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Elements and Performance Criteria

1. Develop and maintain quality framework within work area
   • Distribute and explain information about the workplace's quality system to personnel
   • Encourage personnel to participate in improvement processes and to assume responsibility for quality outputs
   • Allocate responsibilities for quality within work area in accordance with quality system
   • Provide coaching and mentoring to ensure that personnel are able to meet their responsibilities and quality requirements
2. Maintain quality documentation
   • Identify required quality documentation, including records of improvement plans and initiatives
   • Prepare and maintain quality documentation and keep accurate data records
   • Maintain document control system for work area
   • Contribute to the development and revision of quality manuals and work instructions for the work area
   • Develop and implement inspection and test plans for quality controlled products
3. Provide training in quality systems and improvement processes
   • Analyse roles, duties and current competency of relevant personnel
   • Identify training needs in relation to quality system and continuous improvement processes
   • Identify opportunities for skills development and/or training programs to meet needs
   • Initiate and monitor training and skills development programs
   • Maintain accurate training records
4. Optimise and report performance
   • Review performance outcomes to identify ways in which planning and operations could be improved
   • Enhance customer service through the use of quality improvement techniques and processes
   • Adjust plans and communicate these to personnel involved in their development and implementation
5. Evaluate relevant components of quality system
   • Undertake regular audits of components of the quality system that relate to the work area
   • Implement improvements in the quality system in accordance with own level of responsibility and workplace procedures

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 of more of: Australian and international standards, codes and guidelines covering the competence of testing and calibration laboratories, laboratory design and construction, laboratory safety, quality management systems, documentation and plans, environmental management, measurement management, accuracy of measurement methods and results, expression of uncertainty (GUM) and principles of good laboratory practice (GLP) national standards and codes of practice for work health and safety (WHS), and national environment protection measures national measurement regulations and guidelines registration/licensing and/or National Association of Testing Authorities (NATA) accreditation requirements industry-specific codes, guidelines, procedures and methods, such as: National Health and Medical Research Council (NHMRC) Guidelines Association of Analytical Communities International (AOAC International) Official Methods of Analysis Australian code of good manufacturing practice for medicinal products (GMP) and Therapeutic Goods Regulations Australia New Zealand Food Standards (ANZFS) Code gene technology regulations animal welfare legislation and codes of practice 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 product specifications and quality requirements
Quality audits	Quality audits include one or more of: regular checks of laboratory procedures daily and weekly checks of specimen reception, instrumentation and results for control and standard samples to identify non-conformance and problem areas maintenance of appropriate certified reference materials participation in external quality assurance programs
Communication	Communication includes one or more of: liaising with supervisors, managers and quality managers, laboratory and production staff, customers and suppliers providing information, coaching and/or training about quality systems and plans, standards, codes and work practices recording information and preparing reports liaising with auditors and reporting to regulating authorities
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:

ensuring that the quality system requirements of day-to-day operations in the work area are met

implementing, monitoring and evaluating quality system requirements and initiating continuous improvements within the work area

applying effective problem identification, problem solving and quality improvement techniques

gaining commitment of individuals and teams to apply quality principles and practices

using quality improvement techniques to enhance internal and external customer service

encouraging ideas and feedback from team members when developing and refining techniques and processes

analysing training needs and implementing coaching and/or training programs to enhance the performance of individuals and teams

communicating effectively with supervisors, managers, laboratory and/or production personnel and customers about quality requirements

preparing and maintaining quality and audit documentation.

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Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

workplace business goals and key performance indicators (KPIs)

workplace organisational structure, delegations and responsibilities, and information management systems

relevant sections of national and international quality standards, codes and protocols that apply in work area

workplace quality system, plans and documentation

continuous/quality improvement techniques, such as Pareto charts; strengths, weakness, opportunities, threats (SWOT) analysis; and plan, do, check, act (PDCA)

standard operating procedures (SOPs) for the technical work performed in work area

workplace policy and procedure development processes

workplace communication, recording and reporting procedures

work health and safety (WHS) and environment requirements.

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