Application
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.
Elements and Performance Criteria
Elements | Performance Criteria |
Elements describe the essential outcomes. | Performance criteria describe the performance needed to demonstrate achievement of the element. |
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 |
Foundation Skills
This section describes those language, literacy, numeracy and employment skills that are essential for performance in this unit of competency but are not explicit in the performance criteria.
Skill | Description |
Reading | Interpret key information in workplace documentation and CAPA relevant to non-conformance Interpret key information in GMP requirements and workplace procedures relevant to non-conformance |
Writing | Prepare RCA documentation |
Oral Communication | Demonstrate two-way communication including active listening and confirming instructions when explaining implementation plan to team members Use appropriate vocabulary, including technical language, to explain requirements |
Get the work done | Access and use electronic document management systems |
Sectors
Pharmaceutical (PHM)