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PROFILE TRAINER
S-1 IPB, Registered Lead Auditor IRCA CQI UK, QMS & FSMS/Feed, EHS, YUM! USA, FSPCA/PCQI
Consultant – Quality, Food/Feed Safety & Sustainability
Registered Lead Auditor/Auditor/Trainer in Several certification body such as SGS, TUV, BSI,
Certindo
IRCA FSMS (ISO 22000)/FSSC 22000
YUM! & Starbucks Audit
Quality Management System (ISO 9001:2008; ISO 9001:2015)
ISO 17025 (Kompetensi Laboratorium Penguji dan Kalibrasi)
EHS (ISO 14001, OHSAS 18001)
GMP+ International /B1, B2 & B3
BRC, IFS, SQF
Sustainability: RSPO, ISCC UTZ
HACCP
GMP – Codex /RCP
Cotsco, Cargill Feed Safety
SQA (Supplier Quality Audit)
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OBJECTIVE
a
Introduction
Ancaman Food Safety Global
2
Introduction
FSSC 22000 Approved by Global Food Safety Initiative
The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing thought leadership and guidance on food safety
management systems necessary for safety along the supply chain. This work is accomplished through collaboration between the
world's leading food safety experts from retail, manufacturing and food service companies, as well as international organisations,
governments, academia and service providers to the global food industry (source:GFSI)
Introduction
Perlindungan dalam hadapi ancaman Food Safety
Complete Risk Assessment dalam Food Safety
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2.1. Main Components
Food Safety Prerequisite Additional
Management System Programs (PRPs) Requirements
• ISO 22000 • ISO-TS 22002-1, • Additional
• HACCP 2,3,4,5, 6 Scheme
requirements
• FSSC version 4.1
(2017)
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Food Safety Management System
Requirements – ISO 22000:2005
Updating NEW
ISO 22000:2018
(Saat ini masih
DIS 2017)
HACCP & ISO 22000 Pastikan di HACCP ada Analisa bhy Allergen
Key
Steps addressed by Codex Alimentarius HACCP Guidelines 7.3.2 Food safety team 1
ISO 22000 specific steps
2
12 7.3.3 Product Characteristics
4&5
7.3.5.1 Flow Diagram
11
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PRP For FSSC ver. 4.1, 2017 & ISO 22000:2018
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2.1.3. Persyaratan PRP ISO/TS 22002-1 Food
Refer to
1. Scope ISO/TS
2. Normative 22002-1 Food
reference 8. Equipment
3. Term and definitions Suitability, Cleaning &
Maintenance 13. Personal Hygiene
4. Construction & & Employee Facilities
Layout of Buildings 9. Management of
Purchased Materials 14. Rework
5. Layout and
Workspace 10. Measures for the 15. Product Recall
Prevention of Cross Procedures
6. Utilities – Air, Water, Contamination
Energy 16. Warehousing
11. Cleaning and
7. Waste Disposal 17. Product
Sanitizing
Information /
12. Pest Control Consumer Awareness
18. Food Defense
4.0 Bangunan
Bangunan dirancang,
dibangun & dipelihara
dengan tepat (cegah
Lihat sumber kontaminasi dari plant
potensial dari 4.1 Persyaratan dan lingkungan)
lingkungan Umum
eksternal dan
internal Ada batas sisi/lokasi
Akses ke site harus
dikendalikan
Site & tumbuhan
4.2 4.3 Pendirian dirawat
Lingkungan Lokasi/Pabrik
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5.0 Tata letak gedung & tempat kerja
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6.0 Sarana Penunjang-Udara, Air dan Energi
6.1 Persyaratan
• Kontaminasi minimun & dimonitor
umum
• Standar Air Minum Permenkes 492/2010, Jalur di
6.2 Pasokan air
pisah
6.3 Bahan Kimia
• MSDS, Food Grade dan Disimpan terkunci
Boiler
6.4 Air quality
• Dikontrol, dimonitor, diperiksa berkala
& Ventilation
6.5 Compressed
Air & other • Food grade oli dan persyaratan ditentukan
gases
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8.0 Equipment suitability, cleaning and maintenance
• Semua peralatan dan alat pembersih tahan
8.1 Persyaratan Umum lama, mudah dibersihkan
9.3 Persyaratan
kedatangan • dicek, diverifikasi, jika tidak
bahan/ingredient/ sesuai dikendalikan
packaging
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10.0 Measure for prevention of contamination
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12.0 Pengendalian Hama
13.2
13.3 Kantin 13.4 Work
13.1 Personal
karyawan & wear &
Persyaratan Hygiene
Desain area protective
Umum fasilities
makan clothing
and toilets
Berlaku untuk Toilet cukup dan Harus bersih, Bersih & dalam
semua memadai, makan, minum kondisi bagus,
personnel, wastafel, dan merokok di tidak berkancing
pengunjung pengering, air tempat tertentu dan kantong di
dan kontraktor panas dan dingin, bawah pinggang
sabun, loker
tersedia dan
dikendalikan
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13.0 Personal Hygiene and Facilities
14.0 Rework
Rework, harus disimpan, ditangani dan digunakan sedemikian
rupa, memastikan bahwa peraturan keamanan produk, kualitas,
traceability tetap terjaga
15.0 Recall
15.1 Persyaratan Umum memenuhi standar food safety,
lakukan tes/simulasi
15.2 Product Recall Requirements prosedur recall, berisi
key contact (BPOM, Customer, CB, ect)
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16.0 Penyimpanan
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18.0 Food defense, biovigilance &
bioterorrism
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2.1. Main Components
2.1.4. Additional Requirements
• Additional Scheme requirements FSSC version 4.1 (2017)
Dokumen
lengkap untuk
analisa bahaya
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CONTOH SPESIFIKASI PEST CONTROL
(PEST CONTROL)
Identifikasi
Prioritaskan
Potensi Pengembangan
langkah
Ancaman langkah-
pencegahan
(Sabotase, langkah
terhadap
Vandalisme, pencegahan
ancaman
Terorisme)
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Incidents Food Defense
2008: 250 pon daging sapi dikontaminasi
menggunakan pestisida berbasis nikotin
(Michigan, USA)
Sebab: Mantan karyawan yang berselisih dengan
supervisor
Hasil: 92 orang dilaporkan sakit
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“Threat Type (Tipe Ancaman)”
Economically motivated adulteration Espionage (Spionase):
(EMA): One business consultancy uses the
In 2013, allegations were reported that a theft of the intellectual property of a
food factory in Asia was labelling cooking fictitious innovative snack product
oil as peanut, chilli and olive when it as an example of commercial
contained none of these oils espionage
Counterfeiting (Pemalsuan):
Malicious contamination:
In 2013, enforcement officers seized 9 000
In 2005, a major British bakery reported
bottles of fake Glen’s Vodka from an illegal
that several customers had found glass
factory
fragments and sewing needles inside the
wrapper of loaves Cyber crime:
In 2014, Financial Fraud Action UK advised
restaurant managers to stay vigilant as
Extortion (Pemerasan): fraudsters are attempting to target their
In 1990, a former police officer was customers in a new phone scam. They phone
convicted of extortion after restaurants claiming there is a problem with
contaminating baby food with glass and their card payments system, the restaurant is
demanding money from the multi- then told to redirect any card payments to a
national manufacturer. phone number provided by the fraudster
Umur simpan
Batch besar
Mixing
Pengolahan/ penyajian
Oleh konsumen
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PAS 96 Food Defense (Acuan)
Publicly Available Specification (PAS) dipersiapkan
oleh British Standard Institution (BSI) berkolaborasi
dengan the Center Of the Protection of National
Infrastructure (CPNI)
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Assessment TACCP
“Threat Assessment Critical Control Point”
Langkah-
langkah
pembuatan
TACCP
PAS 96
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Contoh Assessment Food Defense
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Matrix
Combination
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Tabel TACCP Monitoring
TACCP Bahaya yang Tindakan Pemantauan Koreksi Tindakan Tanggung Dokumen Verifikasi Validasi
dikendalikan Pengendalian Langsung Koreksi Jawab dan / Catatan
Wewenang
1 Ancaman 1. Control access Apa : Control 1. Pengunci Perawatan Operator Form Pengecek Validasi
Kontaminasi di terkunci & access an access/pe untuk kontrol control an TACCP
Tangki Air 2. CCTV kembali ngecekan akses access produk/air no 1
Proses Dimana : Tangki Air 2. Perbaika kunci tiap bulan Report
n kunci access Staff HRD
Kapan : Tiap Hari untuk training
Training
Siapa : Operator FSSC &
Utility Food
Defense
Bagaimana :
Mengecek apakan
access terkunci
Pelatihan, Pengend
pengecekan latar
belakang, tanda
alian
identifikasi personil karyawan
Pengend Prosedur
alian penerimaan dan
operasio pengiriman,
nal prosedur penarikan
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2.1.4.4 Pencegahan Penipuan/Substitusi
Makanan (Food Fraud)
Identifikasi & dokumentasi potensi
vulnerabilities:
Mengembangkan langkah-
langkah pencegahan
vulnerabilities
Memprioritaskan langkah
pencegahan terkait dengan
vulnerabilities
Penggantian
Pengenceran Penyembunyian
Pemalsuan
Peningkatan/Pengkayaan
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Langkah-langkah pembuatan VACCP
1. Membentuk Team
Supplier X Focuse X
Relationship d
(SR) Consu
mption
History of X X
supplier Nutritio
regulatory nal
Quality and Sufficie
safety issue ncy
(HS)
Susceptibulity X X
of QA methods Public
and specs (SQ) Confide
nce
Testing X
frequency
(TF)
Geopolitical X
considerations
(GC)
Fraud history X
(FH)
Economic X
anomalies (EA)
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Vulnerability Assessment Critical Control-
VACCP
VACCP Mengandung 1. Pengecekan Apa : Melamin 1. Reject Seleksi Puchasing SOP Test Validasi
1- Melamin Kandungan jika dan Incoming, produk VACCP
Bahan Melamin pada Dimana : Di mengand evaluasi Form QC jadi tiap 6 1
Produk produk susu incoming Bhn baku ung supplier Inspectionbln ke lab
Susu melamin eksternal
Kapan : Setiap Audit
datang supplier
Siapa : QC
Incoming
Bagaimana : Cek
melamin melalui
lab test
VACCP Tidak 100% 1. Pengecekan Apa : Tidak 1. Reject Seleksi Puchasing SOP Test Validasi
1- murni (reycle) keaslian/spesifi murni/tdk sesuai jika tidak dan Incoming, produk VACCP
Kertas atau tidak kasi spec sesuai evaluasi Form QC jadi tiap 6 1
sesuai supplier Inspectionbln ke lab
spesifikasi Dimana : Di eksternal
incoming Bhn baku Audit
supplier
Kapan : Setiap
datang
Siapa : QC
Incoming
Bagaimana : Cek
spec/keaslian
melalui lab test
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STEP I. PENILAIAN FAKTOR KONTRIBUSI /
CONTRIBUTING FACTORS ASSESSMENT
Contribution to Vulnerability
Contributing Factor Low Medium-Low Medium Medium-High High
Supplier vertically Supplier Upstream supplier
Supply chain Firm vertically integrated Open market
integrated manufactures manufactures
Immature onsite audit
strategy with no anti-
Robust, onsite, with Robust, onsite, with Immature, onsite,
fraud measures, or No onsite audits being
Audit Strategy numerous anti-fraud limited anti-fraud with limited anti-fraud
strategy with limited anti- used
measures measures measures
fraud measures in
development
Trusted Supplier and
Trusted supplier, Established supplier, Established supplier, no Unestablished supplier,
Supplier relationship previously purchased
new ingredient some relationship relationship No relationship
ingridient(s)
Multiple persistent issues
History of supplier indicating lack of
Strong evidence of quality
Controllable factors
Low to moderate
No reports or few known Moderate volume of reports with good degree of reports, some with high
volume of reports
Fraud history
factors
reports with no or reports with limited of validity; or high degree of validity, and/or
with limited or
unknown validity degree of validity volume of reports with evidence of an ongoing
unknown validity
The United States Pharmacopeial limited validity incident
Frequent but Common but focused
Economic anomalies Nothing unusual Isolated cases Common and broad cases
unrelated cases cases
Respect, Excellence and Improvement… it’s REI www.reisistem.com
No significant
Economic Impact balance sheet Operational Risk Enterprise risk
impact
Potential
Multipliers
Public Specific food Specific Industry selector Industry wide Authorities &
Confidence commodity industry
The United States Pharmacopeial
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Example: Vulnerability Characterization Matrix
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Vulnerability Assessment Critical Control-VACCP for Proses
5 Ancaman A
4 Ancaman C
Dampak 3 Ancaman B
2 Ancaman E
1 Ancaman D
1 2 3 4 5
Kemungkinan
Resiko Sangat Tinggi Ancaman A
Resiko Tinggi Ancaman B
Resiko Sedang Ancaman C
Resiko Ringan Ancaman D
Resiko Sangat Ringan Ancaman E
•Penilaian Resiko
Keterangan:
Resiko Sangat Tinggi : Ancaman Fraud A dan menjadi VACCP Plan/Monitoring
Resiko Tinggi : Ancaman Fraud B
Resiko Sedang : Ancaman Fraud C
Resiko Ringan : Ancaman Fraud D
Resiko Sangat Ringan : Ancaman Fraud E
KEMUNGKINAN (PROBABILITY)
Kemungkinan (Probability) ditentukan berdasarkan historical data, literature ilmiah, issue ilmiah
tentang keamanan pangan dan/atau kemungkinan alamiah terdapatnya bahaya dalam langkah-
langkah proses atau material.
