f ‘SMKP/ASKIFST/O1 00 CV. AJI SAKA KELAPA No. Dok. PEDOMAN KEAMANAN PaNcan [RE | Halaman. (0-202 1 dari 25 |. Ruan Lingkup 4.4 Umum bedoman Keamanan Pangan ini disusun dengan fujuan untuk menciplakan dan menjelaskan ‘Sistem Manajemen Keamanan Pangan, yang mana perusahaan dapat: @) ‘Menunjukkan kernampuannya untuk secara konsisten memberikan pelayanan yang memenuhi | kebutuhan Pelanggan, para pengguna Sistem Manajemen Keamanan Pangan, serta memenuhi | Ketentuan dan peraturan yang ada. b) Menunjukkan kemampuan untuk mengendalkan bahaya keamanan pant dikonsumsi oleh manusia ‘c) Meningkatkan kepuasan pelanggan dengan memenuhi persyaratan pelang¢ gan sehingga aman gan Ja) Mengeveluasi dan mengkomurikasikan secaraefekt iu keamanan pangan yang ada dalam produk pangan baik kepada pelanggan maupun pemasok |Je) Memenuhi Kebutuhan Petanggan melalui efekfiitas Tindakan di dalam Sistem Manajemen Keamanan Pangan, termasuk proses untuk perbaikan yang berkesinambungan serta pencegahan atas ketidaksesuaian dengan Sistem Manajemen Keamanan 1.2 Ruang Lingkup Penerapan Pangan Pedoman Keamanan Pangan ini dterapkan di CV. AJI SAKA KELAPA, mencakup seluruh area bisnis proses perusahaan kecuali pada Bagian Pemasaran dan Keuangan, juga tethadap seluruh produk yang diasilkan 1.3 Profil Perusahaan Nama Perusahaan : CV.AJISAKA KELAPA, Alamat Perusahaan : Jl. Manunggal No. 18, Kel. Mojolangu, Kec. Lowokwaru, Kota Malang, Prov. Jawa Timu No Telepon + 0812-1734-1501 2. Acuan yang Mengatur Acuan yang mengatur adalah: a) SNI ISO 22000:2018 Sistem Manajemen Keamanan Pangan — Persyaratan Untuk Organisasi Dalam Rantai Pangan b) Permenperin No. 75 Tahun 2010 Pedoman Cara Produksi Pangan Olahan yang Baik Scanned with CamScannerCV. AJI SAKA KELAPA No. Dok. | SMKP/ASK/FST/O1 Revisi 00 PEDOMAN KEAMANAN PANGAN Tanggal_| 01-40-2021 Halaman | 2 dari 25 Peraturan Badan Pengawas Obat dan Makanan Nomor 31 Tahun 2018 Tentang Label Pangan Olahan °) d) Peraturan Badan Pengawas Obat dan Makanan Nomor 34 Tahun 2019 Tentang Kategori Pangan e) Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 22 Tahun 2017 Tentang Penarikan Pangan Dari Peredaran f) Peraturan Badan Pengawas Obat dan Makanan Nomor 11 Tahun 2019 Tentang Bahan Tambahan Pangan Scanned with CamScannerCV. AJ SAKA KELAPA No. Dok. [ SMKP/ASKIFST/O1 Revisi__| 00 PEDOMAN KEAMANAN PANGAN, Tanggal_[ 01-10-2021 Halaman | 3 dari 25 3. Istilah dan Definisi Istilah dan definisi yang berhubungan dengan Sistem Manajemen Keamanan Pangan yang digunaken ai delam Manual Pedoman Keamanan Pangan ini sesuai dengan istilah dan definisi yang digunakan dalam SNI ISO 22000:2018 Sistem Manajemen Keamanan Pangan — Persyaratan Untuk Organisasi Dalam Rentai Pangan, 4. Konteks Organisasi 4,1 Memahami Organisasi dan Konteksnya CV. AJI SAKA KELAPA telah menentukan isu intemal dan isu ekstemal yang relevan dengan tujuan dan arahan strategis yang dapat mempengaruhi kemampuan perusahaan dalam mencapai hasil yang diinginkan dari sistem manajemen mutu yang ditetapkan. Isuisu intemal maupun ekstemal kemudian diintegrasikan ke dalam sistem manajemen mutu yang dibuat dengan tujuan dapat menjaga mutu dan pelayanan yang dinasilkan oleh perusahaan. 4.2 Memahami Kebutuhan dan Pihak yang Berkepentingan Direktur beserta segenap mangjemen bertanggung jawab terhadap penerapan sistem marajemen ‘mutu serta menjamin konsistensi mutu produk agar kepuasan dari pihak yang betkepentingan bagi dari sisi manajemen maupun konsumen tetap selalu terjaga. CV. AJl SAKA KELAPA akan selalu ‘memantau dan meninjau informasi tentang pihak-pihak yang berkepentingan dan persyaratan yang relevan dengan semua stakeholders, Informasi terdokumentasi: + Isuinternal dan eksternal (Lampiran 1) ~ Pinak yang Berkepentingan (Lampiran 2) 4.3 Menetapkan Ruang Lingkup Sistem Manjemen Keamanan Pangan Ruang lingkup penerapan SNI ISO 22000:2018 Sistem Manalemen Keamanan Pangan — Persyaratan Untuk Orgenisasi Dalam Rantai Pangan di CV. AJl SAKA KELAPA meliputi seluruh Unit Kerja sesuai struktur organisasi produk dan layanan yang mencakup penerapan sistem anajemen mutu ini meliputi produksi di CV. AJI SAKA KELAPA. 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KONDISIUMUM 1 | Kondisi Produk 1. | wujud air Visual 1.2 | Gramasi 1000mL, 500mL, 350ml, 130mL, | penimbangan om, 30ltr ‘Gelembung Air (saat pengisian ke 1.3 | Cemaran fisik kemassan) dan hilang5-10menit Visual hilang Posisi tertutup plastik : ’ i 2 | fond temasan | Remus tiacotor don wok Visual Eset Kode produksi dan expire date vail terbaca dengan jelas (printing) Kemasan karton dos Visual Kondis k 3 | sckunder | Kemsan tidak kotor dan tidak Ta sobek, printing bagus Kualitas produk [Ware Jernih Visual Rasa Khas minyak kelapa Organoleptik Bau Segar kelapa Organoleptik 5. | Masa simpan 30 bulan (2,5thn) Visual g_| Kondisi Disimpan pd suhu ruang 25-30 ea Penyimpanan C Dibuat oleh Disetujui Food Safety Team Leader Direktur Scanned with CamScannerSTANDART BAHAN BARU KELAPA (Daging Buah Kelapa) (No! PARAMETER | PERSYARATAN (METODE | ‘A. KONDISI PENERIMAAN 1. KONDISI UMUM. kemasan Tidak menggu nakan kemasan khusus, 11 karena sudah ada tempurung/batok Visual 12 [Produk B. KUALITAS SENSORI 1] Bentuk Bahan Visual 2_|Warna Visual 3__| Aroma Organoleptik. 4_[ Rasa Organoleptik. C. KONDIS! PENYIMPANAN. 1_| Kondisi umum Suhu_ Umur simpan Disetujul Ketua Tim Keamanan Pangan Scanned with CamScannerCV. AJI SAKA KELAPA No. Dok. [SMKP-H-001 Revisi co) ‘STRUKTUR ORGANISASI [Tangga ‘01 Okiober 2021 Halaman A derit I — STRUKTUR ORGANISASI ManajemenPuncak Or. Zainal Gani Kontrol Doc/Administrasi KetuaKeamananPangan Fitria Handayani Dedy Prayogo Pembelian Gudang SDM Quality Control Pe _ | ia Handy rayogo Yep Kanban f MamikNurhayet | yaianend prihartonaPriharto no Scanned with CamScanner‘SMKP-M/001 Tanggal 01/10/2023 SURAT PENUNJUKAN TIM KEAMANAN PANGAN NO:ASK/PM/WM/01 Bersama dengan ini saya selaku Top Management menugaskan kepada nama — nama yang tersebut dibawab ini: No Nama Bagian Posisi dalam Tim 1_| Dedy Prayogo Kepala Produksi Ketua Tim Keamanan Pangan 2 | dr. Zainal Gani Direktur Keamanan Pangan a ; ‘Administrasi dan Keamanan Pangan dan Fitria Hi 9 z andayant Document Control Document Control 4 | Dedy Prayogo Produksi Keamanan Pangan 5. | Fitria Handayani SDM dan Qc Keamanan Pangan 6 | Yuyun Kumiawati Pembelian Keamanan Pangan 7 | Mamik Nurhayati ere dan Penerimaan | ie amanan Pangan intuk menjalankan tugas sebagai Tim Keamanan Pangan di CV. Aji Saka Kelapa falang, 01 Oktober 2021. Dibuat Oleh: Direktur Scanned with CamScannerCV. AJI SAKA KELAPA No. Dok. _[SMKP-M/001 JOB DESKRIPSI Revisi | Tanggal_| Halaman Bagian : Pembelian AtasanLangsung —: Direktur Gambaran singkat posisi: Bagian Pembelian bertanggungjawab dalam proses pembelian dan pengadaan barang atau jasa_yang dibutuhkan oleh perusahaan serta mendukung implementasi HACCP di perusahaan Kualifikasi Umum : PriaWanita usia minimal 20 Tahun . Pendidikan Minimal SMA/sederajat Berpengalaman di bidangnya minimal 1 Tahun Teliti, Disiplin, Jujur, Tangkas dan bertanggung jawab . Sehat Jasmani dan Rohani Tidak buta wama OREN Job Deskripsi / tanggung jawab : Bertanggung jawab terhadap permintaan pembelian barang. Mencari supplier baru sesuai dengan kebutuhan barang, Melakukan seleksi dan evaluasi supplier. Mempertanggung jawabkan jumlah dan mutu barang yang dipesan. Menjalin kerjasama yang menguntungkan dengan pihak supplier, Menjaga kerahasiaan semua informasi yang ada pada perusahaan, Melakukan pengarsipan atas dokumen-dokumen yang terkait dengan bagiannya Melakukan analisa untuk peningkatan kinerja bagiannya, Memelihara dan meningkatkan kebersinan, kenyamanan dan keamanan lingkungan kerja. Sen onsen Wewenang : 1. Menolak barang masuk yang tidak sesuai spesifikasi pembelian, 2. Menghapus list supplier yang tidak lulus evaluasi, Malang, Dibuat oleh : Dr. Zainal Gani DIREKTUR Scanned with CamScannerCV. AJI SAKA KELAPA No. Dok. _[ SMKP-M/001 JOB DESKRIPSI Revisi__| 00 Tanggal__| 01-10-2024 Hataman_| 2 dari 8 Bagian : Staff Produksi Atasan Langsung —_: Direktur ‘Gambaran singkat posisi: Bagian Produksi bertanggungjawab dalam proses produksi produk VCO dan mendukung implementasi HACCP di perusahaan ‘Kualifikasi Umum : Pria/Wanita usia minimal 25 Tahun Pendidikan Minimal SMA/sederajat Berpengalaman di bidangnya minimal 3 Tahun Telit, Disiplin, Jujur, Tangkas dan bertanggung jawab Sehat Jasmani dan Rohani Tidak buta wama PRRoON= Job Deskripsi / tanggung jawab : 1. Bertanggung jawab terhadap proses produksi. 2. Bertanggung jawab menghasilkan produk yang sesuai standard 3. Bertanggung jawab melakukan monitoring CCP 4. Bertanggung jawab menjalankan GMP Wewenang : 1. Menolak bahan baku yang tidak sesuai standar. 2. Menghancurkan produk defect Malang, Dibuat oleh : DIREKTUR Scanned with CamScannerCV. AJI SAKA KELAPA No. Dok._| SMKP-M/001 JOB DESKRIPSI Revisl 00 Tanggal_| 01-10-2021 Halaman _|3 dari 8 : QC / quality contro! ‘Atasan Langsung —_: Direktur |Gambaran singkat posisi: Bagian QC bertanggungjawab dalam proses Inspeksi bahan baku, proses produksi dan produk jadi serta mendukung implementasi HACCP di perusahaan Kualifikasi Umum : |. PriaWanita usia minimal 23 Tahun . Pendidikan Minimal D3 Pangan Berpengalaman di bidangnya minimal 2 Tahun Telit, Disiplin, Jujur, Tangkas dan bertanggung jawab Sehat Jasmani dan Rohani . Tidak buta wama Ogaens Job Deskripsi / tanggung jawab - 1. Bertanggung jawab terhadap kualitas dan keamanan produk. 2. Berlanggung jawab menjalankan GMP Wewenang : 1. Menolak bahan baku yang tidak sesuai standar. 2. Menghentikan proses produksi bila terjadi ketidaksesuaian 3. Mereject produk jadi bila tidak sesuai standar Malang, Dibuat oleh : gr. Zainal Gani DIREKTUR Scanned with CamScannerCV. AJI SAKA KELAPA No. Dok.__| SMKP-M/001 JOB DESKRIPSI Revs 002i Halaman _| 4 dari 8 iBagian : SDM 'Atasan Langsung —_: Direktur ‘Gambaran singkat posisi: Bagian SDM bertanggungjawab dalam proses penerimaan karyawan, pelatihan dan evaluasi/ assessment karyawan serta mendukung implementasi HACCP di perusahaan. Kualifikasi Umum : 1. Pria/ Wanita usia minimal 20 Tahun 2. Pendidikan Minimal SMA/ sederajat 3. Berpengalaman di bidangnya minimal 1 Tahun 4, Telit, Disiplin, Jujur, Tangkas dan bertanggung jawab 5. Sehat Jasmani dan'Rohani 6. Tidak buta wana Job Deskripsi/ tanggung jawab : 1. Bertanggung jawab terhadap penerimaan karyawan baru 2 2, Bertanggung jawab terhadap proses evaluasi karyawan 5 3. Bertanggung jawab terhadap peningkatan kompetensi Karyawan melalui program training/ pelatihan Wewenang : 1. Melakukan proses penerimaan karyawan sesuai kebutuhan perusahaan 2. Melakukan uji kompetensi karyawan 3. Mengeluarkan surat peringatan bagi karyawan yang melanggar peraturan perusahaan. Malang, Dibuat oleh : dr. Zainal G: DIREKTUR Scanned with CamScannerCV. AJl SAKA KELAPA No. Dok._[ SMKP-M/001 JOB DESKRIPSI Revisi__ [00 ‘Tanggal_| 01-10-2021 [Halaman [6 dari 8 Bagian : Gudang ‘Atasan Langsung —: Kepala Produksi Gambaran singkat posi Bagian Gudang bertanggungjawab dalam proses monitoring ketersediaan bahan baku, bahan kemas dan produk jadi sera mendukung implementasi HACCP di perusahaan. Kualifikasi Umum : . Pria/ Wanita usia minimal 20 Tahun . Pendidikan Minimal SMAJ sederajat Berpengalaman di bidangnya minimal 1 Tahun . Telit, Disiplin, Jujur, Tangkas dan bertanggung jawab Sehat Jasmani dan Rohani Tidak buta waa Parens Job Deskripsi / tanggung jawab : 4. Bertanggung jawab terhadap monitoring ketersediaan dan penyimpanan bahan baku 2. Bertanggung jawab terhadap monitoring ketersediaan dan penyimpanan behan kemas 3, Bertanggung jawab terhadap monitoring ketersediaan dan penyimpanan produk jadi 4. Monitoring FIFO (First In First Out) / FEFO (First Expired First Out) 5. Menjalankan GMP ‘Wewenang = 4. Melakukan stock opname 2. Mengajukan pembelian ke bagian pembelian Malang, Dibuat oleh : dr. Zainal Gani DIREKTUR Scanned with CamScannerCV. AJl SAKA KELAPA No. Dok._| SMKP-M/00% JOB DESKRIPSI Revisi__| 00 Tanggal | 01-10-2021 Halaman | 6 dari 8 Bagian : Wakil Manajemen Keamanan Pangan (MR) htasen Langsung : Direktur i ‘Gambaran singkat posisi: Bagian Wakil Manajemen Keamanan Pangan bertanggungjawab dalam proses implementasi HACCP : 2048 di perusahaan. en “Kualifikasi Umum : PriaWanita usia minimal 25 Tahun Pendidikan Minimal SMA/sederajat Berpengalaman di bidangnya minimal 3 Tahun Telii, Disiplin, Jujur, Tangkas dan bertanggung jawab ‘Sehat Jasmani dan Rohani Tidak bute warna | Nob Deskripsi /tanggung jawab : 1, Membentuk dan mengatur tugas dan wewenang tim keamanan pangan 2. Memastikan bahwa anggota tim keamanan pangan sudah mendapatkan edukasi dan pelatihan yang relevan dengan bidangnya masing-masing 3, Melakukan koordinasi dengan bagian terkait dalam pelaksanaan sistem keamanan pangan 4. Memantau kesesuaian regulasi-regulasi yang terkait dengan Sistem Manajemen Keamanan Pangan Membuat jadwal intemal audit Mengkoordinir pelaksanaan Management review oe Wewenang : 1, Menentukan dan membagi tugas yang harus dilakukan oleh setiap anggota. 2. Mengganti atau menghentikan anggota tim. 3. Memberikan keputusan terkait pelepasan produk akhir yang terindikasi berpotensi tidak aman lalang, Dibuat oleh : 1 a dt Zainal Gani DIREKTUR a Scanned with CamScannerCV. AJl SAKA KELAPA No. Dok. _| SMKP-M/004 JOB DESKRIPSI Revisi__[ 00) ‘Tanggal_| 01-10-2021 Halaman_| 7 dari 8 Bagian + Adminitrasi kontrol dokumen Atasan Langsung =: Direktur ] Gambaran singkat posisi: | Bagian adminitrasi bertanggungjawab dalam proses adminitrasi dan sistem dukumentasi, pengarsipan yang akan digunakan dalam proses produksi, serta mendukung implementasi HACCP di perusahaan, Kualifikasi Umum : | 4. Wanita usia minimal 20 Tahun 2. Pendidikan Minimal SMA /sederajat 3. Berpengalaman di bidangnya minimal 1 Tahun 4. Tel, Disiptin, Jujur, Tangkas dan bertanggung jawab 5. Sehat Jasmani dan Rohani 8. Tidak but waa Job Deskripsi /tanggung jawab : | 1. Bertanggung jawab membantu manajemen dalam menjalankan prosedur pengendalian dokumen dan rekaman mutu, 2. Bertanggung jawab terhadap sosialisasi dan ditribusi ke seluruh bagian. 3, Bertanggung jawab penyimpanan dokumen, Wewenang : | 4, Membuat dan melaksanakan kearsipan dokumen. 2, Mengkoodinir rapat / meeting seluruh bagian terkait. Malang, Dibuat oleh : ‘dr. Zainal Gani DIREKTUR Scanned with CamScannerCV. AJI SAKA KELAPA No. Dok._| SMKP-M/001 JOB DESKRIPSI Revisi__ [00 ‘Tanggal_| 01-10-2021 Halaman [8 dari 8 re | Bagian + Kepala Bagian Produksi dan PPIC ‘Alasan Langsung —: Direktur Gambaran singkat posisi: Bagian Kepala produksi bertanggungjawab koordinasi, perencanaan, pelaksanaan dan pengendalian dalam proses produksi, serta mendukung implementasi HACCP di Perusahaan, Kualifkasi Umum : 4. Pria usia minimal 25 Tehun 2. Pendidikan Minimal 4 . selenide di bidangnya minimal 2 Tahun . |, Disiplin, Jujur, Tar dan bertanggung jawab Schat Jasmani dan Rohe ear . Tidak buta wama oaae job Deskripsi / tanggung jawab : 1. Berlanggung jawab terhadap kelancaran kegiatan operasional dan administratit di bagian PPIC. 2. Bertanggung jawab tethadap menjamin kelancaran kegiatan produksi. 3. Bertanggung jawab koordinasi dengan bagian lain mengenai penyediaen bahan ku, efisiensi dan efektivitass proses sampai penyiapan barang jadi. 4. Bertanggung jawab membuat jadwal produksi sesuai dengan target yang telah disepakati bersama direktur. . Membuat laporan secara jelas dan terperinci didalam ruang lingkup bagian Perencanaan dan produksi a | Wewenang : 1. Melakukan koordinasi dengan bagian lain dalam melaksanakan proses produksi. 2. Memberikan masukan kepada direktur terhadap kesalahan dan pelanggaran bawahan atau masukan lain untuk perbaikan Perusahaan, ‘Malang, Dibuat oleh : dr. Zainal Gani DIREKTUR Scanned with CamScannerCV. AJI SAKA KELAPA fo. Dok._| SMKP-M/001 JOB DESKRIPSI Reta To0 Tanggal_ | 01-10-2021 Halaman_| 9 dari 8 dagian 2 Teknik i Atasan Langsung —: Kepala Produksi ‘Gambaran singkat posisi: Bagian Teknik bertanggungjawab dalam proses perawatan dan perbaikan mesin dan peralatan yang akan digunakan dalam proses produksi, serla mendukung implementasi HACCP di perusahaan. ] Kualifikasi Umum : | 7. Priausia minimal 18 Tahun | 8. Pendidikan Minimal STM /sederajat | 9, Berpengalaman di bidangnya minimal 1 Tahun | 10. Telit, Disiplin, Jujur, Tangkas dan bertanggung jawab | 14, Sehat Jasmani dan Rohani | 12. Tidak buta warna Lob Deskripsi / tanggung jawab : 6, Bertanggung jawab terhadap Perawatan dan Kualitas mesin 7. Bertanggung jawab terhadap Perbaikan mesin Wewenang : 3. Membuat dan melaksanakan jadwal perawatan mesin 4, Memberikan informasi status/ identitas apabila mesin dalam kondisi tidak standar Malang, Dibuat oleh : gr. Zainal Gani DIREKTUR Scanned with CamScannerKEBIJAKAN KEAMANAN PANGAN KEBLJAKAN KEAMANAN PANGAN AJISAKA KELAPA bertckad untuk menghasilkan produk makanan, aman untuk oe ‘bem dan higinis secara konsisten dalam rangka memenuhh kebutuhan konsumen, mengutat Kepuasan pelanggan dan memenuhi peraturan Perundangan yang berlaku. Perusahaan akan mencapainya melalui penerapan langkah-tangkah berikut: 1, Menjamin seluruh produk yang dibuat mengacu pada system HACCP dan berpedoman pada SMKP 1SO 22000:2018 | 2, Menggunakan bahan baku dan bahan kontak Produk yang aman untuk produk pangan sesuai Persyaratan dalam HACCP dan SMKP 180 22000-2018 3. Menjamin fasilitas produksi yang digunakan bebas dari resiko bahaya pangan. 4. Melatih, mengembangkan dan melibatkan Seluruh stakeholder perusahaan guna memahami | Sistem keamanan pangan, Menyediakan sumberdaya yang diperlukan untuk penyusunan, Penerapan dan Perbaikan berkelanjutan Sistem keamanan pangan, Selalu melakukan Perbaikan yang berkelanjutan / Continues Improvement Tandatangan dr. Zainal Gani Direktur Utama Scanned with CamScanner10 22000:2018(E) | | Contents Page | Foreword. Introduction. 1 2 Normative references, 3 Termsand definitions. 4 Context of the organization, 41 Understanding the organization and its co 42 Understanding the needs and exe eee 43 Determining the scope of the fara 44 Food safety management system 5 Leadership___ 5.1 Leadership and com 52 Policy.__. ——— ann 52.1 Establishing the food safety pol iy 822 _ Communicating the food safety policy. S.3 Organizational roles, responsibilities and authorities. f S1 Actions to address risks and opportunities . i —. 7 pplectives of the food safety management system and planning to achieve them. 63 Planning of changes. SO sesesett rater and pena 7 Support____ 7A Tad 712 743 7.14 Work environment 3 7.1.5 Externally developed elements of the food safety management system... 71.6 Control of externally provided processes, products or services 72 Competence. 73 Awareness 74 744° General 743 Internal communication 75 — Documented information. 75.1 General__~ 752 Creating and updati = 753 Control of documented information 8 Operation = 81 Opera pl cD 82 Prerequisite programmes (PRPs). 83 Traceability system... pa 84 — Emergency preparedness and response. 841 General___ 84.2 Handling of emergencies and incidents. 85 Hazard control : 5.1 Preliminary steps to enable hazard analysis____._____ 85.2 Hazard analysis —_—-—eeemnnmmne 21 85.3 Validation of control measure(s) and combinations of control measures 23 854 Hazard control plan (HACCP/OPRP plan) —_ 86 — Updating the information specifying the PRPs and the hazard control plan. 4 25 "ISO 2018 Ail rightsreserved iii Scanned with CamScanner000:2018(E) a7 ieee somenitoring and measuring... 8 Verification related to PRPs and the hi 88 gai Verification nate =a soe pi 882 Analysis of results of verification activities —_. 89 Control of product and process nonconformities 8.9.1 General. 893 Corrective actions 894 Handling of potential 895 Withdrawal/recall Performance evaluation. 9,1 Monitoring, measurement, 941.1 General. 9.1.2 Analysis and evaluation, 92 Internalaudit 93 Management review 931 General... i 9.3.2 Management review input _ 93.3 Management review output. Improvement. bites tat 10.1 Nonconformity and corrective action. 102 Continual improvement - 10.3 Update of the food safety management. ‘system. ex (informative) Cross references between the CODEX HACCP and this document____ }ec0 (informative) Cross references between this document and ISO 22000:2005, ography Scanned with CamScanneree | troduction 1 | General ‘option ofa food safety management system (FSMS) isa strategic decision foran organization that felp to improve its overall performance in food safety, The potential benefits to an organization of enting @ FSMS based on this document are: ability to consistently provide safe foods and products and services that meet customer and Ipplable statutory and regulatory requirements paressing risks assoctated with its objectives; jeablty to demonstrate conformity to specified FSMS requirements. jsjdocument employs the process approach (see 0.3), which incorporates the Plan-Do-Check-Act pea eyele (See 0.3.2) and risk-based thinking (see 0.3.3). process approach enables an organization to plan its processes and their interactions, ; POCA cycle enables an organization to ensure that its processes are adequately resourced and {aged and that opportunities for improvement are determined and acted on. sktased thinking enables an organization to determine the factors that could cause its processes its FSMS to deviate from the planned results, and to put in place controls to prevent or minimize verse effects. ths document, the following verbal forms are used: “shall” indicates a requirement; + Jnould indicates 2 recommendation; hi indicates a permission; can" indicates a possibility or a capability. OTES* provide guidance in understanding or clarifying the requirements in this document. 2) FSMSprinciples od safety is related to the presence of food safety hazards at the time of consumption (intake by the ‘gumer). Food safety hazards can occur at any stage of the food chain. Therefore, adequate control ‘roughout the food chain is essential. Food safety is ensured through the combined efforts of all the His in the food chain, This document specifies the requirements for a FSMS that combines the loving generally recognized Key elements: snteractive communication; ‘system management; aes programmes; ‘hazard analysis and critical control point (HACCP) principles. ‘ddtion, this document is based on the principles that are common to ISO management system dards, The management principles are: ‘astomer focus; | Veadership; | | eegement of peopl I (© 1502018 - Allright reserved Scanned with CamScannerIso 22000:2018(E) — process approa improvement; — evidence-based decision making; _ relationship management. 