Elements and Performance Criteria

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.
Codes of practice
Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used
Standards, codes, procedures and/or enterprise requirements
Standards, codes, procedures and/or enterprise requirements may include:
Australian and international standards, such as:
AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories
AS/NZS 2243 Set:2006 Safety in laboratories set
AS/NZS ISO 10005:2006 Quality management systems - Guidelines for quality plans
AS/NZS ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment
AS/NZS ISO 9000 Set:2008 Quality management systems set
ISO 5725 Accuracy (trueness and precision) of measurement methods and results
ISO/IEC Guide 98-3:2008 Uncertainty of measurement - Part 3 Guide to the expression of uncertainty in measurement (GUM)
Eurachem/CITAC Guide CG4 Quantifying uncertainty in analytical measurement
Australia New Zealand Food Standards (ANZFS) Code
Association of Analytical Communities International (AOAC International) Official methods of analysis
ICH Q2A: Validation of Analytical Procedures - Guideline for industry
Australian code of good manufacturing practice for medicinal products (GMP)
Australian Quarantine and Inspection Service (AQIS) Export Control (Orders) Regulations 1982 and Import Guidelines
calibration and maintenance schedules
enterprise recording and reporting procedures
equipment and quality manuals
gene technology regulations
intellectual property and copyright
maintenance and confidentiality of records
material safety data sheets (MSDS)
material, production and product specifications
national environment protection measures
National Health and Medical Research Council (NHMRC) Guidelines
national measurement regulations and guidelines
OHS national standards and codes of practice
principles of good laboratory practice (GLP)
product formulation documentation
SOPs
suppliers of raw material catalogues
Therapeutic Goods Regulations 1009
Product/application briefs
Product/application briefs may be provided by:
external customers
internal customers
marketing
production
Materials used to manufacture products/applications
Materials used to manufacture products/applications may include:
solvents
emulsifiers
thickeners
surfactants
disintegrants
fillers
moisturising materials
colouring materials
flavours
perfumes
opacifiers
propellants
sunscreens
Calculations
Calculations may be required to adjust properties, such as:
assay/potency
viscosity
application payload
hardness
moisture content
colour
Occupational health and safety (OHS) and environmental management requirements
OHS and environmental management requirements:
all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time
all operations assume the potentially hazardous nature of samples and require standard precautions to be applied
where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health

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

Critical aspects for assessment and evidence required to demonstrate competency in this unit
Assessors should ensure that candidates can:
evaluate a product/application brief and contribute to the development of products and applications to meet the requirements of the brief
interpret a brief to determine product/application development requirements
apply theoretical knowledge of starting material and formulation principles to develop product/applications
use appropriate procedures to research alternative formulations
use environment friendly strategies for formulations
make formulation recommendations for pilot batch manufacture
manufacture pilot batches
evaluate pilot batches against project brief
evaluate product/application stability
evaluate the OHS requirements to be observed for each ingredient during manufacture of product/application
evaluate the OHS suitability of each ingredient for use in the formulation
ensure that product/application meets regulatory requirements
follow enterprise procedures to document development process.

Context of and specific resources for assessment
This unit of competency is to be assessed in the workplace or simulated workplace environment.
This unit of competency may be assessed with:
MSL977002A Troubleshoot equipment and/or production processes
MSL977003A Contribute to the validation of test methods
MSL977004A Develop or adapt analyses and procedures.
Resources may include:
standard laboratory equipped with appropriate pilot batch manufacturing and testing equipment
online data search facilities
starting material and product formulation information
scheduling charts and project plans
appropriate SOPs and enterprise guidelines.

Method of assessment
The following assessment methods are suggested:
review of development work completed by the candidate
review of development briefs completed by the candidate over time to ensure that they were implemented consistently within the required timeframe
feedback from supervisors and/or clients
oral or written questioning to assess development and problem solving approaches.
In all cases, practical assessment should be supported by questions to assess underpinning knowledge and those aspects of competency which are difficult to assess directly.
Where applicable, reasonable adjustment must be made to work environments and training situations to accommodate ethnicity, age, gender, demographics and disability.
Access must be provided to appropriate learning and/or assessment support when required.
The language, literacy and numeracy demands of assessment should not be greater than those required to undertake the unit of competency in a work like environment.

This competency in practice
Industry representatives have provided the case studies below to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting.
Manufacturing
Technical specialists who formulate cosmetics products must apply theoretical and practical knowledge during each stage of the formulation process. This is illustrated during the perfuming stage of the product development process for a product range consisting of soap, talc and a water-in-oil emulsion. For example, soaps are alkaline and the selected perfume must be stable under alkaline conditions. Perfumes consist of a large number of components, and any preferential adsorption of some of these components on the surface of the talc will alter the odour. When perfuming an emulsion, the components of the perfume will partition between the water and oil phases of the emulsion, altering the odour reaching the consumer. To get the three products smelling the same after manufacture requires attention to these theoretical concepts. Stability studies must be planned and carried out to ensure that the products are stable in the chosen packs and smell the same throughout their lifetime. When perfuming this rather small range of products, the technical specialists must apply a wide range of theoretical and practical knowledge to satisfy the product brief.
Food processing
Technical specialists in food research laboratories evaluate product briefs provided by marketing. They then develop products to meet the requirements of the brief and convert the brief into a marketable product. After the product is successfully introduced, technical specialists must continue to upgrade the quality and desirability of products because of shortened product life cycles.
As part of their role technical specialists may be required to apply technical knowledge to:
reduce ingredient costs of existing formulation
standardise existing formulations and processes for quality and cost control
identify solutions to existing problems, such as product quality or shelf life
develop consumer preparation instruction methods
develop labelling or packaging information
formulate new or improve existing products
locate and evaluate new packaging alternatives to meet a range of requirements
assist in compliance with regulatory standards
assess consumer preferences
prepare pilot batches of new products
assist in scale up of pilot batches to full scale production batches
test product's shelf life.
This requires an in-depth knowledge of how to select and use various ingredients for specific applications, as well as the chemistry, technology and regulatory aspects of their job.