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Elements and Performance Criteria

1. Identify abnormal equipment and/or process performance
   • Determine whether testing equipment is operating to manufacturer specifications
   • Recognise whether equipment outputs are consistent with normal operation
   • Identify signs of equipment degradation and impending failure
   • Inspect equipment outputs to determine nature of the problem
   • Define nature of substandard performance
2. Identify causes of substandard performance
   • Select appropriate technical process for investigation
   • Identify causes using fact-finding processes, including interviews with appropriate personnel
   • Review maintenance records to ensure that system does not need simple maintenance
   • Review calibration records to ensure system is within calibration
   • Verify that the appropriate test procedure, materials and equipment were used
   • Conduct performance tests as appropriate to investigation
   • Analyse equipment and/or testing variables to develop list of possible causes
   • Isolate causes using appropriate elimination techniques
3. Recommend corrective action
   • Propose and trial corrective action based on investigation
   • Monitor trial data to ensure outputs are consistent with normal operation
   • Review trial results to confirm validity of corrective action
   • Maintain workplace records as required
   • Submit report summarising investigation and recommendations

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 work health and safety (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, Association of Analytical Communities International (AOAC International) Official Methods of Analysis, and Validation of Analytical Procedures 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 standard operating procedures (SOPs); 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 sampling procedures (labelling, preparation, storage, transport and disposal) test procedures (validated and authorised)
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

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Performance Evidence

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

troubleshooting at least two (2) different testing equipment/testing issues related to production processes to identify causes of problems and recommend corrective action

locating and interpreting relevant information, such as performance data, calibration and maintenance records

using technical knowledge and skills to investigate abnormal performance and/or assay results

applying technical, instrumental and equipment knowledge and skills to troubleshoot testing equipment/testing issues

identifying causes of faulty or substandard performance

proposing adjustments, rectifications and modifications

testing the results of adjustments, rectifications and modifications

maintaining accurate and complete workplace records

reporting the process and outcomes of investigations with clear recommendations

following workplace safety procedures.

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Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

relevant regulatory, licensing and testing requirements

principles and concepts that underpin operation of testing equipment and test methods

overall characteristics, capabilities and limitations of testing equipment and its components

functions of key equipment components and sub-systems and effects on outputs and results of modifying variables

possible effects of matrix and impurities on analytical methods

effects on outputs and results of varying test procedure and/or modifying test materials or reagents

troubleshooting procedures and elimination techniques for isolating causes of problems

mathematical and statistical procedures for evaluating test data

workplace requirements for problem investigation and reporting

relevant hazards, work health and safety (WHS) and environment requirements.

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