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Elements and Performance Criteria

1. Recognise documentation needs/deficiencies
   • Evaluate current documentation to identify instances where documentation is needed or deficient
   • Analyse development opportunities and discuss with appropriate personnel to assess and confirm requirements
2. Develop/revise documentation
   • Specify documentation need and set/prioritise objectives
   • Analyse existing documentation/records in accordance with specified requirements
   • Develop/amend documentation as a draft in accordance with review requirements
   • Issue documentation to appropriate personnel for review
   • Edit documentation to ensure that the initial identified need/deficiency and review requirements are satisfied
   • Recall superseded documentation and issue new documentation in accordance with document control procedures
3. Implement and evaluate new laboratory documentation
   • Brief personnel on new/revised documentation to ensure successful implementation of new procedures
   • Monitor and evaluate implementation of new/revised documentation and amend documents or provide training, if required

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 competence of testing and calibration laboratories, laboratory safety, and quality and environmental management work health and safety (WHS) national standards and codes of practice registration/licensing and/or National Association of Testing Authorities (NATA) accreditation requirements codes, guidelines, procedures and specific method collections for industry sectors such as: Association of Analytical Communities International (AOAC International) Official Methods of Analysis Australian code of good manufacturing practice for medicinal products (GMP), principles of good laboratory practice (GLP) Australia New Zealand Food Standards (ANZFS) Code Australian Dangerous Goods Code gene technology regulations
Workplace documentation	Workplace documentation includes one or more of: instructions to comply with new legislation, standards, guidelines, codes and permits plans covering management of laboratory services, quality, environment, training and maintenance workplace procedures; standard operating procedures (SOPs) and operating manuals; instructions for equipment installation, commissioning, calibration and maintenance; and waste minimisation and disposal safety requirements for equipment, materials or products; risk evaluation, monitoring or control procedures; and incident and accident/injury reports test procedures, sampling procedures (sampling, preparation, labelling, storage, transport and disposal), methods for extraction or manufacture of a product, and procedures for evaluation of materials or products compliance/non-compliance reports, quality system and continued improvement processes cleaning, hygiene and personal hygiene requirements schematics/workflows/laboratory layouts stock records/inventory training program contents
Record keeping systems	Record keeping systems include: online information systems, databases, record and filing systems
Personnel	Personnel include one or more of: supervisors and managers (laboratory, quality and customer service), and laboratory or production personnel members of the public, customers and suppliers external auditors, regulation and licensing/accreditation authorities, such as National Association of Testing Authorities (NATA), if within limits of responsibility and authority
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:

recognising problems in workplace documentation and systems

analysing, developing and maintaining workplace documentation and systems in response to identified information requirements or changes in laboratory policy or external accreditation requirements

developing and amending workplace documents and systems using established workplace procedures

producing documentation that is accurate and meets specifications, free from editorial errors and omissions, and understood by others

using internal and external information sources efficiently

critically analysing information

obtaining and incorporating relevant feedback on draft documentation

communicating information and developments effectively

completing the preparation and distribution of documentation in the given timeframe.

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Knowledge Evidence

Must provide evidence that demonstrates knowledge of:

the laboratory's business goals, key performance indicators (KPIs), organisational structure, delegations and responsibilities

how work health and safety (WHS), environmental, registration/accreditation and other legislative requirements, regulations and codes govern laboratory documentation

standard operating procedures (SOPs) relevant to the laboratory’s operations and scope of testing

scientific, technical and workplace terminology; and technical developments in the sector (such as current methodologies, ranges and interpretations)

workplace procedures for developing/amending and tracking documentation; records management and maintenance

workplace communication protocols and reporting.

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