Modification History
Not applicable.
Unit Descriptor
Unit descriptor |
This unit of competency covers the skills and knowledge required to weigh, measure and label non-bulk ingredients to meet batch requirements. |
Application of the Unit
Application of the unit |
This unit applies to production operators working in the pharmaceutical sector. This person would typically work within defined Good Manufacturing Practice (GMP) programs and procedures. This unit typically targets the production worker responsible for applying basic operating principles to the operation and monitoring of measuring and dispensing equipment. When batch or product changeover procedures are part of this work process, the procedures should be used to customise the application of this unit. Where more detailed changeovers are carried out, FDFOP2011A Conduct routine maintenance, should be considered. |
Licensing/Regulatory Information
Not applicable.
Pre-Requisites
Prerequisite units |
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Employability Skills Information
Employability skills |
This unit contains employability skills. |
Elements and Performance Criteria Pre-Content
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. |
Elements and Performance Criteria
ELEMENT |
PERFORMANCE CRITERIA |
1. Prepare to dispense raw materials |
1.1. Materials are inspected to confirm type, quality clearance, quantities and identify any obvious contamination or non-compliance 1.2. Measuring and weighing equipment is selected appropriate to dispensing requirements and checked to confirm readiness for use 1.3. Containers/bags and labels are available as required 1.4. Pre-start checks are carried out as required by workplace requirements |
2. Measure and/or weigh raw materials |
2.1. Non-bulk ingredients and additives are weighed/measured to meet production requirements 2.2. Dispensed ingredients are labelled according to workplace procedure 2.3. Accuracy of measuring/dispensing equipment is monitored to identify variation in operating conditions 2.4. Variation in equipment operation is identified and maintenance requirements are reported according to workplace reporting requirements 2.5. The work area is maintained according to housekeeping standards 2.6. Work is conducted in accordance with workplace environmental guidelines |
3. Shut down the dispensing process |
3.1. Dispensing equipment is cleaned according to workplace procedure 3.2. Unacceptable equipment/utensil condition is identified and reported 3.3. Dispensed materials are recorded and reconciled 3.4. Maintenance requirements are identified and reported |
Required Skills and Knowledge
REQUIRED SKILLS AND KNOWLEDGE |
This section describes the skills and knowledge required for this unit. |
Required skills |
Ability to :
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Required knowledge |
Knowledge of :
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Evidence Guide
EVIDENCE GUIDE |
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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. |
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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:
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Context of and specific resources for assessment |
Assessment must occur in a real or simulated workplace where assessee has access to:
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Method of assessment |
This unit should be assessed together with core units and other units of competency relevant to the function or work role. Examples could be:
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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
RANGE STATEMENT |
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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. |
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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:
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Workplace information |
Workplace information may include:
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Dispensing equipment |
Dispensing equipment may include:
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Raw materials |
Raw materials may include:
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Operation of equipment and processes |
Operation of equipment and processes may require:
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Unit Sector(s)
Unit sector |
Pharmaceutical manufacturing |
Competency field
Competency field |
Co-requisite units
Co-requisite units |
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