This describes the essential skills and knowledge and their level required for this unit

Essential knowledge

The candidate must be able to demonstrate essential knowledge required to effectively do the task outlined in elements and performance criteria of this unit manage the task and manage contingencies in the context of the identified work role

This includes knowledge of

Awareness of manufacturing contaminants relevant to the manufacture of optical appliances including

control methods to prevent occurrence

possible consequences and

the conditions under which they occur

the types of contamination likely to occur

Basic concepts of quality assurance including

control methods

operating parameters

quality specifications

validation procedures

understanding of related documentation including Standard Operating Procedures

Basic understanding of the properties handling and storage requirements of manufacturing aids raw materials measuring and calibration devices and manufacturing related components and final products

Control methods and procedures used in the manufacture of optical appliances to maintain GMP which includes

an understanding of the purpose of control

identifying variances to the manufacturing process

the consequences if not controlled and

the method of control if relevant

It may also include

corrected use and supply of quality manufacturing aids

purpose and requirements of validation procedures

purpose of equipment calibration

understanding of methods used to monitor process control

GMP responsibilities and requirements relating to work role

GMP arrangements in the workplace including an awareness of relevant GMP codes of practice and related organisation policies and procedures

Housekeeping requirements and responsibilities relating to own work where relevant this may include use and storage of housekeepingcleaning equipment

Organisation policies and procedures to investigate manufacturing contamination events and performance improvement processes

continued

Essential knowledge continued

Personal clothingfootwear requirements ordering use storage and disposal

Procedures for responding to unacceptable outcomes which include procedures for identifying lens wastage that does not comply with relevant Australian Standards and manufacturing aids of unacceptable quality

Production processing aids and their relationship to legislative responsibilities and potential implications of noncompliance

Recall and traceability procedures relevant to work role

Responsibilities for reporting and recording manufacturing quality information

Standards for materials and equipment used

The relationship between GMP and the quality system personnel responsible for designing and managing GMP personal role in maintaining GMP and external auditors as appropriate

The role of GMP in preventing lens wastage

Understanding of the purpose of keeping records and the recording requirement of GMP which includes an understanding of recording lens wastage and the manufacturing aids products and materials traceability procedures

Waste collection recycling and handling procedures relevant to own work responsibilities

Essential skills

It is critical that the candidate demonstrate the ability to effectively do the task outlined in elements and performance criteria of this unit manage the task and manage contingencies in the context of the identified work role

This includes the ability to

Apply appropriate control measures

Apply appropriate variation identification procedures

Follow validation procedures within level of responsibility

Follow workplace procedures when moving around the workplace or from one task to another

Handle andor dispose of out of specification production aids raw materials measuring and calibration devices and manufacturing related components and final products in accordance with GMP and organisation policies and procedures

Handle clean and store equipment production aids raw materials measuring and calibration devices and manufacturing related components and final products in accordance with GMP and organisation policies and procedures

Identify and report situations which docould compromise GMP

Identify and respond to unacceptable production aids raw materials measuring and calibration devices and manufacturing related components and final products within level of responsibility

Locate and follow workplace information relating to GMP responsibilities

Maintain GMP for own work

Maintain personal hygiene consistent with GMP requirements

Maintain records as requirement by GMP

Maintain work area in a clean and tidy state

Order use handle store and dispose of appropriate clothingfootwear as requirement by work tasks and GMP requirements

Record results of monitoring

Take into account opportunities to address waste minimisation environmental responsibility and sustainable practice issues

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 assignmentsprojects 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 andor Torres Strait Islander clients and communities

GMP requirements include:

Common forms of manufacturing contamination may include but are not limited to:

Variations to lens quality may include but is not limited to:

Reporting systems may include:

Organisation requirements and procedures may include: