Unit of competency details

Unit descriptor 

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.

Application of the unit 

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.

Prerequisite units 

Employability skills 

This unit contains employability skills.

Elements describe the essential outcomes of a unit of competency.

Performance criteria describe the performance needed to demonstrate achievement of the element. Where bold italicised text is used, further information is detailed in the required skills and knowledge section and the range statement. Assessment of performance is to be consistent with the evidence guide.

ELEMENT 

PERFORMANCE CRITERIA 

1. Receive labels

1.1. Label details are identified and verified

1.2. The quantity of labels received is counted and reconciled against receivals documentation

1.3. Discrepancies are identified, investigated and reported

2. Issue and reconcile labels

2.1. Labels are located/created to meet batch requirements

2.2. Labels are issued in correct quantities to meet batch requirements

2.3. Labels returned to store are received, reconciled and recorded according to verification and reconciliation procedures

2.4. Records are maintained to meet workplace and legislative requirements

2.5. Work is conducted in accordance with workplace environmental guidelines

REQUIRED SKILLS AND KNOWLEDGE 

This section describes the skills and knowledge required for this unit.

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

EVIDENCE GUIDE 

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.

RANGE STATEMENT 

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

Unit sector 

Pharmaceutical manufacturing

Competency field 

Co-requisite units