QUALITY AUDIT

INTERNAL AUDIT
TRAINING

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

History of Audit.
Quality Assurance Audit principles come from financial audit
Financial audit have been use for over 300 years.

Surveys and Audits.

Are among the most effective tools used by general
management and quality assurance management.
Give a direct and factual answer to the management
question.
Is what should be done actually done ?
Give management specific instances of system and
implementation deficiencies, so that the cause can be
determined and corrective action can be taken.
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Definition of Survey.
A SURVEY is a documented evaluation of an organizations ability
to perform required activities as verified by determination of the
adequacy of the organizations quality assurance program and by
a review of the implementation of the quality assurance program
or the location of work.

Definition of Audit.
An AUDIT is a systematic, documented examination of the act and
decisions with respect to quality in order to independently verify or
evaluate compliance assurance program or the applicable specification
or contract requirements of the product.

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Features of a Survey.

A survey:
> evaluates a quality assurance program against applicable
requirements
> is broad in scope and requires much judgement
Vendors are surveyed before purchase orders are issued
Survey consists of two parts
> determining that a quality manual and supporting procedures
meet requirements
> determining that the organization follows the quality manual
and supporting procedures.

Requirements for
To
assure compliance with the applicable requirement:
Surveys.

^For qualification of: raw material suppliers

material manufactures and assemblers
supplier of quality related services.
^Performed using checklist
^Performed by qualified surveyors
^Survey report must be accepted by quality assurance management

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Features of an Audit
An audit checks that the requirements of the quality assurance
manual and supporting procedures are implemented
An Audit is black/white, yes/no

Requirement for Audit.

To assure compliance with all aspect of the quality assurance program
^ Planned an periodic
^ Audit schedule required
^ Performed using written checklist
^ Auditors may not have direct responsibility in the area being
audited
^ Corrective action and follow-up audits

Kinds of
^ System audit
audits.

^ Technical audit
^ Follow-up audit
^ Spot in-depth
audit
^/ Tracker
audit CONSULTANT
QUALITY
INDUSTRIAL MANAGEMENT

KASZIEF KASLAN

Internal
Quality
Audits

Operational
Process

OBJECTIVE
Procedures
-existing
-implementation
-effectivity
Management
(procedures)

Internal Q.Audit
-verification
-comparison

Improvement
scheme

Internal Q.Audit
-interview
-documents
-observation

Q.Management Process
Production Process
scope

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

The Audit Triangle

Attribute

PLAN

UA

AD

EQ

Knowledge

CY

Skill

PAPER
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

COMPLIANCE

PRACTICE
KASZIEF KASLAN

Audit are systematic and

independent review.
Purpose of internal audits.

+ to examine if activities and consequent result comply

with the documented procedures and relevant ISO
standard.
+ to examine if the documented procedures have been
implemented effectively
+ to examine if procedures are suitable for achieving
the documented quality objectives
+ to trace and identify possibilities for improvement
of
the production
Final
objective process.

Implementation of measures and actions for

correction and improvement.

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Ingredients of an internal auditing

system
+ team auditors
(staff trained for audits)
+ breakdown of activities
+ audit scheme
* based on breakdown of activities
* full coverage on a yearly basis
+ check lists
aimed at function and/or process
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Breakdown of activities.
1

Activities

Function / Department

x
x

x
x

x
x

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

Primary Responsibility

KASZIEF KASLAN

Checklists.

A checklist is based on questions derived from

+ specific procedures
+ the relevant ISO Standard
+ documented quality objectives.
In general, most questions deal with the following:
+ is there a procedure ?
+ is procedure documented ?
(define procedures, working instructions)
+ is the procedure implemented ?
+ is the procedure effective in relation to the
objectives formulated ?
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Checklist supplement
+ standard checklist
+ study the information received beforehand

Result
+ Observations
+ New checklist (and new issues for special
attention)

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Interviews
What ?
Where .?
When ?
Why ..?
How .?
Who ?
Is there a procedure ?
+ is the procedure documented ?
+ is the procedure implemented ?
+ is the procedure effective in relation to
the objectives formulated
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Interviews
Pay attention to:
+ demonstrability
+ presence of checkpoints
* representative
* flow of information
* statistical techniques
* actions
+ relation customer - supplier
(points of transition in the Q-circle)

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Methodology
+ assemble the audit team
(think independency)
+ training of the team (if necessary)
+ request a coordinator from the department
involved
+ collect information about the subject of
validation (organization chart, responsibilities &
authorities, procedures,process documentation
Q-reports)
+ make a planning for an audit
+ announce the audit to the department
+ arrange a kick-off meeting with the management
involved
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Methodology
During the audit
+ try not to disturb the process as it operates
at the time of the audit
+ for the interview make use of the previously
compiled checklist
+ investigate the issues for special attention
which came up while studying the information
previously received
+ check if the information received is correct
+ finding shall be based on facts
+ do not collect surprises.
inform the department coordinator of your
finding
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Methodology
After the audit.
+ arrange a final meeting with the management
involved and present a summary
+ make an objective report
(summary and detailed observations)
+ discuss the report with the department
management
+ discuss follow-up

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Hint for auditors

* prepare thoroughly
* start with short interview of the department
management
* watch the time schedule
* hear everything, see everything, speak as
little as possible
* motivation of non conformance found must be
base on facts alone
* verify all information received

* no critical remarks
* no arguing, your objective is to diagnose
the problem, not to solve it
* cooperate with the department coordinator
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

* do not make people suspicious;

first explain purpose of the audit and then
ask your questions
* an audit is not a contest - no hunting down if
there is nothing to find
* make sure you plan time for evaluation

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Auditors
Should be:
* trained in auditing
* have knowledge of the job
(applied technique and methods)
* take an interest in auditing
* know how to tell bad news
* have friendly attitude
* have the following qualities:
- flexible in dealing with people
- keen listener
- observant
- analytical
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Auditors
Should not be:
* fond of arguing
* show off your knowledge
* show a lack of enthusiasm
* easy to influence
* jump to hasty conclusions
* credulous

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Perfect Auditor
Positive attitude
Professionalism
Perseverance
Punctual
Pragmatic
Preparedness

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Reporting
1. ORAL
Final meeting:
Summary of findings
2. Written
Findings:
- Summary
- Details

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Executing
a scheduled Audit

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Guideline for Quality System Audit

(Audit Execution)
! Evidence through interview, documents, observations
and work conditions
! Document all audit observations
! Report non-conformance in terms of specific requirements
! Non-conformance must be verified by escort and area
managers
! Questioning techniques (probing, open ended, close ended)
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Guidelines for Quality system Audit

(Audit Planning)
!
!
!
!
!
!
!
!
!
!
!
!

Audit Objectives, Scope, and Standards

Audit Team (Lead auditor, Auditors, Specialist)
Reference documents
Working documents (Checklist, C.A.R)
Audit language
Date and Place
Schedule meeting with management
Organization units to be audited
Time and duration for each audit
Responsible area supervisors
Confidentiality
Report issue date and distribution

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Guidelines for Quality system Audit

(Basic communication principles)
! Focus on the issue, behavior or situation, not
the person
! Maintain the self esteem and self confidence of
others
! Maintain a constructive relationship with everyone
! Take initiative to make thing better
! Lead by example
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Guidelines for Quality system Audit

(Audit Report)
! Scope and objectives
! Audit Plan (team members, auditee rep, date,
department audited)
! Reference documents
! Observation of non-compliance
! Extent of non-compliance
! Summary of strong and weak areas
! Distribution list
Note: Lead auditor is responsible for the reports
accuracy and completeness.
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Guidelines for Quality system Audit

(Corrective action follow-up)
! Corrective action plan by the auditee
! Verify implementation and effectiveness
! Issue new Corrective Action Report (C.A.R) for
unsatisfactory corrective actions
! Apply lessons learnt to other areas
! Highlight any benefits or savings

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Confronting issues
! Explain the problem as you see it
! Describe the impact of the problems on the
performance
! Ask for the other persons view
! Agree on the problem that need to be solved
! Explore and discuss potential solutions
! Agree on what each person will do to resolve
the problems
! Set a follow-up audit
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Line questioning during Management

Interview

! What is your area responsibility

> Response will be compared with management
responsibility in the Quality Manual
> Includes non manufacturing areas
(HRD,Facilities, Store, etc)
> Look for adequacy and commitment
! How do you know your area is functioning as planned ?
> Your feed back loop
> Reviewed how often and with whom
> Follow-up on previous open issues
! Response when thing dont go as planned
> Adequacy of response
> Follow-up and effectiveness of corrective actions
! Supporting records as evidence
! Documented procedures
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

ISO 10011 -1
PART 1 - AUDITING
1.Scope : Establish audit principles, criteria and practices,and provides guidelines
for establishing, planning, carrying out and documenting audits of
quality systems
2.Normative reference
ISO 8402:1986 Quality Vocabulary
3.Definitions
3.1 quality audit:
a systematic and independent examination to determine whether
quality
activities and related result comply with planned arrangements and
and whether these arrangement are implemented effectively and are
suitable to achieve objectives.
ISO 8402
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

4.Audit objectives and responsibilities

4.1. Audit objectives
to determine the conformity & nonconformity
to determine the effectiveness
to provide an opportunity to improve
to meet regulatory requirement
4.2. Roles and responsibilities
4.2.1. auditors
4.2.1.1 audit team
lead auditor should be place
4.2.1.2 auditors responsibilities
complying
communicating
planning and carrying out
documenting
reporting
verifying the effectiveness
retaining and safeguarding
cooperating
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

4.2.1.3 lead auditors responsibilities

assisting
preparation
representing the audit team
submitting the audit report
4.2.1.4 independence
4.2.1.5 auditors activities
define the requirement
comply with applicable auditing requirements
plan the audit
review the documentation
report critical nonconformity
report any major obstacles
report on the audit result clearly
4.2.2 client
determine the need
determine the auditing organization
determine the general scope
receive the audit report
determine what follow up action
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

4.2.3. Auditee inform relevant employees

appoint responsible members
provides all resources
provides access to the facilities
cooperate with the auditors
determine and initiate corrective
5. Auditingaction
5.1 Initiating the audit
5.1.1 Audit scope
5.1.2 audit frequency
5.1.3 preliminary review of quality system
5.2 Preparing the audit
5.2.1 audit plan
identification of individuals
identification of reference documents
identification of the audit team members
the date and place
identification of organization unit to be
audited
the extend time and duration
the schedule of meeting with the auditee
management, confidentiality
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

5.2.2

audit team assignment

5.2.3

working documents
checklist used for evaluating
form for evaluating
form for documenting supporting
evidence
5.3
Executing the audit
5.3.1 Opening meeting
5.3.2 examination
5.3.2.1 collecting evidence
5.3.2.1 audit observation
5.3.3

Closing meeting

5.4
Audit documents
5.4.1 audit report preparation
5.4.2 report content
5.4.3 report distribution
6. Audit completion
5.4.4 record retention
7. Corrective action follow up

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Contoh checklist audit mutu internal

Tinjauan Kontrak (Elamen 4.3)
PT.XXX
1 Apakah telah ada prosedur untuk tinjauan kontrak ?

2 .Bagaimana kegiatan tinjauan kontrak dikoordinasikan ?

3 . Siapa yang diberi kuasa untuk meninjau kontrak ?
Dimana tanggung jawab tersebut didokumentasikan ?
4. Apakah setiap kontrak diperiksa untuk memastikan bahwa:
- semua permintaan didefinisikan dan dicatat
- perbedaan-perbedaan antara permintaan yang terdapat dalam kontrak / order
dengan dalam tender telah diselaesaikan ?
- perusahaan mempunyai kemampuan untuk memenuhi kontrak / permintaan order
5. Bagaimana penyelesaian dilakukan bila permintaan pelanggan tidak terdefinisi
dengan baik ?
6 .Bagaimana perbedaan antara permintaan order dan hal-hal dalam tender
diselesaikan
7 .Bagaimana menentukan apakah perusahaan mempunyai kemampuan untuk memenuhi
kontrak / permintaan order?
8. Apabila perusahaan tidak dapat memenuhi kontrak / permintaan order, apa tindak
lanjutnya?
9. Siapakah yang bewenang mengajukan usul perubahan ?
10.Bagaimana perusahaan menjamin bahwa suatu perubahan terhadap kontrak
disampaikan pada unit-unit kerja terkait ?
11.Apakah arsip-arsip mengenai tinjauan kontrak didokumentasikan dengan baik ?
12.Tipe pencatan apakah yang dilakukan untuk membuktikan bahwa tinjauan kontrak
tekah dilaksanakan ?
13.Bagaimana penyimpananpencatatan dari tinjauan kontrak?
Siapa yang bertanggung jawab menjaga catatan ini ?

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

KASZIEF KASLAN

Tipe-tipe pertanyaan
Tipe pertanyaan
TERBUKA

TERTUTUP/
LANGSUNG

Deskripsi
Pertanyaan terbuka
akan membawa pada
jawaban yang luas
Biasanya digunakan
untuk mengetahui
opini auditee dan
untuk memperoleh
penjelasan dari
auditee.
Pertanyaan tertutup
digunakan untuk
memperoleh jawaban
YA atau TIDAK
Pertanyaan langsung
akan menghasilkan
jawaban pendek yang
terdiri dari satu
atau beberapa kata.
Pertanyaan ini
digunakan untuk
memperoleh informasi
yang lebih spesifik.

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

Contoh
^ bagaimana
intepretasi anda
terhadap hasil yang
diperoleh ?
^ Bagaimana
memperoleh hasil ini?
^ bagaimana anda
menerapkan program
kalibrasi ?
^ Apakah untuk proses
ini ada prosedur yang
terdokumentasi ?
^ Apakah peralatan ini
telah dikalibrasi ?
^Apakah anda
memriksa demensi
demensi yang terukur
terhadap gambar gambar tersebut ?

Keterangan
^Pertanyaan ini mungkin
agak menyulitkan auditee
dalam memberi tanggapan.
^Pertanyaan akan
menghasilkan jawaban yang
umum.

^ Pertanyaan pertanyaan
ini memberikan informasi
yang terbatas. Jika anda
menginginkan jawaban yang
luas,gunakan pertanyaan
terbuka.
^ Hati-hati dengan
intonasi pada saat anda
menggunakan tipe
pertanyaan ini.
^Hindarilah penggunaan
pertanyaan tertutup /
langsung secara berturut
turut
KASZIEF KASLAN

KLARIFIKASI

Merupakan pertanyaan
terbuka,tetapi ditujukan
untuk mendapatkan
informasi lebih lanjut
atau untuk
mengklarifikasi sesuatu

MENUNTUN

Pertanyaan menuntun
sudah menyarankan
suatu jawaban,dimana
jawabantersebut
terkandung secara
implisit dalam
pertanyaan
Pertanyaan-pertanyaan
ini menyebabkan auditee
pasif

INTEROGATIF
/ANTAGONIS
TIK

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

^ Dengan cara apa

tindakan perbaikan
diselesaikan ?
^ Dapatkah anda
memberikan beberapa
contoh untuk hal tersebut
^ Apa yang disebut
dengan memverifikasi
gambar-gambar
^ Anda memeriksa akurasi
peralatan setiap pagi,
bukan ?
^Anda menetapkan bahwa
ukuran sampel anda dianbil
berdasarkan tabel
sampling,bukan ?
^ Setujukah anda bahwa
and tidak memverifikasi
dengan benar data-data
pengujian sesuai dengan
instrusi kerjanya.?

^Jika anda ingin

mendesak auditee untuk
menjawab lebih
pasti,gunakan tipe
pertanyaan ini.
^Hindari penggunaan yang
terlalu sering karena
auditee dapat menganggap
anda tidak mendengarkan
^Tipe pertanyaan ini
harus dihindari karena
dapat memberikan
informasi bias.

^Hindari tipe pertanyaan

ini.

KASZIEF KASLAN

contoh

Jadwal Audit Internal

PT.XXX

AKTIVITAS

DIVISI

Dokumen dan data kontrol

Sekratariat

Pelatihan

HRD

Internal Audit

QA

Kalibrasi

QC

bln
1

bln
2

Bln
3

bln
4

Bln
5

Bln
5

Bln
7

Bln
8

Bln
9

bln
10

Bln
11

Bln
12

Xxx
xxx

Tanggal:

Dibuat oleh:

______________

______________________

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

AUDITOR
UDIB

Xx
xx

MANSUR

Xx
xx

ALI

Xxx
xxx

Tanggal:

________________________

POLAN

Disetujui oleh :

_____________________
KASZIEF KASLAN

Assessment Department:______________________
Nama karyawan

jabatan

1.
2.
3.

Nama karyawa

Jabatan

4
5
6.

Aktifitas
1.
2.
3.

ISO 900.. Requirement

4.
5
6.

audit result on activity

1
2
3
4
5
6
__________________________________________________________________________________________________________
4.1 Management Responsibility.
.
.
.
.
.
.
4.2 Quality system.
.
.
.
.
.
.
4.3 Contract review
.
.
.
.
.
.
4.4 Design control
.
.
.
.
.
.
4.5 Document and data control
.
.
.
.
.
.
4.6 Purchasing
.
.
.
.
.
.
4.7 Control of purchaser supplies product
.
.
.
.
.
.
4.8 Product identification and traceability
.
.
.
.
.
.
4.9 Process Control.
.
.
.
.
.
.
4.10 Inspection and testing
.
.
.
.
.
.
4.11 Control of inspection,measuring,test equipment.
.
.
.
.
.
.
4.12 Inspection and test status.
.
.
.
.
.
.
4.13 Control of nonconforming product.
.
.
.
.
.
.
4.14 Corrective and Preventive action.
.
.
.
.
.
.
4.15 Handling,storage,packaging,preservation and delivery.
.
.
.
.
.
.
4.16 Control of quality records.
.
.
.
.
.
.
4.17 Internal Audit.
.
.
.
.
.
.
4.18 Training.
.
.
.
.
.
.
4.19 Servicing.
.
.
.
.
.
.
4.20 Statistical technique
.
.
.
.
.
.
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT
KASZIEF KASLAN

LAPORAN AUDIT PT.___________________

Laporan ketidak sesuaian.
______________________
Auditor

_______________________
auditee

_______________________
tanggal

_______________________
Divisi/Bagian

_______________________
activitas

________________
Elemen ISO.900..

Katagori temuan

Nonconformity/ Remark

Tanda tangan auditor

No.Laporan:

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

Tanda tangan auditee

KASZIEF KASLAN

Tindakan perbaikan yang akan diambil

auditee

pimpinanunit

Terget penyelesaian

Verifikasi tindakan perbaikan.

Verifikasi

Settled(dng remark/unsettled

auditor

auditee

QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

Tanggal verifikasi
KASZIEF KASLAN

Rangkuman Hasil audit MUTU Internal

PT.___________________
Divisi
Elemen

NC

Divisi
RM

NC

Divisi
RM

NC

Total
RM

NC

RM

1. Management Responsibility
2. Quality system
3. Contract Review
4. Design Control
5.. Document and dta control
6. Purchasing
7. Control of purchaser supplied product
8. Product identification & traceability
9. Process control
10. Inspection and testing
11. Control of inspection measuring & test
equipment
12. Inspection and test status
13. Control of nonconforming product
14. Corrective and preventive action
15. Handling, storage,, packaging,
Preservation and delivery
16. Control of quality records
17. Internal quality audit
18. Training
19. Servicing
20. Statistical technique
Tanggal:
QUALITY / INDUSTRIAL MANAGEMENT CONSULTANT

Dibuat oleh:

)
KASZIEF KASLAN