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

FBPPHM4004 Mapping and Delivery Guide
Participate in change control procedures

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FBPPHM4004 - Participate in change control procedures
Description
Employability Skills
Learning Outcomes and Application This unit of competency describes the skills and knowledge required to participate in planning and implementing change control procedures to meet Good Manufacturing Practice (GMP) requirements in a pharmaceutical manufacturing facility.The unit applies to individuals with specialised skills and knowledge of GMP requirements who contribute to the development of defined change management programs and procedures relevant to pharmaceutical manufacturing operations and have responsibility for the output of others. This includes applying and communicating non-routine technical solutions to predictable and unpredictable problems.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: Participate in planning change
  • Interpret change proposal to identify impact of change on the workplace
  • Interpret workplace procedures and GMP requirements for managing change
  • Conduct risk assessment for change implementation in the workplace
  • Undertake planning of change management
  • Identify workplace procedures affected by change management plan and allocate responsibilities for review
  • Identify training needs arising from change and determine delivery methods and responsibilities
  • Apply authorisation requirements according to workplace change control procedures
  • Finalise change management plan according to workplace procedures and GMP requirements
       
Element: Participate in implementing change
  • Communicate change to all affected personnel
  • Implement training to support affected individuals and groups according to workplace procedures
  • Revise workplace procedures to reflect change requirements
  • Monitor and evaluate change according to workplace change control procedures
  • Implement adjustments to change according to workplace change control procedures
  • Maintain workplace records and documents according to workplace change control procedures and GMP 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.
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
Interpret change proposal to identify impact of change on the workplace 
Interpret workplace procedures and GMP requirements for managing change 
Conduct risk assessment for change implementation in the workplace 
Undertake planning of change management 
Identify workplace procedures affected by change management plan and allocate responsibilities for review 
Identify training needs arising from change and determine delivery methods and responsibilities 
Apply authorisation requirements according to workplace change control procedures 
Finalise change management plan according to workplace procedures and GMP requirements 
Communicate change to all affected personnel 
Implement training to support affected individuals and groups according to workplace procedures 
Revise workplace procedures to reflect change requirements 
Monitor and evaluate change according to workplace change control procedures 
Implement adjustments to change according to workplace change control procedures 
Maintain workplace records and documents according to workplace change control procedures and GMP requirements 

Forms

Assessment Cover Sheet

FBPPHM4004 - Participate in change control procedures
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

FBPPHM4004 - Participate in change control procedures

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: