Reducing Food Safety Risks through

Recognized Systems Thomas Bouraoui -- Exopack Corporate Director of Quality & CI

2/26/2013 2

Agenda

CPG Expectations

FSMA overview

GFSI overview

The “Big 4” GFSI Standards

Summary

CPG Expectations

Necessary mindset

If your product touches food at some point in the downstream supply chain, you are a part of the Food Industry.

Adapted from: Food Safety Alliance for Packaging

Treat Food Packaging (Human and Pet) with the same food safety rigor as food – look at potential risks from design to consumption

Typical Expectations for Packaging Supplier Approval

Supplier survey / risk assessment

Site Audit:

3rd party; perhaps for a GFSI or other Food Safety certification;

CPG internally developed audit

Typical assessments:

GMPs

HACCP

Supply chain management/approval process

Raw material regulatory approvals

RSOL/migration testing

Adapted from: Food Safety Alliance for Packaging

Food Safety is Still Big News

Adapted from: Food Safety Alliance for Packaging

Top Food Safety Related Issues Associated with Packaging

Undeclared /Unlabeled Allergens

Mixed labeled packaging materials (e.g., labels, cartons, film, lids, cups,…)

Printing Errors

Chemical Migration

Migration into product or package (e.g., film, pallets, ink…)

May be “Perceived” food safety issues – ODORS, TASTE

Adapted from: Food Safety Alliance for Packaging

U.S. and Canadian Food Recalls - 2011

Source: Food Industry Report Vol. 24 No. 4 April 2012

0

100

200

300

400

500

600

700

E. coli Listeria Salmonella ForeignMaterial

UndeclaredIngred/

ALLERGENS

U.S. 2011

Canada 2011

Pro-active packaging suppliers prevent mixed labeling

A priority concern:

“misbranding” issue

if allergens = safety issue

A pro-active approach:

assess risks

human and electronic controls

VERIFY

1.3 verify Roll History ticket info against……_____

1.4 load jumbo onto unwind1.5 check off jumbo roll # on p revious op ertn_____

Begin production of new WO

6.2 start mach ine and begin p roduction

2.5 confirm p ap erwork (FG slit roll tally sh eet,

Step # 6

6.1 conduct required quality checks and p ap erwork

Step # 5

5.1 sign off on checklist

Sign off Line Clearance

Remove splice and wind onto

new cores 4.2 jog web until sp lice p asses core4.3 cut off tail w ith sp lice and disp ose of it

4.4 attach new WO to core p er w ind instructions

roll doc area3.5 do not m ix rolls on p allets

Step # 4

4.1 p lace new cores onto rew ind arm s or sh afts

Step # 3

3.1 comp lete all docs in job jacket + p lace on p allet

Remove all of previous WO

from machine area

3.2 current job jacket on roll doc p allet if ap p lic.

3.3 move all current FG material to p allet wrap p ing

3.4 wrap p allet of roll doc material before moving to

Advance new WO thru

machine2.2 remove current slit rolls; sp lice stays on m 'ce

2.3 p lace core tags onto all rolls (roll doc & finish ed)

2.4 bag rolls (if required) roll doc rolls w sticker exp laining defect & WO)

Splice different WO's at

unwind1.2 signoff on Startup Checklist (cop y verified)

Step # 2

2.1 jog and stop sp lice just before rew ind nip

1.6 sp lice current WO & new WO w 2" brown tap e

Step # 1

1.1 verify new WO jacket samp le to new WO jumbo

MAJOR STEPS

KEY POINTS

Finishing Line Clearance

Packaging Suppliers must appreciate…

Controls need to be in place at the packaging manufacturer AND the food processor

HACCP Programs help identify places where controls can be implemented to address hazards

The HACCP approach is a proven food safety program accepted worldwide - the ultimate goals:

Protect consumers (Human and Animal)

Prevent / Eliminate Recalls

Adapted from: Food Safety Alliance for Packaging

The Food Safety Modernization Act

2/26/2013 12

most sweeping overhaul since the Great Depression

vastly broadens FDA power

main areas of enhancements:

Preventive controls - from response to prevention

(holds producer accountable for preventing contamination)

Inspection and compliance

Imported Food Safety

Response - recalls

FSMA signed into U.S. law Jan. 4, 2011

Everyone in the chain

must do their part.

2/26/2013 13

New rules may take several years to go into effect

Trend: though FDA does NOT require HACCP for packaging suppliers; customers increasingly require it!

Where FSMA is headed…. and what does it mean to packaging suppliers?

Preventive focus Proactive bias

2/26/2013 14

don’t fret the review process

see the big picture

common-sense prevails

implement proven concepts and systems

Do the things you know

are right …

…up-date and fine-tune

when rules go into effect!

Proactively prepare until rules finalize

FSMA is predominantly HACCP related …

2/26/2013 Source: Diagram adapted from Certified HACCP Auditor Handbook 15

Be practical: build upon existing GMPs and HACCP efforts!

Big Picture: It’s all about taking risk out of our operations through

v recognized Food Safety Management Systems

Follow the HACCP methodology…

HACCP requirement

1. Assemble the HACCP

team

2. Describe each product

type and distribution

3. Describe the intended

use and customers

4. Develop flow diagram

that describes process

for each product

5. Verify the accuracy of

the flow diagram 5

Pre

lim

inar

y Ta

sks

HACCP requirement

1. Conduct hazard

analysis

2. Identify CCPs

3. Establish critical

limits for each CCP

4. Establish

monitoring procedures

for each CCP

5. Establish corrective

actions

6. Establish verification

procedures

7 Establish record

keeping /documentation

procedures

7 H

AC

CP

Pri

nci

ple

s

GMPs / PRPs

CCPs

Primary Pitfalls in HACCP Plans

food safety policy, objectives, and HACCP plan goals and

responsibilities not adequately defined or communicated.

PRP’s not effective, and/or 5 preliminary steps and/or the 7 principles not well executed.

ineffective ownership and communication across the facility (trying to do it all yourself).

does not accurately reflect the actual products, processes, hazards, and controls.

Don’t overlook keys to success

2/26/2013 18

Hygienic Design Facility - equipment - workplace cleanable and accessible surfaces cleaning practices - tools & supplies

Education and Training

internal/external 100% involvement accountability

Partner with Suppliers and Food Customers concerns / solutions / validation events, technical committees

customers make us better!

Certification (trend: CPGs driving upstream)

Global Food Safety Initiative (GFSI)

Global Food Safety Initiative

2/26/2013 Source: adapted from GFSI website 20

Vision: Safe Food for Consumers Everywhere Mission: Driving continuous improvement in food safety to strengthen

consumer confidence worldwide 650+ members - offices on 3 continents - retail and manufacturing

How does GFSI work?

benchmarks existing food safety schemes

recognizes schemes which are equivalent to the Guidance Document requirements

Key intents:

consumer trust & supply chain safety

harmonization (reduced duplication)

competition (improvement of schemes)

comparable audits w/ equivalent results

a wishful thought … “once certified, accepted everywhere”

Growth of GFSI acceptance

At forefront in 2007: these retailers announce uniform acceptance of GFSI

benchmarked standards:

Companies now accepting or requiring GFSI recognized schemes

(retailers and manufacturers):

The Big 4 GFSI Schemes

The “Big 4” GFSI recognized Standards

2/26/2013 24

IFS – PACsecure

(http://www.ifs-certification.com)

FSSC 22000

(http://www.fssc22000.com/en/)

BRC – Food

(http://www.brcglobalstandards.com)

SQF

(http://www.sqfi.com/)

North American Packaging Supplier perspective

Currently seeking recognition

BRC – British Retail Consortium

2/26/2013 25

categories

high hygiene risk (direct food contact, or hygiene sensitive)

low hygiene risk (pkg for consumer products, non-contact

food pkg)

no separate document review

increased emphasis on factory floor

considers risk assessment based justifications

packaging focused standard -- global recognition

most prescriptive

broad coverage (product safety, quality, compliance)

FSSC 22000

2/26/2013 26

Food Safety Systems Certification

Defined in the two standards:

ISO 22000 – contains requirements for the Food Safety

Mgmt System

PAS 223 – contains requirements for PRPs

PAS 223 – outlines 15 PRPs associated w packaging

evaluates food safety only; not quality

Recertify every 3 yrs.

SQF -- Safe Quality Foods

2/26/2013 27

SQF has Two Codes SQF 1000 = Primary Producers SQF 2000 = Food Processors (and Packaging)

SQF has Three Levels of Certification Level 1 = Food Safety Fundamentals (GMPs, PRPs) Level 2 = Food Safety Plan (HACCP) Level 3 = Food Quality Plan (HACCP – driven)

Requires trained SQF Practitioner on-site Changes are made for compliance and CI:

GFSI Guidance (currently Issue 6) SQF (Edition 7)

Typical Audit Problems (example: SQF)

2/26/2013 28

poor understanding of Verification vs. Validation

verification (are we doing what we say we’re doing?)

validation (is it working? ..)

insufficient understanding of Food Safety Process

employees WILL get questioned

should have access to and be trained on and work to standards

recall teams have not drilled

suppliers not approved /monitored / reviewed

IFS PACsecure

2/26/2013 29

recently joined forces --- seeking GFSI recognition

developed by packaging suppliers and food industry

Codex principles

non-prescriptive, risk-based

excellent program with good tools and training

provides production-floor guidance

on-line training modules

approved by the Food Safety Alliance

for Packaging (FSAP) in the U.S.

Summary

HACCP is core - - regardless of scheme

Hazard Types

Chemical Physical Biological

Materials and Processes

Remember….

understand downstream uses

understand the distribution and ownership

inform your suppliers; hold them accountable

control what you can in your process

manage risks with strong PRPs or with CCPs

systematically address Biological, Chemical, & Physical risks ----- need competent workforce re:

material hazards

process hazards

monitor your control points

Adapted from: Food Safety Alliance for Packaging

Everyone benefits from Food Safety

secures public health and peace of mind

increases exporting opportunities

more conscientious workforce

a clean/hygienic workplace is more efficient - morale

protects reputation / brand equity

reduces business risk

smoother customer relationships; enables growth

key “trust” factor … just like any safety issue

Helpful Resources

Food Safety Alliance for Packaging www.iopp.org/fsap

HACCP Models

List of Service Providers -- training and other resources available (e.g., IFS PACsecure, GFSI Certification)

Adapted from: Food Safety Alliance for Packaging

2/26/2013 35

Blank area for graphics I’d like to thank members from the following organizations as well as

all contributors to the Food Safety Alliance for Packaging for providing content and conversation to support this presentation: