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"Produk steril memiliki persyaratan minimal risiko kontaminasi mikroba, partikulat, dan endotoksin/pirogen pada fasilitas, peralatan, dan proses harus dirancang, dikualifikasi, dan divalidasi dengan tepat untuk meningkatkan perlindungan produk. Strategi pengendalian kontaminasi / Contamition Control Strategy (CCS) harus diterapkan di seluruh fasilitas industri farmasi untuk menilai efektivitas seluruh rancangan, prosedur, teknis, dan organisasional serta pemantauan yang telah digunakan untuk mengelola risiko terhadap mutu produk. Penyusunan Risk Assessment Terkait Control Contamination Strategy (CCS) di PT Finusolprima Farma International dilakukan dengan melakukan studi literatur pada Prosedur Tetap, membandingkan prosedur yang telah ada dengan ketentuan EU GMP & CPOB 2018 dan menyusun hasil penerapan CCS. Dengan adanya kegiatan Penyusunan Risk Assessment Terkait Control Contamination Strategy (CCS) di PT Finusolprima Farma International diketahui elah dilakukannya analisis efektivitas Contamination Control Strategy (CCS) menggunakan prinsip manajemen risiko mutu pada PT Finusolprima Farma International namun masih terdapat prosedur pengendalian kontaminasi yang belum terdokumentasi dengan baik sehingga perlu ditambahkan untuk memudahkan personil terkait dan pencegahan kontaminasi dapat lebih dikendalikan.

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Sterile products have minimal risk requirements for microbial, particulate and endotoxin/pyrogen contamination. Facilities, equipment and processes must be appropriately designed, qualified and validated to increase product protection. Contamination control strategies (CCS) must be implemented in all pharmaceutical industry facilities to assess the effectiveness of all designs, procedures, and technical and organizational monitoring used to manage product quality risks. Preparing a Risk Assessment Related to Control Contamination Strategy (CCS) at PT Finusolprima Farma International was carried out by conducting a literature study on Standing Procedures, comparing existing procedures with the provisions of EU GMP & CPOB 2018 and compiling the results of CCS implementation. With the activity of Preparing a Risk Assessment Related to Control Contamination Strategy (CCS) at PT Finusolprima Farma International, it is known that an analysis of the effectiveness of Contamination Control Strategy (CCS) has been carried out using quality risk management principles at PT Finusolprima Farma International. However, contamination control procedures still need to be properly documented. So, it needs to be added to make it easier for related personnel and contamination prevention to be better controlled."

"Manajemen Risiko Mutu merupakan proses sistematis untuk menilai, mengendalikan, mengkomunikasikan dan mengkaji risiko terhadap mutu obat di sepanjang siklus hidup mutu tersebut. Pada laporan ini akan dilakukan pembuatan risk assessment instrument viscometer ViskoQC 300 sebagai bentuk aplikasi manajemen risiko mutu tahap penilaian risiko. Tugas khusus ini dilaksanakan dengan dilakukan gap analysis dengan membandingkan protokol tetap instrument yang dibuat departemen QC PT Finusolprima Farma Internasional dengan User Guide Instrument Viskometer ViscoQC 300 dari industri manufaktur alat. Tindakan tindak lanjut yang perlu dilakukan antara lain: menambahkan spesifikasi sampel/cairan yang tidak bisa diukur di ViscoQC 300, menambahkan pedoman cara menyesuaikan measuring head dan head retention pada viscometer ViscoQC 300, dan ditambah panduan keamanan instalasi kelistrikan untuk menghubungkan dan menghidupkan ViscoQC 300.

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Quality Risk Management is a systematic process to assess, control, communicate and assess risks to drug quality throughout the quality life cycle. In this report, the ViscoQC 300 risk assessment instrument viscometer will be made as a form of quality risk management application at the risk assessment stage. This special task was carried out by conducting a gap analysis by comparing the fixed protocol of the instrument made by the QC department of PT Finusolprima Farma Internasional with the User Guide Instrument Viscometer Viscometer 300 from the tool manufacturing industry. Follow-up actions that need to be taken include: adding specifications for samples/liquids that cannot be measured on the ViscoQC 300, adding guidelines on how to adjust the measuring head and head retention on the ViscoQC 300 viscometer, and adding an electrical installation safety guide for connecting and turning on the ViscoQC 300."

