Consolidated Standards for Inspection

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2 The AIB International Consolidated Standards for Inspection Food Distribution Centers AIB International I

3 Disclaimer AIB International 2011 The information provided in this or any other version of the AIB International Consolidated Standards is not legal advice, but general information based on good manufacturing practices, common regulatory requirements, and food safety practices typically encountered in a food distribution center. These Standards have been developed as a guide to best practices and are not intended, under any circumstances, to replace or modify the requirement for compliance with applicable laws and regulations. These Standards are not intended to meet all existing laws and regulations, nor those laws or regulations that may be added or modified subsequent to the publication of these Standards. AIB International shall not be liable for any damages of any kind, arising in contract, tort, or otherwise, in connection with the information contained in these Standards, or from any action or omission or decision taken as a result of these Standards or related information. Further, AIB International expressly disclaims any and all representations or warranties of any kind regarding these Standards. Copyright AIB International All rights reserved. Users of these Standards and associated documents are reminded that copyright subsists in all AIB International publications and software. Except where the Copyright Act allows and except where provided for below no part of this publication may be transmitted or reproduced, stored in a retrieval system in any form, or transmitted by any means without prior permission in writing from AIB International. All requests for permission should be addressed to the Vice President of Administration at the address below. No part of this publication may be translated without the written permission of the copyright owner. The use of this material in print form or in computer software programs to be used commercially, with or without payment, or in commercial contracts is subject to the payment of a royalty. AIB International may vary this policy at any time. AIB International 1213 Bakers Way PO Box 3999 Manhattan, KS The AIB International Consolidated Standards for Inspection. Issued March X 11.2.A II AIB International

4 The AIB International Consolidated Standards for Inspection Food Distribution Centers Table of Contents Preface...ii Inspection and Audit...1 Definitions of Inspection and Audit... 1 Benefits of Inspection and Audit... 1 Reasons for Having Inspection and Audit Regulations Industry Best Practices Customer Demands Process Improvements... 3 AIB International...4 History... 4 Mission... 4 Key Offerings... 4 Consolidated Standards and Educational Inspections... 4 Benchmarked Standard Audits... 4 Introduction to the Standards...5 The Categories... 5 How to Read the Standards... 7 Scoring...8 Scoring At-A-Glance The Inspection Determining Risk and Assigning Category Scores Evaluating the Adequacy of the Food Safety Program Total Score Recognition and Laudatory Terms Sample Scoring with Explanations Automatic Assessment of Unsatisfactory Consolidated Standards for Inspection Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs Appendices...66 The Inspection Process A: Participating in an Inspection B: Documents to Have Ready for an Inspection C: Conflict Resolution Process Maintaining and Expanding Programs D: Conducting a Self-Inspection E: Non-Scored Program Enhancements F: GFSI Benchmarked Standard Audit Requirements Learning G: Integrated Quality System (IQS) H: Training and Education Materials I: Glossary Standards Index AIB International i

5 Preface Preface Description of the Document The AIB International Consolidated Standards for Inspection for Food Distribution Centers is a collection of information gathered to help a reader understand: What an inspection is The difference between an inspection and an audit The benefits of and drivers for having an inspection or audit AIB International s role in inspection and audit What the AIB International Consolidated Standards for Inspection are How to read and use the AIB International Consolidated Standards How an AIB International Consolidated Inspection is scored How to prepare for and participate in an AIB International Inspection Additional sources for understanding, implementing and expanding Prerequisite and Food Safety Programs Audience for the Document This document was designed for multiple readers for multiple purposes: Facility personnel preparing for an AIB International Inspection Newcomers to the food industry needing to understand the elements of, and reasons for Prerequisite and Food Safety Programs Experienced personnel who want an easy-to-use reference for the AIB International Consolidated Standards Corporate and Facility personnel wishing to make a business case for the benefits of inspection Regulators and Trade Associations making decisions on industry Standard direction and support Multi-national organizations that want a common Standard that can be implemented globally Organizations that need central Standards for evaluating multiple suppliers Any facility involved in food storage or distribution Any facility wanting to establish and maintain a wholesome and safe food processing environment ii AIB International

6 Preface Structure of the Document Inspection and Audit This section defines inspection and audit, describes benefits of each, and details drivers for having inspection and audit. AIB International This section gives the history and mission of AIB International, and describes the organization s unique position as it relates to inspection. Introduction to the Standards This section describes the Standards, defines how they are categorized and formatted, and visually shows how to read the Standards. Scoring This section defines step-by-step scoring procedures and uses graphics to demonstrate the scoring scenarios. Consolidated Standards for Inspection This section is the core of the document. It documents each Standard and gives the requirements for each. Appendices The multiple appendices attached to this document are not critical to the Standards, but can greatly enhance a facility s inspection experience and food safety performance. Standards Index This section lists each of the Standards by category, and provides a page number so readers can quickly find specific Standards. Design of the Document The design of the document employs the following strategies to support ease of use: Consistent terminology used throughout the document Unambiguous language that can be globally understood Current-use language and not regulation speak Related content grouped in one location Standards constructed with the same hierarchy: Category x Standard»» Requirement As much as possible, one item measured per Standard Meaningful phrases highlighted to support quick scanning AIB International iii

7 Inspection and Audit Inspection and Audit Definitions of Inspection and Audit An inspection is a thorough physical review of a food facility to assess what is actually happening in a facility at a moment in time. This snapshot gives a realistic assessment of conditions that can be both positive and negative for food processing. An inspection focuses on physical review. An audit is a systematic evaluation of food facility documentation to determine if Programs and related activities achieve planned expectations. An auditor looks at data over time to see if positive or negative trends are developing. An audit focuses on documentation review. Benefits of Inspection and Audit Choosing an inspection or an audit depends on the goal. Many organizations choose both because inspections and audits support each other. Choose an inspection to: Reveal actual practices or issues that may not be apparent from paperwork Focus on root causes, not just on symptoms Educate personnel through interaction with an inspector Identify, reduce, eliminate and prevent food hazards in a facility Prevent expensive and damaging recalls Comply with government regulation and industry expectations for safe food Improve and maintain a healthy, sanitary environment for food handling Produce safe food products Choose an audit to: Comply with benchmarked standards Realize efficiencies through better management of documentation Achieve certification Look at trends over time AIB International 1

8 Inspection and Audit Reasons for Having Inspection and Audit 1: Regulations There are many reasons for having an inspection or audit, but the most obvious is to ensure that the facility is meeting regulatory requirements. The following are examples of region-specific regulations that impact inspections and audits: Regulation Food Standards Australia New Zealand (FSANZ) Act 1991 The Food and Drugs Act Food and Drug Regulations Technical Regulation RTCA Regulation (EC) 852/2004 Food Safety Basic Law Food Sanitation Law Technical Regulation GMC No. 80/96 Mexican Official Norm NOM-120-SSA Food Hygiene Law of the People s Republic of China Sans 10049:2001 Food Hygiene Management The Food Hygiene (England) Regulations 2006 The U.S. Federal Food Drug and Cosmetic Act (1938) Good Manufacturing Practices, CFR Title 21, Part 110 (2008) The Bioterrorism Act (2002) U.S. Federal Insecticide, Fungicide, and Rodenticide Act (1972) Seafood HACCP, CFR 21, Part 123, Fish and Fisheries Products Region Australia/New Zealand Canada Canada Central America European Community Japan Japan Mercosur Mexico People s Republic of China South Africa United Kingdom U.S.A. U.S.A. U.S.A. U.S.A. U.S.A. Where there are no region-specific regulations, internationally developed and recognized standards may be used to develop Prerequisite and Food Safety Programs. One example of such a standard is: The Codex Alimentarius Commission Food Hygiene Basic Texts (2003) Other standards that may impact Program requirements are provided by the body requesting the inspection or audit. Two such examples of this would be: The Global Food Safety Initiative (GFSI) Benchmarked Standards The U.S. Military Standards 2: Industry Best Practices The regulations listed above drive regulated standards, but the food industry changes very quickly, and often the regulatory process takes time to catch up. New advances related to the production of safe food are being developed continuously. As the food industry learns about new food safety issues and processes, innovation becomes part of food safety practice. In fact, some large companies create their own standards that are even tougher than the regulations demand. 2 AIB International

9 Inspection and Audit 3: Customer Demands If food facilities do not demand excellence of themselves, their customers will. An ill-timed recall can send consumers to alternate providers, or ruin the reputation of a particular brand or product category. In some cases, the customer demands external verification of Prerequisite and Food Safety Programs as a condition of doing business. 4: Process Improvements Having established Prerequisite and Food Safety Programs provides an environment for the production of safe, legal and quality foods. Periodic verification of Program implementation can assist with identifying opportunities for improvements in productivity and potential profitability. AIB International 3

10 AIB International AIB International History AIB International operates as a non-profit business founded in 1919 as a technology transfer center for food processors and bakers. Although AIB International is historically linked with North American wholesale and retail baking, the Institute currently serves all segments of the food processing, distribution, foodservice, and retail industries worldwide. Mission AIB International exists to serve the food industry. Its mission statement formally reads: AIB International is committed to protecting the safety of the food supply chain and delivering high value technical and educational programs. Through rigorous independent inspections, superior audits and training, and shared expertise, we will empower our clients to lower their business risk and strengthen their reputations. Essentially, AIB International helps food processing facilities help themselves through inspections, audits and education. Key Offerings Consolidated Standards and Educational Inspections The AIB International inspection offering began as a needed service to the food industry in With the Consolidated Standards and Educational Inspections, AIB International has objectives of: 1. Offering easy-to-use Standards that consolidate regulation, industry best practices and experience into one Standard 2. Providing very experienced and highly-calibrated inspectors that are just as interested in educating facility personnel as they are in rating facilities against the Standards 3. Using the extensive experience of conducting thousands of inspections and audits in multiple industries to gather state-of-the-art understanding and interpretation of often conflicting and complex regulations 4. Being incorruptible, objective, unbiased and confidential during inspections Benchmarked Standard Audits AIB International firmly believes in the value of inspection, and considers the AIB International Consolidated Standards for Inspection of Food Distribution Centers a unique value to the food industry. However, AIB International is also aware of the growing interest in internationally accepted certification audit schemes, and is fully accredited to conduct audits against various benchmarked standards. 4 AIB International

11 Introduction to the Standards Introduction to the Standards The AIB International Consolidated Standards for Food Distribution Centers are statements that represent key requirements that a facility must meet in order to keep the food products in a facility wholesome and safe. The Standards also reflect what an inspector would expect to see in a facility that maintains a food-safe processing environment. The Categories The Standards include five Categories: 1. Operational Methods and Personnel Practices The receipt, storage, monitoring and handling of materials to distribute safe final product. Standards in this category are related to food handling and processing. Facilities need to be confident that personnel, processes and conditions do not introduce a food safety concern as materials are received, transferred, stored, transported, manipulated, or processed to deliver a final product. The Operational Methods and Personnel Practices Standards show how a facility can prevent people and processes from contaminating a product. 2. Maintenance for Food Safety The design, upkeep and management of equipment, buildings and grounds to provide a sanitary, efficient, and reliable distribution environment. Standards in this category are related to equipment, grounds and structures. The design, construction, and maintenance of equipment and buildings are critical to providing and maintaining a food-safe environment. The Maintenance for Food Safety Standards provide best practices for optimizing the design and care of the facility and equipment so that they are easy to manage and do not create sanitation or food safety issues. 3. Cleaning Practices The cleaning and sanitizing of equipment, utensils and buildings to provide a wholesome and safe food distribution environment. Standards in this category are related to cleaning and sanitizing. The methods of cleaning and sanitizing, the types of chemicals used, the frequency of cleaning activities, and the control of microbes must all be done expertly to protect products from food safety issues. The Cleaning Practices Standards give cleaning guidelines to prevent contamination. AIB International 5

12 Introduction to the Standards 4. Integrated Pest Management The assessment, monitoring, and management of pest activity to identify, prevent and eliminate conditions that could promote or sustain a pest population. Standards in this category are related to pest management. While it is important to remove pests from a facility, it is more important to prevent pests from ever having the opportunity to thrive in a food environment. The Integrated Pest Management Standards give strategies for managing multiple approaches to ensure that pests do not adulterate food products. 5. Adequacy of Prerequisite and Food Safety Programs The coordination of management support, cross-functional teams, documentation, education, training and monitoring systems to ensure all departments of the facility work together effectively to deliver a wholesome and safe final product. Standards in this category are related to management and teamwork. It is important to have Programs in place, but if a Program is not formalized through designing, planning, management, documentation and review, then Prerequisite Programs will depend on who is undertaking a given activity or task that day. The Adequacy Standards make sure that Prerequisite Programs are carefully designed and implemented to ensure consistency across the entire facility. Note: While other categories focus mainly on inspection, this category largely involves evaluation of Program documentation. However, the observations made and documents reviewed in the first four categories will directly affect how the inspector will assess the facility in the Adequacy category. Findings on the floor are a direct reflection of how well Programs have been implemented. 6 AIB International

13 Introduction to the Standards How to Read the Standards Category Description A full sentence describing how the Standards in the category are related Standard A short phrase defining the key point of the Standard Standard Description A full sentence that describes why a facility would want to implement the Standard Critical Requirements The critical requirements against which a facility is rated. In many regulations, critical requirements are described as SHALLS. Critical requirement observations are rated as Improvement Needed, Serious or Unsatisfactory unless there is an alternate program in place that meets the intent of the requirements. A 4-place number with a 3rd place value of 1 identifies. Minor Requirements These are the minor requirement against which a facility is rated. In many regulations, minor requirements are described as SHOULDS. Minor requirement observations are rated as Minor Issues Noted. A 4-place number with a 3rd place value of 2 identifies Minor Requirements. Key Points Bold type highlights key points to simplify scanning of Critical and Minor Requirements 2. Maintenance for Food Safety The design, upkeep and management of equipment, buildings and grounds to provide a sanitary, efficient, and reliable manufacturing environment. 2.1 Facility Location Category Name Selection and management of the facility location will allow personnel to identify and control potentially negative impacts of surrounding operations The facility identifies and takes measures to prevent product contamination from local activities that could h adverse impacts. Minor Requirements Facility boundaries are clearly defined and control Effective measures are in place to prevent product contamination from neighboring properties. The measures are periodically reviewed. 2.2 Outside Grounds The facility grounds are maintained in a way that prevents adulteration Equipment stored outside is placed to pre harborage, to make the inspection process protect equipment from deterioration and Litter and waste are removed from the Weeds and tall grass are not near the b Roads, yards and parking areas are of dust, standing water and other pote Adequate drainage is provided for g other areas. Outside wet and dry waste or scra tainers are installed in a w ntainers are ma ova AIB International 7

14 8 AIB International The Inspection Scoring At-A-Glance 1The Inspector observes operations on the facility floor to determine the effectiveness of programs, and reviews written programs to determine if there are gaps. A risk assessment of observations is made for each Category: Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs Risk Assessment Description Category Score Range No Issues Observed No identified risk. 200 Minor Issues Noted No potential for contamination Improvement Needed A potential hazard, partial program omission, or food safety finding that is inconsistent with the Standards. If this hazard, omission, or finding is not corrected it could lead to program failure. Serious A significant food safety risk or risk of program failure. Unsatisfactory An imminent food safety hazard, program failure, or departure from the Good Manufacturing Practices. 135 Scores are based on the definitions shown above. Scoring Determining Risk and Assigning Category Scores 2The Inspector determines the most significant food safety observation(s) in each of the first 4 Categories. The Inspector then decides the severity of the most significant observation in each Category. If the most significant observation in the Category is severe, the category will be assigned a score at the bottom of the range. If the most significant observation is not as severe, it will be assigned a score at the top of the range. Multiple observations in a Category will reduce the score in 5 point increments for each additional observation. The score will not drop below the bottom of the Category score range. Evaluating Adequacy 3 Before the Inspector can assign the Total Score, the Adequacy of the Food Safety Programs must be assessed. Assigning Adequacy scores involves comparing written food safety programs to the results they produce in the facility. It is impossible to receive a perfect Adequacy score unless the written programs result in perfect scores for each Category evaluated in the facility. 4Total Score After the Adequacy score is determined, it is added to the scores from the first four Categories to produce the total score. Recognition and Laudatory Terms 5Data from facilities that receive AIB inspections will be collected from October 1 through September 30 each year and a statistical analysis of the data will determine the total score range for the top 25 percent of scores. This range will be the criteria for Recognition of High Achievement-Superior for the following calendar year. Recognition of High Achievement Superior will be awarded to facilities scoring within the statistically calculated total score range. A facility cannot receive a Recognition of High Achievement Superior if there is a category score below 160, irrespective of the total score. Recognition of Accomplishment will be awarded to all facilities scoring between 700 and the required number of points to achieve a Recognition of High Achievement Superior. A facility cannot receive a Recognition of Accomplishment if there is a category score below 140, irrespective of the total score.

15 Scoring Scoring The scoring of the facility occurs in five steps: 1. The Inspection 2. Determining Risk and Assigning Category Scores 3. Evaluating the Adequacy of the Food Safety Program 4. Total Score 5. Recognition and Laudatory Terms A high-level overview of these steps is presented in the Scoring At-A-Glance section. More detailed descriptions follow. 1The Inspection Like a chain, the strength of a Food Safety Program depends on its weakest link. To assess the food safety risks in a facility, an AIB Inspector conducts a thorough and fair physical inspection and concludes with a review of written programs. The Inspector notes observations based on the five Categories of The AIB International Consolidated Standards for Inspection: 1. Operational Methods and Personnel Practices 2. Maintenance for Food Safety 3. Cleaning Practices 4. Integrated Pest Management 5. Adequacy of Prerequisite and Food Safety Programs 2Determining Risk and Assigning Category Scores The AIB Inspector will then assign a level of risk and a Category Score to the five Categories shown above. Use Table 1 as a guide. Risk Assessment Description Category Score Range No Issues Observed No identified risk. 200 Minor Issues Noted No potential for contamination Improvement Needed A potential hazard, partial program omission, or food safety finding that is inconsistent with the standards. If this hazard, omission, or finding is not corrected, it could lead to a program failure. Serious A significant food safety risk or risk of program failure Unsatisfactory An imminent food safety hazard, program failure, or departure from the Good 135 Manufacturing Practices. AIB International 9

