Application
This unit of competency describes the skills and knowledge required to determine quality compliance requirements, and to assist with development and documentation of monitoring programs to ensure those requirements are met.
This unit applies to those working in a senior or team leader role in sterilisation services and/or reprocessing areas.
The skills in this unit must be applied in accordance with Commonwealth and State/Territory legislation, Australian/New Zealand standards and industry codes of practice.
Elements and Performance Criteria
ELEMENT | PERFORMANCE CRITERIA |
Elements define the essential outcomes | Performance criteria describe the performance required to demonstrate achievement of the element |
1. Determine quality requirements | 1.1 Contribute to risk analysis to determine scope and nature of quality requirements according to relevant standards 1.2 Contribute to the development and documentation of monitoring programs for sterilisation processes 1.3 Provide information about monitoring requirements to relevant colleagues |
2. Verify effectiveness of processes | 2.1 Evaluate processes against quality requirements 2.2 Obtain technical and numerical data through use of testing and monitoring systems 2.3 Correctly interpret data from testing and monitoring systems 2.4 Determine need for independent verification and take action accordingly |
3. Monitor administration | 3.1 Monitor accuracy and completeness of records 3.2 Evaluate and act upon non-compliant records and reports 3.3 Maintain and update information on reporting requirements for use by sterilisation staff |
4. Monitor and report on compliance | 4.1 Evaluate performance against quality parameters and determine need for changes to work processes 4.2 Adjust work processes based on outcomes of evaluation 4.3 Seek feedback from staff and end users 4.4 Pro-actively share information with relevant management personnel |
Evidence of Performance
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
Evidence of Knowledge
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
Assessment Conditions
Skills must have been demonstrated in the workplace or in a simulated environment that reflects workplace conditions. The following conditions must be met for this unit:
use of suitable facilities, equipment and resources, including:
test manufacturer’s recommendations
work instructions
maintenance records
AS/NZS 4187 standards
Assessors must satisfy the Standards for Registered Training Organisations (RTOs) 2015/AQTF mandatory competency requirements for assessors
Foundation Skills
The Foundation Skills describe those required skills (language, literacy, numeracy and employment skills) that are essential to performance. |
Foundation skills essential to performance are explicit in the performance criteria of this unit of competency. |