Assessor Resource

MSL936002
Conduct an internal audit of the quality system

Assessment tool

Version 1.0
Issue Date: May 2024


This unit of competency covers the ability to prepare for, conduct and document an internal audit of aspects of the laboratory's quality system. It also covers the implementation of the identified corrective action and opportunities for improvement and the monitoring of their effectiveness.

This unit of competency is applicable to senior technical officers and laboratory supervisors working in all industry sectors. These people play a key role in the audit team due to their knowledge of the quality system and their broad technical expertise and specialised knowledge of procedures and technology. This unit of competency requires a thorough examination of various aspects of the quality system.

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

Prepare for internal audit

1.1

Analyse brief to determine the scope and detailed requirements of the planned audit

1.2

Identify procedures and/or the work area to be audited, and collect relevant information and documentation

1.3

Brief relevant personnel and allocate roles and responsibilities

1.4

Develop a detailed audit plan in consultation with relevant personnel

1.5

Develop a checklist to identify conformance and non-conformance

2

Conduct audit

2.1

Identify the components and elements of the quality system and work area to be audited

2.2

Collaborate with relevant personnel to maximise continuous improvement and ownership of the audit process

2.3

Collect sufficient evidence to identify non-conforming aspects of the quality system

2.4

Analyse evidence to identify suitable corrective actions

3

Report findings

3.1

Document findings from the audit process in the required format

3.2

Present recommendations for corrective actions

3.3

Provide strategies for the implementation of the corrective actions

4

Complete corrective actions

4.1

Develop and implement an action plan to improve the quality system

4.2

Consult with relevant personnel regarding the necessary strategies to improve the quality system

4.3

Evaluate and report the effectiveness of the corrective action after an agreed time interval

4.4

Ensure that relevant certification is maintained

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.

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.

Judgement of competence must be based on holistic assessment of the evidence. Competency must be assessed within the context of a team-based internal quality audit and assessed over a sufficient period of time to enable the candidate to prepare and conduct the audit, report the findings and implement and evaluate any corrective action.

This unit of competency is to be assessed in the workplace or a simulated workplace environment, and assessment evidence must be relevant to the particular workplace context. A simulated workplace environment must reflect realistic operational workplace conditions that cover all aspects of workplace performance, including the environment, task skills, task management skills, contingency management skills and job role environment skills.

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:

MSL916002 Manage and develop teams

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

Holistic assessment methods include:

review of audit plan, checklists, data, findings and recommendations prepared by the candidate as part of the internal audit process

feedback from audit team members about the candidate’s ability to encourage participation and provide useful information and clear instructions

feedback from managers about implementation of the internal audit and the usefulness of the findings and recommendations

questions to assess required knowledge of quality systems, internal audit process, quality improvement techniques and relevant workplace procedures

observation of the candidate's performance at key audit stages.

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 audit documents, workplace quality manual and HACCP plans, and quality (certification or registration) requirements

safety procedures, SOPs and work instructions.

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

Prepare for internal audit

1.1

Analyse brief to determine the scope and detailed requirements of the planned audit

1.2

Identify procedures and/or the work area to be audited, and collect relevant information and documentation

1.3

Brief relevant personnel and allocate roles and responsibilities

1.4

Develop a detailed audit plan in consultation with relevant personnel

1.5

Develop a checklist to identify conformance and non-conformance

2

Conduct audit

2.1

Identify the components and elements of the quality system and work area to be audited

2.2

Collaborate with relevant personnel to maximise continuous improvement and ownership of the audit process

2.3

Collect sufficient evidence to identify non-conforming aspects of the quality system

2.4

Analyse evidence to identify suitable corrective actions

3

Report findings

3.1

Document findings from the audit process in the required format

3.2

Present recommendations for corrective actions

3.3

Provide strategies for the implementation of the corrective actions

4

Complete corrective actions

4.1

Develop and implement an action plan to improve the quality system

4.2

Consult with relevant personnel regarding the necessary strategies to improve the quality system

4.3

Evaluate and report the effectiveness of the corrective action after an agreed time interval

4.4

Ensure that relevant certification is maintained

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

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.

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.

Judgement of competence must be based on holistic assessment of the evidence. Competency must be assessed within the context of a team-based internal quality audit and assessed over a sufficient period of time to enable the candidate to prepare and conduct the audit, report the findings and implement and evaluate any corrective action.

This unit of competency is to be assessed in the workplace or a simulated workplace environment, and assessment evidence must be relevant to the particular workplace context. A simulated workplace environment must reflect realistic operational workplace conditions that cover all aspects of workplace performance, including the environment, task skills, task management skills, contingency management skills and job role environment skills.

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:

MSL916002 Manage and develop teams

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

Holistic assessment methods include:

review of audit plan, checklists, data, findings and recommendations prepared by the candidate as part of the internal audit process

feedback from audit team members about the candidate’s ability to encourage participation and provide useful information and clear instructions

feedback from managers about implementation of the internal audit and the usefulness of the findings and recommendations

questions to assess required knowledge of quality systems, internal audit process, quality improvement techniques and relevant workplace procedures

observation of the candidate's performance at key audit stages.

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 audit documents, workplace quality manual and HACCP plans, and quality (certification or registration) requirements

safety procedures, SOPs and work instructions.

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
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 
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 
Document findings from the audit process in the required format 
Present recommendations for corrective actions 
Provide strategies for the implementation of the 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 

Forms

Assessment Cover Sheet

MSL936002 - Conduct an internal audit of the quality system
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

MSL936002 - Conduct an internal audit of the quality system

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: