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Elements and Performance Criteria

1. Prepare for internal audit
   • Analyse brief to determine the scope and detailed requirements of the planned audit
   • Identify procedures and/or the work area to be audited, and collect relevant information and documentation
   • Brief relevant personnel and allocate roles and responsibilities
   • Develop a detailed audit plan in consultation with relevant personnel
   • Develop a checklist to identify conformance and non-conformance
2. Conduct audit
   • Identify the components and elements of the quality system and work area to be audited
   • Collaborate with relevant personnel to maximise continuous improvement and ownership of the audit process
   • Collect sufficient evidence to identify non-conforming aspects of the quality system
   • Analyse evidence to identify suitable corrective actions
3. Report findings
   • Document findings from the audit process in the required format
   • Present recommendations for corrective actions
   • Provide strategies for the implementation of the corrective actions
4. Complete corrective actions
   • Develop and implement an action plan to improve the quality system
   • Consult with relevant personnel regarding the necessary strategies to improve the quality system
   • Evaluate and report the effectiveness of the corrective action after an agreed time interval
   • Ensure that relevant certification is maintained

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, and hazard analysis and critical control points (HACCP) principles 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
Elements and components of a quality system	Elements and components of a quality system include, but are not limited to, one or more of: responsibilities of personnel within quality system contract review purchasing design control process control, control of customer-supplied product, product identification and traceability inspection and testing, control of inspection, measuring and test equipment, and inspection and test status statistical analysis, internal quality audits, and corrective and preventative action control of documents, data and quality records control of non-conforming product handling, storage, packaging, preservation and delivery training servicing
Information and documentation	Information and documentation include, but are not limited to, one or more of: workplace quality manuals documentation related to the quality elements being audited data records customer complaints training records certification documentation from clients/suppliers material/equipment specifications
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:

preparing for, conducting and documenting at least one (1) internal audit of aspects of the laboratory's quality system in accordance with workplace procedures

collecting and analysing all necessary data, relevant documentation and records

applying effective problem identification, problem solving and quality improvement techniques

encouraging suggestions and feedback from team members to develop improved work practices or processes

documenting audit findings accurately and recommending logical corrective actions to address non-conformance items

communicating effectively with supervisors, managers, laboratory and/or production personnel before, during and after the audit

implementing identified corrective actions and opportunities for improvement and monitoring and evaluating their effectiveness

maintaining and reporting quality and audit documentation.

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Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

workplace quality system, plans and documentation and relevant national and international quality standards and protocols that apply in work area

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

importance of identifying, reporting and addressing non-conformance

laboratory's business goals and key performance indicators (KPIs)

audit process and documentation

problem-solving techniques to identify causes and options to remedy problems

continuous improvement principles and techniques, such as:

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

plan, do, check, act (PDCA)

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

process capability

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

workplace communication, recording and reporting procedures

work health and safety (WHS) and environment requirements.

Additional knowledge requirements may apply for different industry sectors. For example in food processing:

incorporating food safety and/or hazard analysis and critical control points (HACCP) plan requirements into audit

monitoring and verifying critical control limits.

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