FSSC Terbaru Feb 2018
FSSC Terbaru Feb 2018
FSSC Terbaru Feb 2018
UNDERSTANDING REQUIREMENTS
& IMPLEMENTATION
Training Rundown – Day 1
Time Topics
08.30 – 09.30 Introduction to FSSC 22000 : 2010
09.30 – 10.00 Requirement FSSC 22000 : 2010
10.00 – 10.15 Coffee break 1
10.30 – 12.00 ISO 22000 : 2005 clause 4, 5 , & 6
12.00 – 13.00 Lunch break
13.00 – 15.00 ISO 22000 : 2005 clause 7.1 – 7.2
15.00 – 15.15 Coffee break 2
15.15 – 16.30 ISO 22000 : 2005 clause 7.3‐7.8
OCT 2017
Training Rundown – Day 2
Time Topics
08.30 – 10.00 ISO 22000 : 2005 clause 7.9 ‐8
10.00 – 10.15 Coffee break 1
10.30 – 12.00 Additional Requirement in FSSC 22000
12.00 – 13.00 Lunch break
13.00 ‐ 15.00 GROUP WORKSHOP
15.00 ‐16.00 GROUP PRESENTATION
16.00 (End of Training) Coffee break 2
OCT 2017
Food Safety Management System
• Food Safety is concept that food will not cause harm to the
consumer when it is prepared and/or eaten according to
intended use
• Related to the occurrence of biological, chemical (include
allergens), and physical agent that potentially caused an
adverse health effect
Benefit of
Food Safety Implementation
Benefit to Consumer : Benefit to government :
1. Reduce risk of foodborne disease 1. Improved public health
2. Increased awareness of basic hygiene 2. More efficient & targeted food control
3. Increase confidence in the food supply 3. Reduced public health cost
4. Improved quality of life 4. Trade facilitation
Benefit to Industry :
1. Increase consumer& government confidence
2. Reduce legal and insurance cost
3. Increase market access
4. Reduces production cost
5. Improved product consistency
6. Improvement of management commitment to food safety
7. Decrease business risk
Some of the major causes of incidents
related with Food Safety
Raw material and supplier management
Failure in design of equipment
Failure in maintenance
Failure in hazard identification
GMP violation
CCP monitoring failure
Failure in corrective actions
Human negligence or error
Business impact
Welcome
OCT 2017
Development of FSSC 22000 : 2009
OCT 2017
Requirements in FSSC 22000:2009
ISO 22000 is a standard developed by the International Organization for
Standardization dealing with food safety. It is a general derivative of ISO 9001
5. Management
5. Management
NA Responsibility
Responsibility
OCT 2017
RUANG LINGKUP SISTEM KEMANAN PANGAN
Sumber pangan
Pengolahan pangan (industri,
manufaktur)
Transportasi produk pangan olahan
Pendistribusian produk pangan olahan
(eksportir, importir, distributor, dll)
Penjual produk pangan olahan
Pengguna produk pangan olahan
ISO 22000 : 2005 – Elemen dasar
Produsen
Komunikasi Interaktif
Konsumen
Adanya Prosedur implementasi yang
terstruktur baik internal maupun
eksternal untuk memastikan tersedianya Lembaga Perundangan (Dinas
semua Informasi terkait keamanan Perindustrian, Dinas Kesehatan,
BPOM, MUI)
pangan.
