AIB International GMP Inspection Results Report

Transcription

1 AIB International GMP Inspection Results Report Consolidated Standards for Inspection: Distribution Centers Contacts Website US Office: 1213 Bakers Way PO Box 3999, Manhattan, KS (785) (800) Fax (785) UK Office: PO Box 11, Leatherhead, Surrey, KT22 7YZ Fax

2 The AIB International Consolidated Standards for Inspection are statements that represent key requirements that a facility must meet in order to keep products manufactured, processed or handled in a facility wholesome and safe The Standards reflect what an inspector would expect to see in a facility that maintains a food-safe processing environment This report details the findings from an AIB International inspection against the Consolidated Standards The document contains the following sections: Document Section Score and Rating Participant Names Facility-Specific Questions Location Matrices Findings with Risk Additional Comments Standards without identified Risks or Findings Standards Not Applicable x Description of the facility x Number of findings and related risks x Category scores and total score x Rating Description Personnel from the facility who accompanied the inspector Technical information about a facility For example: bulk materials used, temperature control equipment used Two matrices which categorize findings by Category and Risk Descriptions and recommendations related to all findings Comments made by the inspector that have no risk assessment Standards that are applicable to the inspected facility, but based on random review and observation samplings at the time of the inspection, the facility appears to be meeting requirements Standards that are not applicable to the inspected facility 2 of 21

3 The official version of this report is a certified pdf issued by AIB International Score and Rating Inspection Information: Facility Name Standard Used Distribution Centers Facility Address 3143 W Lewis Ave Phoenix, Arizona United States Date(s) of Inspection Audit Type Inspection Type 26-Mar-2012 GMP Scored Products Produced Fruit and vegetable storage warehouse Announcement Type Account # Expected Scope Reinspection No Variations From Expected Scope Terminated No Score Category Minor Issues Noted ( ) Improvement Needed ( ) Serious ( ) Unsatisfactory <= 135 Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs Total Score 960 Scores Rating : Recognition of High Achievement - Superior Disclaimer: AIB International Inc states that this report as dated and provided herein is to be construed as its findings and recommendations, category scores, total score, and rating A passing score of 700 and above is not a certification of the facility, products, or programs AIB International Inc does not accept or assume responsibility for the Prerequisite and Food Safety Programs in effect with the customer named on the title page of this report (the customer) AIB International Inc is only reporting the food safety conditions of the customer as of the date of this report and assumes no responsibility or liability as to whether the customer does or does not carry out the recommendations as contained in this report

4 Participant Names Name Role Inspection Closing Meeting Anthony Calloway Production Manager Yes Yes Jesse Leal Auditor Yes Yes 4 of 21

5 Facility-Specific Questions # Question Comments 19 Does the facility use bulk dry materials? No 19a State the bulk dry materials received N/A 19b Provide the screen size of the sifter N/A 19c State the frequency of screen and tailings checks N/A 111 Does the facility use processing aids? No 111a What are the processing aid(s)? N/A 111b Are processing aids segregated from non-food materials? N/A 111c Is food approval documentation provided? N/A 114 Does the facility use bulk liquid materials? No 114a State the bulk liquid materials received N/A 114b State where strainers are provided N/A 114c State the frequency of strainer inspections and if they are documented N/A 115 Are foreign material control devices used? N/A 115a List the device(s) used N/A 115b Are they present on all lines? N/A 115c Comment on device testing observed during the inspection N/A 122 Does the site have temperature controlled areas such as coolers and freezers? 122a State the temperatures noted at the time of the inspection The temperatures at the time of the audit were the following in the different coolers 39, 48, 52, 35, 54, 34 and 38 degrees 122b State the method of temperature monitoring (manual or continuous) There is a small thermometer located on the outside of the unit which is checked and documented every 4 hours These thermometers are continuous monitoring 122c State if an alarm system is present No there is no alarm system 125 Are cans, bottles, or other rigid packaging materials used at this facility? No 125a What is the rigid packaging? Cans, bottles, boxes? N/A Yes 5 of 21

6 125b State how they are cleaned prior to filling (water, air rinse, etc) N/A 125c State if the systems were functional N/A 125d State the maintenance frequency and records maintained for this equipment 221 Does the site use potable water, ice, or steam for product or food contact? 221a State the source of the potable water supply (well, city, etc) The potable water supply is from the City of Phoenix 221b State the source of the records indicating potability Yes there is a report on file for the potable water information from the City of Phoenix 221c Is ice made in-house or purchased? No 221d 221e List the source of testing records for ice and if they indicated that it was potable Is food approval documentation provided for chemicals used for the generation of steam for food contact? 221f List the source of testing records for steam used for product contact N/A 221g State if the back flow prevention devices are checked for function and provide the last date of testing 32 Does the facility use sanitizers on food contact surfaces? No 32a Is sanitizing followed by a potable water rinse? N/A 32b Is the sanitizer concentration verified? N/A 32c Are corrective actions documented when results are not in compliance with label directions? 44 Are IPM services provided by a contractor? Yes 44a State the name of the service provider Beard Pest Control 44b Is the business license current? Yes 44c Are the PCO licenses current? Yes N/A No N/A N/A The facility was an old furniture storage facility and does not have a back flow system in place It is a small operation so the facility has never received any letters from the city requiring them to test their system 44d If licensing of PCO s is not required, were training records current? PCO licenses are required for application of chemicals 46 Were pesticides used at this site? Yes 46a State the names of the pesticides reviewed during the inspection Conquire 7uer EPA# , Up-cyde , N/A 6 of 21

7 Suspend, b Were current labels provided? Yes, the labels were on file for the materials mentioned in item 46B 46c Were current MSDS (Chemical Safety Data) sheets provided? Yes, the MSDS were on file for the several materials that are used in the facility 52 Who was assigned responsibility for food safety at the facility? The IT Manager 52a 52b Does the facility have a current license to produce, manufacture, or store food products (local health department, state, or other agency)? For facilities producing in or exporting to the USA, has the facility had to report or have they received notice of receipt of a Reportable Food (Reportable Food Registry - RFR)? [INFORMATION ONLY - NOT SCORED] 510 Does the site have a documented Microbiological Control Program in place? 510a State if the testing is for sanitation, environmental, raw materials/finished products Yes, there is a license on file for the Center to handle and store produce It is a business license N/A The plant does test the drains although this is all internal The testing is for Environmental although it is not a formalized 510b State the microorganisms tested for The facility is testing for Listeria 510c State if an in-house or outside lab is used N/A The plant takes swabs of the drains and checks these with regents and look for a color change which would indicate possible microbial activity 511 Does this country have allergen regulations or does the site ship to countries with allergen regulations? 511a State the names of the allergens handled at this facility The facility handles dairy products 516 Has the site been inspected by a regulatory agency in the past year? Yes 516a State the name of the agency and the date of inspection The facility was last visited by the Maricopa County Health Department with no issues noted in February b State if the site addressed findings identified by the regulatory inspection 522 List the materials for which specifications were reviewed N/A 523 List materials for which COA s or letters of guarantees were reviewed N/A 524 Does the process contain a kill step? No 524a State the kill step N/A Yes There were no issues noted 7 of 21

8 525 Is there a HACCP program in place? Yes, although this facility does not handle any HACCP regulated products and they do not have any CCP's 525a List the CCPs There are no CCP's in this Center 525b State if the plan has been validated and who did the validation The plan is reviewed annually by the IT Coordinator who also doubles as the Food Safety Manager 525c State the date of the most recent reassessment The program was most recently reviewed in February during a training Overall the program includes all the necessary prerequisite's even though there are no CCP's in place 525d State the names of the products falling under regulatory HACCP produced or stored at this site N/A 8 of 21

9 Findings by Location and Category Locations Operational Methods and Personnel Practices Maintenance for Food Safety Cleaning Practices Integrated Pest Management Adequacy of Prerequisite and Food Safety Programs Facility Overview Raw Material Storage Totals by Category Totals by Location Locations Findings by Location and Risk Minor Issues Noted Improvement Needed Serious Unsatisfactory Facility Overview Raw Material Storage Totals by Risk Totals by Location 9 of 21

10 Findings with Risk # Risk Standard Standard # Requirement # Location 1 Minor Issues Noted (MI) Floors, Walls, and Ceilings Raw Material Storage Damage to walls, or ceilings was observed There were some areas where the facility was still maintaining the peeling on the walls where the paint was still deteriorating and needs to be managed Recommendation: The writer suggested to continue to stay on top of the painted walls to ensure that if any paint begins to flake it is removed There were no issues with the walls that were jeopardizing the products at the time of the audit 2 Minor Issues Noted (MI) Overhead Structures Raw Material Storage Evidence of some active flaking paint in the overheads away from product storage was observed outside of the product zone Recommendation: It was recommended to stay on top of the painted walls to ensure that any loose paint is immediately removed so it does not jeopardize any products 3 Minor Issues Noted (MI) Facility Assessment Facility Overview The annual IPM assessment did not evaluate all areas inside and outside the facility The assessment did not mention any information of the Manual such as the MSDS and labels or information on the rodent catch units which are glue boards inside the plant and bait stations outside Recommendation: It was recommended to do a more thorough job on the assessment to include the manual and information on the entire program such as bait stations and glue boards 4 Minor Issues Noted (MI) Pesticide Application Documentation Facility Overview Gaps in documentation of pesticide applications were noted The applicator was not listing the non toxic or organic feeding block on the pesticide application records because he felt it was not a considered a chemical or poison Recommendation: All materials even the non toxic blocks need to be included in the pesticide usage log to ensure that are materials are documented, accounted for and tracking of monitoring can be monitored 5 Minor Issues Noted (MI) HACCP Program Facility Overview A Hazard Analysis Critical Control Point (HACCP) Program was developed even though the Center only receives, handles and ships fresh produce and some dairy items There are no Regulated products handled by this facility at this time There were several issues, however, with the wording of the written program Recommendation: The plant was calling the three types of contaminants Physical, Chemical, and Biological CCP's They also identified Security as a CCP The writer suggested for the Food Safety Manager to attend a HACCP seminar to better understand HACCP and to better formalize their written program They have conducted a hazard analysis and did have prerequisite programs in place 6 Minor Issues Noted (MI) HACCP Program Facility Overview Not all members of the HACCP team were trained The coordinator should attend a HACCP seminar to better understand the HACCP principles and to help formalize this program 10 of 21

11 Recommendation: It was recommended to attend a HACCP seminar so the Food Safety Manager has a better understanding of HACCP and the program can be properly developed and implemented 11 of 21

12 Additional Comments # Risk Standard Standard # Requirement # Location 1 Rejection of Shipments Documentation of temperature checks and perishable materials met the temperature requirements defined in the facility's program 2 Storage Conditions Infrequently used materials and packaging were inspected for signs of infestation on a regular basis Due to the nature of the products which are fresh vegetable, there is a potential for pest activity such as fruit flies 3 Storage Conditions Special handling procedures were in place for packaging materials with a product safety risk The Center does handle fresh eggs as well as dairy products although there are no special handling procedures for the storage of these items 4 Storage Conditions Refrigerated docks were provided to prevent food safety issues when staging refrigerated materials 5 Storage Conditions Refrigerated materials were not left for excessive amounts of time to cause thawing or temperature abuse of product when staged on non-refrigerated docks 6 Designated Rework Areas Rework materials were segregated from good stock The rework are products that are inspected and separated based on defects and quality specifications No returned products are reworked 7 Temperature-Sensitive Materials Daily calibrated continuous recording thermometers were placed in all areas where frozen foods were stored or handled 8 Temperature-Sensitive Materials Coolers were provided with self-closing doors, strip curtains or other devices to maintain temperatures 9 Cross Contamination Prevention Protective measures were provided to prevent iced down product stored over like or dissimilar items from contaminating product below The facility does handle some iced down products although they do not ice down products and any products with ice are stored on the floor level 10 Finished Product Transportation Temperatures of perishable products were taken and recorded during loading activities 12 of 21

