Kursus audit kualiti dalaman iso 9001 2008

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KURSUS AUDIT KUALITI DALAMAN

MS ISO 9001:2008oleh

Muhamad Bustaman b. Abdul Manaf

(Pensyarah Cemerlang DG 54) Institut Aminuddin Baki, KPM

0199890524/[email protected]@iab.edu.my

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Taklimat Kursus• Pengenalan Diri • Jadual Kursus dan

Kandungan Kursus

• Peraturan Semasa Berkursus

m bustaman/IAB/KPM/10

3m bustaman/IAB/KPM/10

BIODATA FASILITATOR

MUHAMAD BUSTAMAN BIN HAJI ABDUL MANAFPensyarah 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.







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.





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


TOPIK YANG DILIPUTI

• Bahagian 2: Keperluan Standard MS ISO 9001:2008.

• Bahagian 3: Dokumentasi Sistem Pengurusan Kualiti (SPK).

• Struktur Dokumentasi• Kawalan Dokumentasi SPK


TOPIK YANG DILIPUTI

Bahagian 4: Pengenalan Audit

• Definisi dan Jenis Audit• Prinsip Audit• Tanggungjawab Juruaudit• Kelayakan Juruaudit• Garis Panduan ISO 19011


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


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


Jadual Kursus

• Hari Kedua: Rabu • 8.15 - 10.00: Bhg: 2 & 3- Std & Dokumentasi• 10.00-10.30: Kudapan pagi• 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


Jadual Kursus

• Hari Ketiga: Khamis• 8.15 - 10.00: Bhg 5: Perancangan audit dan

pelaksanaan audit.• 10.00-10.30: Kudapan pagi• 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.


Jadual Kursus

• Hari Keempat: Jumaat

• 8.30- 10.00: Amali Latihan Pelaporan Audit• 10.00-10.30: Kudapan pagi• 10.30 – 12.15: Rumusan, Peperiksaan Audit,

Penilaian Kursus & Penutupan Kursus


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


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 0927

• 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.


Pengertian Kualiti : pendekatan 4

• Berdasarkan kepada pandangan sektor pembuatan,

• kualiti diertikan sebagai memenuhi kehendak atau spesifikasi yang telah ditentukan.



• Bagi sektor swasta, daya persaingan akan ditentukan oleh kehendak dan cita rasa pengguna.

• Dalam konteks perkhidmatan awam, kualiti diertikan sebagai dapat memenuhi yang menerima perkhidmatan




Kesimpulan: DefinisiThe experts and gurus have various

definitions…. But they all add up to the same thing:

“ Meeting the customer’s requirement”



Quality Process Measures


INPUT OUTPUTPROSES

P

D

C

A

@ OUTCOME

1. Kecekapan

3. Kepastian kualiti

4. Inovasi

5. Quality of work life

2. Keberkesanan

6. Produktiviti7. Budgetability

7 Kriteria Prestasi (Sink & Tuttle Model, 1989)


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


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”.


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.


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.


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


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


Versi Standard

Standard Pertama: 1987Standard Kedua: 1994 (IAB bermula-

dengan MAMPU)Standard Ketiga: 2000 (MOODY

INT’)Standard keempat: 2008- versi terkini

mbustamanIABKPM 42hak milik muhd bustaman/IAB/KPM


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.


EMPAT STANDARD MS ISO 9000:2008

1. MS ISO 9000:2008 QMS – Fundamentals and Vocabulary

2. MS ISO 9001:2008 QMS – Requirements3. MS ISO 9004:2008 QMS – Guidance for

Performance Improvement4. 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



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.


Standard merangkumi bidang berikut

• Manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, 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, recreation, fabrication, sanitation, software development, consumer products, transportation, design, instumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, and so on.


What standards doISO 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


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.



• 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.



• 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.



• 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.


Take 5!


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

8 PRINSIPKUALITI


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.



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.


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.


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.


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.


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.


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.


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.


Rehat!


KEPERLUAN-KEPERLUAN SISTEM

PENGURUSAN KUALITI STANDARD

MS ISO 9001: 2008

Bahagian 2

Mbustaman-IAB-KPM 67

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


Penambahbaikan Berterusan Sistem Pengurusan Kualiti (PDCA)

PELANGGAN&

STAKE-HOLDERS

KEPERLUAN

TANGGUNGJAWABPENGURUSAN ATASAN (5.0)

PENGURUSANSUMBER (6.0)

PENGUKURAN,ANALISIS &

PENAMBAHBAIKAN (8.0)

PENZAHIRAN PRODUK

(7.0)(Product Realization)

PELANGGAN&

STAKE-HOLDERS

BERPUAS-HATI

PRODUKINPUT 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.


Struktur Kandungan Standard Terbahagi Kepada 8 Para

0. Pengenalan

1. Skop

2. Rujukan Nomatif3.Terminologi dan definisi 4.Sistem pengurusan kualiti

0.1 Am0.2 Pendekatan proses0.3 Hubung kait dengan ISO

9004.0.4. Kompatibiliti dengan sistem

pengurusan lain

1.1 Am1.2 Applikasi


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.


4.2 Documentation Requirements4.2.1 General documentation

requirementsExtent 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


Clause 4.2.2Quality 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


Clause 4.2.3 Control of documentsQuality records considered as documents but different

requirementsspecified 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


Clause 4.2.4Control 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


Clause 5Management 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


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


Clause 5.3 Quality PolicyTop 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


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


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


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


Clause 5.5.1 Responsibility, Authority and Communication

Functions and interrelations within the organization, including responsibilities and authorities, shall be defined and communicated.


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.


Clause 5.5.3 Internal Communication

Now requirement to ensure adequate

communication between various levels/functions

regarding processes of QMS

and their effectiveness


Clause 5.6 Management ReviewTop management shall review QMS at planned intervals.Purpose of review : To ensure its continuing suitability,

adequacyand effectivenessReview inputs shall cover current performance and

improvementopportunities 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


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


Clause 6 Resource Management

Clause 6.1Provision 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.


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


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


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


Rehat!


Clause 7 Product realizationClause7.1 Planning of realization processes

Planning of sequence of processes and sub processes needed to

achieve the product shall be documentedIn planning of realization processes, the following shall

bedetermined :- 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


Clause 7.2Customer-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)


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


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.


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


Clause 7.3Design 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


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


Clause 7.3.2 Design and 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.


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


Clause 7.3.4 Design and development review

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


Clause 7.3.5 Design and development verification

- Verification shall be performed to ensure output meets

input requirements

- Results of verification and subsequent follow - up action shall be recoded


Clause 7.3.6 Design and development 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


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


Clause 7.4 - Purchasing

7.4.1Purchasing Process

7.4.2Purchasing information

7.4.3Verification of purchased product


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


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


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


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)


Clause 7.5.1 Control of production and service

operationProduction/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


Clause 7.5.2 Validation of processes for production and

service provisionProduction/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


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.


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


Clause 7.5.5 Preservation of Product

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


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


Rehat!


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)


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


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)


Clause 8.2.1 Customer satisfaction

- Monitor information on customer satisfaction /

dissatisfaction;

- Methods for obtaining and utilizing suchinformation shall be determined.


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


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


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


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


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


Clause 8.5 - Improvement

Improvement covers :

- Continual improvement (8.5.1)

- Corrective Action(8.5.2)

- Preventive Action(8.5.3)


Clause 8.5.1 Continual improvementProcesses 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


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


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


Rehat!


AUDIT KUALITI

DALAMANBahagian 4

Pengenalan Audit


11

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)

133

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



16

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)


06/21/98 17@ Hakcipta Terpelihara HMA

Audit Kualiti Bermakna:• 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, prosedur khusus dan arahan.


18

Audit Kualiti Bermakna:• 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)


19

Audit Kualiti Bermakna:• 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.

138

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.



15

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

140

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 programscheduling auditsevaluating auditors

selecting audit teamdirecting audit activiries

maintaining records

Establishingthe internal audit program

obectivesresponsibilitties

resourcesprocedure and guidance

Monitoring & reviewingthe internal audit program

monitoring & reviewingidentifying needs for corrective

identifying needs for prevention actionsidentifying opportunities for improvement

Do


06/21/98 28

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)

142

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.



Audit memberi maklumat tentang:

1. Adakah sistem berjalan baik?

2. Adakah prosedur dan dokumen yang di rujuk adalah yang terkini dan berkesan?


145

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

146

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.

147

148

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

149

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)


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


Rehat!

mbamIABKPM2011 152

BAHAGIAN 5: AKTIVITI AUDIT

mbamIAB11 153

OVERVIEW OF AUDIT ACTIVITES

Planning and scheduling audit

Conducting document review

Conducting audit

Prepare audit report

Conducting follow-up

Preparing for on-site activities

Mbustaman-IAB-KPM 15406/21/98 40

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.

audit


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

157

Masa Pasukan Audit & Ketua Masa Juruaudit


TarikhKetua Juruaudit

Juruaudit

Kriteria Audit

Skop Audit

CONTOH PELAN AUDIT

158

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 questionnaireall records and comments during the audit


JADUAL AUDITJadual 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

160

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


161

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”.m bustaman/IAB/KPM/10


Bahagian di auditTarikh: Muka surat: /

Juruaudit

Rujukan (Klausa) Perkara yang diaudit Catatan Penemuan Audit

SENARAI SEMAK

163

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

164

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

165

Melaksanakan Audit


166

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


167

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


168

Temubual Audit• Temubual adalah salah satu kaedah yang

penting untuk mendapatkan maklumat. Melalui proses temubual, pengumpulan maklumat berlaku dan seterusnya pengumpulan bukti objektif.


169

Temubual AuditSoalan 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.


170

Temubual Audit• Lazimnya, proses temubual audit

mempraktikkan 3 jenis soalan yang berikut:

• SOALAN TERBUKA,• SOALAN TERTUTUP, dan• SOALAN PENJELASAN.


171

Soalan Terbaik Semasa Audit

“SHOW ME…”atau

“BOLEH BERIKAN SAYA...”atau

“Tolong tunjukkan..”


172

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.m bustaman/IAB/KPM/10

173

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 betulm bustaman/IAB/KPM/10

174

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



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


TAKE 5!

mbustamanIABKPM 177hak milik muhd bustaman/IAB/KPM 3INTERNAL Q AUDIT - MAS 97

EXTRA NOTE : AUDIT CONDUCT

�COMMUNICATION SKILLS�QUESTIONING SKILLS�LISTENING SKILLS


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


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

mbustamanIABKPM 180hak milik muhd bustaman/IAB/KPM 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


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


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 ? ”


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.


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”


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?


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.


COLLECTING EVIDENCE• Write down the information

as you conduct the audit.• Keep all of your notes

together.


COLLECTING EVIDENCE

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


Listening Skills• Intelligent and active

listening• Hearing, understanding

and remembering the message

• Taking part in the interaction

• Feedback


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


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 9000Terbahagi 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.

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• 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)



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!

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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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Penemuan Audit & penilaian 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”


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Penemuan Audit & penilaian 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 audit.


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Perbincangan Pasukan (2)Mencapai persetujuan ke atas semua laporan audit yang akan dikemukakan/dilaporkan kepada pihak yang diaudit.Tanggungjawab Ketua juruaudit menentukan klasifikasi NC (ketidakakuran)


200

Perbincangan Pasukan (3)• 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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Perbincangan Pasukan (4) 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 kepada pelangan dan organisasi gagal mengambil tindakan pembetulan


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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.



COMPLETION• All conformities are addressed• All corrective actions implemented• All corrective actions evaluated as effective• Audit completed

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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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Mesyuarat Penutup (2)• 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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Mesyuarat Penutup (3) 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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Mesyuarat Penutup (4) 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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Mesyuarat Penutup (5) 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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Mesyuarat Penutup (6) 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).



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)

217 Module 9GMP Workshop Kuala Lumpur

14-16 Nov 2005

CONCLUSIONS

Nobody likes to be audited………..

It is a means to have continuous improvement

“Kejayaan sebenar ialahbila anda merasai kenikmatan atas hasil perubahan….”

SEKIAN TERIMA KASIH


SEKIAN, TERIMA KASIH

Kursus audit kualiti dalaman iso 9001 2008

Education

makan tengahari

benefits standards

quality management

quality system

pengertian

effective

customer property

quality objectives