Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

FBPPHM3014 Mapping and Delivery Guide
Operate a liquid manufacturing process

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FBPPHM3014 - Operate a liquid manufacturing process
Description
Employability Skills
Learning Outcomes and Application This unit of competency describes the skills and knowledge required to set up, operate, adjust and shut down a liquid manufacturing process in a pharmaceutical manufacturing facility.The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the liquid manufacturing process. Individuals work under broad direction and take responsibility for their own work. No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities
Slides
PPT
Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: Prepare the liquid manufacturing process for operation
  • Confirm materials and equipment are available and meet production requirements
  • Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
  • Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual
  • Enter processing and operating parameters according to safety and production requirements
  • Check and adjust equipment performance according to equipment operating procedures
  • Conduct pre-start checks according to workplace requirements
       
Element: Operate and monitor the liquid manufacturing process
  • Deliver raw materials in required quantities and sequence according to recipe specifications, batch and production requirements
  • Start up and monitor liquid manufacturing process to confirm specifications are within required limits
  • Identify, rectify and report out-of-specification liquid products or process outcomes to maintain process within specifications
  • Conduct in process testing
  • Transfer liquid mix according to production requirements
  • Maintain work area according to workplace cleaning standards
  • Conduct process according to safety and environmental requirements
  • Contain, remove and report spillages according to workplace procedures
  • Complete documentation according to workplace procedures
       
Element: Shut down the liquid manufacturing process
  • Confirm the workplace procedures for shutting down the process
  • Complete end-of-batch procedures according to batch instructions and workplace procedures
  • Safely shut down the process
  • Complete records according to workplace procedures
       

Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)


Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

This section specifies different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Pre-start checks must include:

carrying out required area or line clearances

inspecting equipment condition to identify signs of wear

confirming all safety equipment is in place and operational

confirming that equipment is clean or sanitised

confirming that equipment is correctly configured for processing requirements

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
Confirm materials and equipment are available and meet production requirements 
Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures 
Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual 
Enter processing and operating parameters according to safety and production requirements 
Check and adjust equipment performance according to equipment operating procedures 
Conduct pre-start checks according to workplace requirements 
Deliver raw materials in required quantities and sequence according to recipe specifications, batch and production requirements 
Start up and monitor liquid manufacturing process to confirm specifications are within required limits 
Identify, rectify and report out-of-specification liquid products or process outcomes to maintain process within specifications 
Conduct in process testing 
Transfer liquid mix according to production requirements 
Maintain work area according to workplace cleaning standards 
Conduct process according to safety and environmental requirements 
Contain, remove and report spillages according to workplace procedures 
Complete documentation according to workplace procedures 
Confirm the workplace procedures for shutting down the process 
Complete end-of-batch procedures according to batch instructions and workplace procedures 
Safely shut down the process 
Complete records according to workplace procedures 

Forms

Assessment Cover Sheet

FBPPHM3014 - Operate a liquid manufacturing process
Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:


Assessment Record Sheet

FBPPHM3014 - Operate a liquid manufacturing process

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: