© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL 1 Food Safety ASQ Milwaukee Section November 18, 2013 Nancy Berger EAGLE Food Registrations, Inc November

© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL 1

Food Safety

ASQ Milwaukee SectionNovember 18, 2013

Nancy BergerEAGLE Food Registrations, IncNovember 2013

2© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL

Agenda

FSMA – what it means to the consumer

GFSI – what it is & how it is making the food chain safer

Food Safety – heading in the future


Challenges

Food Safety Crisis – global

Government FDA/USDA budget cuts/not enough manpower

Too many individual audits with different expectations

Recalls and Media

Consumer health # 1 priority


FSMA

FDA Food Safety Modernization Act (FSMA)

Signed into law January 4, 2011

Most sweeping change in 70 years

Applies to human and animal food products

Special areas of the law for imports and produce

Helps the food chain build consumer confidence


FSMA

7 Foundation Standards (such as food safety defense)

still under development, deadline 6/30/2015 for feedback to finalize

5 Areas of FSMA Law


FSMA

Prevention goal of the entire FMSA revisions:

• Preventative rather than reactive approach

• Stop it before it happens

• Reduce the likelihood of bad product out in the industry

• HACCP Program defined and implemented

− Some exclusions apply (seafood; juice; small business less than $500,000 annual revenue)

− Hazard Analysis Critical Control Points - Evaluate hazards; identify and implement preventive controls; monitor performance; maintain records

− Sounds like a FMEA doesn’t it!

Prevent

Food

Hazards!


FSMA

Inspection and compliance -greater access to reports and plant

Catching up to USDA

USDA has been strong in this for a long time – USDA plants have inspection in each day; each shift


FSMA

Regulatory Response – stronger recall processes if reasonable probability of causing serious adverse health consequences or death to humans or animals

• Registration of all food manufacturing facilities

− Any manufacturer, processor, packer or warehouse/distribution

− Not farms, restaurants, retail food establishment

• Detainment of product or suspension if reasonable probability of causing serious adverse health consequences or death to humans or animals


FSMA

Import Safety is a big focus of FSMA

• Foreign supply verification program - 3rd Party Audits

• Importer will have to have the audit certificate on file

• Set criteria for who can do the audits – approved government agencies/staff and approved auditing companies

− Not enough FDA inspectors to do audits

− Auditors will also have to be accredited

− Starting with imports, but you know it will move to US manufacturers in near future

!Safety

BIG Focus


FSMA

Enhanced Partnership

• FDA staff will not be able to do it alone

− Budget restraints

• Look to other agencies and organizations involvement

− State health agencies

− Local health agencies

− Third Party Certification Bodies or Groups

− BRINGS US TO GFSI AUDITS


What is GFSI?

GFSI launched in 2000, following a directive from the CEOs in the food business

Now managed by The Consumer Goods Forum

Benchmarking process of schemes against guidance documents (by sectors)

Encourages stakeholders to share knowledge and strategy for food safety – develop best practices for common global framework


Benefits of an FSMS

Preventive system

Provides systematic approach to managing food safety

Provides standards and guidelines for food safety

Provides verification and validation of system

Improves compliance to regulatory standards

Provides confidence to consumers

Demonstrates due diligence by processor

Auditable


Oversight vs. Non-oversight

Non-oversight, Third-Party Audits

• Audits which are the product of a specific company

− Examples = AIB, Silliker, Cook & Thurber

• These audits are created and controlled by the company who developed the audit criteria

• Type of audit used at Peanut Butter Corporation of America

Oversight Third-Party Audits

• All GFSI schemes


Certification Process

Which program is best for their company?

• What are the reasons for seeking certification?

− Required by customer

• Global business

• Mature vs. New FSMS

Standards are similar in a lot of ways, but unique

• Let’s share some of them


Certification Process


Certification Process (continued)

Supplier Implements The System

*System must be operational for minimum of two months so records are created and it can be verified and validated


Certification Process (continued)

Certification Steps

• Different by Standards

− FSSC: Stage 1 and Stage 2

» Readiness visit (1) Certification Audit (2)

− SQF: Document Review & Certification Audit

Close out Findings

Certification Granted

• Some GFSI audits are scored / some mirror ISO 9001 and are not scored

• Surveillance and or recertification audits

− Requirements by standard


GFSI Schemes

The Three Major FSMS in the U.S. are:

Safe Quality Food (SQF)

British Retail Consortium (BRC)

FSSC 22000


SQF – Overview

SQF = Safe Quality Food

Developed in Australia in 1994

Food Marketing Institute purchased in 2003

One code with defined modules for industry specific operations

3 Levels of Certification (Benefit)

• Level 1 = Food Safety Fundamentals (GMPs, PRPs)

• Level 2 = Food Safety Plan (HACCP)

• Level 3 = Food Quality Plan (HACCP driven)


SQF – Basic Facts & Benefits

All documentation is free on their website (Benefit)

Auditor approval controlled by scheme (Benefit)

Nine basic elements and HACCP based

Includes some elements found in 9001 and 22000

Document Control, Management Review, Internal Audit, Corrective and Preventive Action

Standard by modules by food sector categories (Benefit)

Offers additional tools such as guidance documents for specific industries to strengthen program (Benefit)


SQF – Basic Facts & Benefits

Provides discipline for document control

SQF Practitioner responsible for program (Benefit)

Includes 12 Step HACCP Plan

Food Safety Fundamentals

• Details for building and equipment design and construction

• Specific PRPs with defined criteria

Special attention to identity of preserved foods (i.e.; Kosher, Organic)

Requires verification and validation of system

Includes quality – based on HACCP method (Benefit)


BRC - Overview

Developed in 1998

Published by the British Retail Consortium

Developed in response to retailer demand

Developed by BRC with contributions from retail, manufacturing, industry associations, and certifying bodies

Edition 6 released 2011, effective 1/2012


BRC – Basic Facts & Benefits

Different schemes/standard by food sector categories

Eight fundamental requirements

HACCP based

Includes quality (Benefit)

Includes some elements found in ISO programs

• Document Control, Management Review, Internal Audits, etc.


BRC – Basic Facts & Benefits


Includes 12 step HACCP plan

Very prescriptive PRPs

Special attention to foreign material control such as sharps control (Benefit)

Requires verification and validation of system

Auditor qualifications (Benefit)

Strong in Europe/Canada and for exporting there (Benefit)


FSSC 22000 - Overview

Newest of the three major GFSI standard

Combination of ISO 22000, PAS 220 (ISO 22002-1:2009) and a few more requirements in Part 1 of FSSC 22000

ISO 22000 was published in September 2005

Developed by joint effort of ISO & the food industry

Truly a global standard - 14 different countries represented


FSSC 22000 – Basic Facts & Benefits

100% Food Safety driven (Benefit)

• Does not include a quality component

HACCP based – very specific requirements

Includes pre-requisite programs PAS 220 (ISO 22002-1:2009)

Most aligned elements to 9001 (Benefit)

• Document control, resource management, management review, internal audit

Not scored – aligns with 9001 progress (Benefit)


FSSC 22000 - Basic Facts & Benefits


Foundation for continual improvement

Creation of a Food Safety Team

Includes all steps in the development and implementation of a HACCP plan

Control of non-conforming product critical (Benefit)

Validation & verification of system

Traceability


Last revision changes to FSSC22000

• Category M – food grade packaging - added to scope of standard with the use of PAS 223

− Previously it did not offer an approved GFSI standard to the packaging industry

• Audit time requirements – minimum on site

• Surveillance audit are FULL SYSTEM audits

FSSC 22000 – Basic Facts & Benefits


Future of Food Safety

SQF, FSSC and BRC are benchmarking to FSMA

• Show gaps

• SQF completed GAP analysis and only a few FMS requirements fell short but they have many requirements that are more stringent

• Copy of this comparison is on the SQF website – www.sqfi.com


Future of Food Safety

Complete roll-out of FSMS

• More accountability

• Proactive not Reactive Culture

GFSI keeping up with the changes in industry

• Unannounced audit

• Adding HACCP Hazards when identified

• More involvement with certified client recalls from auditing requirements

• Making a safer food chain!!!!


Contact Information

Questions

For more information please call 800.795.3641,

visit www.eagleregistrations.com or e-mail

[email protected]

Documents

© EAGLE Food Registrations Inc. 2013 CONFIDENTIAL 1 Food Safety ASQ Milwaukee Section November 18, 2013 Nancy Berger EAGLE Food Registrations, Inc November