16 Scoring The Inspector uses a three-step process to assess risk. The inspector: 1. Determines the most significant observation(s) in a Category and assigns a score range. 2. Determines the severity of the most significant observation(s) and decides whether the initial score should be at the top or bottom of the score range assigned. 3. Lowers the initial score in 5 point increments for each additional observation if the assigned score is at the top of the score range. The Inspector determines the most significant risk in a category and assigns it to the Minor Issues Noted score range. The most significant observation is not as severe, and so would be scored at the top of the Category Score range. The most significant observation is severe, and so would be scored at the bottom of the Category Score Range and cannot be further reduced. Highest Category Score Multiple occurrences of separate observations lower the score in increments of 5 until the lowest Category Score is reached. Lowest Category Score Figure 1 Example of Risk and Category Score Determination in the Minor Issues Noted Range. 10 AIB International

17 Scoring Here are some guidelines: The initial score for a Category is always either at the top or the bottom of the range. A Category score can be adjusted from the top of the range, but will never go below the bottom of the range. All critical or minor findings associated with a single Standard of a Category would be grouped together as a single observation. For example, any findings (single or multiple) noted under the following Standard and related requirements would only be counted as one observation: 1.5 Pallets Findings assigned to several Standards within a Category would be considered distinct and separate observations. For example, any findings (single or multiple) noted for each of the following Standards would be counted as 2 observations: 1.1 Rejection of Shipments 1.3 Storage Conditions A single observation in a Category may be severe enough to require the category to be scored at the bottom of the score range. Severity can be due to a single significant observation, or it can be due to multiple findings establishing a pattern within a single observation. Observations of Minor Requirements are always assessed in the Minor Issues Noted score range. If the initial score is at the top of the assigned score range, each additional observation lowers the scores in 5 point increments. Possible scores are listed in Table 2. Table 2 Lowering an Initial Category Score for Multiple Observations # of Observations Category Scores for All Risk Assessments Minor Issues Improvement Noted Needed Serious Unsatisfactory * * Will be lowered an additional 5 points for additional observations. AIB International 11

18 Scoring 3Evaluating the Adequacy of the Food Safety Program Evaluation of the written programs is not limited to determining if a written program and its records are in place and current. What the AIB Inspector sees in the facility determines whether or not the written Food Safety Programs actually work. A facility cannot have perfect programs if food safety observations are noted during the inspection. The Inspector reviews the observations in the facility against the written programs to determine where the gaps in the program exist and what should be done to alleviate these conditions. The score for the Adequacy Category is determined using the same method that is used for calculating the other four Category Scores. The Adequacy score, however, is also guided by four additional rules. Worst Risk Assessment Rules to Determine the Adequacy Score Rule 1 The Adequacy Score cannot be the highest score. How can the programs that manage outcomes in the other categories be scored higher than the categories themselves? Rule 2 The Adequacy score can be no more than one Risk Assessment Category higher than the Category with the worst finding. In other words, if the worst Risk Assessment is Serious, how could the Adequacy section be said to have only minor issues with its operation? Again, this relates to how well the program functions in a facility. See Table 3. Table 3 Maximum Adequacy Score Range Based on Rule 2 Score Range for Worst Risk Assessment Maximum Adequacy Score Range Minor Issues Noted Improvement Needed Serious Unsatisfactory AIB International

19 Scoring Rule 3 If the worst score is at the bottom of the score range, the Adequacy score can be no higher than the bottom category score, one level above. If observations require the score to be at the bottom of the category score range, this indicates that the related program is not effective. Worst Risk Assessment Table 4 Maximum Adequacy Score Based on Rule 3 Score of Worst Risk Assessment at Lowest Number in the Score Range Rule 4 A 200 may only be assigned for Adequacy if the other four category scores are all assigned a 200; i.e., the only way it can be said that the programs are working perfectly is if there are no observations to indicate otherwise. 4Total Score The total score is the sum of the points assigned to each Category: Operational Methods and Personnel Practices, Maintenance for Food Safety, Cleaning Practices, and Integrated Pest Management, but is not complete until aligned with the Adequacy of Prerequisite and Food Safety Programs because written programs drive the results from the other four categories. 5Recognition and Laudatory Terms Maximum Adequacy Score Minor Issues Noted Improvement Needed Serious Unsatisfactory Recognition is based on the total score assigned to the facility. Total scores will be collected from all facilities evaluated against the AIB Consolidated Standards for Inspection. Facilities will be separated into general groups according to the specific standards. Data will be collected from October 1 through September 30 of each year. A statistical analysis of the data will determine the total score range for the top 25 percent of scores for each group. These ranges will be the criteria for Recognition of High Achievement Superior for the following calendar year. The awarded score range for each group will change every year depending on the past year s performance of AIB International s varied client base. AIB International 13

20 Scoring Recognition of High Achievement Superior will be awarded to facilities scoring within a statistically calculated total score range. A facility cannot receive a Recognition of High Achievement Superior if there is a category score below 160, irrespective of total score. If a facility scores within the Recognition of High Achievement Superior range, but also has a category score below 160, the facility will receive a Recognition of Accomplishment. Recognition of Accomplishment will be awarded to all facilities scoring between 700 and the required number of points to achieve a Recognition of High Achievement Superior. A facility cannot receive a Recognition of Accomplishment if there is a category score below 140, irrespective of the total score. The AIB International Recognition Document: Recognizes that on the day of the inspection, the facility achieved a certain score according to the AIB International Consolidated Standards for Inspection. Is not a certificate of compliance (such as an ISO certificate). Does not have a specific expiration date. Is labeled as announced or unannounced. Defines which areas of the facility were included in the inspection. 14 AIB International

21 Sample Scoring with Explanations Category Score Range Category Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs # Minor Issues Noted Observations # Improvement Needed Observations # Serious Observations # Unsatisfactory Observations Category Score Total Score 815 Recognition of Recognition Accomplishment The Inspector noted 6 observations at the lowest risk of severity, but the Category Score does not go lower than the lowest possible score for the Minor Issues Noted Category (180). The severity of the single observation was significant so the score at the bottom of the score range (160) is assigned. Three observations are documented. There were actually 5 findings, but 3 of the findings were related to the same requirement in the Standard and were therefore grouped together as a single observation. The Serious observations that posed the most potential for contamination were at the lowest severity of risk, so the Category score begins with the first observation at 155. There were 2 additional observations, so the score was lowered by 5 points for each to 145. The Adequacy score is determined using the most constraining rules that apply: The observation with the most significant risk is in the Improvement Needed category so the score should fall in the range. The most significant observation is not severe, so the initial score is 175. There are three separate observations, so 5 points are deducted for each additional observation beyond the first (175 to 170 to 165). Rule 1: The highest score in the other 4 categories is 180, but that is outside the range so Rule 1 does not apply. Rule 2: The lowest score in the other 4 categories is 145, so the Adequacy score can be no higher than the range. Rule 3: The lowest category score (145) is not at the bottom of the range, so Rule 3 does not apply. Rule 4: The other 4 categories are not assigned a 200, so rule 4 does not apply. Scoring AIB International 15

22 Scoring Automatic Assessment of Unsatisfactory The following list includes examples of a few commonly found conditions that require an assessment of Unsatisfactory. This list only represents examples of Unsatisfactory conditions, and is not complete. Similar conditions not specifically stated will be assessed by the inspector. 1. Operational Methods and Personnel Practices a. Open sores or boils on personnel who have direct contact with product, packaging materials, or product zones b. Stored product contaminated with poisonous or hazardous chemicals such as pesticides or motor oil c. Perimeter floor/wall junctions completely restricted, preventing management of cleaning, inspection or pest control procedures d. Transporting products in the same trailer or railcar with toxic chemicals, except where they are physically separated on the load. Separation may be by partition or location as long as leaks or spills cannot contaminate product e. Poor personnel practices such as eating and smoking in undesignated areas f. Leaking, iced-down product stored over any other food or food contact materials 2. Maintenance for Food Safety a. Roof leaks contaminating product in storage b. Dock or pedestrian doors not pest-proofed and rodent evidence noted in the facility c. Freezers or coolers with no temperature measuring devices or temperatures maintained above the required minimums, except during periods of heavy traffic or during the defrost cycle 3. Cleaning Practices a. The presence of extensive amounts of mold growth on or in a product zone b. Widespread infestation above product or packaging materials or in areas where product contamination would be likely 4. Integrated Pest Management a. Insects i. Excessive insect activity in equipment or storage areas indicating ineffective control ii. Any cockroach activity or infestation in the facility that would cause regulatory action or adulterate product b. Rodents i. Visual presence of live rodent(s) ii. Evidence of rodent excreta or gnaw marks on product. iii. iv. Decomposed rodent Rodent bait stations containing bait used for routine monitoring inside the product storage area of the warehouse v. No internal rodent control program in place using mechanical traps, snap traps or glue boards as applicable 16 AIB International

23 Scoring c. Birds i. Birds residing in processing, packaging or warehouse areas ii. Bird excreta on product zones, raw materials or finished product d. Pesticides used inconsistently with label directions 5. Adequacy of Prerequisite and Food Safety Programs a. Non-compliance with written programs i. Failure to comply with HACCP Critical Limits or monitoring requirements ii. No HACCP Program in place where this is a defined regulatory requirement b. Poorly defined or poorly written Prerequisite Programs i. Inadequate or ineffective implementation of a Prerequisite Program resulting in actual or likely product contamination AIB International 17

