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Elements and Performance Criteria

1. Confirm equipment has been qualified and validated
   • Confirm that latest editions of manufacturer specifications and operating instructions are present
   • Confirm that equipment, including computer systems, is installed according to manufacturer specifications
   • Confirm that equipment operating instructions exist and conform to manufacturer specifications
   • Confirm that equipment operates according to manufacturer design specifications
   • Verify that equipment calibration complies with appropriate standards
   • Confirm equipment and computer systems are validated
   • Confirm method has an acceptable level of uncertainty
2. Validate test method according to defined protocol
   • Develop validation test protocol in consultation with appropriate personnel
   • Ensure protocol is authorised by appropriate personnel
   • Validate test method according to validation protocol
3. Evaluate and record results
   • Evaluate validation results to confirm suitability of testing method
   • Obtain approval for evaluation recommendations from appropriate personnel
   • Record and file validation records
   • Issue validated method according to workplace procedures
   • Evaluate staff training needs and record appropriately
   • Recommend update of relevant documentation as a result of the validation

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, Validation of Analytical Procedures, Validation of Characteristics of a Method of Analysis, and Validation of Compendial Methods 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 test methods and validation procedures
Validation	Validation includes one or more of the following: 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 (IP) and copyright provision of unbiased, accurate and appropriately qualified information results
Validation protocols include:	Validation protocols include one or more of the following: checks that are considered to ensure performance characteristics of test method are scientifically sound checks, such as: selectivity linearity range sensitivity limit of detection limit of quantitation accuracy precision recovery ruggedness assessment of the clarity and completeness of the description of the method
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:

validating at least two (2) test methods using authorised protocols to ensure they are based on sound scientific principles and are fit for purpose

conducting literature searches on background chemistry/physics/biology/immunology of materials to be evaluated, including likely impurities and degradation products

conducting reliable qualification and validation checks of equipment and computer systems

developing authorised validation test protocols in consultation with appropriate personnel

starting up, setting up, optimising, calibrating and operating equipment to manufacturer specifications

preparing test samples and standards for validation

carefully checking the performance characteristics of the test method

performing required calculations using appropriate equations, units, uncertainties and precision

using relevant mathematical and statistical techniques to analyse results

presenting large amounts of data, validation results and recommendations in appropriate formats for review and authorisation

maintaining accurate and complete validation records

communicating/reporting validation outcomes according to workplace procedures

issuing validated method according to workplace procedures

following workplace safety and environmental management procedures, and principles of good laboratory practice (GLP).

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Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

principles, concepts and workplace/regulatory requirements related to method validation and reporting

calculation steps, mathematical and statistical techniques used to analyse results

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

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

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