revision 1 - the garden produce€¦ · view certificate corrective action activity revision 1...

Corrective Action ActivityView Certificate

Revision 1

FINAL AUDIT REPORT

Operation Type:ProcessingAudit Report Summary

CB Registration No.PA-PGFS-3250-2PrimusGFS ID #122746 - Cert:6

Audited by Primus Auditing Operations

PrimusGFS Version 2.1-2

Ver en Español

Organization:

The Garden WholesaleContact(s): Lawrence Sutton Mike AnthonyAddress: 5400 Longleaf Street 32209Location: Jacksonville, Florida, United StatesPhone Number: 904-768-6888 Ext 226

Operation:

Fresh Services SouthEast IncorporatedContact(s): Lawrence SuttonLocation: 5400 Longleaf Street Jacksonville, Florida 32209, United States

Shipper: The Garden Wholesale Inc

Operation Type: Processing

Audit Type: Announced Audit

Audit Scope:

This PrimusGFS Processing Audit was conducted at the Garden Wholesale facility in Jacksonville, FL. The operation wasmanaged with around twenty (20) employees (including administration) in one (1) shift. The operations were conducted all yearround. The inputs included various types of produce acquired from various suppliers, and these may include organically labelledproducts. There were some allergens managed in the facility (eggs and dairy). The activities included receiving, storing, andshipping of the product. Some product was repacked, and some was processed. The processed product undergo two washingsteps with peracetic acid (Tsunami 100) at 30-80 ppm monitored every 4 hours. There were food-contact surfaces that requiresanitation and these were cleaned with quaternary ammonium compounds (Oasis 146) at 400 ppm. There was no ice orcompressed air used in the products or contact surfaces. A Environmental Microbiological Monitoring Program wasimplemented and the indicator organisms were total counds, coliforms, and Listeria.

Date FSMS Started: 08 Jun 2017 11:00

Date FSMS Finished: 08 Jun 2017 16:00

Date Operation Started: 08 Jun 2017 08:00

Date Operation Finished: 08 Jun 2017 11:00

Product(s) observed during audit: Carrots, Onions, Peppers, Potatoes, TomatoesSimilar product(s)/process(es) not

observed: NoneProduct(s) applied for but not

observed: None

Auditor: Oscar Rodriguez (Primus Auditing Operations)

Preliminary Audit Score: 98%

Final Audit Score: 98%Certificate Valid From: 19 Jul 2017 To 18 Jul 2018

GPS Coordinates:

Latitude Longitude

30° 21' 59" 81° 42' 49" Click here to seemap

of 28

https://secure.azzule.com/PrimusGFSAudits/PDFTranslate.aspx?url=https://secure.azzule.com/PrimusGFSAudits/TestPDF.aspx?AuditHeaderID=35843251558906174472017593618431642235288&LanguageID=1&ISGFS=1&Completed=

mailto: [email protected]



mailto:[email protected]

https://secure.azzule.com/PrimusGFSAudits/testPage.aspx?AuditHeaderID=122746

http://secure.azzule.com/PrimusGFSAudits/testPage.aspx?AuditHeaderID=122746

https://secure.azzule.com/PGFSDocuments/PGFS_CAReport122746_5370_2_EN.pdf

https://secure.azzule.com/PGFSDocuments/PGFS_Certificate_PA-PGFS-3250_122746_0_EN.pdf

AUDIT SCORING SUMMARY Pre-Corrective Action Review Post-Corrective Action Review

Food Safety Management System RequirementsScore: 205Possible Points: 209Percent Score: 98%

Score: 209Possible Points: 209Percent Score: 100%

Good Manufacturing Practices RequirementsScore: 1088Possible Points: 1114Percent Score: 97%


HACCP System RequirementsScore: 270Possible Points: 270Percent Score: 100%


TOTALScore: 1563Possible Points: 1593Percent Score: 98%


Non-Conformance Summary By Count Pre-Corrective Action Non-Conformances

Post-Corrective Action Non-Conformances

Food Safety Management System Requirements 1 0

Good Manufacturing Practices Requirements 5 5

HACCP System Requirements 0 0

TOTAL 6 5

SECTIONS:

Food Safety Management SystemRequirements Good Manufacturing Practices Requirements HACCP System Requirements

Management System

Control of Documents and Records

Procedures and Corrective Actions

Internal and external inspections

Rejection and release of product

Supplier Control

Traceability and Recall

Food Defense

General GMP

Pest Control

Storage Areas & Packaging Materials

Operational Practices

Worker Practices

Equipment

Equipment Cleaning

General Cleaning

Buildings and Grounds

Chemical Files

Pest Control Documentation

Operation Monitoring Records

Maintenance & Sanitation Files

Preliminary Steps

Development of the HACCP Plan

Execution of the HACCP plan on the Plant Floor

of 28

Worker Documentation

Testing/Analyses Records

Temperature Controlled Storage & Distribution Logs

Allergen Control

FSMS Management System

1.01.01

Question: Is there a Food Safety Manual or other documented food safety management system covering thescope of business included in this audit and procedures/instructions for all food safety processes?

Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. A food safety manual was prepared and included five sections: FSMS, HACCP, GMP,SSOP, and Recall procedures.

1.01.02

Question: Is there a documented food safety policy detailing the company´s commitment to food safety?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. A document titled "Food Safety Policy" was prepared and signed on 7-Jun-2017. Thestatement listed that management is committed to the food safety program, and our intent is to provide continuedemployee education utilizing educational materials including internet seminars, videos, learning institutions andoutside sources..

1.01.03

Question: Is there an organizational chart of all workers who have food safety related activities?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. An organizational chart was prepared and listed the president, vice-president,operations manager, director of operations/ fresh services, controller, and director of sales. Food safety includedthe food safety manager, control manager, director of sales, warehouse manager, inventory control, operations (6groups), recall team, and crisis team.

1.01.04

Question: Is there a food safety committee and are there logs of food safety meetings with topics covered andattendees?


Auditor Comments: YES. Records of committee meetings were available. The last meetings were held on 22-May-2017, 8-May-2017, and 26-Apr-2017 and included food safety and health & safety (OSHA) topics.

1.01.05

Question: Is there documented management verification of the entire food safety management system at leastevery 12 months?


Auditor Comments: YES. The review of the management system was recorded in a document titled "ProcessAnalysis and Improvement" and included purpose, commitment, procedure , frequency and responsible person.The document was signed on 7-Jun-2017.

1.01.06

Question: Is there a documented analysis detailing resources required to implement and improve the food safetymanagement system processes with documented commitment from management to provide these resources?


Auditor Comments: YES. The resources needed to implement and improve the food safety management systemwere described in the same document that described management commitment.

FSMS Control of Documents and Records

1.02.01

Question: Is there a written document control procedure describing how documents will be maintained, updatedand replaced?


Auditor Comments: YES. A procedure titled Document Control Procedure was available, and listed the scope andprocess for document control. The procedure included an attachment titled "Writing a Procedure".

of 28

1.02.02

Question: Are all records stored for a minimum period of 12 months or for at least the shelf life of product if greaterthan a year?


Auditor Comments: YES. Records were maintained for a minimum of 3 years. This was confirmed verbally.

1.02.03

Question: Are food safety related documents and records stored and handled in a secured manner?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. Documents related to food safety were stored in the Food Safety Manager's officelocated in the administration area. The area was secured and restricted to authorized personnel only.

1.02.04

Question: Are the records maintained in an organized and retrievable manner?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. Records were filed by type (one binder was assigned to each type of record), and thesewere organized by date.

FSMS Procedures and Corrective Actions

1.03.01

Question: Are there documented instructions for the creation of Standard Operating Procedures?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The procedure for creating documents was described in the Document ControlProcedure. The procedure included an attachment titled "Writing a Procedure".

1.03.02

Question: Are the written procedures available to relevant users and is a master copy maintained in a central file?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The master copy of the files was maintained in a computer drive shared within theadministration personnel and corporate.

1.03.03

Question: Is there a corrective action procedure that describes the requirements for handling deficiencies affectingfood safety and prevention of future occurrences?


Auditor Comments: YES. A Corrective Action Procedure was available, and included scope, principle andprocedure. The procedure included identifying the problem, conducting an investigation, and recording the event.

1.03.04

Question: Is there a daily incidents report, sometimes called a Notice(s) of Unusual Occurrence and CorrectiveActions Log (NUOCA) ?


Auditor Comments: YES. Unusual occurrences were recorded in a form titled "Notice of Unusual Occurrence andCorrective Actions". The form included a description of the problem, corrective action, reported by and supervisoron duty. The last occurrence was reported in 29-Feb-2015.

FSMS Internal and external inspections

1.04.01

Question: Is there documented program for internal audits to be performed at the operations, covering allprocesses impacting food safety and the related documents and records?


Auditor Comments: YES. A procedure for "Self-Audits" was available. The instructions included the completion ofa internal audit monthly by a member of the food safety committee.

of 28

1.04.02

Question: Are there written procedures for handling regulatory inspections?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. A procedure titled "Procedure for Regulatory Inspectors" was available and listed theprotocol for handling visits of regulatory inspectors, including the people authorized to accompany the inspector.

1.04.03

Question: Are there records of regulatory inspections and/or contracted inspections, company responses andcorrective actions, if any?


Auditor Comments: YES. The last regulatory inspection was on 21-Oct-2016 by the Florida Department ofAgriculture and Consumer Services. The final result was: Passed, and there were 6 violations related toconstruction, plumbing, toilets, hand washing facilities, and equipment design.

1.04.04

Question: Are there documented calibration procedures for measuring and monitoring devices used in theoperations that are related to the safety of the product?


Auditor Comments: YES. A Calibration Policy was available and listed that any equipment used to collect data,measure, weigh and sell product to the public shall not be utilized unless properly calibrated.

