STATUS INTERNAL AUDIT ISO 9001 DAN ISO/IEC DI AGENSI NUKLEAR MALAYSIA

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1 STATUS INTERNAL AUDIT ISO 9001 DAN ISO/IEC DI AGENSI NUKLEAR MALAYSIA INTERNAL AUDIT STATUS FOR ISO 9001 AND ISO/IEC IN MALAYSIAN NUCLEAR AGENCY Fazila Said, Nurul Huda Mudri dan Nik Arlina Ali Pusat Pengurusan Penyelidikan dan Inovasi (RIMC) Agensi Nuklear Malaysia (Nuklear Malaysia) Bangi, Kajang, Selangor, ABSTRAK Pembangunan MS ISO 9001 dan MS ISO/IEC di Agenci Nuklear Malaysia merupakan suatu asas bagi meningkat dan menambahbaik Sistem Pengurusan Kualiti (QMS) bagi proses-proses dan makmal-makmal yang terlibat dengan pelanggan dalam pembekalan produk dan perkhidmatan. Keberkesanan QMS ini dipantau Pusat Pengurusan Penyelidikan dan Inovasi (RIMC) yang mengawal dan memastikan bahawa aktiviti-aktiviti audit seperti Audit Dalam dilaksanakan mengikut manual kualiti dan prosedur kerja yang telah didokumenkan. Kertas kerja ini akan memaparkan status audit dalam yang telah dilaksanakan oleh proses yang memiliki persijilan MS ISO 9001 dan makmal yang memiliki MS ISO/IEC pada tahun 2008, 2009 dan Antara faktor yang dapat menunjukkan keberkesanan QMS ialah jumlah ketidakakuran (nc) dan peluang penambahbaikan (ofi) dan bilangan ketidakakuran mengikut keperluan dalam klausa MS ISO 9001 dan MS ISO/IEC bagi setiap proses dan makmal. Kemudian, keberkesanan Sistem Kualiti bagi MS ISO 9001 dan MS ISO/IEC secara keseluruhan melalui bilangan klausa keakuran berbanding klausa ketidakakuran bagi tiga tahun tersebut turut dikira. ABSTRACT The development of MS ISO 9001 and MS ISO/IEC in Malaysian Nuclear Agency is the basic step to enhance and improve the Quality Management System (QMS) for processes and laboratories that involve customers and suppliers in delivering products and services. The effectiveness of QMS is monitored by Research and Innovation Management Centre (RIMC) to ensure that all activities related to audit such as Internal Audit are well organized and implemented as documented in quality manual and procedure. This paper will discuss the status of internal audit for processes that implement MS ISO 9001 and laboratories that accredited with MS/ISO IEC in year 2008, 2009 and The total of non-conformance (nc) and opportunity for improvement (ofi) for processes and laboratories and their numbers as per clause in MS ISO 9001 and MS ISO/IEC are the indicators that reflects the effectiveness of QMS. Then, the total effectiveness of QMS for MS 9001 and MS ISO/IEC is also determined via the number of conformance clause versus non-conformance clause for those three years. Kata kunci : Sistem Pengurusan Kualiti (QMS), MS ISO 9001 dan MS ISO/IEC PENGENALAN Pelaksanaan Audit Dalaman merupakan salah satu proses yang penting untuk dilaksanakan didalam Sistem Pengurusan Kualiti (Quality Management System, QMS) iaitu bagi MS ISO 9001 dan MS ISO/IEC Matlamat proses audit dalaman adalah untuk mengukur tahap keakuran dan juga tahap keberkesanan prosesproses didalam sesebuah sistem pengurusan kualiti didalam mencapai objektif-objektif kualiti yang telah ditentukan.

2 Audit dalaman dijalankan dengan kaedah pemeriksaan, pemerhatian atau temuramah yang berkaitan keatas sampel proses yang terpilih atau secara rambang ke atas orang yang diaudit, mengikut mana-mana yang relevan. Proses ini harus dirancang pelaksanaannya oleh Pengurus Kualiti (QM) /Wakil Pengurusan (MR) pada setiap awal tahun. Jika tahap pencapaian keakuran agak rendah berbanding proses-proses/ makmal-makmal lain, maka audit dalaman yang lebih kerap harus dilaksanakan terhadapnya. Hasil-hasil audit (audit findings) adalah merangkumi unsur-unsur keakuran dan ketidakakuran (nc) dan peluang-peluang penambahbaikan yang boleh dilaksanakan hasil dari pemerhatian dan penilaiannya sewaktu menjalankan audit. Kemudian, laporan daripada hasil audit perlu dibuat salinan dan di hantar kepada pihak RIMC sebagai pusat pemantau. Setiap tahun, RIMC akan mengeluarkan laporan keseluruhan pencapaian proses/makmal daripada kompilasi hasil audit. Ini bertujuan untuk memastikan audit dalam yang dijalankan di Agensi Nuklear Malaysia adalah efektif. 1.1 Skop projek Projek ini bertumpu kepada laporan Audit Dalam bagi enam proses yang memiliki ISO 9001 (Unit Latihan adalah terkecuali) dan dua makmal yang memiliki ISO/IEC bagi tahun 2008, 2009 dan a) Persijilan ISO 9001 i) SINAGAMA -Perkhidmatan penyinaran menggunakan punca Co-60 untuk produk perubatan, pengguna dan farmasiutikal. ii) SSDL-Pembekalan perkhidmatan dosimetri personel merangkumi bekalan lencana dan penilaian dosimeter. iii) Bahagian Teknologi Industi- Pembekalan perkhidmatan ultrasonik, radiografi, ujian imbasan paip dan kolum. iv) RAYMINTEX- penghasilan lateks getah asli pra-tervulkan menggunakan sinaran gama. v) ALURTRON- Pembekalan perkhidmatan penyinaran alur elektron untuk produk komersil. vi) Pusat Pengurusan Sisa (WasTec)-Pengurusan sisa radioaktif dan penyimpanan bahan radioaktif. b) Akreditasi ISO/IEC i) Makmal Radiokimia Dan Alam Sekitar Ujian persampelan ii) Makmal Kalibrasi, SSDL-Kalibrasi peralatan 1.2 Objektif projek i. Memantau Hasilan (finding) Audit Dalam bagi proses dan makmal yang sedia ada melalui jumlah bilangan ketakakuran (nc) dan peluang penambahbaikan (ofi) bagi tahun 2008, 2009 dan 2010; ii. Mengenalpasti jenis kekerapan ketakakuran mengikut klausa MS ISO 9001 dan MS ISO/IEC bagi tiga tahun tersebut; dan iii. Mengira keberkesanan QMS melalui peratus keakuran dan ketidakakuran bagi MS ISO 9001 dan MS ISO/IEC bagi tiga tahun tersebut.

3 2.0 METODOLOGI 2.1 Proses Kerja Langkah 1 Mengumpul maklumat jumlah ketakakuran (nc) dan peluang penambahbaikan (ofi) daripada 6 proses dan 2 makmal bagi tahun 2008, 2009 dan Langkah 2 Menukarkan kepada carta bar. Bagi melihat trend /corak bagi tiga tahun tersebut bagi 6 proses dan 2 makma yang memperoleh nc dan ofi. Langkah 3 Membina carta bar bagi jumlah nc dan ofi mengikut keperluan dalam klausa MS ISO 9001 dan MS ISO/IEC bagi tiga ( ) bagi 6 proses dan 2 makmal. Langkah 4 Membina carta pie bagi melihat keberkesanan Sistem Kualiti bagi MS ISO 9001 dan MS ISO/IEC secara keseluruhan Rajah 1 : Carta Alir Proses Kerja

4 3.0 KEPUTUSAN DAN PERBINCANGAN Keputusan audit dalam melalui jumlah ketakakuran (nc) dan peluang penambahbaikan (ofi) yang diperolehi bagi tahun 2008, 2009 dan 2010 bagi 6 proses dan 2 makmal adalah seperti di bawah. Rajah 2: Jumlah ketakakuran (nc) dan peluang penambahbaikan (ofi) bagi proses dan makmal tahun 2008, 2009 dan Rajah 2 di atas menunjukkan jumlah ketakakuran (nc) dan peluang penambahbaikan (ofi) bagi proses dan makmal tahun 2008, 2009 dan Secara keseluruhan bagi tiga tahun tersebut, didapati BTI mendapat jumlah nc terbanyak (20 nc) didikuti dengan MINTec- Sinagama (18nc) dan SSDL mendapat jumlah ofi terbanyak (50 ofi). Dalam tahun 2008, BTI memperoleh nc terbanyak iaitu 10, tahun 2009 nc dan ofi terbanyak diperoleh oleh SSDL dengan 4 nc dan 27 ofi. Seterusnya tahun 2010, nc terbanyak datang daripada MINTec-Sinagama. Daripada Rajah 2 di atas, proses-proses didapati sering memperoleh jumlah nc yang tinggi berbanding makmal. Kekerapan memperoleh ofi yang tinggi juga agak membimbangkan dan memerlukan tindakan pembetulan segera. Perolehan nc dan ofi yang banyak mungkin juga adalah disebabkan ketelitian barisan juruaudit dalaman dalam melaksanakan audit.

5 Rajah 3 : Ketakakuran mengikut klausa MS ISO 9001 bagi enam proses tahun 2008, 2009 dan 2010 Rajah 4 : Ketakakuran mengikut klausa MS ISO/IEC bagi dua makmal tahun 2008, 2009 dan 2010 Keputusan bagi klausa ketakakuran MS ISO 9001 ditunjukkan dalam Rajah 3 dan Rajah 4 di atas. Senarai klausa MS ISO 9001 seperti berikut: General Requirement Control of Documents Control of Records

6 5.2 - Customer Focus Quality Policy Planning Quality Objectives Review Input Review output Human Resources Competence, Training and Awareness Infrastructure Work Environment 7 - product Realization Planning of Product Realization Customer-related Process Determination of Requirement related to the Product Review of Requirement Related to the Product Customer Communication Purchasing Process Control of Production and Service Provision Validation of Processes for Production and Service Provision Preservation of Product Control of Monitoring and measurement Equipment 8 - Measurement, Analysis and Improvement General Monitoring and Measurement Internal Audit Corrective Action Klausa Pengawalan Dokumen merupakan klausa yang sering mendapt nc sebanyak 16 nc. Proses yang mengahadapi banyak masalah berkenaan dengan pengawalan dokumen adalah BTI diikuti dengan WasTec dan Raymintex. Seterusnya klausa Kompetensi, Latihan dan Kesedaran sebanyak 10 nc. Proses yang lemah bagi klausa ini adalah BTI diikuti dengan WasTec. Kemudian, klausa 7.6 -Pengawalan Alatan Monitor dan Ukuran sebanyak 8 nc, di mana semua proses pernah mendapat nc. Bagi Klausa 6.3- infrastruktur sebanyak 5 nc. Didapati juga klausa Kawalan rekod, klausa Audit Dalam dan klausa Tindakan Pembetulan masing-masing 4nc. Senarai klausa MS ISO/IEC seperti berikut: Management Requirement Organization Corrective Action Internal Audits

7 Management Reviews Management System Document Approval and Issue Documet Changes Personnel Personnel Accommodation and Environmental Conditions Equipment Calibration Handling of Test and Calibration Items Didapati klausa Tindakan pembetulan mendapat 2 nc. Semua klausa nc yang lain memperoleh 1 nc. Ini juga menunjukkan juruaudit telah melihat segala aspek dengan baik. Didapati juga terdapat kesungguhan pihak makmal dalam pelaksanaan standard ini. Rajah 5 : Peratus keakuran dan ketidakakuran bagi MS ISO 9001 dan MS ISO/IEC tahun 2008, 2009 dan Bagi keputusan keberkesanan, MS ISO 9001 memperoleh 65% ketakakuran dan MS ISO/IEC memperoleh 8% ketakakuran. Hasil ini diperoleh daripada jumlah klausa nc yang diperolehi berbanding jumlah klausa di dalam Standard Umum masing-masing. Secara keseluruhan, Carta Pie di dalam Rajah 5 di atas menunjukkan proses dan makmal di Agensi Nuklear Malaysia dapat mengekalkan kepatuhan terhadap Standard Umum bagi kedua-dua persijilan QMS tersebut sepanjang tahun 2008, 2009 dan Walau bagaimana pun, peratus bagi MS ISO 9001 perlu dipertingkatkan sehingga melebihi 50% bagi memastikan setiap proses terus kekal dalam persijilan ini. Oleh yang demikian, kesungguhan dalam melaksanakan QMS ini perlu ditunjukkan pada tahun-tahun yang akan datang.

8 4.0 KESIMPULAN Sebanyak 86 nc (MS ISO 9001) dan 16 nc (MS ISO/IEC 17025) diperolehi bagi hasilan audit dalam sepanjang 2008, 2009 dan Bilangan klausa nc tertinggi bagi MS ISO 9001 adalah Klausa Pengawalan Dokumen sebanyak 16 nc. Seterusnya Klausa Kompetensi, Latihan dan Kesedaran sebanyak 10 nc dan Klausa 7.6 -Pengawalan Alatan Monitor dan Ukuran sebanyak 8 nc. Sebanyak 65% ketidakakuran bagi MS ISO 9001 dan 8% ketidakakuran bagi MS ISO/IEC bagi hasilan audit dalam untuk tahun 2008, 2009 dan Peratus kepatuhan yang tinggi menunjukkan bahawa agensi berjaya mengekalkan budaya kerja yang cemerlang dan memiliki ruang yang luas untuk meningkatkan lagi keberkesanan Sistem Pengurusan Kualiti (QMS). 5.0 PENGHARGAAN Ucapan terima kasih kepada semua proses dan makmal yang terlibat. Juga kepada pegawai-pegawai di RIMC yang turut menyumbang idea. 6.0 RUJUKAN Minit meyuarat Management Review Meeting (MRM) daripada proses dan makmal bagi tahun 2008, 2009 dan 2010.

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