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Follow the links below to find material targeted to the unit's elements, performance criteria, required skills and knowledge

Elements and Performance Criteria

  1. Interpret and communicate current legislation, codes and standards
  2. Ensure that work practices meet compliance requirements
  3. Monitor, analyse, adjust and report performance
  4. Investigate, rectify and report non-conformance

Required Skills

Required skills

Required skills include

ensuring work practices are conducted in an ethical and professional manner

monitoring and analysing work practices to ensure compliance and taking appropriate action to rectify potential problems or instances of nonconformance

detailed analysis of results and long term data trends

providing information and training on roles and responsibilities and enterprise procedures dealing with legalstatutory requirements

communicating appropriately with all customers internal and external

negotiating changes to work processes and procedures to meet statutory or legal requirements

developing and introducing practices to improve the work environment

providing coaching and mentoring support to personnel to change work practices

keeping required records complete current and secure

Required knowledge

Required knowledge includes

enterprise 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 eg 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 health safety and environment requirements

Evidence Required

The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria required skills and knowledge range statement and the Assessment Guidelines for the Training Package

Overview of assessment

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Assessors should ensure that candidate can

ensure work practices are conducted in an ethical and professional manner

supervise laboratory operations to ensure that the work or functional area complies with legislation and laboratory licensing registration or accreditation requirements eg NATA and the enterprises policies and procedures

monitor and analyse work practices to ensure compliance and take appropriate actions to rectify potential problems or instances of nonconformance

provide information and training on roles and responsibilities and enterprise procedures dealing with legalstatutory requirements

communicate appropriately with all customers internal and external and be aware of cultural and social contexts

negotiate changes to work processes and procedures to meet statutory or legal requirements

develop and introduce practices to improve the work environment

provide coaching and mentoring support to personnel to change work practices

keep required records complete current and secure

Context of and specific resources for assessment

This unit of competency should be assessed in a laboratory environment that either meets Australian standards for working laboratories or is accredited by NATA or the Royal College of Pathology as appropriate

This unit of competency may be assessed with

MSLA Provide information to customers

MSL915001A Provide information to customers

MSLA Develop and maintain laboratory documentation

MSL916001A Develop and maintain laboratory documentation

MSLA Supervise laboratory operations in workfunctional area

MSL916003A Supervise laboratory operations in work/functional area

TAADELC Provide training through instruction and demonstration of work skills

TAADEL301C Provide training through instruction and demonstration of work skills.

Resources may include

laboratory equipped with appropriate equipment instruments services and consumables

relevant enterprise policies procedures operational reports financial reports and stock records

technical manuals standard operating procedures SOPs quality manuals and quality system documentation

Method of assessment

The following assessment methods are suggested

observation of the candidates interactions with personnel

review of verified records and reports generated by the candidate

feedback from managers regarding the candidates ability to implement relevant enterprise procedures

review of information developed by the candidate and provided to the workgroup

In all cases practical assessment should be supported by questions to assess underpinning knowledge and those aspects of competency which are difficult to assess directly

Where applicable reasonable adjustment must be made to work environments and training situations to accommodate ethnicity age gender demographics and disability

Access must be provided to appropriate learning andor assessment support when required

The language literacy and numeracy demands of assessment should not be greater than those required to undertake the unit of competency in a work like environment

This competency in practice

Industry representatives have provided the case studies below to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting

Biomedical

A pathology laboratory is preparing for NATA assessment The role of one laboratory supervisor is to organise information sessions to inform personnel about the standards and codes to be followed for accreditation These cover issues such as working with biological chemical and radiation hazards the use of safety equipment the disposal of waste ethics committee requirements and patient confidentiality Training is provided to ensure all personnel are equipped with sufficient knowledge and skills to fulfil their responsibilities in line with the relevant codes and standards The thorough preparation of the laboratory personnel by the laboratory supervisor assists the laboratory to gain NATA accreditation

Environmental

A laboratory supervisor is asked to do an internal audit of a work area as part of an analytical laboratorys preparation for a NATA assessment The supervisor checks items such as the currency of the quality manual and laboratory documentation the storage of reference standards and compares the documentation of test results with NATA requirements As a result of this internal audit the supervisor is confident that the forthcoming NATA assessment will show that the work area complies with all requirements

