Food Safety Management System
Transcript of Food Safety Management System
3/15/17
Ratih Dewanti-Hariyadi/IPB/2017 1
Ratih Dewanti-Hariyadi Department of Food Science and Technology and
Southeast Asia Food Agric Sci & Technol. (SEAFAST) Center Bogor Agricultural University
Bogor, Indonesia
Food Safety Management System : Beyond HACCP
Presented in Seminar “ BUILDING PREVENTIVE FOOD SAFETY MEASURES” Food Review Indonesia,Bogor March 15, 2017
Bogor Agricultural University
• Perkembangan Sistem Manajemen Keamanan Pangan
• Hazard Analysis Critical Control Point (HACCP)
• Tantangan Keamanan Pangan Global • Pertahanan Pangan (Food Defense) • AS : - Intentional Adulteration (IA) Rule
- Vulnerability Assessment - Food Defense Plan
• Inggris: - PAS 96 2014 (BSI) - Threat Assessment Critical Control Point (TACCP)
OUTLINE
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Perkembangan Sistem Manajemen Keamanan Pangan Safety Management*
Process Criteria
Testing
HACCP
(Q)RA
FSO
1900 1920 1940 1960 1980 2000 2020
*adopted from Zwittering 2013 Peraturan Perkembangan
Bogor Agricultural University
• Sistem yang mengidentifikasi, mengevaluasi dan mengendalikan bahaya (hazard) yang penting untuk keamanan pangan *
• Pertama kali dikembangkan tahun 1959 oleh Pillsbury Co and US Natick Army untuk menjamin keamanan makanan astronot
• Dianggap sebagai pencegahan yang mampu meningkatkan jaminan keamanan pangan untuk industri pangan
Hazard Analysis Critical Control Point (HACCP)
*Codex Alimentarius General Principles of Food Hygiene)
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Prinsip HACCP : • Analisis Bahaya (Hazard Analysis) • Penetapan CCP • Penetapan Critical Limit • Penetapan Monitoring Procedures • Penetapan Corrective Action • Penetapan Verification Procedures • Penetapan Documentation System
Bahaya • Senyawa (biologi, kimia dan fisik) dalam pangan
yang dapat menyebabkan ganggunan kesehatan kontaminasi alami, ketidaksengajaan, akibat kekuranghatihatianatau ignorance orang yang terlibat
HACCP
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Perkembangan HACCP
• Prinsip HACCP diadopsi dan diintegrasikan ke berbagai sistem manajemen keamanan pangan:
- Safe Quality Foods (SQF 2000) - ISO 22000: 2005 Food Safety
Management System in Food Chain - Food Safety System Certification (FSSC) - British Retail Consortium (BRC) - GFSI (Global Food Safety Initiative) - Hazard analysis Risk-Based Preventive
Control (HARPC, FSMA)
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• Sistem pangan yang semakin kompleks • Kerentanan (Vulnerable)terhadap serangan • Interconnectedness, menyebar cepat, luas • Terjadi fraud/tampering yang tidak dapat
diprediksi atau dikendalikan melalui HACCP - melamine dalam Powder Infant Formula - S. Typhimurium sengaja ditambahkan ke
salad • Perlunya Food Defense
Tantangan Keamanan Pangan Global
Bogor Agricultural University
Niat untuk menyebabkan celaka/kematian
Niat untuk menyebabkan kerugian ekonomi
TERRORISM SABOTASE ECONOMICALLY MOTIVATED ADULTERATION
Pertikaian Pribadi
PERTAHANAN PANGAN (FOOD DEFENSE)
From : FoodProtection.UMN.EDU, 2016
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K E M A M P U A N
K E R E N T A N A N
M O T I V A S I Niat lawan untuk
mence laka i Pengetahuan lawan tentang adu l te ran, tak t ik
Kond is i akses ib i l i tas dan pe luang menyebabkan dampak
ANCAMAN FOOD
DEFENSE
FOOD DEFENSE
Dari: FoodProtection.UMN.EDU, 2016
Bogor Agricultural University
Food Protection • Prosedur yang dilakukan untuk menghalangi dan
mendeteksi kecurangan/penipuan/pemalsuan pada pangan baik disengaja maupun tidak
Food Defence • Prosedur untuk menjamin keamanan makanan dan
minuman dan rantai suplainya dari serangan bermotif jahat dan ideologis yang mengakibatkan kontaminasi atau gangguan suplai (BSI, 2014)
Food Defense • Upaya untuk melindungi pangan dari kegiatan
pemalsuan (adulteration) yang disengaja (http://www.fda.gov/food/fooddefense/).
ISTILAH TERKAIT FOOD DEFENSE
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Evolusi Kebijakan Food Defense AS
FSIS
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FOOD DEFENSE – AS
Bogor Agricultural University
FOOD SAFETY MODERNIZATION ACT
Latar Belakang FSMA
• 9.3 juta penyakit bawaan pangan (1 dalam 31) per tahun, 53,245 dirawat RS dan 2,377 kenmatian
• Pergeseran fokus industri menuju strategi pencegahan bernasiskan “science-based standards”
• Pangan impor harus memiliki persyaratan sama dengan pangan lokal
• Ditandatangani 4 Januari 2011
• Dokumentasi mengenai kontaminasi dan recall di industri pangan AS
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FSMA– US
Bogor Agricultural University
the 7 rules oF FsMA
preventive controls - huMAn Food
produce sAFety
3rd pArtyAccreditAtion
preventive controls – AniMAl Food
Foreign supplier veriFicAtion progrAM
intentionAl AdulterAtion
sAnitAry trAnsport
rule FinAl rule requireMents deAdline For coMpliAnce
Preventive Controls: Human Food
September 17, 2015 s One year after final rule: general s Two years after final rule: small business* s Three years after final rule: very small business (<$1 million) plus PMO (Pasteurized Milk Ordinance)
s Supply chain: plus six month supplier’s compliance
s September 19, 2016 s September 18, 2017 s September 17, 2018
Preventive Controls: Animal Food
September 17, 2015 s CGMP compliance date s One year after final rule: general s Two years after final rule: small business* s Three years after final rule: very small business (<$2.5 million)
s Preventive controls compliance date: plus one year from above
s Supply-chain: plus six months of supplier’s compliance
s September 19, 2016 s September 18, 2017 s September 17, 2018
Produce Safety November 27, 2015 s One year after final rule: general** s Two years after final rule: small business ($250,000-$500,000)**
s Three years after final rule: very small business ($25,000-$250,000) **
s November 27, 2016 s November 27, 2017 s November 27, 2018
Intentional Adulteration May 27, 2016 s Three years after final rule: general s Four years after final rule: small business* s Five years after final rule: very small business (<$10 million)
s General: July 26, 2019
s Small businesses: July 27, 2020
s Very small businesses: July 26, 2021
Foreign Supplier Verification Program
November 27, 2015 s 18 months after final rule s For produce sector: 18 months plus 6 months or 6 months after supplier’s compliance to PC/Produce rule
s May 27, 2017 s November 27, 2017
Third Party Accreditation November 27, 2015 s ASAP after final fee rules
Sanitary Transport April 6, 2016 s One years after final rule: general** s Two years after final rule: small business* (carriers <$27.5 million)
s April 6, 2017 s April 6, 2018
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* Small business : less than 500 employees business-wide** Except for sprouts farms have + 1 year from listed plus additional 2 years to comply with water requirements
FSMA– US
Rules
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Final Rule: Protecting Food Against Intentional Adulteration (IA) http://www.fda.gov/fsma
Strategi Mitigasi untuk Melindungi Pangan dari Adulterasi yang Disengaja (Mitigation Strategies to Protect Food Against Intentional Adulteration) • Proposed on December 24, 2013 • Public comments: More than 200 for the original proposal • Final rule publication date: May 27, 2016
Bogor Agricultural University
• Menetapkan persyaratan untuk mencegah atau meminimalkan secara signifikan kegiatan yang bertujuan untuk mengakibahkan bahaya kesehatan masyarakat pada skala luas
• Menggunakan pendekatan serupa HACCP, dengan perbedaan pada “Preventive Controls for Human Food”
• Berbasiskan risiko dan fleksibel
Peraturan tentang Intentional Adulteration (IA)
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• Rencana Food Defense – Vulnerability assessment – Strategi Mitigasi – Prosedur monitoring untuk food defense – Prosedur corrective action untuk food defense – Prosedur verifikasi untuk food defense – Perekaman
• Training
Persyaratan untuk Peraturan IA
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• Proses mengidentifikasi dan prioritasisasi titik-titik, langkah proses, prosedur, dalam fasilitas pengolahan pangan yang rentan terhadap adulteration yang disengaja
• Dapat membantu mengidentifikasi: – Actionable Process Steps – Area operasi dimana Strategi Mitigasi
harus diaplikasikan
Vulnerability Assessment
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Metode Vulnerable Assessment Methodology
Tiga faktor paling penting untuk dipertimbangkan : • Aksesibilitas: ukuran kemudahan bagi seorang
penyerang dapat menjangkau secara fisik target yang ingin diserang
• Vulnerabilitas: ukuran kemudahan bagi suatu kontaminan dapat diletakkan dalam jumlah yang cukup untuk mencapai tujuan penyerang (setelah target dijangkau)
• Kritikalitas (impact) : apakah dampak kontaminan terhadap produksi/ gangguan kesehatan
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Skala Accessibility (Dapatkah saya mencapai target?)
CRITERIA SCALE Easily Accessible (e.g., target is outside building and no perimeter fence). 9 – 10
Accessible (e.g., target is inside building, but in unsecured part of facility). 7 – 8
Partially Accessible (e.g. inside building, but in a relatively unsecured, but busy, part of facility). 5 – 6
Hardly Accessible (e.g., inside building in a secured part of facility). 3 – 4
Not Accessible (e.g., there are physical barriers, alarms, and human observation to prevent reaching the target). 1 – 2
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Skala Vulnerability (Setelah mencapai target, bisakan saya meng”adulterate” pangan)
CRITERIA SCALE Highly Vulnerable (e.g., product is openly exposed and there is lots of time to allow for easy introduction of contaminants without being seen).
9 – 10
Vulnerable (e.g., product has some open exposure and there is sufficient time to almost always allow for introduction of contaminants without being seen).
7 – 8
Somewhat Vulnerable (e.g., product has limited exposure points and limited times when contaminant can be added without being seen).
5 – 6
Barely Vulnerable (e.g., product has limited exposure points but is almost always under observation while in production).
3 – 4
Not Vulnerable (e.g., product is in sealed vessels/pipes with no practical exposure points or it is under full and controlled observation).
1 – 2
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Skala Criticality (Jika saya dapat meng”adulterate” apa dampaknya?)
CRITERIA SCALE Very Large Volume Impact (e.g., a single instance of contamination at this point would contaminate multiple days of the production of this line).
9 – 10
Large Volume Impact (e.g., a single instance of contamination at this point would contaminate multiple shifts of the production of this line).
7 – 8
Medium Volume Impact (e.g., a single instance of contamination at this point would contaminate one shift or less of the production of this line).
5 – 6
Small Volume Impact (e.g., a single instance of contamination at this point would contaminate two hours or less of the production of this line).
3 – 4
Low Volume Impact (e.g., a single instance of contamination at this point would contaminate 30 minutes or less of the production of this line).
1 – 2
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Asesmen Vulnerability untuk Fasilitas
• Lakukan vulnerability assessment dengan metode yang tepat dan qualified individual(s)
• Identifikasi da prioritaskan prioritize titik dalam operasi pangan yang rentan (vulnerable) terhadap intentional adulteration
• Identifikasi actionable process untuk vulnerability yang signifikan : a point, step, or procedure in a food process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level.”
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• Evaluasi senyawa yang dikhawatirkan • Buat tim Vulnerability Assessment (VA) • Menyusun diagram alir • Identifikasi Vulnerabilities yang signifikan:
– Public health impact – Volume of product impacted – Downstream processing – Physical access to product – Ability of aggressor to contaminate product
• Identifikasi Actionable Process Steps
Elemen Vulnerability Assessment Untuk Fasilitas
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• Strategi mitigasi harus diidentifikasi dan diimplementasikan iuntuk tiap actionable process step untuk memberi jaminan bahwa vulnerabilitas diminimalkan atau dicegah
• Strategi mitigasi harus disusun khusus (tailored ) untuk fasilitas dan prosedur-prosedur.
• Contoh mitigasi : pagar disekeliling fasilitas untuk mencegah outsider, cara lain mungkin diperlukan untuk melindungi actionable process step dari serangan “insider”
Strategi Mitigasi
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Komponen Strategi Mitigasi • Monitoring: Establishing and implementing
procedures, including the frequency with which they are to be performed, for monitoring the mitigation strategies.
• Corrective actions: The response if mitigation strategies are not properly implemented.
• Verification: Verification activities would ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made.
