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TransCert System Guidelines
And Concepts
Cold Chain World: Module 2
Dr. John M. Ryan
jryan@sanitarycoldchain.com
http://ww...
CONTAINER: Any device used to transport food or food products. Containers
include bins, pallets, trucks, truck trailers, s...
3
Food safety audits, whether conducted under USDA, FDA, GFSI or
any other audit system are based on a once-a-year (or mor...
4
The transportation food safety audit
program is intended to assess a
participant’s efforts to minimize the risk of
adult...
5
http://www.SanitaryColdChain.com
Four Primary Container Standards
Management
HACCP
Sanitation
Traceability
(Maintenance)
6
Purpose
Intended to establish management, HACCP, sanitation and traceability
standards designed to prevent the adulterat...
7
Background
The U.S. food industry is a $1.1 trillion economic activity
encompassing 2.1 million farms, 25,000 food and b...
FDA Guidance for Industry: Sanitary Transportation of Food
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation...
9
The US Food Safety Modernization Act
The FDA can now access records if FDA believes that there is a reasonable probabili...
Transportation Food Safety Standards
http://www.SanitaryColdChain.com
Container Management System ( M )
This section requires a food transporting company to establish policies,
procedures and ...
HACCP
Hazard Analysis and Critical Control Point (HACCP)
involves seven principles:
Analyze hazards
Identify critical cont...
Management
HACCP
Container traceability and temperature control during transport
Sanitation including ATP testing as a min...
Proper unloading practices, conditions, or equipment, including proper
sanitation of equipment and leaving raw materials o...
Container HACCP ( HACCP )
HACCP procedural guidelines are both corrective and preventive in nature.
Seven (7) basic princi...
Container Sanitation ( S )
The Container Sanitation section requires planning as well as procedure
and document developmen...
Container Traceability ( T )
Unique containers must follow a company established traceability plan,
employees must be trai...
Employee Training ( TR )
Employee training standards include sanitation and traceability,
maintenance and maintenance of t...
Transportation Training and Certification
Training and certification procedures to assure that
personnel performing intern...
Certification Rules
If a company moves food through the supply chain, management, HACCP,
cleanliness and traceability requ...
Level 1 - Partial Certification
Level 1 certification requires that an organization has implemented and
passed an audit fo...
Note: A company may choose from a number of certification
categories.
Certification against standards means that the indiv...
Expected Documentation and Point System
The following table exhibits documentation reference codes and the scoring
point s...
Management System Standards
Management system requirements include 17 current
standards and may earn a maximum of 225 poin...
HACCP Standards
The HACCP standards and auditor checklist
contains 40 items worth 405 points. A minimum of
284 points are ...
Sanitation Standards
Sanitation system requirements include 19 current standards and may
earn a maximum of 200 points. Tab...
Traceability Standards
Traceability system requirements include 17 current
standards and may earn a maximum of 190 points....
Total System Point Scoring
Total system point scoring applies only to carriers applying
for Level 2, Class 3 certification...
The Audit
http://www.SanitaryColdChain.com
Problems With Food Safety Audits
• Audit is a tool used to attempt to measure food safety
• Real threats to food safety ar...
The Good About Audits
• Audits cause change – generally for the better
• Better means potential causes are removed
• Remov...
ISO (Is coming)
INTERNATIONAL ISO STANDARD 22000
• First edition 2005-09-01
• Food safety management systems
• Requirement...
Policy
Procedures Proof
The Document and Record System
Leadership
Logs
Lists
Checklists
Internal (Self) Audits
CARs
http:/...
The Policy
1. Clear, simple statement of commitment
2. Specifies – “all personnel”
3. Signed by all corporate officers
4. ...
The Organizational Structure:
Executive (Policy)
Marketing and Sales
Operations
Purchasing/Material Control
Finance/Accoun...
The Importance of Corrective and Preventive Actions
• This is what the game is all about – Compliance and continuous
impro...
Managing Recalls and Returns
http://www.SanitaryColdChain.com
Restaurant Retail Outlet Farmer's Market
Farm
Realization of
Outbreak
Recall
Lab Analysis
Human Sample
Hospitalization
Dr....
Prevention Action Versus Corrective Action
“Corrective Action” does not generally include
causal analysis or prevention.
R...
The Material Review Board for Corrective Action Control
Membership requires many departments to participate:
Finance
Opera...
• “Prevention” implies that you know what causes something
to happen and that you take action to eliminate or control
that...
Problem
Man
Machine Materials
Equipment Environment
My Mother
Why?
Why?
Why?
Why?
Why?
Team Power: Nothing beats experienc...
Prevention Costs
Prevention costs include all activities designed to prevent product defects. Includes training, education...
Graphing Costs for Management Prioritization and Prevention
http://www.SanitaryColdChain.com
Analyzing Recall and Return Costs
http://www.SanitaryColdChain.com
46
Analyzing Recall and Return Costs
http://www.SanitaryColdChain.com
Trending and Managing Return and Recall Costs
http://www.SanitaryColdChain.com
Apply the Same Management to Incoming Return Trends
http://www.SanitaryColdChain.com
Apply the Same Management to Incoming Return Trends
http://www.SanitaryColdChain.com
Procedure
Data Analysis
Measure
Collect Data
(Enter on Form Or ??? )
Pareto Analysis
(1st, 2nd, 3rd, etc.
Baseline Trend
C...
Team Members
1. Set Baseline and
Improvement Target and
Track
2. Count and
prioritize Defects
6. Report Status up the orga...
http://www.SanitaryColdChain.com
End of Module
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Transcert System Guidelines and Concepts

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Module Two of six modules on cold chain supply

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Transcert System Guidelines and Concepts

  1. 1. TransCert System Guidelines And Concepts Cold Chain World: Module 2 Dr. John M. Ryan jryan@sanitarycoldchain.com http://www.SanitaryColdChain.com Module Two
  2. 2. 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 http://www.SanitaryColdChain.com
  3. 3. 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 http://www.SanitaryColdChain.com
  4. 4. 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 http://www.SanitaryColdChain.com
  5. 5. 5 http://www.SanitaryColdChain.com Four Primary Container Standards Management HACCP Sanitation Traceability (Maintenance)
  6. 6. 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. http://www.SanitaryColdChain.com
  7. 7. 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. http://www.SanitaryColdChain.com
  8. 8. 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; http://www.SanitaryColdChain.com
  9. 9. 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 http://www.SanitaryColdChain.com
  10. 10. Transportation Food Safety Standards http://www.SanitaryColdChain.com
  11. 11. 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). http://www.SanitaryColdChain.com
  12. 12. 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. http://www.SanitaryColdChain.com
  13. 13. 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 http://www.SanitaryColdChain.com Recommended Preventive Controls
  14. 14. 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 http://www.SanitaryColdChain.com Recommended Preventive Controls
  15. 15. 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. http://www.SanitaryColdChain.com
  16. 16. 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. http://www.SanitaryColdChain.com
  17. 17. 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. http://www.SanitaryColdChain.com
  18. 18. 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. http://www.SanitaryColdChain.com
  19. 19. 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. http://www.SanitaryColdChain.com
  20. 20. 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. http://www.SanitaryColdChain.com
  21. 21. 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. http://www.SanitaryColdChain.com Certification Levels
  22. 22. 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. http://www.SanitaryColdChain.com
  23. 23. 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 http://www.SanitaryColdChain.com
  24. 24. 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. http://www.SanitaryColdChain.com
  25. 25. 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. http://www.SanitaryColdChain.com
  26. 26. 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. http://www.SanitaryColdChain.com
  27. 27. 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. http://www.SanitaryColdChain.com
  28. 28. 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. http://www.SanitaryColdChain.com
  29. 29. The Audit http://www.SanitaryColdChain.com
  30. 30. 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) http://www.SanitaryColdChain.com
  31. 31. 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. http://www.SanitaryColdChain.com
  32. 32. 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 http://www.SanitaryColdChain.com
  33. 33. Policy Procedures Proof The Document and Record System Leadership Logs Lists Checklists Internal (Self) Audits CARs http://www.SanitaryColdChain.com
  34. 34. 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 http://www.SanitaryColdChain.com
  35. 35. 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” http://www.SanitaryColdChain.com
  36. 36. 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 http://www.SanitaryColdChain.com
  37. 37. Managing Recalls and Returns http://www.SanitaryColdChain.com
  38. 38. 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
  39. 39. 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. http://www.SanitaryColdChain.com
  40. 40. 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). http://www.SanitaryColdChain.com
  41. 41. • “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 http://www.SanitaryColdChain.com
  42. 42. 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 http://www.SanitaryColdChain.com
  43. 43. 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- http://www.SanitaryColdChain.com
  44. 44. Graphing Costs for Management Prioritization and Prevention http://www.SanitaryColdChain.com
  45. 45. Analyzing Recall and Return Costs http://www.SanitaryColdChain.com
  46. 46. 46 Analyzing Recall and Return Costs http://www.SanitaryColdChain.com
  47. 47. Trending and Managing Return and Recall Costs http://www.SanitaryColdChain.com
  48. 48. Apply the Same Management to Incoming Return Trends http://www.SanitaryColdChain.com
  49. 49. Apply the Same Management to Incoming Return Trends http://www.SanitaryColdChain.com
  50. 50. Procedure Data Analysis Measure Collect Data (Enter on Form Or ??? ) Pareto Analysis (1st, 2nd, 3rd, etc. Baseline Trend Causal Analysis Team Preventive Action Process http://www.SanitaryColdChain.com Moving Towards A Preventive Approach to Transportation Food Safety
  51. 51. 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 http://www.SanitaryColdChain.com
  52. 52. http://www.SanitaryColdChain.com End of Module
  53. 53. AFRIS. AsianFoodRegulationInformationService. We have the largest database of Asian food regulations in the world and it’s FREE to use. We publish a range of communication services, list a very large number of food events and online educational webinars and continue to grow our Digital Library. We look forward to hearing from you soon! www.asianfoodreg.com adrienna@asianfoodreg.com

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