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Evidence Guide: MSL977004 - Develop or adapt analyses and procedures

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

 

MSL977004 - Develop or adapt analyses and procedures

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

Determine gaps and deficiencies in present methods and procedures

  1. Identify opportunities to improve analyses and procedures
  2. Identify requirements for new analyses and procedures to meet testing briefs
  3. Define the scope of analysis required by the improvement or new testing brief
  4. Establish that existing workplace test methods/procedures do not meet requirements
  5. Prepare development proposal
  6. Confirm development requirements and development proposal with appropriate personnel
  7. Obtain authorisation to proceed
Identify opportunities to improve analyses and procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify requirements for new analyses and procedures to meet testing briefs

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Define the scope of analysis required by the improvement or new testing brief

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Establish that existing workplace test methods/procedures do not meet requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare development proposal

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm development requirements and development proposal with appropriate personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain authorisation to proceed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Research and propose alternatives

  1. Source relevant documented methods/procedures
  2. Review relevant documented methods/procedures according to workplace procedures
  3. Consult with relevant technical personnel regarding project development issues
  4. Evaluate resource requirements for proposed methods/procedures
  5. Ensure that methods/procedures meet work health and safety (WHS), environmental, regulatory and workplace requirements
  6. Document development requirements, timelines and proposed methods/procedures
  7. Obtain authorisation to proceed
Source relevant documented methods/procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Review relevant documented methods/procedures according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Consult with relevant technical personnel regarding project development issues

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Evaluate resource requirements for proposed methods/procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure that methods/procedures meet work health and safety (WHS), environmental, regulatory and workplace requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Document development requirements, timelines and proposed methods/procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain authorisation to proceed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Evaluate alternatives, develop analyses and recommend methods and procedures

  1. Investigate possible alternative methods and procedures and choose appropriate method/procedure
  2. Develop and/or adapt analytical method or test procedure to meet requirements
  3. Trial method/procedure against test method/procedure requirements
  4. Validate method/procedure
  5. Maintain records to substantiate and justify chosen method/procedure
Investigate possible alternative methods and procedures and choose appropriate method/procedure

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Develop and/or adapt analytical method or test procedure to meet requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Trial method/procedure against test method/procedure requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Validate method/procedure

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain records to substantiate and justify chosen method/procedure

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Document and report new methods and procedure

  1. Prepare and/or update analytical method/procedure and associated standard operating procedures (SOPs)
  2. Obtain final approval for new method/procedure
  3. Withdraw, document and archive superseded method/procedure
  4. Issue new method/procedure according to workplace procedures
Prepare and/or update analytical method/procedure and associated standard operating procedures (SOPs)

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain final approval for new method/procedure

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Withdraw, document and archive superseded method/procedure

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Issue new method/procedure according to workplace procedures

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

Determine gaps and deficiencies in present methods and procedures

1.1

Identify opportunities to improve analyses and procedures

1.2

Identify requirements for new analyses and procedures to meet testing briefs

1.3

Define the scope of analysis required by the improvement or new testing brief

1.4

Establish that existing workplace test methods/procedures do not meet requirements

1.5

Prepare development proposal

1.6

Confirm development requirements and development proposal with appropriate personnel

1.7

Obtain authorisation to proceed

2

Research and propose alternatives

2.1

Source relevant documented methods/procedures

2.2

Review relevant documented methods/procedures according to workplace procedures

2.3

Consult with relevant technical personnel regarding project development issues

2.4

Evaluate resource requirements for proposed methods/procedures

2.5

Ensure that methods/procedures meet work health and safety (WHS), environmental, regulatory and workplace requirements

2.6

Document development requirements, timelines and proposed methods/procedures

2.7

Obtain authorisation to proceed

3

Evaluate alternatives, develop analyses and recommend methods and procedures

3.1

Investigate possible alternative methods and procedures and choose appropriate method/procedure

3.2

Develop and/or adapt analytical method or test procedure to meet requirements

3.3

Trial method/procedure against test method/procedure requirements

3.4

Validate method/procedure

3.5

Maintain records to substantiate and justify chosen method/procedure

4

Document and report new methods and procedure

4.1

Prepare and/or update analytical method/procedure and associated standard operating procedures (SOPs)

4.2

Obtain final approval for new method/procedure

4.3

Withdraw, document and archive superseded method/procedure

4.4

Issue new method/procedure according to workplace procedures

Required Skills and Knowledge

Elements describe the essential outcomes.

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

1

Determine gaps and deficiencies in present methods and procedures

1.1

Identify opportunities to improve analyses and procedures

1.2

Identify requirements for new analyses and procedures to meet testing briefs

1.3

Define the scope of analysis required by the improvement or new testing brief

1.4

Establish that existing workplace test methods/procedures do not meet requirements

1.5

Prepare development proposal

1.6

Confirm development requirements and development proposal with appropriate personnel

1.7

Obtain authorisation to proceed

2

Research and propose alternatives

2.1

Source relevant documented methods/procedures

2.2

Review relevant documented methods/procedures according to workplace procedures

2.3

Consult with relevant technical personnel regarding project development issues

2.4

Evaluate resource requirements for proposed methods/procedures

2.5

Ensure that methods/procedures meet work health and safety (WHS), environmental, regulatory and workplace requirements

2.6

Document development requirements, timelines and proposed methods/procedures

2.7

Obtain authorisation to proceed

3

Evaluate alternatives, develop analyses and recommend methods and procedures

3.1

Investigate possible alternative methods and procedures and choose appropriate method/procedure

3.2

Develop and/or adapt analytical method or test procedure to meet requirements

3.3

Trial method/procedure against test method/procedure requirements

3.4

Validate method/procedure

3.5

Maintain records to substantiate and justify chosen method/procedure

4

Document and report new methods and procedure

4.1

Prepare and/or update analytical method/procedure and associated standard operating procedures (SOPs)

4.2

Obtain final approval for new method/procedure

4.3

Withdraw, document and archive superseded method/procedure

4.4

Issue new method/procedure according to workplace procedures

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

developing or adapting at least one (1) method of analysis and all related methods and procedures to meet workplace and regulatory requirements

interpreting briefs to determine testing requirements

preparing authorised development proposals, including gap/deficiency analysis, details of development requirements, timelines and proposed methods and procedures

applying theoretical concepts and practical principles to develop or adapt methods and procedures to meet requirements

researching alternative methods

evaluating existing testing methods and procedures against new testing requirements

trialling and validating methods and procedures

applying method performance measures, such as accuracy, precision, uncertainty, linearity, selectivity, range, limit of detection and matrix characteristics

generating, recording and reporting data in formats which assist procedure writing

recommending modifications of existing methods and procedures or development of new methods and procedures based on sound principles

preparing and/or updating analytical methods and procedures

documenting and issuing approved new method/procedure in accordance with workplace procedures

following workplace safety and environmental management procedures.

Must provide evidence that demonstrates knowledge of:

concepts relating to method and procedure development, including:

determining and defining development objectives

relating chemical and physical characteristic of sample to possible assay methods

evaluating criteria to choose appropriate analytical method

sample clean-up and preparation techniques

preparation, set-up and calibration of testing equipment

choice of appropriate detection system ensuring accuracy/precision criteria are achieved

optimisation of analysis conditions

criteria for choice of method/procedure, including:

economic factors

safety considerations

resource factors, including equipment and personnel

regulatory, accreditation and registration considerations

detailed theoretical and practical basis of tests/analyses relevant to job role

operating principles and practices and characteristics, capabilities and limitations of testing equipment used

relative advantages and disadvantages of different testing methods

procedures and requirements for method and procedure development, validation and approval

workplace and regulatory testing requirements

relevant hazards, work health and safety (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 safety, quality and environmental management systems, and measurement management systems

national WHS standards and codes of practice, and national measurement regulations and guidelines

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

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 methods and procedures; 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

New methods and related procedures

New methods of analysis and related procedures are required for one or more of the following reasons:

analysis of raw materials

quality control or evaluation of the stability of products

quality control or evaluation of the stability of new formulations of existing products

introduction of new technology

to meet regulatory requirements

to meet customer requirements

improvement of productivity

improvement of accuracy and precision

Analyses

Analyses include, but are not limited to, one or more of:

non-instrumental methods, such as gravimetric, titrimetric and qualitative tests

spectrometric methods, such as ultraviolet-visible (UV-VIS), infrared (IR) (including Fourier transform infrared (FTIR)), near infrared (NIR), atomic absorption (AA) and fluorescence)

chromatographic methods, such as thin layer, paper, gas chromatography (GC), high performance liquid chromatography (HPLC), ion chromatography (IC) and electrophoresis

electrochemical methods, such as ion-selective electrodes and polarography

assays based on biological properties or cell properties for enzyme antibody activity

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