Food Safety, Quality and Food Defense Audit

Transcription

1 Food Safety, Quality and Food Defense Audit Company Information Audit Information Facility: C Royal Gourmet Foods Address: 2876 Main Street San Diego, California United States, Contact: Rene D Rivero Title: Owner Phone: Fax: renerivero@royalgourmetfood.com Audit# - Visit#: Audit Type: BASE1 - Food Safety, Quality and Food Defense Audit Template Version: 1.7 Audit Category: REGULAR Auditor: Frank Richards Audit Start Time: 24-AUG :30:00 AM Audit End Time: 24-AUG :30:00 PM Prior Audit Date: 24-AUG-09 Prior Audit Score: 93.90% Facility and Operating Profile No 1 Facility and Operations Description: Question/Notes Auditor's Notes: Royal Gourmet Foods is located in a light industrial park in the City of San Diego, CA and located at this facility since The facility covers 5,100 square feet of dry storage, cooler, freezers, processing, packaging and office space. Ingredient and finished products require temperature-controlled conditions that are located in coolers or freezers while non-temperature-controlled items are stored in a dry warehouse area. The building has concrete walls, internal walls are FRP panels, insulated roof and sealed concrete floors. Plant operates one shift per day, five days per week followed by a sanitation shift. Company employs 21 individuals. 2 Was the audit Announced or Unannounced? Announced 3 Regulatory Inspection Type: USDA and FDA USDA numbers are and P FDA number is xxxxxxx Products made at this facility: Approximately 300 various assorted appetizers and specialty handmade products that include seafood, meat and poultry ingredients. Products are stored refrigerated and frozen. 5 What is the average lot size in pounds (coded and identifiable)? 200 pounds 6 What is the most probable cause of accidental product contamination? Foreign Material 7 The following departments and individuals participated in the audit process: President and Consultant 08/25/ :04:04 Audit# - Visit # : Page 1 of 17

2 Score Summary By Section Section Name Section Score Section A - Administration and Regulatory Compliance 94.00% Section B - HACCP Management 89.00% Section C - Facilities and Equipment 89.00% Section D - Sanitation, Housekeeping and Hygiene 88.00% Section E - Rodent and Pest Control Management 95.00% Section F - Approved Suppliers, Receiving and Inventory Control 96.00% Section G - Process and Product Evaluation 96.00% Section H - Packaging and Labeling 96.00% Section I - Storage and Shipping 94.00% Section J - Training Requirements 97.00% Section K - Laboratory Support N/A Section L - Food Defense 95.00% Food Safety, Quality and Food Defense Audit Average Score: 93.55% Category Scoring Guide 95% - 100% = Meets or Exceeds Audit Expectations 85% % = Needs Improvement 75% % = Needs Significant Improvement <75% = Critical Automatic Audit Failure (Denoted as a "Critical" item in the audit report) - Product Contamination and/or adulteration - Significant deviation from identified CCP in the HACCP Plan - Mislabeled or misbranded product - Record falsification - Significant deviation from specification - Facility is not operating in compliance with stated regulatory requirements 08/25/ :04:04 Audit# - Visit # : Page 2 of 17

3 No Notes from the auditor: Overview Question/Notes See Notes This was an annual food safety audit for Royal Gourmet Foods. As a result of the audit score, the facility management staff had put a lot of effort into the audit with two repeat observations. Management understood the findings of the audit and indicated a favorable response towards corrective action steps bring taken. Programs, policies and procedures were documented and put together with all the required steps. These documents included food safety, quality, operations, HACCP, SSOPs, sanitation and recall. Documents were easily to read and clearly marked. Records were requested and reviewed from one to nine months. Two HACCP plans were audited (USDA HACCP plan = Raw Not Ground & FDA HACCP plan = Crabmeat) were audited. Hazard analysis and CCPs were documented together with all the required key procedures along with references to scientific data. Training programs are in place for all employees covering GMPs, hygiene, HACCP, sanitation and specific job functions. Employee training is done at new hire and quarterly in English and Spanish. This was confirmed during the facility inspections. Work is needed in the following areas: A. Administration & Regulatory Recall program does not include mock recall or trace exercise requirements B. HACCP Management Intended Use was not identified and FDA HACCP plan records do not include CCP number and critical limits. C. Facility & Equipment Backed up drain procedure was not available and a glass/brittle plastic program has not been developed.. D. Sanitation, Housekeeping & Hygiene MCS tasks are not documented after being completed, sanitation cleaner concentration is not documented and monthly plant wide GMP inspections are not being completed. E. Packaging & Labeling Scale calibration were weekly instead of daily. F. Storage & Shipping Company vans are not inspected daily for cleanliness. G. Food Defense Food defense program did not document team members, responsibilities and quarterly meetings. For foreign material control, the facility does not use a metal detector since products are hand processed and packaged. Knives and blades are inspected for any missing or broken pieces. The facility and equipment were found in good condition with good separation. Equipment was limited and position for easy cleaning with good lighting throughout. The water supply is from the City of San Diego and checked annually. Hand washing stations are located throughout the facility at each entrance. All other sections of the audit were found to be excellent and/or acceptable. Two mock recalls have been completed in the last 12 months meeting audit requirements. Non-Compliance Summary 08/25/ :04:04 Audit# - Visit # : Page 3 of 17

4 Section A /4 Product Identification, Traceability and Recall Plans and Procedures A documented plant specific Recall Program was available that clearly defines a recall coordinator, identifies the recall team members and describes their responsibilities. However, recall program did not address mock recall or trace exercise requirements for % recovery and time. Office and after-hour telephone contact numbers of all recall team members is available for all team members. The Recall Plan was reassessed, signed and reviewed annually. Two trace exercises (March 24, 2010 and August 18, 2010) were completed in the last 12 months for ingredients within one hour and 100% recovery. Recommend that % recovery and time requirements should be part of the recall program for mock recalls or trace exercises. Section B /1 Preliminary HACCP Tasks Facility has completed the Five Preliminary HACCP Tasks (HACCP team, product descriptions, process flow chart and flow chart confirmation). However, intended use was not identified on the two HACCP plans audited. All processing steps documented in the flow chart with addressed in the hazard analysis and verified during the audit. Recommend that intended use should be identified on all HACCP plans. Section B /5 CCP Monitoring (HACCP Principle 4) USDA and FDA CCP monitoring procedures are conducted at sufficient frequencies to detect any loss of control based on random record review from June 12, 2010 August 21, Records were complete and followed documented procedures. Trained QA personnel review CCP records. FDA HACCP records did not identify CCP number and critical limits. Recommend that FDA HACCP records should include CCP number and critical limits. Section C /1 Potable Water, Ice, Backflow Prevention, Steam and Waste Water Management The City of San Diego supplies water and sewage service to the facility. EEL Laboratories tests the plant's city water annually for Total Coliform and E.coli with the last testing date being August 16, City of San Diego building code does not require main water line back flow devices into the building. Hose stations have back flow devices and they are tested annually with the last testing being completed on March 29, 2010 by Sweetwater Backflow Company. There are no dead ends on potable water lines and no hose nozzles were observed submerged in water reservoirs or left laying on the floor. An adequate supply of hot and cold water was readily available for production, sanitation and hand washing. The facility does not have a backed up drain procedure for restrooms and processing areas. Recommend that a backed up drain procedure should be developed. Section C /2 Plant Construction and Design The facility is constructed in a manner conducive to handling product in a sanitary manner. No observations of overhead contamination or cross contamination were observed. Materials are easily cleanable, floors are well drained and drains have traps and covers. No objectionable fumes or vapors were present. No dust or standing water was observed around the exterior. A glass and brittle plastic program has not been developed. However, monthly glass and brittle plastic inspections are being completed. Recommend that a glass and brittle plastic program should be developed. Section D /1 Master Sanitation Schedule and Monitoring There is a documented master cleaning schedule for operational areas, equipment, warehouse, storage, maintenance, cafeterias, break areas and toilet facilities with scheduled tasks (daily, weekly, monthly and annually). However, tasks are not documented on the MCS after completion. Recommend that tasks should be documented on the MCS after they have been completed. 08/25/ :04:04 Audit# - Visit # : Page 4 of 17

5 Section D /3 Cleaning Chemical and Sanitizer Control Chemical and sanitizers are secured in a separated locked cabinet away from ingredients and products except for solutions located in sanitation stations currently being used. A chemical dilution log was being kept for sanitizers and not cleaning solutions. Recommend that cleaning solution concentrations should be documented. Section D /8 GMP Self Inspections and Corrective Actions Monthly GMP audits are not completed for the whole plant both inside and outside. Recommend that monthly GMP audits (inspections) should be completed on a monthly basis. Section I /4 Transport Condition Pre-shipment inspections do not include company vans on a daily basis. Vans are cleaned and inspected on a weekly basis. Random weekly records were reviewed and they were found complete. Recommend that company vans should be inspected daily and documented. 08/25/ :04:04 Audit# - Visit # : Page 5 of 17

6 Section A. Administration and Regulatory Compliance 1 Organization and Responsibilities A management organization chart dated 4/26/10 has the reporting structure of the Quality Supervisor reporting to the Director of Operations. Chart was current, dated and signed. Quality Supervisor's responsibilities are clearly documented that include the evaluation of finished and hold products for proper disposition. 2 Policies and Procedures Manual Quality Manual binders were available having detailed policies and procedures that address relevant food safety, quality and security requirements for the receiving, handling, manufacturing and shipping of product are well organized, thorough and available. Testing procedures, sampling programs and accept/reject criteria are defined. Management had done an excellent job in documenting their programs and procedures. 3 Management Awareness and Commitment Management is committed to food safety, quality and actively supports all their programs through training, auditing for compliance to policies and provision of corrective actions. All levels of management took an active part throughout the audit and during the closing meeting. 4 Product Identification, Traceability and Recall Plans and Procedures A documented plant specific Recall Program was available that clearly defines a recall coordinator, identifies the recall team members and describes their responsibilities. However, recall program did not address mock recall or trace exercise requirements for % recovery and time. Office and after-hour telephone contact numbers of all recall team members is available for all team members. The Recall Plan was reassessed, signed and reviewed annually. Two trace exercises (March 24, 2010 and August 18, 2010) were completed in the last 12 months for ingredients within one hour and 100% recovery. Recommend that % recovery and time requirements should be part of the recall program for mock recalls or trace exercises. 5 Regulatory Compliance A regulatory file is maintained for NRs, third party audits and regulatory reports. Facility has received 19 NRs for 2010 covering HACCP Product, SSOP Monitoring and SSOP Record. Third party audits were available for review. The last FDA inspection was March 11, 2010 with 6 observations. Observations have been corrected. 6 Document and Records Management A document control policy is in place that identifies current revision status, specifies time limit for holding of files and indicates proper disposition of outdated documents and records. Records are indexed and retrievable. 7 Change Management A change management procedure was available and dated 4/9/10 covering procedures that will be taken for processing changes, specification changes, operations, policies and procedures in order to maintain control of the system. 08/25/ :04:04 Audit# - Visit # : Page 6 of 17

7 Section A. Administration and Regulatory Compliance 8 Documentation to Track Effectiveness of Policies Documented management reviews are conducted annually to evaluate the level of conformance to operational policies and assure that policies are properly managed, current and appropriate. Last annual review was conducted from March 2, Crisis and Natural Disaster Management A crisis management plan is in place that defines emergency procedures, outlines the crisis team members and provides key contacts with 24/7 access. Team members have received specific training in crisis management and team meetings were not being held. The crisis management meetings are held monthly with the last meeting being August 10, Customer/Consumer Complaints (Policies, Follow Up and Response) Customer complaint program was available. Program addresses responsibilities, comments and corrective action being that as required. Facility has not received any complaints in Complaints are documented on a Complaint Log along with along complaint, comments and completion. Section B. HACCP Management 1 Preliminary HACCP Tasks Facility has completed the Five Preliminary HACCP Tasks (HACCP team, product descriptions, process flow chart and flow chart confirmation). However, intended use was not identified on the two HACCP plans audited. All processing steps documented in the flow chart with addressed in the hazard analysis and verified during the audit. Recommend that intended use should be identified on all HACCP plans. 2 Hazard Analysis (HACCP Principle 1) A hazard analysis has been completed by the HACCP team and followed the decision tree process addressing chemical, physical and biological hazards that may occur in the process. USDA HACCP hazard analysis identified two hazards for receiving and storage temperatures. FDA HACCP hazard analysis identified one hazard for product labeling. 3 Critical Control Points (HACCP Principle 2) USDA CCPs were identified per the hazard analysis regarding receiving and storage temperatures. CCP1 was identified during receiving and CCP2 during product storage. FDA CCP identified product labeling. 4 Critical Limits (HACCP Principle 3) Critical limits have been established, measurable and validated. Process capabilities are documented to establish that CCP limits are compatible with the plant process and that limits are attainable per record review. Critical temperature limit for UDSA CCP1 and CCP2 is equal too or less than 40. FDA CCP1 critical limit is product label must match the product. 08/25/ :04:04 Audit# - Visit # : Page 7 of 17

8 Section B. HACCP Management 5 CCP Monitoring (HACCP Principle 4) USDA and FDA CCP monitoring procedures are conducted at sufficient frequencies to detect any loss of control based on random record review from June 12, 2010 August 21, Records were complete and followed documented procedures. Trained QA personnel review CCP records. FDA HACCP records did not identify CCP number and critical limits. Recommend that FDA HACCP records should include CCP number and critical limits. 6 Corrective Actions (HACCP Principle 5) Corrective actions are developed for USDA and FDA CCPs that include instructions with the necessary actions to take to secure product and bring the CCP under control in the event a critical limit is exceeded. 7 Verification and Validation (HACCP Principle 6) Documentation is available confirming the HACCP plan is technically sound and that all hazards have been identified along with being effective. CCP records are reviewed daily and verified by QA personnel. Validation of the HACCP plan is performed and documented on an annual basis with the last reassessment being March 2, Documentation and Record Keeping (HACCP Principle 7) HACCP procedures are documented. Records are documented in ink, signed and verified by plant management. Records are securely stored in the main office for easy retrievable. Two HACCP plans and programs were reviewed during the audit. USDA HACCP plan was Raw Not Ground. FDA HACCP plan and programs was Crabmeat. Section C. Facilities and Equipment 1 Potable Water, Ice, Backflow Prevention, Steam and Waste Water Management The City of San Diego supplies water and sewage service to the facility. EEL Laboratories tests the plant's city water annually for Total Coliform and E.coli with the last testing date being August 16, City of San Diego building code does not require main water line back flow devices into the building. Hose stations have back flow devices and they are tested annually with the last testing being completed on March 29, 2010 by Sweetwater Backflow Company. There are no dead ends on potable water lines and no hose nozzles were observed submerged in water reservoirs or left laying on the floor. An adequate supply of hot and cold water was readily available for production, sanitation and hand washing. The facility does not have a backed up drain procedure for restrooms and processing areas. Recommend that a backed up drain procedure should be developed. 2 Plant Construction and Design The facility is constructed in a manner conducive to handling product in a sanitary manner. No observations of overhead contamination or cross contamination were observed. Materials are easily cleanable, floors are well drained and drains have traps and covers. No objectionable fumes or vapors were present. No dust or standing water was observed around the exterior. A glass and brittle plastic program has not been developed. However, monthly glass and brittle plastic inspections are being completed. Recommend that a glass and brittle plastic program should be developed. 08/25/ :04:04 Audit# - Visit # : Page 8 of 17

9 Section C. Facilities and Equipment 3 Plant Condition (Walls, Ceilings, Floors, etc.) Walls, ceilings and floors structures were maintained and clean during the audit. Overhead structures were clean and free of buildup. Materials are easily cleanable, floors are well drained and drains have traps and covers. No objectionable odors, fumes or vapors were present. Interior air supplies are screened and filtered and no dust or standing water was observed around the exterior. 4 Employee Facilities Cafeteria, locker room and toilet facilities are adequately sized, physically separated from food production areas and are maintained in a sanitary condition. Toilet facilities are mechanically ventilated to the outside and doors are self-closing and do not open directly into the production areas. Signs are clearly posted in locker rooms, toilet facilities and at entrances to work areas reminding employees to wash and sanitize their hands before starting work and when leaving toilet facilities. 5 Handwashing Facilities Hand washing facilities are provided in toilet facilities and at entrances to work areas. They are adequate in size. Hand washing sinks had tempered water (95-105F) within 10 seconds, hands free, soap, hand sanitizer and single use towels. 6 Equipment Layout, Design and Conditions Equipment layout is designed to facilitate a one-way flow with the use of separate rooms. Equipment layout provided little chance of cross contamination, adequate spacing for maintenance, cleaning and inspection. Where equipment may make direct product contact, it is constructed with materials that are smooth, non-toxic, non-absorbent and corrosion resistant with appropriate covers and no metal-to-metal contact between moving parts. Processing equipment is limited to mixers, tables, racks and knives. Product is individually cut and assembled. 7 Plant Lighting and Protection The facility was well-lit, good light intensity; safety shields and/or protected coating bulbs were observed throughout the facility during the audit. Light fixtures are maintained clean, free of cracks, dust or other materials that could cause contamination. 8 Maintenance Standard (Support of GMPs, Housekeeping, Lubricants) Facility has a documented preventative maintenance program since processing equipment is limited to mixes, chopper, racks, extruder and patty machine and knives. Facility does not have a documented preventative maintenance program since equipment is limited to mixes, chopper, racks, extruder and patty machine and knives and it is contracted out to an outside service on a regular basis. Not Applicable. N/A 08/25/ :04:04 Audit# - Visit # : Page 9 of 17

10 Section D. Sanitation, Housekeeping and Hygiene 1 Master Sanitation Schedule and Monitoring There is a documented master cleaning schedule for operational areas, equipment, warehouse, storage, maintenance, cafeterias, break areas and toilet facilities with scheduled tasks (daily, weekly, monthly and annually). However, tasks are not documented on the MCS after completion. Recommend that tasks should be documented on the MCS after they have been completed. 2 Standard Sanitation Operating Procedures and Monitoring There is a documented Standard Sanitation Operation Procedure that defines and specifies standard cleaning methods for equipment and facility structures. The procedure includes the frequency of cleaning, the chemicals used and the water temperatures where applicable. Records are kept of all deficiencies found and the corrective action that is taken to bring the equipment into a sanitary condition and prevent a reoccurrence. 3 Cleaning Chemical and Sanitizer Control Chemical and sanitizers are secured in a separated locked cabinet away from ingredients and products except for solutions located in sanitation stations currently being used. A chemical dilution log was being kept for sanitizers and not cleaning solutions. Recommend that cleaning solution concentrations should be documented. 4 Pre Operational Monitoring and Corrective Action Pre-operational inspection program is part of the SSOP. Pre-op inspections are completed, recorded and filed. Random records were reviewed from January 1, 2010 July 30, 2010 during the audit and they were found to be complete. 5 Verification of Cleaning Effectiveness Verification cleaning is performed by visual inspection (pre-op) and ATP testing. Random records were reviewed and found complete. 6 Operational Housekeeping and Monitoring A documented operational checklist has been developed monitoring the cleanliness of the plant during each shift. Random records were reviewed from January 1, 2010 July 30, 2010 during the audit and found to be complete. Areas were clean and properly maintained during the audit. Trash containers are identified and properly maintained. 7 Personal Hygiene and Good Manufacturing Practices The facility complies with 21 CFR Part 110 covering personnel hygiene, hair covering, clothing, smocks or aprons, glove policy, jewelry, illness, drinking, eating, tobacco use, and carry items above the waist. Compliance to GMPs was confirmed during plant tour. 8 GMP Self Inspections and Corrective Actions Monthly GMP audits are not completed for the whole plant both inside and outside. Recommend that monthly GMP audits (inspections) should be completed on a monthly basis. 08/25/ :04:04 Audit# - Visit # : Page 10 of 17

