QUALITY AUDIT COURSE

QUALITY MANAGEMENT SYSTEM

Course Objective
When you completed the course you will be able to:

• Understand how to carry out audit based on the requirements of ISO 9001:2015

• To train auditors in the preparation, planning, conduct, reporting and follow-up of

internal audits

• To learn the qualities of a good auditor

Course Outline
This is a two (2) days course containing the following:

•Introduction to Quality Audit

•Principle of Auditing

•Managing an Audit Programme

•Performing an Audit

•Generating Audit Findings

•Audit Follow-up

•Competence and Evaluation of Auditors

Introduction to Quality Audit
• Quality Audit A systematic, independent and documented process for obtaining
audit evidence and evaluating it objectively to determine the extent to which audit
criteria are fulfilled.

• Objective of Auditing is to determine whether the organization conforms to the

planned arrangements, to the requirements of either company procedure or
regulatory requirements and if it is effectively implemented and maintained.
Introduction to Quality Audit
• Type of Audits:

Internal Quality Audit (IQA) or First-party Audits

Conducted by the organization itself, or on its behalf for management review and other internal purposes.

External Quality Audit (EQA)

Second Party Audits

Conducted by parties having an interest in the organization, such as customers, or other person on their
behalf.

Third Part Audits

Conducted by external, independent, auditing organizations, such as regulatory agencies, and those
agencies providing certification.
PRINCIPLE OF AUDITING
Integrity : the foundation of professionalism.

Fair Presentation : the obligation to report truthfully and accurately.

Due to Professional Care : the application of diligence and judgement in auditing.

Confidentiality : security of information.

Independence : the basis for the impartiality of the audit and objectivity of the audit
conclusions.

Evidence-based Approach : the rational method for reaching reliable and reproducible
audit conclusions in a systematic audit process.
Managing Audit Programme
Audit Programme set of one or more audit planned for specific time frame and
directed towards a specific purpose.

An Audit Program includes all activities necessary for planning, organizing, and
conducting the audits.

Establish, implement, monitor, review, and improve the audit programme.

Identify the necessary resources and ensure that they are provided.
Managing Audit Programme
Objective of an Audit Programme

Purpose – to direct the planning and conduct of audits based on the consideration of:
1.Management Principle
2.Commercial and other business intentions
3.Characteristics or processes, products, and any changes to them
4.Management System requirements
5.Need for supplier evaluation
6.Legal and contractual requirements and other requirements to which the organization is committed
7.Needs and expectations of interested parties
8.Auditees level of performance based on occurrences of failures, incidents, and customer complaints
9.Risk to Audit
10. Result of previous audit
11.Level of maturity of the management system briefing audited
Managing Audit Programme
HOW TO CREATE AUDIT PROGRAMME

AUDIT SCOPE

Audit Scope includes factors such as:

-Physical Location
-Organizational Units
-Activities and processes to be audited
-Time period covered by the audit
Managing Audit Programme
HOW TO CREATE AUDIT PROGRAMME

AUDIT OBJECTIVE

-Determine or evaluate the extent of conformity of the management system to be

audited
-Extent of conformity of the activity
-Capability of the management system
-Areas for potential improvement
Managing Audit Programme
HOW TO CREATE AUDIT PROGRAMME

AUDIT CRITERIA

Audit Criteria are used as reference against which conformity is determined such as:

-Applicable Policy
-Procedure
-Standards
-Legal Requirements
-Management System Requirements
-Sector code of conduct
-Other Planned arrangements
Managing Audit Programme
HOW TO CREATE AUDIT PROGRAMME

AUDIT METHOD

-Conducting Interview
-Conducting document review
-Observation of work performed
-Conducting on-site visit
-Completing checklist
-Sampling
-Analyzing areas
Managing Audit Programme
HOW TO CREATE AUDIT PROGRAMME

SELECTING AUDIT TEAM MEMBERS

-Overall competence of the audit team

-Complexity of the audit scope
-Independence of the audit members
-Ability of audit members to interact effectively with the auditee
-Language of the audit and auditee, social culture, and cultural characteristics
Managing Audit Programme
HOW TO CREATE AUDIT PROGRAMME

CREATION OF AUDIT CHECKLIST

-Identify requirements either organizational procedure or regulatory requirements

-Legal requirements or code
-Standard operating procedures
-And other guideline or reference under the audit scope
Managing Audit Programme
HOW TO CREATE AUDIT PROGRAMME

AUDIT PROGRAMME IMPLEMENTATION

-Approved by the Head of Quality/Department

-Approved by the President or CEO
-Providing necessary resources to the audit teams
-Audit notification to the auditee
-Auditee confirmation and acceptance of the audit programme
Managing Audit Programme
MANAGING AND MAINTAINING AUDIT PROGRAMME RECORDS

Records related to each individual audit:

-Audit Plans and Audit Reports

-Nonconformity reports
-Corrective and preventive action reports
-Audit follow-up reports (as applicable)
-Competency of auditor
Managing Audit Programme
FACTORS TO DETERMINE THE NEED TO MODIFY THE AUDIT PROGRAMME

-Audit findings
-Demonstrate level of management system effectiveness
-Changes to the clients or the auditees management system
-Changes to standards, legal and contractual requirements and other requirements to
which the organization is committed
-Change of supplier
Managing Audit Programme
MANAGING AND MAINTAINING AUDIT PROGRAMME RECORDS

Records related to each individual audit:

-Audit Plans and Audit Reports

-Nonconformity reports
-Corrective and preventive action reports
-Audit follow-up reports (as applicable)
-Competence and performance evaluation of audit team members
-Results and trends from audit programme monitoring
-Alternative or new auditing practices
-Effectiveness of the measures to address the risks
Managing Audit Programme
PROCESS FLOW FOR THE CREATION OF AUDIT PROGRAMME

IDENTIFY THE TYPE OF AUDIT

IDENTIFY THE AUDIT SCOPE

IDENTIFY THE AUDIT CRITERIA

IDENTIFY THE TYPE OF AUDIT OBJECTIVE

IDENTIFY THE TYPE OF AUDIT METHOD

SELECTING OF AUDIT TEAM MEMBER

CREATE AUDIT CHECKLIST

PERFORMING AN AUDIT
PREPARING AN AUDIT PLAN

Audit Plan should cover the following:

-Audit type
-Audit scope
-Audit criteria
-Audit method
-Audit objective
-Location of audit
-Date of audit
-Audit members
-Audit itinerary
-Auditee acceptance
Workshop I
Establishing an Audit Programme, Audit Plan / Notification, Audit Checklist
PERFORMING AN AUDIT
PROCESS FLOW OF TYPICAL AUDIT ACTIVITIES
SENDING OF AUDIT
NOTIFICATION/AUDIT PLAN

AUDIT ENTRY BRIEIFING

AUDIT PROPER

AUDIT EXIT BRIEFING

CREATION OF AUDIT REPORT AND

NON-CONFORMANCE REPORT

DESIMINATION OF AUDIT REPORT

AND NON-CONFORMANCE REPORT

REVIEW OF
CORRECTIVE/PREVENTIVE ACTION

AUDIT FOLLOW-UP

AUDIT CLOSURE
PERFORMING AN AUDIT
OPENING MEETING / AUDIT ENTRY BRIEIFING

Conducting the opening meeting purpose:

-opening remarks of the audit team leader

-Confirm and discuss the agreement of all parties to the audit plan
-Discuss the audit objective, scope, and methodology of the audit
-Introduce the audit team
-Ensure that all planned audit activities can be performed based on the audit itinerary
PERFORMING AN AUDIT
AUDIT PROPER

-The auditee’s relevant documentation should be reviewed to:

a. determine conformity of the system
b. gather information to support the audit activities
-Depending on the audit objective and scope, a decision should be made as to
whether the audit should be continued or suspended until documentation concerns
are resolved
-Perform sampling or records, documents, item, or product to check actual
compliance of procedure or system
-Perform interviews
-Perform observation of activities

NOTE: Always ask permission to the auditee when doing sampling of records, documents, item or product
and when requesting data or pictures as support to the audit
PERFORMING AN AUDIT
QUESTIONING TECHNIQUE

1H & 5Ws

How?
Why?
Why?
Why?
Why?
Why?
PERFORMING AN AUDIT
EXIT MEETING OR EXIT BRIEFING

-Closing remarks of the team leader

-Discuss the result of the audit including possible non-conformance
-Ensure that all non-conformance have proper evidence and reference to show during
the exit meeting
-Ensure that auditee accept and agree to the non-conformance
-Discuss the non-conformity classification and the time frame for proper corrective and
preventive action
GENERATING AUDIT FINDINGS
FINDINGS EVALUATION

-A study of notes and/or comparison of note with the team members

-A review of audit checklist
-Listing of findings together with the audit evidence
-Decisions on non-conformance and/or observation
-The writing or classification of audit findings
-Evaluate audit findings against the audit evidence
GENERATING AUDIT FINDINGS
CLASSIFICATION OF AUDIT FINDINGS

MAJOR
Total breakdown, high risk to safety

MINOR
Could cause potential breakdown,
medium risk to safety

OBSERVATION
Areas for improvement and if not
address may potentially fall to Minor
or Major non-conformance
AUDIT FOLLOW UP
Once a corrective action from auditee was submitted auditor must conform that the
action taken by the auditee is in place:

-Review of corrective action by auditee based from the audit finding

-Review of supporting documents or evidence of corrective action
-Completion of the action taken must be verified on the next audit programme as part
of the audit follow up and verification
Any Questions?