Kursus audit kualiti dalaman iso 9001 2008

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KURSUS AUDIT KUALITI
DALAMAN
MS ISO 9001:2008
oleh
Muhamad Bustaman b. Abdul Manaf
(Pensyarah Cemerlang DG 54)
Institut Aminuddin Baki, KPM
0199890524/mbustaman@iab.edu.my
mbustaman@iab.edu.my

Taklimat Kursus
• Pengenalan Diri • Jadual Kursus dan
Kandungan Kursus
• Peraturan Semasa
Berkursus
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BIODATA
FASILITATOR
MUHAMAD BUSTAMAN BIN HAJI ABDUL MANAF
Pensyarah Cemerlang DG 54, Instutut Aminuddin Baki, KPM
A. Pengalaman: Pengurus kursus Pengurusan Strategik dan Pengurusan Kualiti di Institut Aminuddin
Baki semenjak 1995.
1. Buku: 1. Pengurusan Kualiti dalam pendidikan 2. Perancangan Strategik
B. Latihan Profesionalisme dalam bidang Pengurusan Strategik dan Pengurusan Kualiti:
Latihan Luar Negara:
i. Strategic Management & Leadership Skills: World Trade Institute, New York, USA (1996)
ii. Quality (TQM) in Education: SEAMEO Innotech, Manila (1998)
iii. Strategic Planning in Education: University of York, England (2000- 2004)
iv. Strategy Performance Measurement Systems: U of Adelaide, Australia (2005)
C. Mempunyai sijil profesional Juruaudit (Lead Auditor) ISO 9000 sejak 1997 dan Sijil Kejurulatihan MS
ISO 9000 dari MAMPU.
Berpengalaman menjadi juruaudit bersama dengan MAMPU serta memberi konsultasi dalam
pembinaan dokumen kualiti dan Audit Kualiti Dalaman .
D. Bidang kepakaran lain: Change Management, Benchmarking, Balanced Scorecard (KPI), Strategic
Leadership Skills, Leadership Coaching, Strategic Thinking Skills & Personal Balanced Scorecard.
E. Ahli panel Sistem Star Rating KPM 2008 & Ketua Pasukan 2010.
F. Timbalan Wakil Pengurusan Ssitem Pengurusan Kualiti MS ISO 9000 IAB.

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OBJEKTIF UTAMA
• Untuk melengkapkan peserta
dengan pengetahuan dan
kemahiran yang diperlukan untuk
melaksanakan audit kualiti
dalaman ke atas pelaksanaan
sistem pengurusan kualiti MS ISO
9001:2008 dengan berasaskan
Standard Management System
Auditing ISO 19011:2002.

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TOPIK YANG DILIPUTI
• Bahagian 1:
• Pengenalan Pengurusan Kualiti ,
Standard Sistem Kualiti MS ISO
9001:2008 & faedah kepada
organisasi
• Model Sistem Pengurusan
• Amalan 8 prinsip kualiti dalam
kerja seharian

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TOPIK YANG DILIPUTI
• Bahagian 2: Keperluan Standard
MS ISO 9001:2008.
• Bahagian 3: Dokumentasi Sistem
Pengurusan Kualiti (SPK).
• Struktur Dokumentasi
• Kawalan Dokumentasi SPK

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TOPIK YANG DILIPUTI
Bahagian 4: Pengenalan Audit
• Definisi dan Jenis Audit
• Prinsip Audit
• Tanggungjawab Juruaudit
• Kelayakan Juruaudit
• Garis Panduan ISO 19011

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TOPIK YANG DILIPUTI
• Bahagian 5: Proses Audit Kualiti
Dalaman
• Fasa 1: Perancangan Audit
• Fasa 2: Pelaksanaan Audit
• Fasa 3: Pelaporan Audit
• Bahagian Amali:
• 1. Amali Audit
• 2. Amali Pelaporan

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Jadual Kursus
• Hari Pertama: Selasa
• 8.00 – 8.30 : Taklimat
• 8.30- 10.00: Pengenalan Kursus dan
Bahagian 1
• 10.00-10.30: Kudapan pagi
• 10.30 – 12.45: Sambungan Bahagian 1
• 2.15 - 4.45: Bahagian 2-Std ISO
9001:2008

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Jadual Kursus
• Hari Kedua: Rabu
• 8.15 - 10.00: Bhg: 2 & 3- Std & Dokumentasi
• 10.30 – 12.45: Bhg: 2 & 3- Std & Dokumentasi
• 12.45-2.15: Makan tengahari & rehat
• 2.15 - 4.45: Bhg 4: Pengenalan Audit & Perancangan
audit

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Jadual Kursus
• Hari Ketiga: Khamis
• 8.15 - 10.00: Bhg 5: Perancangan audit dan pelaksanaan
audit.
• 10.30 – 12.45: Bhg 5: Pelaksanaan dan pelaporan Audit
• 1.00-2.00: Makan tengahari & rehat
• 2.00 - 4.30 ptg: Amali Pelaksanaan Audit
• 4.30 ptg dan seterusnya: persiapan pelaporan audit.

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Jadual Kursus
• Hari Keempat: Jumaat
• 8.30- 10.00: Amali Latihan Pelaporan Audit
• 10.30 – 12.15: Rumusan, Peperiksaan Audit, Penilaian
Kursus & Penutupan Kursus

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Bahagian 1
• Definisi Kualiti
• Pengenalan Pengurusan
Kualiti & Standard Sistem
Kualiti ISO 9001:2008
• 8 prinsip kualiti
• Model Sistem Pengurusan
Kualiti
• Faedah Melaksanakan
MS ISO 9000

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Apakah itu Kualiti?
1. Fit for purpose (Juran).
2. Quality is conformance to requirements
(Philip Crosby)
3. Keupayaan sesuatu barang/perkhidmatan
yang mempunyai ciri-ciri kemampuan untuk
memenuhi sesuatu kehendak.
(Shewhart)

Definisi Kualiti –ISO 9000
“ darjah dimana sekumpulan sifat produk atau
perkhidmatan yang wujud memenuhi
keperluan-keperluan” (3.1.1)
Sifat (3.5.1) bermaksud ciri-ciri yang mebezakan sesuatu
samada sedia wujud yang atau diberikan, kualitatif
atau kuantitatif atau jumlah yang banyak dan terdapat
banyak kelas sifat seperti fizikal, deria, kelakuan,batas
waktu, ergonomic dan fungsian.
Keperluan (3.1.2) adalah amalan yang biasa digunakan
oleh syarikat, pelanggannya dan atau pihak yang
berminat.

APA ITU KUALITI
Keupayaan sesuatu produk
atau perkhidmatan memenuhi
kepuasan pelanggan
(pihak berkepentingan)
24Hak Milik MBAM@IAB KPM 09

Pengertian Kualiti : lima pendekatan
• Menyamakan kualiti
sebagai keunggulan
atau kecemerlangan.
Dengan itu kualiti tidak dapat
ditentukan tetapi boleh dirasai
atau dinikmati hanya melalui
pengalaman. Misalnya,
kenyataan yang berbunyi ”
Saya tahu kualiti bila saya
melihatnya/merasainya”.
Hak Milik MBAM@IAB KPM 09 25

Pengertian Kualiti : pendekatan 2
• Berdasarkan kepada keluaran, kualiti dilihat sebagai
mempunyai ciri-ciri tertentu yang boleh diukur. Ciri-
ciri ini adalah ketahanan, boleh diharap, rupa bentuk
dan keselamatan. Pendekatan ini membawa
implikasi bahawa semakin banyak ciri ini dirangkumi
dalam satu keluaran, kos pengeluaran akan
meningkat.

