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Evidence Guide: MSL977001A - Contribute to the development of products and applications

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

MSL977001A - Contribute to the development of products and applications

What evidence can you provide to prove your understanding of each of the following citeria?

Scope the development project

  1. Confirm details of new product/application brief
  2. Specify new product/application requirements
  3. Analyse existing products (internal and external to enterprise) to determine if they meet customer need
  4. Interpret and apply relevant Acts, regulations and codes of practice
  5. Prepare product development plan
  6. Obtain approval for development plan from appropriate personnel
Confirm details of new product/application brief

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Specify new product/application requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Analyse existing products (internal and external to enterprise) to determine if they meet customer need

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Interpret and apply relevant Acts, regulations and codes of practice

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare product development plan

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain approval for development plan from appropriate personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Set scope of project

  1. Estimate resource requirements, including staffing, equipment and materials needed to undertake the project
  2. Identify roles and responsibilities of project team members
  3. Identify quality requirements and quality standards
  4. Prepare project timelines taking into account any constraints
Estimate resource requirements, including staffing, equipment and materials needed to undertake the project

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify roles and responsibilities of project team members

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify quality requirements and quality standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare project timelines taking into account any constraints

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Develop new product formulation

  1. Prepare documentation for new product pilot batch
  2. Evaluate/recommend materials for new product/application
  3. Calculate required quantities of materials and adjust for properties as appropriate
  4. Develop/modify products in pilot batch scale in accordance with enterprise and regulatory requirements
  5. Arrange for product evaluation against development brief
  6. Modify product/application to meet evaluation recommendations
  7. Edit documentation and issue to appropriate personnel
  8. Recommend and evaluate packaging for new product/application
  9. Prepare protocol for stability (shelf) testing of new product/application
Prepare documentation for new product pilot batch

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Evaluate/recommend materials for new product/application

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Calculate required quantities of materials and adjust for properties as appropriate

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Develop/modify products in pilot batch scale in accordance with enterprise and regulatory requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Arrange for product evaluation against development brief

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Modify product/application to meet evaluation recommendations

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Edit documentation and issue to appropriate personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Recommend and evaluate packaging for new product/application

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare protocol for stability (shelf) testing of new product/application

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assist in preparation of quality/regulatory compliance procedures/materials

  1. Develop in-process and laboratory testing protocols
  2. Prepare product labelling and submit for approval
  3. Assist in product and analytical method validation
  4. Implement an effective plant hygiene and asepsis program, if applicable
  5. Develop good manufacturing principles for medicinal products (GMP)/principles of good laboratory practice (GLP) protocols for approval by appropriate personnel
  6. Prepare standard operating procedures (SOPs) for quality and laboratory related procedures
  7. Prepare occupational health and safety (OHS) procedures for the laboratory and manufacturing environment and submit for approval
Develop in-process and laboratory testing protocols

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare product labelling and submit for approval

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assist in product and analytical method validation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Implement an effective plant hygiene and asepsis program, if applicable

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Develop good manufacturing principles for medicinal products (GMP)/principles of good laboratory practice (GLP) protocols for approval by appropriate personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare standard operating procedures (SOPs) for quality and laboratory related procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare occupational health and safety (OHS) procedures for the laboratory and manufacturing environment and submit for approval

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Document and report project outcomes

  1. Document and report project outcomes
  2. Complete project reporting requirements
Document and report project outcomes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete project reporting requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

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.

Required Skills and Knowledge

Required skills

Required skills include:

interpreting and explaining sections of legislation, codes, regulations and Australian standards that apply to the tasks undertaken in developing products and applications

evaluating a product/application brief and contributing to the development of products and applications to meet the requirements of the brief

interpreting a brief to determine product/application development requirements

applying theoretical knowledge of starting material and formulation principles to develop product/applications

using appropriate procedures to research alternative formulations

using environment friendly strategies for formulations

making formulation recommendations for pilot batch manufacture

manufacturing pilot batches

evaluating pilot batches against project brief

evaluating product/application stability

evaluating the OHS requirements to be observed for each ingredient during manufacture of product/application

evaluating the OHS suitability of each ingredient for use in the formulation

ensuring that product/application meets regulatory requirements

following enterprise procedures to document development process

Required knowledge

Required knowledge includes:

theoretical and practical aspects of product/application development

physical and chemical aspects of product/application development

principles and practices of operation of a range of pilot batch equipment

uses, characteristics and limitations of formulation starting materials

formulation development procedures

performance outcomes expected and key indicators

enterprise and regulatory development, quality and stability testing requirements

business goals and the impact of their projects on these goals

operating budgets and plans for work area

relevant health, safety and environment requirements

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