Monitor the implementation of Good Manufacturing Practice procedures

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 FDFPHGMP3A, 'Monitor the implementation of Good Manufacturing Practice procedures'.
Google Links
links to google searches, with filtering in place to maximise the usefulness of the returned results
Books
Reference books for 'Monitor the implementation of Good Manufacturing Practice procedures' 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

Elements and Performance Criteria

Element

Performance Criteria

1

Ensure others in the work area are able to meet GMP requirements

1.1

Relevant clothing and equipment appropriate towork requirements are available, functional and correctlyfitted

1.2

Advice on GMP responsibilities and proceduresis accessible and clearly explained

1.3

GMP control measures used in the work area canbe identified by those in the work area

1.4

Mentoring and coaching support is available tosupport individuals/groups to implement GMP and relatedprocedures

1.5

Training needs are identified and addressedwithin level of responsibility

2

Monitor personal hygiene and conduct of team members in the work area

2.1

Personal hygiene of work team meets GMPrequirements

2.2

Clothing is prepared, used, stored anddisposed of according to GMP and workplace procedures

2.3

Personal movement around the workplacecomplies with area entry and exit procedures

3

Monitor implementation of GMP requirements in the work area

3.1

GMP procedures in the work area are clearlydefined, documented and followed

3.2

Non-compliance with identified procedures isreported and addressed within level of responsibility

3.3

Personal behaviour is consistent withworkplace policies and procedures that support GMP

3.4

Workplace procedures to control resourceallocation and process are followed to meet GMP requirements

3.5

GMP non-conformance is identified and reportedaccording to workplace procedure

3.6

GMP information is recorded to meet workplacereporting requirements

3.7

The workplace is maintained in a clean andtidy order to meet GMP housekeeping standards

4

Contribute to validation processes

4.1

Validation practices and procedures arereviewed in consultation with relevant personnel

4.2

Validation results and issues are identifiedand corrective action taken within level of responsibility

4.3

Documentation and recording requirements meetGMP code and company requirements

5

Take corrective action in response to GMP non-compliance

5.1

Processes, practices or conditions which couldresult in non-compliance with GMP are identified and reportedaccording to workplace reporting requirements

5.2

Corrective action is taken in accordancewithin level of responsibility

5.3

GMP issues are raised with designatedpersonnel

6

Maintain and improve GMP in the work area

6.1

Processes or conditions which could result innon-conformance with GMP are identified, reported and correctedwithin level of responsibility

6.2

Matters raised relating to GMP are promptlyresolved and/or referred to appropriate personnel

6.3

Effectiveness of control measures aremonitored within level of responsibility

6.4

Others in the work area are advised of GMPmatters relevant to work role

6.5

Changes to documentation are proposed inaccordance with workplace procedures to maintain GMP

6.6

GMP audits are conducted to meet company andlegislative requirements

6.7

Action is taken to respond to auditrecommendations within level of responsibility


Qualifications and Skillsets

FDFPHGMP3A appears in the following qualifications:

  • PMA30108 - Certificate III in Process Plant Operations
  • PMA40108 - Certificate IV in Process Plant Technology