Monitor implementation of good manufacturing practice in the ophthalmic industry

Formats and tools

Unit Description
Reconstruct the unit from the xml and display it as an HTML page.
Assessment Tool
an assessor resource that builds a framework for writing an assessment tool
Assessment Template
generate a spreadsheet for marking this unit in a classroom environment. Put student names in the top row and check them off as they demonstrate competenece for each of the unit's elements and performance criteria.
Assessment Matrix
a slightly different format than the assessment template. A spreadsheet with unit names, elements and performance criteria in separate columns. Put assessment names in column headings to track which performance criteria each one covers. Good for ensuring that you've covered every one of the performance criteria with your assessment instrument (all assessement tools together).
Wiki Markup
mark up the unit in a wiki markup codes, ready to copy and paste into a wiki page. The output will work in most wikis but is designed to work particularly well as a Wikiversity learning project.
Evidence Guide
create an evidence guide for workplace assessment and RPL applicants
Competency Mapping Template
Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners. A template for developing assessments for a unit, which will help you to create valid, fair and reliable assessments for the unit, ready to give to trainers and students
Observation Checklist
create an observation checklist for workplace assessment and RPL applicants. This is similar to the evidence guide above, but a little shorter and friendlier on your printer. You will also need to create a seperate Assessor Marking Guide for guidelines on gathering evidence and a list of key points for each activity observed using the unit's range statement, required skills and evidence required (see the unit's html page for details)

Self Assessment Survey
A form for students to assess thier current skill levels against each of the unit's performance criteria. Cut and paste into a web document or print and distribute in hard copy.
Moodle Outcomes
Create a csv file of the unit's performance criteria to import into a moodle course as outcomes, ready to associate with each of your assignments. Here's a quick 'how to' for importing these into moodle 2.x
Registered Training Organisations
Trying to find someone to train or assess you? This link lists all the RTOs that are currently registered to deliver HLTOPT405B, 'Monitor implementation of good manufacturing practice in the ophthalmic industry'.
Google Links
links to google searches, with filtering in place to maximise the usefulness of the returned results
Books
Reference books for 'Monitor implementation of good manufacturing practice in the ophthalmic industry' on fishpond.com.au. This online store has a huge range of books, pretty reasonable prices, free delivery in Australia *and* they give a small commission to ntisthis.com for every purchase, so go nuts :)


Elements and Performance Criteria

ELEMENT

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.


Qualifications and Skillsets

HLTOPT405B appears in the following qualifications:

  • HLT43707 - Certificate IV in Optical Technology
  • HLT43712 - Certificate IV in Optical Technology