Elements and Performance Criteria

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 10013-2003 Guidelines for quality management system documentation
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
Guidelines for collaborative study procedures to validate characteristics of a method of analysis, Fourth (Final) Draft; J. of Anal. Chem., Vol 72, No 4, 694-704
ICH Q2A: Validation of Analytical Procedures - Guideline for industry
United States Pharmacopoeia (USB) General chapter - Validation of Compendial Methods (1225)
OHS national standards and codes of practice
principles of good laboratory practice (GLP)
Australia New Zealand Food Standards (ANZFS) Code
Australian code of Good Manufacturing Practice for medicinal products (GMP)
Australian Dangerous Goods Code
Australian Quarantine and Inspection Service (AQIS) Export Control (Orders) Regulations 1982 and Import Guidelines
gene technology regulations
maintenance and confidentiality of records
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
Therapeutic Goods Regulations 1009
Test methods requiring validation
Test methods requiring validation may include:
identification and impartial resolution of ethical issues, such as conflict of interest
ethical decision making
provision of products and services which match the operational and financial needs of stakeholders, including realistic quotes for work
accurate representation of skills, services, knowledge and qualifications of individuals and the organisation
acknowledgment of services and products developed by others, intellectual property and copyright
provision of unbiased, accurate and appropriately qualified information results
Validation protocols include:
Validation protocols include:
those checks which should be considered to ensure performance characteristics of test method are scientifically sound
examples of checks include:
selectivity
linearity
range
sensitivity
limit of detection
limit of quantitation
accuracy
precision
recovery
ruggedness
an assessment of the clarity and completeness of the description of the method
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

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:
validate test methods as fit for purpose following a validation protocol established in consultation with appropriate personnel
conduct literature searches on background chemistry/physics/biology/immunology of materials to be evaluated, including likely impurities and degradation products
start up, set up/optimise, calibrate and operate equipment to manufacturer's 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:
MSL977001A Contribute to the development of products and applications
MSL977002A Troubleshoot equipment and production processes
MSL977004A Develop or adapt analyses and procedures
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 and/or 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 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
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 2,4-dinitrophenylhydrazine. The filters were desorbed with acetonitrile and the DNPH derivative analysed by highperformance liquid chromatography (HPLC) at 365nm. 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:
ultraviolet-visible (UV-VIS) spectrometer for colour analysis
HPLC for food preservative analysis
inductively coupled plasma-atomic 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.