{"id":2425,"date":"2024-12-17T10:45:20","date_gmt":"2024-12-17T02:45:20","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2425"},"modified":"2026-02-09T09:58:51","modified_gmt":"2026-02-09T01:58:51","slug":"eo-sterilization-equipment-and-process-characteristic-patterns-and-effect-analysis","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/eo-sterilization-equipment-and-process-characteristic-patterns-and-effect-analysis\/","title":{"rendered":"EO sterilization equipment and process characteristic patterns and effect analysis"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-de5b384b wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-68.webp\" alt=\"\" class=\"uag-image-8473\" width=\"1024\" height=\"768\" title=\"ethylene-oxide-sterilization-68\" role=\"img\" \><\/figure><\/div>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Start cycle phase(Select parameters\/sterilization recipe)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"2\">1<\/td><td rowspan=\"2\">Memilih resep yang salah<\/td><td rowspan=\"2\">Kurangnya kehati-hatian dalam memilih formulasi<\/td><td>Siklus tidak valid. Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Nama resep berbeda<\/td><td>6<\/td><td>5<\/td><td>10<\/td><td>300<\/td><td>1. Instruksi kerja 2. Pemeriksaan cermat sebelum siklus dimulai 3. Pelatihan operator<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>1. Instruksi kerja 2. Inspeksi yang cermat sebelum memulai siklus 3. Pelatihan operator<\/td><td>pengguna<\/td><\/tr><tr><td>Loss of product\/packaging functionality and integrity due to unvalidated cycle parameters<\/td><td>1. Nama resep berbeda<\/td><td>6<\/td><td>4<\/td><td>10<\/td><td>240<\/td><td>1. Instruksi kerja 2. Pemeriksaan cermat sebelum siklus dimulai 3. Pelatihan operator<\/td><td>2<\/td><td>4<\/td><td>4<\/td><td>32<\/td><td>1. Instruksi kerja 2. Inspeksi yang cermat sebelum memulai siklus 3. Pelatihan operator<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Fase pemanasan (Pemanasan kabinet)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Suhu kotak lebih rendah dari nilai batas bawah<\/td><td>Kegagalan pompa sirkulasi air panas<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi 3. Kompensasi waktu pemanasan otomatis<\/td><td>5<\/td><td>3<\/td><td>2<\/td><td>30<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan tabung pemanas listrik<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td><br>1. Sensor suhu berlebihan 2. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>2<\/td><td>Suhu di dalam kabinet terlalu tinggi<\/td><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td><br>1. Sensor suhu berlebihan 2. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap isolasi (Menjaga suhu kabinet)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Suhu kotak lebih rendah dari nilai batas bawah<\/td><td>Kegagalan pompa sirkulasi air panas<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi<\/td><td>5<\/td><td>3<\/td><td>2<\/td><td>30<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan tabung pemanas listrik<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>2<\/td><td>Suhu di dalam kabinet terlalu tinggi<\/td><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>3<\/td><td>Kurangnya waktu<\/td><td>Kesalahan Pemrograman<\/td><td>Ulangi sterilisasi<\/td><td>1. Inspeksi siklus otomatis<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>tidak ada<\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap pra-vakum (Mengeluarkan udara dari ruangan memungkinkan proses berlangsung di bawah batas mudah terbakar EO)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Udara yang dikeluarkan tidak cukup<\/td><td>Efisiensi pompa vakum rendah<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Alarm waktu pra-vakum melebihi batas 2. Alarm kelebihan beban pompa vakum 3. Secara otomatis mendeteksi aliran air dan mematikan pompa tanpa air<\/td><td>5<\/td><td>3<\/td><td>2<\/td><td>30<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Katup salah<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Waktu pra-vakum melebihi batas alarm 2. Alarm kelebihan beban pompa vakum<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Bahaya Zona Mudah Terbakar<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>2<\/td><td>Terlalu banyak ruang hampa<\/td><td>Kegagalan sensor tekanan<\/td><td>Product and\/or packaging damage (classification)<\/td><td>1. Sensor tekanan redundan 2. Alarm perbedaan tekanan dikeluarkan ketika perbedaan tekanan lebih besar dari 1kpa.<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap deteksi kebocoran (Periksa kekencangan kotak)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Kebocoran kabinet<\/td><td>Kebocoran paking<\/td><td>Tidak ada dampak<\/td><td>1. Alarm kegagalan uji kebocoran 2. Proses berakhir<\/td><td>10<\/td><td>5<\/td><td>2<\/td><td>100<\/td><td>1. Pemeliharaan preventif<\/td><td>3<\/td><td>5<\/td><td>2<\/td><td>30<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kebocoran katup<\/td><td>Tidak ada dampak<\/td><td>1. Alarm kegagalan uji kebocoran<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kebocoran saluran udara sistem sirkulasi<\/td><td>Tidak ada dampak<\/td><td>1. Alarm kegagalan uji kebocoran<\/td><td>4<\/td><td>3<\/td><td>2<\/td><td>24<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap penggantian nitrogen (Isi ruangan dengan gas inert untuk menggantikan oksigen)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Tidak cukup nitrogen yang masuk ke dalam ruangan<\/td><td>Nitrogen tidak mencukupi<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>Akhir proses<\/td><td>3<\/td><td>3<\/td><td>2<\/td><td>18<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>N\/A<\/td><td><\/td><\/tr><tr><td>Katup rusak<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>N\/A<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Bahaya Zona Mudah Terbakar<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"2\">2<\/td><td rowspan=\"2\">Terlalu banyak nitrogen di pintu lemari<\/td><td>Katup rusak<\/td><td>Konsentrasi EO lebih rendah dari nilai yang divalidasi karena pada saat injeksi EO, jika dikontrol oleh tekanan (resterilisasi), N2 tambahan akan disuntikkan<\/td><td>1. Alarm tegangan tinggi dalam ruangan 2. Akhir proses<\/td><td>6<\/td><td>5<\/td><td>4<\/td><td>120<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan pemancar tekanan<\/td><td>Terlalu banyak gas EO yang disuntikkan. Residu EO tinggi. Waktu degassing yang diperpanjang saya)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>3<\/td><td>Suhu kabinet lebih tinggi dari batas atas t<\/td><td><\/td><td>Dampak terhadap fungsi produk (penyortiran)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"4\">4<\/td><td rowspan=\"4\">Suhu kotak lebih rendah dari nilai batas bawah<\/td><td>Kegagalan pompa sirkulasi air panas<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi 3. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan tabung pemanas listrik<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Sensor suhu berlebihan 2. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>Temperatur karburator rendah<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm bila suhu karburator lebih rendah dari batas 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap pelembapan (Meningkatkan kelembapan beban dengan menginjeksikan uap)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"4\">1<\/td><td rowspan=\"4\">Uap tidak mencukupi<\/td><td>Kegagalan pembangkit uap<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm ketika tekanan uap lebih rendah dari batas<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan katup<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Alarm batas frekuensi pelembab<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Pressure transmitter\/humidity sensor failure<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Redundant pressure\/humidity sensor 2. Alarm when pressure\/humidity difference exceeds limit<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>Filter tersumbat<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Alarm batas frekuensi pelembab<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"2\">2<\/td><td rowspan=\"2\">Injeksi uap terlalu banyak<\/td><td>Katup rusak<\/td><td>Injeksi uap berlebihan, karton basah (penyortiran)<\/td><td>1. Alarm tegangan tinggi dalam ruangan 2. Akhir proses<\/td><td>6<\/td><td>5<\/td><td>4<\/td><td>120<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Pressure transmitter\/humidity sensor failure<\/td><td>Injeksi uap berlebihan, karton basah (penyortiran)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>3<\/td><td>Suhu terlalu tinggi<\/td><td>Kegagalan sensor suhu<\/td><td>Dampak pada fungsi produk (peringkat)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"3\">4<\/td><td rowspan=\"3\">Suhu kotak lebih rendah dari nilai batas bawah<\/td><td>Kegagalan pompa sirkulasi air panas<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi 3. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan tabung pemanas listrik<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Alarm batas waktu pemanasan 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Fase diam humidifikasi (kelembaban seimbang)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td>1<\/td><td>Kurangnya waktu<\/td><td>waktu habis<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Inspeksi siklus otomatis<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif<\/td><td>1<\/td><td>5<\/td><td>2<\/td><td>10<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap bantalan nitrogen (Isi ruangan dengan gas inert untuk mengencerkan oksigen)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Tidak cukup nitrogen yang masuk ke kabinet<\/td><td>Kekurangan nitrogen<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Periksa tekanan N2 sebelum memulai siklus 2. Alarm bila tekanan N2 lebih rendah dari batas<\/td><td>3<\/td><td>3<\/td><td>2<\/td><td>18<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>0<\/td><td><\/td><td><\/td><\/tr><tr><td>Kegagalan katup<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>tidak ada<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Bahaya Zona Mudah Terbakar<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif<\/td><\/tr><tr><td rowspan=\"2\">2<\/td><td rowspan=\"2\">Terlalu banyak nitrogen yang disuntikkan ke dalam kabinet<\/td><td>Katup rusak<\/td><td>Konsentrasi EO lebih rendah dari nilai yang divalidasi karena pada saat injeksi EO, jika dikontrol oleh tekanan (resterilisasi), N2 tambahan akan disuntikkan<\/td><td>1. Alarm tegangan tinggi dalam ruangan 2. Akhir proses<\/td><td>6<\/td><td>5<\/td><td>4<\/td><td>120<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif<\/td><\/tr><tr><td>Kegagalan pemancar tekanan<\/td><td>Terlalu banyak gas EO yang disuntikkan. Residu EO tinggi. (Memperpanjang waktu degassing)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><\/tr><tr><td>3<\/td><td>Suhu di dalam kabinet melebihi batas atas<\/td><td>Kegagalan sensor suhu<\/td><td>Dampak terhadap fungsi produk (penyortiran)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><\/tr><tr><td rowspan=\"4\">4<\/td><td rowspan=\"4\">Suhu kotak lebih rendah dari nilai batas bawah<\/td><td>Kegagalan pompa sirkulasi air panas<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi 3. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif<\/td><\/tr><tr><td>Kegagalan tabung pemanas listrik<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi 3. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif<\/td><\/tr><tr><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Sensor suhu berlebihan 2. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><\/tr><tr><td>Temperatur karburator rendah<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm bila suhu karburator lebih rendah dari batas 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>pengguna<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap injeksi EO (Isi kabinet dengan gas EO)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"4\">1<\/td><td rowspan=\"4\">Tidak cukup etilen oksida yang masuk ke dalam kabinet<\/td><td>APAKAH ITU<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1.Alarm lubang silinder EO 2.Alarm batas waktu injeksi EO<\/td><td>10<\/td><td>5<\/td><td>2<\/td><td>100<\/td><td>1. Pelatihan operator 2. Pemeriksaan berat badan EO sebelum siklus dimulai<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pelatihan operator 2. Pemeriksaan berat badan EO sebelum siklus dimulai<\/td><td>pengguna<\/td><\/tr><tr><td>Katup rusak<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Alarm batas waktu injeksi EO<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kebocoran pipa EO<\/td><td>Batch yang melebihi periode kualifikasi dapat disterilkan kembali<\/td><td>tidak ada<\/td><td>6<\/td><td>5<\/td><td>3<\/td><td>90<\/td><td>1. Pemeliharaan preventif 2. Alarm detektor LEL EO<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Alarm detektor LEL EO<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Konsentrasi EO lebih rendah dari nilai validasi (sterilisasi ulang)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"2\">2<\/td><td rowspan=\"2\">Liquid EO memasuki kabinet<\/td><td>Temperatur karburator rendah<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Suhu karburator lebih rendah dari batas alarm<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Air di karburator tidak cukup karena katup rusak<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Ketinggian air karburator lebih rendah dari batas alarm<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"2\">3<\/td><td rowspan=\"2\">Terlalu banyak masukan etilen oksida ke dalam kabinet<\/td><td>Katup rusak<\/td><td>Karantina lebih lama, memerlukan pengujian tambahan<\/td><td>1. Alarm tegangan tinggi dalam ruangan<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif 2. Pemeriksaan sisa EO<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif 2. Pemeriksaan sisa EO<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Karantina lebih lama, memerlukan pengujian tambahan<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>4<\/td><td>Suhu di dalam kabinet melebihi batas atas<\/td><td>Kegagalan sensor suhu<\/td><td>Dampak terhadap fungsi produk (penyortiran)<\/td><td>1. Sensor suhu berlebihan 2. Alarm suhu tinggi ruang 3. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"4\">5<\/td><td rowspan=\"4\">Suhu kotak lebih rendah dari nilai batas bawah<\/td><td>Kegagalan pompa sirkulasi air panas<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi 3. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan tabung pemanas listrik<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Sensor suhu berlebihan 2. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>Temperatur karburator rendah<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm bila suhu karburator lebih rendah dari batas 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap tutup nitrogen (Tambahkan N2 untuk menutupi EO)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Tidak cukup nitrogen yang masuk ke kabinet<\/td><td>Kekurangan nitrogen<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Periksa tekanan N2 sebelum memulai siklus 2. Alarm bila tekanan N2 lebih rendah dari batas<\/td><td>3<\/td><td>3<\/td><td>2<\/td><td>18<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>N\/A<\/td><td><\/td><\/tr><tr><td>Kegagalan katup<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>tidak ada<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Bahaya Zona Mudah Terbakar<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>2<\/td><td>Terlalu banyak nitrogen yang disuntikkan ke dalam kabinet<\/td><td>Katup rusak<\/td><td>Kabin berada di bawah tekanan positif. Siklus ini akan berakhir.<\/td><td>1. Alarm tegangan tinggi dalam ruangan 2. Akhir proses<\/td><td>6<\/td><td>5<\/td><td>4<\/td><td>120<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>5<\/td><td>4<\/td><td>40<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>3<\/td><td>Suhu di dalam kabinet melebihi batas atas<\/td><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Sensor suhu berlebihan 2. Alarm suhu tinggi ruang 3. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"4\">4<\/td><td rowspan=\"4\">Suhu kotak lebih rendah dari nilai batas bawah<\/td><td>Kegagalan pompa sirkulasi air panas<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi 3. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan tabung pemanas listrik<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Sensor suhu berlebihan 2. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>Temperatur karburator rendah<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm bila suhu karburator lebih rendah dari batas 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap pemaparan EO (Disinfektan produk)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td>1<\/td><td>Kurangnya waktu<\/td><td>Kesalahan Pemrograman<\/td><td>Ulangi sterilisasi<\/td><td>1. Inspeksi siklus otomatis<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif<\/td><td>1<\/td><td>5<\/td><td>2<\/td><td>10<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"3\">2<\/td><td rowspan=\"3\">Suhu kotak lebih rendah dari batas bawah t<\/td><td>Kegagalan pompa sirkulasi air panas<\/td><td>Siklus dikunci pada satu tahap hingga dipulihkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>Batas waktu pemanasan 2. Alarm kelebihan beban pompa air sirkulasi 3. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan tabung pemanas listrik<\/td><td>Siklus dikunci dalam satu fase hingga dilanjutkan dan dimulai ulang setelah masa siaga. Batch yang telah melebihi siklus yang memenuhi syarat dapat disterilkan kembali.<\/td><td>1. Alarm batas waktu pemanasan 2. Kompensasi waktu pemanasan otomatis<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Sensor suhu berlebihan 2. Perbedaan suhu melebihi batas alarm<\/td><td>6<\/td><td>5<\/td><td>2<\/td><td>60<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>5<\/td><td>2<\/td><td>20<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>3<\/td><td>Suhu di dalam kabinet melebihi batas atas<\/td><td>Kegagalan sensor suhu<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Sensor suhu redundan 2. Alarm suhu tinggi ruangan 3. Alarm suhu<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"2\">4<\/td><td rowspan=\"2\">Tidak mendapatkan campuran EO yang cukup homogen<\/td><td>Kegagalan kipas sirkulasi<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Alarm kecepatan rendah<\/td><td>6<\/td><td>5<\/td><td>3<\/td><td>90<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>5<\/td><td>3<\/td><td>30<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Posisi produk sangat dekat dengan dinding rongga<\/td><td>Mempengaruhi sterilitas produk (sterilisasi ulang)<\/td><td>1. Pagar Pembatas digunakan untuk mencegah produk menyentuh dinding rongga<\/td><td>2<\/td><td>5<\/td><td>3<\/td><td>30<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>0<\/td><td>N\/A<\/td><td><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">EO Removal Phase(Create vacuum\/remove sterilization gas)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Tidak cukup mengeluarkan gas<\/td><td>Pompa vakum tidak efisien<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Alarm batas waktu pelepasan EO 2. Alarm kelebihan beban pompa vakum 3. Secara otomatis mendeteksi aliran air dan mematikan pompa tanpa air<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Katup rusak<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1.Alarm batas waktu pelepasan EO 2.Alarm kelebihan beban pompa vakum<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Waktu isolasi lebih lama dan pengujian tambahan diperlukan karena lebih sedikit gas EO yang dibuang<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>2<\/td><td>Buang terlalu banyak bensin<\/td><td>Kegagalan sensor tekanan<\/td><td>Product and\/or packaging damage (classification)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap pembersihan nitrogen (Pastikan lingkungan