Elements and Performance Criteria

Range description
Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements, and industrial awards and agreements. When applied to the pharmaceutical industry, relevant GMP codes apply and reference to food safety is replaced by GMP
Workplace information may include work instructions/operating procedures (SOPs), specifications, production schedules, labels and codes, safety signs and symbols, materials safety data sheets (MSDSs), standard forms, verbal messages, requests or instructions
Operation of equipment and processes may require the use of simple operating panels
Shutdown procedures may include cleaning. In some cases cleaning may be carried out by a dedicated cleaning crew

Ability to:
Access workplace information on equipment operating requirements and procedures
Select, fit and use personal protective clothing and/or equipment
Conduct pre-start checks. This may involve inspecting equipment condition to identify any signs of wear; selecting appropriate settings and/or related parameters; cancelling isolation or lockouts as required; and confirming that equipment is clean and that all safety guards are in place and operational
Start and operate equipment according to procedure
Monitor the output of equipment operation against requirements
Take corrective action in response to out-of-specification results
Shut down and clean equipment as required
Respond to and/or report equipment failure within level of responsibility
Locate emergency stop functions on equipment
Maintain work area to meet housekeeping standards

May include ability to:

Use basic process control screens and panels
Complete workplace records

Knowledge of:
Basic operating principles of equipment used. This may include an operational understanding of main equipment components; status and purpose of guards; emergency stop, isolation and lockout controls; equipment operating capacities and applications; and a knowledge of services required and action to take if services are not available
Quality requirements of materials/consumables used and the effect of variation on outputs
Operating requirements and parameters and corrective action required where operation is outside specified operating parameters
Typical equipment faults and related causes. This includes recognition of signs and symptoms of faulty equipment and early warning signs of potential problems
Contamination/food safety risks associated with equipment operation and related control measures
Common causes of variation and corrective action required
OHS hazards and controls
Shutdown and cleaning procedures. This includes awareness of isolation, lock out and tag out procedures and responsibilities
Environmental issues and controls relevant to equipment operation. This includes waste collection and handling procedures related to the process

May include knowledge of:

Basic operating principles of process control where relevant. This includes the relationship between control panels and systems and the physical equipment
Recording procedures and responsibilities

Relationship with other standards
Pre-requisite units
There are no pre-requisite units for this competency standard.
Co-assessment of related units

This unit should be assessed together with core units and other units of competence relevant to the function or work role. In addition, the following optional or ancillary units may be relevant:

FDFZCSCS2A Clean and sanitize equipment

Resources required 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, food safety, quality and environmental requirements
Item of equipment to be operated and relevant materials, consumables and services
Workplace records as required
Cleaning procedures, materials and equipment as required

Assessment requirements
For information on how to assess this competency standard and who can assess, refer to the Assessment Guidelines for this Training Package.