Transforming the Cold Chain

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)

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
jryan@SanitaryColdChain.com
(808) 469-0046
Module 1

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
LoadTruck
Dock
Unload
Re-Pallet
Distributor
(Wholesaler)
Truck ChillerStore
Shelf
(Remaining
Shelf Life)
Car PurchasePrep-
Cook
RefrigeratorYum!
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
Chemical
Fertilizers
Microbial
Unknowns
Samples
Lab Analysis
Primary Risk
Assessment (1)
Site Visit Risk
Assessment
Food Safety
Certification (3)
Certification
Auditor
Central Hosted
System (5)
System Reports
Distribution
Center
Restaurant
Retailer
Public ID
# Access
USHI9Y4
Food Supply Chain Traceability System (2)
Real-Time Biosensors & Temp/Hum Sensors (4)
VBA Marketing
Capabilities
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://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 Cases
With
Bar Code
Tags
RFID Temp-Tag
Pallet
Pallet
Ship
Read Data
Parent-Child
RFID/BarCode
Data Relationship
Established
Farm Level
Handheld
Local
Know-The-Flow
Database
At the Farm

50
RFID Pallet
Tag Temp Reads
Pallet Tag
Reads at
Dist Center Incoming
Pallet Tag
Reads at
Dist Center Cooler-In
Transit
Parent-Child
RFID/BarCode
Data Relationship
Established
Portal
Portal
Handheld
RFID Temp-Tag
Pallet
Outgoing
Pallet Build
Local
Know-the-Flow
Database
TaggedCases
With HarvestMark
Bar Code
Tags
ReadData
Cooler/ShipOut
Distribution
Center
Distribution

Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail Chain
Know-the-Flow
Database
Retail Tracking

52
Load APP
Pallet
Tag Cases With
HarvestMark
Bar Code
Tags
Intelleflex RFID
Temp-Tag
Pallet
APP Pallet
Ship
Read Data
Intelleflex RFID
APP Pallet
Tag Temp Reads
Intelleflex Pallet Tag
Reads at
Dist Center Incoming
Intelleflex Pallet Tag
Reads at
Dist Center Cooler-In
ezTRACK
or
Internet
Primary
Tracking
Database
Parent-Child
RFID/BarCode
Data Relationship
Established
Farm Level
Transit
Parent-Child
RFID/BarCode
Data Relationship
Established
Handheld
Portal
Portal
Handheld
Intelleflex RFID
Temp-Tag
APP Pallet
Outgoing
Pallet Build
Local
IFSS
Database
Local IFSS
Database
TaggedCases
With HarvestMark
Bar Code
Tags
ReadData
Cooler/ShipOut
Distribution
Center
Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail Outlet
Incoming
Handheld
Retail
Outlet
Handheld
Retail Chain
IFSS
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

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
CoolerCoolerCooler Cooler
Cooler
P
o
r
t
a
l
P
o
r
t
a
l
P
o
r
t
a
l
P
o
r
t
a
l
CONFIG
PO/SO
Invoice
10 + 2
Tag Read StopTag 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
PO/SO
Invoice
10 + 2

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
PO/SO
Invoice
10 + 2
PO/SO
Invoice
10 + 2

• 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
Distribution
Center
Store
Store
Store
Store
Store
Store
Supplier
Supplier
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
All Tag Temp/Time Data
Available via
BlueTooth
ZigBee Systems

Supplier
Supplier
Supplier
Distribution
Center
Store
Store
Store
Store
Store
Store
Supplier
Supplier
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Available via
BlueTooth
All Supplier, Reefer,
Distributor, Store Data
housed in Corporate
Server
Supplier
Supplier
Supplier
Distribution
Center
Store
Store
Store
Store
Store
Store
Supplier
Supplier
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Available via
BlueTooth
Supplier
Supplier
Supplier
Distribution
Center
Store
Store
Store
Store
Store
Store
Supplier
Supplier
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Available via
BlueTooth
Supplier
Supplier
Supplier
Distribution
Center
Store
Store
Store
Store
Store
Store
Supplier
Supplier
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Reefer
Available via
BlueTooth
ZigBee Systems

Receiver
Repeater
(Optional)
Mobile Modules
Facility Modules
Facility Modules
Receiver - USB Cable to PC or
Laptop
Network PCs
ZigBee Systems

Reader
Computer
Facility Layout
Supplier
Distributor
Store
Floor
Tag
Cooler
Tag
Cooler
Tag
ReeferTag
Tag
ZigBee Systems

Maintenance: Container Sanitation and Test

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
http://www.SanitaryColdChain.co

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

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.

AFRIS. AsianFoodRegulationInformationService.
We have the largest database of Asian food regulations in the world and it’s
FREE to use.
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food events and online educational webinars and continue to grow our Digital
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www.asianfoodreg.com
adrienna@asianfoodreg.com

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