond to non-conformance and review processes to minimise risk of recurrence to meet Good Manufacturing Practice (GMP) requirements in a pharmaceutical manufacturing facility.The unit applies to individuals with specialised skills and knowledge of GMP requirements who respond to non-conformance relevant to pharmaceutical manufacturing operations and have responsibility for the output of others. This includes applying and communicating non-routine technical solutions to predictable and unpredictable problems.No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.
Notes
Elements and Performance Criteria
1. Identify non-conformance
  • 1.1 Interpret workplace procedures and documentation relevant to non-conformance
  • 1.2 Identify nature of non-conformance
  • 1.3 Follow non-conformance corrective and preventive action (CAPA) according to GMP requirements and workplace procedures
2. Identify causes of non-conformance
  • 2.1 Investigate possible causes of non-conformance
  • 2.2 Conduct root cause analysis (RCA) to determine cause of non-conformance
  • 2.3 Conduct non-conformance risk assessment on current and previous material according to workplace procedures
3. Review processes to minimise risk of recurrence
  • 3.1 Assess and select solutions to eliminate or minimise the risk of recurrence
  • 3.2 Develop an implementation plan for risk minimisation solutions
  • 3.3 Conduct CAPA effectiveness checks according to GMP requirements and workplace procedures
  • 3.4 Establish consultative mechanisms and communicate implementation plan to support continuous improvement according to GMP requirements and workplace procedures
No information
No information
Replaces
State Code National Code Title Type
D4696 FDFPH4006A Respond to non-conformance Unit of competency