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Elements and Performance Criteria

1. Elements define the essential outcomes
2. Determine quality requirements
   • Contribute to risk analysis to determine scope and nature of quality requirements according to relevant standards
   • Contribute to the development and documentation of monitoring programs for sterilisation processes
   • Provide information about monitoring requirements to relevant colleagues
3. Verify effectiveness of processes
   • Evaluate processes against quality requirements
   • Obtain technical and numerical data through use of testing and monitoring systems
   • Correctly interpret data from testing and monitoring systems
   • Determine need for independent verification and take action accordingly
4. Monitor administration
   • Monitor accuracy and completeness of records
   • Evaluate and act upon non-compliant records and reports
   • Maintain and update information on reporting requirements for use by sterilisation staff
5. Monitor and report on compliance
   • Evaluate performance against quality parameters and determine need for changes to work processes
   • Adjust work processes based on outcomes of evaluation
   • Seek feedback from staff and end users
   • Pro-actively share information with relevant management personnel

Performance Evidence

The candidate must show evidence of the ability to complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the job role. There must be evidence that the candidate has:

contributed to the development and use of monitoring programs according to national standards for at least 2 types of cleaning processes

contributed to the development and use of monitoring programs according to national standards for both a packaging process and a sterilisation process, including:

documented risk analysis

process verification systems

record keeping systems

work instructions for monitoring processes

evaluated incidences of non-compliance and contributed to appropriate responses

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Knowledge Evidence

The candidate must be able to demonstrate essential knowledge required to effectively complete tasks outlined in elements and performance criteria of this unit, manage tasks and manage contingencies in the context of the work role. This includes knowledge of:

testing systems requirements for cleaning, packaging, sterilisation and storage according to relevant standards

administration and record keeping requirements for testing, monitoring and maintenance

types of process problems that occur, reasons for these occurring and ways to resolve them

risk control solutions and how these are implemented

scope of job role and delegation and escalation within scope of job role

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