Transforming the Cold Chain

Module One

Standards and Technology for Maintaining Food Safety in Food

Transportation Cold Chain Processes

http://www.SanitaryColdChain.com

Transportation Food Safety Training, GAP Analysis and Certification Services

(TransCert.com)

http://www.sanitarycoldchain.com/

Workshop Schedule 08:30 Registration 09:00 Workshop commences 10:30 Morning refreshments and coffee break 11:00 Workshop re-commences 12:30 Luncheon 13:45 Workshop re-commences 16:00 End of Workshop


Instructor Dr. John M. Ryan

Retired Administrator Hawaii State Department of Agriculture

Quality Assurance Division


Dr. John Ryan is the retired quality assurance administrator for the Hawaii State Department of Agriculture and the owner of Ryan Systems, Inc. He has spent 30 years designing and implementing quality and operational control systems for international companies throughout Asia and the U.S. Ryan Systems specializes in helping select monitoring technology and designing the systems required for establishing food safety systems for the transportation sector. The company provides certification, gap analysis, training, planning and consulting services for companies in need of controlling food sanitation, traceability and monitoring during transportation processes.

The company owns and operates three websites: http://www.SanitaryColdChain provides training and certification audit functions for food carriers, maintenance stations and companies that transport food. http://www.RyanSystems.com is focused on consulting to help select food transportation traceability systems. http://www.QualityInFoodSafety.com provides training and planning services for food supply companies to use their current quality systems to establish and maintain systems that combine quality and food safety into a single system.


• Technology and Costs

• Impact of the U.S. Food Safety Modernization Act (FSMA)

• Current and emerging International Transportation • Food Safety Guidance and Laws

• Hard Data: What happens during cold chain food transportation • processes: Farms, air, ship, truck, trays, bins

• Management, HACCP implementation, sanitation, traceability

standards and record keeping requirements

• Implementing an auditable system

• Return on investment and marketing advantages

• The future of cold chain transportation food safety


We will cover

Transportation Delivery Controls

Sanitation and Traceability

Dr. John M. Ryan [email protected]

(808) 469-0046

Module 1


mailto:[email protected]

Welcome to class!


Ask questions any time.



What is your job title:

What is our company’s primary function?

Why are you in this training?

Your name:

Your email address:

Data

Agenda


• Some Definitions • Food Safety Modernization Act (food handling, transportation) - import, local and export • International food safety and temperature controls • The Cold Chain • Transporter, carrier and maintenance station standards • Sanitation and traceability technologies • Temperature tracking sensors that communicate via RFID • GPS tracking to provide the "ANYWHERE" data and GSM to communicate ANYTIME • Real-Time cold chain traceability approaches • Return on investment (ROI) issues • Plastic pallets: costs, weight, recycling, cleaning, food safety • Continuous improvement controls • Capturing data from the grower pallet loop • Intelligent routing configuration from cooling, at the distribution center and during transit • How the system can be designed to provide anytime/anywhere transportation control data

Food on the move

Cold Chain Market is Poised to Grow at a CAGR of 13.2% &

to Reach $157,142.2 Million by 2017

New Report by MarketsandMarkets



CONTAINER: Any device used to transport food or food products between or among distant operations. Containers include bins, trays, pallets, trucks, truck trailers, shipping containers and other similar devices and are used to move or hold food on the move. The term “device” excludes what is commonly referred to as packaging. CARRIER: Any company or individual responsible for the transportation of food and food products MAINTENANCE STATION: Any company involved in the sanitation or traceability implementation for carriers or containers. FOOD SAFETY: Freedom from adulterants including chemical, bacteriological, radiological, or metal, glass, wood, etc. FOOD QUALITY: Appearance (commodity standards), taste and nutrition

A Few Definitions


System Goal


Homeostasis

A process in which the body's internal environment is kept stable.

View transportation as a process – Farm to Fork

The idea of limited responsibility for food safety and quality as food moves through

the supply chain is dying out.

“One Up and One Down”

One up and one down is dead!

Harvest to Bins

Truck (Reefer)

Distributor (Wholesale)

Truck (Shipping Container)

Pallet Packing House (Cold)

Ship

Chiller

Dock Load Truck

Dock Unload

Re-Pallet Distributor (Wholesaler) Truck Chiller Store

Shelf (Remaining Shelf Life)

Car Purchase Prep- Cook

Refrigerator Yum!

The Cold Chain


Prevention Versus Corrective Action

Prevention requires causal analysis and removal of causes. Corrective action means to get a quick fix in place to stop and control escaped products. Generally considered a material review board (MRB) activity. (More later)

Quality Control and Food Safety

Quality Control to provide stability and control over transportation processes Food Safety to prevent adulteration of food in short and long transportation processes

Current food safety certification activities are moving towards applying both food safety and quality control principles and practices into “food safety” certification.

Exercise


1. Draw a quick flow of your transportation process 2. On your drawing, make notes showing how you control the process. You may show inspections, temperature measurements, food safety certification points at farms, distributors, etc. or other details that you know about.


What’s wrong with this picture?




Water Soil Produce

FARM USHI9Y4 Pesticides and

ChemicalFertilizers

MicrobialUnknowns

Samples

Lab AnalysisPrimary RiskAssessment (1)

Site Visit RiskAssessment

Food SafetyCertification (3)

CertificationAuditor

Central HostedSystem (5)

System Reports

DistributionCenter

Restaurant

Retailer

Public ID# AccessUSHI9Y4

Food Supply Chain Traceability System (2)

Real-Time Biosensors & Temp/Hum Sensors (4)

VBA MarketingCapabilities

23

Think “System”


The Warm Chain Countries with no or limited refrigeration: Duration = 1 Day Distance = Less than 50 miles Distribution = Simple 1. Harvest 2. Market 3. Preparation 4. Eat

The Cold Chain Duration = Shelf Live Distance = Thousands of Miles (international) Distribution = Complex

Evolution of Food Transportation Models


Three primary factors cause food suppliers to adopt food safety measures:

Market Forces – Risk of recall forces buyers to purchase from safety certified sources (Customers can’t afford to pay for your problems) (Standards like ISO 22000 cascade downward) Product Liability – You are liable for what you buy and sell. Insurance costs go up as suppliers are forced to pay for recall and food safety coverage – lawyers get rich. Food Safety Laws and Regulations - Government involvement and oversight increases (HR 2749, SB 510 = FSMA)


The U.S. Food Safety Modernization Act Impact to the Entire Food Chain

A. From Farm-to-Retail B. Local and Imported (Same Requirements) C. Heavy Fines ($244/Hour for Inspection) D. Stoppage of shipments “Suspected” of adulteration E. Vicarious Liability (is Shared - Top to Bottom) F. New Documentation Requirements to prove all handlers control their suppliers and all trucks, bins touching food are sanitized, tracked and controlled. Enhanced Tracking and Tracing and Recordkeeping of Food and Containers Provisions for secure electronic data sharing Pallet level Temperature Control Monitoring for produce food safety, frozen foods, etc. (HACCP)


Establishment of Plans Focused on Hazards and Prevention

Hazard Analysis

Preventive Controls (Causal Analysis)

Monitoring

Corrective Action

Verification

Record Keeping

FSMA: Importing to the U.S.

Critical Control Points (CCP) Debate

Goal: Reduce risks to human health and prevent deaths

Appropriate temperature control during transport; Sanitation, including:

Monitoring and ensuring the sanitation and condition of transportation vehicles as appropriate; Pest control; and Sanitation associated with loading/unloading procedures;

Appropriate packaging/packing of food products and transportation units (e.g., good quality pallets, correct use of packing materials); Good communications between shipper, transporter and receiver; Employee awareness and training

FDA Guidance for Industry: Sanitary Transportation of Food


Vicarious liability is a form of strict, secondary liability that arises under the common law doctrine of agency – respondeat superior – the responsibility of the superior for the acts of their subordinate, or, in a broader sense, the responsibility of any third party that had the "right, ability or duty to control" the activities of a violator. It can be distinguished from contributory liability, another form of secondary liability, which is rooted in the tort theory of enterprise liability. Product Liability is the area of law in which manufacturers, distributors, suppliers, retailers, and others who make (or grow) products available to the public are held responsible for the injuries those products cause

From Wikipedia, the free encyclopedia

Vicarious and Product Liabilities


http://en.wikipedia.org/wiki/Strict_liability

http://en.wikipedia.org/wiki/Secondary_liability

http://en.wikipedia.org/wiki/Common_law

http://en.wikipedia.org/wiki/Agency_(law)

http://en.wikipedia.org/wiki/Respondeat_superior

http://en.wikipedia.org/wiki/Contributory_liability

http://en.wikipedia.org/wiki/Tort

http://en.wikipedia.org/wiki/Enterprise_liability

http://en.wikipedia.org/wiki/Product_%28business%29

http://www.ers.usda.gov/amberwaves/february08/datafeature/



Establishing Standards for Food Transporters


33


Four Primary Container Standards

Management

HACCP

Sanitation

Traceability

Container Standards

Container Maintenance Maintenance Capabilities Maintenance Stations • Independent Sanitation (Wash) • Company Owned Sanitation • Independent Traceability/Monitoring • Company Owned Traceability/Monitoring

1. Is there a documented container sanitation and traceability policy detailing the company's

commitment to safe food transportation?

2. Is there a container sanitation and traceability component to the company's food safety manual?

3. Is there a detailed organizational structure chart of all employees whose activities affect container sanitation and traceability?

4. Is there a specific individual named with primary responsible for container sanitation and traceability?

5. Is there evidence of an annual container sanitation and traceability system review by

management level personnel?

6. A container sanitation and traceability HACCP Plan exists and is reviewed annually: Auto Fail if no HACCP Plan

7. Does a system for maintaining HACCP records exist?

8. Is there a numbering and filing system that makes container sanitation and traceability procedures easy to find?

System Management Standards (1)


9. Filing system is organized to include HACCP, management, sanitation and traceability. 10. Container records are inspected to determine records maintenance and accuracy.

11. Preventive planning and implementation activities include causal analysis, cost analysis, action plans, measurement and implementation results.

12. Preventive action program activities are recorded.

13. The preventive action component establish elimination of causes as a primary goal. 14. A system for corrective action records is maintained.

15. Data for proof of prevention is available.

16. Container records merge container ID, sanitation and traceability and corrective action information electronically for fast recall.

17. Container sanitation and traceability records are maintained for at least two years?

System Management Standards (2)


HACCP • • Analyze hazards (contaminants, adulterants)

• • Identify critical control points

• • Establish preventive measures with critical limits for each control point • • Establish procedures to monitor the critical control points

• • Establish corrective actions to be taken when monitoring

• • Establish procedures to verify that the system is working

• • Establish effective recordkeeping


Container HACCP Standards

(1 – Planning) •A HACCP Plan exists •The plan is supported by procedures •A support team is in place •HACCP training is ongoing •There is location specific information in all records •HAZARDS are identified •CCPs are identified •CRITICAL Limits are identified •Monitoring procedures assure critical limits are met •CORRECTIVE ACTIONS keep adulterated food out of commerce •RECORD KEEPING documents CCP monitoring •VERIFICATION ACTIVITIES are listed •VERIFICATION ACTIVITIES are implemented •HACCP plan is signed and dated


Container HACCP Standards (2 – Implementation) 1. MONITORING and RECORDKEEPING procedures are implemented. 2. RECORDS contain actual values obtained. 3. Data is recorded when collected. 4. RECORDS and timeframes are reviewed 5. RECORD formats meet general requirements are performed and documented. 6. CORRECTIVE ACTIONS are documented, taken, recorded reviewed, and prevent food from entering commerce. 7. PREVENTIVE ACTIONS are taken, documented and reviewed within timeframes. Instruments are CALIBRATED according to established procedures. 8. CALIBRATION RECORDS REVIEW are performed and assure procedural conformance. 9. VERIFICATION activities are performed include complaints, calibration, monitoring and records review and are documented. 10. CORRECTIVE ACTION is completed when required by VERIFICATION. 11. HACCP records are maintained for 2 years and available to copy.


Container Sanitation • Container Adulteration Prevention Planning • Container Sanitation Procedures • Containers have unique ID numbers • Records are maintained for each Unique Container ID Number • Container sanitation • Container Inspection • Inspection Data Sheets are available • If Fail, containers are sanitized • Containers are tested for sanitation • If Fail, Containers are retested • Container ATP test data is required • Pre and Post Inspection Reports are Maintained • The water source is recorded • Wash water is tested against city standards on an annual basis • Water quality must meet city standards • Wash water temperatures are verified annually • Temperature measurement devices are calibrated • The container is pest free • Container is dedicated to food transportation


Transportation Controls


Truck Washout


Mobile Truck Washout


Harvest Bin Sanitizers



Container Traceability • A container traceability system has been defined and is in place • Traceability plan • Responsibilities • Training plan • Competency • Monitoring • Records • Performance • Internal Audits • Management Review • Corrective Action • Recall procedures exist • Recall system has been tested • Pallet Level Traceability is functional • Container Tampering • Container accident control procedures exist • Container accident control records exist


47


Farm to Retail Stream


49

Load Pallet

Tag CasesWith

Bar CodeTags

RFID Temp-TagPallet

PalletShip

Read Data

Parent-ChildRFID/BarCode

Data RelationshipEstablished

Farm Level

Handheld

LocalKn ow-Th e-Flow

Database

At the Farm


50

RFID PalletTag Temp Reads

Pallet TagReads at

Dist Center Incoming

Pallet TagReads at

Dist Center Cooler-In

Transit



Portal

Portal

Handheld

RFID Temp-Tag Pallet

OutgoingPallet Build

LocalKnow-the-Flow

Database

Tagged CasesWith HarvestMark

Bar CodeTags

Read DataCooler/Ship Out

DistributionCenter

Distribution


Retail OutletIncoming

Handheld


HandheldRetail Outlet

Incoming

Handheld



Incoming

Handheld


Handheld

Retail ChainKnow-the-Flow

Database

Retail Tracking


52

Load APPPallet

Tag Cases WithHarvestMark

Bar CodeTags

Intelleflex RFIDTemp-Tag

Pallet

APP PalletShip

Read Data

Intelleflex RFIDAPP Pallet

Tag Temp Reads

Intelleflex Pallet TagReads at

Dist Center Incoming

Intelleflex Pallet TagReads at

Dist Center Cooler-In

ezTRACKor

InternetPrimaryTrackingDatabase



Farm Level

Transit



Handheld

Portal

Portal

Handheld

Intelleflex RFIDTemp-Tag

APP Pallet

OutgoingPallet Build

LocalIFSS

Database

Local IFSSDatabase

Tagged CasesWith HarvestMark

Bar CodeTags

Read DataCooler/Ship Out

DistributionCenter


Handheld



Incoming

Handheld



Incoming

Handheld

RetailOutlet

Handheld

Retail ChainIFSS

Database

Cold Chain Traceability


Pallet versus Container Tracking (Intermodal Monitoring)

Pallet: Track from Farm into distribution using Pallet tags (and maybe case Level barcode tags)

Container: ILC or RFID GPS Real-time satellite or RF





Pallet (Plastic) Traceability



Container Level Traceability Technology




Container Tracker with eSeal and Mapping


Financial Losses to the Industry: Waste

Inspection Yield Culls Recalls Rejected Disposal Returned Loads Lost Customers

The Supply Chain Ignores Losses Throughout


Supply Chain Loss Analysis


Summary


Why the waste?


Lack of or Improper Pre-cool Contributes to the Losses


Mexico to California – Truck 1031 Ambient Air INSIDE of FLAT (the real temperature to consider)


1. Lots of temp variation during that early handling - and even on the ship - these warmer temps mean shorter shelf life - easily shorter by a few days. 2. Relative stability during sea transport – But lines trend upwards indicating that the pallet was warming during ship transportation for some reason. 3. Top of pallets are warmer than bottom - by up to 5 degrees F.

Lack of Shipment Controls Add to Pre-cool Problems



Pallet Temperatures


Pallet Temperatures

Some Solutions


Intelligent Delivery Control Systems

Real-Time GPS & Sensor Enabled Tracking & Detection

Temperature Explosives

Bacterial Contamination

Shipper S/O

Invoice 10 + 2


Receiving Docks

Shipping Docks

Cooler Cooler Cooler Cooler

Cooler

Portal

Portal

Portal

Portal

CONFIG

PO/SO Invoice 10 + 2

Tag Read Stop Tag Start Read

Truck To Air Cargo At the Distribution Center

RFID Fixed Readers

RFID Fixed Readers

GPS/GMS Read/Transmit

En-route SAT/Cell

Inbound Pallets

Intelligent Routing Configuration



RFID Temperature Sensor

Waypoint Reads

Train

Ship

Truck

SAT British

Telecom

Cell

GPS GMS

Shipping Container

(ID)

Plastic Pallet

RFID Tags

GS1 HK

GTS

ARKNAV Module Explosive Sensor

Contamination Sensor Tamper Detection

Sensor (eSeal)

DHS CBP IFS




• Identity – What is it?

• Location – Time/LAT/LON (Track)

• Condition – Quality Control Requirements Temperature Cleanliness (Sanitation) • History – Records – Source/Handlers

• Cost - ROI

ILC


Real-Time Visibility


All Supplier, Reefer,Distributor, Store Data

housed in Corporate Server

Supplier

Supplier

Supplier

DistributionCenter

Store

Store

Store

Store

Store

Store

Supplier

Supplier

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

All Tag Temp/Time DataAvailable viaBlueTooth

ZigBee Systems

Supplier

Supplier

Supplier

DistributionCenter

Store

Store

Store

Store

Store

Store

Supplier

Supplier

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer


All Supplier, Reefer,Distributor, Store Data

housed in Corporate Server

Supplier

Supplier

Supplier

DistributionCenter

Store

Store

Store

Store

Store

Store

Supplier

Supplier

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer


Supplier

Supplier

Supplier

DistributionCenter

Store

Store

Store

Store

Store

Store

Supplier

Supplier

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer


Supplier

Supplier

Supplier

DistributionCenter

Store

Store

Store

Store

Store

Store

Supplier

Supplier

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer

Reefer



ZigBee Systems

Receiver

Repeater(Optional)

Mobile Modules

Facility Modules

Facility Modules

Receiver - USB Cable to PC or Laptop

Network PCs

ZigBee Systems



Reader

ComputerFacility Layout Supplier Distributor Store

FloorTag

CoolerTag

CoolerTag

ReeferTag

Tag

ZigBee Systems


Maintenance: Container Sanitation and Test

Maintenance: Container Sanitation and Test

InterModal

ROI Issues

Old Process (A) Define the process steps (flowchart or using the process SOP) Add up man hour and other costs for each process step Add up all costs for a single event (or sample and take the average). Proposed Process (B) Define the process steps for the “NEW” process Add up man hour and other costs for each process step Add up all costs for a single event If the new process is cheaper, try to figure out how many times per year that particular process is actually done (Estimate it!). Multiply that number by the new process cost for years 1, 2 and 3 (for both A and B). Subtract the cost of the Proposed Process from the cost of the Old Process (B-A) If B minus A is negative, the old process is cheaper (keep it). If B minus A is positive, the new process is cheaper – show your analysis to your boss.

ROI Depends on Process Comparison

Run ROI Calculations for Losses Due to Waste


Shipment & Tracking Results


GPS/Temp Tracking From So. Cal Farm to Port



Capturing product event data (traceability information and temperature status) in real-time


http://www.google.com/imgres?imgurl=http://www.odt.co.nz/files/story/2008/11/pacifica_shipping_s_new_vessel_spirit_of_endurance_3762392604.jpg&imgrefurl=http://www.odt.co.nz/news/business/30233/container-service-link-port&usg=__5kFL5WG4Op0vTxrQy1Hhh-4-qNs=&h=585&w=800&sz=80&hl=zh-TW&start=4&zoom=1&um=1&itbs=1&tbnid=aPF8WIuh2F9GVM:&tbnh=105&tbnw=143&prev=/search?q=shipping+port&um=1&hl=zh-TW&sa=N&rls=com.microsoft:zh-hk:IE-SearchBox&rlz=1I7MOOI_zh-TW&tbm=isch&ei=2crxTeH8O42mvQPn4cCVBA

http://www.google.com/imgres?imgurl=http://www.americanexpress.com/hk/en/personal/Cards/rewards/images/watsons_wine_cellar_web.jpg&imgrefurl=http://www.americanexpress.com/hk/en/personal/Cards/rewards/10x_watsons_wine_cellar.shtml&usg=__DTEcSyuijvYFFtWnhPxlLMJkcP8=&h=130&w=125&sz=31&hl=zh-TW&start=27&zoom=1&um=1&itbs=1&tbnid=uUdEPaAWNwJrbM:&tbnh=91&tbnw=88&prev=/search?q=watson's+wine+cellar&start=20&um=1&hl=zh-TW&sa=N&rls=com.microsoft:zh-hk:IE-SearchBox&rlz=1I7MOOI_zh-TW&ndsp=20&tbm=isch&ei=Wc3xTbGtEoKevgO935ikBA

2nd GPS/Temp Trans-Pacific Tracking (7 Days)

Consolidation Center (LA) Truck Pier On Board Receipt in HNL


Make container sanitation and traceability an installed part of the basic business strategy. It will help you sell more product.

The Bottom Line


Exercise 2

1. Look at the drawing you made in Exercise 1. 2. On your drawing, show any changes you might make to your original drawings.


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