24 Special Note Ө Indicates Standards not applicable to Distribution Centers Note: The Consolidated Standards for Inspection of Distribution Centers is a targeted version of the more general AIB International Consolidated Standards for Inspection of Prerequisite and Food Safety Programs. The numbering convention from the Prerequisite and Food Safety Programs Standard is preserved in the Distribution Centers Standard in order to keep numbering consistent. However, any Standards or requirements from the Prerequisite and Food Safety Program Standard that are not applicable to food distribution centers are not included in this document. A symbol, Ө, signifies that missing numbers in series of Standards or requirements are intentional. 18 AIB International

25 Operational Methods and Personnel Practices Consolidated Standards for Inspection 1. Operational Methods and Personnel Practices The receipt, storage, monitoring and handling of materials to distribute safe final product. 1.1 Rejection of Shipments A facility can safeguard its food products by identifying and barring entry to potentially contaminated materials Damaged, infested or dirty transports/containers are rejected Materials shipped in damaged, infested or dirty vehicles are rejected Perishable or frozen materials meet specific minimum temperature requirements at points of shipment, transportation, and receipt The facility maintains documentation of temperature checks for perishable goods at receiving points The facility maintains documentation of rejected shipments that includes defect specifications and reasons for rejection. 1.2 Storage Practices After receiving, materials are stored in a way to meet Program requirements for safe storage of materials Food products are stored and removed from storage in a manner that prevents contamination Receiving dates are visible on the bottom unit of the pallet or individual container Materials are stored off the floor on pallets, slipsheets or stands Materials are stored at least 18 in or 45 cm away from walls and ceilings Adequate space is maintained between rows of stored materials to allow cleaning and inspection. Procedures are followed to guarantee the proper cleaning, inspection and monitoring for pest activity in storage areas, where an 18 in or 45 cm inspection perimeter cannot be provided. AIB International 19

26 Consolidated Standards for Inspection Minor Requirements Receiving dates are on a permanent part of materials packaging (i.e., not on stretch-wrap) There are at least 14 in or 35 cm of space between pallet rows Storage slots and traffic lanes are provided for items stored at floor level If an 18 in or 45 cm clearance from walls is impossible due to aisle widths and forklift turning space, a rack system can be installed against the wall. In this case, a bottom rail is installed 18 in or 45 cm off the floor so that no pallets are stored on the floor. 1.3 Storage Conditions Materials are stored in a clean storage area to protect them from contamination sources Storage areas are clean, well ventilated, and dry. Materials and packaging materials are protected from condensate, sewage, dust, dirt, chemicals or other contaminants. Ө All toxic chemicals, including cleaning and maintenance compounds, and non-product materials, including equipment and utensils, are stored in a separate area Research and Development items, and infrequently used materials and packaging supplies are regularly inspected for signs of infestation Special handling procedures are followed for packaging materials that pose a product safety risk if mishandled (e.g., aseptic or glass packaging). Failures and Corrective Actions are documented. Minor Requirements Packaging is stored away from food materials and finished product in a designated area, if possible. Ө Frozen foods are not staged for longer than 30 minutes on docks that are refrigerated to hold an air temperature not exceeding 40 F or 4 C If the dock is not refrigerated, products are not kept there for longer than 15 minutes. 20 AIB International

27 Operational Methods and Personnel Practices An 18 in or 45 cm painted inspection line is provided on the floor wall junctions around the perimeter and interior partition walls to aid in the detection of pest activity. 1.4 Material Inventory Material inventories are maintained at reasonable volumes to avoid excessive age and insect infestation Ingredients, packaging supplies and other materials are rotated on a First-In, First-Out (FIFO) basis or other verifiable method (such as First Expired, First Out [FEFO]) to ensure stock rotation Insect-susceptible materials in storage longer than four weeks are regularly inspected. Minor Requirements The repalletizing date or inspection date is located near the original receiving date. 1.5 Pallets Clean and well-maintained pallets minimize opportunities for contamination Pallets are clean and in good repair. Minor Requirements Pallets and other wooden surfaces are properly dried after being washed Slipsheets are placed between pallets and bags of ingredients, and between double-stacked pallets to protect ingredients from damage by the pallet. 1.6 Designated Rework Areas Rework or salvage, if not segregated and managed properly, can cause contamination of materials There is a designated rework area The rework area is segregated from usable materials Rework is processed weekly or often enough to keep rework quantities at minimal levels Rework is identified for traceability purposes. AIB International 21

28 Consolidated Standards for Inspection 1.7 Release Procedures Release procedures ensure that materials are checked for defined food safety hazards before being released into the facility, or shipped to a customer. Ө The facility follows release procedures Products are not released unless all release procedures have been followed Food materials are only released by authorized personnel Sampling Procedures If samples are taken of products stored in the facility, documented procedures define handling and identifying sampled product containers. Sampling may not be required in every facility. Ө The facility has documented aseptic sampling procedures in place for obtaining samples of incoming food materials All openings created for sampling in bags, boxes or containers are properly resealed and identified as such Staples and other items likely to cause product contamination are not used to reseal packaging materials Waste Material Disposal Waste materials and their removal are managed to avoid contamination. Ө Trash or inedible waste is stored in properly covered, labeled containers Waste containers are emptied at least daily Trash or inedible waste does not come in contact with materials, work-in-progress or finished product at any time Licensed contractors remove waste, where required Waste disposal meets regulatory requirements. 22 AIB International

29 Operational Methods and Personnel Practices 1.20 Single-Service Containers Residue can contaminate any new materials or products added to an old container. Ө Single-service containers are not reused All single-service containers are crushed, punctured or otherwise disposed of so that they cannot be reused Temperature-Sensitive Materials Temperature controls prevent the growth of pathogens in susceptible materials Materials, work-in-progress and finished product capable of supporting the rapid growth of pathogenic microorganisms are properly stored Temperature-sensitive materials are stored to maintain appropriate internal temperatures: 40 F or 4 C or below 140 F or 60 C or above Or in accordance with country-specific regulation Minor Requirements Continuous recording thermometers are placed in all rooms or areas where frozen foods are stored or handled and the thermometers are calibrated and maintained Freezers and coolers are provided with vinyl strip doors, self-closing devices, or other methods to maintain temperatures Cross Contamination Prevention Incompatible or hazardous materials require separate handling to prevent contamination Incompatible materials (such as raw and cooked products) are stored under conditions that prevent cross contamination Measures are taken to prevent cross contamination by hazardous ingredients, such as allergens. AIB International 23

30 Consolidated Standards for Inspection Systems are set up to reduce any potential physical, chemical or microbiological contamination risks. Ө Protective measures are provided in areas where iced down product is stored over like or dissimilar items in order to prevent melting ice from contaminating product below Containers and Utensils If not managed, any food contact containers or utensils have the potential to create food safety hazards. Ө Containers and utensils used to transport, process, hold or store food materials are constructed, handled and maintained in a way that prevents contamination Containers for food products are only used for their designated purposes Containers are legibly labeled with contents Finished Product Transportation Finished product is coded for traceability, and shipping requirements are in place to prevent product contamination Legible code marks that are easily seen by consumers are placed on all finished products Code marks satisfy regulatory packaging requirements and lot definitions, and are used in the Recall Program Distribution records identify the initial point of distribution as per regulatory requirements Finished products are handled and transported in a way that prevents actual or potential contamination Finished products are loaded or transferred in covered bays or canopies to protect the product from weather damage Temperatures of perishable and frozen products are taken and recorded upon loading Documentation validates that temperature-sensitive products are loaded into vehicles that are designed to sustain required temperatures during delivery Temperatures of vehicles are checked and recorded before loading. 24 AIB International

31 Operational Methods and Personnel Practices The facility enforces transportation breakdown procedures Prior to loading, all shipping vehicles are inspected for cleanliness and structural defects that could jeopardize the product Shipping vehicle inspections are documented Local delivery trucks and route trucks are inspected and cleaned at least weekly to identify potential sources of foreign material contamination. Minor Requirements Common carriers and customers are encouraged to maintain their delivery vehicles in sanitary condition, and in good repair Security seals or padlocks are provided, and their use is documented as per facility or customer requirements. Ө Transport refrigeration units have recording devices Adequate free air circulation is provided all around the load during refrigerated or frozen product transportation. Pallets with slipsheets or another way to allow adequate air circulation under the load is in place unless the transport has a channeled floor to maintain air circulation If applicable, the vehicle s refrigeration unit is turned on and the doors are closed when loading and unloading are not taking place The thermostat on the vehicle s refrigeration unit is set to maintain an air temperature of 0 F or -18 C or lower for frozen food Dome lights provided in transports are shielded to prevent glass breakage Hand Washing Facilities Personnel are provided the equipment to effectively remove contaminants from their hands Suitable and properly maintained hand washing facilities are located at the entrance to work areas, and at other appropriate sites Single use towels or air dryers are provided at hand washing stations Hand sanitizing stations are provided, where appropriate Hand sanitizers are regularly monitored for proper concentration to ensure effectiveness. AIB International 25