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

FDFPH2007A Mapping and Delivery Guide
Coordinate a label store

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FDFPH2007A - Coordinate a label store
Description This unit of competency covers the skills and knowledge required to manage a label store in a pharmaceutical workplace to meet workplace and legislative requirements.
Employability Skills This unit contains employability skills.
Learning Outcomes and Application This unit applies to management of a secure label store and has application in a pharmaceutical manufacturing environment. It typically targets the production worker responsible for receiving, issuing and reconciling labels for pharmaceutical products.
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: Receive labels
  • Label details are identified and verified
  • The quantity of labels received is counted and reconciled against receivals documentation
  • Discrepancies are identified, investigated and reported
       
Element: Issue and reconcile labels
  • Labels are located/created to meet batch requirements
  • Labels are issued in correct quantities to meet batch requirements
  • Labels returned to store are received, reconciled and recorded according to verification and reconciliation procedures
  • Records are maintained to meet workplace and legislative requirements
  • Work is conducted in accordance with workplace environmental guidelines
       


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 must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations.

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

Evidence of ability to:

receive and verify labels

issue labels according to batch requirements

take corrective action in response to typical faults and discrepancies

complete workplace records as required

apply safe work practices and identify OHS hazards and controls

apply food safety procedures to work practices.

Context of and specific resources for assessment

Assessment must occur in a real or simulated workplace where the assessee has access to:

label management system and procedures

documentation and recording requirements and procedures

labels

label counting equipment

label printing equipment and consumables as required.

Method of assessment

This unit should be assessed together with other units of competency relevant to the work role.

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:

follow receivals procedures to receive, count and store labels

access production schedule to identify label requirements

carry out procedures to test accuracy of label counting machines and record results

verify that label information meets batch type, including setting up and using label counting equipment

demonstrate the procedure for removing and accounting for damaged or other non-conforming labels

select and issue labels to meet batch requirements and documentation

demonstrate procedures to receive labels issued and returned from production

conduct reconciliations of labels received and issued and conduct backup verification as required

maintain security of label store

maintain work area to meet housekeeping standards

operate label coding and printing equipment according to enterprise procedures

use oral communication skills/language competence to fulfil the job role as specified by the organisation, including questioning, active listening, asking for clarification and seeking advice from supervisor

work cooperatively within a culturally diverse workforce

Required knowledge

Knowledge of:

system of label control, including the purpose and procedures for receiving, issuing, reconciling and verifying label management

legislative responsibilities relating to label management

purpose and requirements of security procedures and responsibilities

types of labels received and issued and significance of codes

consequences of issuing incorrect labels

procedures for setting up, testing and operating label store equipment, including label counting equipment

corrective action required if a discrepancy is identified

occupational health and safety (OHS) hazards associated with the work role

procedures and responsibility for recording and reporting information

operating procedures for label coding and printing equipment where relevant

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.

Policies and procedures

Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements, and industrial awards and agreements

Legislative requirements

Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:

relevant Good Manufacturing Practice (GMP) codes

the Therapeutic Goods Act and/or other relevant legislation

legislation covering environmental management, OHS, anti-discrimination and equal opportunity

Workplace information

Workplace information may include:

standard operating procedures (SOPs)

labels and related documentation

production schedules and instructions

standard forms and reports

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
Label details are identified and verified 
The quantity of labels received is counted and reconciled against receivals documentation 
Discrepancies are identified, investigated and reported 
Labels are located/created to meet batch requirements 
Labels are issued in correct quantities to meet batch requirements 
Labels returned to store are received, reconciled and recorded according to verification and reconciliation procedures 
Records are maintained to meet workplace and legislative requirements 
Work is conducted in accordance with workplace environmental guidelines 

Forms

Assessment Cover Sheet

FDFPH2007A - Coordinate a label store
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

FDFPH2007A - Coordinate a label store

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: