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Food Safety

Danang Suryo Wardhono


Perkenalan Diri
▪ NAME: DANANG SURYO WARDHONO ST MM

▪ OCCUPATION:
▪ REGISTERED TRAINER /AUDITOR PECB, TRAINER/ AUDITOR
MANAGEMENT SYSTEM FOR CERTIFICATION BODY LRQA, MUTU
CERTIFICATION INTERNATIONAL, RINA, AFNOR INDONESIA, IAPMO,
TUV RHEINLAND, PUSDIKLAT GADJAHMADA, BINA PROFESI
INSTITUTE, MUTU INSTITUTE, NQA, WQA, ITS TEKNOSAINS, ISQ,
SUCOFINDO ETC
▪ LA IRCA /PECB CERTIFIED ISO 9K, 14K, 18K,20000-1, 22K, 22301, 27K,
37K, 45, 50 K ,SMK3 AUDITOR, HALAL, BRC VERSI 8 AUDITOR
CONVERSION, PAK KPK ETC

▪ TELP/WA: 081567796679, 08112999715

▪ danangsuryowardhono@gmail.com
FOOD SAFETY TOPIC
➢ ISO 22000:2018
➢ GMP
➢ HACCP
➢ FSSC 5
➢ Peraturan perundangan terkait
UU 18 2012 pangan
• Keamanan Pangan adalah kondisi dan
upaya yang diperlukan untuk
mencegah Pangan dari kemungkinan
cemaran biologis, kimia, dan benda
lain yang dapat mengganggu,
merugikan, dan membahayakan
kesehatan manusia serta tidak
bertentangan dengan agama,
keyakinan, dan budaya masyarakat
sehingga aman untuk dikonsumsi.
http://ik.pom.go.id/v2016/
Berita Keracunan Bulan Juli – September 2017
• Informasi Kejadian Keracunan yang
Diberitakan Oleh 138 Media
Massa Online pada Bulan Juli – September
2017
• Insiden keracunan yang disebabkan
oleh makanan olahan jasaboga
sebanyak 9 insiden dengan 422
korban,
• makanan olahan rumah tangga
sebanyak 8 insiden dengan 249
korban dan 1 orang diantaranya
meninggal dunia,
• makanan olahan jajanan (PKL)
sebanyak 6 insiden dengan 88 orang
korban,
• makanan olahan dalam kemasan
sebanyak 2 insiden yang
menyebabkan 37 orang korban
Source laporan tahunan BPOM 2017
Open standard and book
• ISO 22000:2018 • PEDOMAN HACCP PROGRAM
MANAJEMEN RISIKO, Industri
• ISO 22001:2009 Formula Bayi, Formula Lanjutan dan
• FSSC Ver 5 Formula Pertumbuhan, Direktorat
Inspeksi dan Sertifikasi Pangan
• FSPCA Deputi Bidang Pengawasan
• Food Code 2017 Keamanan Pangan dan Bahan
Berbahaya BPOM 2015
• Bad Bug Book Handbook of
Foodborne Pathogenic
Microorganisms and Natural
Toxins
• World food safety guidelines
Regulasi terkait
jenis No tahun tentang
PERATURAN
12 2019 Cemaran Dalam Kosmetika
KBPOM
PERATURAN Batas Maksimal Cemaran Mikroba Dalam Pangan
13 2019
KBPOM Olahan
PERATURAN Batas Maksimum Cemaran Logam Berat Dalam
5 2018
KBPOM Pangan Olahan
PERATURAN Batas Maksimum Cemaran Kimia Dalam Pangan
8 2018
KBPOM Olahan
PERATURAN
2 2020 Pengawasan Produksi Dan Peredaran Kosmetika
KBPOM
PERATURAN Pengawasan Obat Dan Makanan Yang Diedarkan
8 2020
KBPOM Secara Daring
PERATURAN
22 2017 Penarikan Pangan Dari Peredaran
KBPOM
PERATURAN
27 2017 Pendaftaran Pangan Olahan
KBPOM
PERATURAN
34 2018 Pedoman Cara Pembuatan Obat Yang Baik
KBPOM
Peraturan Menteri75/M- Pedoman Cara Produksi Pangan Olahan Yang Baik
2010
Perindustrian IND/PER/7/2010 (Good Manufacturing Practices)
Regulasi terkait
jenis No tahun tentang
PERUBAHAN ATAS PERATURAN BADAN PENGAWAS OBAT DAN
PERATURAN
6 2020 MAKANAN NOMOR 9 TAHUN 2019 TENTANG PEDOMAN TEKNIS
KBPOM
CARA DISTRIBUSI OBAT YANG BAIK
PERATURAN PENILAIAN PEMENUHAN PERSYARATAN CARA PEMBUATAN
7 2019
KBPOM OBAT YANG BAIK TERHADAP FASILITAS PEMBUATAN OBAT IMPOR
PERATURAN
9 2019 PEDOMAN TEKNIS CARA DISTRIBUSI OBAT YANG BAIK
KBPOM
PERATURAN
25 2019 Pedoman Cara Pembuatan Kosmetika Yang Baik
KBPOM
PERATURAN
25 2017 Tata Cara Sertifikasi Cara Distribusi Obat Yang Baik
KBPOM
PERATURAN
5 2015 Pedoman Cara Ritel Pangan Yang Baik Di Pasar Tradisional
KBPOM
PERATURAN
11 2014 Tata Cara Sertifikasi Cara Produksi Pangan Olahan Yang Baik
KBPOM
PERATURAN HK.03.1.23.
2012 Cara Produksi Pangan Yang Baik Untuk Industri Rumah Tangga
KBPOM 04.12.2206
PERATURAN HK.03.1.23.0 TATA CARA PEMERIKSAAN SARANA PRODUKSI PANGAN INDUSTRI
2012
KBPOM 4.12.2207 RUMAH TANGGA
Regulasi terkait
jenis No tahun tentang
PERATURAN
11 2019 Bahan Tambahan Pangan
KBPOM
PERATURAN
8 2016 Persyaratan Bahan Tambahan Pangan Campuran
KBPOM
PERATURAN
22 2016 Persyaratan Penggunaan Bahan Tambahan Pangan Perisa
KBPOM
PERATURAN Pencantuman Informasi Tanpa Bahan Tambahan Pangan Pada
23 2016
KBPOM Label Dan Iklan Pangan
PERATURAN Batas Maksimum Penggunaan Bahan Tambahan Pangan
4 2014
KBPOM Pemanis
PERATURAN
7 2018 BAHAN BAKU YANG DILARANG DALAM PANGAN OLAHAN
KBPOM
Penarikan Dan Pemusnahan Obat Yang Tidak Memenuhi
PERATURAN
14 2019 Standar Dan/atau Persyaratan Keamanan, Khasiat, Mutu, Dan
KBPOM
Label
PERATURAN
22 2019 Informasi Nilai Gizi Pada Label Pangan Olahan
KBPOM
PERATURAN
31 2018 Label Pangan Olahan
KBPOM
Regulasi terkait
jenis No tahun tentang
PERATURAN
9 2016 Acuan Label Gizi
KBPOM
PERATURAN Pengawasan Klaim Pada Label Dan Iklan Pangan
13 2016
KBPOM Olahan
PERATURAN
20 2019 Kemasan Pangan
KBPOM
PERATURAN
28 2019 Bahan Penolong Dalam Pengolahan Pangan
KBPOM
PERATURAN
34 2019 Kategori Pangan
KBPOM
ISO 22000 family standard
• ISO 22000 - Food safety management systems - Requirements for any organization in the food
chain.
• ISO 22001 - Guidelines on the application of ISO 9001:2000 for the food and drink industry
(replaces: ISO 15161:2001).
• ISO/TS 22002- Prerequisite programs on food safety—Part 1: Food manufacturing; Part 2:
Catering; Part 3: Farming; Part 4: Food packaging manufacturing; Part 6: Feed and animal food
production
• ISO TS 22003 - Food safety management systems for bodies providing audit and certification of
food safety management systems.
• ISO TS 22004 - Food safety management systems - Guidance on the application of ISO
22000:2005.
• ISO 22005 - Traceability in the feed and food chain - General principles and basic requirements for
system design and implementation.
• ISO 22006 - Quality management systems - Guidance on the application of ISO 9002:2000 for crop
production.
• ISO 22000 is also used as a basis for the Food Safety Systems Certification (FSSC) Scheme FSSC
22000. FSSC 22000 is a Global Food Safety Initiative (GFSI) approved scheme.
Source:
https://www.nqa.com/medialib
raries/NQA/NQA-Media-
Library/PDFs/NQA-ISO-22000-
Implementation-Guide.pdf
FSMS principles The management principles

• — interactive communication; • — customer focus;


• — system management; • — leadership;
• — prerequisite programmes; • — engagement of people
• — hazard analysis and critical • — process approach;
control point (HACCP) principles. • — improvement;
• — evidence-based decision
making;
• — relationship management.
PDCA at
two levels
Risk-based thinking
• Risk-based thinking is essential for achieving an effective FSMS. In this document, risk-based
thinking is addressed on two levels, organizational and operational, which is consistent with the
process approach.
• Organizational risk management, Risk is the effect of uncertainty, and any such uncertainty can
have positive or negative effects. In the context of organizational risk management, a positive
deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in
opportunities. To conform to the requirements of this document, an organization plans and
implements actions to address organizational risks (Clause 6) . Addressing risks establishes a basis
for increasing the effectiveness of the FSMS, achieving improved results and preventing negative
effects.
• Hazard analysis — Operational processes the concept of risk-based thinking based on the HACCP
principles at the operational level is implicit in this document.
1 Scope
This document specifies requirements • d) to effectively communicate food
for a food safety management system safety issues to interested parties
(FSMS) within the food chain;
a) to plan, implement, operate, • e) to ensure that the organization
maintain and update a FSMS providing conforms to its stated food safety
products and services that are safe, in policy;
accordance with their intended use; • f) to demonstrate conformity to
b) to demonstrate compliance with relevant interested parties;
applicable statutory and regulatory food • g) to seek certification or registration
safety requirements; of its FSMS by an external
c) to evaluate and assess mutually organization, or make a self
agreed customer food safety assessment
requirements and to demonstrate • or self-declaration of conformity to
conformity with them; this document.
3 Terms and definitions
• 3.2 action criterion, measurable or observable • 3.21 food safety, assurance that food will not
specification for the monitoring (3.27) of an cause an adverse health effect for the
OPRP (3.30) consumer when it is prepared and/or
• 3.11 critical control point CCP, step in the consumed in accordance with its intended
process (3.36) at which control measure(s) use
(3.8) is (are) applied to prevent or reduce a • 3.22 food safety hazard, biological, chemical
significant food safety hazard (3.40) to an or physical agent in food (3.18) with the
acceptable level, and defined critical limit(s) potential to cause an adverse health effect
(3.12) and measurement (3.26) enable the
application of corrections (3.9) • Note 2 to entry: Food safety hazards include
allergens and radiological substances
• 3.12 critical limit, measurable value which • 3.30 operational prerequisite programme,
separates acceptability from unacceptability OPRP control measure (3.8) or combination of
• 3.20 food chain, sequence of the stages in the control measures applied to prevent or
production, processing, distribution, storage reduce a significant food safety hazard (3.40)
and handling of a food (3.18) and its to an acceptable level (3.1) , and where action
ingredients, from primary production to criterion (3.2) and measurement (3.26) or
consumption observation enable effective control of the
process (3.36) and/or product (3.37)
• 3.35 prerequisite programmes PRP, basic • 3.44 Validation,<food safety> obtaining
conditions and activities that are evidence that a control measure (3.8) (or
necessary within the organization (3.31) combination of control measures) will be
and throughout the food chain (3.20) to capable of effectively controlling the
maintain food safety significant food safety hazard (3.40)
• Note 1 to entry: The PRPs needed depend • 3.45 verification, confirmation, through
on the segment of the food chain in the provision of objective evidence, that
which the organization operates and the specified requirements (3.38) have been
type of organization. Examples of fulfilled
equivalent terms are: good agricultural
practice (GAP) , good veterinary practice
(GVP) , good manufacturing practice
(GMP) , good hygiene practice (GHP) ,
good production practice (GPP) , good
distribution practice (GDP) and good
trading practice (GTP) .
4 Context of the organization
• 4.1 Understanding the organization and its context External Issues
• The organization shall determine external and • Cultural, social, political, legal, financial, technological,
economic and natural surroundings including the
internal issues that are relevant to its purpose and environment in which the organization operates
that affect its ability to achieve the intended
result(s) of its FSMS. • Who the competitors are and any contractors,
subcontractors, suppliers, partners and providers
• 4.2 Understanding the needs and expectations of • National and international law
interested parties
• Availability and variety of external providers of
• To ensure that the organization has the ability to services/products
consistently provide products and services that Internal Issues
meet applicable statutory, regulatory and customer
requirements with regard to food safety, the • Governance, organizational structure, roles and
organization shall determine: accountabilities
• Policies, objectives and the strategies in place to
• a) the interested parties that are relevant to the achieve them
FSMS;
• Competence of personnel
• b) the relevant requirements of the interested
• Food Safety culture within the organization and the
parties of the FSMS relationship with workers
• 4.3 Determining the scope of the food
safety management system
• The 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 in the FSMS.
• 4.4 Food safety management system
• The organization shall establish,
implement, maintain, update and
continually improve a FSMS, including the
processes needed and their interactions,
in accordance with the requirements
• Source picture:
https://www.nqa.com/medialibraries/NQ
A/NQA-Media-Library/PDFs/NQA-ISO-
22000-Implementation-Guide.pdf
5 Leadership
5.1 Leadership and commitment • 5.3 Organizational roles, responsibilities and
• Top management shall demonstrate leadership authorities
and commitment with respect to the FSMS by:
• 5.3.1 Top management shall ensure that the
• a) ensuring that the food safety policy and the responsibilities and authorities for relevant roles are
objectives of the FSMS are established and are assigned, communicated and understood within the
• compatible with the strategic direction of the organization
organization;
• a) ensuring that the FSMS conforms to the
• b) ensuring the integration of the FSMS requirements of this document;
requirements into the organization’s business
processes; • b) reporting on the performance of the FSMS to top
5.2 Policy management;
• 5.2.1 Establishing the food safety policy • c) appointing the food safety team and the food safety
• c) includes a commitment to satisfy applicable team leader;
food safety requirements, including statutory • 5.3.2 The food safety team leader shall be responsible
and regulatory requirements and mutually
agreed customer requirements related to food for:
safety;
• a) ensuring the FSMS is established, implemented,
• 5.2.2 Communicating the food safety policy maintained and updated;
• a) be available and maintained as documented • b) managing and organizing the work of the food safety
information;
team;
6 Planning
6.1 Actions to address risks and opportunities • 6.3 Planning of changes
• a) give assurance that the FSMS can achieve its • When the organization determines the need for
intended result(s); changes to the FSMS, including personnel changes,
the changes shall be carried out and
• b) enhance desirable effects; communicated in a planned manner
• c) prevent, or reduce, undesired effects
6.2 Objectives of the food safety management system
and planning to achieve them
a) be consistent with the food safety policy;
b) be measurable (if practicable);
c) take into account applicable food safety
requirements, including statutory, regulatory and
customer requirements;
d) be monitored and verified;
The organization shall retain documented
information on the objectives for the FSMS
7 Support
• 7.1 Resources • 7.1.4 Work environment
• 7.1.1 General • The organization shall determine, provide and
maintain the resources for the establishment,
• The organization shall determine and provide the management and maintenance of the work
resources needed for the establishment, environment necessary to achieve conformity
implementation, maintenance, update and continual with the requirements of the FSMS
improvement of the FSMS • 7.1.5 Externally developed elements of the
• 7.1.2 People food safety management system
• The organization shall ensure that persons necessary • When an organization establishes, maintains,
to operate and maintain an effective FSMS are updates and continually improves its FSMS by
competent
using externally developed elements of a
FSMS, including PRPs, the hazard analysis and
• 7.1.3 Infrastructure the hazard control plan (see 8.5.4) ,
• The organization shall provide the resources for the • 7.1.6 Control of externally provided
determination, establishment and maintenance of the processes, products or services
infrastructure necessary to achieve conformity with • The organization shall:
the requirements of the FSMS
• a) establish and apply criteria for the
evaluation, selection, monitoring of
performance and reevaluation
• of external providers of processes, products
and/or services;
• 7.4.2 External communication
• 7.2 Competence • The organization shall ensure that sufficient
• The organization shall: information is communicated externally and is
available for interested parties of the food chain.
• a) determine the necessary competence of
person(s) , including external providers, doing work • The organization shall establish, implement and
under maintain effective communications with:
• its control that affects its food safety performance • a) external providers and contractors;
and effectiveness of the FSMS; • b) customers and/or consumers, in relation to:
• b) ensure that these persons, including the food • 1) product information related to food safety, to
safety team and those responsible for the enable the handling, display, storage, preparation,
operation distribution and use of the product within the food
• of the hazard control plan, are competent on the chain or by the consumer;
basis of appropriate education, training and/or • 2) identified foods safety hazards that need to be
experience; controlled by other organizations in the food chain
• 7.3 Awareness and/or by consumers;
• The organization shall ensure that all relevant • 3) contractual arrangements, enquiries and orders,
persons doing work under the organization’s including their amendments;
control shall be aware of: • 4) customer and/or consumer feedback, including
• a) the food safety policy; complaints;
• b) the objectives of the FSMS relevant to their task
7.4.3 Internal communication
• a) products or new products; • h) applicable statutory and regulatory
• b) raw materials, ingredients and requirements;
services; • i) knowledge regarding food safety
• c) production systems and equipment; hazards and control measures;
• d) production premises, location of • j) customer, sector and other
equipment and surrounding requirements that the organization
environment; observes;
• e) cleaning and sanitation • k) relevant enquiries and
programmes; communications from external
interested parties;
• f) packaging, storage and distribution • l) complaints and alerts indicating
systems food safety hazards associated with
• g) competencies and/or allocation of the end product
responsibilities and authorizations;
7.5 Documented information

• 7.5.1 General • 7.5.2 Creating and updating


• The organization’s FSMS shall • 7.5.3 Control of documented
include: information
• a) documented information
required by this document;
• b) documented information
determined by the organization as
being necessary for the
effectiveness of the FSMS;
• c) documented information and
food safety requirements required
by statutory, regulatory authorities
and customers.
8 Operation

• 8.1 Operational planning and control • 8.2 Prerequisite programmes (PRPs)


• The organization shall plan, implement, • 8.2.1 The organization shall establish,
control, maintain and update the processes implement, maintain and update PRP(s) to
needed to meet requirements for the facilitate the prevention and/or reduction of
realization of safe products, and to implement contaminants (including food safety hazards)
the actions determined in 6.1, by: in the products, product processing and work
environment
• a) establishing criteria for the processes;
• b) implementing control of the processes in • 8.2.3 When selecting and/or establishing
accordance with the criteria; PRP(s) , the organization shall ensure that
applicable statutory, regulatory and mutually
• c) keeping documented information to the agreed customer requirements are identified.
extent necessary to have the confidence to The organization should consider:
demonstrate that the processes have been • a) the applicable part of the ISO/TS 22002
carried out as planned. series;
• b) applicable standards, codes of practice and
guidelines.
• 8.2.4 When establishing PRP(s) the organization shall
consider:
• Construction dan layout building
• Layout of premises
• Utilities air, water, energy
• Waste disposal
• Equipment suitability, maintenance, cleaning
• Management of purchased materials
• Prevention of cross contamination
• Cleaning and sanitizing
• Pest control
• Personal hygiene
• Rework
• Product recall
• Warehousing
• Product information
• Food defense
• 8.3 Traceability system • 8.4 Emergency preparedness and response
• The traceability system shall be able to uniquely • 8.4.2 Handling of emergencies and incidents
identify incoming material from the suppliers and
the first stage of the distribution route of the end • The organization shall:
product. When establishing and implementing the • a) respond to actual emergency situations and
traceability system, the following shall be incidents by:
considered as a minimum:
• 1) ensuring applicable statutory and regulatory
• a) relation of lots of received materials, ingredients requirements are identified;
and intermediate products to the end products;
• 2) communicating internally;
• b) reworking of materials/products;
• 3) communicating externally (e.g. suppliers,
• c) distribution of the end product. customers, appropriate authorities, media);
• b) take action to reduce the consequences of the
emergency situation, appropriate to the magnitude
of the emergency or incident and the potential
food safety impact;
• c) periodically test procedures where practical;
• d) review and, where necessary, update the
documented information after the occurrence of
any incident, emergency situation or tests.
8.5 Hazard control
• 8.5.1 Preliminary steps to enable hazard • f) method of packaging and delivery;
analysis • g) storage conditions and shelf life;
• 8.5.1.2 Characteristics of raw materials, • h) preparation and/or handling before use
ingredients and product contact materials or processing;
• a) biological, chemical and physical • i) acceptance criteria related to food
characteristics; safety or specifications of purchased
• b) composition of formulated ingredients, materials and ingredients
including additives and processing aids; • appropriate to their intended use.
• c) source (e.g. animal, mineral or
vegetable);
• d) place of origin (provenance);
• e) method of production;
• 8.5.1.3 Characteristics of end products • f) labelling relating to food safety and/or
• The organization shall ensure that all instructions for handling, preparation and
applicable statutory and regulatory food intended use;
safety requirements are identified for all the • g) method(s) of distribution and delivery
end products intended to be produced
• 8.5.1.4 Intended use
• a) product name or similar identification; • The intended use, including reasonably
• b) composition; expected handling of the end product and any
• c) biological, chemical and physical unintended use but reasonably expected
characteristics relevant for food safety; mishandling and misuse of the end product,
shall be considered and shall be maintained
• d) intended shelf life and storage conditions; as documented information to the extent
needed to conduct the hazard analysis (see
• e) packaging; 8.5.2)
• Where appropriate, groups of
consumers/users shall be identified for each
product.
• Groups of consumers/users known to be
especially vulnerable to specific food safety
hazards shall be identified.
• 8.5.1.5 Flow diagrams and description of processes • 8.5.1.5.2 On-site confirmation of flow diagrams
• 8.5.1.5.1 Preparation of the flow diagrams • The food safety team shall confirm on-site the accuracy of
the flow diagrams, update the flow diagrams where
• a) the sequence and interaction of the steps in the operation; appropriate and retain as documented information.
• b) any outsourced processes; • 8.5.1.5.3 Description of processes and process environment
• c) where raw materials, ingredients, processing aids, • The food safety team shall describe, to the extent needed to
packaging materials, utilities and intermediate products enter conduct the hazard analysis:
the flow;
• a) the layout of premises, including food and non-food
• d) where reworking and recycling take place; handling areas;
• e) where end products, intermediate products, by-products • b) processing equipment and contact materials, processing
and waste are released or removed. aids and flow of materials;
• c) existing PRPs, process parameters, control measures (if
any) and/or the strictness with which they are applied, or
procedures that can influence food safety;
• d) external requirements (e.g. from statutory and regulatory
authorities or customers) that can impact the choice and the
strictness of the control measures.
8.5.2 Hazard analysis
• 8.5.2.2 Hazard identification and determination of acceptable • 8.5.2.2.2 The organization shall identify step(s) (e.g. receiving
levels raw materials, processing, distribution and delivery) at which
each food safety hazard can be present, be introduced,
• 8.5.2.2.1 The organization shall identify and document all increase or persist.
food safety hazards that are reasonably expected to occur in
relation to the type of product, type of process and process • 8.5.2.2.3 The organization shall determine the acceptable
environment. level in the end product of each food safety hazard identified,
whenever possible.
• The identification shall be based on:
• When determining acceptable levels, the organization shall:
• a) the preliminary information and data collected in
accordance with 8.5.1; • a) ensure that applicable statutory, regulatory and customer
requirements are identified;
• b) experience;
• b) consider the intended use of end products;
• c) internal and external information including, to the extent
possible, epidemiological, scientific and other historical data; • c) consider any other relevant information.
• d) information from the food chain on food safety hazards
related to the safety of the end products, intermediate
products and the food at the time of consumption;
• e) statutory, regulatory and customer requirements.
• 8.5.2.3 Hazard assessment • 8.5.2.4 Selection and categorization of
• The organization shall conduct, for control measure(s)
each identified food safety hazard, a • 8.5.2.4.1 Based on the hazard
hazard assessment to determine assessment, the organization shall
whether its prevention or reduction to select an appropriate control measure
an acceptable level is essential or combination of control measures
• The evaluation of hazards, based on that will be capable of preventing or
their severity of harm and probability reducing the identified significant
of occurrence, will include the food safety hazards to defined
establishment of specific measures or acceptable levels.
combination of them to prevent or • The organization shall categorize the
reduce the significant food safety selected identified control measure(s)
hazards to acceptable levels to be managed as OPRP(s) (see 3.30)
or at CCPs (see 3.11) .
• The categorization shall be carried out using a • 8.5.3 Validation of control measure(s) and
systematic approach combinations of control measures
• a) the likelihood of failure of its functioning; • The food safety team shall validate that the
selected control measures are capable of
• b) the severity of the consequence in the case achieving the intended control of the
of failure of its functioning; this assessment significant food safety hazard(s) . This
shall include: validation shall be done prior to
• 1) the effect on identified significant food implementation of control measure(s) and
safety hazards; combinations of control measures to be
included in the hazard control plan (see 8.5.4)
• 2) the location in relation to other control and after any change therein (see 7.4.2, 7.4.3,
measure(s); 10.2 and 10.3) .
• 3) whether it is specifically established and
applied to reduce the hazards to an
acceptable level;
• 4) whether it is a single measure or is part of
combination of control measure(s) .
8.5.4 Hazard control plan (HACCP/OPRP plan)
• 8.5.4.1 General • 8.5.4.2 Determination of critical limits and action
criteria
• The organization shall establish, implement and
maintain a hazard control plan. The hazard control • 8.5.4.3 Monitoring systems at CCPs and for OPRPs
plan shall be maintained as documented
information and shall include the following • 8.5.4.4 Actions when critical limits or action criteria
information for each control measure at each CCP are not met
or OPRP: • 8.5.4.5 Implementation of the hazard control plan
• a) food safety hazard(s) to be controlled at the CCP
or by the OPRP;
• b) critical limit(s) at CCP or action criteria for OPRP;
• c) monitoring procedure(s);
• d) correction(s) to be made if critical limits or
action criteria are not met;
• e) responsibilities and authorities;
• f) records of monitoring
• OPEN
• PEDOMAN HACCP PROGRAM
MANAJEMEN RISIKO, Industri
Formula Bayi, Formula Lanjutan
dan Formula Pertumbuhan,
Direktorat Inspeksi dan
Sertifikasi Pangan Deputi Bidang
Pengawasan Keamanan Pangan
dan Bahan Berbahaya BPOM
2015 Start page 25
• Sampel open: SNI 01-2712-2006
• 8.6 Updating the information specifying the PRPs and the • 8.8 Verification related to PRPs and the hazard control plan
hazard control plan
• 8.8.1 Verification
• 8.7 Control of monitoring and measuring The organization
shall provide evidence that the specified monitoring and • The organization shall establish, implement and maintain
measuring methods and equipment in use are adequate for verification activities. The verification planning shall define
the monitoring and measuring activities related to the PRP(s) purpose, methods, frequencies and responsibilities for the
and the hazard control plan verification activities.
• The results of calibration and verification shall be retained as • The verification activities shall confirm that:
documented information. The calibration of all the • a) the PRP(s) are implemented and effective;
equipment shall be traceable to international or national
measurement standards • b) the hazard control plan is implemented and effective;
• Software used in monitoring and measuring within the FSMS • c) hazard levels are within identified acceptable levels;
shall be validated by the organization, software supplier or
third party prior to use. Documented information on • d) input to the hazard analysis is updated;
validation activities shall be maintained by the organization
and the software shall be updated in a timely manner. • e) other actions determined by the organization are
implemented and effective
• Whenever there are changes, including software
configuration/modifications to commercial off-the shelf • Where verification is based on testing of end product
software, they shall be authorized, documented and samples or direct process samples and where such test
validated before implementation samples show nonconformity with the acceptable level of the
food safety hazard (see 8.5.2.2) , the organization shall
handle the affected lot(s) of product as potentially unsafe
(see 8.9.4.3) and apply corrective actions in accordance with
8.9.3
• 8.8.2 Analysis of results of verification activities • 8.9.2.2 When critical limits at CCPs are not met,
The food safety team shall conduct an analysis of affected products shall be identified and handled
the results of verification that shall be used as an as potentially unsafe products (see 8.9.4) .
input to the performance evaluation of the FSMS
• 8.9.2.3 Where action criteria for an OPRP are not
• 8.9 Control of product and process met, the following shall be carried out:
nonconformities
• a) determination of the consequences of that
• 8.9.1 General failure with respect to food safety;
• The organization shall ensure that data derived • b) determination of the cause(s) of failure;
from the monitoring of OPRPs and at CCPs are
evaluated by designated persons who are • c) identification of the affected products and
competent and have the authority to initiate handling in accordance with 8.9.4.
corrections and corrective actions. • 8.9.2.4 Documented information shall be retained
• 8.9.2 Corrections to describe corrections made on nonconforming
products and processes
• 8.9.2.1 The organization shall ensure that when
critical limits at CCP(s) and/or action criteria for
OPRPs are not met, the products affected are
identified and controlled with regard to their use
and release.
• 8.9.3 Corrective actions • 8.9.4.2 Evaluation for release
• The organization shall establish and maintain • Each lot of products affected by the nonconformity
documented information that specifies appropriate shall be evaluated.
actions to identify and eliminate the cause of
detected nonconformities, to prevent recurrence, • Products affected by failure to remain within
and to return the process to control after a critical limits at CCPs shall not be released, but
nonconformity is identified shall be handled in accordance with 8.9.4.3
• 8.9.4.1 General • 8.9.4.3 Disposition of nonconforming products
• The organization shall take action(s) to prevent • Products that are not acceptable for release shall
potentially unsafe products from entering the food be:
chain, unless it can demonstrate that: • a) reprocessed or further processed within or
• a) the food safety hazard(s) of concern is (are) outside the organization to ensure that the food
reduced to the defined acceptable levels; safety hazard is reduced to acceptable levels; or
• b) the food safety hazard(s) of concern will be • b) redirected for other use as long as food safety in
reduced to identified acceptable levels prior to the food chain is not affected; or
entering the food chain; or • c) destroyed and/or disposed as waste.
• c) the product still meets the defined acceptable
level(s) of the food safety hazard(s) of concern
despite the nonconformity
• 8.9.5 Withdrawal/recall • 9 Performance evaluation
• The organization shall be able to ensure the timely • 9.1 Monitoring, measurement, analysis and evaluation
withdrawal/recall of lots of end products that have been
identified as potentially unsafe, by appointing competent • 9.1.1 General
person(s) having the authority to initiate and carry out the • The organization shall determine:
withdrawal/recall.
• a) what needs to be monitored and measured;
• b) the methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results;
• c) when the monitoring and measuring shall be performed;
• d) when the results from monitoring and measurement shall
be analysed and evaluated;
• e) who shall analyse and evaluate the results from monitoring
and measurement.
• The organization shall retain appropriate documented
information as evidence of the results.
• The organization shall evaluate the performance and the
effectiveness of the FSMS.
• 9.1.2 Analysis and evaluation • 9.2 Internal audit
• The organization shall analyse and • 9.2.1 The organization shall
evaluate appropriate data and conduct internal audits at planned
information arising from intervals to provide information on
monitoring and measurement, whether the FSMS:
including the results of verification • a) conforms to:
activities related to PRPs and the
hazard control plan (see 8.8 and • 1) the organization’s own
8.5.4) , the internal audits (see 9.2) requirements for its FSMS;
and external audits • 2) the requirements of this
document;
• b) is effectively implemented and
maintained
9.3 Management review
• The management review input shall consider: • 9.3.3 Management review output
• a) the status of actions from previous management • The outputs of the management review shall
reviews; include:
• b) changes in external and internal issues that are • a) decisions and actions related to continual
relevant to the FSMS, including changes in the improvement opportunities;
organization and its context (see 4.1);
• b) any need for updates and changes to the FSMS,
• c) information on the performance and the including resource needs and revision of the food
effectiveness of the FSMS, including trends in: safety policy and objectives of the FSMS
• 1) result(s) of system updating activities (see 4.4
and 10.3);
• 2) monitoring and measurement results;
• 3) analysis of the results of verification activities
related to PRPs and the hazard control plan (see
8.8.2);
• 4) nonconformities and corrective actions;
• 5) audit results (internal and external); etc
• 10 Improvement • 10.2 Continual improvement
• 10.1 Nonconformity and corrective action • The organization shall continually improve the
suitability, adequacy and effectiveness of the
• 10.1.1 When a nonconformity occurs, the FSMS.
organization shall:
• Top management shall ensure that the
• a) react to the nonconformity and, as applicable: organization continually improves the effectiveness
• 1) take action to control and correct it; of the FSMS through the use of communication
(see 7.4) , management review (see 9.3) , internal
• 2) deal with the consequences; audit (see 9.2) , analysis of results of verification
activities (see 8.8.2) , validation of control
• b) evaluate the need for action to eliminate the measure(s) and combination(s) of control
cause(s) of the nonconformity, in order that it does measure(s) (see 8.5.3) , corrective actions (see
not recur or occur elsewhere, by: 8.9.3) and FSMS updating (see 10.3) .
• 1) reviewing the nonconformity;
• 2) determining the causes of the nonconformity;
• 3) determining if similar nonconformities exist, or
could potentially occur;
• 10.3 Update of the food safety management
system
• Top management shall ensure that the FSMS is
continually updated. To achieve this, the food
safety team shall evaluate the FSMS at planned
intervals. The team shall consider whether it is
necessary to review the hazard analysis (see 8.5.2)
, the established hazard control plan (see 8.5.4)
and the established PRPs (see 8.2) . The updating
activities shall be based on:
• a) input from communication, external as well as
internal (see 7.4);
• b) input from other information concerning the
suitability, adequacy and effectiveness of the
FSMS;
• c) output from the analysis of results of verification
activities (see 9.1.2);
• d) output from management review (see 9.3) .
documentation
4.3 Determining the 8.1 Operational planning 8.5.1.5.3 Description of 8.5.4.2 Determination of
scope of the food safety and control processes and process critical limits and action
management system 8.2 PRPs environment criteria
5.2.2 Food Safety Policy 8.3 Traceability 8.5.2.2 Hazard 8.5.4.3 Monitoring
6.2.2 FSMS Objectives 8.4 Emergency identification and systems at CCPs and for
7.1.2 People preparedness and determination of OPRPs
7.1.5 Externally response acceptable levels 8.5.4.5 Implementation
developed elements of 8.5.1.1 Preliminary steps 8.5.2.3 Hazard of the hazard control plan
the food safety to enable hazard analysis assessment 8.7 Control of monitoring
management system 8.5.1.2 Characteristics of 8.5.2.4.2 Selection and and measuring
7.1.6 Control of raw materials, categorisation of control 8.8 Verification related to
externally provided ingredients and product measures PRPs and the hazard
processes, products or contact materials 8.5.3 Validation of control control plan
services 8.5.1.3 Characteristics of measure(s) and 8.9.2 Corrections
7.2 Competence end products combinations of control 8.9.3 Corrective actions
7.4.2 External 8.5.1.4 Intended use measures 8.9.4.1 Handling of
communication 8.5.1.5.2 On-site 8.5.4.1 Hazard control potentially unsafe
confirmation of flow plan products
8.9.4.2 Evaluation for release
8.9.4.3 Disposition of nonconforming products
8.9.5 Withdrawal/ recall
9.1 Monitoring, measurement, analysis and
evaluation
9.2 Internal Audit
9.3 Management review
10.1 Nonconformity and corrective actions
10.3 Update of the FSMS
7 principles of HACCP

