Transcert System Guidelines and Concepts

TransCert System Guidelines
And Concepts
Cold Chain World: Module 2
Dr. John M. Ryan
jryan@sanitarycoldchain.com
http://www.SanitaryColdChain.com
Module Two

CONTAINER: Any device used to transport food or food products. Containers
include bins, pallets, trucks, truck trailers, shipping containers and other similar
devices. Includes bins, trays, etc. used to move food over short distances.
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.
Definitions

3
Food safety audits, whether conducted under USDA, FDA, GFSI or
any other audit system are based on a once-a-year (or more) visual
inspection, depend on little, if any, hard data and have been shown to
be of little preventive consequence.
If you are involved in a recall, the FDA will take biological and
chemical samples and will ignore any food safety certificates
A Snapshot in Time
Audits

4
The transportation food safety audit
program is intended to assess a
participant’s efforts to minimize the risk of
adulteration during food moving phases.
The Primary Purpose

5
Four Primary Container Standards
Management
HACCP
Sanitation
Traceability
(Maintenance)

6
Purpose
Intended to establish management, HACCP, sanitation and traceability
standards designed to prevent the adulteration of food during
transportation.
Scope
The standards are designed for processes during which food is moving
from location to location in trucks, planes, trains and ships and do not
cover food processes that include loading, unloading storage or staging.
The standards also cover short food movement processes such as from
the field to a packing house or through picking operations in a distribution
center.
The certification program is voluntary and intended to assist food
transporters to achieve sanitation and traceability levels required by
customers, to prevent potential liability issues and to partially meet
federal laws covering the safe and clean transportation of food.

7
Background
The U.S. food industry is a $1.1 trillion economic activity
encompassing 2.1 million farms, 25,000 food and beverage
processors, 33,000 wholesalers, 113,000 food and beverage
retailers, and 378,000 restaurants or other food service
establishments. In addition, some 200,000 foreign food
establishments have registered with the FDA as potential
exporters to the United States. Unfortunately, the industry
is in a state of disarray and confusion resulting in dynamic
market shifts.
Bad publicity, foreign competition, transportation costs, huge
financial losses due to recalls and lack of food safety
standards and new federal laws are some of the factors
contributing significantly to these shifts.

FDA Guidance for Industry: Sanitary Transportation of Food
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm208199.htm
“III. Discussion
In our effort to assist the food transport industry in preventing food safety problems
during transport while we are implementing the 2005 SFTA, we want them to be
aware of the following problem areas where food may be at risk for physical,
chemical, or biological contamination during food transport:
Improper refrigeration or temperature control of food products
Improper management of transportation units to preclude cross-contamination,
Improper packing of transportation units (or storage facilities used during
transport),
including incorrect use of packing materials and poor pallet quality;
Improper loading practices, conditions, or equipment, including improper sanitation
of loading equipment,
Not using dedicated units where appropriate and transporting mixed loads that
increase the risk for cross-contamination;

9
The US Food Safety Modernization Act
The FDA can now access records if FDA believes that there is a reasonable probability that the use of or exposure to
an article of food, and any other article of food that FDA reasonably believes is likely to be adulterated. Each person
(excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, transports or
imports food shall permit such FDA officer or employee to have access to and copy all records relating to such
article and any other article of food that FDA reasonably believes is likely to be adulterated.
The FDA shall have access to the records that are needed to assist them in determining whether there is a
reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or
death to humans or animals.
The FDA may establish requirements regarding establishment and maintenance, for not longer than 2 years, of
records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive,
hold, or import food. The records that are required to be kept by these regulations are those needed by FDA for
inspection (That is called “Audit”) to allow FDA to identify the immediate previous
sources and immediate subsequent recipients of food (That is called
“traceability”).
Food Safety or Other Audits (GFSI/ISO/Etc.)
Imports – DHS and CBP
Background: Record Requirements

Transportation Food Safety Standards

Container Management System ( M )
This section requires a food transporting company to establish policies,
procedures and a documentation system for logs, records and other records
needed to maintain the system.
The system is required to be managed and reviewed.
The Container Management System also requires a HACCP plan that includes
corrective and preventive action activities.
Container Management also requires the establishment of a record keeping
system that matches specific container sanitation with traceability against a
unique container ID number and maintains record data for at least two years.
All audit and certification activities related to TransCert require a review of the
Container Management System (See “Rules” below).

HACCP
Hazard Analysis and Critical Control Point (HACCP)
involves seven principles:
Analyze hazards
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 shows that a
critical limit has not been
Establish procedures to verify that the system is working
Establish effective recordkeeping to document the HACCP system.

Management
HACCP
Container traceability and temperature control during transport
Sanitation including ATP testing as a minimum
Monitoring and ensuring the sanitation and condition of transportation
vehicles as appropriate
Pest control
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
Recommended Preventive Controls

Proper unloading practices, conditions, or equipment, including proper
sanitation of equipment and leaving raw materials on loading docks after
hours;
Driver training and/or supervisor/manager/owner knowledge of food
safety
Transportation unit design and construction (ATP Certification)
Adequate preventive maintenance for transportation units
Employee hygiene
Adequate policies for the safe and/or secure transport
Proper use of security seals
Proper handling and tracking of rejected loads and salvaged, reworked,
and returned products
Recommended Preventive Controls

Container HACCP ( HACCP )
HACCP procedural guidelines are both corrective and preventive in nature.
Seven (7) basic principles are involved as noted.
The identification of hazards and establishment of critical control points are
basic to process control and set the stage for measuring, monitoring, correcting
and documenting a systematic approach to continual improvement.
In this context, teams can rely on an approach that transcends seat of the
pants management approaches more common to smaller operations.

Container Sanitation ( S )
The Container Sanitation section requires planning as well as procedure
and document development and record keeping that allows an auditor to
verify that a company is cleaning, sanitizing and testing container interiors.
Container sanitation also requires that employees are adequately trained
and that container owners and users perform self-inspections, or internal
audits and corrective actions if containers are found to be out of
specification.

Container Traceability ( T )
Unique containers must follow a company established traceability plan,
employees must be trained to implement and follow the plan.
The plan and its implementation must be managed and monitored
through records review, internal audits and management reviews.
Corrective actions are required, especially in the event of recalls or
accidents involving food carrying containers.
Container Traceability also recognizes the need for pallet level tracking
systems that prevent the carrier from assuming liabilities that might
occur in the event that food producers and suppliers do not adequately
protect food from adulteration or spoilage.

Employee Training ( TR )
Employee training standards include sanitation and traceability,
maintenance and maintenance of training records and controlling
assignments of personnel to prevent unqualified personnel from
performing sanitation or traceability functions.

Transportation Training and Certification
Training and certification procedures to assure that
personnel performing internal audits or assisting in the
container sanitation or installation and testing of
traceability systems are properly trained and certified.

Certification Rules
If a company moves food through the supply chain, management, HACCP,
cleanliness and traceability requirements apply. Planes, trucks, shipping
containers, pallets and all food holding or moving containers must be numbered,
documented, sanitary, tested and traceable.
Standards will help companies comply with newly evolving food safety logistics
laws. Transportation compliance certificates are awarded to companies
meeting these food logistics standards.
Once certified, a company may advertise compliance status to customers
demanding supply chain control.
Two certification levels: Partial and Full. Certification may be achieved by
individuals who may become certified to perform sanitation and traceability installer
standards. Maintenance stations and food carriers are certified in a similar
manner.

Level 1 - Partial Certification
Level 1 certification requires that an organization has implemented and
passed an audit for either the traceability or sanitation carrier requirements.
Level 1 certification establishes many of the basic requirements for attaining
Level 2 (Dual) certification
Level 2 – Full Certification
Level 2 certification requires that an organization pass all management,
HACCP, traceability and sanitation audit standards.
Certification Levels

Note: A company may choose from a number of certification
categories.
Certification against standards means that the individual,
maintenance station or carrier must pass ALL standard groups
required for the chosen certification level.
For instance, MS 1, Level 2 requires that the Maintenance Station
implement and pass the Management plus the individual TransCert
Traceability Installer standard.
In this example, the maintenance station is expected to maintain
management standards as well as all requirements for traceability
system installers.

Expected Documentation and Point System
The following table exhibits documentation reference codes and the scoring
point system. “POL”, for example, indicates that a policy is required and that a
maximum of 10 points may be awarded.
Documentation References
POL=Policy - 10
PL=Plan - 20
P=Procedure - 15
D=Document - 10
O=Observation - 5
R=Record - 5
L=Log - 5

Management System Standards
Management system requirements include 17 current
standards and may earn a maximum of 225 points.
Standards contain numbered system components, points, and
expected documentation.
Each standard is matched to the audit sheets used during
various audit phases. The minimum score needed to pass the
management system section is 258 which represent 70% of
the total available points for this component.

HACCP Standards
The HACCP standards and auditor checklist
contains 40 items worth 405 points. A minimum of
284 points are required to achieve a passing score.
The checklist document refers the company and
auditor to preparation and evaluation for planning
and implementation components that cover the
seven (7) HACCP principles presented earlier in this
document.

Sanitation Standards
Sanitation system requirements include 19 current standards and may
earn a maximum of 200 points. Table below contains numbered
system components, points, and expected documentation.
The minimum score needed to pass the management system section is
140 which represent 70% of the total available points for this
component.

Traceability Standards
Traceability system requirements include 17 current
standards and may earn a maximum of 190 points.
Each standard is matched to the audit sheets used during
various audit phases. The minimum score needed to pass
the management system section is 133 which represent 70%
of the total available points for this component.

Total System Point Scoring
Total system point scoring applies only to carriers applying
for Level 2, Class 3 certification. As shown there are 650
points possible and 455 points are required for a minimum
pass.
For carriers that apply for Level 2, Class 3 certification, all
required audit sections must receive a minimum of 70% score.

The Audit

Problems With Food Safety Audits
• Audit is a tool used to attempt to measure food safety
• Real threats to food safety are of a biological, chemical, or radiation in nature
and you cannot see or detect these problems with a visual audit.
• There is no set audit standard – there are hundreds of different audit sheets in
use (but most are similar). One may fail you for pests, the other for water
quality
• Auditor repeatability and reliability are questionable (measurement-wise)
This leads to questionable audit validity
• Audit standards contain subjective terms (This leads to questionable audit
validity)
• No one is addressing the problems of auditor reliability, repeatability and
validity.
• T=M+E (and E is a large part of safety, quality, etc)

The Good About Audits
• Audits cause change – generally for the better
• Better means potential causes are removed
• Removal of potential causes means prevention
• Prevention means fewer laws, lawsuits, deaths, businesses
going bankrupt due to misdirection of blame.
• An improved level of food safety control is achieved – even
though special causes are not eliminated.
• Special causes are removed by good management.

ISO (Is coming)
INTERNATIONAL ISO STANDARD 22000
• First edition 2005-09-01
• Food safety management systems
• Requirements for any organization in the food chain
INTERNATIONAL ISO STANDARD
• First edition 22005:2007(E)
• Traceability in the feed and food chain
• General principles and basic requirements for system
design and implementation

Policy
Procedures Proof
The Document and Record System
Leadership
Logs
Lists
Checklists
Internal (Self) Audits
CARs

The Policy
1. Clear, simple statement of commitment
2. Specifies – “all personnel”
3. Signed by all corporate officers
4. Dated
5. Posted
6. Commits to annual internal review

The Organizational Structure:
Executive (Policy)
Marketing and Sales
Operations
Purchasing/Material Control
Finance/Accounting
Food Safety/Quality
Etc.
All organizational functions are included!
The “Org Chart”

The Importance of Corrective and Preventive Actions
• This is what the game is all about – Compliance and continuous
improvement are demonstrated through corrective and preventive
action records.
• Whatever points lost during an audit are required to be corrected or
prevented within a limited time period.
• Can you “correct” something while the auditor is there? YES – If
you can, do it!
• Implement and stick with the self audit system – Internal Auditors
• Audits are usually annually - manage the system

Managing Recalls and Returns

Restaurant Retail Outlet Farmer's Market
Farm
Realization of
Outbreak
Recall
Lab Analysis
Human Sample
Hospitalization
Dr. Visit
Onset of Illness
Contaminant
Ingestion
Organize to
Recall
Consumer
Purchase
Outbreak
Investigation
Federal
Robots
The Recall Phenomenon

Prevention Action Versus Corrective Action
“Corrective Action” does not generally include
causal analysis or prevention.
Recall activities are NOT preventive – they are
extremely expensive activities that are the
result of a failure to prevent.
Corrective actions generally “get the thing going
again so shipments can resume”. Corrective
actions include quick fixes focused on
symptoms rather than causes (take an aspirin
for your daily headache).
Corrective actions are Material Review Board
(MRB) activities.

The Material Review Board for Corrective Action Control
Membership requires many departments to participate:
Finance
Operations
Food Safety
Quality
Etc.
Each member gets one vote – Group Decision
Product Disposition (return, recall, scrap, sort/cull, etc.
is the primary goal
Disposition and system changes are Corrective Action
oriented
If the problem persists, a Preventive Action Team is
assigned to formalize causal analysis and
prevention planning (procedural changes).

• “Prevention” implies that you know what causes something
to happen and that you take action to eliminate or control
that cause
More importantly –
a. If you cannot figure out what caused a problem, you
cannot eliminate the problem
b. If you can’t measure it, you cannot control it
• And the problem will return - repeatedly
Prevention Concepts

Problem
Man
Machine Materials
Equipment Environment
My Mother
Why?
Why?
Why?
Why?
Why?
Team Power: Nothing beats experience (yours or someone else’s)
Causal Analysis: If you can’t figure out what caused it, you can’t fix it.
Kaoru
Ishikawa
Purchasing
Price
President

Prevention Costs
Prevention costs include all activities designed to prevent product defects. Includes training, education, planning, supplier
qualification/reviews, process capability studies, process capability studies, food safety improvement projects, food safety
improvement team meetings and includes labor, overhead, benefits and expenses. Considering the current trend in food
safety, especially in the food transportation arena, prevention becomes king.
Appraisal Costs
Costs associated with measuring, inspection, audit, and tests used to assure conformance to standards including inspection
(sorting, resorting, culling), audits, the materials and supplies used for appraisal activities, quality
documentation/specifications and standards/drawings), materials, labor/overhead/Expenses/Benefits/etc.
3. Failure Costs
Failure costs include all costs required to evaluate (including corrective action activities) and correct or replace products not
conforming to requirements or customer needs.
a. Internal Failure Cost
Internal failure costs include all costs occurring prior to completion or shipment of the product and include all costs associated
with mistakes made in processes that have to be corrected within organizational walls. These costs are incurred (rework,
scrap)
b. External Failure Costs
External failure costs are those associated with transporting, returning, reworking, retesting and reshipping products that
escaped to the customer and had to be returned or disposed of. External failure costs could also include the cost of the "lost
customer" or "lost business" and have the potential for the most devastating impact on a company.
Companies that consider costs from the cost of food safety and food quality perspective presented above develop a new way
of looking at their businesses. With so many carriers lacking sufficient sanitation, temperature and traceability controls over
the food being moved, exposure to such losses is extremely high.
Classifications for Costs of Food Safety and Food Quality-

Graphing Costs for Management Prioritization and Prevention

Analyzing Recall and Return Costs

46
Analyzing Recall and Return Costs

Trending and Managing Return and Recall Costs

Apply the Same Management to Incoming Return Trends

Procedure
Data Analysis
Measure
Collect Data
(Enter on Form Or ??? )
Pareto Analysis
(1st, 2nd, 3rd, etc.
Baseline Trend
Causal
Analysis
Team Preventive
Action Process
Moving Towards A Preventive Approach to Transportation Food Safety

Team Members
1. Set Baseline and
Improvement Target and
Track
2. Count and
prioritize Defects
6. Report Status up the organization
4. Establish CA Plan,
Assign team members
Meet deadlines
5. Monitor Implementation and do NOT forget about “Lag Time”
3. Perform Causal
Analysis (Ishikawa)
Define Hazards, Measure at Critical Control Points

End of Module

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