Pengertian Kualiti: pendekatan 3
• Berdasarkan
pandangan pengguna
• “quality lies in the eye of the
beholder.”
• Tiap-tiap pengguna mempunyai
kehendak yang berbeza-beza dan mana-
mana keluaran atau perkhidmatan yang
memenuhi kehendak ini akan dianggap
sebagai berkualiti.
Hak Milik MBAM@IAB KPM 09
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• Berdasarkan kepada
nilai, kualiti dilihat dari
segi kos dan harga.
• Keluaran atau perkhidmatan yang
berkualiti dilihat dari segi keperluan
memenuhi kehendak pengguna dengan
harga yang boleh diterima oleh mereka.
Hak Milik MBAM@IAB KPM 09 28
Pengertian Kualiti :
pendekatan 4

• Berdasarkan
kepada pandangan
sektor pembuatan,
• kualiti diertikan sebagai
memenuhi kehendak atau
spesifikasi yang telah
ditentukan.
pendekatan 3

• Bagi sektor
swasta, daya persaingan
akan ditentukan oleh
kehendak dan cita rasa
pengguna.
• Dalam konteks
perkhidmatan
awam, kualiti diertikan
sebagai dapat Hak Milik MBAM@IAB KPM 09 30
pendekatan 5

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Kesimpulan: Definisi
The experts and gurus have various
definitions…. But they all add up to the
same thing:
“ Meeting the customer’s
requirement”

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Quality Process Measures

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INPUT OUTPUTPROSES
P
D
C
A
@ OUTCOME
1. Kecekapan
3. Kepastian kualiti
4. Inovasi
5. Quality of work life
2. Keberkesanan
6. Produktiviti
7. Budgetability
7 Kriteria Prestasi (Sink & Tuttle Model, 1989)

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SEJARAH MENGENAI ISO
• ISO atau International Organisation For
Standardisation- organisasi antarabangsa
bukan kerajaan dengan keahlian lebih 170
buah negara.
• “In 1946, delegates from 25 countries met in London and
decided to create a new international organization, of which
the object would be "to facilitate the international coordination
and unification of industrial standards".
• Badan ISO, rasmi beroperasi 23 February
1947, in Geneva, Switzerland

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Latarbelakang ISO
• Because "International Organization for
Standardization" would have different acronyms in
different languages ("IOS" in English, "OIN" in
French for Organisation internationale de
normalisation), its founders decided to give it also a
short, all-purpose name”.
• “They choose "ISO", derived from the Greek
isos, meaning "equal". Whatever the
country, whatever the language, the short
form of the organization's name is always
ISO”.

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INTERNATIONAL ORGANISATION FOR
STANDARDISATION (IOS)
1. Tujuan:
“untuk mempromosi pembangunan standard .... untuk
memajukan kerjasama di kalangan negara ahli dalam
bidang saintifik, ekonomi dan teknologi”
2. Fungsi Utama IOS
• Menghasilkan siri standard yang boleh diguna pakai
dalam semua jenis industri/perkhidmatan di pelbagai
negara
• Jenis standard: simbol, kod, sukatan, saiz dan
kelajuan.

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Apa itu ISO 9000?
ISO 9000, adalah satu standard bertulis
yang menetapkan dan menerangkan
elemen keperluan asas yang perlu ada
dalam SISTEM KUALITI bagi
memastikan perkhidmatan diberikan oleh
sesebuah organisasi dapat memenuhi
kehendak pelanggan.

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ISO
• Sistem Pengurusan Kualiti : Berasaskan
dokumentasi. “Document what you do, do
what you document and prove it”
• Bukan standard atau perkhidmatan: Konsep
pencegahan
• Berasaskan kepada prinsip kepastian kualiti :
Konsep kualiti yang universal dan
dikenal pasti melalui pengiktirafan oleh pihak
ketiga

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ISO...
1.„Say what you do‟- mendokumenkan prosedur
pelaksanaan proses kerja yang memberi kesan kepada
kualiti produk atau perkhidmatan.
2.„Do what you say‟- melaksanakan aktiviti kerja
sebagaimana dinyatakan dalam prosedur
3.„Record what is done‟ - senggara rekod aktiviti sebagai
bukti pematuhan kepada apa yang didokumenkan.
4.„Improve, based on results‟- perbandingan antara apa
yang sebenarnya dilakukan dengan apa yang dirancang.
Maklumat tersebut boleh membantu sebarang kekurangan
kepada sistem kualiti

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Versi Standard
Standard Pertama: 1987
Standard Kedua: 1994 (IAB bermula-
dengan MAMPU)
Standard Ketiga: 2000 (MOODY INT‟)
Standard keempat: 2008- versi terkini

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PRINSIP ASAS ISO 9000
Prinsip Pertama: ISO 9000 adalah
standard bagi sistem kualiti.
Prinsip Kedua: ISO 9000 berasaskan kepada
dokumentasi
Prinsip Ketiga: ISO 9000 menekankan
pencegahan
Prinsip Keempat: ISO 9000 adalah satu
standard universal.

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EMPAT STANDARD MS ISO
9000:2008
1. MS ISO 9000:2008 QMS – Fundamentals
and Vocabulary
2. MS ISO 9001:2008 QMS – Requirements
3. MS ISO 9004:2008 QMS – Guidance for
Performance Improvement
4. MS ISO 19011: Guidelines on Quality and
Environmental Auditing

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BENGKEL
• Bincangkan faedah-faedah
penggunaan standard dalam
meningkatkan prestasi kerja
organisasi?
• Masa : 10 minit
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Why Standards Matter?
Standards make an enormous and positive
contribution to most aspects of our lives.
• Standards ensure desirable characteristics of products and services such as
quality, environmental friendliness, safety, reliability, efficiency and
interchangeability - and at an economical cost.
• When products and services meet our expectations, we tend to take this for
granted and be unaware of the role of standards. However, when standards
are absent, we soon notice. We soon care when products turn out to be of
poor quality, do not fit, are incompatible with equipment that we already
have, are unreliable or dangerous.
• When products, systems, machinery and devices work well and safely, it is
often because they meet standards. And the organization responsible for
many thousands of the standards which benefit the world is ISO.
When standards are absent, we soon notice.

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Standard merangkumi
bidang berikut
• Manufacturing, processing, servicing, printing, forestry, ele
ctronics, steel, computing, legal services, financial
services, accounting, trucking, banking, retailing, drilling, re
cycling, aerospace, construction, exploration, textiles, phar
maceuticals, oil and gas, pulp dan paper, petrochemicals
publisching, shipping, energy, telecommunications, plastics,
metals, research, health care, hospitality, utilities, pest
control, aviation, machine tools, food
processing, agriculture, government, education, recreati
on, fabrication, sanitation, software development, consumer
products, transportation, design, instumentation, tourism, co
mmunications, biotechnology, chemicals, engineering, farmi
ng, entertainment, horticulture, consulting, insurance, and
so on.

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What standards do
ISO standards:
• make the development, manufacturing and supply of
products and services more efficient, safer and cleaner
• facilitate trade between countries and make it fairer
• provide governments with a technical base for
health, safety and environmental legislation, and
conformity assessment
• share technological advances and good management
practice
• disseminate innovation
• safeguard consumers, and users in general, of products
and services
• make life simpler by providing solutions to common
problems

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Examples of the benefits
standards provide
• Standardization of screw threads helps to keep
chairs, children's bicycles and aircraft together and solves
the repair and maintenance problems caused by a lack of
standardization that were once a major headache for
manufacturers and product users.
• Standards establishing an international consensus on
terminology make technology transfer easier and safer.
They are an important stage in the advancement of new
technologies and dissemination of innovation.
• Without the standardized dimensions of freight
containers, international trade would be slower and more
expensive.

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Examples of the benefits standards
provide
• Without the standardization of telephone and banking
cards, life would be more complicated.
• A lack of standardization may even affect the quality of life
itself: for the disabled, for example, when they are barred
access to consumer products, public transport and buildings
because the dimensions of wheel-chairs and entrances are
not standardized.
• Standardized symbols provide danger warnings and
information across linguistic frontiers.
• Consensus on grades of various materials gives a common
reference for suppliers and clients in business dealings.

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standards provide
• Consensus on grades of various materials gives a common
reference for suppliers and clients in business dealings.
• Agreement on a sufficient number of variations of a product
to meet most current applications allows economies of
scale with cost benefits for both producers and consumers.
An example is the standardization of paper sizes.
• Standardization of performance or safety requirements of
diverse equipment makes sure that users' needs are met
while allowing individual manufacturers the freedom to design
their own solution on how to meet those needs.
• Standardized computer protocols allow products from
different vendors to "talk" to each other.
• Standardized documents speed up the transit of goods, or
identify sensitive or dangerous cargoes that may be handled
by people speaking different languages.

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standards provide
• Standardization of connections and interfaces of all types
ensures the compatibility of equipment of diverse origins
and the interoperability of different technologies.
• Agreement on test methods allows meaningful
comparisons of products, or plays an important part in
controlling pollution - whether by noise, vibration or
emissions.
• Safety standards for machinery protect people at work, at
play, at sea... and at the dentist's.
• Without the international agreement contained in ISO
standards on metric quantities and units, shopping and
trade would be haphazard, science would be unscientific
and technological development would be handicapped.

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Take 5!

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Dalam Standard versi 2008, ia
berlandaskan kepada amalan
lapan prinsip kualiti
8
PRINSIP
KUALITI

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Prinsip Pertama:
Bermatlamatkan Pelanggan
• Organisasi bergantung kepada pelanggan mereka.
Oleh itu organisasi hendaklah memahami keperluan pelanggan yang
sedia ada dan pada masa akan datang, memenuhi keperluan pelanggan
dan berusaha untuk melebihi jangkaan pelanggan.
Faedah Utama
• Pemahaman menyeluruh organisasi terhadap keperluan dan jangkaan
pelanggan dan stakeholder
• Matlamat dan sasaran prestasi yang ditetapkan mestilah berkaitan
dengan memenuhi keperluan pelanggan.
• Peningkatan prestasi organisasi (perubahan) mestilah berasaskan untuk
memenuhi keperluan pelanggan.
• Memastikan sumber manusia mempunyai pengetahuan dan kemahiran
yang diperlukan untuk memenuhi keperluan pelanggan.

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Prinsip Kedua: Kepimpinan
Ketua organisasi (PIHAK PENGURUSAN) bertanggungjawab:
• mewujudkan halatuju dan matlamat organisasi dengan
jelas.
• mewujudkan dan mengekalkan persekitaran dalaman yang
sesuai untuk stafnya supaya mereka dapat terlibat
sepenuhnya dalam mencapai objektif-objektif organisasi
yang telah ditetapkan bersama.
Faedah Utama
• Staf akan lebih faham dan bermotivasi ke arah pencapaian
objektif dan matlamat.
• Aktiviti akan dinilai, diperkemas dan dilaksanakan dengan
cara yang lebih bersatu.
• Kepimpinan melalui teladan, menggalakkan
penambahbaikan yang berterusan.

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Prinsip Ketiga: Penglibatan Staf
(kerja berpasukan)
Staf atau pekerja di semua peringkat adalah
merupakan tunggak sesebuah organisasi dan
penglibatan mereka sepenuhnya membolehkan
keupayaan mereka digunakan untuk faedah-
faedah organisasi.
Faedah Utama
• Pekerja yang bermotivasi, komited dan terlibat.
• Pekerja merasakan lebih bertanggungjawab atas
prestasi masing-masing.
• Pekerja lebih seronok untuk terlibat dan
menyumbang kepada penambahbaikan.

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Prinsip Keempat: Pendekatan
Proses
Hasil yang dikehendaki dapat diperolehi dengan
lebih efisien apabila sumber-sumber dan aktiviti
yang berkaitan diurus sebagai suatu proses.
Faedah Utama
• Keupayaan mengurangkan kos dan memendekkan
cycle times melalui penggunaan sumber-sumber.
• Hasil yang bertambah baik, konsisten dan boleh
jangka.
• Membolehkan peluang-peluang penambahbaikan
diberi keutamaan dan fokus.

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Prinsip Kelima: Pendekatan
Sistem Untuk Pengurusan
Dengan mengenal pasti, memahami dan
menguruskan sesuatu sistem untuk proses-proses
yang berhubung kait bagi sesuatu objektif, ia dapat
menambahkan kecekapan dan keberkesanan
sesebuah organisasi.
Faedah Utama
• Memperkemaskan proses-proses yang akan
menyumbang kepada hasil yang diperlukan.
• Keupayaan untuk fokus kepada usaha proses-
proses
• Memberikan keyakinan kepada pihak yang
berkepentingan terhadap keberkesanan dan
kecekapan organisasi.

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Prinsip Keenam: Peningkatan
Berterusan
• Peningkatan berterusan hendaklah
dijadikan sebagai objektif tetap sesuatu
organisasi.
Faedah Utama
• Peningkatan kelebihan persaingan boleh
menyumbang kepada penambahbaikan
keupayaan organisasi.
• Keupayaan bertindak balas dengan cekap
kepada peluang-peluang.

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Prinsip Ketujuh: Pendekatan Berfakta
Dalam Membuat Keputusan
• Keputusan yang efektif dibuat berdasarkan analisa
sesuatu data/maklumat.
Faedah Utama
• Keputusan yang lebih jelas
• Keupayaan untuk mempamerkan keberkesanan
keputusan yang lalu melalui rujukan kepada fakta-
fakta sejarah.
• Keupayaan untuk mengkaji semula dan
merangsang ke arah penyemakan semula
keputusan dan pandangan.

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Prinsip Kelapan: Hubungan yang Saling
Bermanfaat Dengan Pembekal
Sesuatu organisasi dan pembekal-pembekalnya
adalah saling bergantung antara satu sama lain
dan hubungan yang saling bermanfaat dapat
mempertingkatkan keupayaan yang
menguntungkan kedua-dua pihak.
Faedah Utama
• Meningkatkan keupayaan untuk mewujudkan nilai bagi
kedua-dua pihak
• Fleksibel dan pantas bertindak ke atas maklum balas
bersama terhadap pasaran yang berubah-ubah.
• Mengoptimumkan kos dan sumber-sumber.

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Rehat!

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KEPERLUAN-
KEPERLUAN SISTEM
PENGURUSAN
KUALITI STANDARD
MS ISO 9001: 2008
Bahagian 2

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Std MS ISO 9001: 2008 SPK
Standard yang menjadi asas bagi….
• Keperluan yang mesti dipatuhi
• Keperluan asas bagi membentuk sistem kualiti
• Persijilan. Asas penilaian oleh badan persijilan.
• Standard yang menjelaskan keperluan SPK bagi
tujuan menilai kemampuan organisasi memenuhi
kehendak pelanggan.
• Standard adalah anjal

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Penambahbaikan Berterusan Sistem
Pengurusan Kualiti (PDCA)
PELANGGAN
&
STAKE-
HOLDERS
KEPERLUAN
TANGGUNGJAWAB
PENGURUSAN
ATASAN (5.0)
PENGURUSAN
SUMBER (6.0)
PENGUKURAN,
ANALISIS &
PENAMBAHBAIKAN (8.0)
PENZAHIRAN
PRODUK
(7.0)
(Product Realization)
PELANGGAN
&
STAKE-
HOLDERS
BERPUAS-
HATI
PRODUK
INPUT OUTPUT
Aktiviti Penambahan Nilai
Aliran informasi
4.0
Model Proses Sistem Pengurusan

Keperluan MS ISO 9001:2008
dibahagikan kepada lima seksyen:
Seksyen
4
Sistem Pengurusan
Kualiti
Pemahaman mengenai proses dan
dokumentasi
Seksyen
5
Tanggungjawab
Pengurusan
Pengurusan dan isu pentadbiran
Seksyen
6
Pengurusan sumber Mengenai sumber kewangan,
manusia, peralatan dan persekitaran
kerja
Seksyen
7
Proses penyampaian
perkhidmatan.
Keperluan proses dan proses yang
diperlukan bagi mengubah input
kepada produk
Seksyen
8
Pengukuran, Analisis
dan Penambahbaikan
Mengenai isu seperti pengukuran
produk/perkhidmatan, pemantauan
sistem dan proses penambahbaikan.

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Struktur Kandungan Standard
Terbahagi Kepada 8 Para
0. Pengenalan
1. Skop
2. Rujukan Nomatif
3.Terminologi dan definisi
4.Sistem pengurusan kualiti
0.1 Am
0.2 Pendekatan proses
0.3 Hubung kait dengan ISO
9004.
0.4. Kompatibiliti dengan sistem
pengurusan lain
1.1 Am
1.2 Applikasi

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Clause 4.1 Quality Management
System (General Requirements)
Organization shall establish, document, implement, maintain
and continually improve quality management system. Steps
required are:
- Identify processes for QMS;
- Determine sequence and interaction of these processes;
- Determine criteria and methods for effective operation and
control;
- Ensure availability of information to support effective
operation and monitoring of processes;
- Measure, monitor, analyze processes and implement action
to achieve planned result and continual improvement.

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4.2 Documentation Requirements
4.2.1 General documentation
requirements
Extent of QMS dependent upon:
(a) Size and type of organization
(b) Complexity and interaction of
processes
(c) Competence of personnel
QMS shall include :
(a) Documented procedures required
by the standard
(b) Documentation required by
organization for ensuring effective operation and
control of its processes

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Clause 4.2.2
Quality Manual shall include :
- Scope of quality management system
(including justification for any
exclusions);
- Description of sequence and interaction of
processes in the QMS;
- Documented procedures or reference

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Clause 4.2.3 Control of documents
Quality records considered as documents but different requirements
specified for quality records.
Control of documents “required by the quality management system”
Control shall cover :
- approved prior to issue
- reviewed, updated as necessary and reapproved
- current revision status of documents identified
- relevant versions of applicable documents at all points of use
- legible, readily identifiable and retrievable
- documents of external origin given identification and distribution
controlled
- obsolete documents to prevent unintended use and suitably
identified if retained

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Clause 4.2.4
Control of Quality records
Control shall cover “records required by the quality
management system”;
Records maintained to provide evidence of
conformance and effective operation of the quality
management system;
Requirements include : identification, storage,
retrieval, protection, retention time and disposition

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Clause 5 Management Responsibility
Clause 5.1 Management Commitment
Top management shall provide evidence of commitment
by :
- Communicating importance of meeting
customer and legal/regulatory requirements
- Establishing quality policy and objectives
- Conducting management reviews
- Ensuring availability of necessary
resources

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Clause 5.2 Customer focus
Top management shall ensure
customer needs and expectations
are determined and converted into
requirements and fulfilled with aim
of achieving customer satisfaction

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Clause 5.3 Quality Policy
Top management shall ensure that the quality policy:
- Is appropriate to the purpose of the organization
- Includes commitment to meeting requirements and
continual improvement
- Provides framework for establishing and reviewing
quality objectives
- Is communicated and understood at relevant levels in
the organization
- Is reviewed for continuing suitability
Quality policy shall be controlled

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Clause 5.4 Planning
Clause 5.4.1 Quality objectives
Top management shall ensure that quality
objectives:
- are established at relevant functions and
levels
- are measurable and consistent with QP
(including commitment to continual
improvement)
- include objectives needed to meet
requirements of product

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Clause 5.4.2 Quality Planning
- Top management shall
ensure that resources needed
to achieve quality objectives
are identified and planned
- Output of planning shall be
documented

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Clause 5.4.2 (Coned)
Quality Planning shall include :
(1) Processes of the QMS (considering
permissible exclusions)
(2) Resources needed
(3) Continual improvement of the QMS
Change shall be conducted in a controlled
manner and system integrity shall be maintained
during this process

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Clause 5.5.1 Responsibility, Authority
and Communication
Functions and interrelations within
the organization, including
responsibilities and authorities, shall
be defined and communicated.

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Clause 5.5.2 Management Representative
• Shall be appointed by top management;
• Allows for more than one management
representative;
• Responsibility enhanced to include
reporting on needs for improvement and
promoting awareness of customer
requirements throughout the organization.

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Clause 5.5.3 Internal
Communication
Now requirement to ensure
adequate communication between
various levels/functions regarding
processes of QMS and their
effectiveness

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Clause 5.6 Management Review
Top management shall review QMS at planned intervals.
Purpose of review : To ensure its continuing suitability, adequacy
and effectiveness
Review inputs shall cover current performance and improvement
opportunities related to :
- result of audits
- customer feedback
- process performance and product conformance
- status of corrective and preventive actions
- follow-up actions from earlier management
reviews
- changes affecting QMS

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Review output shall include actions
related to :
- Improvement of QMS and processes
- Improvement of product related to
customer requirements
- Resource needs
Records of reviews shall be maintained

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Clause 6 Resource
Management
Clause 6.1
Provision of resources
Provision of resources : Resources needed to
implement and improve processes of QMS and
to address customer satisfaction shall be
determined and provided in a timely manner.

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Clause 6.2 Human Resources
Personnel assigned responsibilities shall be
competent on the basis of applicable education, training,
skills and experience.
Training, awareness and competency shall include:
- Identify competency needs for personnel
- Provide training to satisfy needs
- Evaluate effectiveness of training
- Awareness relating to relevance and importance of
activities and contribution to achievement of quality
objectives
- Maintaining records of education training,
qualification & experience

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Clause 6.3 Infrastructure
Identify, provide & maintain facilities needed to
achieve conformity of product.
This shall cover:
- Workspace and associated facilities
- Equipment, hardware and software
- Supporting services

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Clause 6.4 Work Environment
- Identify and manage the human and
physical factors of the work environment
- Specific reference to health & safety conditions,
work methods, work ethics & ambient working
conditions have been removed

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Clause 7 Product realization
Clause7.1 Planning of realization processes
Planning of sequence of processes and sub processes needed to
achieve the product shall be documented
In planning of realization processes, the following shall be
determined :
- quality objectives for the product;
- the need to establish processes and
documentation and provide resources and
facilities;
- verification and validation activities and criteria for
acceptability;
- records needed to provide confidence of
conformity

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Clause 7.2 Customer-related
processes
Customer related processes involve :
- Determination of requirements related to the
product (7.2.1)
- Review of requirement related to the product
(7.2.2)
- Customer communication (7.2.3)

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Clause 7.2.1 Determination of
requirements related to the product
Identification of customer requirements shall include :
- Customer requirements for product
including those for availability, delivery and
support;
- Product requirements not specified but
necessary for intended/specified use;
- Regulatory and legal requirements

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Clause 7.2.2 Review of requirements
related to the product
Before commitment to supply, organization shall ensure:
- Product requirements are defined
- Where no documented statement of requirement,
confirm requirement before acceptance
- Conflicting/ambiguous requirements resolved
- Ability to meet requirements
Results of review and follow-up actions shall be recorded
Revision to requirements shall result in amendment to
relevant documentation and communicated to personnel in
organization.

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Clause 7.2.3 Customer Communication
Communication to customer relating to following shall
be identified and implemented :
- product information
- enquiry /contract/ order handling
- customer feedback, including complaints

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Clause 7.3 Design and
development
Covers :
- Design and development planning
- Design and development inputs
- Design and development outputs
- Design and development review
- Design and development verification
- Design and development validation
- Control of changes

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Clause 7.3.1 Design and
development planning
- stages of the design/development
process
- required review, verification and validation
activities appropriate to the stage
- responsibilities & authorities for design /
development planning
Interfaces between different groups shall be
effectively managed.
Planning output shall be updated

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development inputs
Product requirements shall be defined and
documented, including :
- Functional and performance requirements
- Applicable regulatory/legal requirements
- Information derived from previous similar
designs
- Other requirements essential for design/
development.
Requirement shall be reviewed for adequacy.
Incomplete, ambiguous or conflicting requirements
shall be resolved.

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Clause 7.3.3 Design and development
output
Outputs of design/development process shall be documented.
Design/development output shall :
- Meet design/development input requirements
- Provide information for production/service
operations
- Contain or reference product acceptance criteria
- Define characteristics of product essential for safe and
proper use.
Design/development documents approved prior to release

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review
Review shall be conducted at suitable stages to:
- Evaluate capability to fulfil requirements
- Identify problems and propose follow-up
action
Participants shall include personnel relevant to the stage
being reviewed
Result of review and follow-up actions shall be recorded

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development
verification
- Verification shall be performed to
ensure output meets input
requirements
- Results of verification and subsequent
follow - up action shall be recoded

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validation
- Design validation shall be carried out to
confirm resultant product/service capable
of meeting requirements of intended use
- Partial validation may be done if full
validation not practical prior to delivery of
product or implementation of service
- Results of validation and follow-up action shall
be recorded

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Clause 7.3.7 Control of changes
- Design/development changes shall be
identified, documented and controlled
- Evaluation of effects of changes on components
parts and delivered products required.
- Changes shall be verified, validated and
approved before implementation
Results of review and follow-up actions shall be
recorded

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Clause 7.4 - Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing information
7.4.3 Verification of purchased product

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Clause 7.4.1 Purchasing Process
- Purchasing processes shall be controlled to ensure
purchased product conforms to organization
requirements
- Type and extent of control dependent on effect on
delivered product
- Evaluation and selection of suppliers shall be
carried out
- Criteria for selection and periodic evaluation shall be
defined
- Results of evaluations and follow-up actions shall be
recorded