13 11 Finished Product Transportation Documentation indicated that climate-controlled vehicles capable of maintaining temperatures for shipping refrigerated materials were used at this facility Records indicated that perishable materials were shipped in these vehicles 12 Hand Washing Facilities Single use towels were used at this facility 13 Hand Washing Facilities Pre mixed hand sanitizers were provided 14 Hand Washing Facilities Paper towel dispensers were maintained covered 15 Washrooms, Showers, and Locker Rooms Open food and drinks were not noted This was one of the issues noted in the previous training audit which was corrected as open containers are not left in the break area 16 Personal Items and Jewelry Control Personnel were not observed eating, drinking, or smoking in unauthorized areas No violations were observed in any areas of the facility 17 Outside Grounds No issues with drainage from the roof, grounds, or other areas were observed This roof was not inspected as the only way to inspect it would be an extension ladder that does not have a safety cage around it 18 Outside Grounds Truck bays were examined were well maintained at the time of the inspection 19 Security Equipment Some measures were taken to maintain facility security Security strategies included fencing, controlled gate access, controlled parking, locked doors, limited access to sensitive areas, surveillance cameras, truck seals, employee screening, and awareness and training programs 20 Floors, Walls, and Ceilings Ceilings and overhead structures were found to be clean and well maintained 21 Floors, Walls, and Ceilings Wall/floor junctions and corners were properly maintained to facilitate cleaning 22 Temperature Measuring Devices Temperature measuring devices were calibrated on a defined frequency Thermometers were maintained on each cooler and are checked every 4 hours 13 of 21

14 23 Temperature Measuring Devices Thermometers were provided in coolers and temperature-controlled storage areas 24 Temperature Measuring Devices Temperature measuring devices used in processes not critical to food safety were calibrated to a defined standard The thermometers are calibrated daily 25 Transporting Equipment Cleaning of transporting equipment was formally tracked and included follow up The forklift service is subcontracted out to an outside service 26 Periodic (Deep) Cleaning Racks and storage shelves examined during the inspection were clean and well maintained The housekeeping in all storage areas were all found to be well maintained 27 Periodic (Deep) Cleaning Drains in Produce areas were cleaned and sanitized as defined in the MCS 28 Facility Assessment Trained personnel completed the assessment The assessment was conducted by the outside pest control technician 29 Credentials and Competencies Regulation does require certification or licensing of IPM personnel There was a license on file for the technician who conducts the service 30 Exterior Monitoring Devices Non toxic feeding blocks were used in secured exterior bait stations 31 Recall/Withdrawal Program The Recall Program was tested twice annually and test results were documented and included the success rate and the time it took to complete the exercise The plant actually conducted a real withdrawal of products due to a customer withdrawal on 12/10/ HACCP Program Finished Product Profiles were provided for each product produced The facility only receives, stores and ships fresh produce and vegetables 33 HACCP Program The Seven Principles of HACCP were followed in the development of the HACCP Program and included a risk assessment for products received 34 HACCP Program of 21

15 This facility did not handle and/or store products subject to regulatory HACCP and had a HACCP Plan in place to address these requirements 15 of 21

16 Standards without identified Risks or Findings Based on random review and observation samplings at the time of the inspection, the facility appears to be meeting the requirements of the following Standards: Standard Standard # Standard Goal Rejection of Shipments 11 Random review of records and programs related to safeguarding of food products by identifying and barring entry to potentially contaminated materials met the requirements of the standard as applicable to this site Storage Practices 12 Materials appeared to be stored in a way that met the program requirements as defined by this site, as well as the applicable requirements in the standard Storage Conditions 13 Materials appeared to be stored in a clean storage area and were protected from contamination as observed during the inspection Material Inventory 14 Material inventories appeared to be maintained at a reasonable volume A random review did not identify aged or infested materials during the inspection Pallets 15 Pallets examined were found to be clean and well maintained Designated Rework Areas 16 Materials identified for rework appeared to be managed and segregated to prevent contamination Waste Material Disposal 116 Waste material and waste material removal were managed to avoid product contamination Single-Service Containers 120 Single-service containers appeared to be properly disposed of to prevent reuse Temperature-Sensitive Materials 122 Appropriate storage temperatures were noted during the inspection to prevent microbial growth in susceptible food products Cross Contamination Prevention 123 Incompatible or hazardous materials observed during the inspection appeared to be segregated and handled to prevent product contamination Containers and Utensils 124 Containers and utensils observed during the inspection were constructed, handled, and maintained to prevent food safety hazards Finished Product Transportation 126 Transportation and finished product coding randomly reviewed during the inspection was provided in a manner to allow traceability of materials Transports examined during the inspection were found to be clean and in good condition Hand Washing Facilities 127 Hand washing facilities examined during the inspection appeared to be appropriately located, functional, and stocked to allow hand washing to occur Washrooms, Showers, and Locker Rooms 128 Employee welfare areas examined were maintained in good condition Personal Hygiene 129 No personal hygiene practices issues were identified during the inspection 16 of 21

17 Personal Items and Jewelry Control 132 No issues with the control of personal items were identified during the inspection Health Conditions 133 Health policies were defined for the facility No issues that were inconsistent with these policies were identified Non-Facility Personnel 134 Non-facility personnel were observed to be in compliance with the facility defined GMP Programs Facility Location 21 No evidence of issues from local activities or the facility location were identified during the inspection Outside Grounds 22 Facility grounds appeared to be well maintained No issues were identified Security Equipment 23 Physical security measures were implemented at this facility Layout 24 No issues with placement of equipment and structures were identified Appropriate access for cleaning, inspection, and maintenance activities was noted Glass, Brittle Plastics, and Ceramics Control 27 No issues with glass, brittle plastics, or ceramics were identified during the inspection Air Makeup Units 28 Filters and screens examined during the inspection were found to be well maintained and in good condition Pest Prevention 29 No identified issues with building maintenance were observed that would allow pest harborage or entry into the facility Cross Contamination Prevention 212 Segregation of operations based on process flow appeared to be practiced as observed during the inspection Temporary Repair Materials 215 Temporary repairs noted during the inspection were consistent with the facility defined program Food Contact Surface Construction 216 Food contact surfaces accessible for observation were found to be smooth and made of appropriate materials Temperature Measuring Devices 217 Temperature measuring devices were routinely calibrated and monitored to ensure product safety Records randomly reviewed indicated that calibrations were current Transporting Equipment 219 Transporting equipment appeared to be well maintained at the time of the inspection Water Quality 221 Water, water sources, and water management strategies were implemented to ensure safe water for product contact and use Random reviews of the records indicated that programs were implemented Hand Washing Facilities Design 222 Hand washing facilities were provided and were observed to be operational during the inspection Cleaning 31 Cleaning appeared to be completed in a way to prevent contamination of materials, products, and equipment 17 of 21

18 Equipment and Tools 33 Cleaning tools and equipment appeared to be managed and maintained to prevent product contamination No issues were identified Daily (Housekeeping) Cleaning 34 No issues were identified with daily housekeeping practices observed during the inspection Periodic (Deep) Cleaning 35 Periodic (deep) cleaning practices appeared to completed according to the Master Cleaning Schedule (MCS) No issues were identified Maintenance Cleaning 36 Debris or issues with maintenance cleaning practices were not observed during the inspection Food Contact Surface Cleaning 37 Food contact surfaces available for observation were found to be clean and well maintained Integrated Pest Management (IPM) Program 41 A written IPM Program outlining controls and processes to minimize pest activity were defined Signed Contracts 44 Signed contracts between the facility and the external service provider defined the requirements for pest management activities for this facility Credentials and Competencies 45 Qualifications examined for selected IPM service providers were documented and current Pesticide Documentation 46 Pesticide labels and MSDS were provided for the pesticides randomly examined during the inspection Pesticide Control 48 Management or use of pesticide chemicals appeared to be as defined in the facility's Chemical Control/ IPM Program Trend Analysis 49 Service records of monitoring devices and pest sightings reviewed appeared to be used to identify and eliminate areas of pest activity as noted by the lack of significant activity observed during the inspection Monitoring Device Documentation 410 Monitoring devices were mapped and maintained to ensure proper placement and monitoring for pest activity and trending The map appeared to be current based on observation during the inspection Exterior Monitoring Devices 411 Exterior rodent control devices were placed and those randomly reviewed were maintained to provide rodent monitoring and to deter entry into the facility Interior Rodent Monitoring Devices 412 Interior rodent monitoring devices were placed and those randomly reviewed were maintained to identify and capture rodents that have gained access to the facility Bird Control 415 Bird control activities were addressed and the lack of activity noted during the inspection indicated that the program was effective Wildlife Control 416 No evidence of rodent, bird, insect, or other pest issues were identified during the inspection Pest Habitat 417 No issues with identification or elimination of pest habitat were noted Written Policy 51 A written policy emphasizing the facility's commitment to provide safe and legal food products was documented for this facility 18 of 21

19 Accountability 52 Management authorization and support of supervisory compliance to programs, laws, and regulations was defined for this site and appeared to be implemented Support 53 Human and financial resources were provided to support implementation of the Food Safety and Prerequisite Programs Written Procedures 54 Written procedures randomly reviewed for food safety activities at the facility defined owners, actions, and timelines Training and Education 55 Regularly scheduled training activities were documented and consistently carried out to ensure appropriate implementation of Food Safety and Prerequisite Programs at this facility Records of training that were randomly reviewed were current Self-Inspections 56 Monthly documented self-inspections were carried out to assess how well the facility was implementing and monitoring Prerequisite and Food Safety Programs Random review of the self-inspections indicated that they were current and Corrective Actions were defined and carried out Written Procedure Audits 57 Written procedure audits were documented to validate the appropriateness and implementation of procedures defined for this site Records randomly reviewed indicated that audits were conducted and current Customer Complaint Information 58 A Customer Complaint Program was implemented to respond to customer concerns Protocols were in place to ensure that food safety issues were responded to in a prompt and effective manner, whether it be at the facility level or as managed by corporate Chemical Control Program 59 A documented Chemical Control Program was implemented to provide a centralized approach to manage and control purchase and use of nonfood chemicals Random review of chemicals and program requirements indicated that this program had been implemented as applicable for this facility Allergen Control Program 511 Allergen controls were implemented to identify allergen control throughout the process from receiving to distribution of product Random review of the program, records, and observations during the inspection indicated that the program was implemented Glass, Brittle Plastics, and Ceramics Program 512 A documented Glass, Brittle Plastics, and Ceramics Program was provided to identify processes that prevent contamination of product There were no identified deficiencies noted during the inspection to indicate that the program was ineffective Cleaning Program 513 A Cleaning Program with schedules and procedures for accomplishing cleaning tasks critical to maintenance of the food processing environment was documented Random review of schedules and cleaning procedures, in addition to observations, indicated that the program appeared to be effective Preventive Maintenance Program 514 A Preventive Maintenance Program that addressed building, utensil, and equipment construction and maintenance to ensure safe food production was implemented Observations noted during the inspection indicated that this program appeared to be effectively carried out 19 of 21

20 Receiving Program 515 The Receiving Program implemented at the facility outlined and identified requirements for the materials received at this site Random review of the program and documentation of receipt of materials indicated that materials receipts were consistent with the defined program requirements Regulatory Affairs and Inspection Program 516 A documented Regulatory Affairs and Inspections Program provided instructions for handling of regulatory, third party, and customer inspections Food Defense Program 517 A Vulnerability Assessment was performed to identify and reduce the risk of intentional harm to the facility, its personnel, and food products No inconsistencies with the program, as defined for the facility, were identified during the inspection Traceability Program 518 The written Traceability Program defined the methodology to allow quick location of suspect materials, food contact packaging materials, rework, and related finished products Recall/Withdrawal Program 519 The written Recall/Withdrawal Program documented the procedures for quick and controlled recovery of product from the market Random review of the records and mock recovery exercises indicated that the program was implemented as defined for this facility Nonconforming Product Program 520 The Nonconforming Products Program defined the guidelines for isolation, investigation, and disposition of materials, packaging materials, work-in-progress, returned goods, and finished products as applicable to the facility Random review of records and observations during the inspection did not identify any current deficiencies with this program 20 of 21

21 Standards Not Applicable Standard # Standard Name 17 Release Procedures 110 Sampling Procedures 210 Leaks and Lubrication 220 Parts Storage 32 Food Contact Cleaning Compounds and Sanitizers 43 Other Guidelines 413 Insect Light Traps 414 Pheromone Monitoring Devices 21 of 21