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 17025-2005 General requirements for the competence of testing and calibration laboratories
AS/NZS 2243 Set:2006 Safety in laboratories set
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
Australia New Zealand Food Standards (ANZFS) Code
Australian code of good manufacturing practice for medicinal products (GMP)
calibration and maintenance schedules
enterprise recording and reporting procedures
equipment startup, operation and shutdown procedures
gene technology regulations
material safety data sheets (MSDS)
material, production and product specifications
National Association of Testing Authorities (NATA) Accreditation programs requirements
National Health and Medical Research Council (NHMRC) Guidelines
national measurement regulations and guidelines
occupational health and safety (OHS) national standards and codes of practice
principles of good laboratory practice (GLP)
production and laboratory schedules
quality manuals, equipment and procedures manuals
standard operating procedures (SOPs)
Therapeutic Goods Regulations 1009
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:
troubleshoot testing equipment and testing issues related to production processes to identify causes of problems and recommend corrective action
identify causes of faulty or substandard performance
propose adjustments/ rectifications/ modifications
test results of adjustments/rectifications/modifications
locate, interpret and apply relevant information
maintain relevant workplace records
identify and safely handle products and materials
apply safety precautions appropriate to the task.

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 development of products and applications
MSL977003A Contribute to validation of test methods.
MSL977004A Develop or adapt analyses and procedures.
Resources may include:
standard laboratory equipped with appropriate equipment, samples, reagents and test methods
laboratory procedures and SOPs.

Method of assessment
The following assessment methods are suggested:
completion of a troubleshooting brief or a troubleshooting proficiency test
review of workplace troubleshooting briefs completed by the candidate
feedback from supervisors and/or clients
oral or written questioning to assess underpinning knowledge of equipment operation, troubleshooting procedures and problem solving techniques
simulated equipment failure scenarios.
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
Emission spectroscopy is a technique often used by technicians to troubleshoot problems resulting from contamination. For example, a sample of stainless steel that showed signs of corrosion was submitted to a chemical technician for analysis. The technician subjected the sample to a spark and compared the spectra of the composite steel to spectra of a control sample of stainless steel. The technician concluded that the vanadium concentration in the sample was higher than that of the control sample. After doublechecking the work, the technician passed the results back to the engineering staff who were able to find the source of error and correct the manufacturing problem.
Biomedical
The immuno-analyser has become non-functional. The senior technical officer notifies the laboratory manager and then checks out the instruction sequence for that assay, checks the diagnostics for the detection unit, and reagent and sample lines, and then runs the diagnostic check program provided by the company. The officer concludes that the fault is due to instrument failure.
Food processing
A food company received a large number of customer complaints regarding the taste of its flavoured yoghurt product. The technician asked their sales representative to collect samples of the product from sales outlets while she/he collected retained reference samples with the same batch number/expiry date for examination. The technician developed a strategy for troubleshooting the production process and followed the following steps:
analysis of the returned product and reference samples indicated that the sugar concentration was above specification in both, suggesting that an error occurred during manufacturing or packaging
examination of batching sheets with the appropriate product code indicated that the correct formula and quantities of raw materials were used
retention samples were re-analysed and indicated that all were within specification
discussions with operators did not uncover any cause for the defect
observation of the process indicated that a non-standard batching drum was being used
discussions with the operator revealed that the tared standard drum used for weighing raw materials had been damaged and a lighter non-standard drum was being used with the original tare weight.
Analysis of the sugar content in the yoghurt indicated that the increased sugar content was due to the incorrect tare weight.