dalam ruangan tidak mudah terbakar)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"4\">1<\/td><td rowspan=\"4\">Tidak cukup nitrogen yang masuk ke dalam ruangan<\/td><td>Kekurangan nitrogen<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Periksa tekanan N2 sebelum memulai siklus 2. Alarm bila tekanan N2 lebih rendah dari batas<\/td><td>3<\/td><td>3<\/td><td>2<\/td><td>18<\/td><td><\/td><td><\/td><td><\/td><td><\/td><td><\/td><td>N\/A<\/td><td><\/td><\/tr><tr><td>Katup rusak<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>tidak ada<\/td><td>6<\/td><td>3<\/td><td>3<\/td><td>54<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>3<\/td><td>18<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"2\">Kegagalan sensor tekanan<\/td><td>Bahaya Zona Mudah Terbakar<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Karantina yang lebih lama memerlukan pengujian tambahan<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Air cleaning stage(Create vacuum\/remove residual sterilization gas, eliminate residual EO)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td rowspan=\"3\">1<\/td><td rowspan=\"3\">Tidak cukup mengeluarkan gas<\/td><td>Pompa vakum tidak efisien<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Alarm batas waktu pelepasan EO 2. Alarm kelebihan beban pompa vakum 3. Secara otomatis mendeteksi aliran air dan mematikan pompa tanpa air<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Katup rusak<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1.Alarm batas waktu pelepasan EO 2.Alarm kelebihan beban pompa vakum<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Waktu isolasi lebih lama dan pengujian tambahan diperlukan karena lebih sedikit gas EO yang dibuang<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td>2<\/td><td>Buang terlalu banyak bensin<\/td><td>Kegagalan sensor tekanan<\/td><td>Product and\/or packaging damage (classification)<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>4<\/td><td>2<\/td><td>48<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><tr><td rowspan=\"3\">3<\/td><td rowspan=\"3\">Udara di dalam kabin tidak mencukupi<\/td><td>Katup rusak<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Waktu injeksi gas melebihi batas alarm<\/td><td>6<\/td><td>4<\/td><td>3<\/td><td>72<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>4<\/td><td>3<\/td><td>24<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Filter tersumbat<\/td><td>Siklus dikunci dalam satu fase hingga dipulihkan dan dimulai ulang setelah masa siaga<\/td><td>1. Waktu injeksi gas melebihi batas alarm<\/td><td>6<\/td><td>4<\/td><td>3<\/td><td>72<\/td><td>1. Pemeliharaan preventif<\/td><td>2<\/td><td>4<\/td><td>3<\/td><td>24<\/td><td>1. Pemeliharaan preventif<\/td><td>pengguna<\/td><\/tr><tr><td>Kegagalan sensor tekanan<\/td><td>Karantina yang lebih lama memerlukan pengujian tambahan<\/td><td>1. Sensor tekanan redundan 2. Alarm ketika perbedaan tekanan melebihi batas<\/td><td>6<\/td><td>3<\/td><td>2<\/td><td>36<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>2<\/td><td>4<\/td><td>2<\/td><td>16<\/td><td>1. Pemeliharaan preventif 2. Kalibrasi<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"16\">Tahap penghapusan (Hilangkan residu dari produk)<\/td><\/tr><tr><td rowspan=\"2\">Nomor seri<\/td><td colspan=\"3\">Konten yang berpotensi berisiko<\/td><td colspan=\"5\">Penilaian risiko dalam kondisi proses yang ada<\/td><td colspan=\"5\">Penilaian risiko hasil setelah mengambil tindakan<\/td><td rowspan=\"2\">Tindakan yang Direkomendasikan<\/td><td rowspan=\"2\">Tanggung jawab dan status saat ini<\/td><\/tr><tr><td>Nama kesalahan<\/td><td>Menyebabkan<\/td><td>Dampak Kegagalan<\/td><td>Kontrol Sekarang<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><td>Ambil tindakan<\/td><td>peristiwa<\/td><td>Kerasnya<\/td><td>meneliti<\/td><td>Prioritas Risiko<\/td><\/tr><tr><td>1<\/td><td>Waktu aerasi kurang dari waktu yang ditentukan<\/td><td>Kesalahan Pemrograman<\/td><td>Ulangi sterilisasi<\/td><td>1. Inspeksi siklus otomatis<\/td><td>2<\/td><td>3<\/td><td>2<\/td><td>12<\/td><td>1. Restart komputer Anda secara teratur<\/td><td>1<\/td><td>3<\/td><td>2<\/td><td>6<\/td><td>1. Restart komputer Anda secara teratur<\/td><td>pengguna<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">JIKA ANDA INGIN TAHU LEBIH LANJUT Tentang Sterilisasi Etilen Oksida<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telepon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-mail:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Situs Lokal: Kamar 1202, Caitong Zhongxin, Distrik Xiasha, Kota Hangzhou, Provinsi Zhejiang, Tiongkok<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Situs web:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">&nbsp;zjbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Start cycle phase(Select parameters\/sterilization recipe) Serial number Potentially risky content Risk assessment under existing process conditions Risk assessment of the 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