Assessor Resource

MSL936001
Maintain quality system and continuous improvement processes within work or functional area

Assessment tool

Version 1.0
Issue Date: May 2024


This unit of competency covers responsibility for the day-to-day operation of the work or functional area and ensuring that quality system requirements are met and continuous improvements are initiated.

This unit of competency is applicable to senior technical officers and laboratory supervisors working in all industry sectors. Quality audits and evaluations for the work area may be undertaken as an individual or as part of a team under broad direction from scientists/medical staff/engineers.

While no specific licensing or certification requirements apply to this unit at the time of publication, laboratory operations are governed by relevant legislation, regulations and/or external accreditation requirements. Local requirements should be checked.

You may want to include more information here about the target group and the purpose of the assessments (eg formative, summative, recognition)



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.

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1

Develop and maintain quality framework within work area

1.1

Distribute and explain information about the workplace's quality system to personnel

1.2

Encourage personnel to participate in improvement processes and to assume responsibility for quality outputs

1.3

Allocate responsibilities for quality within work area in accordance with quality system

1.4

Provide coaching and mentoring to ensure that personnel are able to meet their responsibilities and quality requirements

2

Maintain quality documentation

2.1

Identify required quality documentation, including records of improvement plans and initiatives

2.2

Prepare and maintain quality documentation and keep accurate data records

2.3

Maintain document control system for work area

2.4

Contribute to the development and revision of quality manuals and work instructions for the work area

2.5

Develop and implement inspection and test plans for quality controlled products

3

Provide training in quality systems and improvement processes

3.1

Analyse roles, duties and current competency of relevant personnel

3.2

Identify training needs in relation to quality system and continuous improvement processes

3.3

Identify opportunities for skills development and/or training programs to meet needs

3.4

Initiate and monitor training and skills development programs

3.5

Maintain accurate training records

4

Optimise and report performance

4.1

Review performance outcomes to identify ways in which planning and operations could be improved

4.2

Enhance customer service through the use of quality improvement techniques and processes

4.3

Adjust plans and communicate these to personnel involved in their development and implementation

5

Evaluate relevant components of quality system

5.1

Undertake regular audits of components of the quality system that relate to the work area

5.2

Implement improvements in the quality system in accordance with own level of responsibility and workplace procedures

Evidence of competence in this unit must satisfy all of the requirements of the elements and performance criteria, and include demonstration of:

ensuring that the quality system requirements of day-to-day operations in the work area are met

implementing, monitoring and evaluating quality system requirements and initiating continuous improvements within the work area

applying effective problem identification, problem solving and quality improvement techniques

gaining commitment of individuals and teams to apply quality principles and practices

using quality improvement techniques to enhance internal and external customer service

encouraging ideas and feedback from team members when developing and refining techniques and processes

analysing training needs and implementing coaching and/or training programs to enhance the performance of individuals and teams

communicating effectively with supervisors, managers, laboratory and/or production personnel and customers about quality requirements

preparing and maintaining quality and audit documentation.

Must provide evidence that demonstrates knowledge of:

workplace business goals and key performance indicators (KPIs)

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

relevant sections of national and international quality standards, codes and protocols that apply in work area

workplace quality system, plans and documentation

continuous/quality improvement techniques, such as Pareto charts; strengths, weakness, opportunities, threats (SWOT) analysis; and plan, do, check, act (PDCA)

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

workplace policy and procedure development processes

workplace communication, recording and reporting procedures

work health and safety (WHS) and environment requirements.

Judgement of competence must be based on holistic assessment of the evidence. Assessment methods must confirm consistency of performance over time, rather than a single assessment event.

This unit of competency must be assessed in a laboratory environment that either meets Australian standards for working laboratories or is accredited by the National Association of Testing Authorities (NATA) or the Royal College of Pathology, as appropriate.

Foundation skills are integral to competent performance of the unit and should not be assessed separately.

Assessment processes and techniques must be appropriate to the language, literacy and numeracy requirements of the work being performed and the needs of the candidate.

Knowledge evidence may be collected concurrently with performance evidence or through an independent process, such as workbooks, written assessments or interviews (provided a record is kept in each case).

This unit of competency may be assessed with:

MSL915001 Provide information to customers

MSL916004 Maintain registration and statutory or legal compliance in work or functional area

MSL916001 Develop and maintain laboratory documentation

Holistic assessment methods include:

review of quality documentation prepared and maintained by the candidate

review of verified reports of improvement initiatives and/or projects conducted by the candidate

review of audit processes and outcomes generated by the candidate

review of information and training resources prepared by the candidate for personnel in the work area

feedback from peers and team members about the candidates ability to encourage participation and provide useful information, coaching and training

feedback from supervisors, managers and/or customers that the quality system requirements of day-to-day operations are met in the work area

observation of the candidate leading a quality improvement team

questions to assess required knowledge of quality systems, documentation, quality tools, continuous improvement processes and relevant workplace procedures.

Access is required to all instruments, equipment, materials, workplace documentation, procedures and specifications associated with this unit, including, but not limited to:

documentation, such as sampling plans, workplace quality manual, quality (certification or registration) requirements, quality and customer data, audit documents, performance plans and reports, and training records and/or plans

workplace procedures relating to WHS, equal opportunity, environmental legislative requirements, and industrial awards and workplace agreements.

Assessors must satisfy the assessor competency requirements that are in place at the time of the assessment as set by the VET regulator.

The assessor must demonstrate both technical competence and currency.

Technical competence can be demonstrated through:

relevant VET or other qualification/Statement of Attainment AND/OR

relevant workplace experience.

Currency can be demonstrated through:

performing the competency being assessed as part of current employment OR

having consulted with a laboratory about performing the competency being assessed within the last twelve months.


Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, 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.

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1

Develop and maintain quality framework within work area

1.1

Distribute and explain information about the workplace's quality system to personnel

1.2

Encourage personnel to participate in improvement processes and to assume responsibility for quality outputs

1.3

Allocate responsibilities for quality within work area in accordance with quality system

1.4

Provide coaching and mentoring to ensure that personnel are able to meet their responsibilities and quality requirements

2

Maintain quality documentation

2.1

Identify required quality documentation, including records of improvement plans and initiatives

2.2

Prepare and maintain quality documentation and keep accurate data records

2.3

Maintain document control system for work area

2.4

Contribute to the development and revision of quality manuals and work instructions for the work area

2.5

Develop and implement inspection and test plans for quality controlled products

3

Provide training in quality systems and improvement processes

3.1

Analyse roles, duties and current competency of relevant personnel

3.2

Identify training needs in relation to quality system and continuous improvement processes

3.3

Identify opportunities for skills development and/or training programs to meet needs

3.4

Initiate and monitor training and skills development programs

3.5

Maintain accurate training records

4

Optimise and report performance

4.1

Review performance outcomes to identify ways in which planning and operations could be improved

4.2

Enhance customer service through the use of quality improvement techniques and processes

4.3

Adjust plans and communicate these to personnel involved in their development and implementation

5

Evaluate relevant components of quality system

5.1

Undertake regular audits of components of the quality system that relate to the work area

5.2

Implement improvements in the quality system in accordance with own level of responsibility and workplace procedures

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

gene technology regulations

animal welfare legislation and codes of practice

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

Quality audits

Quality audits include one or more of:

regular checks of laboratory procedures

daily and weekly checks of specimen reception, instrumentation and results for control and standard samples to identify non-conformance and problem areas

maintenance of appropriate certified reference materials

participation in external quality assurance programs

Communication

Communication includes one or more of:

liaising with supervisors, managers and quality managers, laboratory and production staff, customers and suppliers

providing information, coaching and/or training about quality systems and plans, standards, codes and work practices

recording information and preparing reports

liaising with auditors and reporting to regulating authorities

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

Evidence of competence in this unit must satisfy all of the requirements of the elements and performance criteria, and include demonstration of:

ensuring that the quality system requirements of day-to-day operations in the work area are met

implementing, monitoring and evaluating quality system requirements and initiating continuous improvements within the work area

applying effective problem identification, problem solving and quality improvement techniques

gaining commitment of individuals and teams to apply quality principles and practices

using quality improvement techniques to enhance internal and external customer service

encouraging ideas and feedback from team members when developing and refining techniques and processes

analysing training needs and implementing coaching and/or training programs to enhance the performance of individuals and teams

communicating effectively with supervisors, managers, laboratory and/or production personnel and customers about quality requirements

preparing and maintaining quality and audit documentation.

Must provide evidence that demonstrates knowledge of:

workplace business goals and key performance indicators (KPIs)

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

relevant sections of national and international quality standards, codes and protocols that apply in work area

workplace quality system, plans and documentation

continuous/quality improvement techniques, such as Pareto charts; strengths, weakness, opportunities, threats (SWOT) analysis; and plan, do, check, act (PDCA)

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

workplace policy and procedure development processes

workplace communication, recording and reporting procedures

work health and safety (WHS) and environment requirements.

Judgement of competence must be based on holistic assessment of the evidence. Assessment methods must confirm consistency of performance over time, rather than a single assessment event.

This unit of competency must be assessed in a laboratory environment that either meets Australian standards for working laboratories or is accredited by the National Association of Testing Authorities (NATA) or the Royal College of Pathology, as appropriate.

Foundation skills are integral to competent performance of the unit and should not be assessed separately.

Assessment processes and techniques must be appropriate to the language, literacy and numeracy requirements of the work being performed and the needs of the candidate.

Knowledge evidence may be collected concurrently with performance evidence or through an independent process, such as workbooks, written assessments or interviews (provided a record is kept in each case).

This unit of competency may be assessed with:

MSL915001 Provide information to customers

MSL916004 Maintain registration and statutory or legal compliance in work or functional area

MSL916001 Develop and maintain laboratory documentation

Holistic assessment methods include:

review of quality documentation prepared and maintained by the candidate

review of verified reports of improvement initiatives and/or projects conducted by the candidate

review of audit processes and outcomes generated by the candidate

review of information and training resources prepared by the candidate for personnel in the work area

feedback from peers and team members about the candidates ability to encourage participation and provide useful information, coaching and training

feedback from supervisors, managers and/or customers that the quality system requirements of day-to-day operations are met in the work area

observation of the candidate leading a quality improvement team

questions to assess required knowledge of quality systems, documentation, quality tools, continuous improvement processes and relevant workplace procedures.

Access is required to all instruments, equipment, materials, workplace documentation, procedures and specifications associated with this unit, including, but not limited to:

documentation, such as sampling plans, workplace quality manual, quality (certification or registration) requirements, quality and customer data, audit documents, performance plans and reports, and training records and/or plans

workplace procedures relating to WHS, equal opportunity, environmental legislative requirements, and industrial awards and workplace agreements.

Assessors must satisfy the assessor competency requirements that are in place at the time of the assessment as set by the VET regulator.

The assessor must demonstrate both technical competence and currency.

Technical competence can be demonstrated through:

relevant VET or other qualification/Statement of Attainment AND/OR

relevant workplace experience.

Currency can be demonstrated through:

performing the competency being assessed as part of current employment OR

having consulted with a laboratory about performing the competency being assessed within the last twelve months.

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
Distribute and explain information about the workplace's quality system to personnel 
Encourage personnel to participate in improvement processes and to assume responsibility for quality outputs 
Allocate responsibilities for quality within work area in accordance with quality system 
Provide coaching and mentoring to ensure that personnel are able to meet their responsibilities and quality requirements 
Identify required quality documentation, including records of improvement plans and initiatives 
Prepare and maintain quality documentation and keep accurate data records 
Maintain document control system for work area 
Contribute to the development and revision of quality manuals and work instructions for the work area 
Develop and implement inspection and test plans for quality controlled products 
Analyse roles, duties and current competency of relevant personnel 
Identify training needs in relation to quality system and continuous improvement processes 
Identify opportunities for skills development and/or training programs to meet needs 
Initiate and monitor training and skills development programs 
Maintain accurate training records 
Review performance outcomes to identify ways in which planning and operations could be improved 
Enhance customer service through the use of quality improvement techniques and processes 
Adjust plans and communicate these to personnel involved in their development and implementation 
Undertake regular audits of components of the quality system that relate to the work area 
Implement improvements in the quality system in accordance with own level of responsibility and workplace procedures 

Forms

Assessment Cover Sheet

MSL936001 - Maintain quality system and continuous improvement processes within work or 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

MSL936001 - Maintain quality system and continuous improvement processes within work or 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: