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 info@fssc22000.com

Phone +1 508 932 6421

Twitter @FSSC22000 LinkedIn Group FSSC 22000

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