1. Conduct a Hazard Analysis


2. Identify Critical Control Points (CCP)
3. Establish Critical Limits for CCP
4. Establish Monitoring Procedures
5. Establish Corrective Actions
6. Establish Recordkeeping Procedures
7. Establish Verification Procedures
5 preliminary HACCP

1. Bring together the HACCP resources/assemble the


HACCP team.
2. Describe the product and its method of
distribution.
3. Develop a complete list of ingredients and raw
materials used in the product.
4. Develop a process flow diagram.
5. Confirmasi bagan alir
Kelompok Resiko
tinggi
REQUIREMENTS
• GENERAL • 2.5 FSSC 22000 ADDITIONA L
• Organizations shall develop, implement REQUIREMENTS
and maintain all the requirements • 2.5.1 MANAGEMENT OF SERVICES
outlined below and will be audited by a • 2.5.2 PRODUCT LABELLING
licensed Certification Body in order to
receive a valid certificate. • 2.5.3 FOOD DEFENSE 2.5.3.1 THREAT
• The audit requirements for FSSC 22000 ASSESSMENT
certification consist of: • The organization shall have a documented
• 1) ISO 22000:2018 food safety procedure in place to:
management system requirements; • a) Conduct a threat assessment to
• 2) sector specific prerequisite program identify and assess potential threats;
(PRPs) requirements (ISO/TS 22002-x • b) Develop and implement mitigation
series or other specified PRP standard) measures for significant threats.
and;
• 3) FSSC 22000 Additional requirements
• 2.5.4 FOOD FRAUD MITIGATION 2.5.4.1 VULNERABILITY • 2.5.7 ENVIRONMENTAL MONITORING (FOOD CHAIN
ASSESSMENT CATEGORIES C, I & K)
• The organization shall have a documented procedure in place • The organization shall have in place:
to:
• a) Risk-based environmental monitoring program;
• a) Conduct a food fraud vulnerability assessment to identify
and assess potential vulnerabilities; • b) Documented procedure for the evaluation of the
effectiveness of all controls on preventing contamination
• b) Develop and implement mitigation measures for from the manufacturing environment and this shall include,
significant vulnerabilities at a minimum, the evaluation of microbiological and allergen
controls present;
• 2.5.5 LOGO USE
• c) Data of the monitoring activities including regular trend
• 2.5.6 MANAGEMENT OF ALLERGENS (FOOD CHAIN analysis
CATEGORIES C, E, FI, G, I & K)
• 2.5.8 FORMULATION OF PRODUCTS (FOOD CHAIN CATEGORY
• The organization shall have a documented allergen D)
management plan that includes:
• The organization shall have in place procedures to manage
• a) Risk assessment covering all potential sources of allergen the use of ingredients that contain nutrients that can have
cross-contamination and; adverse animal health impact.
• b) Control measures to reduce or eliminate the risk of cross- • 2.5.9 TRANSPORT AND DELIVERY (FOOD CHAIN CATEGORY FI)
contamination.
• The organization shall ensure that product is transported and
delivered under conditions which minimize the potential for
contamination.
Food defense
• The GFSI definition of Food Defense is: “The
process to ensure the security of food and drink
from all forms of intentional malicious attack
including ideologically motivated attack leading to
contamination.” (GFSI 2017)1.
• Other frequently used definitions are:
• PAS 96:2017: Food defense: procedures adopted to
assure the security of food and drink and their
supply chains from malicious and ideologically
motivated attack leading to contamination or
supply disruption (PAS 96:2017)2.
• FDA (FSMA-Intentional Adulteration Rule): Food
defense is the effort to protect food from
intentional adulteration from acts intended to
cause wide-scale harm to public health, including
acts of terrorism targeting the food supply (FDA
Food Defense fact sheet)
• Food Fraud is the collective term
encompassing the intentional
substitution, addition, tampering
or misrepresentation of
food/feed, food/feed ingredients
or food/feed packaging,
labelling, product information or
false or misleading statements
made about a product for
economic gain that could impact
consumer health (GFSI
BRv7:2017).
• 2.5.3 FOOD DEFENSE • 2.5.4 FOOD FRAUD MITIGATION
• 2.5.3.1 Threat assessment • 2.5.4.1 Vulnerability assessment
• The organization shall have a documented procedure in place • The organization shall have a documented procedure in place
to: to:
• a) Conduct a threat assessment to identify and assess • a) Conduct a food fraud vulnerability assessment to identify
potential threats; and assess potential vulnerabilities;
• b) Develop and implement mitigation measures for • b) Develop and implement mitigation measures for
significant threats. significant vulnerabilities.
• 2.5.3.2 Plan • 2.5.4.2 Plan
• a) The organization shall have a documented food defense • a) The organization shall have a documented food fraud
plan specifying the mitigation measures covering the mitigation plan specifying the mitigation measures covering
processes and products within the FSMS scope of the the processes and products within the FSMS scope of the
organization. organization.
• b) The food defense plan shall be supported by the • b) The food fraud mitigation plan shall be supported by the
organization’s FSMS. organization’s FSMS.
• c) The plan shall comply with applicable legislation and be • c) The plan shall comply with the applicable legislation and
reviewed regularly. be reviewed regularly
PAS 96 2017
PAS 96
2017
Some controls
Food chain category taken
from ISO 22003:2013
Remember…
Safety First!
Thank you