"Kegiatan eksplorasi di industri hulu minyak dan gas merupakan kegiatan dengan risiko yang tinggi. Hasil analisis investigasi menyatakan faktor yang paling berkontribusi menyebabkan insiden adalah tidak efektifnya penilaian risiko. Dalam melakukan kegiatan berisiko tinggi diperlukan suatu perencanaan agar tetap bekerja dengan aman dan selamat, yaitu manajemen risiko. Metode yang digunakan untuk manajemen risiko aktifitas keselamatan kerja adalah HIRADC. Oleh karena itu, peneliti mencoba untuk melihat penerapan proses risk assessment pada HIRADC. Penelitian ini bertujuan mengkaji hazard identification, risk assessment, and determining control HIRADC di PT. X. Penelitian ini menggunakan desain penelitian observasional deskriptif dengan metode kualitatif. Hasil penelitian menyarankan bahwa perlu dibuatnya satu system yang mencakup semua system pada kesehatan, keselamatan, dan lingkungan. Selain itu, perlu dilakukan sinergi tim HSSE yang ada di lapangan dalam memonitor HIRADC dan PTW sehingga terjadi keterkaitan antara keduanya. Dalam memaksimalkan sinergi tersebut perlu dibuat suatu work instruction oleh Safety Manager. Penegasan tugas dan tanggung jawab pekerja di lapangan perlu dijelaskan secara tertulis.

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Exploration activities in upstream oil and gas industries are high risk activities. The results of the investigation analysis stated that the most factors that contribute to the incidence is the ineffectiveness of risk assessment. In conducting high risk activities, a plan is required in order to keep working safely, ie risk management.

The method used for risk management of occupational safety activities is HIRADC. Therefore, the researcher tries to see the implementation of risk assessment process at HIRADC. This study aims to examine the hazard identification, risk assessment, and determining control HIRADC in PT. X. This research used descriptive observational research design with qualitative method.

The results suggested that it is necessary to create one system that includes all systems on health, safety, and environment. In addition, there should be synergy HSSE team on the ground to monitor HIRADC and PTW so that there is a correlation between the two. In maximizing the synergy need to be made a work instruction by Safety Manager. Affirmation of the duties and responsibilities of workers in the field need to be explained in writing."

"Setiap kegiatan termasuk kegiatan transportasi mempunyai risiko terjadinya kecelakaan kerja. Transportasi sungai menggunakan Smallboat memiliki risiko terjadinya kecelakaan, khususnya yang berkaitan dengan bahaya perairan. Terdapat beberapa kecelakaan didalam transportasi sungai menggunakan Smallboat. Tujuan Penelitian ini untuk mengetahui bahaya-bahaya dan tingkat risiko yang ada dalam transpotasi sungai menggunakan Smallboat. Penelitian ini menggunakan desain deskriptif observasional, JHA (Job Hazards Analysis) untuk identifikasi bahaya dan metode penilaian risiko semi kuantitatif. Hasil penelitian menunjukkan tingkat risiko diawal cukup tinggi untuk beberapa kategori bahaya, terutama untuk bahaya yang berhubungan dengan perairan (Marine Hazard) tabrakan, drifted (akibat gagal mesin), pengikatan tali mooring, sampai bahaya orang jatuh ke air (dengan nilai risiko <350-sangat tinggi). Dengan beberapa tindakan pengendalian yang sudah ada dan saran dari peneliti, risiko dapat berkurang menjadi beberapa kategori (prioritas 3, substansial dan dapat diterima). Penulis menyarankan untuk melakukan beberapa tindakan (prosedural, training dan engineering control) untuk dapat mengurangi nilai risiko yang ada dari setiap potensi bahaya dan perlu adanya penilaian risiko lanjutan untuk area-area kerja lainnya.

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All work activity include transportation have a risk of accident. Small boat Marine (river) transportation have a specific risk of accident, especially regarding marine hazards. There were many accidents happen regarding small boat transportation. The purpose of this study is to know what kind/type of hazards and level of risk from small transportation activity. This study uses design of observational descriptive, Job Hazard Analysis (JHA) for identify hazards tools and semi quantitative for risk assessment approach/technique.

The result showed that there have high level of risk assessment from several specific hazards (regarding marine hazards), specially related with collision, drifted (engine failure), mooring line, and until man overboard (with result is more than 350 which is very high category risk level). With some existing and recommend action for mitigation from author to reduce risk level from the activity the result can be reduce until low category (priority 3, substantial and acceptable risk level). The author suggested that mitigation action (procedural, training and engineering control) should implemented and perform other risk assessment for the others work area location."

"Tesis ini membahas tentang penilaian risiko dari kegiatan penanganan bahan baku kimia dan produk kimia di PT. N pada tahun 2009 dimana fokus penilaian risiko dilihat pada pekcxja di gudang bahan baku, pnoduksi, gudang produk, laboratorium Serta kontrol teknik. Penelitian ini adalah peneiitian semi-kuamitatii Data dikumpulkan dengan pengamatan dan diolah dengan matriks penilaian risiko autara iiwekuensi kejadian, peluang teljadi dan kosekuensi kejadian. Hasil penclitian menyarankan bahwa perlunya dilakukan pengendalian bempa pelatihan terhadap pekerja, komitmen manajemen dan penggunaan alat pelindung diri yang tepat bagi para pekerja untuk mengurangi risiko dari kegiatan penanganan bahan baku kimia dan produk kimia di PT. N.

