FSSC 22000 : 2010 FOOD SAFETY MANAGEMENT SYSTEM FOR FOOD PRODUCERS
UNDERSTANDING REQUIREMENTS & IMPLEMENTATION
Trai Tr aini ning ng Ru Rund ndow own n – Da Day y1 Time
Topics
08.30 – 09.30
Introduction to FSSC 22000 : 2010
09.30 – 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 – 12.00 – 13.00
Lunch break
13.00 – 13.00 – 15.00
ISO 22000 : 2005 clause 7.1 – 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
Trai Tr aini ning ng Ru Rund ndow own n – Da Day y1 Time
Topics
08.30 – 09.30
Introduction to FSSC 22000 : 2010
09.30 – 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 – 12.00 – 13.00
Lunch break
13.00 – 13.00 – 15.00
ISO 22000 : 2005 clause 7.1 – 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
Trai Tr aini ning ng Ru Rund ndow own n – Da Day y2 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 – 12.00 – 13.00
Lunch break
13.00 ‐ 15.00
GROUP WORKSHOP
15.00 ‐16.00
GROUP PRESENTATION
16.00 (End of T of Traini aining ng))
Coff Coffee ee 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 : 1. Reduce risk of foodborne disease 2. Increased awareness of basic hygiene 3. Increase confidence in the food supply 4. Improved quality of life
Benefit to government : 1. Improved public health 2. More efficient & targeted food control 3. Reduced public health cost 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 Content of ISO 22000
1
Scope
2
Normative Reference
3
Definition
4
Food Safety Management System
5
Management Responsibility
6
Resource Management
7
Planning and Realization of Safe Products
8
Validation, Verification and Improvement of FSMS
• Clause no. 4‐8 are auditable • Consist of 29 sub clauses • For clause 7.2.3 refer to ISO TS 22002‐1: 2009
Requirements in ISO TS 22002-1:2009 Specifies
requirements for establishing, implementing and maintaining Prerequisite Programmes (PRP) to assist in controlling food safety hazards.
Complete
requirement of FSSC 22000:2009, Clause 7.2.3 Key Elements
1. Scope
10. Measures for the Prevention of Cross Contamination
2. Normative Reference
11. Cleaning and Sanitizing
3. Terms and definition
12. Pest Control
4. Construction and Layout of Buildings
13. Personnel hygiene and Employee Facilities
5. Layout of Premysis and Workspace
14. Rework
6. Utilities: Air, Water, Energy
15. Product Recall Procedures
7. Waste Disposal
16. Warehousing
8. Equipment Suitability, Cleaning and Maintenance
17. Product Information/Consumer Awareness
9. Management of Purchased Materials
18. Food Defense: Biovigilance and Bioterrorism
Relevance of FSSC 22000:2009 with ISO 9001 and HACCP HACCP
ISO 9001
FSSC 22000:2009
Principle 7 (Documentation and Record)
4. Quality Management System
NA
5. Management Responsibility
Establish HACCP Team
6. Resource Management
6. Resource Management
Principle 1‐4
7. Product Realization
7. Planning and Realization of Safe Products
Principle 5‐6
8. Measurement, Analysis and Improvement
4. Food Safety Management System 5. Management Responsibility
8. Validation, Verification and Improvement of FSMS
4.1. General – ISO 22000:2005 Keyword: Establish, document, implement, maintain FSMS SCOPE
Identify, evaluate, control, & communicate
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
Komunikasi interaktif
Pemenuhan persyaratan dasar pembuatan makanan yang baik
Pengelolaan sistem
Penerapan prinsip HACCP
ISO 22000 : 2005 – Komunikasi Interaktif
Produsen
Supplier (bahan mentah, peralatan, jasa) Komunikasi Interaktif
Konsumen Adanya Prosedur implementasi yang terstruktur baik internal maupun eksternal untuk memastikan tersedianya semua Informasi terkait keamanan pangan.
Lembaga Perundangan (Dinas Perindustrian, Dinas Kesehatan, BPOM, MUI)
ISO 22000 : 2005
OCT 2017
4.1. General Requirements Food Safety Management System
Establish
Document
Implement
Maintain
Update
18
4.1. General Requirements Food Safety Management System
Communicate to organization Communicate to food chain Food Safety Hazard
Evaluate Periodically & Update
• Development • Implementation • Updating
• 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
Identify
Approval
Control of document & records
Storage & Distribution
Transition
Disposition
21
5. Management Responsibility In order to provide evidence to show to commitment, Top Management must:
Have Commitment
• Business Objectives • Communicate •Food Safety Policy • Management Review • Availability of Resource
Food Safety Policy
• Appropriate to the role • Conforms to statutory & Regulatory • Communicated, implemented, maintained • Reviewed • Measurable objectives
22
5. Management Responsibility In order to provide evidence to show to commitment, Top Management must:
FSMS Planning
• Food Safety Target (KPI – Key Performance Indicator) • Change Management related to food safety system Responsibility & Authority
• Job Description
FS Team Leader
• Manage FSMS • Training & Education • Report
23
5. Management Responsibility Communication
External
Internal
Suppliers & Contractors
Customers/Consumers
Statutory & Regulatory authorities
Changes (products/new products, RM/service, production system & equipment, production premises, cleaning & sanitation, packaging, personnel, legal requirements, knowledge, complaint, etc
Other organizations
24
5. Management Responsibility 5.6. Management Review Review Input Minimum 7 review input in Management Review FUP Previou s MR
Customer feedback
CHANGES
Emergency situation / Withdrawal s
Audits
Analysis of verification
System updating
Commu 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 EVALUATION
TRAINING MTRIX VS PERFORMANCE
• 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 Audit Rework Control Equipment Calibration
PRP/ GMP
Utilities Management Quality Mgmt System
Equipment Design
Document Control
Foreign Object Prevention Consumer Testing
Maintenance
Emergency Preparedness
Product Recall Consumer Response
Storage and Transport
Shelf Li fe Evaluation
Label Design
Hold and Release
Allergen Control
Control of Operation
Corrective Action
Good Lab Practice Weight Control
Specification
Sanitation
Training
Identification & Traceabilit y Incoming Inspection
Pest Control
Hygiene
Housekeeping
Supplier Quality Mgt
Waste Disposal
Product Development Plant Structure
Zoning
PRP FROM ISO/TS 22002‐1
OCT 2017
GOOD MANUFACTURING PRACTICES
Zoning
Building design
Air conditioning
Cleaning
Equipment design
Hygiene concept
Behaviour of people
GOOD MANUFACTURING PRACTICES
Hygiene rules – Examples Hand hygiene Reporting of illness
Personal Hygiene
Eating and drinking Personal gear Equipment and building design Zoning Cleaning
Process Hygiene
GOOD MANUFACTURING PRACTICES
Personal Hygiene
GOOD MANUFACTURING PRACTICES 1. Take a shower before working 2.Short and neat haircut, mustache, and beard
3. Clean and short nails 4. Washing hands and use disinfectant 5. No spitting, smoking, and eating in production areas
GOOD MANUFACTURING PRACTICES • Reference • ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing Construction
Environment
Durable
Location shall far from potential contamination
Maintained
Access controlled
Prevent contamination
Clear boundaries Vegetation shall be tended or removed Road, yard, parking areas shall be drained
GOOD MANUFACTURING PRACTICES • Reference • ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing
• Layout of premises and workspace Internal design, layout and traffic patterns • Physical separation • Minimize foreign materials entry Internal structures and fittings • • • • •
Building junction easy to cleaned, rounded No standing water Trapped and covered drainage Minimize dirt accumulation and condensation Insect screen and curtains in external openings 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 • Minimize risk of contamination • Microbiology lab designed to prevent contamination Temporary or mobile premises and vending machines • Prevention of pest harborage and post contamination • Control others hazards
Storage of food, packaging materials, ingredients and non-food chemicals • • • • •
Food materials shall be stored away from sources of contamination Dry and well ventilated Temperature and RH control where specified Designed for inspection, cleaning, and minimize deterioration Segregation materials
GOOD MANUFACTURING PRACTICES • Utilities – Water, Air, Energy • Reference • ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing
1. 2. 3. 4.
Water quality shall be comply to regulation and specification Control chlorine residue if applicable Separation system from non potable water 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 – Utilities – Lighting
1. Appr Approp opri riat ate e intensity of lighting of lighting for operation and inspection 2. Ligh Lighti ting ng fixture shall be protected to prevent contamination
• Waste disposal 1. Waste materials are identified, collected, removed and disposed of in of in a manner which prevents contamination of products of products or production areas. 2. Cont Contai aine ners rs 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 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. Prov Provis isio ion n shall be made for the segregation, storage and removal of waste. of waste.
GOOD MANUFACTURING PRACTICES • Reference • ISO/TS 22002‐1 ‐ Prerequisite programs on food safety —Part 1: Food manufacturing
• Drains and drainage 1. Desi Design gned ed,, constructed and located so that the risk of contamination of contamination of materials of materials or products is avoided 2. Shall have capacity sufficient to remove expected flow loads 3. Drai Draina nage ge 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, by, the intended product or cleaning. 2. Equip quipme ment nt shall be able to meet established principles of hygienic of hygienic design 3. Pipin iping g and ductwork shall be cleanable, drainable, and with no dead ends 4. Equip quipme ment nt shall be designed to minimize contact between the operator’s hands and the products. 5. Ma Mate teri rials als 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. Equip quipme ment nt 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 of cleaning (e.g. CIP, COP), the use of dedicated of dedicated cleaning tools, removal or disassembly requirements and methods for verifying the effectiveness of the of the cleaning. 4. A preventive maintenance program shall be in place 5. Lubr Lubric ican ants ts and heat transfer fluids shall be food grade where there is a risk of direct 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. Ma Main inte tena nanc nce e personnel shall be trained in the product hazards associated with their activities.
7. PRP – PRE REQUISITES PROGRAM No
1.
2.
Subject Construction, lay out buildings and associated utilities Lay out premises, workspace, employee facilities
Supplies of air, water, 3. energy, and other utilities
Record
Verification Programs
‐ Plant lay out ‐ Machine drawings ‐ Drainage & Sewage diagram ‐ Water piping diagram
Internal audit every 6 months
‐ Process area layout ‐ Water treatment plan ‐ Compressed air flow ‐ Energy Direct contact? ‐ Filter spec for water, air,
‐ Quality Plan for water, air, and gas ‐ Finished goods analysis
and gas Supporting services 4. including waste and sewage 5
Suitability of equipment for cleaning and maintenance
‐ Waste management ‐ Waste water treatment plan Preventive & corrective maintenance report
‐ Internal audit ISO 14001 ‐ Waste water check Internal audit every 6 months
7. PRP – PRE REQUISITES PROGRAM No
6.
7.
Subject Management of purchased material, supplies, and handling of products Measures for the prevention of cross contamination
Record
‐ Supplier selection and evaluation ‐ Supplier categorization
‐ GMP Inspection ‐ Hygienic Environment
Verification Programs
‐ Supplier Audit ‐ Internal audit every 6 monthds
‐ GMP Inspection ‐
report Lab analysis result
‐ Cleaning monitoring 8.
Cleaning & Sanitizing
‐ CIP or COP ‐
9.
Pest Management
result FG analysis result
‐ IPM plan 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 Keparahan
Kriteria
Jenis Bahan Kimia/ Standar
‐Sengaja ditambahakan dalam makanan
Low
Medium
High
: kelompok food additive/minerals, supplements ‐Tidak ada resiko toksikologis yang serius pada level yang diijinkan ‐Pengunaan kurang dari 50% dari standar ‐Bahan pembantu proses yang tidak bersifat toxic pada level yang diizinkan
‐ ‐ Mineral : Zn, Fe ‐ Chlorine ‐ Residu Solvent ‐ BrownColour: 300ppm
Merupakan kontaminan pangan Tidak bersifat karsinogenik, teratogen, mutagen, dan atau neurotoksik Tidak terakumulasi dan dikeluarkan dalam urine
‐ Pestisida
Merupakan kontaminan pangan Terakumulasi dalam tubuh Resiko toksikologis berdampak panjang : karsinogenitas, teratogenitas atau nurotoksisitas
‐ Hg, As, Cd, Pb ‐ Aflatoksin ‐ Organoklorin : 1 ppb ‐ Hg
Zn : 5 ppm Chlorine : 5 ppm R. Solvent : 15 mg/m2
Reference
‐ Depkes ‐ Feron dalam De Vries (1997) for Nutritional ‐PDR Supplements Medical Economics. Thomson Healthcare.2000 ‐Singapore Std, SS 459:1999 Guidelines for Residual Solvent in Food Pack. Mtrl
(karbamat, ‐ Janssen dalam De Vries (1997)
organofosfor) ‐ Logam berat (Cu, Zn, Sn) yang bukan sengaja ditambahkan
As, Cd : 5 ppb Pb Aflatoksin : 20 ppb
‐ Lund, Parker, and Gould (2000) ‐ Janssen dalam De Vries (1997)
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 Penetapan signifikansi bahaya dilakukan dengan bantuan matriks berikut ini : Keterangan: S = Significant NS = Not Significant
Likely
Low
Medium
High
S
S
S
Medium
NS
NS
S
Low
NS
NS
S
High
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 Control measures hanya ada 2 yaitu : PRP atau spesifik PRP Control measures selected shall be categorized as to whether they need to be managed through OPRP or by the HACCP Plan.
Hazard analysis (7.4) • 7.4.4 : Selection and assessment of control measures links to 7.3.5.2 (existing control measures) 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 Proces HAZARD Step
CCP No
Critical Limit
What
Where
How
Who
When
Correction & Corr.Action (What&Who)
Verification (What & Who)
Record
OPRP MONITORING Monitoring Procedure No
Process HAZARD Description
OPRP No.
Control Measures
Correction (What)
(Where)
(How)
(Who)
(When)
Corr. Action Verification Record (What&Who) Program
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
Hasil verifikasi harus dikomunikasikan ke food safety team. Jika system verifikasi berdasarkan check finished product, dan hasilnya diluar spec, product yg terkait harus dihandle sebagai “potentially unsafe” sesuai dengan 7.10.3.
Control of Nonconformity (7.10) 7.10. 1 : Corrections
terhadap produk langsung pada saat terjadi penyimpangan
Harus didokumentasikan dalam bentuk procedure dan mendefinisikan:
‐ Identifikasi dan assessment dari finished product spy bisa menentukan penanganan yang sesuai
‐ Review corrective actions Harus ada approval dari PIC, direcord dengan informasi berdasarkan nature dari NC, sebab terjadinya, konsekuensi dan informasi yg dibutuhkan utk traceability.
Control of Nonconformity (7.10) • Corrective Actions tindakan perbaikan (produk, lingkungan, mesin, peralatan, dll) karena penyimpangan dari sekarang sampai seterusnya • Corrective action harus ditulis jika critical limits melebihi limit dan ketika ada gap conformity OPRP. 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
Validasi dilakukan 1x saja atau jika ada perubahan untuk hazard atau control measure Verifikasi hanya untuk PRP saja, OPRP adalah bagian dari PRP
8. Validation, verification and improvement of the food safety system 8.2 : Validasi dari control measure combinations Sebelum implementasi control measures yg dimasukkan ke OPRP dan HACCP Plan dan setelah perubahan, validasi harus dilakukan terhadap : ‐ Control measures mampu utk mencapai intended control dari food safety hazards ‐ Control measures efektif dan mampu utk mengkontrol hazards agar end product masuk standard. Jika hasil validasi “tidak confirm” : control measure dan atau combinations harus dimodifikasi dan dianalisa ulang (7.4.4)
8. Validation, verification and improvement of the food safety system 8.3 Untuk menjamin data yang valid maka alat ukur dan metode uji harus:
Dikalibrasi atau verifikasi pada “specified intervals” Diadjust atau re‐adjust ketika diharuskan Ada identifikasi untuk determinasi calibration status Dilindungi dari adjusment yg mungkin bisa membuat invalid measurements Dilindungi dari kerusakan dan kerusakan
8. Validation, verification and improvement of the food safety system 8.4 : Food safety management system verification Dapat dilakukan dengan : ‐ Analisis (ex. swab test, air check, etc)
‐ Audit 8.4.1 : Internal audit Harus ada audit plan. Dalam audit plan : audit criteria, scope, frequency, dan metode. 8.4.2 : Evaluation of individual verification results If verification does not conform, organization shall take action including :
‐ ‐ ‐ ‐
Existing procedures Conclusion of hazard analysis, OPRP, HACCP Plan PRPs Efektifitas human resource management dan training aktifitas (6.2).
8. Validation, verification and improvement of the food safety 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 Physical Hazards
• • • •
Hair Metal pieces Paper/plastic from packaging Jewelry, etc
Chemical Hazards
• • • •
Lubricating oil, grease Cleaning agent residue Mycotoxin Heavy metals, etc
Biological Hazard
• • • • •
Bacteria Viruses Yeast Molds Pest, etc
Faktor penyebab foodborne illness & gangguan kesehatan
Kontaminasi ‐ Peralatan tidak bersih ‐ Raw material ‐ Insects / rodents ‐ Aerosols / kondensasi ‐ Operator yang terinfeksi
Survival
Growth/umbuh
‐ cooking / reheating tdk cukup ‐ cooling / hot holding tdk sesuai
Sakit yang akut (acute illness) :
Sakit kronis (chronic illness) :
Kematian (death)
choking vomiting abdominal cramps diarrhoea nausea fever chronic infections damage of various organs cancer
79
Bacterial growth curve Toxic - - - - - - - - - - - -+++++++++++
Spoils
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
9 8
+ + +
Time to spoilage
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 > 70 Cwaktu 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.
Bakteri
Suhu
Kondisi
Sifat Bakteri
Resiko
-18 C
Beku
Dormant –tidakaktif/tidakberkembangbiak
Aman
1–4 C
Dingin
Umunyatidakdapat berkembangbiak
Aman
5–63 C
Kondisi dimanabakteri dapattumbuhdan berkembangbiakdenganpesat
Berbahaya/ Danger Zone
64–74 C
SuhuRuang(10- 36 C) SuhuTubuh(37 C) MakananHangat (38–63 C) MakananPanas
Umumnyatidakdapat berkembangbiak
Aman
73–100 C
SuhuPemasakan
Umunyabakteri mati
Aman
>100 C
Masakanyangdirebus Pemasakandengantekanan
Umumnyabakteri dansporamati
Aman
81
Hazards and sources of hazards
Keberadaan yang tidak bisa diterima: Biological
Raw materials
Chemical
Semi‐finished product
contaminant in
Physical
Finished 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 or production line
Growth
Salmonella
of microorganisms in
Survival
Semi‐finished or finished product
Staphylococcus
83
Hazard Analysis Identifikasi ketidakterimaan (re)contamination dari Biological agent
Semi‐finished products
oleh
Chemical agent
Physical agent
Finished products
Bacteria – Viruses – Moulds ‐ Parasites
Toxins
Chemicals
Foreign material 84
Critical Control Point (CCP) • • • • •
A Critical Control Point (CCP) is an identifiable point in the production chain where a hazard may occur. Action is taken to prevent the hazard from occurring. This can either be a point, step or procedure at which control can be applied and is essential to prevent or eliminate a hazard or reduce it to an acceptable level. A CCP can be used to control more than one hazard – refrigeration storage CCP. Alternatively, several CCPs may be needed to control one hazard.
7 HACCP PRINCIPLES
1
Conduct hazard analysis
The first step involves identifying any hazards that must be prevented, eliminated or reduced to acceptable levels. All potential hazards, from the receipt of raw materials through to release of the finished product, must be considered. A hazard must be controlled if it is likely to occur, and/or likely to result in an unacceptable risk to consumers.
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 Keparahan
Kriteria
Jenis Bahan Kimia/ Standar
‐Sengaja ditambahakan dalam makanan
Low
Medium
High
: kelompok food additive/minerals, supplements ‐Tidak ada resiko toksikologis yang serius pada level yang diijinkan ‐Pengunaan kurang dari 50% dari standar ‐Bahan pembantu proses yang tidak bersifat toxic pada level yang diizinkan
‐ ‐ Mineral : Zn, Fe ‐ Chlorine ‐ Residu Solvent ‐ BrownColour: 300ppm
Merupakan kontaminan pangan Tidak bersifat karsinogenik, teratogen, mutagen, dan atau neurotoksik Tidak terakumulasi dan dikeluarkan dalam urine
‐ Pestisida
Merupakan kontaminan pangan Terakumulasi dalam tubuh Resiko toksikologis berdampak panjang : karsinogenitas, teratogenitas atau nurotoksisitas
‐ Hg, As, Cd, Pb ‐ Aflatoksin ‐ Organoklorin : 1 ppb ‐ Hg
Zn : 5 ppm Chlorine : 5 ppm R. Solvent : 15 mg/m2
Reference
‐ Depkes ‐ Feron dalam De Vries (1997) for Nutritional ‐PDR Supplements Medical Economics. Thomson Healthcare.2000 ‐Singapore Std, SS 459:1999 Guidelines for Residual Solvent in Food Pack. Mtrl
(karbamat, ‐ Janssen dalam De Vries (1997)
organofosfor) ‐ Logam berat (Cu, Zn, Sn) yang bukan sengaja ditambahkan
As, Cd : 5 ppb Pb Aflatoksin : 20 ppb
‐ Lund, Parker, and Gould (2000) ‐ Janssen dalam De Vries (1997)
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 Penetapan signifikansi bahaya dilakukan dengan bantuan matriks berikut ini : Keterangan: S = Significant NS = Not Significant
Likely
Low
Medium
High
S
S
S
Medium
NS
NS
S
Low
NS
NS
S
High
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
A critical limit is a maximum or minimum value to which a biological, chemical or physical limit must be controlled at a CCP. This is set in order to prevent, eliminate or reduce a hazard to an acceptable level.
HACC HACCP P Dec Decis isio ion n Tr Tree ee – Camp Campde den n BRI BRI 2009 2009 Q1 Is the hazard managed by the PRP?
YES
NOT a CCP Record the PRP
NO Q2 Are control measures in place for the hazard?
NO
YES Q3 Is the process step specifically designed to eliminate or reduce the hazard to an acceptable level?
Q2a Is control necessary? (If no (If no stop, it is not a CCP, if yes, if yes, modify the step, process or product to obtain control)
CCP
YES STOP NOT a CCP
NO Q4 Could contamination with the hazard occur at unacceptable levels or increase to unacceptable levels (if the control failed)
NO
YES
YES Q5 Will subsequent process step eliminate the identified hazard (s) or reduce the hazard to an acceptable level?
NO
HACCP HACCP Decisi Decision on Tree Tree – Codex Codex Q1 Do control preventive measure(s) exist?
NO
Is control as this step necessary for safety?
YES
Modify step, process, or product
YES Q2 Is the step specifically designed to eliminate/reduce the likely occurrence of a of a hazard to an acceptable level?
NO
STOP NOT a CCP
YES
CCP
NO Q3 Could contamination with identified hazard(s) occur in excess of acceptable of acceptable level(s) or could increase to unacceptable levels?
NO
YES Q4 Will a subsequent step eliminate identified hazard)s) or reduce likely occurrence to an acceptable level?
YES NO
Hazard Analysis Hints Significant
N Y
Control Measures PRP Ex. Cleanliness of equipment Specific PRP N
decision tree :
Ex. Ice water temperature
Y
Specific PRP Y
decision tree :
Ex. pasteurization
PRP
OPRP
CCP
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 Hazard Fresh Shrimp – pathogens
Q1 Q2 Q3 Y
N
‐
CCP/CP
Rationale
CCP
Shrimps for Sushi – eaten raw Allergen risk to facility Product label must declare wheat as ingredient.
Wheat Flour allergen (gluten)
Y
N
‐
CCP
Spices – pathogens
Y
Y
N
CP
Spices to be cooked in pasta sauce.
REFERENCE: 1 CODEX Alimentarius Commission, Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application, Alinorm 97/13 Appendix II. 2 S. Mortimore and C. Wallace, HACCP a Practical Approach (1994), Chapman & Hall, London.
7 HACCP PRINCIPLES
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 in the food production.
identified
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 System monitoring harus terdiri dari related procedures, instructions dan record yg mengcover : a.
measurements atau observations that provides results within an adequate time frame (how)
b.
Instrument yg digunakan utk check (what)
c.
Calibration method yg sesuai
d.
Frekuensi monitoring (when)
e.
Tanggung jawab dan autoritas yg berhubungan dengan monitoring dan evaluasi dari monitoring results (who)
f.
Record
7.6.5 : Actions when monitoring results > critical limits • Planning Corrections dan Corrective actions yg harus dikerjakan ketika critical limits terlampaui harus dijelaskan di HACCP Plan. • Actions harus : Identifikasi sebab dari NC, parameters yg dikontrol di CCP dikembalikan ke under control, dan mencegah pengulangan NC. • Procedures harus terdokumentasi (NC procedure) – tidak boleh release sebelum dievaluasi.
Hazard analysis (7.4)
CCP MONITORING Monitoring Procedure Proces HAZARD Step
CCP No
Critical Limit
What
Where
How
Who
When
Correction & Corr.Action (What&Who)
Verification (What & Who)
Record
