SOP Penerimaan Bahan Mentah, Bahan Pembungkus & Bahan Bercetak Dari Jabatan Pengeluaran - IDAMAN PHARMA - PDF

Summary

Dokumen ini merupakan satu prosedur operasi standard (SOP) untuk penerimaan bahan mentah, bahan pembungkus, dan bahan bercetak dari Jabatan Pengeluaran. Ia merangkumi objektif, skop, kekerapan, dan tanggungjawab yang terlibat dalam proses penerimaan.

Full Transcript

IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Departm...

IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 6 / 21 SCM/SOP-0035 15 1. Memansuhkan penggunaan ‘airlock’ steril pada KlausaPage Material from Production Department 6.2.4 & 6.2.5. Obsolete the use of sterile air locks in Clauses 6.2.4 & 6.2.5. 2. Memansuhkan prosedur baki bahan streril pada Klausa 7.1.3.1.7. Obsolete the procedure for remaining sterile materials in Clause 7.1.3.1.7. 3. Memansuhkan penggunaan stok kad pada Klausa 7.1.7. Obsolete the use of card stock in Clause 7.1.7. 4. Penukaran SCM/SOP-0002 kepada ENG/SOP-0068-Pengurusan Bahan Buangan Terjadual Conversion of SCM/SOP-0002 to ENG/SOP-0068-Scheduled Waste Management. 5. Penambahan pada senarai edaran Jabatan Kejuruteraan pada klausa 10.2.6. Addition to the distribution list for the Engineering Department under clause 10.2.6. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 7 / 21 Material from Production Department Page 1. OBJEKTIF (OBJECTIVE) 2. Menerangkan prosedur penerimaan baki Bahan Mentah, Bahan Pembungkus dan Bahan Pembungkus Bercetak dari Jabatan Pengeluaran. Explain the reception procedure Raw Materials, Packaging Materials and Printed Packaging from the Production Department. 3. SKOP (SCOPE) 4. Meliputi semua Bahan Mentah, Bahan Pembungkus dan Bahan Pembungkus Bercetak yang dipulangkan oleh Jabatan Pengeluaran ke Gudang Inbound. Covering all of the remaining Raw Materials, Packaging material and Printed Packaging Materials returned by Production Department to Inbound Warehouse. 1. Selepas proses penimbangan Bahan Mentah. After process of weighing Raw Material. 2. Selepas proses pembungkusan Produk Siap. After process of packaging Finished Goods Product. 3. Sebab-sebab yang tidak dapat dielakkan. Any inevitable reasons. 5. KEKERAPAN (FREQUENCY) 6. Situasi Rutin: Routine Condition: 1. Selepas proses penimbangan di Jabatan Pengeluaran. After process of weighing in Production Department. 2. Selepas proses pembungkusan di Jabatan Pengeluaran. After process of packaging in Production Department. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 8 / 21 Material from Production Department Page 3.2 Situasi Bukan Rutin. Rujuk PRO/SOP(O)-0002 Pengendalian Bahan Mentah di Kawasan Dispensing Jabatan Pengeluaran. Non-routine Condition. Refer PRO/SOP(O)-0002 Handling of raw Material in Dispensing Area in Production Department. 1. LANGKAH BERJAGA-JAGA (PRECAUTION) 2. Hendaklah sentiasa memakai topi dan kasut keselamatan. Sekiranya kakitangan gudang diperlukan memasuki ‘airlock’, ‘shoes cover’ mestilah dipakai dan pastikan tiada staff Jabatan Pengeluaran di dalam ‘airlock’. Always wear a safety helmet and safety shoes. The shoe cover must be used if warehouse staff required to enter airlock and make sure there are no Production Department staff in the airlock. 2. Hendaklah berhati-hati semasa mengendalikan akitiviti ini agar bahan sentiasa dalam keadaan baik. Always be careful during this activity so that the materials are in a good condition. 3. Untuk baki bahan mentah cecair dalam drum dan kontena, pastikan drum dan kontena tersebut telah ditutup dengan kemas dan ketat. For the remainder of the liquid raw material in the drum and container, make sure the drums and containers were covered with neat and tight. 4. Pastikan tidak ada sebarang serbuk, habuk dan kotoran pada semua bekas bahan mentah dan bahan pembungkus yang dipulangkan. Make sure there is no powder, dust and dirt on all containers raw materials and packaging materials returned. 5. Semua baki yang dipulangkan perlu mempunyai label ‘QUARANTINE’ dan ‘APPROVED’. Sekiranya tiada, kakitangan stor berhak menolak dan Jabatan Pengeluaran perlu memohon label daripada jabatan yang berkaitan (rujuk QC/SOP-0049 Pengurusan Label Terkawal). All balance of materials returned should have ‘Quarantine’ and 'Approved' label. Store staff have the right to reject if it is not complied and the Production Department should request the labels from the related deparment (refer QC/SOP-0049 Controlled Label Management). IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 9 / 21 Material from Production Department Page 1. TANGGUNGJAWAB (RESPONSIBILITY) 2. Eksekutif Gudang bertanggungjawab mengurus dan menyelia kerja-kerja penerimaan baki bahan mentah dan bahan pembungkus dari Jabatan Pengeluaran. The Warehouse Executive is responsible for managing and supervise the work of receiving the remaining raw materials and packing materials from the Production Department. 2. Penyelia Jabatan Pengeluaran bertanggungjawab memastikan semua prosedur berkaitan dilakukan dan dipatuhi. The Supervisor’s Production Department is responsible for ensuring that all related procedures performed and complied with. 3. Kakitangan gudang bertanggungjawab / Warehouse staff is responsible to: 1. Melakukan kerja-kerja penerimaan baki bahan mentah, bahan pembungkus dan bahan pembungkus bercetak dari Jabatan Pengeluaran. Reception of raw materials, packaging materials and printed packaging from the Production Department. 2. Melakukan kerja-kerja menghapuskan atau merosakkan label pada pembungkusan seperti drum dan kotak yang diterima daripada Jabatan Jabatan Pengeluaran bagi tujuan penggunaan semula. Performs the work of removing or damaging labels on packaging such as drums and boxes received from Production Department for reuse purposes. 4. Kerani Gudang bertanggungjawab melakukan transaksi di dalam sistem SAP. Warehouse Clerk is responsible to move the material transaction in SAP System. 5. PENGENALAN (INTRODUCTION) 6. Bahan permulaan merupakan bahan mentah, bahan pembungkus dan bahan bercetak. Pemulangan bahan ke stor berlaku dalam dua situasi: - IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 10 / 21 Starting materials consistfrom Material of Raw Materials, Production Packaging Materials Department Pageand Printed Materials. Material will be returned to the warehouse in two conditions: - 1. Situasi Rutin – merupakan pemulangan baki bahan permulaan yang digunakan oleh Jabatan Pengeluaran selepas sesuatu proses dijalankan. Permohonan bahan permulaan ini adalah berpandukan kepada ‘Process Order’ yang diwujudkan di dalam sistem SAP. Ianya terdiri daripada: Routine Condition - returned of balanced material used by the Production Department after a process is executed. Requisition of this material is referred to a Process Order generated via SAP System. It consists of: 1. Bahan Mentah Raw Materials 2. Bahan Pembungkus dan Bercetak Packaging and Printed Materials 2. Situasi Bukan Rutin Non-Routine Condition 1. Aktiviti Pengeluaran menggunakan ‘Process Order’ – merupakan pemulangan bahan permulaan yang disebabkan oleh sesuatu perkara yang mengakibatkan Jabatan Pengeluaran tidak dapat meneruskan aktiviti pengeluaran seperti kerosakkan HVAC. Production Activities using Process Order - returned of starting material due to a matter which resulted in the Production Department unable to continue production activities such as HVAC breakdown. 2. Aktiviti Pengeluaran yang tidak menggunakan ‘Process Order’ - merupakan pemulangan bahan permulaan yang digunakan oleh mana-mana jabatan selepas sesuatu aktiviti dijalankan seperti ujian prestasi mesin atau pemulangan bahan ‘consumable’ seperti bahan pencucian dan beg plastik. Production Activities which do not use Process Order - returned of the starting material used after a process is executed such as machine performance test or consumable materials returns such as cleaning agent and plastic bags. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 11 / 21 Material from Production Department Page 6.2 Penerimaan bahan permulaan daripada Jabatan Pengeluaran perlulah melalui ‘airlock’ mengikut jenis bahan tersebut. Receiving starting materials from the Production Department should be through airlock based on the material type. 1. Air Lock 1 (1W11) Bahan mentah bukan steril. Non-sterile raw material. 2. Air Lock 3 (1W22) Bahan pembungkus utama bukan steril contoh botol, foil & pvdc. Non-sterile primer packing material eg. bottle, foil & pvdc. 3. Air Lock 5 (1G10) Bahan pembungkus sekunder dan ketiga bukan steril contoh label & shipper. Non-sterile secondary and tertiary packing material eg. label & shipper. 6.3 Berikut adalah senarai singkatan yang digunakan dalam SOP ini: Below is the list of abbreviation used in this SOP: ABBREVIATION MEANING SOP Standard Operating Procedure MRS Material Requisition Slip QI Quality Inspection UU Unrestricted to Use AMR Additional Material Requisition FIFO First in First Out PO Process Order 1. PROSEDUR (PROCEDURE) 2. Situasi Rutin / Routine Condition: 1. Penyelia Jabatan Pengeluaran akan memberitahu Eksekutif Gudang, Penyelia atau Kerani mengenai pemulangan baki bahan permulaan. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 12 / 21 Supervisor The supervisor Materialoffrom Production ProductionDepartment Department will notify the Warehouse Executive, Page or clerk regarding the return of the remaining starting materials. 2. Sebelum membuka pintu ‘airlock’ pastikan: - Before opening the airlock door make sure: - 1. Pintu ‘airlock’ lain bertutup. Others airlock door closed. 2. Tidak ada pekerja Jabatan Pengeluaran berada di kawasan ‘airlock’. No personnel were in the Production Department airlock. 3. Pemeriksaan berikut mestilah dilakukan sebelum menerima baki bahan permulaan dari Jabatan Pengeluaran: - The following checks must be carried out before receiving the remaining starting materials from the Production Department: - 1. Bahan Mentah / Raw Materials 1. Baki bahan mentah yang dipulangkan hendaklah disertakan dengan ‘Material Requisition Slip’ atau ‘Additional Material Requisition’. Returned of raw materials must be accompanied by Material Requisition Slip or Additional Material Requisition. 2. Bahan mentah yang dipulangkan mempunyai label ‘QUARANTINE’, ‘APPROVED’ dan ‘For Dispensing Purpose Only’. Material returned shall have QUARANTINE, APPROVED and For Dispensing Purpose Only label on it. 3. Pastikan jumlah pemulangan yang dicatitkan pada ‘Material Requisition Slip’ atau ‘Additional Material Requisition’ adalah sama seperti kuantiti yang ada pada label ‘For Dispensing Purpose Only’. Ensure that the returned amount recorded in the Material Requisition Slip or Additional Material Requisition is equal to the amount on the For Dispensing Purpose label only. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 13 / 21 4. Sekiranya bahan mentah Material from Production Department yang Page dipulangkan oleh Jabatan Pengeluaran adalah tanpa pembungkusan asal seperti kotak atau drum, periksa bahan tersebut dibungkus dengan dua lapisan beg plastik dan diikat dengan pengikat kabel. (rujuk Lampiran 5 untuk mengetahui kuantiti lapisan beg plastik bagi bahan yang diterima). If the raw material returned by the Production Department is without the original packaging such as boxes or drums, check the material is packed with two layers of plastic bags and tied with cable ties. (refer Annexure 5 to determine the quantity of plastic bag layers for the material received). 5. Kakitangan gudang hendaklah menimbang bahan tersebut. Setiap proses penimbangan hendaklah direkod dalam buku Log Rekod Penimbangan (rujuk SCM/SOP-0065). Jika terdapat perbezaan, potong maklumat yang asal. Kemudian tandatangan dan tulis maklumat yang betul pada label ‘For Dispensing Purpose Only’. Warehouse staff should weigh the materials. Each of the weight to be recorded in the Weighing Log Records (refer SCM/SOP-0065). If there any differences, remove the unnecessary information. Then, sign and write the correct quantity on label For Dispensing Purpose Only. 6. Kakitangan gudang akan memindahkan Bahan Mentah tersebut ke dalam kotak asal. Warehouse staff will trasfer raw materials in to the original box. 7. Kakitangan gudang perlu menghantar bahan mentah mengikut turutan nombor kelompok terawal bagi kelompok terlibat. Ini kerana jika terdapat permulangan akan memudahkan aktiviti kakitangan stor untuk mengenal pasti bahan mentah berstatus ‘loose’. Warehouse staff must send the raw material by earliest batch number for the batch involved. This is because, in case of returns, it will ease the staff’s activities to identify raw materials with the status ‘loose’. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 14 / 21 2. Bahan Pembungkus dan Pembungkusan Bercetak Material from Production Department Page Packaging Material and Printed Packaging Material 1. Baki bahan yang dipulangkan hendaklah disertakan dengan ‘Material Requisition Slip’ atau ‘Additional Material Requisition’. Returned of materials must be accompanied by Material Requisition Slip or Additional Material Requisition. 2. Bahan yang dipulangkan mempunyai label ‘QUARANTINE’, dan ‘APPROVED’. Material returned shall have QUARANTINE and APPROVED label on it. 3. Baki Bahan Pembungkus ‘Direct Contact’ seperti botol dan penutup perlu dibungkus dengan dua lapis beg plastik dan diikat dengan pengikat kabel. (Rujuk Lampiran 5 untuk mengetahui kuantiti lapisan beg plastik bagi bahan yang diterima) Balance of direct contact packaging materials such as bottle and cap should be packed in two layers of plastic bags and tied with cable tie. (Refer to Annexure 5 to determine the quantity of plastic bag layers for the material received). 4. Sekiranya salah satu daripada prosedur tidak dipatuhi, pihak stor tidak akan menerima baki bahan permulaan tersebut sehinggalah semua prosedur tersebut dipatuhi sepenuhnya. If the procedures are not followed, the store will not accept the remaining starting materials until all these procedures are fully complied. 5. Keluarkan baki bahan permulaan dari palet Jabatan Pengeluaran ke atas palet stor. Rujuk Lampiran 4 untuk melihat perbezaan jenis palet di Jabatan Pengeluaran dan Stor. Tutup semula pintu ‘airlock’ dan bawa baki bahan tersebut ke stor berkaitan. Remove the balance of starting materials from Production Department’s pallets to store pallets. (Reference Annexure 4) shows the different type of pallets in Production Department and store. Close the airlock door and transfer the materials to respective store. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 15 / 21pembungkus 6. Bagi bakiMaterial bahanfrom permulaan Productionbukan steril seperti bahan Department mentah dan bahan Page boleh disimpan di Inbound D. Tujuan praktis adalah untuk pengasingan bahan berstatus ‘loose’ bagi memudahkan FIFO penghantaran ke Jabatan Pengeluaran. For remaining balance of starting non-sterile material such as raw materials and packaging materials can be stored in Inbound D. This practice is to separate loose quantity materials for good FIFO practices to deliver materials to Production Department. 7. Kakitangan stor perlu mengemaskini buku log (rujuk SCM/SOP-0004) dan sekiranya perlu, melakukan pemindahan lokasi bin di dalam sistem SAP dalam masa 2 hari bekerja. Rujuk FIT/SOP-0039 Pemindahan Stok. Store staff need to update logbook (refer SCM/SOP-0004) and if required, to perform transfer bin location in SAP system within 2 working days. Refer FIT/SOP-0039-Stock Transfer. 2. Situasi Bukan Rutin: Aktiviti Pengeluaran menggunakan ‘Process Order’ Non-Routine Condition: Production Activities using Process Order 1. Penyelia Pengeluaran akan memaklumkan kepada Eksekutif atau Penyelia Gudang mengenai pemulangan semula bahan mentah yang sudah ditimbang. Production Supervisor will inform the Warehouse Executive or Supervisor regards to returning raw material which already weighted. 2. Periksa ‘Material Requisition Slip’ atau ‘Additional Material Requisition’ telah diterima dari Jabatan Pengeluaran untuk kelompok produk yang terlibat. Check Material Requisition Slip or Additional Material Requisition has received from Production Department for batch number involve. 1. Sekiranya ‘Material Requisition Slip’ (MRS) atau ‘Additional Material Requisition’ (AMR) telah dilengkapkan sebelum aktiviti pemulangan, maka Jabatan Pengeluaran perlu mengisi borang ‘Material Return Form’ (Lampiran 8). If the ‘Material Requisition Slip’ (MRS) or ‘Additional Material Requisition’ (AMR) has been completed before the return activity, then the Production Department must fill in the ‘Material Return Form’ (Annexure 8). IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure 3. Receiving of Raw Material, Packaging Material and Printed Mukasurat: 16 / 21 Sebelum Material membuka pintu ‘airlock’ pastikan: - from Production Department Page Before opening the airlock door make sure: - 1. Pintu ‘airlock’ lain bertutup. Other’s airlock door closed. 2. Tidak ada pekerja Jabatan Pengeluaran berada di kawasan ‘airlock’. No personnel were in the Production Department airlock. 4. Bagi bahan mentah yang telah ditimbang melebihi 7 hari daripada tarikh penimbangan, Jabatan Pengeluaran perlu menyerahkan borang Pemulangan Bahan Mentah Dari Jabatan Pengeluaran ke Jabatan Pengurusan Perolehan dan Bekalan (rujuk Lampiran 8 Borang SCM-0035 F1). Bahan mentah tersebut ditampal dengan label ‘QUARANTINE’ (Required Testing). For raw materials that have been dispensed more than 7 days, the Production Department must submit a form named Return of Raw Material from Production Department to Supply Chain Management (refer Annexure 8 Form SCM-0035 F1). The raw material shall have QUARANTINE (Required Testing). 5. Pindahkan bahan mentah tersebut dari palet Jabatan Pengeluaran ke palet Gudang Inbound. Transfer the raw materials from Production Department’s pallet to Inbound Warehouse pallet. 6. Tutup semula pintu airlock dan terus bawa bahan mentah tersebut untuk disimpan di dalam kawasan Gudang Inbound. Close airlock door and immediately take the raw material to Inbound Warehouse. 7. Kakitangan stor perlu mengemaskini stok kad dan dalam 2 hari bekerja melakukan pemindahan lokasi di dalam sistem SAP. Salinan borang PRO(O)-0002 F1 akan dihantar ke Jabatan Kawalan Kualiti (QC). Store staff need to update stock card and within 2 working days to perform transfer in SAP system. A copy of PRO(O)-0002 F1 form will be given to Quality Control (QC) Department. 8. Jabatan QC akan menukar status daripada ‘Unrestricted to Use’ (UU) kepada ‘Quality Inspection’ (QI) di dalam sistem SAP. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Receiving of Raw Material, Packaging Material and Printed Mukasurat: Procedure QC Department staffProduction Material from will change the status from Unrestricted Department Page to Use 17(UU) / 21 to Quality Inspection (QI) in SAP system. 9. Bahan mentah yang telah ditimbang ini akan diberi keutamaan untuk diberikan kepada Jabatan Pengeluaran sekiranya ada rancangan pengeluaran membabitkan bahan mentah tersebut. Priority will be given to this weighed raw material if the Production Department had planned to do operation related to this kind of raw material. 10. Eksekutif Gudang perlu mengisi ‘Borang Permohonan Analisis’ sebelum bahan mentah tersebut boleh digunakan semula oleh Jabatan Pengeluaran. Rujuk QC/SOP-0087 Khidmat Pelanggan. Warehouse Executive will request ‘Analysis Requisition Form’ before that materials can be used again for Production Department. Refer QC/SOP-0087 Customer Service. 11. Keputusan Ujian Kawalan Kualiti / Result of Quality Control Test 7.2.11.1 LULUS – label ‘APPROVED’ akan ditampal. PASSED – APPROVED label will be pasted. 7.2.11.2 GAGAL – label ‘REJECTED’ akan ditampal. Bahan mentah tersebut akan dipindahkan ke Kawasan ‘Reject’. FAILED’ – Rejected label will be pasted. The raw material will be transfer to Reject Area. 7.2.12 Pemulangan label hologram dibenarkan sekiranya terdapat pemberhentian aktiviti pengilangan dimana aktiviti pembungkusan belum dimulakan. Kakitangan stor hendaklah merekodkan pemulangan hologram yang belum digunakan tersebut menggunakan dakwat merah pada buku log hologram (Rujuk Lampiran 9). The return of the hologram label is allowed if there is a cessation of manufacturing activities where packaging activities have not started. Store staff should record the return of the unused hologram using red ink pen in the hologram log book (Refer Annexure 9). IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 18 / 21 7.2.13 Bahan yang telahfrom Material mempunyai label ‘REJECTED’ akan Production Department dibuang ke Kualiti Page Alam setelah senarai lupus mendapat kelulusan daripada pihak pengurusan. Rujuk ENG/SOP-0068. Pengurusan bahan buangan terjadual. Materials that have REJECTED label will be disposed of to Kualiti Alam after the write off list has been approved by the management. Refer ENG/SOP-0068 of Scheduled Waste Management. 3. Situasi Bukan Rutin: Aktiviti Pengeluaran tidak menggunakan ‘Process Order’ Non-Routine Condition: Production Activities do not use Process Order 1. Kakitangan jabatan yang terlibat akan memaklumkan kepada Eksekutif atau Penyelia Gudang mengenai pemulangan semula bahan. Staff will inform the Warehouse Executive or Supervisor regards to returning material. 2. Pastikan Borang Permohonan dan Pemulangan Bahan (Rujuk SCM/SOP -004) telah diterima dari jabatan terlibat untuk bahan yang berkaitan. Make sure Returned Material Form (Refer SCM/SOP -004) has received from Production Department for material involved. 3. Sekiranya pemulangan adalah melalui ‘airlock’ Jabatan Pengeluaran pastikan: - If the material returned is through the Production Department 'airlock' door, make sure: - 1. Pintu ‘airlock’ lain bertutup. Other’s airlock door closed. 2. Tidak ada pekerja Jabatan Pengeluaran berada di kawasan ‘airlock’. No Production Department was in the airlock. 3. Dibungkus dalam lapisan beg plastik mengikut jenis bahan (Rujuk Lampiran 5). Packed in a layer of plastic bags according to the specified type (Refer Annexure 5). 4. Pindahkan bahan mentah tersebut dari palet Jabatan Pengeluaran ke palet Stor Inbound. Transfer the raw materials from the Production Department’s pallet to Inbound Store’s pallet. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure 4. Receiving of Raw Material, Packaging Material and Printed Mukasurat: 19 / 21 Simpan bahan tersebut di dalam kawasan gudang inbound Material from Production Department Pageyang bersesuaian. Store the material in a suitable inbound warehouse area. 5. Kakitangan stor perlu membuat penambahan stok di dalam sistem SAP menggunakan MIGO – Good Issues. The store staff should perform MIGO – Good Issues in SAP System. 