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Unit of competency details

FBPPHM3017 - Coordinate a label store (Release 1)

Summary

Usage recommendation:
Current
Mapping:
MappingNotesDate
Supersedes and is equivalent to FDFPH2007A - Coordinate a label storeUpdated to meet Standards for Training Packages Changes to performance criteria for clarity Code changed to reflect AQF alignment 17/Dec/2018

Release Status:
Current
Releases:
ReleaseRelease date
1 1 (this release) 18/Dec/2018


Classifications

SchemeCodeClassification value
ASCED Module/Unit of Competency Field of Education Identifier 089901 Purchasing, Warehousing And Distribution  

Classification history

SchemeCodeClassification valueStart dateEnd date
ASCED Module/Unit of Competency Field of Education Identifier 089901 Purchasing, Warehousing And Distribution  18/Dec/2018 
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Unit Of competency

Modification History

Release 

Comments 

Release 1

This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.

Application

This unit of competency describes the skills and knowledge required to receive, issue and reconcile labels for pharmaceutical products in a pharmaceutical manufacturing facility.

The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the coordination of a label store. 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.

Pre-requisite Unit

Nil

Unit Sector

Pharmaceutical (PHM)

Elements and Performance Criteria

Elements 

Performance Criteria 

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1. Receive labels

1.1 Locate label details required for type of pharmaceutical product

1.2 Confirm the quantity of labels received and reconcile against receival documentation

1.3 Identify and report discrepancies to supervisor

2. Issue and reconcile labels

2.1 Create labels to meet batch requirements

2.2 Issue labels in correct quantities to meet batch requirements

2.3 Receive, reconcile and record labels returned to store according to workplace verification and reconciliation procedures

2.4 Maintain records to meet workplace and legislative requirements

2.5 Coordinate the issue and reconciliation of labels according to workplace requirements

Foundation Skills

This section describes those language, literacy, numeracy and employment skills that are essential for performance in this unit of competency but are not explicit in the performance criteria.

Skill 

Description 

Reading

  • Read and identify label information

Writing

  • Record workplace information using appropriate language and in required format

Numeracy

  • Verify that label information meets batch type
  • Use label counting equipment

Navigate the world of work

  • Apply workplace procedures to own role and responsibilities
  • Understand main tasks, responsibilities and boundaries of own role

Interact with others

  • Report operational and safety information to relevant personnel using required communication method

Get the work done

  • Issue labels according to batch requirements
  • Solve routine problems according to workplace guidelines and using experience of past solutions

Unit Mapping Information

Code and title current version 

Code and title previous version 

Comments 

Equivalence status 

FBPPHM3017 Coordinate a label store

FDFPH2007A Coordinate a label store

Updated to meet Standards for Training Packages

Changes to performance criteria for clarity

Code changed to reflect AQF alignment

Equivalent unit

Links

Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4

 

Assessment requirements

Modification History

Release 

Comments 

Release 1

This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.

Performance Evidence

An individual demonstrating competency in this unit must satisfy all the elements and performance criteria of this unit.

There must be evidence that the individual has coordinated at least one label store, including:

  • followed receival procedures to receive, count and store labels
  • accessed the production schedule to identify label requirements
  • tested accuracy of label counting machines and recorded results
  • verified that label information meets batch type, including setting up and using label counting equipment
  • removed and accounted for damaged labels, or other non-conforming labels
  • selected and issued labels to meet batch and documentation requirements
  • received labels that have been issued and returned from production
  • conducted reconciliations of labels received and issued including back-up verification
  • maintained security of label store
  • maintained a clean and hazard free work area
  • operated label coding and printing equipment according to workplace procedures
  • completed records according to workplace requirements.

Knowledge Evidence

An individual must be able to demonstrate the knowledge required to perform the tasks outlined in the elements and performance criteria of this unit. This includes knowledge of:

  • system of label control, including purposes and procedures for receiving, issuing and reconciling labels and verifying label management
  • Good Manufacturing Practice (GMP) requirements and workplace procedures relating to label management
  • purposes and requirements of security procedures and responsibilities
  • types of labels received and issued and the 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
  • workplace procedures and responsibility for recording and reporting information
  • workplace procedures for label coding and printing equipment.

Assessment Conditions

Assessment of skills must take place under the following conditions:

  • physical conditions:
  • a pharmaceutical manufacturing workplace or an environment that accurately represents workplace conditions
  • resources, equipment and materials:
  • label management system and procedures
  • labels and label counting equipment
  • label printing equipment and consumables
  • record keeping systems
  • specifications:
  • batch instructions
  • documentation and workplace procedures about recording requirements
  • workplace procedures relating to coordinating a label store and label management that comply with GMP requirements.

Assessors of this unit must satisfy the requirements for assessors in applicable vocational education and training legislation, frameworks and/or standards.

Links

Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4