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Evidence Guide: HLTOPT404C - Implement good manufacturing processes in the ophthalmic industry

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

HLTOPT404C - Implement good manufacturing processes in the ophthalmic industry

What evidence can you provide to prove your understanding of each of the following citeria?

Identify requirements of GMP as related to the optical industry

  1. Identify and locate sources of information on GMP
  2. Identify requirements and responsibilities related to own work
Identify and locate sources of information on GMP

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify requirements and responsibilities related to own work

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Observe personal hygiene requirements of GMP

  1. Ensure personal hygiene meets GMP requirements
  2. Prepare, order, use, handle, store and dispose of PPE (personal protective equipment) according to GMP and workplace requirements
  3. Ensure personal movement around workplace complies with safety requirements, company procedures and policies
Ensure personal hygiene meets GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare, order, use, handle, store and dispose of PPE (personal protective equipment) according to GMP and workplace requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure personal movement around workplace complies with safety requirements, company procedures and policies

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Implement GMP requirements

  1. Identify GMP requirements
  2. Routinely monitor work area, work flow, materials. equipment and products to ensure compliance with GMP requirements
  3. Ensure production aids, measuring and calibration devices and manufacturing related products are handled according to GMP and workplace requirements
  4. Follow workplace procedures to control resource allocation and process in accordance with GMP requirements
  5. Identify common forms of contamination that contributes to lens wastage and implement appropriate control measures in accordance with GMP requirements
  6. Ensure work and use of resources meets current legislation, approved codes of practice and organisation requirements
  7. Maintain the workplace in accordance with GMP requirements
  8. Identify and implement correct handling practices for lens materials during the manufacturing process
  9. Identify and implement correct handling practices and procedures for gauges, instruments, machinery and other manufacturing correctly
Identify GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Routinely monitor work area, work flow, materials. equipment and products to ensure compliance with GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure production aids, measuring and calibration devices and manufacturing related products are handled according to GMP and workplace requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Follow workplace procedures to control resource allocation and process in accordance with GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify common forms of contamination that contributes to lens wastage and implement appropriate control measures in accordance with GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure work and use of resources meets current legislation, approved codes of practice and organisation requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain the workplace in accordance with GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and implement correct handling practices for lens materials during the manufacturing process

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and implement correct handling practices and procedures for gauges, instruments, machinery and other manufacturing correctly

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Participate in improving GMP

  1. Recognise and correct existing and potential disruptions to the workflow
  2. Identify and report processes, practices or conditions which are not compliant with GMP in accordance with organisation policies and procedures
  3. Implement corrective action in line with organisation policies and procedures and own level of responsibility
  4. Raise GMP issues with supervisor or designated personal in accordance with organisation policies and procedures
Recognise and correct existing and potential disruptions to the workflow

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and report processes, practices or conditions which are not compliant with GMP in accordance with organisation policies and procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Implement corrective action in line with organisation policies and procedures and own level of responsibility

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Raise GMP issues with supervisor or designated personal in accordance with organisation policies and procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Participate in quality and validation processes

  1. Follow validation processes to GMP requirements
  2. Raise issues identified in validation processes with supervisor or designated personal in accordance with organisation policies and procedures
  3. Document validation procedures in line with GMP and in accordance with organisation policies and procedures
  4. Information is recorded in line with GMP and organisation reporting requirements
Follow validation processes to GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Raise issues identified in validation processes with supervisor or designated personal in accordance with organisation policies and procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Document validation procedures in line with GMP and in accordance with organisation policies and procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Information is recorded in line with GMP and organisation reporting requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Apply stock control procedures

  1. Maintain stock of machinery parts, preventive maintenance parts and accessories and manufacturing consumables
  2. Reduce shrinkage with effective and efficient procedures and processes
  3. Recognise and apply stock-on-hand practices to maintain adequate stock levels
Maintain stock of machinery parts, preventive maintenance parts and accessories and manufacturing consumables

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Reduce shrinkage with effective and efficient procedures and processes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Recognise and apply stock-on-hand practices to maintain adequate stock levels

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

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

Required Skills and Knowledge

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 housekeeping/cleaning equipment)

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

continued ,,,

Essential knowledge continued:

Personal clothing/footwear 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 non-compliance

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 and/or 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 do/could 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 clothing/footwear 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

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.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