Unit of competency Outline
Date retreived
22/07/2026 8:28 AM AWST
22/07/2026 8:28 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.
Monitor implementation of good manufacturing practice in the ophthalmic industry
Monitor implementation of good manufacturing practice in the ophthalmic industry
Unit of competency
National Code
HLTOPT405B
HLTOPT405B
State Code
d8394
d8394
TGA Status
Replaced
Replaced
DTWD Status
Deleted
Deleted
State Implementation and Classification
Approved Date
01/08/2011
Field of Education
060903 - Optical Technology
Original Release Date
01/08/2011
Nominal Hours
40
Description
DescriptorThis unit of competency describes the skills and knowledge required to provide a supervision and leadership role in the implementation of Good Manufacturing Practices (GMP) for the manufacturing of optical appliances
Notes
Elements and Performance Criteria
1. Ensure others in the work area are able to meet GMP requirements
- 1.1 Ensure relevant clothing and equipment appropriate to work requirements is available, functional and correctly fitted
- 1.2 Ensure advice on GMP responsibilities and procedures is accessible and clearly explained
- 1.3 Ensure that GMP control measures used in the work area can be identified by others
- 1.4 Provide mentoring and support to individuals/groups to implement GMP and related procedures
2. Monitor personal hygiene and conduct of team members in the work area
- 2.1 Ensure personal hygiene of team members meets GMP requirements
- 2.2 Prepare, order use, handle store and dispose of PPE (personal protective equipment) according to GMP and organisational policies and procedures
- 2.3 Ensure personal movement around the workplace complies with safety requirements and company procedures and policies
3. Monitor the implementation of GMP requirements
- 3.1 Define, document and follow GMP procedures
- 3.2 Report non-compliance from identified procedures and address within level of responsibility
- 3.3 Ensure personal behaviour is consistent with GMP and organisation policies and procedure
- 3.4 Follow organisation procedures to control resource allocation and process to meet GMP requirements
- 3.5 Identify and report GMP non-conformance in accordance with organisation policies and procedures
- 3.6 Document GMP information in line with organisation reporting requirements
- 3.7 Ensure the workplace is maintained in a clean and tidy order to meet GMP housekeeping standards
4. Contribute to validation processes
- 4.1 Review validation practices and procedures in consultation with relevant personnel.
- 4.2 Identify validation results and issues and take corrective action within level of responsibility
- 4.3 Document GMP validation information in line with GMP code and organisation reporting requirements
5. Take corrective action in response to GMP non-compliance
- 5.1 Identify and report processes, practices and conditions which could result in non-compliance with GMP in accordance with organisation requirements
- 5.2 Take corrective action in accordance with level of responsibility
- 5.3 Raise GMP issues with designated personnel
6. Maintain and improve GMP in the workplace
- 6.1 Identify, report and correct processes or conditions which could result in non-conformance with GMP
- 6.2 Ensure matters raised relating to GMP are promptly resolved and/or referred to appropriate personnel
- 6.3 Monitor effectiveness of control measures within level of responsibility
- 6.4 Advise others in the workplace of GMP matters relevant to work role
- 6.5 Propose changes to documentation in line with organisation requirements to maintain GMP
- 6.6 Conduct GMP audits to meet organisation and legislative requirements
- 6.7 Take action to respond to audit recommendations within level of responsibility.
RANGE STATEMENT
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. occupational health and safety, anti-discrimination and equal opportunity
Reporting systems include:
Electronic data recording
Manual recording
Storage and filing systems
Products/materials stored may include:
Raw materials
Packaging components
Consumables
Part-processed products
Finished products
Cleaning materials
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. occupational health and safety, anti-discrimination and equal opportunity
Reporting systems include:
Electronic data recording
Manual recording
Storage and filing systems
Products/materials stored may include:
Raw materials
Packaging components
Consumables
Part-processed products
Finished products
Cleaning materials
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
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
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
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
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 |
|---|---|---|---|
| C9398 | HLTOPT405A | Monitor implementation of good manufacturing practice in the ophthalmic industry | Unit of competency |
| State Code | National Code | Title | Type |
|---|---|---|---|
| D079 | HLT43507 | Certificate IV in Optical Dispensing | Qualification |
| D081 | HLT43707 | Certificate IV in Optical Technology | Qualification |
| J194 | HLT43712 | Certificate IV in Optical Technology | Qualification |