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The focus of this study is the risk assessment of chemical material and product handling at PT. N in 2009, the focus of risk assessment are the employee in the material warehouse, production, Enishcd-good warehouse, laboratory and technical control. This research is semi-quantitative. The data were collected by observation and being input in the risk assessment matrix of frequencies, probability and Severity. The researcher recommend that training for employee, management commitment and usage of personal protection equipment are needed to the risk of material and product chemical handling at PT. N."

"Peralatan yang digunakan untuk pengukuran, penimbangan, pencatatan, dan pengendalian di industri harus terkalibrasi. Kalibrasi adalah pendemonstrasian hasil kinerja alat pada kondisi tertentu dibandingkan dengan standar referensi untuk menetapkan akurasi pengukuran serta menyediakan ketelusuran alat. Kalibrasi perlu dilakukan pada interval waktu atau frekuensi tertentu dengan metode yang ditetapkan. Tidak ada syarat resmi atau terstandar untuk penentuan frekuensi pelaksanaan kalibrasi. Tetapi, keputusan interval waktu kalibrasi tidak boleh ditetapkan hanya berdasarkan pertimbangan biaya. Penetapan interval waktu kalibrasi dapat dilakukan dengan kajian risiko (risk assessment) agar didapatkan keseimbangan antara biaya yang dibutuhkan untuk kalibrasi rutin dengan biaya yang perlu ditanggung akibat potensi deviasi dalam suatu periode, karena dilakukan dengan mempertimbangkan faktor hubungan langsung dengan stabilitas jangka panjang, keakuratan dan kepresisian pengukuran, rekomendasi produsen, intensitas penggunaan, riwayat perawatan dan perbaikan, dan lain-lain. Selain itu, penetapan interval waktu kalibrasi juga penting untuk mempertahankan keakuratan dan reliabilitas alat. Berdasarkan kajian risiko yang telah dilakukan, interval waktu kalibrasi alat-alat di pabrik PT CKD OTTO Pharmaceuticals yang terdaftar di Calibration Masterlist (FPT12-009A-00) edisi April 2023 terbagi menjadi setiap 6 bulan, 12 bulan, dan 24 bulan.

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Equipment used for measuring, weighing, recording, and controlling in industry must be calibrated. Calibration demonstrates the results of tool performance under certain conditions compared to a reference standard to determine measurement accuracy and provide tool traceability. Calibration must be done at certain time intervals or frequencies with a set method. There are no official or standardized requirements for determining the calibration interval. However, decisions about calibration intervals should not be made solely on cost considerations. Determination of calibration intervals can be carried out a risk assessment in order to obtain a balance between the costs required for routine calibration and the costs that need to be borne due to potential deviations in a because the risk assessment is carried out by considering factors directly related to long-term stability, accuracy and precision measurements, manufacturers' recommendations, the intensity of use, history of maintenance and repairs, more. In addition, determining the calibration time interval is also essential to maintain the accuracy and reliability of the tool. Based on the risk assessment that has been carried out, the time intervals for calibrating equipment at the PT CKD OTTO Pharmaceuticals factory, which are registered in the Calibration Masterlist (FPT12-009A-00) in the April 2023 edition, are divided into every 6 months, 12 months and 24 months"

"Penelitian ini membahas mengenai risiko keselamatan pada Pekerjaan Instalasi Pipa Hydrant dan Sprinkler di Proyek Pembangunan Gedung XY oleh PT. X Tahun 2012. Penilaian risiko dilakukan dengan menganalisis nilai probabilitas, konsekuensi dan eksposur dari setiap tahapan pekerjaan yang kemudian dibandingkan dengan standar tingkat risiko semi kuantitatif W.T. Fine J untuk mengetahui tingkat risiko. Penelitian ini menggunakan metode semi kuantitatif AS/NZS 4360:2004. Hasil penelitian menyatakan bahwa prioritas risiko yang dimiliki pada setiap tahapan pekerjaan di pekerjaan instalasi pipa hydrant dan sprinkler meliputi very high, priority 1, substantial, priority 3, dan acceptable.

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This study discusses the safety risks at work hydrant and sprinkler pipes installation on XY building Project by PT. X in 2012. Risk assessment is done by analyzing the value of risk probability, consequence and exposure of each phase of the work which is then compared with the standard semi-quantitative risk level WT Fine J to determine the level of risk. This study using semi-quantitative methods AS / NZS 4360:2004.

The results stated that the priority risks that exist at every stage of work on the job hydrant and sprinkler pipe installation includes very high, priority 1, substantial, priority 3, and acceptable."

"Risiko kesehatan di tempat kerja adalah permasalahan yang harus diminimalisasi agar para pekerja tetap sehat dan selamat. Penelitian yang dilakukan di Area Gas Plant dan Power Plant PT.X menunjukkan bahwa dua area pendukung eksplorasi minyak dan gas bumi PT.X ini masih banyak bahaya kesehatan yang belum teridentifikasi sehingga belum dilakukan pengendaliannya. Penelitian ini bertujuan untuk mengetahui nilai dan tingkat risiko Area Gas Plant dan Power Plant PT.X sehingga dapat diberikan rekomendasi pengendalian bahaya kesehatan yang sesuai untuk meminimalisasi risiko yang ada, berdasarkan penilaian risiko kesehatan dan analisis sumber daya. Desain studi yang digunakan adalah desktiptif analitik dengan pendekatan observasional yang mengacu pada standar AS/NZS 4360:2004 dan perhitungan nilai risiko berdasarkan metode semikuantitatif ICMM (2011). Hasil penelitian ini menunjukkan bahwa terdapat berbagai bahaya kesehatan yang mendapatkan prioritas tinggi pengendalian yaitu bahaya bising, bahan kimia silika, dan bahan kimia amina di dua area tersebut.

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Health risks in the workplace are the problem that must be minimized in order to keep workers healthy and safe. Research conducted in Gas Plant and Power Plant Area shows that the two areas of PT.X, which to support oil and gas exploration, still have many health hazards that have not been identified so that control is not performed. This study aims to determine the level of risk and the value of Gas Plant and Power Plant Area of PT.X so it can be given appropriate health hazard control recommendations to minimize risks, based on the health risk assessment and analysis of resources. Study design used is descriptive analytical observational approach which refers to standard AS/NZS 4360:2004 and calculation of risk based on a semiquantitative method of ICMM (2011). The results of this study indicate that there are a variety of health hazards whose priority is high, that is, noise hazards, silica chemicals, and chemicals amine in both areas."

"[ABSTRAKKecelakaan pada Alur Pelayaran Masuk dan Kolam Pelabuhan berdampak besar bagi pelabuhan tersebut, mulai dari nyawa manusia, kerugian materi, pencemaran lingkungan, hingga dampak buruk bagi stakeholder pelabuhan. Berdasar dari laporan investigasi kecelakaan KNKT, Risk Assessment dibuat. Risk Assessment diperlukan untuk menilai bobot dari resiko terjadinya kembali kecelakaan tersebut. Dari contoh Risk Assessment yang dibuat, disimpulkan bahwa faktor yang kerap menyebabkan kecelakaan di Alur Pelayaran Masuk dan Kolam Pelabuhan adalah Nakhoda yang tidak mengikuti prosedur pelayanan pandu dengan benar dan pemeliharaan fasilitas pelabuhan yang kurang baik. Untuk mencegah keccelakaan terulang, dibuat Lembar Permohonan Tanpa Pandu dan Lembar Pemeliharaan Fasilitas Pelabuhan.

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ABSTRACT

Ship accident at port entrance channel and port basin has a major impact on human lives, material losses, environmental pollution, and bad impact for the port stakeholders. Risk Assessment is based on KNKT?s investigation reports , Risk Assessment is needed to assess the weight of the risk recurrence similar accident. An example of a Risk Assessment Pelabuhan Tanjung Perak concluded that the bad procedure pilot service execution and bad port facilities maintenance are mostly causes ship accidents at port entrance channel and port basin. The recommendations to reduce the similar accidents are to apply ?Lembar Permohonan Tanpa Pandu? and ?Lembar Pemeliharaan Fasilitas Pelabuhan?.;Ship accident at port entrance channel and port basin has a major impact on human lives, material losses, environmental pollution, and bad impact for the port stakeholders. Risk Assessment is based on KNKT?s investigation reports , Risk Assessment is needed to assess the weight of the risk recurrence similar accident. An example of a Risk Assessment Pelabuhan Tanjung Perak concluded that the bad procedure pilot service execution and bad port facilities maintenance are mostly causes ship accidents at port entrance channel and port basin. The recommendations to reduce the similar accidents are to apply ?Lembar Permohonan Tanpa Pandu? and ?Lembar Pemeliharaan Fasilitas Pelabuhan?., Ship accident at port entrance channel and port basin has a major impact on human lives, material losses, environmental pollution, and bad impact for the port stakeholders. Risk Assessment is based on KNKT’s investigation reports , Risk Assessment is needed to assess the weight of the risk recurrence similar accident. An example of a Risk Assessment Pelabuhan Tanjung Perak concluded that the bad procedure pilot service execution and bad port facilities maintenance are mostly causes ship accidents at port entrance channel and port basin. The recommendations to reduce the similar accidents are to apply “Lembar Permohonan Tanpa Pandu” and “Lembar Pemeliharaan Fasilitas Pelabuhan”.]"