Unit of competency Outline
Date retreived
22/07/2026 7:12 AM AWST
22/07/2026 7:12 AM AWST
Whilst all efforts are made to provide accurate and timely information from the relevant source/documentation, please be aware that the information supplied may not be the most current version. The accuracy of the detail has not been confirmed by the Department and therefore should not be relied upon without first confirming the contents.
Implement good manufacturing processes in the ophthalmic industry
Implement good manufacturing processes in the ophthalmic industry
Unit of competency
National Code
HLTOPT404C
HLTOPT404C
State Code
WD235
WD235
TGA Status
Replaced
Replaced
DTWD Status
Deleted
Deleted
State Implementation and Classification
Approved Date
19/07/2012
Field of Education
060903 - Optical Technology
Original Release Date
19/07/2012
Nominal Hours
40
Description
DescriptorThis unit of competency describes the skills and knowledge required to comply with relevant Good Manufacturing Practice (GMP) codes for the manufacturing of optical appliances
Notes
Elements and Performance Criteria
1. Identify requirements of GMP as related to the optical industry
- 1.1 Identify and locate sources of information on GMP
- 1.2 Identify requirements and responsibilities related to own work
2. Observe personal hygiene requirements of GMP
- 2.1 Ensure personal hygiene meets GMP requirements
- 2.2 Prepare, order, use, handle, store and dispose of PPE (personal protective equipment) according to GMP and workplace requirements
- 2.3 Ensure personal movement around workplace complies with safety requirements, company procedures and policies
3. Implement GMP requirements
- 3.1 Identify GMP requirements
- 3.2 Routinely monitor work area, work flow, materials. equipment and products to ensure compliance with GMP requirements
- 3.3 Ensure production aids, measuring and calibration devices and manufacturing related products are handled according to GMP and workplace requirements
- 3.4 Follow workplace procedures to control resource allocation and process in accordance with GMP requirements
- 3.5 Identify common forms of contamination that contributes to lens wastage and implement appropriate control measures in accordance with GMP requirements
- 3.6 Ensure work and use of resources meets current legislation, approved codes of practice and organisation requirements
- 3.7 Maintain the workplace in accordance with GMP requirements
- 3.8 Identify and implement correct handling practices for lens materials during the manufacturing process
- 3.9 Identify and implement correct handling practices and procedures for gauges, instruments, machinery and other manufacturing correctly
4. Participate in improving GMP
- 4.1 Recognise and correct existing and potential disruptions to the workflow
- 4.2 Identify and report processes, practices or conditions which are not compliant with GMP in accordance with organisation policies and procedures
- 4.3 Implement corrective action in line with organisation policies and procedures and own level of responsibility
- 4.4 Raise GMP issues with supervisor or designated personal in accordance with organisation policies and procedures
5. Participate in quality and validation processes
- 5.1 Follow validation processes to GMP requirements
- 5.2 Raise issues identified in validation processes with supervisor or designated personal in accordance with organisation policies and procedures
- 5.3 Document validation procedures in line with GMP and in accordance with organisation policies and procedures
- 5.4 Information is recorded in line with GMP and organisation reporting requirements
6. Apply stock control procedures
- 6.1 Maintain stock of machinery parts, preventive maintenance parts and accessories and manufacturing consumables
- 6.2 Reduce shrinkage with effective and efficient procedures and processes
- 6.3 Recognise and apply stock-on-hand practices to maintain adequate stock levels
The Range Statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Add any 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.
GMP requirements include:
Legislative requirements relevant to Good Manufacturing practice including
Good Manufacturing Practice codes
the Therapeutic Goods Act and/or other relevant legislation
legislation covering environmental management.work health and safety (WHS), occupational health and safety, anti-discrimination and equal opportunity
Requirements to comply with Standards Australia
Common forms of manufacturing contamination may include but are not limited to:
Fining emery contamination
Poor quality surfacing pads
Polishing compound contamination via foreign matter not conducive to polishing surfaces
Poor or inadequate machinery maintenance
Poor or inadequate calibration of equipment
Variations to lens quality may include but is not limited to:
Non compliance to Australian Standards
Non compliance to prescription/order
Reporting systems may include:
electronic data recording
manual data recording
storage and filing systems
Organisation requirements and procedures may include:
Goals, objectives, plans, systems and processes
Legal and organisation policy/guidelines and requirements
WHS policies, procedures and programs
Business and performance plans
Anti-discrimination and related policy
Access and equity principles and practice
Ethical standards
Quality and continuous improvement processes and standards
Defined resource parameters and financial/administrative procedures
Reporting procedures
GMP requirements include:
Legislative requirements relevant to Good Manufacturing practice including
Good Manufacturing Practice codes
the Therapeutic Goods Act and/or other relevant legislation
legislation covering environmental management.work health and safety (WHS), occupational health and safety, anti-discrimination and equal opportunity
Requirements to comply with Standards Australia
Common forms of manufacturing contamination may include but are not limited to:
Fining emery contamination
Poor quality surfacing pads
Polishing compound contamination via foreign matter not conducive to polishing surfaces
Poor or inadequate machinery maintenance
Poor or inadequate calibration of equipment
Variations to lens quality may include but is not limited to:
Non compliance to Australian Standards
Non compliance to prescription/order
Reporting systems may include:
electronic data recording
manual data recording
storage and filing systems
Organisation requirements and procedures may include:
Goals, objectives, plans, systems and processes
Legal and organisation policy/guidelines and requirements
WHS policies, procedures and programs
Business and performance plans
Anti-discrimination and related policy
Access and equity principles and practice
Ethical standards
Quality and continuous improvement processes and standards
Defined resource parameters and financial/administrative procedures
Reporting procedures
EVIDENCE GUIDE
The evidence guide provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package.
Critical aspects for assessment and evidence required to demonstrate this competency unit:
The individual being assessed must provide evidence of specified essential knowledge as well as skills
Observation of actual or simulated workplace performance is essential for assessment of this unit
Consistency of performance should be demonstrated over the required range of situations relevant to the workplace
Where, for reasons of safety, space, or access to equipment and resources, assessment takes place away from the workplace, the assessment environment should represent workplace conditions as closely as possible
Context of and specific resources for assessment:
Resources essential for assessment include:
Access to an optical appliance manufacturing workplace
Method of assessment
Observation in the work place (if possible)
Written assignments/projects or questioning should be used to assess knowledge
Case study and scenario as a basis for discussion of issues and strategies to contribute to best practice
Questioning
Role play simulation
Access and equity considerations:
All workers in the health industry should be aware of access and equity issues in relation to their own area of work
All workers should develop their ability to work in a culturally diverse environment
In recognition of particular health issues facing Aboriginal and Torres Strait Islander communities, workers should be aware of cultural, historical and current issues impacting on health of Aboriginal and Torres Strait Islander people
Assessors and trainers must take into account relevant access and equity issues, in particular relating to factors impacting on health of Aboriginal and/or Torres Strait Islander clients and communities
The evidence guide provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package.
Critical aspects for assessment and evidence required to demonstrate this competency unit:
The individual being assessed must provide evidence of specified essential knowledge as well as skills
Observation of actual or simulated workplace performance is essential for assessment of this unit
Consistency of performance should be demonstrated over the required range of situations relevant to the workplace
Where, for reasons of safety, space, or access to equipment and resources, assessment takes place away from the workplace, the assessment environment should represent workplace conditions as closely as possible
Context of and specific resources for assessment:
Resources essential for assessment include:
Access to an optical appliance manufacturing workplace
Method of assessment
Observation in the work place (if possible)
Written assignments/projects or questioning should be used to assess knowledge
Case study and scenario as a basis for discussion of issues and strategies to contribute to best practice
Questioning
Role play simulation
Access and equity considerations:
All workers in the health industry should be aware of access and equity issues in relation to their own area of work
All workers should develop their ability to work in a culturally diverse environment
In recognition of particular health issues facing Aboriginal and Torres Strait Islander communities, workers should be aware of cultural, historical and current issues impacting on health of Aboriginal and Torres Strait Islander people
Assessors and trainers must take into account relevant access and equity issues, in particular relating to factors impacting on health of Aboriginal and/or Torres Strait Islander clients and communities
Replaces
| State Code | National Code | Title | Type |
|---|---|---|---|
| D8393 | HLTOPT404B | Implement good manufacturing processes in the ophthalmic industry | Unit of competency |
| State Code | National Code | Title | Type |
|---|---|---|---|
| J194 | HLT43712 | Certificate IV in Optical Technology | Qualification |