• MSL977004A - Develop or adapt analyses and procedures

MSL977004A
Develop or adapt analyses and procedures

This unit of competency covers the ability to develop or adapt analyses and procedures to meet enterprise and/or regulatory requirements. New analyses and associated procedures may be required to meet a customer's brief, analyse new products or raw materials, improve laboratory efficiency or meet changing regulatory requirements.

Application

This unit of competency is applicable to senior technical officers, laboratory supervisors and technical specialists working in all industry sectors. All operations must comply with relevant standards, appropriate procedures and/or enterprise requirements. The work may involve developing new testing methods or adapting existing methods to satisfy a testing need.

Industry representatives have provided case studies to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting. These can be found at the end of this unit of competency under the section 'This competency in practice'.


Prerequisites

MSL976003A

Evaluate and select appropriate test methods and/or procedures


Elements and Performance Criteria

ELEMENT

PERFORMANCE CRITERIA

1. Determine gaps and deficiencies in present analyses and/or procedures

1.1. Identify opportunities to improve analyses and/or 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 enterprise 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 enterprise 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 occupational health and safety (OHS), environmental, regulatory and enterprise 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 method/ 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 enterprise procedures

Required Skills

Required skills

Required skills include:

developing or adapting analyses and procedures to meet requirements

interpreting a brief to determine testing requirements

applying theoretical concepts and practical principles to develop or adapt methods

evaluating existing testing procedures against new testing requirements

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

researching alternative methods

making recommendations for modification of existing procedures or development of new procedures

following enterprise procedures to document and circulate new procedures

Required knowledge

Required knowledge includes:

detailed knowledge of theoretical and practical basis of test/analysis

principles and practices of operation of a range of testing equipment

characteristics, capabilities and limitations of equipment

relative advantages/disadvantages of different analytical methods

theoretical procedures for method development

method validation requirements

enterprise and regulatory testing requirements

relevant health, safety and environment requirements

Evidence Required

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:

develop or adapt analyses and procedures to meet requirements

interpret a brief to determine testing requirements

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

evaluate existing testing procedures against new testing requirements

use appropriate procedures to research alternative methods

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

make recommendations for modification of existing procedures or development of new procedures based on sound principles

follow enterprise procedures to document and circulate new procedures.

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:

MSL925002A Analyse measurements and estimate uncertainties

MSL977001A Contribute to the development of products and applications

MSL977002A Troubleshoot equipment and production processes

MSL977003A Contribute to validation of test methods.

Resources may include:

standard laboratory equipped with appropriate equipment, reagents, samples and test methods

online data search facilities.

Method of assessment

The following assessment methods are suggested:

review of development or adaptation of methods completed by the candidate

review of workplace development briefs completed by the candidate

feedback from supervisors and/or clients

oral or written questioning to assess underpinning knowledge of analyses, instrument operation, procedures and problem solving techniques.

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 often have to apply their practical and theoretical knowledge of laboratory instrumentation to adapt or develop methods to solve specific problems. For example, a technical specialist in a consulting laboratory was asked to determine why heat-sealing bags were not sealing properly. Using infrared spectroscopy, the specialist ran spectra on several samples and noticed a difference in the coating on the bags which didn't seal compared with the coating on bags which sealed correctly. The spectra indicated that the coatings were different polymers. The technical specialist notified the supplier of the sealing problem and new bags were forwarded. To ensure that the problem didn't occur again, an infrared spectroscopy test method was developed to ensure that the correct polymer coating was on the new bags. As a result, production flowed smoothly when bags were delivered to the production line.

Biomedical

A laboratory manager determined that there is sufficient demand for a particular enzyme activity assay. Currently, this assay is performed manually by kinetic assay using a spectrometer. A senior technical officer has been given the task of converting the method to one that can be run on an automated biochemical analyser. The method will be translated to instructions regarding wavelength, absorbance increase or decrease, time of reading and intervals of the readings, sequence of addition of the reagents and sample, ratio of the volumes (they will be reduced in the automated procedure) and incubation conditions.

Food processing

The water activity of food is affected by temperature. The measurement of water activity takes considerable time, due in part to the time required for the sample to reach the specified test temperature in the instrument. A technician suggested that the test time could be reduced if the samples were presented to the instrument at the test temperature, rather than room temperature. She/he also raised concerns about water loss which could occur while raising the sample to test temperature. The technician planned an investigation and ran tests using standard Greenspan salts to compare results from normal testing with testing using pre-warm samples. Pre-warm samples held for 30 minutes in a pre-warm cabinet gave different results from the normal test method samples. However, samples held for 15 minutes in the pre-warm cabinet did not. A test method was subsequently introduced with samples being held for a maximum of 10 minutes in a pre-warm cabinet prior to being loaded into the water activity instrument. This gave excellent statistical correlation with the normal method and provided increased throughput of samples.


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 1000-1998 The international system of units (SI) and its application

AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories

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 14000 Set:2005 Environmental management standards set

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

appropriate journals and Internet sites

Australia New Zealand Food Standards (ANZFS) Code

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

ethics committee requirements

gene technology regulations

intellectual property and copy right

material safety data sheets (MSDS)

material, production and product specifications

National Association of Testing Authorities (NATA) Accreditation programs requirements

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)

production and laboratory schedules

quality manuals, equipment and procedures manuals

Therapeutic Goods Regulations 1009

New methods of analysis and related procedures

New methods of analysis and related procedures may be required to:

analyse raw materials

quality control or evaluate the stability of products

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

use new technology

meet regulatory requirements

meet customer requirements

improve productivity

improve accuracy and precision

Analyses

Analyses may include:

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

spectrometric methods, such as ultraviolet-visible (UV-VIS), infra red (IR) (including fourier transform infra red (FTIR)), near infra red (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

Procedures

Procedures are:

directions for conducting analyses

hard copy

online format

Concepts relating to method development

Concepts relating to method development include:

determining and defining development objectives

relating chemical and physical characteristic of sample to possible assay methods

evaluating criteria to choose appropriate analytical method

sample cleanup and preparation techniques

preparation, setup and calibration of testing equipment

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

optimisation of analysis conditions

generating, recording and reporting data in format which assists procedure writing

Criteria for choice of method

Criteria for choice of method may include:

economic factors

safety considerations

resource factors, including equipment and personnel

regulatory, accreditation and registration considerations

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


Sectors

Unit sector

Testing


Employability Skills

This unit contains employability skills.


Licensing Information

Not applicable.