Alignment of FSSC 22000 with FSMA versus FSMA FSP (HARPC) Element HACCP PLAN FSMA FOOD SAFETY PLAN...
Transcript of Alignment of FSSC 22000 with FSMA versus FSMA FSP (HARPC) Element HACCP PLAN FSMA FOOD SAFETY PLAN...
Alignment of FSSC 22000 with FSMA
Aldin Hilbrands, Technical Director
Food Safety Modernization Act (FSMA)
• Necessary update of GMPs and old legislation
• Move to be preventive rather than reactive
• Developed following some major incidences
• Months of consultation with private sector
• Series of 7 regulations
• Publication of Final Rules from Sept 2015
Rules and Dates of Compliance
Final Rule Date of Issue
Compliance
Large Business
Compliance
Small Business
CGMP and Preventive Controls for Human Food Sept 17th 2015 Sept 19th 2016 Sept 18th 2017
CGMP and Preventive Controls for Animal Feed Sept 17th 2015 Sept 19th 2016 (cGMP)
Sept 18th 2017 (PCs)
Sept 18th 2017 (cGMP)
Sept 17th 2018 (PCs)
Produce Safety Rule Nov 27th 2015 Jan 26th 2018 Jan 26th 2019
Foreign Supplier Verification Program Nov 27th 2015 May 27th 2017 N/A
3rd Party Accreditation and Certification
Nov 27th 2015
Requirements into
effect after FDA
publishes Accreditation
Standards
Sanitary Transportation of Human
and Animal Food April 6th 2016 April 6th 2017 April 6th 2018
Food Defense / International Adulteration May 27th 2016 July 26th 2019 July 26th 2020
PC for Human Food
FSMA Food Safety Plan
Subparts Established in 21 CFR Part 117 Subpart Title
A. General Provisions
B. Current Good Manufacturing Practice
C. Hazard Analysis and Risk Based Preventive Controls
D. Modified Requirements
E. Withdrawal of a Qualified Facility Exemption
F. Requirements Applying to Records
G. Supply Chain Program
Current GMP and Hazard Analysis and Risk-
Based Preventive Controls for Human Food
• Published Sept 2015
• Implementation Sept 2016
• US-Centric but with far reaching influences
• Focus on Prevention:
– Inspections, compliance and response
– Supply chain and Import Safety
– Enhanced Partnerships and Training
FSMA and FSSC 22000 – Similarities
Shared goals of food safety through preventive
controls and flexible management system approach
• FSMA requires a Food Safety Plan
• Requires flexibility with accountability
• HARPC is modification of HACCP with PRP’s
• Training is an important element
• Focus on the Supply Chain
HACCP versus FSMA FSP (HARPC) Element HACCP PLAN FSMA FOOD SAFETY PLAN
Hazard Analysis Biological, Chemical and
Physical Processes
Chemical hazards include radiological hazards and
consideration of economically motivated adulteration
( 21 CFR 117.130 (b)(1)( ii ))
Preventive Controls CCP's for processes
Process CCP's & Controls at other points that are
not CCP's ( 21 CFR 117.135 (a)(2))
Parameter and Values Critical limits at CCP's Parameters and min/max values
(equivalent to critical limits for process controls )
(21 CFR 117.135 (c)(1))
Monitoring Required for CCP's
Required as appropriate for preventive controls
(21 CFR 117.145)
Corrective Actions and
Corrections Corrective actions
Corrective actions or corrections as appropriate
(21 CFR 117.150 (a)
Verification including
Validation For process controls
Verification as appropriate for all preventive controls:
Validation for all process controls:
Supplier verification required when supplier controls
a hazard ( 21 CFR 117.155, 117.160 )
Records For process controls
As appropriate for all preventive controls
(21 CFR 117.190 )
Recall Plan Not required in the Plan
Required when a hazard requiring a preventive
control is identified (21 CFR 117.139)
Gap analysis of FSSC 22000 versus FSMA
• Current Good Manufacturing Practice and
Hazard Analysis and Risk-Based
Preventive Controls for Human Food
versus
• FSSC 22000
ISO 22000
PRP (ISO 22002-1)
Additional requirements
General comparison FSSC 22000 vs FSMA
• “FSSC 22000 required elements exceed the rule in
several areas. Where it is not exceeding
…measure comparable to the Final Rule
requirements”.
• There are no elements of the FDA preventive
control and cGMP requirements that are clearly just
‘missing’ in FSSC 22000 that we could
determine...”
Detailed comparison FSMA vs FSSC 22000
• Mapping of FSMA requirements against FSSC 22000
• Provides a reference for industry and regulators
• Shows alignment and differences in the details
– Increased documentation
– Demand for the verification of suppliers
– Foreign Supplier Verification Program
FSMA FSP vs FSSC 22000 FSMS FSMA FOOD SAFETY PLAN FSSC 22000 Comments
117.130 (b)(1)( ii )) Chemical hazards include radiological hazards
and consideration of economically motivated
adulteration
Comparable:
ISO 22000 7.3.3
Will include radiological
and EA in FSSC 22000
version 4
( 21 CFR 117.135 (a)(2)) Process CCP's & Controls at other points that are
not CCP's Comparable:
ISO 22000 7.4.4 & 7.6.2
FSSC 22000 refers to
control measures that
can be managed though
operational PRP's or
HACCP
(21 CFR 117.135 (c)(1)) Parameters and min/max values (equivalent to
critical limits for process controls ) Comparable:
ISO 22000 7.6.3
(21 CFR 117.145) Required as appropriate for preventive controls Comparable:
ISO 22000 7.6.4
(21 CFR 117.150 (a) Corrective actions or corrections as appropriate Comparable:
ISO 22000 7.6.5
( 21 CFR 117.155, 117.160 ) Verification as appropriate for all preventive
controls: Validation for all process controls:
Supplier verification required when supplier
controls a hazard
Comparable
ISO 22000 8
Additional details
Verification by a PCQI
within 90 days- Supplier
verification: more detail
required
(21 CFR 117.190 ) As appropriate for all preventive controls Comparable
ISO 22000 4.3
(21 CFR 117.139) Required when a hazard requiring a preventive
control is identified Comparable:
ISO 22000 7.10.4
ISO 22002-1 15.2
Additional details re
disposal may be needed
FSMA Guidance issued by FDA
Alignment of FSSC 22000 with FSMA
• Revision of Version 4 to add more requirements to
the FSSC 22000 scheme
• A supplementary FSMA module could provide the
detail required by the legislative standard
• Extend resources of FDA by providing:
– Evidence of supplier verification for FSVP
– Risk assessment of companies
– Evidence of overall compliance
Website www.fssc22000.com
E-mail [email protected]
Phone +1 508 932 6421
Twitter @FSSC22000 LinkedIn Group FSSC 22000
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