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Elements and Performance Criteria

1. Interpret and communicate current legislation, codes and standards
   • Maintain knowledge of current and new requirements impacting on work/functional area
   • Distribute clear information regarding the roles and responsibilities of teams and individuals to maintain the laboratory's statutory or legal compliance
   • Explain the implications of non-conformance to all personnel within the work area
2. Ensure that work practices meet compliance requirements
   • Plan work practices to ensure compliance with relevant legislation and licensing, registration, ethical or accreditation requirements
   • Ensure that calibration and testing procedures are implemented so that equipment and methods are fit for purpose and reliable
   • Empower team members through coaching and mentoring to manage their responsibilities
3. Monitor, analyse, adjust and report performance
   • Ensure that actual and potential problems are identified, rectified and reported promptly to ensure workplace compliance
   • Analyse and supervise activities so that potential non-compliance is minimised
   • Recommend to designated personnel, strategies to improve compliance
   • Ensure that individuals/teams are informed of new and improved procedures
   • Maintain systems, records and reporting procedures according to legislative and licensing, registration, ethical or accreditation requirements and workplace procedures
4. Investigate, rectify and report non-conformance
   • Investigate and deal with non-conformance according to legislative and licensing, registration or accreditation requirements and workplace procedures
   • Provide on/off-the-job training for personnel to acquire and apply competencies to meet legislative and licensing, registration or ethical accreditation requirements
   • Re-design or adjust workplace practices to ensure that non-conformance is not repeated

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 covering the competence of testing and calibration laboratories, laboratory design and construction, laboratory safety, and quality and environmental management registration/licensing and/or National Association of Testing Authorities (NATA) accreditation requirements national work health and safety (WHS) standards and codes of practice, and national environment protection measures Australian and international standards, codes and guidelines covering measurement management, accuracy of measurement methods and results, expression of uncertainty (GUM) and principles of good laboratory practice (GLP) 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 Australian Dangerous Goods Code gene technology regulations animal welfare legislation and codes of practice legislation and regulations covering intellectual property (IP) and copyright, freedom of information, human rights and equal opportunity, privacy and industrial relations
Workplace policy and procedures	Workplace policy and procedures include one or more of: operation of representative work groups/committees (ethics and WHS) audit requirements maintenance and confidentiality of laboratory records maintenance of certified reference materials maintenance of records of breaches
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:

monitoring day-to-day operations of the work/functional area

analysing results and long-term trends in data

monitoring, analysing and changing work practices to ensure compliance with workplace requirements, legal requirements and relevant policies and procedures

making improvements to rectify potential problems or instances of non-conformance

providing information and training about roles, responsibilities and workplace procedures dealing with legal/statutory requirements

providing coaching and mentoring support to personnel to change work practices

communicating effectively with others who may have diverse work styles, cultures and perspectives

keeping records complete, current and secure.

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Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

workplace procedures governing document control, record management, communication and reporting, and internal and external audits

scientific technical terminology used to describe legislative, licensing or registration requirements (e.g. traceability)

legal, ethical and welfare issues associated with laboratory and technical work

role, structure and responsibilities of ethics committees

statutory and legal compliance requirements

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

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