Required skills

Required skills include

validating test methods as fit for purpose following a validation protocol established in consultation with appropriate personnel

conducting literature searches on background chemistryphysicsbiologyimmunology of materials to be evaluated including likely impurities and degradation products

starting up setting upoptimising calibrating and operating equipment to manufacturers specifications

preparing test samples and standards for validation

carrying out validation tests according tothe validation protocol

applying theoretical knowledge and appropriate statistics to interpret validation data and reach correct conclusions

recording results and communicating recommendations according to enterprise procedures

arranging large amounts of data into logical format so other technical personnel can review and reach the same valid conclusions

followingoccupational health and safety OHS and environmental management procedures and principles of good laboratory practice GLP

Required knowledge

Required knowledge includes

principles concepts and enterpriseregulatory requirements related to method validation

traceability including legal requirements for traceability

principles and procedures of testing equipment operation

characteristics capabilities and limitations of equipment

variables which should be validated and criteria for choice

mathematicalstatistical evaluation of results and present data and results in appropriate formats

enterpriseregulatory requirement regarding validation and reporting

relevant health safety and environment requirements

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

validate test methods as fit for purpose following a validation protocol established in consultation with appropriate personnel

conduct literature searches on background chemistryphysicsbiologyimmunology of materials to be evaluated including likely impurities and degradation products

start up set upoptimise calibrate and operate equipment to manufacturers specifications

prepare test samples and standards for validation

carry out validation tests according tothe validation protocol

apply theoretical knowledge and appropriate statistics to interpret validation data and reach correct conclusions

record results and communicate recommendations according to enterprise procedures

arrange large amounts of data into logical format so other technical personnel can review and reach the same valid conclusions

follow OHS and environmental management procedures and principles of GLP

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

MSLA Contribute to the development of products and applications

MSL977001A Contribute to the development of products and applications

MSLA Troubleshoot equipment and production processes

MSL977002A Troubleshoot equipment and production processes

MSLA Develop or adapt analyses and procedures

MSL977004A Develop or adapt analyses and procedures

MSLA Analyse measurements and estimate uncertainties

MSL925002A Analyse measurements and estimate uncertainties.

Resources may include

standard laboratory equipped with appropriate equipment reagents samples and test methods

validation protocol

Method of assessment

The following assessment methods are suggested

completion of validation brief or validation proficiency test

review of workplace validation briefs completed by the candidate

feedback from supervisors andor clients

oral or written questioning to assess underpinning knowledge of equipment operation methods and 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 andor 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

A technical specialist was developing a method for testing samples taken while monitoring a workplace for glutaraldehyde a toxic chemical The samples were collected in air monitoring cassettes and on glass fibre filters impregnated with dinitrophenylhydrazine The filters were desorbed with acetonitrile and the DNPH derivative analysed by highperformance liquid chromatography HPLC at nm The new method was validated by checking and documenting factors such as selectivity linearity range limit of detection accuracy precision recovery and ruggedness Although this involved considerable work the specialist was confident that the testing method would deliver reliable results after completing the validation

Biomedical

A number of pituitary hormone assays are to be converted from radioimmunoassay RIA to enzyme linked immunosorbent assay ELISA Both configurations of assays are available in kit form but the laboratory manager would like the new procedures validated The task has been given to a senior technical officer The project involves comparison of the average and variance of results obtained for a number of quality control sera The variance and precision of the signal output counts per minute for RIA absorbance for ELISA are examined as well as sensitivity estimates for both assays All investigations are documented and reported in the laboratory notes for accreditation audit purposes

Food processing

A food research laboratory uses the following instrumental techniques

ultravioletvisible UVVIS spectrometer for colour analysis

HPLC for food preservative analysis

inductively coupled plasmaatomic emission spectrometry and flame atomic absorption analysis for metal contaminant analysis

Each of the above methods is validated to assure that it is based on sound scientific principles and will deliver results appropriate to requirements Factors such as accuracy linearity range limit of detection precision recovery ruggedness and selectivity are evaluated and documented This investigation provides confidence that methods are used within their limits of detection are linear and selective over the required range and deliver suitable accuracy and precision The investigation is documented according to enterprise requirements and provides detailed reference for accreditation audit and future laboratory use

Codes of practice

Standards, codes, procedures and/or enterprise requirements

Test methods requiring validation

Validation protocols include:

Occupational health and safety (OHS) and environmental management requirements