transforming the cold chain
TRANSCRIPT
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
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Instructor Dr. John M. Ryan
Retired Administrator Hawaii State Department of Agriculture
Quality Assurance Division
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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.
http://www.SanitaryColdChain.com
• 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
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We will cover
Transportation Delivery Controls
Sanitation and Traceability
Dr. John M. Ryan [email protected]
(808) 469-0046
Module 1
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http://www.SanitaryColdChain.com
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
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• 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
http://www.SanitaryColdChain.com
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
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System Goal
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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
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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
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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.
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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
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Think “System”
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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
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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)
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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)
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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
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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
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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)
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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)
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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
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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
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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.
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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
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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
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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
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RFID PalletTag Temp Reads
Pallet TagReads at
Dist Center Incoming
Pallet TagReads at
Dist Center Cooler-In
Transit
Parent-ChildRFID/BarCode
Data RelationshipEstablished
Portal
Portal
Handheld
RFID Temp-Tag Pallet
OutgoingPallet Build
LocalKnow-the-Flow
Database
Tagged CasesWith HarvestMark
Bar CodeTags
Read DataCooler/Ship Out
DistributionCenter
Distribution
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Retail OutletIncoming
Handheld
Retail OutletIncoming
HandheldRetail Outlet
Incoming
Handheld
Retail OutletIncoming
HandheldRetail Outlet
Incoming
Handheld
Retail OutletIncoming
Handheld
Retail ChainKnow-the-Flow
Database
Retail Tracking
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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
Parent-ChildRFID/BarCode
Data RelationshipEstablished
Farm Level
Transit
Parent-ChildRFID/BarCode
Data RelationshipEstablished
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
Retail OutletIncoming
Handheld
Retail OutletIncoming
HandheldRetail Outlet
Incoming
Handheld
Retail OutletIncoming
HandheldRetail Outlet
Incoming
Handheld
RetailOutlet
Handheld
Retail ChainIFSS
Database
Cold Chain Traceability
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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
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Financial Losses to the Industry: Waste
Inspection Yield Culls Recalls Rejected Disposal Returned Loads Lost Customers
The Supply Chain Ignores Losses Throughout
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Mexico to California – Truck 1031 Ambient Air INSIDE of FLAT (the real temperature to consider)
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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
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Intelligent Delivery Control Systems
Real-Time GPS & Sensor Enabled Tracking & Detection
Temperature Explosives
Bacterial Contamination
Shipper S/O
Invoice 10 + 2
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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
PO/SO Invoice 10 + 2
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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
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• Identity – What is it?
• Location – Time/LAT/LON (Track)
• Condition – Quality Control Requirements Temperature Cleanliness (Sanitation) • History – Records – Source/Handlers
• Cost - ROI
ILC
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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 Tag Temp/Time DataAvailable viaBlueTooth
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
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
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
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ZigBee Systems
Receiver
Repeater(Optional)
Mobile Modules
Facility Modules
Facility Modules
Receiver - USB Cable to PC or Laptop
Network PCs
ZigBee Systems
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Reader
ComputerFacility Layout Supplier Distributor Store
FloorTag
CoolerTag
CoolerTag
ReeferTag
Tag
ZigBee Systems
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
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Capturing product event data (traceability information and temperature status) in real-time
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2nd GPS/Temp Trans-Pacific Tracking (7 Days)
Consolidation Center (LA) Truck Pier On Board Receipt in HNL
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Make container sanitation and traceability an installed part of the basic business strategy. It will help you sell more product.
The Bottom Line
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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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