PT.

XXXXX

Internal Auditor Course on

Quality Management System
 Objectives of Training
At the end of the course you will :
 Understand the application of Quality Management System
 Perform audits and display auditing techniques attributes
 Preparing plan for an internal audit & Developing Internal
Auditor
 Be able to collect and analyze evidence , exercising objectivity,
reporting non-conformance and writing audit reports
 Developing ability to identify and close quality gaps
 Introduction Basic of
Quality Management System
 Quality Management System is Collection
What is QMS……..? Business process to meet customer
requirement.

Business process is a collection of

related, structured activities or tasks by people or
equipment which in a specific sequence produce a
service or product (serves a
particular business goal) for a particular customer
or customers
 Stakeholder/Business Owner Customer
1. Store Primary, Secondary, Logistic

2. Primary Secondary

3. Secondary Warehouse/Store

Example :

In Primary  How to meet Customer Requirement

What is the Business process to follow…….?

 PT. XXXX

Internal Quality Audit

 Chapter 1 What and
why is an, Audit?
In this chapter we will cover:

 Why are audits important

 What are audits and their outputs

 What is the audit process?

 Who is involved in an Internal Audit and what are their

responsibilities?
 What is audit?
Systematic, independent and documented process for obtaining audit
evidence and evaluating it objectively to determine the extent to which the
audit criteria (Set the Policies, Procedures or requirement) are fulfilled.

PRACTICE = POLICY, PROCESS AND PROCEDURE

ISO 9001:2015, under clause

• 9.2 Internal Audit

• 9.2.1 The Organization shall conduct internal audits at planned intervals to

provide information on whether the quality management system (See
attached “Audit Plan”)
 Why are audits important?
Some of the basic reasons for conducting internal Quality management system audits
include:
 Ensuring adherence to the procedures

 Ensuring the effectiveness of the System

 Providing Information for Management Reviews

 Identifying Opportunities for Improvement

 Driving continual Improvement

 To ensure that adequate and complete records are maintained to

demonstrate compliance and system effectiveness

 Types Of audits
Audits can be distinguished into first, second and third-party audits.

First Party audit

Organization audits itself with a focus on risk areas in their processes (Internal quality Audit)

Second Party audit

Organization audits the contractor/supplier with a focus on risks related to the subcontracted
work

Third Party/external audit

Audit by an independent organization (Risk Based Certification)
 National Accreditation
Committee
ISO Certification Bodies
 Glossary of Terminology
Audit findings

Audit findings should be relevant to the audit objectives,

and it is suggested that these are categorized into two
areas:

 Non-conformities (Non Compliance)

 Observations
 Glossary of Terminology
Non-conformities / Non Compliance
 Nonconformity (ISO 9001): “Non-fulfilment of a requirement”

 For non-conformity to exist there has to be a requirement, a failure and

evidence

 Requirements can come from a variety of sources:

 Organization’s processes and operations
 Procedures
 Work Instructions
 Specifications
 Statutory/Legislative requirements
 System Standard
 Glossary of Terminology
The important point here is that they are not just the "wishes" of the auditor.
They must be tangible and not simply imposed by the auditor.

Failure
Clearly there must be a failing or otherwise there is no problem.

Evidence
"Objective Evidence" must be obtained.

NOTE: Objective evidence may be obtained through observation, measurement,

test, or other means.
 Glossary of Terminology
Observation

Observations can be:

 Potential problems

 Risks

 Inefficiencies

 Ineffectiveness

 Failure to apply best practice

 Misunderstandings
 Glossary of Terminology
Auditee Acknowledgement
ISO 19011 advises that nonconformities should be reviewed with an appropriate auditee
representative to obtain acknowledgement of the audit evidence and that every attempt should be
made to resolve any divergence of opinion concerning the audit evidence and/or findings.
Unresolved points should be recorded.

In practical terms this usually requires the relevant manager to “sign” or acknowledge the
nonconformity.

If all nonconformities are clear statements of requirement, failing and evidence, there should not
be a problem in obtaining their acknowledgement. Wherever possible it is good practice to obtain
this acknowledgement prior to attending the closing meeting.

To leave acknowledgement to the closing meeting could seriously protract the meeting. It is not
the place to be debating the validity or acceptance of nonconformities. If the nonconformities are
acknowledged prior to the meeting the potential for discussion, disagreement and argument is
reduced, thereby reducing the pressures and stress on the auditor.
What is the Audit Process
 Chapter 2 Plan an Audit
In this chapter we will cover:

 What needs to be considered when planning?

 What should be included in an audit plan

 How do you prepare a checklist?

Audit Plan
The audit planning process
There are four main stages in
planning an internal audit:

 Initiate

 Research

 Prepare Plan

 Communicate
 Audit Plan
The audit plan should include information on:

 Audit Objectives and Scope

 Audit Criteria
 Reference Documents (e.g. procedures / permits)
 Developing the Working Documents
 Audit team members

It is important to communicate your plan in advance of the audit. This should

include communicating to the rest of the audit team, the department or company
management and the auditee.

This is to ensure that everyone is available and any necessary preparations can be
made such as logistical arrangements, entrance to site, security clearance etc.
 Audit Plan
Personal preparation
Having prepared the plan for the audit, each auditor should also consider their personal
preparation.

One example is to use a checklist. The advantages of checklists are:

1. They focus the auditor

2. Ensure issues are not forgotten
3. Aid consistency
4. Assist with reporting
5. Help with time keeping

It is important not to use this as your only guide when auditing, if a checklist is relied
upon you can become blinkered and not notice other important issues which may arise.
Chapter 3 Conduct an Audit
In this chapter we will cover:

1. Manage an opening meeting

2. Understand elements of verbal and non-verbal communication

3. Conduct an Internal Audit

Conduct Audit
 Conduct Audit
Opening Meeting
The opening meeting should include:

a) Introductions

b) Confirmation of audit objectives, scope and criteria

c) Confirmation of focus areas

d) Review of the audit plan,

e) Agree meeting times and attendees

f) Method of reporting
 Conduct Audit-Guidelines
Obtaining the Information
There are a number of ways in which information can be
obtained:

 Interviewing people
 Examining documents, including records
 Observing activities and conditions
 Conduct Audit-Guidelines
Interviewing People
Constructive and correct use of questioning is used to gather information and confirm or clarify
findings

Examining Documents
When examining documents, auditors must decide which samples to select. Ideally an audition
should attempt to gain a representative sample of how the EMS is operating.

Observe Activities and Conditions

Another question favored by auditors is "Show me...."
Here the auditor is given the chance to observe the actual performance of an activity, but be
aware that the act of observing can sometimes alter the way in which a person undertakes the
activity.
If nervous, the auditee may forget to perform a part of the activity because they are being
observed and are feeling under pressure.
In such a situation the auditor needs to determine whether the person genuinely forgot or
whether they were not aware of what had to be done.
 Conduct Audit
Communication Rules:

The sender is responsible for accurate communication It is not important what A says,
but what B understands
You cannot not communicate

Rapport
A good rapport can be built through reaction and similarity in:
 Voice
 Language
 Appearance/clothing
 Gesture
 Posture
 Expression

“Build rapport by mirroring!”

 Conduct Audit-Guidelines
How much evidence should be collected?

The level of sampling performed must be balanced against the risk of errors occurring and
their level of importance. Where there is a need to confirm compliance with controls in a
critical environmental area (e.g. legal compliance issues), then the sample size should be
greater.

Select what you believe to be a representative sample and review it. If the sample indicates
that there is not a problem, don't waste time hunting through more and more samples in the
hope that you will eventually find an error. This can be a waste of time and unfair to the
auditee.

If your sample uncovers a problem, you should take a few more samples to determine
whether the problem is isolated or more widespread.
 Conduct Audit-Guidelines
Taking Notes

One of the key difficulties an auditor faces is holding effective and fluid interviews whilst also
taking meaningful notes and completing checklists. It is important not to disrupt an otherwise
normal conversation by repeatedly pausing to take copious notes.

You should make notes:

 To record objective evidence for later reporting. Record all the necessary facts in your notes to
enable a finding to be prepared later, and then move on to the next aspect of the audit
 If you need to follow up an audit trail with another individual or individuals. An aide memoir of
the key issues will be required to facilitate an effective follow-up
 Of the samples of records you selected for review
 To confirm that an area has been audited and the results were satisfactory
 Of procedure /work instruction references if not already identified on audit plans or checklists
 Conduct Audit-Guidelines
Handling Nonconformities

It is vital that auditors, on discovering non-conformity, act in a professional manner.

The auditees must always be given the opportunity to put their points of view, and it is
possible that the auditor may not have the correct facts. There may also be mitigating
circumstances as to why a particular situation arose, but this should not sway the
auditor from raising non-conformity.

If a guide is present the auditor should ensure they understand that a nonconformity
has been found and seek their acknowledgement of the situation.
 Conduct Audit-Guidelines
Handling Nonconformities

All the necessary information for the preparation of a formal nonconformity note should
be collected and recorded in the auditor’s notes to enable you to produce your findings.

When you have completed your investigations in an area always thank the people you
have met before you leave.
Chapter 4 Audit Reporting and Follow Up
In this chapter we will cover:

 Prepare a report of the audit including focus areas

 Communicate the audit results effectively
 Manage a closing meeting
Audit Reporting and Follow Up
 Audit Report
The report should contain:
 Scope and objectives of the audit
 Dates of the audit
 Identity of audit team members
 Details of any nonconformities raised
 Feedback on control of Focus/Risk Areas
 Details of observations related to potential nonconformities or aspects which the auditor
considers may benefit from further clarification

It should be written with the recipient in mind and mention any strength observed as well as
weaknesses and information about any obstacles encountered.

Where a formal copy of the audit report is required following an audit this should be issued as
soon as possible, within an agreed timescale.
 Audit Reporting and Follow Up
The closing meeting

“Golden Rules:”
 Prepare properly
 No surprises
 Start on a positive note
 Present and discuss all findings
 Be systematic in presentation of findings
 Remember that your audience are also your colleagues or customers
 Generate understanding
• Link the findings to the company’s business goals and priorities higher risk points
 Beware! The management team will be ready to dispute the non conformities
 Listen to your audience
 Thank everybody involved
 Audit Reporting and Follow Up
Follow-up
"Follow-up" is the term ascribed to the actions of verification and assessment of the
effectiveness of corrective, preventive and/or improvement actions resulting from an audit.
This essentially entails the Auditor or Management Representative in:

 Verifying the implementation and effectiveness of agreed actions

 Closure of audit findings where agreed actions are verified as implemented and effective

 Escalation of situations where required actions are not implemented or effective

 Audit Reporting and Follow Up
Follow-up
Follow up may be performed through a complete or partial re- audit, depending on the importance
and significance of the issue being looked at. If significant re-audit activity is required, adequate
preparation and planning as described in this manual may be necessary.

In most cases follow-up activities will be limited to assessment of the newly available objective
evidence. This may simply require an evaluation of one or more of the following:
 Revised documents
 Corrected records
 Recalibrated or repaired monitoring equipment
 Retrained personnel
 Changes to procedures, processes, services or operations
 Audit Reporting and Follow Up
Follow-up

Where it is found that defined action has been successfully implemented and is effective in
achieving the desired result, follow up records should indicate this together with the date of
completion. At this point the issue is usually considered to be closed.

Where required action has either not been implemented or is ineffective, this must also be
recorded. In such cases a copy of the finding and a brief synopsis of the situation should be
escalated to higher Management for further action.
THANK YOU