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

FDFPH4004A Mapping and Delivery Guide
Participate in change control procedures

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FDFPH4004A - Participate in change control procedures
Description This unit of competency targets content outlined in Chapter 4 of the Australian Code of Good Manufacturing Practice for Medicinal Products and should be read in conjunction with this document. It covers the skills and knowledge required to participate in change control procedures.
Employability Skills This unit contains employability skills.
Learning Outcomes and Application This unit provides an overview of the change management and validation procedures that form part of Good Manufacturing Practice (GMP).This unit applies to people working in supervisory or line management production/packaging roles. This person would typically work within defined change management and validation programs and procedures. They contribute to the development of these procedures as a team member and are responsible to ensure procedures are supported in the work area.
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
  • Regulations, codes and guides relevant to the work area are identified
  • Procedures, roles and responsibilities for managing change are identified
  • Risk assessment is conducted
  • Planning of change management is undertaken within level of responsibility
  • Workplace documentation affected by the change is identified and responsibilities for review are allocated within level of responsibility
  • Any training needs arising from change are identified and delivery method/s and responsibilities are determined
  • Validation and/or other relevant authorisation requirements and procedures are identified and followed
       
Element: Participate in implementing change
  • Change is implemented according to the change management plan and occupational health and safety (OHS) procedures
  • Advice on change is communicated to all affected personnel
  • Relevant training is sourced
  • Workplace documentation is revised to reflect change requirements
  • Change is monitored and evaluated against established evaluation criteria
  • Any further adjustments or modifications are identified and implemented or reported according to change control procedure
  • Outcomes are documented and reported to meet change control requirements
       


Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment

Assessment may occur in a real or simulated pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation and document management systems related to change control that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide a range of commercial manufacturing packaging equipment and activities typically used in a commercial manufacturing environment.

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of participation in a project team to control change in a work area. This includes providing evidence that the candidate:

identifies situations requiring change control for a given set of change scenarios

participates in developing a change management plan

develops a documented implementation plan to introduce change into a work area. This may be a sub-set of a larger change management plan

leads the implementation of change in a work area. This includes reviewing relevant workplace documentation, ensuring that required training occurs, consulting with parties affected by change and negotiating any issues raised, monitoring and reporting on change and liaising with relevant departments/ personnel to ensure that authorisation and validation processes occur as required.

Context of and specific resources for assessment

Resources for assessment

change request

workplace documentation including procedures relating to change control

real or simulated workplace context.

Method of assessment

This unit could be assessed concurrently with other units relating to problem solving and process improvement. Examples could be:

FDFOP2015A Apply principles of statistical process control

FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPH4002A Facilitate and monitor Good Manufacturing Practice

FDFPH4003A Facilitate contamination control

FDFPH4005A Participate in validation processes

MSACMT450A Undertake process capability improvements.

Guidance information for assessment

To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.

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.

Required skills

Ability to:

locate regulations, codes, guides and internal company documentation relevant to GMP and products/processes used in the work area

participate in change control procedures

apply communication and consultation skills to engage and consult with work areas and personnel affected by change

ensure that related skills and knowledge requirements are addressed by the training system

apply negotiation/issue resolution skills

prepare workplace documentation in plain English and suited to purpose and audience

demonstrate and support cooperative work practices within a culturally diverse workforce

Required knowledge

Knowledge of:

types of change that come within the scope of change control procedures

change classification procedures and responsibilities

principles of risk management and related procedures

documentary evidence required to support change request

change control procedures, roles and responsibilities

workplace documentation including procedures for review, authorisation and control of documents

training system including assessment methods and documentation

validation system, procedures and responsibilities

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Regulations, codes and guides

Relevant regulations, codes and guides include:

Therapeutic Goods Act

Therapeutic Goods Regulations

Australian Code of Good Manufacturing Practice for Medicinal Products

Therapeutic Goods Act guides to interpretation of legal requirements

regulations, codes and guides related to other relevant international legislation (appropriate to product and market)

company policies and guidelines

Change

Change that must be controlled refers to any change that may affect product quality or reproducibility of the process. This may include but is not limited to change in:

formulation

product component

method of production or testing

process environment (or site)

batch size

equipment

Change management

Change management procedures and data requirements must meet the requirements of Change Management as outlined in Annex 15 of the Australian Code of Good Manufacturing Practice for Medicinal Products

Workplace documentation

Workplace documentation relevant to work area activities includes:

company policies and procedures

specifications

manufacturing formulae

processing and packaging instructions

scaling batch size up or down

batch production and packaging records

standard operating procedures (SOPs)

operating manuals

OHS information, including material safety data sheets (MSDS)

Authorisation requirements

Authorisation requirements reflect regulatory requirements and internal authorisation processes

Change management plan

A change management plan includes steps or activities required to approve and implement the proposed change. Typically these steps will be described in a change control SOP. Depending on the significance/level of the change, this could include:

process capability assessment

test methods

validation

liaison with regulator

It also includes:

timelines

responsibilities, including sign-off/approval

verification of the effectiveness of change

OHS implications

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
Regulations, codes and guides relevant to the work area are identified 
Procedures, roles and responsibilities for managing change are identified 
Risk assessment is conducted 
Planning of change management is undertaken within level of responsibility 
Workplace documentation affected by the change is identified and responsibilities for review are allocated within level of responsibility 
Any training needs arising from change are identified and delivery method/s and responsibilities are determined 
Validation and/or other relevant authorisation requirements and procedures are identified and followed 
Change is implemented according to the change management plan and occupational health and safety (OHS) procedures 
Advice on change is communicated to all affected personnel 
Relevant training is sourced 
Workplace documentation is revised to reflect change requirements 
Change is monitored and evaluated against established evaluation criteria 
Any further adjustments or modifications are identified and implemented or reported according to change control procedure 
Outcomes are documented and reported to meet change control requirements 

Forms

Assessment Cover Sheet

FDFPH4004A - 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

FDFPH4004A - 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: