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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
Kursus audit kualiti dalaman  iso 9001 2008
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Kursus audit kualiti dalaman iso 9001 2008

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  • 1. 1KURSUS AUDIT KUALITIDALAMANMS ISO 9001:2008olehMuhamad Bustaman b. Abdul Manaf(Pensyarah Cemerlang DG 54)Institut Aminuddin Baki, KPM0199890524/mbustaman@iab.edu.mymbustaman@iab.edu.my
  • 2. Taklimat Kursus• Pengenalan Diri • Jadual Kursus danKandungan Kursus• Peraturan SemasaBerkursusmbustaman/IAB/KPM/102
  • 3. mbustaman/IAB/KPM/103BIODATAFASILITATORMUHAMAD BUSTAMAN BIN HAJI ABDUL MANAFPensyarah Cemerlang DG 54, Instutut Aminuddin Baki, KPMA. Pengalaman: Pengurus kursus Pengurusan Strategik dan Pengurusan Kualiti di Institut AminuddinBaki semenjak 1995.1. Buku: 1. Pengurusan Kualiti dalam pendidikan 2. Perancangan StrategikB. 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 MSISO 9000 dari MAMPU.Berpengalaman menjadi juruaudit bersama dengan MAMPU serta memberi konsultasi dalampembinaan dokumen kualiti dan Audit Kualiti Dalaman .D. Bidang kepakaran lain: Change Management, Benchmarking, Balanced Scorecard (KPI), StrategicLeadership 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.
  • 4. mbustaman/IAB/KPM/104
  • 5. mbustaman/IAB/KPM/105
  • 6. mbustaman/IAB/KPM/106
  • 7. mbustaman/IAB/KPM/107
  • 8. mbustaman/IAB/KPM/108
  • 9. m bustaman/IAB/KPM/10 9OBJEKTIF UTAMA• Untuk melengkapkan pesertadengan pengetahuan dankemahiran yang diperlukan untukmelaksanakan audit kualitidalaman ke atas pelaksanaansistem pengurusan kualiti MS ISO9001:2008 dengan berasaskanStandard Management SystemAuditing ISO 19011:2002.
  • 10. mbustaman/IAB/KPM/1010
  • 11. m bustaman/IAB/KPM/1011
  • 12. mbustaman/IAB/KPM/1012
  • 13. mbustaman/IAB/KPM/1013TOPIK YANG DILIPUTI• Bahagian 1:• Pengenalan Pengurusan Kualiti ,Standard Sistem Kualiti MS ISO9001:2008 & faedah kepadaorganisasi• Model Sistem Pengurusan• Amalan 8 prinsip kualiti dalamkerja seharian
  • 14. mbustaman/IAB/KPM/1014TOPIK YANG DILIPUTI• Bahagian 2: Keperluan StandardMS ISO 9001:2008.• Bahagian 3: Dokumentasi SistemPengurusan Kualiti (SPK).• Struktur Dokumentasi• Kawalan Dokumentasi SPK
  • 15. mbustaman/IAB/KPM/1015TOPIK YANG DILIPUTIBahagian 4: Pengenalan Audit• Definisi dan Jenis Audit• Prinsip Audit• Tanggungjawab Juruaudit• Kelayakan Juruaudit• Garis Panduan ISO 19011
  • 16. mbustaman/IAB/KPM/1016TOPIK YANG DILIPUTI• Bahagian 5: Proses Audit KualitiDalaman• Fasa 1: Perancangan Audit• Fasa 2: Pelaksanaan Audit• Fasa 3: Pelaporan Audit• Bahagian Amali:• 1. Amali Audit• 2. Amali Pelaporan
  • 17. mbustaman/IAB/KPM/1017Jadual Kursus• Hari Pertama: Selasa• 8.00 – 8.30 : Taklimat• 8.30- 10.00: Pengenalan Kursus danBahagian 1• 10.00-10.30: Kudapan pagi• 10.30 – 12.45: Sambungan Bahagian 1• 2.15 - 4.45: Bahagian 2-Std ISO9001:2008
  • 18. mbustaman/IAB/KPM/1018Jadual 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 & Perancanganaudit
  • 19. mbustaman/IAB/KPM/1019Jadual Kursus• Hari Ketiga: Khamis• 8.15 - 10.00: Bhg 5: Perancangan audit dan pelaksanaanaudit.• 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.
  • 20. mbustaman/IAB/KPM/1020Jadual 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, PenilaianKursus & Penutupan Kursus
  • 21. mbustaman/IAB/KPM/1021Bahagian 1• Definisi Kualiti• Pengenalan PengurusanKualiti & Standard SistemKualiti ISO 9001:2008• 8 prinsip kualiti• Model Sistem PengurusanKualiti• Faedah MelaksanakanMS ISO 9000
  • 22. mbustaman/IAB/KPM/1022Apakah itu Kualiti?1. Fit for purpose (Juran).2. Quality is conformance to requirements(Philip Crosby)3. Keupayaan sesuatu barang/perkhidmatanyang mempunyai ciri-ciri kemampuan untukmemenuhi sesuatu kehendak.(Shewhart)
  • 23. m bustaman/IAB/KPM/10 23Definisi Kualiti –ISO 9000“ darjah dimana sekumpulan sifat produk atauperkhidmatan yang wujud memenuhikeperluan-keperluan” (3.1.1)Sifat (3.5.1) bermaksud ciri-ciri yang mebezakan sesuatusamada sedia wujud yang atau diberikan, kualitatifatau kuantitatif atau jumlah yang banyak dan terdapatbanyak kelas sifat seperti fizikal, deria, kelakuan,bataswaktu, ergonomic dan fungsian.Keperluan (3.1.2) adalah amalan yang biasa digunakanoleh syarikat, pelanggannya dan atau pihak yangberminat.
  • 24. APA ITU KUALITIKeupayaan sesuatu produkatau perkhidmatan memenuhikepuasan pelanggan(pihak berkepentingan)24Hak Milik MBAM@IAB KPM 09
  • 25. Pengertian Kualiti : lima pendekatan• Menyamakan kualitisebagai keunggulanatau kecemerlangan.Dengan itu kualiti tidak dapatditentukan tetapi boleh dirasaiatau dinikmati hanya melaluipengalaman. Misalnya,kenyataan yang berbunyi ”Saya tahu kualiti bila sayamelihatnya/merasainya”.Hak Milik MBAM@IAB KPM 09 25
  • 26. Pengertian Kualiti : pendekatan 2• Berdasarkan kepada keluaran, kualiti dilihat sebagaimempunyai ciri-ciri tertentu yang boleh diukur. Ciri-ciri ini adalah ketahanan, boleh diharap, rupa bentukdan keselamatan. Pendekatan ini membawaimplikasi bahawa semakin banyak ciri ini dirangkumidalam satu keluaran, kos pengeluaran akanmeningkat.26Hak Milik MBAM@IAB KPM 09
  • 27. Pengertian Kualiti: pendekatan 3• Berdasarkanpandangan pengguna• “quality lies in the eye of thebeholder.”• Tiap-tiap pengguna mempunyaikehendak yang berbeza-beza dan mana-mana keluaran atau perkhidmatan yangmemenuhi kehendak ini akan dianggapsebagai berkualiti.Hak Milik MBAM@IAB KPM 092
  • 28. • Berdasarkan kepadanilai, kualiti dilihat darisegi kos dan harga.• Keluaran atau perkhidmatan yangberkualiti dilihat dari segi keperluanmemenuhi kehendak pengguna denganharga yang boleh diterima oleh mereka.Hak Milik MBAM@IAB KPM 09 28Pengertian Kualiti :pendekatan 4
  • 29. • Berdasarkankepada pandangansektor pembuatan,• kualiti diertikan sebagaimemenuhi kehendak atauspesifikasi yang telahditentukan.29Hak Milik MBAM@IAB KPM 09Pengertian Kualiti :pendekatan 3
  • 30. • Bagi sektorswasta, daya persainganakan ditentukan olehkehendak dan cita rasapengguna.• Dalam konteksperkhidmatanawam, kualiti diertikansebagai dapat Hak Milik MBAM@IAB KPM 09 30Pengertian Kualiti :pendekatan 5
  • 31. mbustaman/IAB/KPM/1031Kesimpulan: DefinisiThe experts and gurus have variousdefinitions…. But they all add up to thesame thing:“ Meeting the customer’srequirement”
  • 32. Hak Milik MBAM@IAB KPM 09 32
  • 33. mbustaman/IAB/KPM/1033Quality Process Measures
  • 34. mbustaman/IAB/KPM/1034INPUT OUTPUTPROSESPDCA@ OUTCOME1. Kecekapan3. Kepastian kualiti4. Inovasi5. Quality of work life2. Keberkesanan6. Produktiviti7. Budgetability7 Kriteria Prestasi (Sink & Tuttle Model, 1989)
  • 35. mbustaman/IAB/KPM/1035SEJARAH MENGENAI ISO• ISO atau International Organisation ForStandardisation- organisasi antarabangsabukan kerajaan dengan keahlian lebih 170buah negara.• “In 1946, delegates from 25 countries met in London anddecided to create a new international organization, of whichthe object would be "to facilitate the international coordinationand unification of industrial standards".• Badan ISO, rasmi beroperasi 23 February1947, in Geneva, Switzerland
  • 36. mbustaman/IAB/KPM/1036Latarbelakang ISO• Because "International Organization forStandardization" would have different acronyms indifferent languages ("IOS" in English, "OIN" inFrench for Organisation internationale denormalisation), its founders decided to give it also ashort, all-purpose name”.• “They choose "ISO", derived from the Greekisos, meaning "equal". Whatever thecountry, whatever the language, the shortform of the organizations name is alwaysISO”.
  • 37. mbustaman/IAB/KPM/1037INTERNATIONAL ORGANISATION FORSTANDARDISATION (IOS)1. Tujuan:“untuk mempromosi pembangunan standard .... untukmemajukan kerjasama di kalangan negara ahli dalambidang saintifik, ekonomi dan teknologi”2. Fungsi Utama IOS• Menghasilkan siri standard yang boleh diguna pakaidalam semua jenis industri/perkhidmatan di pelbagainegara• Jenis standard: simbol, kod, sukatan, saiz dankelajuan.
  • 38. mbustaman/IAB/KPM/1038Apa itu ISO 9000?ISO 9000, adalah satu standard bertulisyang menetapkan dan menerangkanelemen keperluan asas yang perlu adadalam SISTEM KUALITI bagimemastikan perkhidmatan diberikan olehsesebuah organisasi dapat memenuhikehendak pelanggan.
  • 39. mbustaman/IAB/KPM/1039ISO• Sistem Pengurusan Kualiti : Berasaskandokumentasi. “Document what you do, dowhat you document and prove it”• Bukan standard atau perkhidmatan: Konseppencegahan• Berasaskan kepada prinsip kepastian kualiti :Konsep kualiti yang universal dandikenal pasti melalui pengiktirafan oleh pihakketiga
  • 40. mbustaman/IAB/KPM/1040ISO...1.„Say what you do‟- mendokumenkan prosedurpelaksanaan proses kerja yang memberi kesan kepadakualiti produk atau perkhidmatan.2.„Do what you say‟- melaksanakan aktiviti kerjasebagaimana dinyatakan dalam prosedur3.„Record what is done‟ - senggara rekod aktiviti sebagaibukti pematuhan kepada apa yang didokumenkan.4.„Improve, based on results‟- perbandingan antara apayang sebenarnya dilakukan dengan apa yang dirancang.Maklumat tersebut boleh membantu sebarang kekurangankepada sistem kualiti
  • 41. mbustaman/IAB/KPM/1041Versi StandardStandard Pertama: 1987Standard Kedua: 1994 (IAB bermula-dengan MAMPU)Standard Ketiga: 2000 (MOODY INT‟)Standard keempat: 2008- versi terkini
  • 42. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 42
  • 43. mbustaman/IAB/KPM/1043PRINSIP ASAS ISO 9000Prinsip Pertama: ISO 9000 adalahstandard bagi sistem kualiti.Prinsip Kedua: ISO 9000 berasaskan kepadadokumentasiPrinsip Ketiga: ISO 9000 menekankanpencegahanPrinsip Keempat: ISO 9000 adalah satustandard universal.
  • 44. mbustaman/IAB/KPM/1044EMPAT STANDARD MS ISO9000:20081. MS ISO 9000:2008 QMS – Fundamentalsand Vocabulary2. MS ISO 9001:2008 QMS – Requirements3. MS ISO 9004:2008 QMS – Guidance forPerformance Improvement4. MS ISO 19011: Guidelines on Quality andEnvironmental Auditing
  • 45. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 45
  • 46. BENGKEL• Bincangkan faedah-faedahpenggunaan standard dalammeningkatkan prestasi kerjaorganisasi?• Masa : 10 minitmbustaman/IAB/KPM/1046
  • 47. mbustaman/IAB/KPM/1047Why Standards Matter?Standards make an enormous and positivecontribution to most aspects of our lives.• Standards ensure desirable characteristics of products and services such asquality, environmental friendliness, safety, reliability, efficiency andinterchangeability - and at an economical cost.• When products and services meet our expectations, we tend to take this forgranted and be unaware of the role of standards. However, when standardsare absent, we soon notice. We soon care when products turn out to be ofpoor quality, do not fit, are incompatible with equipment that we alreadyhave, are unreliable or dangerous.• When products, systems, machinery and devices work well and safely, it isoften because they meet standards. And the organization responsible formany thousands of the standards which benefit the world is ISO.When standards are absent, we soon notice.
  • 48. mbustaman/IAB/KPM/1048Standard merangkumibidang berikut• Manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financialservices, accounting, trucking, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, oil and gas, pulp dan paper, petrochemicalspublisching, shipping, energy, telecommunications, plastics,metals, research, health care, hospitality, utilities, pestcontrol, aviation, machine tools, foodprocessing, agriculture, government, education, recreation, fabrication, sanitation, software development, consumerproducts, transportation, design, instumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, andso on.
  • 49. mbustaman/IAB/KPM/1049What standards doISO standards:• make the development, manufacturing and supply ofproducts and services more efficient, safer and cleaner• facilitate trade between countries and make it fairer• provide governments with a technical base forhealth, safety and environmental legislation, andconformity assessment• share technological advances and good managementpractice• disseminate innovation• safeguard consumers, and users in general, of productsand services• make life simpler by providing solutions to commonproblems
  • 50. mbustaman/IAB/KPM/1050Examples of the benefitsstandards provide• Standardization of screw threads helps to keepchairs, childrens bicycles and aircraft together and solvesthe repair and maintenance problems caused by a lack ofstandardization that were once a major headache formanufacturers and product users.• Standards establishing an international consensus onterminology make technology transfer easier and safer.They are an important stage in the advancement of newtechnologies and dissemination of innovation.• Without the standardized dimensions of freightcontainers, international trade would be slower and moreexpensive.
  • 51. mbustaman/IAB/KPM/1051Examples of the benefits standardsprovide• Without the standardization of telephone and bankingcards, life would be more complicated.• A lack of standardization may even affect the quality of lifeitself: for the disabled, for example, when they are barredaccess to consumer products, public transport and buildingsbecause the dimensions of wheel-chairs and entrances arenot standardized.• Standardized symbols provide danger warnings andinformation across linguistic frontiers.• Consensus on grades of various materials gives a commonreference for suppliers and clients in business dealings.
  • 52. mbustaman/IAB/KPM/1052Examples of the benefitsstandards provide• Consensus on grades of various materials gives a commonreference for suppliers and clients in business dealings.• Agreement on a sufficient number of variations of a productto meet most current applications allows economies ofscale with cost benefits for both producers and consumers.An example is the standardization of paper sizes.• Standardization of performance or safety requirements ofdiverse equipment makes sure that users needs are metwhile allowing individual manufacturers the freedom to designtheir own solution on how to meet those needs.• Standardized computer protocols allow products fromdifferent vendors to "talk" to each other.• Standardized documents speed up the transit of goods, oridentify sensitive or dangerous cargoes that may be handledby people speaking different languages.
  • 53. mbustaman/IAB/KPM/1053Examples of the benefitsstandards provide• Standardization of connections and interfaces of all typesensures the compatibility of equipment of diverse originsand the interoperability of different technologies.• Agreement on test methods allows meaningfulcomparisons of products, or plays an important part incontrolling pollution - whether by noise, vibration oremissions.• Safety standards for machinery protect people at work, atplay, at sea... and at the dentists.• Without the international agreement contained in ISOstandards on metric quantities and units, shopping andtrade would be haphazard, science would be unscientificand technological development would be handicapped.
  • 54. mbustaman/IAB/KPM/1054Take 5!
  • 55. mbustaman/IAB/KPM/1055Dalam Standard versi 2008, iaberlandaskan kepada amalanlapan prinsip kualiti8PRINSIPKUALITI
  • 56. mbustaman/IAB/KPM/1056Prinsip Pertama:Bermatlamatkan Pelanggan• Organisasi bergantung kepada pelanggan mereka.Oleh itu organisasi hendaklah memahami keperluan pelanggan yangsedia ada dan pada masa akan datang, memenuhi keperluan pelanggandan berusaha untuk melebihi jangkaan pelanggan.Faedah Utama• Pemahaman menyeluruh organisasi terhadap keperluan dan jangkaanpelanggan dan stakeholder• Matlamat dan sasaran prestasi yang ditetapkan mestilah berkaitandengan memenuhi keperluan pelanggan.• Peningkatan prestasi organisasi (perubahan) mestilah berasaskan untukmemenuhi keperluan pelanggan.• Memastikan sumber manusia mempunyai pengetahuan dan kemahiranyang diperlukan untuk memenuhi keperluan pelanggan.
  • 57. Hak Milik MBAM@IAB KPM 09 57
  • 58. mbustaman/IAB/KPM/1058Prinsip Kedua: KepimpinanKetua organisasi (PIHAK PENGURUSAN) bertanggungjawab:• mewujudkan halatuju dan matlamat organisasi denganjelas.• mewujudkan dan mengekalkan persekitaran dalaman yangsesuai untuk stafnya supaya mereka dapat terlibatsepenuhnya dalam mencapai objektif-objektif organisasiyang telah ditetapkan bersama.Faedah Utama• Staf akan lebih faham dan bermotivasi ke arah pencapaianobjektif dan matlamat.• Aktiviti akan dinilai, diperkemas dan dilaksanakan dengancara yang lebih bersatu.• Kepimpinan melalui teladan, menggalakkanpenambahbaikan yang berterusan.
  • 59. mbustaman/IAB/KPM/1059Prinsip Ketiga: Penglibatan Staf(kerja berpasukan)Staf atau pekerja di semua peringkat adalahmerupakan tunggak sesebuah organisasi danpenglibatan mereka sepenuhnya membolehkankeupayaan mereka digunakan untuk faedah-faedah organisasi.Faedah Utama• Pekerja yang bermotivasi, komited dan terlibat.• Pekerja merasakan lebih bertanggungjawab atasprestasi masing-masing.• Pekerja lebih seronok untuk terlibat danmenyumbang kepada penambahbaikan.
  • 60. mbustaman/IAB/KPM/1060Prinsip Keempat: PendekatanProsesHasil yang dikehendaki dapat diperolehi denganlebih efisien apabila sumber-sumber dan aktivitiyang berkaitan diurus sebagai suatu proses.Faedah Utama• Keupayaan mengurangkan kos dan memendekkancycle times melalui penggunaan sumber-sumber.• Hasil yang bertambah baik, konsisten dan bolehjangka.• Membolehkan peluang-peluang penambahbaikandiberi keutamaan dan fokus.
  • 61. mbustaman/IAB/KPM/1061Prinsip Kelima: PendekatanSistem Untuk PengurusanDengan mengenal pasti, memahami danmenguruskan sesuatu sistem untuk proses-prosesyang berhubung kait bagi sesuatu objektif, ia dapatmenambahkan kecekapan dan keberkesanansesebuah organisasi.Faedah Utama• Memperkemaskan proses-proses yang akanmenyumbang kepada hasil yang diperlukan.• Keupayaan untuk fokus kepada usaha proses-proses• Memberikan keyakinan kepada pihak yangberkepentingan terhadap keberkesanan dankecekapan organisasi.
  • 62. mbustaman/IAB/KPM/1062Prinsip Keenam: PeningkatanBerterusan• Peningkatan berterusan hendaklahdijadikan sebagai objektif tetap sesuatuorganisasi.Faedah Utama• Peningkatan kelebihan persaingan bolehmenyumbang kepada penambahbaikankeupayaan organisasi.• Keupayaan bertindak balas dengan cekapkepada peluang-peluang.
  • 63. mbustaman/IAB/KPM/1063Prinsip Ketujuh: Pendekatan BerfaktaDalam Membuat Keputusan• Keputusan yang efektif dibuat berdasarkan analisasesuatu data/maklumat.Faedah Utama• Keputusan yang lebih jelas• Keupayaan untuk mempamerkan keberkesanankeputusan yang lalu melalui rujukan kepada fakta-fakta sejarah.• Keupayaan untuk mengkaji semula danmerangsang ke arah penyemakan semulakeputusan dan pandangan.
  • 64. mbustaman/IAB/KPM/1064Prinsip Kelapan: Hubungan yang SalingBermanfaat Dengan PembekalSesuatu organisasi dan pembekal-pembekalnyaadalah saling bergantung antara satu sama laindan hubungan yang saling bermanfaat dapatmempertingkatkan keupayaan yangmenguntungkan kedua-dua pihak.Faedah Utama• Meningkatkan keupayaan untuk mewujudkan nilai bagikedua-dua pihak• Fleksibel dan pantas bertindak ke atas maklum balasbersama terhadap pasaran yang berubah-ubah.• Mengoptimumkan kos dan sumber-sumber.
  • 65. mbustaman/IAB/KPM/1065Rehat!
  • 66. mbustaman/IAB/KPM/1066KEPERLUAN-KEPERLUAN SISTEMPENGURUSANKUALITI STANDARDMS ISO 9001: 2008Bahagian 2
  • 67. Mbustaman-IAB-KPM 67Std MS ISO 9001: 2008 SPKStandard 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 bagitujuan menilai kemampuan organisasi memenuhikehendak pelanggan.• Standard adalah anjal
  • 68. mbustaman/IAB/KPM/1068Penambahbaikan Berterusan SistemPengurusan Kualiti (PDCA)PELANGGAN&STAKE-HOLDERSKEPERLUANTANGGUNGJAWABPENGURUSANATASAN (5.0)PENGURUSANSUMBER (6.0)PENGUKURAN,ANALISIS &PENAMBAHBAIKAN (8.0)PENZAHIRANPRODUK(7.0)(Product Realization)PELANGGAN&STAKE-HOLDERSBERPUAS-HATIPRODUKINPUT OUTPUTAktiviti Penambahan NilaiAliran informasi4.0Model Proses Sistem Pengurusan
  • 69. Mbustaman-IAB-KPM 69Keperluan MS ISO 9001:2008dibahagikan kepada lima seksyen:Seksyen4Sistem PengurusanKualitiPemahaman mengenai proses dandokumentasiSeksyen5TanggungjawabPengurusanPengurusan dan isu pentadbiranSeksyen6Pengurusan sumber Mengenai sumber kewangan,manusia, peralatan dan persekitarankerjaSeksyen7Proses penyampaianperkhidmatan.Keperluan proses dan proses yangdiperlukan bagi mengubah inputkepada produkSeksyen8Pengukuran, Analisisdan PenambahbaikanMengenai isu seperti pengukuranproduk/perkhidmatan, pemantauansistem dan proses penambahbaikan.
  • 70. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 70Struktur Kandungan StandardTerbahagi Kepada 8 Para0. Pengenalan1. Skop2. Rujukan Nomatif3.Terminologi dan definisi4.Sistem pengurusan kualiti0.1 Am0.2 Pendekatan proses0.3 Hubung kait dengan ISO9004.0.4. Kompatibiliti dengan sistempengurusan lain1.1 Am1.2 Applikasi
  • 71. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 71Clause 4.1 Quality ManagementSystem (General Requirements)Organization shall establish, document, implement, maintainand continually improve quality management system. Stepsrequired are:- Identify processes for QMS;- Determine sequence and interaction of these processes;- Determine criteria and methods for effective operation andcontrol;- Ensure availability of information to support effectiveoperation and monitoring of processes;- Measure, monitor, analyze processes and implement actionto achieve planned result and continual improvement.
  • 72. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 724.2 Documentation Requirements4.2.1 General documentationrequirementsExtent of QMS dependent upon:(a) Size and type of organization(b) Complexity and interaction ofprocesses(c) Competence of personnelQMS shall include :(a) Documented procedures requiredby the standard(b) Documentation required byorganization for ensuring effective operation andcontrol of its processes
  • 73. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 73Clause 4.2.2Quality Manual shall include :- Scope of quality management system(including justification for anyexclusions);- Description of sequence and interaction ofprocesses in the QMS;- Documented procedures or reference
  • 74. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 74Clause 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 distributioncontrolled- obsolete documents to prevent unintended use and suitablyidentified if retained
  • 75. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 75Clause 4.2.4Control of Quality recordsControl shall cover “records required by the qualitymanagement system”;Records maintained to provide evidence ofconformance and effective operation of the qualitymanagement system;Requirements include : identification, storage,retrieval, protection, retention time and disposition
  • 76. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 76Clause 5 Management ResponsibilityClause 5.1 Management CommitmentTop management shall provide evidence of commitmentby :- Communicating importance of meetingcustomer and legal/regulatory requirements- Establishing quality policy and objectives- Conducting management reviews- Ensuring availability of necessaryresources
  • 77. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 77Clause 5.2 Customer focusTop management shall ensurecustomer needs and expectationsare determined and converted intorequirements and fulfilled with aimof achieving customer satisfaction
  • 78. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 78Clause 5.3 Quality PolicyTop management shall ensure that the quality policy:- Is appropriate to the purpose of the organization- Includes commitment to meeting requirements andcontinual improvement- Provides framework for establishing and reviewingquality objectives- Is communicated and understood at relevant levels inthe organization- Is reviewed for continuing suitabilityQuality policy shall be controlled
  • 79. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 79Clause 5.4 PlanningClause 5.4.1 Quality objectivesTop management shall ensure that qualityobjectives:- are established at relevant functions andlevels- are measurable and consistent with QP(including commitment to continualimprovement)- include objectives needed to meetrequirements of product
  • 80. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 80Clause 5.4.2 Quality Planning- Top management shallensure that resources neededto achieve quality objectivesare identified and planned- Output of planning shall bedocumented
  • 81. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 81Clause 5.4.2 (Coned)Quality Planning shall include :(1) Processes of the QMS (consideringpermissible exclusions)(2) Resources needed(3) Continual improvement of the QMSChange shall be conducted in a controlledmanner and system integrity shall be maintainedduring this process
  • 82. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 82Clause 5.5.1 Responsibility, Authorityand CommunicationFunctions and interrelations withinthe organization, includingresponsibilities and authorities, shallbe defined and communicated.
  • 83. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 83Clause 5.5.2 Management Representative• Shall be appointed by top management;• Allows for more than one managementrepresentative;• Responsibility enhanced to includereporting on needs for improvement andpromoting awareness of customerrequirements throughout the organization.
  • 84. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 84Clause 5.5.3 InternalCommunicationNow requirement to ensureadequate communication betweenvarious levels/functions regardingprocesses of QMS and theireffectiveness
  • 85. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 85Clause 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 managementreviews- changes affecting QMS
  • 86. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 86Review output shall include actionsrelated to :- Improvement of QMS and processes- Improvement of product related tocustomer requirements- Resource needsRecords of reviews shall be maintained
  • 87. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 87Clause 6 ResourceManagementClause 6.1Provision of resourcesProvision of resources : Resources needed toimplement and improve processes of QMS andto address customer satisfaction shall bedetermined and provided in a timely manner.
  • 88. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 88Clause 6.2 Human ResourcesPersonnel assigned responsibilities shall becompetent 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 ofactivities and contribution to achievement of qualityobjectives- Maintaining records of education training,qualification & experience
  • 89. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 89Clause 6.3 InfrastructureIdentify, provide & maintain facilities needed toachieve conformity of product.This shall cover:- Workspace and associated facilities- Equipment, hardware and software- Supporting services
  • 90. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 90Clause 6.4 Work Environment- Identify and manage the human andphysical factors of the work environment- Specific reference to health & safety conditions,work methods, work ethics & ambient workingconditions have been removed
  • 91. mbustaman/IAB/KPM/1091Rehat!
  • 92. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 92Clause 7 Product realizationClause7.1 Planning of realization processesPlanning of sequence of processes and sub processes needed toachieve the product shall be documentedIn planning of realization processes, the following shall bedetermined :- quality objectives for the product;- the need to establish processes anddocumentation and provide resources andfacilities;- verification and validation activities and criteria foracceptability;- records needed to provide confidence ofconformity
  • 93. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 93Clause 7.2 Customer-relatedprocessesCustomer related processes involve :- Determination of requirements related to theproduct (7.2.1)- Review of requirement related to the product(7.2.2)- Customer communication (7.2.3)
  • 94. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 94Clause 7.2.1 Determination ofrequirements related to the productIdentification of customer requirements shall include :- Customer requirements for productincluding those for availability, delivery andsupport;- Product requirements not specified butnecessary for intended/specified use;- Regulatory and legal requirements
  • 95. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 95Clause 7.2.2 Review of requirementsrelated to the productBefore 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 requirementsResults of review and follow-up actions shall be recordedRevision to requirements shall result in amendment torelevant documentation and communicated to personnel inorganization.
  • 96. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 96Clause 7.2.3 Customer CommunicationCommunication to customer relating to following shallbe identified and implemented :- product information- enquiry /contract/ order handling- customer feedback, including complaints
  • 97. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 97Clause 7.3 Design anddevelopmentCovers :- 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
  • 98. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 98Clause 7.3.1 Design anddevelopment planning- stages of the design/developmentprocess- required review, verification and validationactivities appropriate to the stage- responsibilities & authorities for design /development planningInterfaces between different groups shall beeffectively managed.Planning output shall be updated
  • 99. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 99Clause 7.3.2 Design anddevelopment inputsProduct requirements shall be defined anddocumented, including :- Functional and performance requirements- Applicable regulatory/legal requirements- Information derived from previous similardesigns- Other requirements essential for design/development.Requirement shall be reviewed for adequacy.Incomplete, ambiguous or conflicting requirementsshall be resolved.
  • 100. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 100Clause 7.3.3 Design and developmentoutputOutputs of design/development process shall be documented.Design/development output shall :- Meet design/development input requirements- Provide information for production/serviceoperations- Contain or reference product acceptance criteria- Define characteristics of product essential for safe andproper use.Design/development documents approved prior to release
  • 101. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 101Clause 7.3.4 Design and developmentreviewReview shall be conducted at suitable stages to:- Evaluate capability to fulfil requirements- Identify problems and propose follow-upactionParticipants shall include personnel relevant to the stagebeing reviewedResult of review and follow-up actions shall be recorded
  • 102. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 102Clause 7.3.5 Design anddevelopmentverification- Verification shall be performed toensure output meets inputrequirements- Results of verification and subsequentfollow - up action shall be recoded
  • 103. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 103Clause 7.3.6 Design and developmentvalidation- Design validation shall be carried out toconfirm resultant product/service capableof meeting requirements of intended use- Partial validation may be done if fullvalidation not practical prior to delivery ofproduct or implementation of service- Results of validation and follow-up action shallbe recorded
  • 104. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 104Clause 7.3.7 Control of changes- Design/development changes shall beidentified, documented and controlled- Evaluation of effects of changes on componentsparts and delivered products required.- Changes shall be verified, validated andapproved before implementationResults of review and follow-up actions shall berecorded
  • 105. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 105Clause 7.4 - Purchasing7.4.1 Purchasing Process7.4.2 Purchasing information7.4.3 Verification of purchased product
  • 106. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 106Clause 7.4.1 Purchasing Process- Purchasing processes shall be controlled to ensurepurchased product conforms to organizationrequirements- Type and extent of control dependent on effect ondelivered product- Evaluation and selection of suppliers shall becarried out- Criteria for selection and periodic evaluation shall bedefined- Results of evaluations and follow-up actions shall berecorded
  • 107. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 107Clause 7.4.2 PurchasingInformationPurchasing documents shall contain informationdescribing product ordered, including :- Requirements for approval or qualification ofproduct- Quality management systems requirements- Adequacy of specified requirement indocuments shall be ensured prior to release
  • 108. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 108Clause 7.4.3 Verification of purchasedProduct- Activities necessary for verification ofpurchased product shall be determined andimplemented- Supplier shall be informed throughpurchasing information of intendedverification by organization or customer atsupplier’s premises
  • 109. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 109Clause 7.5 Production and serviceoperationsProduction and service operation covers :- Control of production and serviceprovision (7.5.1)- Validation of processes for production andservice provision (7.5.2)- Identification and traceability (7.5.3)- Customer property (7.5.4)- Preservation of product (7.5.5)
  • 110. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 110Clause 7.5.1 Control of production andservice operationProduction/service operations controlled through :- Availability of information that specifiescharacteristics of product- Availability of work instruction, where necessary- Use and maintenance of suitable equipment- Availability and use of suitable measuring andmonitoring devices- Implementation of monitoring activities- Defined processes for release, delivery andapplicable post-delivery activities
  • 111. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 111Clause 7.5.2 Validation of processesfor production andservice provisionProduction/service processes where output is not verified by subsequentmeasurement 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
  • 112. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 112Clause 7.5.3 Identification andTraceability- Where appropriate, product shall beidentified at all stages of production/serviceoperations- Status of product with respect tomeasurement and monitoring requirements- Control and record unique identification ofproduct if traceability required.
  • 113. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 113Clause 7.5.4 Customer property- Care shall be exercised with customer property whenunder organization’s control or being used by it- Customer property provided for use or forincorporation into product shall be identified,verified, protected and maintained.- Record and report to customer if lost, damaged orunsuitable for use.- May include intellectual property
  • 114. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 114Clause 7.5.5 Preservation ofProductConformity to customer requirement shall bepreserved during internal processing and delivery tointended destinationIt shall include : identification, handling, packaging,storage and protection.Applicable to parts or components of product orelements of service
  • 115. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 115Clause 7.6 Control of Measuring andMonitoring Devices- Measurements to be made and measuring andmonitoring device required shall be identified;- M & M devices shall be used and controlled in a manner thatensure measurements are consistent with measurementrequirements;- Software shall be validated before use;- Calibration at specified intervals or before use, withtraceability 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 beout of calibration and take appropriate action
  • 116. mbustaman/IAB/KPM/10116Rehat!
  • 117. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 117Clause 8 Measurement, analysisand improvementMeasurement, 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)
  • 118. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 118Clause 8.1 General- Define, plan and implement measuring andmonitoring activities to assure conformityand achieve improvement;- Includes determination of need for and useof applicable methodologies includingstatistical techniques
  • 119. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 119Clause 8.2 Measuring andMonitoringMeasuring and monitoring covers :- Customer satisfaction (8.2.1)- Internal audit (8.2.2)- Processes (8.2.3)- Product (8.2.4)
  • 120. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 120Clause 8.2.1 Customer satisfaction- Monitor information on customersatisfaction / dissatisfaction;- Methods for obtaining and utilizing suchinformation shall be determined.
  • 121. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 121Clause 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 ofactivities and (ii) results of previous audits;• Audit scope, frequency and methodologies shall bedefined• Audits performed by personnel other then those whoperformed work being audited;• Procedure covering responsibilities and requirements,ensuring independence, recording results andreporting to management ; timely corrective actionrequired;• Follow-up to include verification of CA and reportingresults
  • 122. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 122Clause 8.2.3 Measurement andMonitoring of ProcessesSuitable methods shall be applied for measurementand monitoring of realization processes necessary tomeet customer requirements;Methods shall confirm continuing ability of eachprocess to satisfy intended purpose
  • 123. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 123Clause 8.2.4 Measurement andMonitoring of Product• Product/service characteristics shall bemeasured and monitored measurement andmonitoring shall be carried out at variousstages;• Evidence of conformance with acceptancecriteria shall be recorded;• Authority responsible for release of product/service shall be indicated in records;• Product shall not be released until allspecified activities have been satisfactorilycompleted unless otherwise approved by customer
  • 124. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 124Clause 8.3 Control of nonconformingproductNon-conforming product/service shall be identified andcontrolled to prevent unintended use or delivery;Non-conforming product shall be corrected andreverified;Appropriate action to be taken if non-conformingproduct/service is detected after delivering or use hasstarted;Proposed rectification of non-conforming product shallbe reported to customers, end-user, regulatory body orother body for concession
  • 125. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 125Clause 8.4 Analysis of data- Collect and analyze appropriate data- Data analysis to be used for determining suitability andeffectiveness of QMS and for identifying areas forimprovement- Data to be analyzed may include those from measuringand monitoring activitiesData analysis to provide information on :- Customer satisfaction/dissatisfaction ;- Conformance to customer requirements ;- Characteristics of processes/products services;- suppliers
  • 126. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 126Clause 8.5 - ImprovementImprovement covers :- Continual improvement (8.5.1)- Corrective Action(8.5.2)- Preventive Action(8.5.3)
  • 127. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 127Clause 8.5.1 Continual improvementProcesses necessary for continual improvementof QMS shall be planned and managedContinual improvement shall be facilitatedthrough use of:(1) Quality Policy(2) Quality Objectives(3) Audit Result(4) Analysis of data(5) Correction/Preventive Action(6) Management Review
  • 128. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 128Clause 8.5 2 Corrective Action.- To eliminate causes of non-conformance to preventrecurrence- Shall be appropriate to the magnitude and impact ofproblemsProcedure to cover :- Identification of non-conformities (including customercomplaints)- 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
  • 129. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 129Clause 8.5.3 Preventive Action- To eliminate causes of potential non-conformities to prevent occurrence- Shall be appropriate to the magnitude and impactof problems encounteredProcedure 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
  • 130. mbustaman/IAB/KPM/10130Rehat!
  • 131. m bustaman/IAB/KPM/10 131AUDITKUALITIDALAMANBahagian 4PengenalanAudit
  • 132. mbustaman/IAB/KPM/1013211Definisi Audit KualitiProses yangsistematik, berkecuali dandidokumenkan untukmendapatkan bukti audit danmenilaikannya secara objektifdalam menentukan kriteria audittelah dipenuhi.(ISO 19011:2002, page 1)
  • 133. Penjelasan: definisi1. Kriteria audit (3.2):• Set dasar, prosedur atau keperluanyang digunakan sebagai rujukan.• Set of policies, procedures or requirements2. Bukti Audit (3.3)Keputusan penilaian yang dibuat keatas bukti yang telah diperolehidengan kriteria audit. Penemuanboleh menyatakan keakuran terhadapkriteria audit, atau peluang untukpenambahbaikanmbustaman/IAB/KPM/10133
  • 134. mbustaman/IAB/KPM/1013416Audit Kualiti Bermakna:• Mesti Sistematik (bukan rambang tetapiterperinci)• Mesti Bebas (tidak dilakukan oleh merekayang berkepentingan)• Mesti menentukan sama ada aktiviti-aktivitikualiti telah memenuhi keperluan “plannedarrangements” (termasuk aktiviti-aktiviti dalamQuality Std ISO 9004)
  • 135. mbustaman/IAB/KPM/1013506/21/98 17@ Hakcipta Terpelihara HMAAudit Kualiti Bermakna:• Mesti meliputi “related results” iaitu memeriksahasil setelah aktiviti-aktiviti kualiti dilaksanakan(dengan memeriksarekod, produk, proses, membuat keputusan dll)• Mesti menentukan “compliance with plannedarrangements” iaitu dasar dan prosedur umumsepertikontrak, pelan, spesifikasi, lukisan/lakaran, prosedur khusus dan arahan.
  • 136. mbustaman/IAB/KPM/1013618Audit Kualiti Bermakna:• Mesti menentukan sama ada “arrangements”diimplementasikan dengan berkesan. Keberkesanandiukur 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 adaperuntukan yang dibuat oleh pembekal dapatmemenuhi objektif organisasinya (objektif kualiti)
  • 137. mbustaman/IAB/KPM/1013719Audit Kualiti Bermakna:• Audit Sistem Kualiti melibatkanpemeriksaan sesuatu “produk”tetapibukan untuk mengesahkannya (certify)• Audit Sistem Kualiti juga melibatkanpemeriksaan sesuatu operasi dan rekod-rekod operasi untuk mempastikan rekod-rekod itu menggambarkan operasi yanglalu.
  • 138. SAMBUNGAN : Kesimpulan MAKNA AUDIT• Ia adalah aktiviti pengumpulan maklumatuntuk membolehkan tindakan pembetulan danpenambahbaikan dapat dikesan secaraobjektif.• Ia dilaksanakan secara terancang/sistematik• Dilaksanakan olek mereka yang terlatih• Berdasarkan std & kriteria yang ditetapkan• Melaporkan dengan tepat, benar dan lengkap.mbustaman/IAB/KPM/10 138
  • 139. mbustaman/IAB/KPM/1013915Jenis Audit– 1. Audit Luaran (External Audit) = AuditPersijilan/pihak ketiga– 2. Audit Dalaman (Internal Audit) = Auditpertama– International Register of Certified Auditors(IRCA) menggunakan :– Assessment = Audit– Assessors = Auditors
  • 140. 140FLOW CHART OF IQA: ISO 19011Improving the auditprogrammecompetence andevaluation ofauditorsAuthority for the auditprogrammeAudit activitiesActPlanCheckImplementing internal audit programscheduling auditsevaluating auditorsselecting audit teamdirecting audit activiriesmaintaining recordsEstablishingthe internal audit programobectivesresponsibilittiesresourcesprocedure and guidanceMonitoring & reviewingthe internal audit programmonitoring & reviewingidentifying needs for correctiveidentifying needs for prevention actionsidentifying opportunities for improvementDo
  • 141. mbustaman/IAB/KPM/1014106/21/98 28Tujuan Pengauditan• Audit dilaksanakan untuk:• mencari fakta, bukan kecacatan• mengelak daripada “deterioration” dalamstandard• Kegunaan audit dapat dilihat apabilaianya diasaskan kepada standard yangperlu dipatuhi oleh sesebuah organisasi(contohnya standard ISO 9000)
  • 142. Tujuan Audit Dalaman (AD)• Untuk mengumpul bukti objektif mengenaitahap keakuran pelaksanaan, kecekapandan keberkesanan sistem pengurusankualiti (SPK) organisasi (MS ISO 9000)dan mengesan peluang penambahbaikan(inovasi) SPK dan prestasi organisasi.mbustaman/IAB/KPM/10142
  • 143. Mbustaman-IAB-KPM 143Audit memberi maklumattentang:1. Adakah sistem berjalan baik?2. Adakah prosedur dan dokumen yang dirujuk adalah yang terkini dan berkesan?
  • 144. Mbustaman-IAB-KPM 144
  • 145. 145ROLES OF IQA As a powerful tool to measure the effectivenessof quality management system Evaluates organisation‟s compliance with QMSin all aspects related production and qualitycontrol Detects any shortcomings in the implementationof QMS Recommend the necessary corrective andpreventive actions
  • 146. 146BENEFITS OF IQA Tells you the health of a quality system Identify the root of a problem and plan forcorrective and preventive actions with timeline Achieve better allocation of resources Able to avoid potentially big problem Learn what an auditors look for Continuous improvement
  • 147. Limitations of audit• It can neither help in prioritizing changes nor in allocatingresources.• Audit cannot mobilize people to take action.• Audit cannot generate better data than the measuresused to gather those.• An audit, by itself cannot improve performance.• An audit should not be used for wrongful purposes. Itshould not be used for personal indictment and to justifyimprove actions.147
  • 148. 148Prinsip Audit• Kelakuan beretika – asas kepadaprofesionalismekepercayaan, integriti, kerahsiaan, dankebijaksanaan• Kewajaran Penyampaian – kewajipan untukmelaporkan yang benar & tepat• Berkecuali – asas kepada keadilan dankebenaran kesimpulan audit• Pendekatan berasaskan bukti – kaedah yangrasional untuk menghasilkan kesimpulanaudit yang boleh dipercayai
  • 149. 149Keperibadian Juruaudit (ISO 19011)• Berfikiran terbuka dan matang• Mempunyai pertimbangan yang baik• Mempunyai kemahiran analisis/teknikaldan berpendirian tetap• Bersikap realistik dan mempunyaikemahiran sosial• Berkemahiran kemunikasi• Personaliti positif: peramah, tolongmenolong, bersopan, merendah diri &jujur)
  • 150. mbustaman/IAB/KPM/10150Ciri-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
  • 151. mbustaman/IAB/KPM/10151Rehat!
  • 152. mbamIABKPM2011 152BAHAGIAN 5: AKTIVITI AUDIT
  • 153. mbamIAB11 153OVERVIEW OF AUDIT ACTIVITESPlanning and scheduling auditConducting document reviewConducting auditPrepare audit reportConducting follow-upPreparing for on-site activities
  • 154. Mbustaman-IAB-KPM 15406/21/98 401. Program Audit• Program disediakan oleh WakilPengurusan• Program audit dalaman: 2 kali• Program audit luar: 1kali (BadanPersijilan)• Program audit mendefinisikanlokasi, tarikh audit danmengenalpasti auditor.
  • 155. Mbustaman-IAB-KPM 15506/21/98 41Merancang Pengauditan• Menjadi tanggungjawab Wakil Pengurusan &Ketua juruaudit merancang dan mengelola• Pasukan audit dipilih daripada mereka yangberkelayakan.• Mengumpulkan maklumat untuk merancangyang berkaitan dengan skop, termasukmaklumat juruaudit untuk penyusunan ahlipasukan dan proses yang akan diaudit.• Memeriksa dokumen sistem kualiti untukperancangan audit
  • 156. Mbustaman-IAB-KPM 15606/21/98 42Merancang Pelan Pengauditan• Pelan audit adalah gambaran mengenaiaktiviti dan penyusunan audit.• Ia merangkumi maklumat pelaksanaanaudit 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 Juruauditmbustaman/IAB/KPM/10157TarikhKetua JuruauditJuruauditKriteria AuditSkop AuditCONTOH PELAN AUDIT
  • 158. 158AUDIT 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
  • 159. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 159JADUAL AUDITJadual Audit Jan 20, 20118:00 – 8:30 Persediaan Auditor8:30 – 9:00 Mesyuarat Pembukaan9:00 – 9:30 Kawalan Dokumen9:30–10:30 Komitmen Pengurusan Atasan10:30–11:30 Pengurusan Pelanggan11:30–12:30 Pengurusan kursus-jabatan Inovasi12:30– 2:30 Rehat2:30 – 4:30 Pengurusan Latihan4:30 – 5:00 Mesyuarat penutup
  • 160. Penyediaan Senarai Semak• Alat bantuan untuk memandu, memberiperingatan mengenai maklumat yang perludiperolehi dan fakta yang perlu disahkan.• Panduan mengenai soalan yang akan ditanyadan keberkesanan proses temubual.• Kaedah popular dalam menyediakan soalan:• a. menukar kenyataan dalam standard atau prosedurmenjadi soalan• b. meringkaskan kenyataan tersebut• c. ayat peringatanmbustaman/IAB/KPM/10160
  • 161. contoh• “ Catatkan maklumat pelanggan dalam borang maklumbalasdengan betul dan lengkap”• Kenyataan ini akan ditukar seperti berikut:• “ Apakah maklumat pelanggan yang dicatatkan dalam BorangMaklumbalas?”• Atau,• “Catatkan maklumat pelanggan dalam Borang Maklumbalas denganbetul dan lengkap”.• Jika diringkaskan, ia akan ditulis seperti berikut:• “Maklumat pelanggan- Borang Maklumbalas”.• Atau,• “catatkan maklumat pelanggan dalam Borang Maklumbalas denganbetul dan lengkap”.• Jika ditulis sebagai peringatan:• “Semak maklumat pelanggan dalam Borang Maklumbalas”.mbustaman/IAB/KPM/10161
  • 162. mbustaman/IAB/KPM/10162Bahagian di auditTarikh: Muka surat: /JuruauditRujukan (Klausa) Perkara yang diaudit Catatan PenemuanAuditSENARAI SEMAK
  • 163. 163EXAMPLE OF AN AUDITCHECKLISTCHECKING LIST FOR GMP ASSESSMENTDate : Location : WarehouseAuditor : Auditee :DESCRIPTION GMP.REF. PARAMETER AUDIT FINDINGPersonnel 1.2.15.1.22.1.5- Organization structure- Personnel hygiene- Training recordStorage area 10.1.13.13.63.9 & 3.103.12.2- Design and layout of defined area- Flow of personnel and goods- Structure of the storage area, basedon GMP- HVAC system- Record of monitoring parameterSanitation 3.15.3- Pest record program- The map of bait- The cleanliness of weighingapparatusDocumentation 4.310.2.2.310.2.2.1- Record of maintenance andcalibration of weighing apparatus- The effectiveness of label system- Inventory stock control
  • 164. 164INTERNAL: AUDIT QUESTIONAIRESArea audited : ______________________ Date: __________________Question Response1. Does the company have a work instruction tooperate the machine?2. How is the machine being cleaned andmaintained?3. Are personnel trained to use the machine?4.How often is the equipment being calibratedand cleaned?5. When is the last breakdown of the machine?Are there any product being affected?IA MONITORING
  • 165. Melaksanakan Auditmbustaman/IAB/KPM/10165
  • 166. Mesyuarat Pembukaan• Sesi perbincangan „pembukaan‟ di antarapasukan audit dan auditee.• Pengerusi: Ketua Juruaudit• Agenda mesyuarat:• 1. Memperkenalkan juruaudit terlibat• 2. Penerangan mengenaitujuan/skop/kaedah auditmbustaman/IAB/KPM/10166
  • 167. Mesyuarat Pembukaan• 3. Penerangan mengenai ketidakakuran• 4. Pengesahan Jadual audit• 5. Pengesahan kerahsiaan• 6. Melangkapkan keperluan pentadbiranaudit spt borang kehadiran, borangmaklumbalas• 7. Penjelasan mengenai isu-isu yangmungkin timbul ketika auditmbustaman/IAB/KPM/10167
  • 168. Temubual Audit• Temubual adalah salah satu kaedah yangpenting untuk mendapatkan maklumat.Melalui proses temubual, pengumpulanmaklumat berlaku dan seterusnyapengumpulan bukti objektif.mbustaman/IAB/KPM/10168
  • 169. Temubual AuditSoalan yang akan dikemukakan olehJuruaudit mestilah:*Memerlukan jawapan yang boleh memberimaklumat yang dikehendaki,*Tidak mencadangkan jawapan, dan*Tidak mengandungi ayat dan implikasiyang beremosi.mbustaman/IAB/KPM/10169
  • 170. Temubual Audit• Lazimnya, proses temubual auditmempraktikkan 3 jenis soalan yangberikut:• SOALAN TERBUKA,• SOALAN TERTUTUP, dan• SOALAN PENJELASAN.mbustaman/IAB/KPM/10170
  • 171. Soalan Terbaik Semasa Audit“SHOW ME…”atau“BOLEH BERIKAN SAYA...”atau“Tolong tunjukkan..”mbustaman/IAB/KPM/10171
  • 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 atasbukti objektif,• Buat catatan yang perlu,• Jika sudah berpuashati, tanya soalan yangseterusnya.mbustaman/IAB/KPM/10172
  • 173. Persekitaran Audit• Faktor elemen fizikal: keselesaanpersekitaran• Elemen emosi: mencari keakuran bukanketidakakuran. Jaga “eye contact”‟ danbody language”.• Kaji pendengar yang baik:• a. mendengar dengan fikiran terbuka• b. Gunakan bahasa badan yang betulmbustaman/IAB/KPM/10173
  • 174. sambungan• c. menjadi pemerhati- auditi cakap lebih.Jangan menyampuk atau ganggu auditibercakap.• d. Tumpukan kepada maklumat yang ingindicari• e. elak dari terus buat kesimpulanmbustaman/IAB/KPM/10174
  • 175. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 175THE GOLDEN RULES OF AUDITING• Be prepared• Retain an open mind• Be professional• Do not waste time• Present a true and fair viewCalm, Courteous, Professional, Polite & Firm
  • 176. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 176TAKE 5!
  • 177. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 1773INTERNAL Q AUDIT - MAS 97EXTRA NOTE : AUDITCONDUCT•COMMUNICATION SKILLS•QUESTIONING SKILLS•LISTENING SKILLS
  • 178. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 178DEVELOP GOOD AUDITING SKILLS• Avoid leading, multiple, & trick questions• Listen intently• Be observant & take note• Try to establish root cause of deficiencies• Actually witness & document objectiveevidence• Avoid giving advice• Remain calm, courteous, polite,professional & firm
  • 179. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 179COLLECTING EVIDENCE…Communication• Communicate clearly• Be open minded• Be aware of biases• Ask question in regard to theQMS• Do not make assumptions• Lead auditors should rely on theaudit team
  • 180. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 1805Questioning SkillsExplaining your need :• Give reasons for asking questions• Don’t demand information, requestit politely• Don’t use deception to obtaininformation
  • 181. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 1816Type of Questions• Closed questions• Probing questions• Emotive questions• Trick questions• Hypothetical questions• Systematic questions• Leading questions• Multiple questions
  • 182. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 1827Don’t ask• Leading questions• Emotive questions“Don’t you use red reject labels ?”“ Why don’t you stamp these documentsUNCONTROLLED”• In general don’t ask closed questions:“…Do you have a procedure forcontrolling noncomforming product ? ”
  • 183. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 18310Requests- Sebagai tambahan kepadasoalan, auditor perlu memeriksadan mendapatkan bukti-bukti.- Jika auditee tidak memberikankerjasama, auditor perlumeminta dengan cara yang baikuntuk mendapatkan bukti.
  • 184. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 18411Example Requests• “ I would like to see some results ofthe design verification activitiesyou performed on project X”• “Having examined your auditprocedures and found themsatisfactory, I would now like toexamine the file of audit reports”
  • 185. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 185SOME QUESTION TO ASK THE AUDITEEAre 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 ownprocedures 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?
  • 186. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 186METHODS FOR IMPROVING AUDITING SKILLSAsk question instead of giving direct orders, if you arethe audit team leader.There are two things that every person in the worldappreciates….…..to be asked…..to be thanked.
  • 187. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 187COLLECTING EVIDENCE• Write down the informationas you conduct the audit.• Keep all of your notestogether.
  • 188. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 188COLLECTING EVIDENCEDocumentation to audit:• Policies• Procedures• Work instructions• Records• External documents
  • 189. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 1898Listening Skills• Intelligent and activelistening• Hearing, understandingand remembering themessage• Taking part in theinteraction• Feedback
  • 190. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 1909One of the firststeps to improvinglistening skills isto identify factorswhich hindereffective listeningListening problems:• Selective attention• Prematureconclusions• Personal prejudices
  • 191. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 19113Giving Feedback• When something is found that is in youropinion good, give praise• When problems are uncovered, don’t jumpto conclusions• Don’t indicate that there is nonconformity• Point out potential problems• If there is evidence of nonconformity in thesystem then say that there is a weaknessnot a NC
  • 192. Mbustaman-IAB-KPM 19206/21/98 44Pengumpulan & PengesahanBukti Objektif• Bukti objektif merujuk kepada:“ data supporting the existence or verify ofsomething” Std ISO 9000Terbahagi 3 kategori:1. Dokumen (rekod, fail, minit mesyuarat, laporankursus)bukti ini menunjukkan perkara yang telah berlakuatau aktiviti/proses yang telah dilaksanakanmengikut prosedur.
  • 193. • 2. Pelaksanaan – ia merujuk kepadaaktiviti yang dilaksanakan sebenar danboleh diperhatikan.(present)• 3. Manusia – tahap pengetahuan danpemahaman yang diperlukan untukmelaksanakan prosedur pada masa depan(future)mbustaman/IAB/KPM/10193
  • 194. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 194WHAT ARE AUDIT FINDINGS?• An observation is a positive, negative, or neutral factthat is supported by objective.• A nonconformity is the non-fulfillment of a requirement.• An audit-finding is a written statement or conclusiondescribing a nonconformity. It concludes:• The requirement, as it is stated In the quality standard, or regulation• The observation which provides evidence that the standard orregulation is not being metRECORD ALL AUDIT FINDINGS!
  • 195. Penemuan Audit & penilaianAwal (1)• Maklumat atau bukti audit yang diperolehisemasa sesi temubual, pemerhatian keatas aktiviti atau proses dan pengesahanyang dibuat ke atas dokumen hendaklahdicatatkan atau direkodkan di dalamSenarai Semak. Maklumat atau bukti audittersebut hendaklah dicatat atau direkoddengan jelas dan lengkap termasuk buktiyang spesifik dan objektif.mbustaman/IAB/KPM/10195
  • 196. Penemuan Audit & penilaianAwal (2)• Catatan atau rekod ini adalah penting untukmenyediakan laporan penemuan audit dankesimpulan audit serta hendaklah diikutidengan penilaian awal ke atas keakuranpelaksanaan sesuatu aktiviti atau prosesseperti: “AKUR” atau “TIDAK AKUR” “TIDAK BOLEH DISAHKAN” “TIDAK CUKUP BUKTI”mbustaman/IAB/KPM/10196
  • 197. Penemuan Audit & penilaianAwal (3) “PERLU RUJUK…” atau “BERKESAN” atau “TIDAK BERKESAN”mbustaman/IAB/KPM/10197
  • 198. Perbincangan Pasukan (1)• Perbincangan ini bertujuan untuk: Membuat penilaian semula ke ataspenemuan audit dan lain-lain maklumatyang dikumpulkan oleh semua juruaudit(menilai pelan audit, kerjasamaauditee, rintangan/kesusahan yangdihadapi).Persediaan untuk menyediakan laporanaudit.mbustaman/IAB/KPM/10198
  • 199. Perbincangan Pasukan (2)Mencapai persetujuan ke atas semualaporan audit yang akandikemukakan/dilaporkan kepada pihakyang diaudit.Tanggungjawab Ketua juruauditmenentukan klasifikasi NC (ketidakakuran)mbustaman/IAB/KPM/10199
  • 200. Perbincangan Pasukan (3)• Keputusan yang dicapai melalui penilaianke atas penemuan audit bolehdikategorikan kepada tiga (3) iaitu: KeakuranIni menunjukkan bukti objektif yangdiperolehi dapat membuktikan keakuranpelaksanaan kepada keperluan yang telahditentukan.mbustaman/IAB/KPM/10200
  • 201. Perbincangan Pasukan (4) KetidakakuranKetidakakuran (nonconformance) bermaksudtidak memenuhi keperluan yang telahditetapkan (the nonfulfillment of specifiedrequirements) Pemerhatian/peluang penambahbaikanKomen yang dibuat ke atas sistempengurusan kualiti untuk tujuanpenambahbaikan atau perkara kurang bukti.mbustaman/IAB/KPM/10201
  • 202. Klasifikasi Ketidakakuran• 1 : Major• a. “ Ketidakakuran yang berlaku telahmenunjukan kegagalan sepenuhnya untukmemenuhi mana-mana klausa STD 9001:2008atau kriteria audit yang lain”• b. tidak akur kepada keperluan SPK yangmengakibatkan kesan buruk/besar terhadapkualiti produk/perkhidmatan yang diberikankepada pelangan dan organisasi gagalmengambil tindakan pembetulanmbustaman/IAB/KPM/10202
  • 203. Sambungan: major• c. Ketidakakuran yang konsisten danberulang-ulang terhadap keperluan SPK.• d. Ketidakakuran yang berlaku terhadapSPK yang boleh membawa kepadaketidakpatuhan kepada keperluan undang-undang yang berkaitan dengan kualitiproduk/perkhidmatan.mbustaman/IAB/KPM/10203
  • 204. NC Minor• NC yang terasing dan tidak konsistendalam memenuhi keperluan yang telahditetapkan• NC yang berlaku tidak memberi kesankepada kualiti produl/perkhidmatan• NC yang tidak memberi kesan dalammemenuhi keperluan, kehendak danjangkaan pelanggan.mbustaman/IAB/KPM/10204
  • 205. Kesimpulan Audit• Semasa membuat kesimpulan audit,Ketua Juruaudit haruslah mengambil kiratujuan utama audit dilaksanakan. Selaindaripada menilai sejauh mana keakurankepada keperluan yang ditetapkan, auditjuga adalah aktiviti untuk mengenalpastipeluang penambahbaikan. Maka, bolehkita katakan bahawa peluangpenambahbaikan perlumbustaman/IAB/KPM/10205
  • 206. Kesimpulan Auditdiutamakan kepada pihak pengurusanauditee berbanding dengan ketidakakuran.mbustaman/IAB/KPM/10206
  • 207. hak milik muhdbustaman/IAB/KPMmbustamanIABKPM 207COMPLETION• All conformities are addressed• All corrective actions implemented• All corrective actions evaluated as effective• Audit completed
  • 208. Mesyuarat Penutup (1)• Mesyuarat ini dipengerusikan oleh KetuaJuruaudit dan dihadiri oleh pasukan audit,auditee dan pengurusan atasan organisasiyang di audit. Mesyuarat ini adalah aktivitipenutup proses audit untuk pasukan auditmembuat kesimpulan ke atas audit yangtelah dilaksanakan.mbustaman/IAB/KPM/10208
  • 209. Mesyuarat Penutup (2)• Tujuan Mesyuarat Penutup diadakanadalah untuk: Mengucapkan terima kasih kepadasemua pihak yang terlibat dalam prosesaudit di atas sokongan dan kerjasamayang telah diberikan sepanjang prosesaudit.mbustaman/IAB/KPM/10209
  • 210. Mesyuarat Penutup (3) Menjelaskan secara ringkas mengenaiproses audit yang telah dilaksanakan (cth:kaedah audit, persampelan dan laporan). Menjelaskan bahawa semua penemuanaudit ankan dikekalkan kerahsiaannya.Mana-mana rekod/laporan/dokumen yangmengandungi maklumat rahsia akandikembalikan kepada organisasi.mbustaman/IAB/KPM/10210
  • 211. Mesyuarat Penutup (4) Melaporkan semua penemuan audit yangmerangkumi Laporan Ketidakakuran,Laporan Pemerhatian dan LaporanPeluang Penambahbaikan supayadifahami dan dipersetujui, dan disahkanoleh auditee. Biasanya ia dilaporkan olehjuruaudit yang bertanggungjawab ke ataspenemuan audit atau laporan tersebut.mbustaman/IAB/KPM/10211
  • 212. Mesyuarat Penutup (5) Menjelaskan kaedah untuk menutupketidakakuran yang dilaporkan danpersetujuan mengenai jangkamasatindakan susulan (lihat Bahagian 9) Menjelaskan kesimpulan audit sertasyor/cadangan bagi tujuan persijilankepada organisasi yang diaudit. Ini adalahpenting untuk memastikan organisasimbustaman/IAB/KPM/10212
  • 213. Mesyuarat Penutup (6)faham mengenai keputusan yang akandiambil oleh Badan Persijilan. Memastikan semua rekod audit adalahlengkap ( senarai kehadiran, pengesahanaudit daripada organisasi, laporan telahditandatangani dan lain-lain dokumen bagitujuan pentadbiran audit).mbustaman/IAB/KPM/10213
  • 214. Mbustaman-IAB-KPM 21406/21/98 45Laporan Hasil Audit• Dapatan audit dibuat secara verbal semasamengaudit.• Hasil audit didokumenkan dalam bentuklaporan (conformities and nonconformities)• Dilaporkan dalam Mesyuarat Penutup(closing meeting)• Cadangan tindakan pembetulandikemukakan kepada pihak pengurusanorganisasi
  • 215. Mbustaman-IAB-KPM 21506/21/98 46Audit Susulan• Cadangan tindakan pembetulan dikemukakankepada auditor untuk dinilai.• Auditor membuat keputusan menerima/menolak.• Jika auditor menerima, teruskan untukdiimplementasi.• Jika sebaliknya, buat cadangan baru.• Implementasi tindakan pembetulan diperiksasama ada melalui perhubungan ataupengauditan terus di tempat organisasi.• Hendak melihat sama ada nonconformity telahdapat diatasi.
  • 216. Mbustaman-IAB-KPM 21606/21/98 47Melengkapkan Rekod Audit• Auditor perlu mengawasi pelaksanaan tindakanpembetulan• Lengkapkan rekod audit setelah semuatindakan pembetulan dilakukan denganberkesan.• Masa / tarikh ditentukan untuk auditpengawasan (surveillence audit)
  • 217. Module 9GMP Workshop Kuala Lumpur 14-217CONCLUSIONSNobody likes to beaudited………..It is a means to havecontinuous improvement
  • 218. “Kejayaan sebenar ialahbila anda merasai kenikmatanatas hasil perubahan….”SEKIAN TERIMA KASIH
  • 219. mbustaman/IAB/KPM/10219SEKIAN, TERIMA KASIH

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