Role of Analytical Capability in the Execution of a Comprehensive Food Safety / Quality Plan

John WardDirector , Global Quality Analytical ServicesThe Coca-Cola Company

FACE – CII ConferenceNew Delhi, IndiaOctober 12, 2012

“Quality is more than just something we taste or see or measure…..quality shows itself in our every action. From Processing to Packaging to Pouring, nothing less than 100% quality is acceptable”

The Coca Cola Quality Management System 1996

Our Commitment to Quality

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One of the Greatest Challenges we have faced as Food Safety Professionals over the past 10-15 years

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Points for Discussion

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• Company’s must find a way to “manage information” before “information manages you” !!

• Connected consumers will drive expectations …whether we have prepared / are prepared to deal with them or not

• At what point do “perception” and “reality” collide?

• A strategy built around “analytical intelligence” can effectively enable a robust food safety program

• How Coca-Cola has enabled analytical capability to enhance food safety performance

The Power of the Internet

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* September 2009Asia – 922.2MM in 2011

The Power of the Internet

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Asia – 922.2MM in 2011

555 Million websites300 Million websites added 2011

2.1 Billion Web Users1 Billion Facebook Users

255 Million Twitter accounts250 Million Tweets per day

Food Safety Blog (example)

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Show us the data, forget the faith; food sickens millions as company-paid checks find it safePosted on October 11, 2012 by Doug Powell

• THE FOOD INDUSTRY HIRES FOR-PROFIT INSPECTION COMPANIES — KNOWN AS THIRD-PARTY AUDITORS — WHO AREN’T REQUIRED BY LAW TO MEET ANY FEDERAL STANDARDS AND HAVE NO GOVERNMENT SUPERVISION.

• THE PRIVATE INSPECTORS THAT COMPANIES SELECT OFTEN CHECK ONLY THOSE AREAS THEIR CLIENTS ASK THEM TO REVIEW. THAT MEANS THEY CAN MISS DEADLY PATHOGENS LURKING IN PLACES THEY NEVER EXAMINED.

• IN SOME CASES, FOR-HIRE AUDITORS HAVE FINANCIAL TIES TO EXECUTIVES AT COMPANIES THEY’RE REVIEWING.

• AS FLAWED AS THE INSPECTION SYSTEM IS IN THE U.S., IT’S MORE PROBLEMATIC WITH IMPORTED FOOD, ESPECIALLY COMING FROM COUNTRIES WITH LOWER SANITARY STANDARDS, SAYS MICHAEL DOYLE, DIRECTOR OF THE UNIVERSITY OF GEORGIA’S CENTER FOR FOOD SAFETY. IN SOME EMERGING MARKETS, FARMS GROWING FOOD FOR EXPORT TO THE U.S. AREN’T INSPECTED AT ALL.

• “IF YOU HAVE A PROGRAM FOR ADDING RAT POISON TO A FOOD, THE AUDITOR WILL ASK, ‘DID YOU ADD AS MUCH AS YOU INTENDED?”’ SAMADPOUR SAYS. “MOST WON’T ASK, ‘WHY THE HELL ARE WE ADDING POISON?”’

• NOT ONLY HAS THE GOVERNMENT OUTSOURCED AUDITING TO THE FOOD INDUSTRY; THE AUDITORS THEMSELVES OFTEN OUTSOURCE THEIR VETTING TO INDEPENDENT CONTRACTORS — PEOPLE OVER WHOM THEY DON’T HAVE DIRECT MANAGEMENT CONTROL.

http://barfblog.com/show-us-the-data-forget-the-faith-food-sickens-millions-as-company-paid-checks-find-it-safe/

How Low Can We Go…….the “Vanishing Zero”Abbrev. Notation Equivalence Just How Small Exactly Comment

ppm parts per million

1ppm 1 second in 280 hoursThese measures have been

standardized in chemistry since 1920s

= 1 part in 1,000,000 1 cent in $10,000

= 1 mg/L 1 cm in 10 km

1 teaspoon of water in a bathtub

ppb parts per billion

1 ppb 1 second in 32 years

Ppb became common in the 1960s as analytical techniques improved

= 1 part per 1,000,000,000 1 cent in $10,000,000

= 1 microgram / L 1 cm in 10,000km

1 drop of ink in 75,000L of water

ppt parts per trillion

1 ppt 1 second in 320 centuries The remarkable advances in the sensitivity of modern techniques in

the 1980's made it possible to detect some substances at ppt levels .

= 1 part per 1,000,000,000,000 1 cent in $10,000,000,000

= 1 nanogram / L 1 cm in 10million km

1 drop of ink in 75 million litres of water

ppq parts per quadrillion

1 ppq 1 second in 32 million yearsThe ability to measure contaminants such as dioxin and radioactivity to

ppq levels is now possible following advances in instrumentation in

recent years.

= 1 part in 1,000,000,000,000,000 1 cent in $10,000,000,000,000

= 1 picogram / L 1 cm in 10 billion km

1 drop of ink in 75 billion L of water

1 human hair off all the heads in the world

Where do “Perception” and “Reality” meet??

Creating Perception – if Company’s choose not to test, others will

Perception or Reality - Emerging risks

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Reality - Food Safety

Reality - Food Safety

• Connectivity of consumers to food safety / quality information (good and bad)

• Diversification of Portfolio to meet Consumer demands

• Food Recalls Eroding Consumer Confidence

• Food Safety Systems Evolving / Regulations changing rapidly

• Environmental Changes bringing New Challenges

With the world in constant change, Company’s must take an honest look in the mirror ……. and determine how to proactively identify / meet the new business realities

• Demographics Changing Rapidly (age, urbanization, size, availability of resources)

• Businesses Growing Globally versus locally (borderless societies)

• Media Created Perceived Risks

• “Brand Jacking” / “whistleblowing”

• Health strategies shifting from the Medicine Cabinet to the Refrigerator

● Unimpeachable product quality● World-leading environmental care● Top-notch regulatory tracking and

management● Sustainable management systems

● World Class Analytical capability

What we saw at Coca-Cola was a need to redefine our capability and capacity in order to become a recognized global leaderWhat we saw at Coca-Cola was a need to redefine our capability and capacity in order to become a recognized global leader

In isolation does not add strategic value. Must be in alignment with :

• Integrated supplier management process

• Effective manufacturing systems, processes and controls

• Well defined scientific & regulatory affairs framework

• Process to identify and trend global risks and threats eg Advanced Warning and Threats (AWAT) assessment process

When all of these elements are fully integrated and aligned

• Enables effective identification and management of food safety risk

• Defines processes to drive proactive risk mitigation versus reactive risk removal

Key criteria for success / Decision points• Insourcing versus outsourcing (buy it

or build it)• Must stay current / relevant…..or

world will pass you by

Why is Analytical Capability a strategic pillar?

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Food Safety & Quality Assurance

An Effective Analytical Strategy must consider the entire supply chain…… from Conceptualization to Consumption

Distribution

Conceptualization Consumption

Food Safety & Quality Assurance

Product Integrity testing Regulatory complianceSupplier authorizationRisk based monitoring Adv. Troubleshooting Consumer quality monitoring

ManufacturedQuality

Incoming receipt testingWater quality monitoring Production monitoring Environmental monitoring Product release

Research and Innovation

Breakthrough InnovationFunctional Performance Product stabilityProduct registrationConnection to marketing /

customer

North America Analytical Services Atlanta, GA

Eurasia Analytical Services Pune, India(June 2009)

Total associates worldwide : 206 / 11% US ; 89 % Non US basedTotal associates worldwide : 206 / 11% US ; 89 % Non US based

Latin AmericaAnalytical Services

Mexico City, MX(July 2009)

Africa Technical Center

Johannesburg, SA(March 2008)

European Union Analytical Services

Brussels, Belgium(2002)

Asia PacificTechnical Center

Shanghai, China(March 2009)

Our focus at Coca-Cola has been on enhancing our analytical framework through a global network of Technical Centers of Excellence

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Eurasia Analytical Services Center Location : Pune IndiaDirector : Mr Navneet MehtaOpened : February 2010Size : 2000sqm / 20,500 sq ftCountries supported: 33No of associates : 18Programs: Consumer Quality program

Product Integrity ProgramCO2 Monitoring programIS14543 TestingMicrobiological analysisSensory testingAdvanced Troubleshooting

Equipment: UPLC / LCMSMSGC/GC MSICP MSAAFTIRPhysical / wet chemistry

Provide critical support and leading analytical intelligence on the quality and integrity of our ingredients and products in order to enhance food safety and quality performance, enable innovation and drive our long term strategic growth

• Key components of GQAS activities• Brand / trademark protection (governance)• Timely support for investigations and incidences• Routine testing / quality monitoring programs• M&A support (due - diligence /risk assessment )• Capability development / operations support

Objective of GQAS Organization

Our Responsibility / opportunity is simple:“Ensure every consumer receives the perfect product ….every time”

…… “Perfect Product, Trusted everywhere”.

Our Challenge though is immense:• 1.7 billion servings per day• 3000+ beverage products (480 brands)• 1.2 trillion liters of beverage per year• 3.5 trillion liters of water per year• 1100 + manufacturing locations • 5000+ ingredients / 10,000+ suppliers• 1 million + fountain outlets• 3 million + vending machines• 40 million + customers • 150 million points of sale

Coca-Cola Global Analytical Capability

It is not possible to test every product …..what is possible;

To define a mitigation strategy… one that delivers programs that help us obtain a greater understanding of our ingredients and products in order to drive quality, ensure food safety and address risk … Proactively

To deliver programs that address our due-diligence obligations as the owner of the trademark in order to have a baseline understanding of the quality and integrity of our ingredients and products

…..BEFORE OTHERS SEEK TO DO SO

………the Reality of any Analytical program

Consumer Quality Monitoring Program (TSP)

Traditional Critical-to-Consumer quality parameters• Beverage and Package Appearance• Torque• Carbonation• Micro• Brix / aspartame• Acidity (TTA/PO4)• Caffeine• Net content / weight• Product age

Test Laboratories : All

Product Integrity Program Risk-focused Food Safety assessment of Products• Consumer quality attributes• Intended / regulated compounds • Label claims• Unintended / regulated compounds

Key areas of focus• Growing beverage categories eg dairy, soy, tea, sports/energy drinks• New product Integrity /risk assessment as part of commercialization• Special projects

Testing Laboratories : All (includes internal outsourcing)

Global Monitoring ProgramsPackaged Water Quality• Compliance to Company and local regulations (eg IS14543• Test Methods : Residues / Metals / VOC’s / sVOC’s /

inorganics / organics microbiology / Disinfection and Disinfection by-products

Global Monitoring ProgramsCarbon Dioxide• CO2 quality monitoring

• Samples obtained from bottling plants to verify supplier performance and testing capability against BP-SP-110 & BP-SP-545 (eg Volatiles / Btex / light hydrocarbons / Sulphurs / NOX / permanent gases (O2/N2/H2)

Testing Laboratory : Eurasia Analytical Services CenterAsia Pacific Technical CenterEU Analytical ServicesLatin America Analytical Services (inc. N. America)Africa Technical Center

Developing a comprehensive analytical /risk focussedprogram requires planning and a little “imagination”

DiscoveryImagination

Quality Food Safety

Quality Specifications

Scientific Research

Audit data

Processing information

Historical performance

Supplier information

Predictive Modeling

Building a Test Protocol

Analytical Intelligence

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“ The laboratory is an extension of our senses, enabling us to obtain data on substances beyond what we can see with the naked eye and in amounts that our hands could never achieve. Data is compiled into reports and is ultimately used for making decisions ; decisions that cannot be confirmed with our unaided senses.The quality of any of these decisions is absolutely dependent on the quality of the data ; junk data leads to junk decisions.”

Thomas Layoff FDA

Legally Defendable

Success….the ability to ANTICIPATE the next threat, proactively mitigating risk

Athletes like Sachin Tendulkar and Pele have had no rivals in their intelligence and reading of their respective sports, being able to anticipate where the ball is going and executing the right moves at the right time.

Although success will allow us to anticipate emerging issues, we must also be prepared to REACT

Classified - Internal use

THANK YOU

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Appendix

The World’s Greatest Brands . . . and Growing

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….Largest Consumer Goods System in the World

Operating in more than

200 countries

1.7 billion servings per

day

20 million customer visits

per week

1 MM fountain outlets

$50 Billion dollar supply

chain

3000 products 500 brands 1100

Manufacturing Locations

500,000 trucks5 x UPS

300 Franchise Bottlers

92,400 associates1MM + worldwide

Our Analytical Instrumentation …• Gas Chromatography with detection using

MS, dual ECD, dual NPD, dual FPD, FID, Ion Trap for liquid, headspace, Twister, SPME, and automated extraction using DBX

• Liquid Chromatography using UPLC and HPLC with detection of MS/MS, MS/TOF, PDA, UV/Vis, Fluorescence, ELSD, and RI

• Ion Chromatography with detection using UV/Vis, Amperometric, Fluorescence, Conductivity, and MS

• Metals analysis using ICP-MS , ICP-OES and CVAFS for dedicated mercury analysis

• Stability Chambers with computerized monitoring of temperature and humidity

• Infrared Spectroscopy using FT-IR and RAMAN

• Instrumentation for Beverage Quality Testing