6. Eksekutif kemudiannya akan mengesahkan transaksi tersebut telah pun dilakukan dengan melihat Material Movement Report di TCODE: MMBE. The executive is required to verify that the transaction has been made by viewing at the Material Movement Report at TCODE: MMBE. 8.0 RUJUKAN / DOKUMEN BERKAITAN (REFERENCE / RELATED DOCUMENT) 8.1 PRO/SOP (O)-0002 Pengendalian Bahan Mentah Dikawasan ‘Dispensing’ Jabatan Pengeluaran. Handling of Raw Material in Dispensing Area in Production Department. 8.2 QC/SOP-0087 Perkhidmatan Pelanggan Customer Service 8.3 FIT/ SOP-0039 Pemindahan Stok Stock Transfer 8.4 ENG/SOP-0068 Pengurusan Bahan Buangan Terjadual Management of Scheduled Waste 8.5 QC/SOP -0049 Pengurusan Label Terkawal Controlled Label Management 8.6 SCM/SOP-0004 Permohonan Bahan Mentah, Bahan Pembungkus dan Bahan Bercetak Request of Raw Material, Packaging Material dan Printed Material 8.7 SCM/BL-0034 Buku Log Daftar Label Keselamatan Registered Safety Label Log Book. IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 20 / 21 Material from Production Department Page 8.8 SCM/SOP-0065 Penggunaan Mesin Penimbang di Jabatan Pengurusan Perolehan dan Bekalan Operation Weighing Balance in Supply Chain Management Department 9.0 LAMPIRAN (ANNEXURE) 9.1 Lampiran 1 Carta Alir Penerimaan Situasi Rutin Annexure 1 Routine Receiving Flow Chart 9.2 Lampiran 2 Carta Alir Penerimaan Situasi Bukan Rutin menggunakan ‘Process Order’ Annexure 2 Non-Routine Receiving with Process Order Flow Chart 9.3 Lampiran 3 Carta Alir Penerimaan Situasi Bukan Rutin tanpa ‘Process Order’ Annexure 3 Non-Routine Receiving without Process Order Flow Chart 9.4 Lampiran 4 Contoh Palet Yang Digunakan Di Jabatan Pengeluaran dan Stor Annexure 4 Examples of Pallet Use by Production Department and Store 9.5 Lampiran 5 Jadual Kuantiti Lapisan Beg Plastik Semasa Penerimaan Bahan Annexure 5 Table of Plastic Beg Quantity Layers for Starting Materials Received 9.6 Lampiran 6 Contoh Label yang perlu ada semasa penerimaan bahan Annexure 6 Sample of Labels required upon material received. 9.7 Lampiran 7 Contoh ‘Material Requisition Slip’ dan ‘Additional Material Requisition’ Annexure 7 Sample of Material Requisition Slip and Additional Material Requisition 9.8 Lampiran 8 Material Return Form (link with PO) Annexure 8 Material Return Form (link with PO) 9.9 Lampiran 9 Contoh Format Buku Log Daftar Label Keselamatan Annexure 9 Example of Registered Security Label Log Book Format IDAMAN PHARMA MANUFACTURING SDN. BHD. Lot 120, Taman Farmaseutikal, 32610 Bandar Seri Iskandar, Perak PROSEDUR JABATAN PENGURUSAN PEROLEHAN DAN BEKALAN No. SOP: SCM/SOP-0035/15 OPERASI Supply Chain Management Department SOP No. PIAWAI PENERIMAAN BAHAN MENTAH, BAHAN PEMBUNGKUS Menggantikan: SCM/SOP-0035/14 Standard DAN BAHAN BERCETAK DARIPADA JABATAN Supersedes Operating PENGELUARAN Procedure Receiving of Raw Material, Packaging Material and Printed Mukasurat: 21 / 21 Material from Production Department Page 1. SENARAI EDARAN (DISTRIBUTION LIST) 2. Salinan Asal (Original Copy). 1. Jabatan Jaminan Kualiti (QA). Quality Assurance Department (QA). 2. Salinan Terkawal (Controlled Copy). 1. Jabatan Pengurusan Perolehan & Bekalan (SCM). Supply Chain Management (SCM). 2. Jabatan Pengeluaran (PROD). Production Department (PROD). 3. Jabatan Kawalan Kualiti (QC). Quality Control Department (QC). 4. Jabatan Keselamatan, Kesihatan dan Alam Sekitar (SHE). Safety, Health and Environment Department (SHE). 5. Jabatan Kewangan & Teknologi Maklumat (FIT). Finance & Information Technology Department (FIT). 6. Jabatan Kejuruteraan. Engineering Department (ENG).

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