11 Section E. Rodent and Pest Control Management 1 Documented and Specific Pest Control Program Plant has a documented pest control program that is handled by Western. Pest control operator licenses and insurance certificate were current and dated. A pest control book had all required information including contact numbers, MSDS, labels, license (6/30/11) and services on a monthly basis. Random Service records were reviewed from September 22, 2009 July 23, 2010 and they were found complete. 2 Outside Premises Management (Grounds, Waste Disposal Areas) Two bait stations protect the building two exterior walls since the plant has two joining walls with other tenants. Inspection cards were located on the inside. Exterior and grounds were maintained and no pest harborages were observed during the audit. Adequate trash and waste disposal facilities are available. Dumpsters were covered. 3 Inside Premises Management Inside premises had six Tin Cats and one ILT traps. They were in place as stated. Inspection cards were located on the inside. Inside perimeters were maintained and clean with no evidence of pests during the audit. 4 Pest Tight Doors and Entrance Closures All doors were tight closing for overhead and employee doors along with being proper sealed. 5 Secure Storage and Documentation of Pest Related Chemicals Western Pest Control Company maintains all pest control chemicals off-site. 6 Activity Reports Detailed with Corrective Actions Activity reports are hand written with notes to the facility for chemical used, usage, location, repairs, traps replaced and findings. Reports are reviewed by plant management and signed off. Random records were reviewed from September 22, 2009 July 23, 2010 and they were found complete. Three chemicals were picked and their MSDS were available. These chemicals were Advion Roach Gel - EPA # , Contrac Blox EPA # and Tempo SC Ultra EPA # Section F. Approved Suppliers, Receiving and Inventory Control 1 Supplier Approval Policies and Procedures A vendor approval program was available for review that included all the required steps for the approval of new suppliers. All ingredients and supplies are purchased from approved vendors. Current specifications for purchased ingredients and supplies were available. Incoming materials and ingredients are inspected for damage, contamination and other unacceptable conditions as described by the receiving policy. Records are maintained along with supplier codes for lot traceability. 08/25/ :04:04 Audit# - Visit # : Page 11 of 17

12 Section F. Approved Suppliers, Receiving and Inventory Control 2 Incoming Vehicle Inspection and Documentation Facility has an incoming vehicle inspection procedure-detailing trailer and product conditions were available for review. Trailers and ingredients are inspected for acceptable conditions before unloading and documented. Ingredient temperatures (as required) are taken for temperature requirements. Random records were reviewed from June 1, 2010 August 19, 2010 and they were found complete. 3 Release Criteria for Ingredients Facility receives approved goods and packaging materials from approved vendors only. COAs are reviewed and ingredients must pass receiving inspection prior to release. FIFO stock rotation is used. 4 Storage and Handling Policies and Practices Procedures for the storage and handling practices have been established to assure they do not become a source of contamination. All cases were observed sealed during facility audits with no cross contamination noted. Receiving areas and storage locations are maintained in a clean and sanitary manner. All ingredients and packaging materials are properly held under necessary conditions to maintain product integrity. 5 Bulk Receiving Systems Sanitation and Monitoring The facility does not receive any bulk shipments. Not applicable. N/A 6 Restricted and/or Sensitive Ingredient Control, Including Chemical Compounds Restricted and potentially toxic chemicals are stored separately and maintained under strict control. Toxic chemicals and flammable solvents are stored in a secured cabinet. Logs are maintained for toxic materials and Material Data Safety Sheet (MSDS) are readily available for all chemical compounds in the facility including the three sanitation chemicals requested during the audit. Section G. Process and Product Evaluation 1 Process Control and Documentation Procedures CCPs frequency and monitoring are reviewed per the HACCP plan. They are clearly marked, identified and controlled. Testing is conducted per specification attribute requirements. In-process ingredients and products are adequately protected and properly labeled with date and lot number. Plant management reviews all records. Random records were reviewed from June 12, 2010 August 21, 2010 and found complete. 2 Specification and Formulation Control and Accuracy Processing records were available and reviewed that demonstrate compliance to product blends and finished product specifications. Formulas are verified through record review and confirmed to current formulas. Formulas are computer base maintained with limited access. Random records were reviewed for August 2010 confirming procedures were being followed. 08/25/ :04:04 Audit# - Visit # : Page 12 of 17

13 Section G. Process and Product Evaluation 3 Routine Calibration of Operational Equipment and Measuring Devices (such as thermometers, scales, flow meters, counters, metal detectors, etc.) Thermometers are certificated or calibrated as least daily. Thermometers are calibrations daily using an ice bath method along with an NIST thermometer. A calibration log is maintained. Corrective actions are taken when measuring devices are found to be out of calibration and documented. 4 Foreign Material Control The facility does use a metal detector since product is hand processed. Knives and blades are checked for any missing pieces and documented. 5 Application of Statistical Control Statistical controls are not used to monitor process since meat is hand cut. Not Applicable N/A 6 Allergen and Sensitive Ingredient Controls The facility has a food allergen program with peanuts, tree nuts, Crustacea, fish, egg, milk, soy, wheat, mollusks, seeds and legumes and sensitizing agents (sulfites, monosodium glutamate, autolyzed yeast, hydrolyzed protein) being used or stored in the plant. Food allergens are identified and stored properly. Food allergens are scheduled in the process with a full clean-up being required. Pre-Op inspections are completed after each clean up. Food Allergen labeling compliance is a CCP in the HACCP plan for FDA products. 7 Specification Compliance Documentation Product is produces to customer specifications and conformance to specifications. QA personnel are responsible for product releases prior to shipment. Random records were reviewed and confirmed procedures were being followed. Records are maintained for two years. 8 Rework and Carryover Products The plant does not do any rework or carryover. Not Applicable. N/A 9 Analytical Records Management Records are securely stored in the main office for easy retrievable, easy feedback and reference with limited access. EEL Laboratories are used as an outside laboratory. Section H. Packaging and Labeling 1 Label Accuracy and Regulatory Compliance USDA approves all labels while plant approves FDA labels. Case labels are pre-printed. Production confirms the right product with the right label. 2 Documented Net Weight or Count Compliance Policy and Performance Product is sold by count or pieces. Pieces or counts are confirmed during packing. 08/25/ :04:04 Audit# - Visit # : Page 13 of 17

14 Section H. Packaging and Labeling 3 Clear Manufacturing Codes on Individual and Cased Product Cases are coded with Month xx, day xx, year xxxx and time (xxxx). Codes were checked during the audit and they were clear and legible. 4 Package Integrity and Function for Distribution Packaging is fit for its intended use and meets specifications. Product is placed in plastic lined cases and sealed. Cases are placed on pallets. 5 Label Security and Obsolete Label Controls Pre-printed case labels are applied by hand during packaging. Labels were verified during packaging. Current label must match the product per CCP requirements. Any excessive labels are properly stored. Section I. Storage and Shipping 1 Warehouse and Finished Product Management Finished products were properly stored during the audit. Finished product warehousing area was clean, in order, maintained and controlled in a manner to assure product integrity. Once product is approved, product is ready for shipment. Freezer and cooler temperatures are monitored and documented. The plant uses First In First Out (FIFO) stock rotation policy. 2 Retained and Returned Products The plant does not retain or rework products. Not Applicable N/A 3 Storage Facility and Dock Maintenance Warehouse storage areas (cooler & freezer) are small, clean and orderly and have adequate space for access, inspection and cleaning. Items are stored off the floor; floors and walls are in good condition. Again shipping area is small with no dock or levelers. Shipping area was clean and kept orderly as observed during the audit. 4 Transport Condition Pre-shipment inspections do not include company vans on a daily basis. Vans are cleaned and inspected on a weekly basis. Random weekly records were reviewed and they were found complete. Recommend that company vans should be inspected daily and documented. 5 Release Authorization to Ship Product Plant management approves all finished goods before shipping. Record reviewed showed products in compliance with specifications and formulas. Finished products are tested per finished product specifications and/or customer requirements. Products are properly held before shipping. 08/25/ :04:04 Audit# - Visit # : Page 14 of 17

15 Section J. Training Requirements 1 New Hire Training (GMP, Food Defense, HACCP) Training documentation demonstrates a commitment by management and includes training of all new employees in GMP's and basic food handling sanitation. Training is provided and records are kept for each individual in their personnel files. Training is presented in English & Spanish so employees can have a clear understood with the use of videos and written text. 2 Prerequisite Program Training Prerequisite training is conducted at new hire and continuously on monthly basis. Employee training is provided with the use of sign-in sheets and prerequisite topics covered. Testing is used and documented. Prerequisite training includes Good Manufacturing Practices, Personal Hygiene and Sanitation. Training is presented in English & Spanish so employees can have a clear understood. 3 Refresher Training Refresher training is provided on a monthly basis, documented with sign-in sheets and topics covered. Testing is documented. Employee training is provided that covers plant specific Good Manufacturing Practices, Personal Hygiene, Plant Sanitation and HACCP. Training is presented in appropriate languages (English & Spanish) to be clearly understood by all employees. 4 Proof of Knowledge Proof of knowledge used as a verification tool for employee training consists of on-the-job observations and third party audits. 5 Training Records Training records are documented on an individual basis, classroom sign-in sheets. Records are maintained in personnel files or topic files. Topic files are securely stored in the main office for easy retrievable. 6 Training Program Review Training programs are reviewed annually to evaluate the level of conformance to regulatory and customer policies. Last annual review was conducted March 2, Section K. Laboratory Support N/A Plant does not do any chemical or microbiological testing. Samples would be sent to EEL Laboratories for testing. 08/25/ :04:04 Audit# - Visit # : Page 15 of 17

16 Section L. Food Defense 1 Management A documented Food Defense program was available for review during the audit. Tam members have been identified. Plant management completed a risk assessment of the facility using FDA guidelines, team member roles and responsibilities are documented. Facility has a registration number from the applicable regulatory agency. All incoming mail and packages passes through the front desk. Computers are backed up and computer access is password protected. Recommend that team members should be identified along with responsibility, training and quarterly meetings. 2 Human Element All individuals entering the facility must scan their hand for proof of identification. Employees are supervised at all times. Contractors and visitors are required to show identification and sign in and out. Visitors are accompanied while in the facility. A current roster of employees and work assignments is maintained and employees are prohibited from bringing personal items such as purses, cases, containers, lunch boxes, etc. into processing areas. A screening program is in place for all employees and a program to train Food Defense rules at the facility has been implemented. Training is documented for each individual at the facility. 3 Facility A schematic of the facility was available that identifies all entrances into the building, access to the roof and sensitive areas. Employees enter the facility through a single door. Access to sensitive areas and utilities is restricted. When not in use, non-traffic doors, doors and utility access are secured. Emergency doors are alarmed. A process for issuing, tracking, cameras and retrieving keys. 4 Operations Operational and quality procedures are implemented to protect the product from contamination. Formulas and confidential information are protected with limited access. Non-employee drivers and delivery personnel have designated areas. Trucks and/or trailers are inspected before unloading and loading. Designated parking is provided. Section 1.A. Ingredients of Concern 1 Does the plant use or store Peanuts or Peanut Products? 2 Does the plant use or store Tree Nuts? 3 Does the plant use or store Crustacea? 4 Does the plant use or store Fish? 5 Does the plant use or store Egg or Egg Products? 08/25/ :04:04 Audit# - Visit # : Page 16 of 17

17 Section 1.A. Ingredients of Concern 6 Does the plant use or store Milk or Milk Products? 7 Does the plant use or store Soybean or Soy Products? 8 Does the plant use or store Wheat, Corn (Maize) or Related Grains? 9 Does the plant use or store Mollusks? 10 Does the plant use or store Seeds? 11 Does the plant use or store Cottonseed Products? No 12 Does the plant use or store Legumes? 13 Does the plant use or store Sulfites? 14 Does the plant use or store FD&C Yellow #5 or #6? No 15 Does the plant use or store Monosodium Glutamate, Autolyzed yeast, Hydrolyzed protein? 16 Does the plant use or store Meat? 17 Does the plant use or store Poultry? The information contained in this report is confidential. This report and its content is the copyright of NSF International - NSF International All rights reserved. This report may only be re-distributed in its entirety. *Represents Non Compliances. If you have any questions about this report, please contact your NSF Representative at NSF-MARK. 08/25/ :04:04 Audit# - Visit # : Page 17 of 17