0.3 Process approach 034 General This document adopts a process approach when developing and implementing a FSMS and tapesing its effectiveness to enhance production of safe Products and services while meeting applical a requirements, Understanding and managing interrelated processes as a system contributes to tl organization's effectiveness and efficiency in achieving its intended results. The process approac involves the systematic definition and management of processes, and their interactions, SO as to achieve the intended results in accordance with the food safety policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cyde, with an overall focus on risk-based thinking aimed at taking advantage of opportunities an preventing undesirable results, The recognition of the organization's role and position within the food chain is essential to ensure effective interactive communication throughout the food chain, 032 Plan-Do-Check-Act cycle The PDCA cycle can be described briefly as follows: Flan: establish the objectives of the system and its processes, provide the resources needed to deliver the results, and identify and address risks and opportunities; Do: implement what was planned; Check: monitor and (where relevant) measure processes and the resulting products and services, analyse and evaluate information and data from monitoring, measuring and verification activities, and report the results; ‘Act take actions to improve performance, as necessary. in this document, and as illustrated in Figure 1, the process approach uses the concept of the PDCA cycle at two levels. The first covers the overall frame of the FSMS (Clause 4 to Clause 7 and Clause 9 to GLause 10). The other level (operational planning and control) covers the operational processes within the food safety system as described in Clause 8. Communication between the two levels is therefore essential, Scanned with CamScannerCT Oreanizational planning and control Figure 1—Mustration ofthe Plan-Do-Check-Act cycle at the two levels Risk-based thinking ased thinking is essential for achieving an effective FSMS. In this document, risk-based thinking Hesed ontwo levels, organizational (see 0.3.3.2) and operational (See 0.3.3.3), which is consistent ie Process approach described in 0.3.2. i? Organizational risk management orm to the requirements of this document, an organization plans and implements actions SS organizational risks (Clause 6). Addressing risks establishes a basis for increasing the {'stess ofthe FSM, achieving improved results and preventing negative effects, j Hazard analysis — operational processes pacePt of risk-based thinking based on the HACCP Principles at the operational level is implicit in bcument, ©150 2018 Allrishte recent Scanned with CamScannerIso 22000:2018(E) Decisions taken in the application of HACCP should be b: from bias and documented. The documentation should include any key assumptions Inte dession-na -making process. 04 _ Relationship with other management system standards This document has been developed within the ISO high level structure (HLS). The objective of the HLS is to rar alignment between Iso ‘Management system Standards The document enables an Ee use the process ‘approach, coupled with the PDCA cycle and risk-based thinking, to align ve Pe - approach with the requirements of other management systems and supporting st ‘ This document is the core principle and framew ific FSMS ene jork for FSMSs and sets out the specific requirements for organizations throughout the food chain. Other guidance related to food safety, specifications and/or requirements specific to food sectors can be used together with this framework. Inaddition, ISO has developed a family of associated documents, These include documents for: — Prerequisite programmes (ISO/TS 22002 series) for specific sectors of the food chain; i — requirements for auditing and certification bodies; — traceability. ISO also provides guidance documents for organizations on how to implement this document and | related standards. Information is available on the ISO website. Scanned with CamScannerfl |nTERNATIONAL STANDARD 150 22000:2018(F) ee safety management systems — Requirements for any organization in the food chain | |1 Scope | This document specifies requirements for a food safety management system (FSMS) to enable an | organization that is directly or indirectly involved in the food chain: a}_toplan, implement, operate, maintain and update a FSMS providing products and services that are safe,in accordance with their intended use, 4) todemonstrate compliance with applicable statutory and regulatory food safety requirements; to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them; 4) effectively communicate food safety issues to interested parties within the food chain; @)_toensure that the organization conforms to its stated food safety policy; f)todemonstrate conformity to relevant interested parties; @) to seek certification or registration ofits FSMS by an external organization, or make a self- assessment or self-declaration of conformity to this document. | Allzequirements of this document are generic and are intended to be applicable to all organizations | in the food chain, regardless of size and complexity. Organizations that are directly or indirectly Javolved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials. This document allows any organization, including small and/or less developed organizations (eg. a | small farm, a small packer-distributor, a small retail or food service outlet) to implement externally || developed elements in their FSMS, Internal and/or external resources can be used to meet the requirements of this document. 2 Normative references ‘There are no normative references in this document, 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 'SO.and EC maintain terminological databases for use in standardization atthe following addresses: — 180 Online browsing platform: available at https://wwwiso.org/obp ~ HEC Electropedia: available at http://wwwelectropedia.org/ Os02m0 Scanned with CamScanner— 72000:2018(E) | | 1 aptablelevel if a food safety hazard (3.22) not to be exceeded in the end product (3.18) provided by the prization (2.31) jon criterion syrable or observable specification forthe monitoring (2.27) ofan OPRP (3.0) ; : j to entry: An action criterion js established to determine iether an OPRP remains in control, and uses berween whats Aceeptsbe (eiteion met orachleyed mane the OFRE le opereing ed needed) ;aceeptable (criterion not met nor. ‘achieved means: the OPRP Is ‘not operating as Intended). oe Fanatle, Independent and documented process (3.36) for obtaining audit evidence and evaluating it ively to determine the extent to which the audit criteria are fulliied toentry: Anaudlt can bean internal audit (rst or an external audit second party or third party), ieenbea combined audlt combining two ormore dscns), te eftoentry: Aninternal audit is ‘conducted by the organization itself, or by an external party on its behall sent Au vec” and “ut rter ae dtd ins So, 4 to entry: Relevant disciplines are, for examy le, food safety management, quality management or omental management. E ee tence ‘to apply knowledge and skills to achieve intended results — rmity ‘iment of a requirement (3,38) tamination ‘iluction or occurrence of a contaminant: ‘including a food safety hazard (3,22) in a product (3.37) or ‘dssingenvironment nual improvement tring activity to enhance performance (3,33) ‘ol measure or activity that is essential to prevent a significant food safety hazard (2.22) or reduce it to an table level (3,1) = Nae. toentry: See also significant food safety hazard (3.40). toentry: Control measure(s is are) identified by hazard analysis. ‘ rection Santo climinate a detected nonconformity (3.28) Re {centry: A correction includes the handling of potentially unsafe products and can: therefore be made in ct with a corrective ation (3.10). ett: A correction may be, for example, reprocessing, further processing and/or elimination ofthe “consequences of the nonconformity (such as disposal for ther use or specifi labelling). © 150 2018 Allrights reserved Scanned with CamScanner10 22000:2018(E) 0 i 22 reason action to elinat the cause ofa nonconormity (3.26 andto Prevent recurrence Note tent? There can be more than one cause fora onconformity, Note 20 entry Corrective action includes cause analyte, 1 al control point cr in the process (2.36) at which contro! measun i t or reduce a oan a ees rol measure(s) (3,8) is (are) applied to prevent 0 to an acceptath ele to rere aia) and reosurement (3.26) nable the spplicaton of corrections (gy and defined critica limie( | 342 | critical limit s | measurable value which separates acceptability from unacceptablty | Note tt ent Critical limits are established to determine whether a remains in control fa critical | toe ceeded crosman determine whether a CCP (311) ‘Products alfected are tobe handled as potentially unsafe products. [SOURCE: CAC/RCP 1.1969, modified — ‘The definition has been modified and Note 1 to entry has | been added] 313 | documented information | information required to be controlled and maintained ton (2.31) and the medium on which itis contained intained by an organization (3,31) Note to entry: Documented information can bein any format and media and from any source. Note2to entry: Documented information can refer to: | ~ themanagementsystem (3.25) ctding related processes (3.36) | ~ formation erated in order forthe organtzation to operate (documentation | = evidence of results achieved (records). aut effectiveness | etent to which planned activities are realized and planned results achieved (345 | end product | Poder (2.37) that will undergo no further processing or transformation by the organization (2.31) ir Lt entry: A product that undergoes futher processing or transformation by another organisation isan Sebinlte nthe content ofthe ist organization and a raw material or an ingredient tte omnes second organization, 316 feed single or multiple product(s), wi nether processed, semi-processed or raw, which is (are) intended to be fedto food-producing animals et ae Distinctions are made in this document between the terms food (3.18), feed (3.16) and animal ~ God isintended for consumption by humans and animals, and includes feed and animal foods ~ Fedisintended to be fed to food-producing animals; 1802010 aright reserved Scanned with CamScannercin | mae, such GL 81-2013, modified — ‘aS pets, a carn deleted) The word + fe tient), whether proces: d, ince (ingredi sed, semi-proce, drink, chewing gum and Ssed or raw, which is inten consumption, fl yeror treatment of food but set neg WHIEH has been used ie ae rE loes not include eo. een used in the manufacture, teepas ts lude c Smetics or tobacco or substances (ingredients) 7 Distinctions are made i 0 mane ' this document between the terms 5 food (3.18), feed (3.46) and animal | jedisintended for consumption by humans and animals and includes feed and animal food; edisintended tobe fed to food-producing animals; | puimaloods intended tobe ed to non o04-pradcing animals such _— cE: CAC/GL81-2013, modified — The word “human has been deleted] pial food ple product(s), whether ‘ ; Me eeiaige animals '“*SS°4:Semi-processed or raw, which is (are) intended to be ‘inctions are made in this document between the terms food (21), fed (8.16) and animal inal foods intended tobe fed to non-food-producing animals, suchas pets. \CE: CAC/GL. 81-2013, modified — The word "materials" has been changed to “products’, ‘non? aided and “directly” has been deleted] chain nce ofthe stages in the production, processing, distribution, storage and handling of a food (3.18) j'singredients, from primary production to consumption !toeatry: This includes the production of feed (3.16) and animal food (3.19). 2toentry: The food chain also includes the production of materials intended to come into contact with food materials, toentry: The food chain also includes service providers. safety io ce that food will not cause an adverse health effect forthe consumer when itis prepared and/or fmedin accordance with its intended use to entry: Food safety i food safety hazards (3.22) In end products (3.15) and ay: fety is related to the occurrence o mtinctude other hes aspects related to, for example, malnutrition. © 150 2018~ Allrights reserved Scanned with CamScanner150 22000:2018(E) Note to entry: TeIsnot tobe confused withthe avallabiltyof and access to, food (food security")- Note 3 toentry: Ths includes feed and animal food, [SOURCE: CAC/RCP 1-1969, modified — The word "harm" “adverse health effect” and notes to entry have been added) ‘The word "harm* has been changed to “adverse 22 food safety hazard biological, chemical or physical agent in ood (3.18) with the potential to cause an adverse health effect Note toentry: The term “hazard” not tobe confused with the term “isk” (3:39) which, in the context of food safzmeans function ofthe probability aan aversealth fect fg becoming ceased) andthe every oF thateffect (¢, death, hospitalization) when exposed toa specified hazard. Note 2 toentry: Food safety hazards include allergens and radiological substances. Note 3 to entry: In the context of fee presentin and/or on feed and feed in fo food and can thushave the potenti 4 and feed ingredient, relevant food safety hazards are those that can be edits and that cn through animal consumption fed be transferee lal to cause an adverse health effec or the anlmal or the human consumer. In the contest of operations other than those directly handling feed and food (eg producers of packaging materials, disinfectants), relevant food safety hazards are thase hazards that can be directly or indirectly transferred to food when used as intended (eee 85.1.4, Note 4to entry: In the context of animal food, relevant food safety hazards are those that are hazardous to the animal species for which the food is intended. 7 [SOURCE: CAC/RCP 1-1969, modified — The phrase “or condition of” has been deleted from the definition and notes to entry have been added] 3.23 interested party (preferred term) stakeholder (admitted term) person or organization (3,34) that can affect, be affected by, or perceive itself to beaffected by a decision oractivity 3.24 Jot defined quantity of a product (3.37) produced and/or processed and/or packaged essentially under the same conditions Note 4 to entry: The lot is determined by parameters established beforehand by the organization and may be described by other terms, e.g batch. Note to entry: The lot may be reduced to. single unit of product, (SOURCE: CODEX STAN 1, modified — Reference to “and/or processed and/or packaged” has been Included in the definition and notes to entry have been added] 3.28 management system set of interrelated or interacting elements of an organization (3.31) to establish policies (3.34) and objectives (3.29) and processes (3.36) to achieve those objectives Note’ to entry: A management system ean address a single discipline or several disciplines, Note2 to entry: The system elements include the organizations structure, rles and responsibilities, planning and operation Note 3 to entry: The scope of a management system may include the whole of the organization, specific and \Wentitied functions of the arganization, specific and {dentified sections of the organization, or one or rors functions across a group of organizations. i ©1S02016~ all rights reserved s Scanned with CamScanner6 Bt mie avalue eea) Bet ting the stats of8SSIEM, 8 Process (3.36) or an activity tobeachieved toentry: An objective can be strategic, tactical, or operational, 2 to entry: Objectives can relate to differer nt disciplines (such as financial, health and safety, and ental goals) and can apply at different levels (suchas strategic, organization-wide, project, product and (638) to entry: An objective can be expressed in other ways, tional criterion, as a FSMS objective, or by the use of other ¢g, as an intended outcome, a purpose, an ‘words with similar meaning (e.g, aim, goal, or {o try: In the context of FSMS, objectives are set by the organization, consistent with the food safety joachieve specific results, tional prerequisite programme measure (3,8) or combination of control measures applied to prevent or reduce a significant food Pozar (240) toan acceptable level (2.1) and where action criterion (2.2) and measurement (3.26) tion enable effective control of the process (3.36) and/or product (3.37) ities, authorities and relationships includes, butis not limited to sole-trader, company, corporation, firm, Partnership, charity or institution, or part or combination thereof, whether incorporated vate, (© 1502018 All rights reserved Scanned with CamScanner| | 1s0 22000:2018(E) | 3.32 Scsource, verb makean arrangement where an exte orprocess (3.36) ‘al organization (3.31) performs pat of an organization's function Nae 3 to ery At Xero oreanation i outside th ‘outsourced function oF process is within the scope, "N° Pe of the management system (3.25), although the 3.33 performance measurable result cluding services, systems or organs, «2 tHE Management of activities, processes (3:36), products (3:37) (in ‘organizations (231), 3.34 policy directi esos Siesta podactn (2.7) as realy apse ty fap aap LAN 335 | prerequisite programme | PRP | basic conditions and activities that _ . | od chan (20) to malntain ocd see ME the orgontzton (2.21) and throughout the | Nets Lt etry: PRPS needed depend onthe ard he Poy reanization. Examples of equivalent terms are: good apricataral | 2 7 practice (GAP), good veterinary | practice (GV), Good manufacturing practice (GMP), good a ice od production practice (GP?), good distribution practice (GDP) and good reqs ee rate (GHP), good pr P ing practice (GTP). | 3.36 | process setof interrelated or interacting activites which transforms inputs to outputs 337 product || output that is a result of a process (3.36) Note 1 to entry: A product can be a service. 338 requirement need or expectation that is stated, generally implied or obligatory Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization and Interested parties that the need or expectation under consideration is implied. Note2 to entry: A specified requirement is one that is stated, for example in documented information, 3.29 risk effect of uncertainty Note to entry: An effect is a deviation from the expected - positive or negative, Note 2to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or ‘nowledge of, an event, its consequence, or likelihood, Note 3 to entry: Risk is often characterized by reference to potential “events” (as defined in ISO Guide 73:2009, 354.3) and “consequences” (as defined in ISO Guide 73:2009, 3.6.1.3), ora combination of these. 1502018 au rights reserved 7 Scanned with CamScannerTh oan sk Is often = pate corinstances) and ieee rms inca omblnation ofthe consequences of an event (Including Di in circ likelihood" fasdefinedin iso Guide 73:2009, 3.6.1.1) of occurrence. entry: Food safety risklsa function ofthe iso ersvential to (a) hazard(s) infood as ain adverse health effect andthe severity ofthat - Codex Procedural Manuallil). 4 cant food safety, hazard 2, , ii sf versa) ontified through the hazard assessment, which needs to be controlled by mm [dto entry: If the scope of the Jfementrefers to those who dire wan the history, applicati ‘to follow | f applicat ion, movement and k ati ji ified stage(s) eee eae location of an object through specified stage(s) ‘management system covers only part of an organizati tof ization, then top “tand control that partof the organieatinn, teen: Movement can relate to the origin ofthe materials, processing history or distribution of the toentry: An object can be a product (3,37), a ‘material, a unit, equipment, a service, etc. CE: CAC/GL 60-2006, modified — Notes to entry have been added] teand/or planned activity to ensure application of the most recent information toentry: Update is different from the terms “maintain” and ‘retain’: Safety» obtaining evidence that a control measure (3.8) (or combination of control measures) will ble of effectively controling the significant food safety hazard (3,40) ‘to entry: Validation is Performed at the time a control measure combination is designed, or whenever ‘aremade to the implemented control measures. HienttY Distinctions are made inthis document between the terms validation (2.4), ‘monitoring (3.27) ication (3.45). lidation is applied prior to an activity and provides information about the capability to deliver intended sults; Pstringis applied during an activity and provides information for action within specified time frame; *Wication is applied after an activity and provides information for confirmation of conformity. Scanned with CamScanner) Iso 22000:2018(E) | 345 yerification on (through the provision of objective evidence, that specified requirements (3.38) have been " : Distinctions are ma tes es icatog (aay on He Made inthis document between the terms vodation (344), monitoring (3.27) validation is applied results; Prior to an activity and provides information about the capability to deliver Intended monitoringis applied during an activity and provides information for action within a specified time frame ‘verifications applied after an activity and provides information for confirmation of conformity. Context of the organization fuel 41 Understanding the organization and its context Fa Tne rei cetermine external and internal issues that are relevant to its purpose and that aifectits ability to achieve the intended result) ofits FSMS. The organization shall identify, review and update information related to these external and internal issues. NOTE _ Issues can include positive and negative factors or conditions for consideration, NoTE2 | Understanding the context can be facilitated by considering external and internal issues, including, but not limited to, legal, technological, competitive, market, cultural, social and economic environments, cybersecurity and food fraud, food defence and intentional contamination, knowledge and performance of the organization, whether international, national, regional or local 4.2 Understanding the needs and expectations of interested parties [oensure that the organization has the ability to consistently provide products and services that meet plicable statutory, regulatory and customer requirements with regardto food safety the organization Stall determine: a the interested parties that are relevant to the FSMS; }) the relevant requirements of the interested parties of the FSMS, [The organization shall identify, review and update information related to the interested parties and e requirements. i. Determining the scope of the food safety management system he organization shall determine the boundaries and applicability of the FSMS to establish its scope. (The scope shall specify the products and services, processes and production site(s) that are included jin the FSMS. The scope shall include the activities, processes, products or services that can have an linfluence on the food safety of ts end products. ‘When determining this scope, the organization shall consider: |) theexternal and internal issues referred to in 4.1; |) therequirements referred to in 4.2. | |The cope shall be available and maintained as documented information. Scanned with CamScanner