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Clause 7.4.2 Purchasing
Information
Purchasing documents shall contain information
describing product ordered, including :
- Requirements for approval or qualification of
product
- Quality management systems requirements
- Adequacy of specified requirement in
documents shall be ensured prior to release

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Clause 7.4.3 Verification of purchased
Product
- Activities necessary for verification of
purchased product shall be determined and
implemented
- Supplier shall be informed through
purchasing information of intended
verification by organization or customer at
supplier’s premises

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Clause 7.5 Production and service
operations
Production and service operation covers :
- Control of production and service
provision (7.5.1)
- Validation of processes for production and
service provision (7.5.2)
- Identification and traceability (7.5.3)
- Customer property (7.5.4)
- Preservation of product (7.5.5)

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Clause 7.5.1 Control of production and
service operation
Production/service operations controlled through :
- Availability of information that specifies
characteristics of product
- Availability of work instruction, where necessary
- Use and maintenance of suitable equipment
- Availability and use of suitable measuring and
monitoring devices
- Implementation of monitoring activities
- Defined processes for release, delivery and
applicable post-delivery activities

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Clause 7.5.2 Validation of processes
for production and
service provision
Production/service processes where output is not verified by subsequent
measurement or monitoring shall be validated.
Validation shall demonstrate ability of process to achieve planned results.
Validation shall include, as applicable :
- qualification of processes
- qualification of equipment and personnel
- use of defined methods and procedures
- requirements for records
- revalidation, when applicable

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Clause 7.5.3 Identification and
Traceability
- Where appropriate, product shall be
identified at all stages of production/service
operations
- Status of product with respect to
measurement and monitoring requirements
- Control and record unique identification of
product if traceability required.

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Clause 7.5.4 Customer property
- Care shall be exercised with customer property when
under organization’s control or being used by it
- Customer property provided for use or for
incorporation into product shall be identified,
verified, protected and maintained.
- Record and report to customer if lost, damaged or
unsuitable for use.
- May include intellectual property

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Clause 7.5.5 Preservation of
Product
Conformity to customer requirement shall be
preserved during internal processing and delivery to
intended destination
It shall include : identification, handling, packaging,
storage and protection.
Applicable to parts or components of product or
elements of service

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Clause 7.6 Control of Measuring and
Monitoring Devices
- Measurements to be made and measuring and
monitoring device required shall be identified;
- M & M devices shall be used and controlled in a manner that
ensure measurements are consistent with measurement
requirements;
- Software shall be validated before use;
- Calibration at specified intervals or before use, with
traceability to national/international standards;
- Safeguard against adjustments;
- Provide protection from damage/deterioration during handling,
maintenance and storage;
- Record results of calibration;
- Assess validity of previous results when equipment is found to be
out of calibration and take appropriate action

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Clause 8 Measurement, analysis
and improvement
Measurement, analysis and improvement covers:
- General (8.1)
- Measurement and monitoring (8.2)
- Control of non-conforming (8.3)
- Analysis of data (8.4)
- Improvement (8.5)

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Clause 8.1 General
- Define, plan and implement measuring and
monitoring activities to assure conformity
and achieve improvement;
- Includes determination of need for and use
of applicable methodologies including
statistical techniques

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Clause 8.2 Measuring and
Monitoring
Measuring and monitoring covers :
- Customer satisfaction (8.2.1)
- Internal audit (8.2.2)
- Processes (8.2.3)
- Product (8.2.4)

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Clause 8.2.1 Customer satisfaction
- Monitor information on customer
satisfaction / dissatisfaction;
- Methods for obtaining and utilizing such
information shall be determined.

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Clause 8.2.2 Internal Audits
• Periodic internal audits to determine if QMS
- Conforms to requirements of this international standard
- Has been effectively implemented and maintained;
• Audits planned based on (i) status and importance of
activities and (ii) results of previous audits;
• Audit scope, frequency and methodologies shall be
defined
• Audits performed by personnel other then those who
performed work being audited;
• Procedure covering responsibilities and requirements,
ensuring independence, recording results and
reporting to management ; timely corrective action
required;
• Follow-up to include verification of CA and reporting
results

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Clause 8.2.3 Measurement and
Monitoring of Processes
Suitable methods shall be applied for measurement
and monitoring of realization processes necessary to
meet customer requirements;
Methods shall confirm continuing ability of each
process to satisfy intended purpose

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Clause 8.2.4 Measurement and
Monitoring of Product
• Product/service characteristics shall be
measured and monitored measurement and
monitoring shall be carried out at various
stages;
• Evidence of conformance with acceptance
criteria shall be recorded;
• Authority responsible for release of product/
service shall be indicated in records;
• Product shall not be released until all
specified activities have been satisfactorily
completed unless otherwise approved by customer

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Clause 8.3 Control of nonconforming
product
Non-conforming product/service shall be identified and
controlled to prevent unintended use or delivery;
Non-conforming product shall be corrected and
reverified;
Appropriate action to be taken if non-conforming
product/service is detected after delivering or use has
started;
Proposed rectification of non-conforming product shall
be reported to customers, end-user, regulatory body or
other body for concession

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Clause 8.4 Analysis of data
- Collect and analyze appropriate data
- Data analysis to be used for determining suitability and
effectiveness of QMS and for identifying areas for
improvement
- Data to be analyzed may include those from measuring
and monitoring activities
Data analysis to provide information on :
- Customer satisfaction/dissatisfaction ;
- Conformance to customer requirements ;
- Characteristics of processes/products services;
- suppliers

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Clause 8.5 - Improvement
Improvement covers :
- Continual improvement (8.5.1)
- Corrective Action(8.5.2)
- Preventive Action(8.5.3)

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Clause 8.5.1 Continual improvement
Processes necessary for continual improvement
of QMS shall be planned and managed
Continual improvement shall be facilitated
through use of:
(1) Quality Policy
(2) Quality Objectives
(3) Audit Result
(4) Analysis of data
(5) Correction/Preventive Action
(6) Management Review

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Clause 8.5 2 Corrective Action.
- To eliminate causes of non-conformance to prevent
recurrence
- Shall be appropriate to the magnitude and impact of
problems
Procedure to cover :
- Identification of non-conformities (including customer
complaints)
- Determination of causes of non-conformities
- Evaluation of need for actions to prevent recurrence
- Determine and implement corrective action needed
- Review of corrective action taken

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Clause 8.5.3 Preventive Action
- To eliminate causes of potential non-
conformities to prevent occurrence
- Shall be appropriate to the magnitude and impact
of problems encountered
Procedure to cover :
- Identification of potential non-conformities
- Determine of potential causes
- Determination of preventive action needed
- Implementation of preventive actions
- Review of preventive action taken

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AUDIT
KUALITI
DALAMAN
Bahagian 4
Pengenalan
Audit

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Definisi Audit Kualiti
Proses yang
sistematik, berkecuali dan
didokumenkan untuk
mendapatkan bukti audit dan
menilaikannya secara objektif
dalam menentukan kriteria audit
telah dipenuhi.
(ISO 19011:2002, page 1)

Penjelasan: definisi
1. Kriteria audit (3.2):
• Set dasar, prosedur atau keperluan
yang digunakan sebagai rujukan.
• Set of policies, procedures or requirements
2. Bukti Audit (3.3)
Keputusan penilaian yang dibuat ke
atas bukti yang telah diperolehi
dengan kriteria audit. Penemuan
boleh menyatakan keakuran terhadap
kriteria audit, atau peluang untuk
penambahbaikan
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Audit Kualiti Bermakna:
• Mesti Sistematik (bukan rambang tetapi
terperinci)
• Mesti Bebas (tidak dilakukan oleh mereka
yang berkepentingan)
• Mesti menentukan sama ada aktiviti-aktiviti
kualiti telah memenuhi keperluan “planned
arrangements” (termasuk aktiviti-aktiviti dalam
Quality Std ISO 9004)

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• Mesti meliputi “related results” iaitu memeriksa
hasil setelah aktiviti-aktiviti kualiti dilaksanakan
(dengan memeriksa
rekod, produk, proses, membuat keputusan dll)
• Mesti menentukan “compliance with planned
arrangements” iaitu dasar dan prosedur umum
seperti
kontrak, pelan, spesifikasi, lukisan/lakaran, prosed
ur khusus dan arahan.

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• Mesti menentukan sama ada “arrangements”
diimplementasikan dengan berkesan. Keberkesanan
diukur melalui:
» sama ada aktiviti telah dilakukan dengan betul
» Menepati sasaran
» Jadual ditepati dll
• Mesti menentukan sama ada “planned arrangements”
adalah sesuai untuk mencapai objektif iaitu sama ada
peruntukan yang dibuat oleh pembekal dapat
memenuhi objektif organisasinya (objektif kualiti)

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• Audit Sistem Kualiti melibatkan
pemeriksaan sesuatu “produk”tetapi
bukan untuk mengesahkannya (certify)
• Audit Sistem Kualiti juga melibatkan
pemeriksaan sesuatu operasi dan rekod-
rekod operasi untuk mempastikan rekod-
rekod itu menggambarkan operasi yang
lalu.

SAMBUNGAN : Kesimpulan MAKNA AUDIT
• Ia adalah aktiviti pengumpulan maklumat
untuk membolehkan tindakan pembetulan dan
penambahbaikan dapat dikesan secara
objektif.
• Ia dilaksanakan secara terancang/sistematik
• Dilaksanakan olek mereka yang terlatih
• Berdasarkan std & kriteria yang ditetapkan
• Melaporkan dengan tepat, benar dan lengkap.
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Jenis Audit
– 1. Audit Luaran (External Audit) = Audit
Persijilan/pihak ketiga
– 2. Audit Dalaman (Internal Audit) = Audit
pertama
– International Register of Certified Auditors
(IRCA) menggunakan :
– Assessment = Audit
– Assessors = Auditors

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FLOW CHART OF IQA: ISO 19011
Improving the audit
programme
competence and
evaluation of
auditors
Authority for the audit
programme
Audit activitiesAct
Plan
Check
Implementing internal audit program
scheduling audits
evaluating auditors
selecting audit team
directing audit activiries
maintaining records
Establishing
the internal audit program
obectives
responsibilitties
resources
procedure and guidance
Monitoring & reviewing
the internal audit program
monitoring & reviewing
identifying needs for corrective
identifying needs for prevention actions
identifying opportunities for improvement
Do

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Tujuan Pengauditan
• Audit dilaksanakan untuk:
• mencari fakta, bukan kecacatan
• mengelak daripada “deterioration” dalam
standard
• Kegunaan audit dapat dilihat apabila
ianya diasaskan kepada standard yang
perlu dipatuhi oleh sesebuah organisasi
(contohnya standard ISO 9000)

Tujuan Audit Dalaman (AD)
• Untuk mengumpul bukti objektif mengenai
tahap keakuran pelaksanaan, kecekapan
dan keberkesanan sistem pengurusan
kualiti (SPK) organisasi (MS ISO 9000)
dan mengesan peluang penambahbaikan
(inovasi) SPK dan prestasi organisasi.
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Audit memberi maklumat
tentang:
1. Adakah sistem berjalan baik?
2. Adakah prosedur dan dokumen yang di
rujuk adalah yang terkini dan berkesan?

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ROLES OF IQA
 As a powerful tool to measure the effectiveness
of quality management system
 Evaluates organisation‟s compliance with QMS
in all aspects related production and quality
control
 Detects any shortcomings in the implementation
of QMS
 Recommend the necessary corrective and
preventive actions

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BENEFITS OF IQA
 Tells you the health of a quality system
 Identify the root of a problem and plan for
corrective and preventive actions with timeline
 Achieve better allocation of resources
 Able to avoid potentially big problem
 Learn what an auditors look for
 Continuous improvement

Limitations of audit
• It can neither help in prioritizing changes nor in allocating
resources.
• Audit cannot mobilize people to take action.
• Audit cannot generate better data than the measures
used to gather those.
• An audit, by itself cannot improve performance.
• An audit should not be used for wrongful purposes. It
should not be used for personal indictment and to justify
improve actions.
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Prinsip Audit
• Kelakuan beretika – asas kepada
profesionalisme
kepercayaan, integriti, kerahsiaan, dan
kebijaksanaan
• Kewajaran Penyampaian – kewajipan untuk
melaporkan yang benar & tepat
• Berkecuali – asas kepada keadilan dan
kebenaran kesimpulan audit
• Pendekatan berasaskan bukti – kaedah yang
rasional untuk menghasilkan kesimpulan
audit yang boleh dipercayai

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Keperibadian Juruaudit (ISO 19011)
• Berfikiran terbuka dan matang
• Mempunyai pertimbangan yang baik
• Mempunyai kemahiran analisis/teknikal
dan berpendirian tetap
• Bersikap realistik dan mempunyai
kemahiran sosial
• Berkemahiran kemunikasi
• Personaliti positif: peramah, tolong
menolong, bersopan, merendah diri &
jujur)

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Ciri-Ciri Personaliti Negatif Juruaudit
•Suka berdebat
•Mudah membuat keputusan tanpa usul periksa
(bukti)
•Agresif
•Pemalas
•Cuai
•Tidak konsisten dengan keputusan yang dibuat
•Sikap tahu semuanya
•MENCARI KESALAHAN

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Rehat!

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BAHAGIAN 5: AKTIVITI AUDIT

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OVERVIEW OF AUDIT ACTIVITES
Planning and scheduling audit
Conducting document review
Conducting audit
Prepare audit report
Conducting follow-up
Preparing for on-site activities

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1. Program Audit
• Program disediakan oleh Wakil
Pengurusan
• Program audit dalaman: 2 kali
• Program audit luar: 1kali (Badan
Persijilan)
• Program audit mendefinisikan
lokasi, tarikh audit dan
mengenalpasti auditor.

Merancang Pengauditan
• Menjadi tanggungjawab Wakil Pengurusan &
Ketua juruaudit merancang dan mengelola
• Pasukan audit dipilih daripada mereka yang
berkelayakan.
• Mengumpulkan maklumat untuk merancang
yang berkaitan dengan skop, termasuk
maklumat juruaudit untuk penyusunan ahli
pasukan dan proses yang akan diaudit.
• Memeriksa dokumen sistem kualiti untuk
perancangan audit

Merancang Pelan Pengauditan
• Pelan audit adalah gambaran mengenai
aktiviti dan penyusunan audit.
• Ia merangkumi maklumat pelaksanaan
audit seperti:
• 1. proses/aktiviti yang akan diaudit
• 2. Tarikh, masa pengauditan
• 3. Kriteria audit
• 4. Nama juruaudit dan auditi
• 5. Masa untuk mesyuarat pembukaan &
penutupan

Masa Pasukan Audit & Ketua Masa Juruaudit
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Tarikh
Ketua Juruaudit
Juruaudit
Kriteria Audit
Skop Audit
CONTOH PELAN AUDIT

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AUDIT DOCUMENTATION
• Audit report is an
 official document to report the audit findings
• Audit plan
 should be sent to auditee prior to audit activity
 findings from the last audit should be also mentioned
• Audit note should include
 an audit questionnaire
 all records and comments during the audit

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JADUAL AUDIT
Jadual Audit Jan 20, 2011
8:00 – 8:30 Persediaan Auditor
8:30 – 9:00 Mesyuarat Pembukaan
9:00 – 9:30 Kawalan Dokumen
9:30–10:30 Komitmen Pengurusan Atasan
10:30–11:30 Pengurusan Pelanggan
11:30–12:30 Pengurusan kursus-jabatan Inovasi
12:30– 2:30 Rehat
2:30 – 4:30 Pengurusan Latihan
4:30 – 5:00 Mesyuarat penutup

Penyediaan Senarai Semak
• Alat bantuan untuk memandu, memberi
peringatan mengenai maklumat yang perlu
diperolehi dan fakta yang perlu disahkan.
• Panduan mengenai soalan yang akan ditanya
dan keberkesanan proses temubual.
• Kaedah popular dalam menyediakan soalan:
• a. menukar kenyataan dalam standard atau prosedur
menjadi soalan
• b. meringkaskan kenyataan tersebut
• c. ayat peringatan
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contoh
• “ Catatkan maklumat pelanggan dalam borang maklumbalas
dengan betul dan lengkap”
• Kenyataan ini akan ditukar seperti berikut:
• “ Apakah maklumat pelanggan yang dicatatkan dalam Borang
Maklumbalas?”
• Atau,
• “Catatkan maklumat pelanggan dalam Borang Maklumbalas dengan
betul dan lengkap”.
• Jika diringkaskan, ia akan ditulis seperti berikut:
• “Maklumat pelanggan- Borang Maklumbalas”.
• Atau,
• “catatkan maklumat pelanggan dalam Borang Maklumbalas dengan
betul dan lengkap”.
• Jika ditulis sebagai peringatan:
• “Semak maklumat pelanggan dalam Borang Maklumbalas”.
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Bahagian di audit
Tarikh: Muka surat: /
Juruaudit
Rujukan (Klausa) Perkara yang diaudit Catatan Penemuan
Audit
SENARAI SEMAK

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EXAMPLE OF AN AUDIT
CHECKLIST
CHECKING LIST FOR GMP ASSESSMENT
Date : Location : Warehouse
Auditor : Auditee :
DESCRIPTION GMP.REF. PARAMETER AUDIT FINDING
Personnel 1.2.1
5.1.2
2.1.5
- Organization structure
- Personnel hygiene
- Training record
Storage area 10.1.1
3.1
3.6
3.9 & 3.10
3.12.2
- Design and layout of defined area
- Flow of personnel and goods
- Structure of the storage area, based
on GMP
- HVAC system
- Record of monitoring parameter
Sanitation 3.1
5.3
- Pest record program
- The map of bait
- The cleanliness of weighing
apparatus
Documentation 4.3
10.2.2.3
10.2.2.1
- Record of maintenance and
calibration of weighing apparatus
- The effectiveness of label system
- Inventory stock control

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INTERNAL: AUDIT QUESTIONAIRES
Area audited : ______________________ Date: __________________
Question Response
1. Does the company have a work instruction to
operate the machine?
2. How is the machine being cleaned and
maintained?
3. Are personnel trained to use the machine?
4.How often is the equipment being calibrated
and cleaned?
5. When is the last breakdown of the machine?
Are there any product being affected?
IA MONITORING

Melaksanakan Audit
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Mesyuarat Pembukaan
• Sesi perbincangan „pembukaan‟ di antara
pasukan audit dan auditee.
• Pengerusi: Ketua Juruaudit
• Agenda mesyuarat:
• 1. Memperkenalkan juruaudit terlibat
• 2. Penerangan mengenai
tujuan/skop/kaedah audit
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Mesyuarat Pembukaan
• 3. Penerangan mengenai ketidakakuran
• 4. Pengesahan Jadual audit
• 5. Pengesahan kerahsiaan
• 6. Melangkapkan keperluan pentadbiran
audit spt borang kehadiran, borang
maklumbalas
• 7. Penjelasan mengenai isu-isu yang
mungkin timbul ketika audit
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Temubual Audit
• Temubual adalah salah satu kaedah yang
penting untuk mendapatkan maklumat.
Melalui proses temubual, pengumpulan
maklumat berlaku dan seterusnya
pengumpulan bukti objektif.
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Temubual Audit
Soalan yang akan dikemukakan oleh
Juruaudit mestilah:
*Memerlukan jawapan yang boleh memberi
maklumat yang dikehendaki,
*Tidak mencadangkan jawapan, dan
*Tidak mengandungi ayat dan implikasi
yang beremosi.
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Temubual Audit
• Lazimnya, proses temubual audit
mempraktikkan 3 jenis soalan yang
berikut:
• SOALAN TERBUKA,
• SOALAN TERTUTUP, dan
• SOALAN PENJELASAN.
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Soalan Terbaik Semasa Audit
“SHOW ME…”
atau
“BOLEH BERIKAN SAYA...”
atau
“Tolong tunjukkan..”
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Kaedah A-LOCK (ask, listen, Observe & Check)
• Tanya soalan,
• Berhenti bercakap,
• Dengar jawapan yang diberikan,
• Minta penjelasan jika keliru/tidak faham
• Langkah pemerhatian dan pemeriksaan ke atas
bukti objektif,
• Buat catatan yang perlu,
• Jika sudah berpuashati, tanya soalan yang
seterusnya.
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Persekitaran Audit
• Faktor elemen fizikal: keselesaan
persekitaran
• Elemen emosi: mencari keakuran bukan
ketidakakuran. Jaga “eye contact”‟ dan
body language”.
• Kaji pendengar yang baik:
• a. mendengar dengan fikiran terbuka
• b. Gunakan bahasa badan yang betul
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sambungan
• c. menjadi pemerhati- auditi cakap lebih.
Jangan menyampuk atau ganggu auditi
bercakap.
• d. Tumpukan kepada maklumat yang ingin
dicari
• e. elak dari terus buat kesimpulan
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THE GOLDEN RULES OF AUDITING
• Be prepared
• Retain an open mind
• Be professional
• Do not waste time
• Present a true and fair view
Calm, Courteous, Professional, Polite & Firm

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TAKE 5!

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3INTERNAL Q AUDIT - MAS 97
EXTRA NOTE : AUDIT
CONDUCT
•COMMUNICATION SKILLS
•QUESTIONING SKILLS
•LISTENING SKILLS

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DEVELOP GOOD AUDITING SKILLS
• Avoid leading, multiple, & trick questions
• Listen intently
• Be observant & take note
• Try to establish root cause of deficiencies
• Actually witness & document objective
evidence
• Avoid giving advice
• Remain calm, courteous, polite,
professional & firm

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COLLECTING EVIDENCE…Communication
• Communicate clearly
• Be open minded
• Be aware of biases
• Ask question in regard to the
QMS
• Do not make assumptions
• Lead auditors should rely on the
audit team

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5
Questioning Skills
Explaining your need :
• Give reasons for asking questions
• Don’t demand information, request
it politely
• Don’t use deception to obtain
information

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6
Type of Questions
• Closed questions
• Probing questions
• Emotive questions
• Trick questions
• Hypothetical questions
• Systematic questions
• Leading questions
• Multiple questions

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7
Don’t ask
• Leading questions
• Emotive questions
“Don’t you use red reject labels ?”
“ Why don’t you stamp these documents
UNCONTROLLED”
• In general don’t ask closed questions:
“…Do you have a procedure for
controlling noncomforming product ? ”

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10
Requests
- Sebagai tambahan kepada
soalan, auditor perlu memeriksa
dan mendapatkan bukti-bukti.
- Jika auditee tidak memberikan
kerjasama, auditor perlu
meminta dengan cara yang baik
untuk mendapatkan bukti.

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11
Example Requests
• “ I would like to see some results of
the design verification activities
you performed on project X”
• “Having examined your audit
procedures and found them
satisfactory, I would now like to
examine the file of audit reports”

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SOME QUESTION TO ASK THE AUDITEE
Are these open ended or closed ended?
1. Are things being done the way you documented them?
2. Is the department manager and staff following their own
procedures and work instructions?
3. Is your system effective?
4. Are you meeting your quality objectives?
5. Is the quality objectives?
6. What is your responsibility and authority?
7. In what way does the quality policy effect what you do?
8. What feedback do you receive about your performance?
9. When problems arise, what do you do about them?

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METHODS FOR IMPROVING AUDITING SKILLS
Ask question instead of giving direct orders, if you are
the audit team leader.
There are two things that every person in the world
appreciates….
…..to be asked
…..to be thanked.

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COLLECTING EVIDENCE
• Write down the information
as you conduct the audit.
• Keep all of your notes
together.

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COLLECTING EVIDENCE
Documentation to audit:
• Policies
• Procedures
• Work instructions
• Records
• External documents

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8
Listening Skills
• Intelligent and active
listening
• Hearing, understanding
and remembering the
message
• Taking part in the
interaction
• Feedback

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9
One of the first
steps to improving
listening skills is
to identify factors
which hinder
effective listening
Listening problems:
• Selective attention
• Premature
conclusions
• Personal prejudices

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13
Giving Feedback
• When something is found that is in your
opinion good, give praise
• When problems are uncovered, don’t jump
to conclusions
• Don’t indicate that there is nonconformity
• Point out potential problems
• If there is evidence of nonconformity in the
system then say that there is a weakness
not a NC

Pengumpulan & Pengesahan
Bukti Objektif
• Bukti objektif merujuk kepada:
“ data supporting the existence or verify of
something” Std ISO 9000
Terbahagi 3 kategori:
1. Dokumen (rekod, fail, minit mesyuarat, laporan
kursus)
bukti ini menunjukkan perkara yang telah berlaku
atau aktiviti/proses yang telah dilaksanakan
mengikut prosedur.

