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

FBPPHM3003 Mapping and Delivery Guide
Work in a controlled environment

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FBPPHM3003 - Work in a controlled environment
Description
Employability Skills
Learning Outcomes and Application This unit of competency describes the skills and knowledge required to prepare to enter, work and exit a controlled environment in a pharmaceutical manufacturing facility.The unit applies to individuals who apply Good Manufacturing Practice (GMP) requirements and operating principles to working in a controlled environment. 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 to enter a controlled environment
  • Obtain workplace information, including workplace procedures related to working in a controlled environment
  • Remove jewellery and makeup according to workplace procedures
  • Wash hands according to workplace procedures
  • Source and fit personal protective equipment (PPE) and contamination prevention clothing prior to entering controlled environment
  • Check controlled environment operating conditions prior to entry
       
Element: Work in a controlled environment
  • Enter controlled environment according to workplace procedures
  • Take commodity items into the controlled environment according to workplace procedures
  • Conduct work activities to minimise risk of contamination
       
Element: Maintain a controlled environment
  • Identify controlled environment contamination risks
  • Control environmental contamination according to GMP requirements and workplace procedures
  • Maintain controlled environment work area according to workplace cleaning standards and environmental requirements
  • Report practices inconsistent with GMP according to workplace procedures
       
Element: Exit a controlled environment
  • Follow workplace procedures to exit a controlled environment
  • Remove PPE and contamination prevention clothing according to workplace procedures
  • De-gown according to workplace procedures
  • Check, store and dispose of PPE according to manufacturer specifications, environmental and work health and safety requirements
       

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.

Controlled environment must include at least one of the following:

controlled, non-classified environment

cleanrooms that are controlled environments that have been certified as meeting an internationally recognised standard.

Contamination prevention clothing must include at least one of the following:

facility suits for controlled, non-classified environment

disposable and reusable garments for controlled, classified cleanroom environments.

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
Obtain workplace information, including workplace procedures related to working in a controlled environment 
Remove jewellery and makeup according to workplace procedures 
Wash hands according to workplace procedures 
Source and fit personal protective equipment (PPE) and contamination prevention clothing prior to entering controlled environment 
Check controlled environment operating conditions prior to entry 
Enter controlled environment according to workplace procedures 
Take commodity items into the controlled environment according to workplace procedures 
Conduct work activities to minimise risk of contamination 
Identify controlled environment contamination risks 
Control environmental contamination according to GMP requirements and workplace procedures 
Maintain controlled environment work area according to workplace cleaning standards and environmental requirements 
Report practices inconsistent with GMP according to workplace procedures 
Follow workplace procedures to exit a controlled environment 
Remove PPE and contamination prevention clothing according to workplace procedures 
De-gown according to workplace procedures 
Check, store and dispose of PPE according to manufacturer specifications, environmental and work health and safety requirements 

Forms

Assessment Cover Sheet

FBPPHM3003 - Work in a controlled environment
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

FBPPHM3003 - Work in a controlled environment

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: