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


•  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


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


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


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

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FOOD DEFENSE – AS


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


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

4

* 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


•  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


•  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


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


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.”


•  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


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


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


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)


•  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


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


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


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


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?


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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?



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?



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?


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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


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


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]

Documents

Food Safety Management System