Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

MSL916004A Mapping and Delivery Guide
Maintain registration and statutory or legal compliance in work/functional area

Version 1.0
Issue Date: March 2024


Qualification -
Unit of Competency MSL916004A - Maintain registration and statutory or legal compliance in work/functional area
Description This unit of competency covers responsibility for the day-to-day operation of the work/functional area and its compliance with legislation and licensing, registration, ethical or accreditation requirements (e.g. National Association of Testing Authorities (NATA)) and enterprise policies and procedures.
Employability Skills This unit contains employability skills.
Learning Outcomes and Application This unit of competency is applicable to senior technical officers and laboratory supervisors in all industry sectors. While statutory or legal compliance is the responsibility of all personnel, supervisors have an important leadership role in promoting and monitoring workplace practices which enhance compliance. They work under broad supervision of scientists/medical staff/engineers.Industry representatives have provided case studies to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting. These can be found at the end of this unit of competency under the section 'This competency in practice'.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities
Slides
PPT
Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: 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
       
Element: 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 the calibration system is implemented to meet traceability requirements
  • Ensure that testing procedures are implemented so that methods and equipment are fit for purpose
  • Implement systems to ensure the accuracy of measuring equipment
  • Empower team members through coaching and mentoring to manage their responsibilities
       
Element: 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
       
Element: 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 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
       


Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

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 (e.g. NATA) and the enterprise's policies and procedures

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

provide information and training on roles and responsibilities and enterprise procedures dealing with legal/statutory 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:

MSL915001A Provide information to customers

MSL916001A Develop and maintain laboratory documentation

MSL916003A Supervise laboratory operations in work/functional area

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 candidate's interactions with personnel

review of verified records and reports generated by the candidate

feedback from managers regarding the candidate's 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 and/or 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 laboratory's 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 laboratory's 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 laboratory's standards of compliance and enhanced the level of communication and cooperation with the team.


Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)


Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

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 non-conformance

detailed analysis of results and long term data trends

providing information and training on roles and responsibilities and enterprise procedures dealing with legal/statutory 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 (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 health, safety and environment requirements

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

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
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 
Plan work practices to ensure compliance with relevant legislation and licensing, registration, ethical or accreditation requirements 
Ensure that the calibration system is implemented to meet traceability requirements 
Ensure that testing procedures are implemented so that methods and equipment are fit for purpose 
Implement systems to ensure the accuracy of measuring equipment 
Empower team members through coaching and mentoring to manage their responsibilities 
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 
Investigate and deal with non-conformance according to legislative and licensing, registration or accreditation requirements and workplace procedures 
Provide on/off 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 

Forms

Assessment Cover Sheet

MSL916004A - Maintain registration and statutory or legal compliance in work/functional area
Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:


Assessment Record Sheet

MSL916004A - Maintain registration and statutory or legal compliance in work/functional area

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: