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Evidence Guide: MSL977001 - 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

 

MSL977001 - 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 workplace) 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 workplace) 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 workplace 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 workplace 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 with 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 work health and safety (WHS) 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 work health and safety (WHS) 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

Elements describe the essential outcomes.

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

1

Scope the development project

1.1

Confirm details of new product/application brief

1.2

Specify new product/application requirements

1.3

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

1.4

Interpret and apply relevant Acts, regulations and codes of practice

1.5

Prepare product development plan

1.6

Obtain approval for development plan from appropriate personnel

2

Set scope of project

2.1

Estimate resource requirements, including staffing, equipment and materials needed to undertake the project

2.2

Identify roles and responsibilities of project team members

2.3

Identify quality requirements and quality standards

2.4

Prepare project timelines taking into account any constraints

3

Develop new product formulation

3.1

Prepare documentation for new product pilot batch

3.2

Evaluate/recommend materials for new product/application

3.3

Calculate required quantities of materials and adjust for properties as appropriate

3.4

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

3.5

Arrange for product evaluation against development brief

3.6

Modify product/application to meet evaluation recommendations

3.7

Edit documentation and issue to appropriate personnel

3.8

Recommend and evaluate packaging for new product/application

3.9

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

4

Assist with preparation of quality/regulatory compliance procedures/materials

4.1

Develop in-process and laboratory testing protocols

4.2

Prepare product labelling and submit for approval

4.3

Assist in product and analytical method validation

4.4

Implement an effective plant hygiene and asepsis program, if applicable

4.5

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

4.6

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

4.7

Prepare work health and safety (WHS) procedures for the laboratory and manufacturing environment and submit for approval

5

Document and report project outcomes

5.1

Document and report project outcomes

5.2

Complete project reporting requirements

Required Skills and Knowledge

Elements describe the essential outcomes.

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

1

Scope the development project

1.1

Confirm details of new product/application brief

1.2

Specify new product/application requirements

1.3

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

1.4

Interpret and apply relevant Acts, regulations and codes of practice

1.5

Prepare product development plan

1.6

Obtain approval for development plan from appropriate personnel

2

Set scope of project

2.1

Estimate resource requirements, including staffing, equipment and materials needed to undertake the project

2.2

Identify roles and responsibilities of project team members

2.3

Identify quality requirements and quality standards

2.4

Prepare project timelines taking into account any constraints

3

Develop new product formulation

3.1

Prepare documentation for new product pilot batch

3.2

Evaluate/recommend materials for new product/application

3.3

Calculate required quantities of materials and adjust for properties as appropriate

3.4

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

3.5

Arrange for product evaluation against development brief

3.6

Modify product/application to meet evaluation recommendations

3.7

Edit documentation and issue to appropriate personnel

3.8

Recommend and evaluate packaging for new product/application

3.9

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

4

Assist with preparation of quality/regulatory compliance procedures/materials

4.1

Develop in-process and laboratory testing protocols

4.2

Prepare product labelling and submit for approval

4.3

Assist in product and analytical method validation

4.4

Implement an effective plant hygiene and asepsis program, if applicable

4.5

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

4.6

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

4.7

Prepare work health and safety (WHS) procedures for the laboratory and manufacturing environment and submit for approval

5

Document and report project outcomes

5.1

Document and report project outcomes

5.2

Complete project reporting requirements

Evidence of competence in this unit must satisfy all of the requirements of the elements and performance criteria, and include demonstration of:

evaluating at least one (1) product/application brief, preparing the product development plan and contributing significantly to product/application development

interpreting a brief to determine product or application development requirements

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

applying theoretical knowledge of starting material and formulation principles to develop products or applications

researching alternative formulations and making formulation recommendations for pilot batch manufacture

using environment-friendly strategies for formulations

manufacturing pilot batches

evaluating pilot batches against the project brief

evaluating product or application stability

evaluating the work health and safety (WHS) requirements to be observed for each ingredient during manufacture of product or application

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

ensuring that the product or application meets regulatory requirements

documenting the development process in accordance with workplace procedures.

Must provide evidence that demonstrates knowledge of:

principles of product or application development

business goals and their relationship to specific product or application development

new product/application requirements, expected performance outcomes and key indicators

physical and chemical aspects of new product or application development

details of development plan, budget and timeline for new product/application

principles and practices of operation of pilot batch equipment

uses, characteristics and limitations of formulation starting materials

formulation development procedures

details of regulatory compliance, quality and stability testing protocols and procedures required for new product/application

relevant hazards, WHS and environment requirements.

Range Statement

This field allows for different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Standards, codes, procedures and/or workplace requirements

Standards, codes, procedures and/or workplace requirements include the latest version of one or more of:

Australian and international standards covering the requirements for the competence of testing and calibration laboratories, laboratory design and construction, physical containment levels and facility types, laboratory safety, quality and environmental management systems, and measurement management systems

national WHS standards and codes of practice, national measurement regulations and guidelines, and intellectual property (IP) and copyright legislation

Australian and international standards and guidelines covering specialised analysis, accuracy of measurement methods and results, expression of uncertainty, quantifying uncertainty, Association of Analytical Communities International (AOAC International) Official Methods of Analysis, and Validation of Analytical Procedures

specific codes, guidelines, procedures and methods, such as National Association of Testing Authorities (NATA) accreditation programs requirements, Australian code of good manufacturing practice for medicinal products (GMP), principles of good laboratory practice (GLP), Food Standards Australia New Zealand (FSANZ) Code, Australian Dangerous Goods Code, gene technology regulations, National Health and Medical Research Council (NHMRC) Guidelines, and Therapeutic Goods Regulations

workplace documents, such as SOPs; quality and equipment manuals; calibration and maintenance schedules; material safety data sheets (MSDS) and safety procedures; material, production and product specifications; production and laboratory schedules; workplace recording and reporting procedures; waste minimisation and safe disposal procedures; cleaning, hygiene and personal hygiene requirements; stock records and inventory; and raw material catalogues

sampling procedures (labelling, preparation, storage, transport and disposal)

test procedures (validated and authorised)

Product/application briefs

Product/application briefs are provided by, but are not limited to, one or more of:

internal or external customers

marketing

production

Materials used to manufacture products/applications

Materials used to manufacture products/applications include, but are not limited to, one or more of:

solvents

emulsifiers

thickeners

surfactants

disintegrants

fillers

moisturising materials

colouring materials

flavours

perfumes

opacifiers

propellants

sunscreens

Calculations

Calculations are required to adjust properties, such as:

assay/potency

viscosity

application payload

hardness

moisture content

colour

WHS and environmental management requirements

WHS and environmental management requirements include:

· complying with WHS and environmental management requirements at all times, which may be imposed through state/territory or federal legislation. These requirements must not be compromised at any time

· applying standard precautions relating to the potentially hazardous nature of samples

accessing and applying current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health, where relevant