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Elements and Performance Criteria

  1. Satisfy quality system requirements in daily work
  2. Analyse opportunities for corrective and/or optimisation action
  3. Recommend corrective and/or optimisation actions
  4. Participate in the implementation of recommended actions
  5. Participate in the development of continuous improvement strategies

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, and sampling and testing

national work health and safety (WHS) standards and codes of practice, and 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

Quality control procedures

Quality control procedures include one or more of:

standards imposed by regulatory and licensing bodies

working to a customer brief or batch card and associated quality procedures

checklists to monitor job progress against agreed time, costs and quality standards

preparation of sampling plans

the use of hold points to evaluate conformance

the use of inspection and test plans to check compliance

Sustainable work practices

Sustainable work practices include, but are not limited to, one or more of:

examining work practices that use excessive electricity

switching off equipment when not in use

regularly cleaning filters

insulating rooms and buildings to reduce energy use

recycling and reusing materials wherever practicable

minimising process waste

Quality improvement tools and techniques

Quality improvement tools and techniques include using one or more of:

plan, do, check, act (PDCA)

Ishikawa fishbone diagrams and cause and effect diagrams, logic tree, similarity/difference analysis, Pareto charts and analysis, force field/strength, weakness, opportunities, threats (SWOT) analysis

run charts, control charts, histograms and scattergrams to present routine quality control data

statistical analysis of quality control data, mean, median, mode, ranges and standard deviations

Communication

Communication includes interactions with one or more:

supervisors, managers and quality managers

administrative, laboratory and production personnel

internal/external contractors, customers and suppliers

Quality improvement opportunities

Quality improvement opportunities include, but are not limited to, one or more of:

production processes

hygiene and sanitation procedures

reductions in waste and re-work

laboratory layout and work flow

safety procedures

communication with customers

methods for sampling, testing and recording data

Documenting and reporting information about quality

Documenting and reporting information about quality includes, but are not limited to, one or more of:

verbal responses

data entry into laboratory or workplace database

brief written reports using workplace proformas

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:

applying relevant quality control procedures and regulatory requirements to ensure the quality and integrity of the products/services or data provided in work area

applying and promoting sustainability principles and work practices in work area

detecting non-conforming products or services and recognising opportunities for improvements in work area

using at least three (3) quality improvement tools and techniques to analyse performance in work area

applying effective problem-solving strategies, such as identifying inputs and outputs, sequencing a process, identifying and rectifying a problem step, and root cause analysis

following workplace procedures for recording and reporting information about quality

implementing and monitoring approved actions, changes and improvement strategies

consulting and working with other team members to suggest improvements in productivity and quality.

Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

business goals and quality requirements associated with job function and/or work area as a basis for decision making and action

scientific and technical requirements of the processes, procedures, equipment and instrumentation associated with the candidate's work tasks and duties

specifications for laboratory products and services in the work area

sustainable energy principles

workplace procedures associated with the candidate's regular technical duties

layout of the workplace, divisions and laboratory

organisational structure of the workplace

lines of communication

role of laboratory services to the workplace and customers

work health and safety (WHS) and environment requirements.