The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment

Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations.

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of ability to:

conduct pre-start checks on autoclave and materials to be sterilised

start, operate, monitor and adjust autoclave to achieve required quality outcomes

take corrective action in response to typical faults and inconsistencies

complete workplace records as required

apply safe work practices and identify OHS hazards and controls

safely shut down equipment and remove items

apply food safety procedures to work practices.

Context of and specific resources for assessment

Assessment must occur in a real or simulated workplace where the assessee has access to:

personal protective clothing and equipment

work procedures, including advice on safe work practices, GMP, quality and environmental requirements

information on equipment capacity and operating parameters

sterilisation schedule/instructions

specifications, control points and processing parameters

autoclave equipment and services

wrapping materials and tape/heat sensitive markers as required

items to be sterilised

materials handling equipment as required

sampling schedules and test procedures and equipment as required

documentation and recording requirements and procedures

cleaning procedures, materials and equipment as required.

Method of assessment

This unit should be assessed together with core units and other units of competency relevant to the function or work role. Examples could be:

FDFOP2004A Clean and sanitise equipment

FDFOP2011A Conduct routine maintenance

FDFOP2013A Apply sampling procedures

FDFOP2030A Operate a process control interface

MSL973001A Perform basic tests.

Guidance information for assessment

To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.

Required skills

Ability to:

access workplace information to identify sterilisation requirements

select, fit and use personal protective clothing and/or equipment

confirm supply of necessary materials and services

prepare items by wrapping and marking with temperature-sensitive tape/material and ensure clothing is folded correctly

load items according to loading pattern

conduct pre-start checks on the autoclave, such as inspecting equipment condition to confirm that all water has been drained, pulling a vacuum to remove as much air as possible from the autoclave, selecting appropriate settings to meet sterilisation requirements, cancelling isolation or lock outs as required, confirming that equipment is clean and operational, positioning sensors and controls correctly, and ensuring all safety guards/signs are in place and operational

start, operate and monitor the autoclave to confirm that the required outcomes are achieved, such as monitoring time, temperature and pressure gauges

identify out-of-specification results and take appropriate corrective action within level of responsibility

follow procedures to open autoclave and remove items from the autoclave to maintain sterility and personal safety

respond to and/or report equipment failure within level of responsibility

locate emergency stop functions on equipment

follow isolation and lock out/tag out procedures as required to take process off-line in preparation for cleaning and/or maintenance within level of responsibility

complete workplace records

maintain work area to meet housekeeping standards

use process control systems according to enterprise procedures

collect samples and conduct tests according to enterprise procedures

conduct routine maintenance according to enterprise procedures

use oral communication skills/language competence to fulfil the job role as specified by the organisation, including questioning, active listening, asking for clarification and seeking advice from supervisor

work cooperatively within a culturally diverse workforce

Required knowledge

Knowledge of:

purpose and basic principles of terminal sterilisation, including principles of heat transfer, properties of saturated steam, and the relationship between time, temperature and pressure as they affect the kill rate

the nature of items to be sterilised using an autoclave and related preparation requirements, such as handling/preparation requirements for porous and non-porous loads

the nature of wrapping materials suitable for use, the methods used to wrap items, methods used to monitor that time/temperature parameters are met - typically heat-sensitive tape or markers and the significance of loading patterns in achieving effective sterilisation

basic operating principles of equipment, such as main equipment components, status and purpose of guards, equipment operating capacities and applications, and the purpose and location of sensors and related feedback instrumentation, and where relevant, the calibration schedule and procedures to confirm that instruments are within calibration

services required and action to take if services are not available

time/temperature parameters required to achieve terminal sterilisation and corrective action required where operation is outside specified operating parameters

typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems

methods used to monitor the sterilisation process, such as inspecting, measuring and testing as required

inspection or test points (control points) and the related procedures and recording requirements

possible causes of variation in outcome and corrective action required

occupational health and safety (OHS) hazards related to autoclave operation and associated control measures, such as working with superheated steam and around hot surfaces, manual handling and steam leaks

purpose and limitations of protective clothing and equipment

emergency and routine shutdown procedures and procedures to follow in the event of a power outage

isolation, lock out and tag out procedures and responsibilities

procedures and responsibility for recording and reporting information on autoclave performance

environmental issues and controls relevant to the process, including waste/rework collection and handling procedures related to the process

basic operating principles of process control, where relevant, including the relationship between control panels and systems and the physical equipment

sampling and testing associated with process monitoring and control where relevant

routine maintenance procedures where relevant

cleaning and sanitation procedures where relevant

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Policies and procedures

Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements, and industrial awards and agreements

Legislative requirements

Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:

relevant Good Manufacturing Practice (GMP) codes

the Therapeutic Goods Act and/or other relevant legislation

legislation covering environmental management, OHS, anti-discrimination and equal opportunity

Workplace information

Workplace information may include:

standard operating procedures (SOPs)

specifications

production schedules and instructions

manufacturers' advice

standard forms and reports

Materials

Materials include:

wrapping material

printed paper rolls

temperature-sensitive tape or other indicator

Operation of equipment and processes

Operation of equipment and processes may require:

the use of simple control panels

Services

Services may need to be confirmed. Typical examples include:

power

steam

water

vacuum and compressed air