Penentuan Kemungkinan (Probability) berdasarkan historical data diatur sebagai berikut:
-Kesempatan Sangat Besar Untuk terjadi: Terjadi 5 kali atau lebih dalam 1 tahun terakhir
-Kesempatan Besar Untuk Terjadi : Terjadi 4 kali dalam 1 tahun terakhir
-Beberapa Kesempatan: Terjadi 3 kali dalam 1 tahun terakhir
-Mungkin Terjadi: Terjadi maksimal 2 kali dalam 1 tahun terakhir
-Tidak Mungkin Terjadi: Terjadi maksimal 1 kali atau belum pernah terjadi
KEPARAHAN (IMPACT)
Tingkat Keparahan di bagi menjadi 4 macam yaitu:
•Bencana Besar (Catastropic)
•Major
•Signifikan
•Sebagian
• Minor
Note: Dampak bisa di detailkan lebih rinci berdasarkan dampak ke Food Safety, Operational/Bisnis,
Kepercayaan Public, Cost, dll
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Vulnerability Assessment Critical Control-VACCP for Proses
Dibuat mulai dari incoming, proses s/d FG & Delivery
Potensi/Bahaya Penilaian Resiko
:
(Informasi
dari:•
Foodfraud.org/
Vulnerability
USP/BPOM • SOP, WI &
Characterizati Pengendalian/M
No. Process Asosiasi Record / Catatan Catatan
on Matrix onitoring
perdagangan • Probability Impact
THREAT TYPE
Sumber
pemerintah •
Pusat sumber
swasta • Data
internal)
Apa :
Pengecekan Prosedur Inspeksi
komposisi dan Pengujian
material
Dimana : Area
Standar komposisi
Komposisi produksi
material tidak Form Pengecekan
Proses Siapa : QA dan
1 sesuai dengan 1 4 D Komposisi
Mixing Produksi
standar Material
formulation Kapan : Setiap
shift
Bagaimana :
Pengecekan
komposisi pada
form/checksheet
2.1.4.5 Logo
Logo FSSC 22000 Penggunaan logo
tidak digunakan hitam & putih
untuk produk, digunakan ketika
pelabelan, kemasan, semua teks &
dan dalam bentuk gambar lain dalam
lain yang warna hitam dan
menyiratkan produk, putih
proses ataupun jasa
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2.1.4.6 Manajemen Allergen
Prosedur manajemen allergen tersedia dan meliputi :
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Mengapa pengontrolan ALLERGEN penting?
Daftar Allergen
1. Milk (susu)
2. Egg (telur)
3. Soy (kacang kedelai)
4. Wheat (gandum) Penyebab 90%
5. Peanuts (kacang2an) food allergies
6. Crustacean (e.g.kepiting,
udang)
7. Fish (ikan)
8. Tree Nuts (e.g. Wallnuts,
Almonds)
9. Biji (biji matahari, biji sesame)
10. Seledri (akar, batang atau daun)
11. Moluska (e.g. oysters)
12. Sulfites
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Penanganan Allergen
Berdasarkan Urutan Pengendaliannya :
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2.1.4.8 Formulasi Produk
untuk: pet food for dog & cat
Dimasukkan ke dalam
tempat yang tepat dengan
perlindungan dan kontrol
untuk melindungi kesehatan
masyarakat dan hewan
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Others Changes – Unannounced Audit
Unannounced audit program (Bagian dari 3 tahun cycle audit)
Sifat Wajib
Paling sedikit 1 kali dalam 3 tahun unannounced audit
CB yg menentukan waktunya (bisa juga shift malam)
a
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Workshop/Set up
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www.reitrainingcenter.com
Hotline: 081.380.602.166
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