Strategi Mitigasi
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Rencana Food Defense
Rencana Food Defense tertulis mencakup : • Vulnerability Assessment • Actionable process steps • Mitigation strategies
Monitoring Corrective actions Verification Training
• Recordkeeping
Bogor Agricultural University
2014: The British Standards
Institution (BSI) : PAS 96 2014
Guide to protecting and defending food
and drink from deliberate attack
FOOD DEFENCE UK : PAS 96 2014
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Background • HACCP tidak digunakan untuk mendeteksi atau
mengurangi serangan yang disengaja dalam sistem pangan yang menyebabkan bahaya keamanan pangan maupun merusakn reputasi perusahaan(pemerasan dsb))
• Faktor umum serangan disengaja: orang, motivasi • PAS 96 panduan bagi manajer industri pangan melalui
pendekatan dan prosedur untuk meningkatkan ketahanan rantai pangan dari penipuan/bentuk serangan lain
• Menekankan pada Threat Assessment Critical Control Points (TACCP),
• Proses TACCP diasumsikan dan dibangun di atas HACCP
PAS 96 2014
Bogor Agricultural University
TACCP Manajemen risiko secara sistematis melalui evaluasi ancaman (threats), identifikasi vulnerability, dan penerapan pengendalian terhadap bahan dan produk, pembelian, proses, fasilitas, jaringan distribusi dan sistem bisnis dengan tim terpercaya dan berpengetahuan yang diberi otoritas untuk mengubah prosedur Ancaman Sesuatu yang dapat mengakibatkan kehilangan atau bahaya yang timbul karena orang yang berniat jahat
Threat Assessment Critical Control Point (TACCP)
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Jenis Ancaman
• Pemalsuan bermotif ekonomi (Economically motivated adulteration/EMA)
• Kontaminasi karena unsur kejahatan (Malicious contamination)
• Pemerasan (Extortion) • Spionase (Espionage) • Pemalsuan (Counterfeiting) • Kejahatan cyber (Cyber crime)
Bogor Agricultural University
• Keberhasilan serangan (attack) yang disengaja terhadap pangan atau rantai pangan tergantung dari : a) Apakah penyerang memiliki motivasi dan dorongan
untuk mengatasi hambatan baik besar atau kecil b) Apakah penyerang memiliki kemampuan untuk
melakukan serangan? c) Apakah penyerang memiliki
kesempatan(=akses)untuk menjalankan serangan d) Apakah penyerang akan mengurungkan niatnya jika
terdeteksi atau ana kemungkinan dihukum?
Memahami Ancaman
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• Jenis Penyerang: - Pemeras (the extortionist) - Oportunis (the opportunis) - Ekstrimis (the extremist) - Perorangan yang tak rasional (the irrational
individual) - Perorangan yang tidak puas (the disgruntled
individual) - Hackivist dan penjahat cyber lainnya (the
hacktivist and other cyber criminals)
Memahami Ancaman
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Tujuan : • mengurangi peluang serangan yang disengaja
• mengurangi dampak serangan (jika terjadi)
• melindungi reputasi organisasi
• menmberi jaminan pada konsumen. Pers, masyarakat bahwa langkah-langkah pencegahan telah disiapkan untuk melindungi pangan dari serangan yang disengaja
• Memuaskna harapan international dan mendukung trading partners
• Mendemonstrasikan bahwa pencegahjan telah dilakukan dan uji kelayakan telah dipraktekkan
TACCP
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• Dalam banyak kasus, TACCP seharusnya merupakan kerja tim. Untuk bisnis skala kecil yang tidak praktis untuk membuat tim, dapat menjadi tugas 1 orang
• Tim TACCP harus melakukan exercise setidaknya 4 pertanyaan berikut :
a) Siapa yang mungkin ingin menyerang kita?
b) Bagaimana mereka akan melakukannya?
c) Dimana titik kerentanan (vulnerable) kita?
d) Bagaimana kita dapat menghentikannya?
Proses dalam TACCP
Bogor Agricultural University
Tim TACCP dapat terdiri dari orang yang menguasai : • security; • human resources; • food technology; • process engineering; • production and operations; • purchasing and supply; • distribution; • communications; and • commercial/marketing.
Proses dalam TACCP
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Langkah • Mengidentifikasi ancaman spesifik terhadap bisnis
perusahaan • mengases peluang suatu serangan dengan
mempertimbangkan : motivasi kandidat penyerang, vulnerability proses, kesempatan dan kemampuan untuk melakukan serangan,mengases dampak
• Menimbang prioritas pada berbagai ancamandengan memperhatikan likelihood and impact
• Menetapkan pengendalian yang tepat untuk menghalangi (discourage) penyerang dan membuat early warning
• Memelihara sistem informasi dan intelijen untuk merevisi prioritas
Proses dalam TACCP
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Form TACCP team
1. Assess new information
2. Identify and assess threat to organization
3. Identify and assess threat to operation
4. Select product
5. Identify and assess threat to product
6. Device flowchart of product supply chain
7. Identify key staff and vulnerable points
8. Consider impact of threats identified
9. Identify which supply points are most critical
10. Determine if control procedures will detect the threats
11. Likelihood v. impact : priority 12. Who could
carry it out
13. Decide and implement necessary controls
14. Review and revise
15. Monitor horizon scans and emerging risks
Proses dalam TACCP
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Ancaman terhadap tempat, misalnya: • Are the premises located in a politically or socially sensitive area? • Do the premises share access or key services with controversial
neighbours? • Are new recruits, especially agency and seasonal staff,
appropriately screened? • Are services to the premises adequately protected? • Are external utilities adequately protected? • Are hazardous materials, which could be valuable to hostile groups,
stored on site? • Are large numbers of people (including the general public) using the
location? • Do any employees have reason to feel disgruntled or show signs of
dissatisfaction? • Are internal audit arrangements independent?
Have key roles been occupied by staff for many years with little supervision?
Asesmen Ancaman dalam TACCP
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Asesmen ancaman terhadap organisasi : • Are we under foreign ownership by nations involved in international conflict?
• Do we have a celebrity or high profile chief executive or proprietor?
• Do we have a reputation for having significant links, customers, suppliers, etc. with unstable regions of the world?
• Are our brands regarded as controversial by some? • Do we or our customers supply high profile customers or events?
Asesmen Ancaman dalam TACCP
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Asesmen ancaman terhadap produk : • Have there been significant cost increases which have
affected this product? • Does this product have particular religious, ethical or
moral significance for some people? • Could this product be used as an ingredient in a wide
range of popular foods? • Does the product contain ingredients or other material
sourced from overseas?
Asesmen Ancaman dalam TACCP
Bogor Agricultural University
Untuk EMA: • Are low cost substitute materials available? • Have there been significant material cost increases? • Has pressure increased on suppliers’ trading margins? • Do you trust your suppliers’ managers, and their
suppliers’ managers? • Do key suppliers use personnel security practices? • Do suppliers think that we monitor their operation • and analyze their products? • Which suppliers are not routinely audited? • Are we supplied through remote, obscure chains? • Are major materials becoming less available (e.g. from
crop failure) or alternatives plentiful (e.g. from overproduction)?
Asesmen Vulnerability dalam TACCP
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Untuk EMA: • How do suppliers dispose of excessive amounts of
waste materials? • Are we aware of shortcuts to the process which
could affect us? • Are our staff and those of suppliers encouraged to
report concerns (whistleblowing)? • Are accreditation records, certificates of
conformance and analyzes reports independent?
Asesmen Vulnerability dalam TACCP
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Untuk Malicious Contamination: • Are food safety audits rigorous and up-to-date? • Are personnel security procedures in use? • Is access to product restricted to those with a business need? • Do storage containers have tamper-evident seals? • Is the organization involved with controversial trade? • Is the organization owned by nationals from conflict areas? • Is there opportunity for access by sympathizers of single issue
groups? • Do any employees bear a grudge against the organization? • Is staff boredom, discipline, recruitment a problem? • Have business competitors been accused of espionage • or sabotage?
Asesmen Vulnerability dalam TACCP
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Likelihood of threat happening
Score Impact
Very High Chance 5 Catastrophic High Chance 4 Major Some Chance 3 Significant May Happen 2 Some Unlikely to Happen 1 Minor
Contoh Matriks untuk Skoring Risiko
Asesmen Risiko dalam TACCP
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Likelihood of threat happening
Impact Catas-trophic
Major Significant
Some Minor
Very High Chance
Threat 1
High Chance Threat 3 Some Chance May Happen Unlikely to Happen
Threat 2
Contoh Matriks untuk Skoring Risiko
Asesmen Risiko dalam TACCP
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Laporan TACCP
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Bahan Bacaan
• British Standard Institute. 2014. PAS 96 2014. Guide to protecting and defending food and drink from deliberate attack
• SGS. 2016. Understanding the US Food Safety Modernization Act (FSMA)
• USFDA. 2011. Food Safety Modernization Act. https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm
• USFDA. 2016. Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (IA). https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm
• Food Defense Training Materials. FoodProtection.UMN.Edu
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Thank You
Thank You [email protected]