ISO 22000 : 2005
OCT 2017
4.1. General Requirements
Food Safety Management System
18
4.1. General Requirements
Food Safety Management System
Evaluate
Periodically &
Communicate to Update
organization
Communicate to • Development
food chain • Implementation
Food Safety • Updating
Hazard
• Identified
• Evaluated
• Controlled
19
4.2. Documentation Requirements
4.2. Documentation Requirements
4.2.1. Food Safety Manual
Policy
Procedures & Records
as ISO requirements
Document needed by
the organization
20
4.2. Documentation Requirements
4.2.3. Control of Documents
Control of
Storage &
Identify Approval document & Transition Disposition
Distribution
records
21
5. Management Responsibility
In order to provide evidence to show to commitment, Top Management must:
• Business Objectives
• Communicate
Have • Food Safety Policy
Commitment • Management Review
• Availability of Resource
• Appropriate to the role
• Conforms to statutory
Food Safety
& Regulatory
• Communicated,
Policy implemented,
maintained
• Reviewed
• Measurable objectives
22
5. Management Responsibility
In order to provide evidence to show to commitment, Top Management must:
• Food Safety Target (KPI – Key Performance
Indicator)
FSMS Planning
• Change Management related to food safety
system
Responsibility
& Authority
• Job Description
• Manage FSMS
FS Team • Training & Education
Leader
• Report
23
5. Management Responsibility
Communication
External Internal
Suppliers & Contractors
Changes (products/new products,
RM/service, production system &
Customers/Consumers equipment, production premises,
cleaning & sanitation, packaging,
personnel, legal requirements,
Statutory & Regulatory authorities knowledge, complaint, etc
Other organizations
24
5. Management Responsibility
5.6. Management Review
Review Input Minimum 7 review input in Management Review
FUP Analysis of
Previou verification
s MR
Customer
feedback CHANGES
Emergency
situation / System
Withdrawal updating
s
Commu
Audits
nication
25
5. Management Responsibility
Review Output
The top management must make a decision after all the Review Input had
been discussed, the decisions and actions related to:
• Assurance of food safety
• Improvement of the effectiveness
• Resource needed
• Is our manpower enough for next one year? Any addition head
count?
• Any training needed for our manpower?
• Any addition machine or infrastructure require to meeting
customer requirements?
• Revisions of FSMS Policy & related objectives
26
6. Resources Management
6.1. Provision of Resources
Adequate resources for establish, implement, maintain, and update the
FSMS
6.2. Human Resource
6.2.1 General : Selection of employee (appropriate education, training,
skills, and experience)
6.2.2. Competence, Training, Awareness
• TRAINING NEEDS ANALYSIS TRAINING MTRIX VS PERFORMANCE
EVALUATION
• TRAINING ACTIVITIES PLANNING IMPLEMENTATION
EVALUATION ACTION PLANS
27
6. Resources Management
6.3. Infrastructure
Organization must identify, provide and maintain the facilities needed to
ensure to achieve conformity of product, including:
• Building, workspace and associated facilities ISO/TS 22002‐1
• Equipment needed related to process or product requirement, either
hardware or software
• Supporting activities such as communication method, transport and
etc.
All pertinent infrastructures must be identified, available and maintained.
This requires a maintenance plan or preventive maintenance plan and
records to ensure the maintenance job was done effectiveness.
6.4. Work Environment
28
7. Planning & Realization of
Safe Products
OCT 2017
7.1 • General
7.2 • Pre Requisites Program (PRP)
OCT 2017
HACCP – IMPLEMENTATION CONCEPT
HACCP Study HACCP
Quality Corrective
Audit Action
OCT 2017
GOOD MANUFACTURING PRACTICES
Building
Zoning
design
Air
Cleaning conditioning
Hygiene rules – Examples
Hand hygiene
Reporting of illness
Personal Hygiene
Eating and drinking
Personal gear
Equipment and building design
• Physical separation
• Minimize foreign materials entry
Location of Equipment
• Designated location
• Permit access for operation, cleaning, and maintenance
GOOD MANUFACTURING PRACTICES
• Layout of premises and workspace
• The movement patterns of materials, products and people, and the layout of equipment, shall
be designed to protect against potential contamination sources
• Reference
• ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing
No Zoning Zoning
GOOD MANUFACTURING PRACTICES
• Layout of premises and workspace
• Reference
• ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing
Laboratory facilities
1. Water quality shall be comply to regulation and specification
2. Control chlorine residue if applicable
3. Separation system from non potable water
4. Disinfected pipes for contact product water
GOOD MANUFACTURING PRACTICES
• Reference
• ISO/TS 22002‐1 – Prerequisite programs on food safety —Part 1: Food
manufacturing
Utilities – Boiler Chemicals
1. Approved additives
2. Separation and access controlled storage
Utilities ‐ Air quality and ventilation
1. Air specification and control
2. Ventilation system shall be provided, maintained, and specified pressure
3. Positive air flow
4. Minimize contamination from air
Utilities ‐ Compressed air and other gases
1. Constructed and maintained so as to prevent contamination
2. Food contact gases shall be Approved for food contact use, filtered to remove
dust, oil and water
3. Oil free compressors
GOOD MANUFACTURING PRACTICES
• Reference
• ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing
• Utilities – Lighting
1. Appropriate intensity of lighting for operation and inspection
2. Lighting fixture shall be protected to prevent contamination
• Waste disposal
1. Waste materials are identified, collected, removed and disposed of in
a manner which prevents contamination of products or production areas.
2. Containers for waste and inedible or hazardous substances shall be:
a) clearly identified for their intended purpose;
b) located in a designated area;
c) constructed of impervious material which can be readily cleaned and sanitized;
d) closed when not in immediate use;
e) locked where the waste may pose a risk to the product
3. Provision shall be made for the segregation, storage and removal of waste.
GOOD MANUFACTURING PRACTICES
• Reference
• ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing
• Drains and drainage
1. Designed, constructed and located so that the risk of contamination of materials
or products is avoided
2. Shall have capacity sufficient to remove expected flow loads
3. Drainage direction shall not flow from a contaminated area to a clean area.
• Equipment suitability, cleaning and maintenance
1. Food contact equipment shall be designed and constructed to facilitate
cleaning, disinfection and maintenance. Contact surfaces shall not affect, or be
affected by, the intended product or cleaning.
2. Equipment shall be able to meet established principles of hygienic design
3. Piping and ductwork shall be cleanable, drainable, and with no dead ends
4. Equipment shall be designed to minimize contact between the operator’s hands
and the products.
5. Materials designed for food use. They shall be impermeable and rust or
corrosion free.
GOOD MANUFACTURING PRACTICES
• Reference
• ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing
• Equipment suitability, cleaning and maintenance
1. Equipment used for thermal processes shall be able to meet the temperature gradient
and holding conditions given in relevant product specifications.
2. Wet and dry cleaning programs shall be documented to ensure that all plant, utensils
and equipment are cleaned at defined frequencies.
3. The programs shall specify what is to be cleaned (including drains), the responsibility,
the method of cleaning (e.g. CIP, COP), the use of dedicated cleaning tools, removal or
disassembly requirements and methods for verifying the effectiveness of the cleaning.
4. A preventive maintenance program shall be in place
5. Lubricants and heat transfer fluids shall be food grade where there is a risk of direct or
indirect contact with the product.
6. The procedure for releasing maintained equipment back to production shall include
clean up, sanitizing, where specified in process sanitation procedures, and pre‐use
inspection.
7. Local area PRP requirements shall apply to maintenance areas and maintenance
activities in process areas.
8. Maintenance personnel shall be trained in the product hazards associated with their
activities.
7. PRP – PRE REQUISITES PROGRAM
No Subject Record Verification Programs
‐ Plant lay out
Construction, lay out ‐ Machine drawings
1. buildings and associated ‐ Drainage & Sewage
utilities diagram Internal audit every 6
‐ Water piping diagram months
Lay out premises,
2. workspace, employee ‐ Process area layout
facilities
‐ Water treatment plan
‐ Compressed air flow ‐ Quality Plan for water,
Supplies of air, water,
3. ‐ Energy Direct contact? air, and gas
energy, and other utilities
‐ Filter spec for water, air, ‐ Finished goods analysis
and gas
‐ Waste management ‐ Internal audit ISO
Supporting services
4. ‐ Waste water treatment 14001
including waste and sewage
plan ‐ Waste water check
Suitability of equipment for Preventive & corrective Internal audit every 6
5
cleaning and maintenance maintenance report months
7. PRP – PRE REQUISITES PROGRAM
No Subject Record Verification Programs
Management of
‐ Supplier selection and ‐ Supplier Audit
purchased material,
6. evaluation ‐ Internal audit every 6
supplies, and handling of
‐ Supplier categorization monthds
products
Measures for the ‐ GMP Inspection
‐ GMP Inspection
7. prevention of cross report
‐ Hygienic Environment
contamination ‐ Lab analysis result
‐ Cleaning monitoring
8. Cleaning & Sanitizing ‐ CIP or COP result
‐ FG analysis result
‐ IPM plan
9. Pest Management IPM monthly report
‐ Contract (if use 3rd party)
Preliminary steps to enable hazard analysis (7.3)
7.3.1 : General : All relevant information yg diperlukan utk conduct hazard analysis
harus dikumpulkan, maintained, updated dan documented
records harus dipelihara (Cth. Filter spec)
7.3.2 : Food safety team (bukan HACCP Team lagi)
Multi‐disciplinary knowledge dan pengalaman – harus terrecord
7.3.3 : Product Characteristic
7.3.3.1 : Raw materials, ingredients and product contact material – Food safety team
incoming materials
a. Biological, chemical and physical characteristics
b. Composition of formulated ingredients, including additives and processing aids
c. Origin
d. Method of production
e. Packaging n delivery methods
f. Storage condition and shelf life
g. Preparation and/or handling before use or processing
h. Food safety related acceptance criteria or spec of purchased materials and
ingredients appropriate to their intended uses,
Preliminary steps to enable hazard analysis (7.3)
7.3.3.2 : Characteristic of end product –refer to product description
7.3.4 : Intended use 7.3.5 :
flow diagrams, process steps and control measures
7.3.5.1 : Flow diagrams
+ subcontracted work, reworking and recycling, waste
7.3.5.2 : Description of process step and control measures
Hazard analysis (7.4)
• 7.4.1 : food safety team shall conduct a hazard analysis,
which hazards to be controlled, which combination
of control measures
• 7.4.2 : Hazard identification and determination of acceptable levels.
7.4.2.1 : all food safety hazards shall be identified, based on :
a. preliminary information dan data collection (7.3)
b. pengalaman
c. external information, extent possibility, epidemiology dan historical data
d. Informasi dari food chains pada end prod, intermediate prod, food at
consumption
How Strict your Food Safety Standard?
HAZARDS SEVERITY
Physical Hazard Severity – FDA
guidance
Kriteria Low :
Tidak berpengaruh nyata terhadap kesehatan (tidak menimbulkan luka),
tidak keras & tidak tajam, ukuran 7 mm – 25 mm (sesuai ketentuan FDA).
Kriteria Medium :
menimbulkan sakit ringan (tidak memerlukan pertolongan medis), cemaran
fisik bersifat keras tetapi tidak tajam dengan ukuran 7 mm – 25 mm (sesuai
ketentuan FDA); misalnya potongan baut, mur, ring.
Kriteria High :
menimbulkan sakit berat (memerlukan pertolongan medis), cemaran fisik
bersifat keras dan tajam dengan ukuran 7 mm – 25 mm (sesuai ketentuan
FDA); misalnya patahan paku rivet, potongan kawat, pecahan kaca.