Food processing

A team of technical assistants performs a common set of food analyses that are essential to the operations of a food processing company After a period of rapid staff turnover their supervisor noticed that the degree of variance in the analytical results has increased An internal proficiency study confirmed that this rise was not due to compositional differences between samples The supervisor sought to overcome this problem by first discussing it with the team The supervisor realised that some of the recently employed technical assistants did not fully understand some analytical procedures Furthermore each member of the team for various reasons has a distinct preference for performing some procedures over others and this appeared to influence their competency to conduct all other analyses

In consultation with the team the supervisor made several changes to the way they work A more structured induction of new staff was introduced and where possible each technician was allocated the analyses that they preferred and were most competent to perform The supervisor also instigated a review of the analytical methods involved and identified the critical steps in each assay as defined by the laboratorys accreditation authority Particular attention was paid to steps regularly misunderstood by one or more technicians in the past and a series of critical operating procedures were developed These procedures together with the SOPs were clearly displayed in the area where the relevant assay was conducted Overall these actions by the laboratory supervisor improved the work performance and satisfaction of the staff maintained the laboratorys standards of compliance and enhanced the level of communication and cooperation with the team


Range Statement

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Codes of practice

Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used

Standards, codes, procedures and/or enterprise requirements

Standards, codes, procedures and/or enterprise requirements may include:

Australian and international standards, such as:

AS ISO 1000-1998 The international system of units (SI) and its application

AS ISO 10013-2003 Guidelines for quality management system documentation

AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories

AS/NZS 2243 Set:2006 Safety in laboratories set

AS/NZS 2982.1:1997 Laboratory design and construction - General requirements

AS/NZS ISO 10005:2006 Quality management systems - Guidelines for quality plans

AS/NZS ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment

AS/NZS ISO 14000 Set:2005 Environmental management standards set

AS/NZS ISO 9000 Set:2008 Quality management systems set

ISO 5725 Accuracy (trueness and precision) of measurement methods and results

ISO/IEC Guide 98-3:2008 Uncertainty of measurement - Part 3 Guide to the expression of uncertainty in measurement (GUM)

animal welfare legislation and codes of practice

Eurachem/CITAC Guide CG4 Quantifying uncertainty in analytical measurement

occupational health and safety (OHS) national standards and codes of practice

principles of good laboratory practice (GLP)

Australia New Zealand Food Standards (ANZFS) Code

Australian code of good manufacturing practice for medicinal products (GMP)

Australian Dangerous Goods Code

Anti-discrimination Acts

Australian Quarantine and Inspection Service (AQIS) Export Control (Orders) Regulations 1982 and Import Guidelines

dispute resolution

ethics committee requirements

freedom of information

gene technology regulations

general duty of care

Human Rights and Equal Opportunity Commission Act 1986

intellectual property and copyright

maintenance and confidentiality of records

maintenance of certified reference materials and regulation 80 certificates

maintenance of records of breaches

National Association of Testing Authorities (NATA) Accreditation programs requirements

national environment protection measures

National Health and Medical Research Council (NHMRC) Guidelines

national measurement regulations and guidelines

natural justice

privacy legislation

representative work groups/committees

Therapeutic Goods Regulations 1009

workers' compensation, WorkCover and industrial relations

Ethical considerations

Ethical considerations may include:

identification and impartial resolution of ethical issues, such as conflict of interest

ethical decision making

provision of products and services which match the operational and financial needs of stakeholders, including realistic quotes for work

accurate representation of skills, services, knowledge and qualifications of individuals and the organisation

acknowledgment of services and products developed by others, intellectual property and copyright

provision of unbiased, accurate and appropriately qualified information results

Communication

Communication may involve:

managers and supervisors

laboratory and production staff

regulating authorities

provision of information and training

explanation of legislation, codes, standards and work practices

Occupational health and safety (OHS) and environmental management requirements

OHS and environmental management requirements:

all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time

all operations assume the potentially hazardous nature of samples and require standard precautions to be applied

where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health