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Evidence Guide: MSL936002 - Conduct an internal audit of the quality system

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

MSL936002 - Conduct an internal audit of the quality system

What evidence can you provide to prove your understanding of each of the following citeria?

Prepare for internal audit

  1. Analyse brief to determine the scope and detailed requirements of the planned audit
  2. Identify procedures and/or the work area to be audited, and collect relevant information and documentation
  3. Brief relevant personnel and allocate roles and responsibilities
  4. Develop a detailed audit plan in consultation with relevant personnel
  5. Develop a checklist to identify conformance and non-conformance
Analyse brief to determine the scope and detailed requirements of the planned audit

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Brief relevant personnel and allocate roles and responsibilities

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Develop a detailed audit plan in consultation with relevant personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Develop a checklist to identify conformance and non-conformance

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct audit

  1. Identify the components and elements of the quality system and work area to be audited
  2. Collaborate with relevant personnel to maximise continuous improvement and ownership of the audit process
  3. Collect sufficient evidence to identify non-conforming aspects of the quality system
  4. Analyse evidence to identify suitable corrective actions
Identify the components and elements of the quality system and work area to be audited

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Analyse evidence to identify suitable corrective actions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Report findings

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Present recommendations for corrective actions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Provide strategies for the implementation of the corrective actions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete corrective actions

  1. Develop and implement an action plan to improve the quality system
  2. Consult with relevant personnel regarding the necessary strategies to improve the quality system
  3. Evaluate and report the effectiveness of the corrective action after an agreed time interval
  4. Ensure that relevant certification is maintained
Develop and implement an action plan to improve the quality system

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ensure that relevant certification is maintained

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

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

Required Skills and Knowledge

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.

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 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