Chemical Hazard Severity – FDA guidance
Tingkat
Kriteria Jenis Bahan Kimia/ Standar Reference
Keparahan
‐Sengaja ditambahakan dalam makanan ‐ Depkes
: kelompok food additive/minerals, ‐ ‐ Mineral : Zn, Fe ‐ Feron dalam De Vries (1997)
supplements ‐ Chlorine ‐PDR for Nutritional
‐Tidak ada resiko toksikologis yang ‐ Residu Solvent Supplements Medical
Low serius pada level yang diijinkan ‐ BrownColour: 300ppm Economics. Thomson
‐Pengunaan kurang dari 50% dari Zn : 5 ppm Healthcare.2000
standar Chlorine : 5 ppm ‐Singapore Std, SS 459:1999
‐Bahan pembantu proses yang tidak R. Solvent : 15 mg/m2 Guidelines for Residual Solvent
bersifat toxic pada level yang diizinkan in Food Pack. Mtrl
Merupakan kontaminan pangan ‐ Pestisida (karbamat, ‐ Janssen dalam De Vries (1997)
Tidak bersifat karsinogenik, teratogen, organofosfor)
Medium mutagen, dan atau neurotoksik ‐ Logam berat (Cu, Zn, Sn)
Tidak terakumulasi dan dikeluarkan yang bukan sengaja
dalam urine ditambahkan
Merupakan kontaminan pangan ‐ Hg, As, Cd, Pb ‐ Lund, Parker, and Gould
Terakumulasi dalam tubuh ‐ Aflatoksin (2000)
Resiko toksikologis berdampak panjang : ‐ Organoklorin ‐ Janssen dalam De Vries (1997)
High karsinogenitas, teratogenitas atau ‐ Hg : 1 ppb
nurotoksisitas As, Cd : 5 ppb
Pb
Aflatoksin : 20 ppb
Microbiological Hazard Severity – FDA guidance
Likely/Frequency to occur
Kriteria Low : bila bahaya tidak pernah ditemukan
Kriteria Medium : bila bahaya ditemukan 1 x/tahun
Kriteria High : bila bahaya ditemukan > 1 x/tahun
Severity
Low Medium High
Likely High S S S
Medium NS NS S
Low NS NS S
Hazard analysis (7.4)
• 7.4.2.2 : Identify hazard, harus memperhatikan :
‐ steps bersangkutan dan sesudah specified operation
‐ process equipment, utilities dan sekeliling
‐ sebelum dan sesudah food chain
• 7.4.3 : Hazard assessment
evaluasi berdasarkan : possible severity dan likelihood of their occurrence.
Methodology harus dideskripsikan dan hasilnya harus direcord ‐ hazard
analysis matrix di Q–manual.
Hazard analysis (7.4)
• 7.4.4 : Selection and assessment of control measures links to 7.3.5.2
(existing control measures)
Based on hazard assessment of 7.4.3, control measures are selected to prevent,
eliminate or reduce food safety hazards to defined acceptable levels.
Each of control measures shall be reviewed w/ respect to its effectiveness
The selection and categorization shall be carried out using
a. Its effect on identified food safety hazards relative to the strictness applied
b. Its feasibility for monitoring (ability to be monitored in a timely manner to enable
immediate corrective action)
c. Its place within the system relative to other control measures
d. The likelihood of failure in the functioning of a control measures of significant
processing variability
e. The severity of the consequences in the case of failure in its functioning
f. Whether the control measure is specifically established and applied to eliminate or
significantly reduce the level of hazards
g. Synergistic effect
Hazard analysis (7.4)
• Control measures categorized as belonging to the HACCP Plan shall be
implemented in accordance with 7.6.
• Other control measures shall be implemented as OPRPs according to 7.5
• The methodology and parameters used for this categorization shall be
described in documents, and the results of the assessment shall be
recorded.
ACTION :
categorization in column : PRP – OPRP ‐ CCP
Hazard analysis (7.4)
CCP MONITORING
Monitoring Procedure
Correction & Verification
Proces CCP Critical
HAZARD Corr.Action (What & Record
Step No Limit What Where How Who When (What&Who) Who)
OPRP MONITORING
Monitoring Procedure
Process OPRP Control Corr. Action Verification
No HAZARD Correction Record
Description No. Measures (What&Who) Program
(What) (Where) (How) (Who) (When)
Establishing the OPRPs (7.5)
• OPRP shall be documented and shall include the
following information :
a. Hazards to be controlled by the program
b. Control measures
c. Monitoring procedure that demonstrated that the
OPRPs are implemented
d. Corrections and corrective actions
e. Responsibility and authorities
f. Records monitoring
Establishing the HACCP Plan (7.6)
7.6.1 : Shall include :
Parameter in OPRP + Critical Limits
7.6.2 : Identification of CCPs
‐ no method stated (no a must for decision tree)
‐ use decision tree
7.6.3 : Determination of critical limits for CCPs
‐ CCP harus : ditetapkan, end product dijamin tidak melebihi CL, terukur
‐ Sebab pemilihan critical limits harus didokumentasikan
‐ Criticial Limits based on subjective data (e.g visual inspection, process,
handling) harus disupport dengan instructions atau specifications and/or
education and training
Updating of preliminary information & docs
specifying the PRPs and the HACCP Plan (7.7)
Pada saat mengerjakan OPRP dan HACCP Plan, organisasi harus
update, jika diperlukan :
‐product characteristic
‐Intended use
‐Flow diagrams
‐Process steps
‐Control measures
Note:
- Recording min 3 months before audit
Verification Planning (7.8)
Verification harus bisa membuktikan :
‐ PRPs diimplementasikan
‐ Input to hazard analysis
‐ OPRP dan HACCP Plan diimplementasikan dan efektif
‐ Hazard level masih di range acceptable
‐ Procedures yg diimplementasikan dan efektif
Actions harus meliputi :
‐ reviewing NC (termasuk market complaints)
‐ Review trends yg bisa berindikasi ke loss control
‐ Deteksi sebab NCs
‐ Evaluasi action yg dibutuhkan utk menjamin NC tidak terjadi lagi
‐ Implementasi actions
‐ Review Corrective actions utk menjaga tetap efektif
‐ Record dari hasil CAR yg sudah disepakati
Control of Nonconformity (7.10)
7.10.3.1 : General
7.10.3.2 : Evaluation for release
• bukti lain selain monitoring system bahwa control measures
efektif
• Bukti bahwa combined effects dari control measures, product
bersangkutan sesuai dengan spec yg dinginkan
• Bukti analisa samples dan atau aktifitas verification lainnya
menunjukkan lot bersangkutan sesuai dengan level yg bisa
diterima
Control of Nonconformity (7.10)
• 7.10.3.3 : Jika tidak bisa direlease :
reprocess atau destruction
Matriks Reprocess/Rework
Allergen management for Reprocess/Rework
• 7.10.4 : Withdrawals = market recalls
8. Validation, verification and improvement of the food
safety system
8.1 : General
Food safety team harus merencanakan, dan implementasikan
process yg dibutuhkan utk validasi control measures dan/atau
control measure combinations, dan verifikasi serta improve
food safety management system
8.4.3 : Analysis of results of verification activities
8.5 : Improvement
8.5.1 : Continual improvement
Shall be based on :
a. Input from communication, external and internal
b. Input from other information concerning the
suitability, adequacy and effectiveness of the FSMS
c. Output from the analysis of results of verification
activities
d. Output from management review
How to Prevent Food Contamination?
7 HACCP PRINCIPLES
1 Conduct hazard analysis
2 Determine critical control point (CCP)
3 Establish critical limit
4 Establish monitoring system
5 Establish corrective action
6 Establish verification procedure
7 Establish documentation
Food Hazard/Contaminant
• Conditions or contaminants that can cause illness or injury
• Hair
Physical • Metal pieces
Hazards • Paper/plastic from packaging
• Jewelry, etc
• Bacteria
• Viruses
Biological
• Yeast
Hazard
• Molds
• Pest, etc
Faktor penyebab foodborne illness & gangguan kesehatan
Kontaminasi ‐ Peralatan tidak bersih
‐ Raw material
‐ Insects / rodents
‐ Aerosols / kondensasi
‐ Operator yang terinfeksi
Survival ‐ cooking / reheating tdk cukup
Growth/umbuh ‐ cooling / hot holding tdk sesuai
chronic infections
damage of various organs
Kematian (death)
cancer
79
Bacterial growth curve
Toxic
- - - - - - - - - - - -+++++++++++
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Spoils
+ + +
9
Time to spoilage
8
7
6
5
4
3
2
1
0
Time
Lag phase Log phase Stationary phase
80
Bacterial Growth & Prevention
Bakteri perlu 4 hal untuk dapat berkembang biak yakni: makanan, suhu, air dan waktu.
Memutus salah satu dari empat unsur tersebut, maka dapat mengurangi/menghentikan
pertumbuhan bakteri
Suhu Suhu dingin memperlambat bakteri berkembang biak dan suhu > 70C waktu tertentu dapat membunuh
hampir semua bakteri. Hati-hatilah pada kisaran suhu bahaya: 5 - 63 C !!! Atau biasa disebut DANGER ZONE.
Karena kisaran tersebut bakteri mengalami puncak perkembangbiakan paling optimum.
Keberadaan yang tidak bisa diterima:
Biological Raw materials
Semi‐finished
Chemical contaminant in product
Finished
Physical
product
Aflatoxins (B1, G1, B2, G2 and M1) are the best known
mycotoxins, produced mainly in corn and peanuts by
Aspergillus flavus and A. parasiticus. IARC has classified
aflatoxin B1 as a known human carcinogen
82
Hazard Analysis
Indentifikasi ketidakterimaan
Line environment
Growth or
production line
Salmonella
of
microorganisms
in
Semi‐finished
Survival or finished
product
Staphylococcus
83
Hazard Analysis
Identifikasi ketidakterimaan
(re)contamination dari
Semi‐finished Biological
products agent
oleh Chemical
agent
Finished Physical
products agent
1 Conduct hazard analysis
HAZARDS SEVERITY
Physical Hazard Severity – FDA
guidance
Kriteria Low :
Tidak berpengaruh nyata terhadap kesehatan (tidak menimbulkan luka),
tidak keras & tidak tajam, ukuran 7 mm – 25 mm (sesuai ketentuan FDA).
Kriteria Medium :
menimbulkan sakit ringan (tidak memerlukan pertolongan medis), cemaran
fisik bersifat keras tetapi tidak tajam dengan ukuran 7 mm – 25 mm (sesuai
ketentuan FDA); misalnya potongan baut, mur, ring.
Kriteria High :
menimbulkan sakit berat (memerlukan pertolongan medis), cemaran fisik
bersifat keras dan tajam dengan ukuran 7 mm – 25 mm (sesuai ketentuan
FDA); misalnya patahan paku rivet, potongan kawat, pecahan kaca.
Chemical Hazard Severity – FDA guidance
Tingkat
Kriteria Jenis Bahan Kimia/ Standar Reference
Keparahan
‐Sengaja ditambahakan dalam makanan ‐ Depkes
: kelompok food additive/minerals, ‐ ‐ Mineral : Zn, Fe ‐ Feron dalam De Vries (1997)
supplements ‐ Chlorine ‐PDR for Nutritional
‐Tidak ada resiko toksikologis yang ‐ Residu Solvent Supplements Medical
Low serius pada level yang diijinkan ‐ BrownColour: 300ppm Economics. Thomson
‐Pengunaan kurang dari 50% dari Zn : 5 ppm Healthcare.2000
standar Chlorine : 5 ppm ‐Singapore Std, SS 459:1999
‐Bahan pembantu proses yang tidak R. Solvent : 15 mg/m2 Guidelines for Residual Solvent
bersifat toxic pada level yang diizinkan in Food Pack. Mtrl
Merupakan kontaminan pangan ‐ Pestisida (karbamat, ‐ Janssen dalam De Vries (1997)
Tidak bersifat karsinogenik, teratogen, organofosfor)
Medium mutagen, dan atau neurotoksik ‐ Logam berat (Cu, Zn, Sn)
Tidak terakumulasi dan dikeluarkan yang bukan sengaja
dalam urine ditambahkan
Merupakan kontaminan pangan ‐ Hg, As, Cd, Pb ‐ Lund, Parker, and Gould
Terakumulasi dalam tubuh ‐ Aflatoksin (2000)
Resiko toksikologis berdampak panjang : ‐ Organoklorin ‐ Janssen dalam De Vries (1997)
High karsinogenitas, teratogenitas atau ‐ Hg : 1 ppb
nurotoksisitas As, Cd : 5 ppb
Pb
Aflatoksin : 20 ppb
Microbiological Hazard Severity – FDA guidance
Likely/Frequency to occur
Kriteria Low : bila bahaya tidak pernah ditemukan
Kriteria Medium : bila bahaya ditemukan 1 x/tahun
Kriteria High : bila bahaya ditemukan > 1 x/tahun
Severity
Low Medium High
Likely High S S S
Medium NS NS S
Low NS NS S
Hazard analysis (7.4)
7 HACCP PRINCIPLES
2 Determine critical control point (CCP)
Identifying the Critical Control Point (CCP) at the steps or at which control
is essential to prevent or eliminate a hazard or to reduce it to acceptable
levels.
3 Establish critical limit
NO
Q2 NO Q2a
Are control measures in place for the Is control necessary? (If no stop,
hazard? it is not a CCP, if yes, modify the
step, process or product to obtain
YES control)
CCP
Q3
Is the process step specifically YES
designed to eliminate or reduce the
STOP
hazard to an acceptable level?
NOT a CCP
NO
YES
Q4 NO
Could contamination with the hazard Q5
occur at unacceptable levels or Will subsequent process step eliminate the NO
increase to unacceptable levels (if identified hazard (s) or reduce the hazard to
YES an acceptable level?
the control failed)
HACCP Decision Tree – Codex
YES
Q2 NO STOP
Is the step specifically designed to NOT a CCP
eliminate/reduce the likely occurrence of a
YES
hazard to an acceptable level?
CCP
NO
Q3 NO
Could contamination with identified hazard(s) occur
in excess of acceptable level(s) or could increase to
unacceptable levels?
YES
Q4 YES
Will a subsequent step eliminate identified hazard)s) or NO
reduce likely occurrence to an acceptable level?
Hazard Analysis Hints
PRP
N
Ex. Cleanliness of equipment
Specific PRP decision tree :
Y N
Ex. Ice water temperature
Specific PRP decision tree :
Y Y
Ex. pasteurization
Raw Material Decision Tree
To assess whether a raw material is a critical control point another decision
tree can be used. Once again remember that decision trees should be used
with flexibility.
Raw Material Decision Tree
An example of a Raw Material Decision Tree
REFERENCE:
1 CODEX Alimentarius Commission, Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application,
4 Establish monitoring system
A planned series of observations or measurements need to be taken to assess
whether a CCP is within critical limits.
This also helps to produce an accurate record for future use in verification.
5 Establish corrective action
Corrective actions, are procedures to be followed when a hazard is identified
in the food production.
The aim is to correct and eliminate the cause of the hazard and bring CCP back
under control.
The cause of problem must be identified to prevent future recurrence.
Establishing corrective actions when monitoring procedures at CCP is not under
control.
7 HACCP PRINCIPLES
5 Establish corrective action
Some examples of corrective actions can include:
• isolating and holding product for safety evaluation;
• diverting the affected product or ingredients to another line where deviation would
not be considered critical;
• reprocessing;
• destroying the product.
6 Establish verification procedure
Verification procedures are those activities, other than monitoring CCPs, that verify
the HACCP plan and show the system is operating according to the plan.
7 Establish documentation
Documentation and record keeping help to demonstrate the effective
implementation of the previous principles of HACCP.
7 HACCP PRINCIPLES
7 Establish documentation
Four different types of HACCP records include:
1. HACCP plan and support documentation used in developing the
plan.
2. Records of CCP monitoring.
3. Records of corrective actions.
4. Records of verification activities
7.6.4 : System for monitoring of CCPs
Monitoring Procedure
Correction & Verification
Proces CCP Critical
HAZARD Corr.Action (What & Record
Step No Limit What Where How Who When (What&Who) Who)
OPRP MONITORING
Monitoring Procedure
Process OPRP Control Corr. Action Verification
No HAZARD Correction Record
Description No. Measures (What&Who) Program
(What) (Where) (How) (Who) (When)