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Elements and Performance Criteria

  1. Verify accuracy of data and technical records
  2. Assess the quality of data/results
  3. Identify potential causes for unacceptable results
  4. Report findings to relevant personnel

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, quality management systems and plans, measurement management, accuracy of measurement methods and results, expression of uncertainty (GUM), quantifying uncertainty in analytical measurement, and sampling and testing methods

National Association of Testing Authorities (NATA) accreditation program requirements

national measurement regulations and guidelines

specific codes, regulations, guidelines, procedures and methods, such as Australia New Zealand Food Standards (ANZFS) Code, Australian code of good manufacturing practice for medicinal products (GMP), principles of good laboratory practice (GLP), 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; and waste minimisation and safe disposal procedures

customer-specific requirements/standards

Technical records

Technical records include, but are not limited to, one or more of:

request forms, service agreements and contracts, client notes, papers and feedback

worksheets, work books, check sheets and work notes, original observations, derived data and calculations, and control graphs

external, internal test reports and calibration certificates

listing of data and the personnel responsible for sampling, performance of each test/calibration and checking of results

Instrument calibration/performance records

Instrument calibration/performance records include, but are not limited to, one or more of:

checks that equipment/instrument complies with specifications

dates, results and copies of reports and certificates of calibrations, adjustments, acceptance criteria and due date of next calibration

maintenance plan and maintenance carried out to date

damage, malfunction, modification or repairs

data files and technical records, and laboratory information management system (LIMS)

Charts, tables and statistical analysis tools and techniques

Charts, tables and statistical analysis tools and techniques include one or more of:

run charts and control charts

histograms, frequency plots, stem and leaf plots, boxplots and scatter plots

probability and normal probability plots

Pareto diagrams, Shewhart control charts and CuSum control charts

regression methods for calibration, linearity checks and comparing analytical methods

calculations of means, ranges, standard deviations, confidence limits

analysis of variance (ANOVA)

data acceptability tests, such as Q, T and Youden

Sources of interference

Sources of interferences include, but are not limited to, one or more of:

spectral interference

physical interference

matrix effects

presence of contaminants

masking of analytes

Human and environmental factors

Human and environmental factors include, but are not limited to, one or more of:

lack of operator competence and/or training

inadequate attention to detail, fatigue and stress

inadequate hygiene and sterility

unacceptable dust, humidity, temperature and illumination levels

electromagnetic disturbances

variations to gas, electricity and water supply

unacceptable sound and vibration levels

Sample collection and preparation problems

Sample collection and preparation problems include, but are not limited to, one or more of:

incorrect sample containers

incorrect sample handling (filtered/non-filtered, temperature control and preservation), sample disturbance and sample segregation

incomplete sample preparation

incorrect particle size

incorrect matrix

incomplete digest

Preventative/corrective actions

Preventative/corrective actions include, but are not limited to, one or more of:

regular use of certified reference materials

internal quality controls using secondary reference materials

participation in inter-laboratory comparison or proficiency testing programs

replicate tests or calibrations using the same or different methods

retesting or recalibration of retained items

correlation of results for different characteristics of an item

additional audits and management reviews

regular quality checks on consumables

enhanced staff observation, supervision and/or training

more detailed sample specifications, test methods and procedures

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

Performance Evidence

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

analysing at least one (1) series of test results and data to detect potential or actual non-conformances, assessing their significance, identifying potential causes and recommending preventative or corrective actions

reviewing the accuracy and completeness of at least one (1) set of technical records for sampling or testing activities

reviewing the accuracy and completeness of at least one (1) set of instrument calibration/performance records

recognising significant trends in data and/or aberrant results

using statistical tests to estimate uncertainties and determine data acceptability

applying effective problem-solving strategies, such as root cause analysis

following workplace procedures for documenting and reporting information about quality.

Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

characteristic properties of the materials under investigation

specifications for samples, tests and/or calibration activities under investigation

scientific and technical knowledge of the procedures, equipment, materials and instrumentation used to generate the test results and data

at least three (3) statistical tests used to estimate uncertainties and determine data acceptability

workplace data quality procedures and/or legal traceability requirements

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