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Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 2
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 5
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 6
Identify
y all integrated
g programs
p g and p
procedures used by
y the
organisation to achieve food safety objectives.
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 7
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 8
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 10
NOTE:
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 12
www.iso.org
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 13
Over 745
Collection of 22754 organizations in
ISO Standards liaison
Customer
1 637 standards
produced
Vision Internal
in 2018 Financial & Process
Strategy
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 15
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 16
10. Improvement
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 17
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 18
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 19
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 20
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 21
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 22
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 23
g - New understanding
Risk-based thinking g of the concept
p of “risk”
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 25
Interactive System
Communication Management
Pre-Requisite
Programs (PRPs) Codex HACCP
Principles
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 26
Leadership
Engagement of people
Process approach
Improvement
Relationship management
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 27
ISO 22000
22000::2018
Clause Description
One of the big 1 Scope
changes to come in
the
th new versioni off 2 Normative References
ISO 22000:2018 is its 3 Terms and Definitions
Structure. 4 Context of the Organization
5 Leadership
There will now be 10 6 Planning
Clauses (instead of 8) 7 Support
in the Standard; the 8 Operation
requirements are set
out in Clauses 4 – 10. 9 Performance Evaluation
10 Improvement
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 28
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 29
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 30
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 32
2 Normative References
Monitor and
Check Do
measure processes
and product in IImplement
l t the
th
comparison with processes
policies, objectives
and requirements of
the product and
records the results Continual Improvement
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 35
1. Planning and
1. control
1. 1. 1.
1. Address 1.
Organizatio Resources Monitoring,
Leadership & risk and 2. PRPs Nonconformity
n and measuremen
Commitment opportunit and corrective
context t, analysis
y action
2. 3. Traceability and
Competenc evaluation
2. 2. e 4. Emergency
2.
Interested FMSM 2.
Policy 2.
parties objectives Continual
3. Internal audit
5. Hazard control improvement
Awareness
3. 3.
3.
Roles , Planning
FSMS 4. 3.
responsibilitie of 6. Updating
Scope Communica Management
s etc. changes
tions review
7. Monitoring and
4. measuring
5.
FSMS
Documente 8. Verification
d info
9. Product and
process NCs
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 36
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 37
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 38
PRPs
Hazard control
Validation of plan CCPs /
p
Hazard Verification
Traceability C t l
Control OPRPs
Analysis planning
measures
Emergency preparedness
PLAN
ACT CHECK DO
Implementation of the FS plan
Updating of Monitoring &
verification activities
preliminary Control of monitoring &
measuring
information PRPs
Analysis of results of
& Hazard control verification activities
Control of product & process
nonconformities
plan
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 39
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 40
4.2
4.1
Understanding the 4.3
Understanding the 4.4
needs and Determining the
organization and FSMS
expectation of scope of the FSMS
its context
interested parties
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 41
5 Leadership
5 Leadership
p
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 42
6 Planning
6.2
6.1
Objectives of the FSMS
Actions to address risks 6.3
and planning to achieve
and opportunities Planning of changes
them
6.1.1 - 6.1.2 – 6.1.3
6.2.1 – 6.2.2
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 43
7 Support
7 Support
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 44
8.2 Prerequisite
q programmes
p g (PRPs)
( )
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 45
8.5.1.1 General
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 46
8.5.2.1 General
8 5.2.4
8. 5 2 4 Selection
S l ti & categorization
t i ti off control
t l measure(s)
( )
8.5.4.1 General
8 5.
8. 5 4.4
4 4 Action
A ti when
h critical
iti l limits
li it or action
ti criteria
it i are nott mett
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 48
8.9.1 General
8.9.2 Corrections
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 49
8.9.4 Handling
g of potentially
p y unsafe products
p
8.9.4.1 General
8. 9.5 Withdrawal/recall
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 50
2. Describe
1. Assemble 3. Identify intended
product /
HACCP team use / misuse
processes
8. Control
7. Risk assessment
measures
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 51
11. Establish
10. Validate control
9. Determine CCP’s critical limits for
measures
each CCP
15. Establish
16. Review HACCP
documentation
system
and record keeping
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 52
9 Performance Evaluation
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 53
10 Improvement
10 Improvement
10
10..1 10.2 10.3
Nonconformity & Continual Updated FSMS
Corrective actions improvement
10.1.1 Occurring of Nonconformity
10.1.2 Retain documented
information
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 54
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 55
2001 - 2005:
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 56
2007 - 2009:
2007: Top seven retailers agree to reduce duplication in
the supply
pp y chain through
g the common acceptance
p of anyy
of the GFSI benchmarked schemes (BRC, IFS, SQF or Dutch
HACCP)
2009 - www.
www.fssc 22000.com launched and FSSC 22000
fssc22000
22000.
issued (combining ISO 22000:2005 and PAS 220:2008)
2017 - 2019:
2017 – Version 4 of FSSC 22000 replaced version 3
2018 - Version 4.1 of FSSC 22000 additional requirements
becomes mandatory
2018 - ISO 22000
22000::2018 new version of FSMS - update to the
standard replacing 2005
2019 - The Foundation release FSSC 22000 Certification
Scheme V5
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 58
Non-profit organization
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 59
Benchmarking
B h ki food
f d safety
f t standards
t d d worldwide
ld id
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 60
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 61
Additional
Scheme PRP:
Requiremen ISO/TS
ts - V5 22002-x
ISO
22000:2018
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 62
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 63
Independent
p scheme – non p
profit
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 64
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 65
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 66
Introduction + 6 Parts
1 Scheme Overview
2 Requirements for Organizations to be audited
Organizations
3 Requirements for the Certification Process
4 Requirements for Certification Bodies
5 Requirements for Accreditation Bodies
6 Requirements for Training Organizations
Appendix 1 Definitions
Appendix 2 References
Seven (7) Separate Annexes
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 67
Scheme v5
v5 Annexes:
Annex 1 CB Scope Statements
Annex 2 CB Audit Report Template (FSSC 22000)
Annex 3 CB Audit Report Template (FSSC 22000-Quality)
Annex 4 CB Certificate Template
Annex 5 AB Accreditation Certificate Scope
Annex 6 TO Course Specifications
Annex 7 TO Training Certificate Templates
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 68
Audits against V4
V4.1 only allowed until 31 December 2019
https://www.fssc22000.com/scheme/scheme-documents/
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 70
ISO 2
meat/milk/eggs/honey ISO/TS 22002-3:2011
AII Farming of fish and seafood
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 71
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 72
1. Purpose
2. R
Requirements
i t
2.1 General
2.2 ISO 22000:2018
2.3 ISO 9001:2015
2 4 Pre-requisite
2.4 P i i programs
2.5 FSSC 22000 Additional Requirements
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 73
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 76
ISO/TS 22002-2:2013
Prerequisite programs on food safety – Part 2: Catering.
1. Scope
2. Normative Reference
3. Terms and definitions
4. Gereric Prerequisite Programs
5. Specific Prerequisite programs
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 77
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 79
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 80
1. Management of Services
2. Product Labelling
3. Food Defense
4. Food Fraud Mitigation
5. Logo Use
6. Management of Allergen
7. Environmental Monitoring
8. Formulation of Products
9. Transport and Delivery
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 81
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 83
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 84
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 86
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 87
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 88
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 89
The organization
organi ation shall:
shall
Ensure that product is transported and delivered under conditions
which minimize the potential for contamination
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 90
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 91
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 92
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 93
VACCP
Types of opportunities for fraud and criminal activity:
Mislabelling or misdescription
Varietal misdescription
Incorrect country of origin labelling
Adulteration
Dilution
C l t
Concealment
Counterfeiting
Unapproved enhancements
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 94
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 95
VACCP Assessment
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 96
Risks of contamination
Site security
Transport security
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 97
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 98
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 99
Unannounced Visits
Critical non-conformances
non conformances have been included
New Requirements
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 100
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 101
FSMA Objectives
Designed
g to improve
p the safety
y of imported
p food.
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 102
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 103
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 104
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 105
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 106
Preventive Controls- Human Food Sept. 17, 2015 Sept. 17, 2016
Preventive Controls- Animal Food Sept. 17, 2015 Sept. 17, 2016 (cGMPs)
Sept. 19, 2017 (PC)
Accreditation of Third Party Auditors Sept. 17, 2015 May 31, 2017
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 107
Prevention
Control Plan
Produce Safety
Rule
Foreign Supplier
Verification
Sanitary
Transportation
Food Defense
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 108
Administrative detention
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 109
p
Subpart A – General Provision
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 110
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 111
Qualified
Q lifi d Individuals
I di id l – have
h education,
d ti training
t i i or
experience necessary to perform assigned tasks.
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 112
Standardized Curriculum
Recognized
as Adequate by the FDA
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 113
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 114
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 115
HACCP FSMA
Corrective actions including When issues are identified
all preventive actions taken in during the review, corrective
response to a deviation action is required
Re-assessment of the HACCP Re-assessment of the Food Safety
Plan – specified in the plan Plan – at least every 3 years
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 116
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 117
Hazard
Analysis
Critical
Control
Points
(CCPs)
Critical
Limits
Monitor
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 118
Hazard
Analysis
Preventive
Controls
(CCPs, allergen,
sanitation, supplier,
chain & recall)
Parameters &
Values
Monitor
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 119
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 120
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 121
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 122
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 123
FSMA requires
i you to
t manage any potential
t ti l or remaining
i i
food safety and food fraud related risk in the entire supply
chain leading up to your company.
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 124
Food
ood Safety
Sa ety Preventive
e e t e Controls
Co t o s
for Human Food
PCQI
Foreign Supplier
S pplier Verification Program
FSVP
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 125
www.FSPCA.org
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 126
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 127
Prof. Dr. Yehia El-Samragy FSSC 22000 Scheme Version 5 All rights reserved 128