• 2. Pelaksanaan – ia merujuk kepada
aktiviti yang dilaksanakan sebenar dan
boleh diperhatikan.(present)
• 3. Manusia – tahap pengetahuan dan
pemahaman yang diperlukan untuk
melaksanakan prosedur pada masa depan
(future)
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WHAT ARE AUDIT FINDINGS?
• An observation is a positive, negative, or neutral fact
that is supported by objective.
• A nonconformity is the non-fulfillment of a requirement.
• An audit-finding is a written statement or conclusion
describing a nonconformity. It concludes:
• The requirement, as it is stated In the quality standard, or regulation
• The observation which provides evidence that the standard or
regulation is not being met
RECORD ALL AUDIT FINDINGS!

Penemuan Audit & penilaian
Awal (1)
• Maklumat atau bukti audit yang diperolehi
semasa sesi temubual, pemerhatian ke
atas aktiviti atau proses dan pengesahan
yang dibuat ke atas dokumen hendaklah
dicatatkan atau direkodkan di dalam
Senarai Semak. Maklumat atau bukti audit
tersebut hendaklah dicatat atau direkod
dengan jelas dan lengkap termasuk bukti
yang spesifik dan objektif.
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Awal (2)
• Catatan atau rekod ini adalah penting untuk
menyediakan laporan penemuan audit dan
kesimpulan audit serta hendaklah diikuti
dengan penilaian awal ke atas keakuran
pelaksanaan sesuatu aktiviti atau proses
seperti:
 “AKUR” atau “TIDAK AKUR”
 “TIDAK BOLEH DISAHKAN”
 “TIDAK CUKUP BUKTI”m
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Awal (3)
 “PERLU RUJUK…” atau
 “BERKESAN” atau “TIDAK BERKESAN”
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Perbincangan Pasukan (1)
• Perbincangan ini bertujuan untuk:
 Membuat penilaian semula ke atas
penemuan audit dan lain-lain maklumat
yang dikumpulkan oleh semua juruaudit
(menilai pelan audit, kerjasama
auditee, rintangan/kesusahan yang
dihadapi).
Persediaan untuk menyediakan laporan
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Mencapai persetujuan ke atas semua
laporan audit yang akan
dikemukakan/dilaporkan kepada pihak
yang diaudit.
Tanggungjawab Ketua juruaudit
menentukan klasifikasi NC (ketidakakuran)
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• Keputusan yang dicapai melalui penilaian
ke atas penemuan audit boleh
dikategorikan kepada tiga (3) iaitu:
 Keakuran
Ini menunjukkan bukti objektif yang
diperolehi dapat membuktikan keakuran
pelaksanaan kepada keperluan yang telah
ditentukan.
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 Ketidakakuran
Ketidakakuran (nonconformance) bermaksud
tidak memenuhi keperluan yang telah
ditetapkan (the nonfulfillment of specified
requirements)
 Pemerhatian/peluang penambahbaikan
Komen yang dibuat ke atas sistem
pengurusan kualiti untuk tujuan
penambahbaikan atau perkara kurang bukti.
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Klasifikasi Ketidakakuran
• 1 : Major
• a. “ Ketidakakuran yang berlaku telah
menunjukan kegagalan sepenuhnya untuk
memenuhi mana-mana klausa STD 9001:2008
atau kriteria audit yang lain”
• b. tidak akur kepada keperluan SPK yang
mengakibatkan kesan buruk/besar terhadap
kualiti produk/perkhidmatan yang diberikan
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Sambungan: major
• c. Ketidakakuran yang konsisten dan
berulang-ulang terhadap keperluan SPK.
• d. Ketidakakuran yang berlaku terhadap
SPK yang boleh membawa kepada
ketidakpatuhan kepada keperluan undang-
undang yang berkaitan dengan kualiti
produk/perkhidmatan.
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NC Minor
• NC yang terasing dan tidak konsisten
dalam memenuhi keperluan yang telah
ditetapkan
• NC yang berlaku tidak memberi kesan
kepada kualiti produl/perkhidmatan
• NC yang tidak memberi kesan dalam
memenuhi keperluan, kehendak dan
jangkaan pelanggan.
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Kesimpulan Audit
• Semasa membuat kesimpulan audit,
Ketua Juruaudit haruslah mengambil kira
tujuan utama audit dilaksanakan. Selain
daripada menilai sejauh mana keakuran
kepada keperluan yang ditetapkan, audit
juga adalah aktiviti untuk mengenalpasti
peluang penambahbaikan. Maka, boleh
kita katakan bahawa peluang
penambahbaikan perlu
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Kesimpulan Audit
diutamakan kepada pihak pengurusan
auditee berbanding dengan ketidakakuran.
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COMPLETION
• All conformities are addressed
• All corrective actions implemented
• All corrective actions evaluated as effective
• Audit completed

Mesyuarat Penutup (1)
• Mesyuarat ini dipengerusikan oleh Ketua
Juruaudit dan dihadiri oleh pasukan audit,
auditee dan pengurusan atasan organisasi
yang di audit. Mesyuarat ini adalah aktiviti
penutup proses audit untuk pasukan audit
membuat kesimpulan ke atas audit yang
telah dilaksanakan.
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• Tujuan Mesyuarat Penutup diadakan
adalah untuk:
 Mengucapkan terima kasih kepada
semua pihak yang terlibat dalam proses
audit di atas sokongan dan kerjasama
yang telah diberikan sepanjang proses
audit.
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 Menjelaskan secara ringkas mengenai
proses audit yang telah dilaksanakan (cth:
kaedah audit, persampelan dan laporan).
 Menjelaskan bahawa semua penemuan
audit ankan dikekalkan kerahsiaannya.
Mana-mana rekod/laporan/dokumen yang
mengandungi maklumat rahsia akan
dikembalikan kepada organisasi.
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 Melaporkan semua penemuan audit yang
merangkumi Laporan Ketidakakuran,
Laporan Pemerhatian dan Laporan
Peluang Penambahbaikan supaya
difahami dan dipersetujui, dan disahkan
oleh auditee. Biasanya ia dilaporkan oleh
juruaudit yang bertanggungjawab ke atas
penemuan audit atau laporan tersebut.
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 Menjelaskan kaedah untuk menutup
ketidakakuran yang dilaporkan dan
persetujuan mengenai jangkamasa
tindakan susulan (lihat Bahagian 9)
 Menjelaskan kesimpulan audit serta
syor/cadangan bagi tujuan persijilan
kepada organisasi yang diaudit. Ini adalah
penting untuk memastikan organisasi
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faham mengenai keputusan yang akan
diambil oleh Badan Persijilan.
 Memastikan semua rekod audit adalah
lengkap ( senarai kehadiran, pengesahan
audit daripada organisasi, laporan telah
ditandatangani dan lain-lain dokumen bagi
tujuan pentadbiran audit).
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Laporan Hasil Audit
• Dapatan audit dibuat secara verbal semasa
mengaudit.
• Hasil audit didokumenkan dalam bentuk
laporan (conformities and nonconformities)
• Dilaporkan dalam Mesyuarat Penutup
(closing meeting)
• Cadangan tindakan pembetulan
dikemukakan kepada pihak pengurusan
organisasi

Audit Susulan
• Cadangan tindakan pembetulan dikemukakan
kepada auditor untuk dinilai.
• Auditor membuat keputusan menerima/menolak.
• Jika auditor menerima, teruskan untuk
diimplementasi.
• Jika sebaliknya, buat cadangan baru.
• Implementasi tindakan pembetulan diperiksa
sama ada melalui perhubungan atau
pengauditan terus di tempat organisasi.
• Hendak melihat sama ada nonconformity telah
dapat diatasi.

Melengkapkan Rekod Audit
• Auditor perlu mengawasi pelaksanaan tindakan
pembetulan
• Lengkapkan rekod audit setelah semua
tindakan pembetulan dilakukan dengan
berkesan.
• Masa / tarikh ditentukan untuk audit
pengawasan (surveillence audit)

Module 9
GMP Workshop Kuala Lumpur 14-
217
CONCLUSIONS
Nobody likes to be
audited………..
It is a means to have
continuous improvement

“Kejayaan sebenar ialah
bila anda merasai kenikmatan
atas hasil perubahan….”
SEKIAN TERIMA KASIH

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SEKIAN, TERIMA KASIH

Kursus audit kualiti dalaman iso 9001 2008

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