FSMS Rejection and release of product

1.05.01

Question: Is there a written procedure for handling on hold or rejected products?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. A procedure titled "Product Hold and Release Procedure" was available and listed theproducts that may be put on QA hold, investigation of corrective actions, and release of product determined to besafe.

1.05.02

Question: Are there records of the handling of on hold or rejected products kept on file?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. Records of product put on hold or rejected consisted of Purchase Orders stamped witha "BAD P.O." red sign. A summary of Invoice Modifications was prepared and included "holds and rejects due to"Poor Quality".

1.05.03

Question: Is there a documented product release procedure available?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. A procedure titled "Rejection of Deliveries", and included reasons on why a deliverymay be rejected. It also stated that rejected product should be evaluated by the USDA if the shipper determined itto be necessary.

1.05.04

Question: Are there records of product releases kept on file?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The records of product release were the same as the shipping records (Driver'sManifesto). The information considered included product temperature.

1.05.05

Question: Is there a documented system for dealing with customer and buyer food safety complaints/feedbackalong with records and company responses, including corrective actions?


Auditor Comments: YES. A procedure for dealing with customer complaints was available and consisted ofreceiving complaints by customer service personnel, and further analysis and documentation by the food safetymanager to determine the severity of the situation.

FSMS Supplier Control

of 28

View Files

1.06.01

Question: Are there current written food safety related specifications for all raw products, ingredients, materialsand services purchased?


Auditor Comments: YES. A series of "Product Specification Sheets" was prepared and included basicinformation, description of product, ingredients, additives and reason for use, primary supplier of raw ingredients,and packing and processing. Examples observed included red beets diced 3/4 ", Mango Diced 1/4", and OnionRing Yellow 1/2" .

1.06.02

Question: Is there a written procedure detailing how suppliers are evaluated, approved and monitored?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. A "Vendor Verification Process" procedure was available and included requirements forvendors to provide a 3rd party audits, have a background check program for employees, participate in microbialtesting program, and receive inspectors as needed.

1.06.03

Question: Is there a list of approved suppliers?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. An approved supplier list was available and listed around sixty (57) suppliers ofproducts and services.

1.06.04

Question: Does the organization have documented evidence to ensure that all products, ingredients or materialsand services suppliers comply with the approval requirements and that they are being monitored as defined in theprocedure?


Auditor Comments: YES. Copies of food safety certificates were available. Most suppliers were PrimusGFScertified and their certificates were valid.

1.06.05

Question: If the organization is outsourcing any processes that may affect food safety, are there controlprocedures over such processes?


Auditor Comments: YES. Outsourced processes included pest control, waste disposal, and laboratorymicrobiological analysis. The operation maintained control over these processes by monitoring their in-houseactivities, and credentials.

1.06.06

Question: If tests and/or analysis within scope to food safety are performed by external laboratories, are theylicensed/accredited (e.g. ISO 17025 or equivalent, National Regulations, State Department, etc.)?

Possible Points: 5Points Scored: 1Score: Major Deficiency

Auditor Comments: MJ. A laboratory certificate by A2LA on ISO 17025: 2005 valid until 31-Aug-2017 wasavailable for ABC Research Laboratories. The scope of accreditation included APC, Coliforms, Yeast and Molds.But the laboratory reports were prepared under a different company name (Silliker of Jacksonville).

Auditee Comments: The lab was bought out and name changed. We have upload their updatedaccreditation and new name. Please see attached files.

CAAccepted?

CB/Auditor Review Comments: YES. The evidence submitted of corrective action includedthe scope of accreditation for Silliker Laboratories (Gainesville, FL branch), and includedinformation on the laboratory qualifications to conduct microbiological testing. The certificatewas prepared by A2LA and was valid until 28-Feb-2018.

YesPossible Points: 5

Points Scored: 5

New Score: TotalCompliance

FSMS Traceability and Recall

1.07.01

Question: Is there a document that indicates how the company product tracking system works, thereby enablingtrace back and trace forward to occur in the event of a potential recall issue?


Auditor Comments: YES. Traceback Instructions (FSMS-1091) procedure, listed generating trace-back reports(creating pack-out reports, getting farm/ harvest information from DAX, getting sales/shipment reports, and gettinginventory information).

of 28

https://secure.azzule.com/PrimusGFSManagement/AuditFiles.aspx?ResponseHeaderID=122746&AuditTemplateID=29&CategoryID=1&SubCategoryID=46&DocumentType=2&QuestionID=1404&DisableUpload=1&LanguageID=2

1.07.02

Question: Does the organization have a documented recall program including procedures, recall team roles andcontact details, external contact listings and explanation of different recall classes?


Auditor Comments: YES. The "Trace-Back Program" included a traceback procedure, and a recall procedure.The recall procedure listed the various types of recalls, the recall team, and external contacts.

1.07.03

Question: Is testing of recall procedures (including trace back) performed and documented at least every sixmonths? Can the company identify where affected product was sent?


Auditor Comments: YES. A Mock Recall was conducted in 14-Mar-2017, it was classified as class III, and thesupporting evidence included database searches of the affected product. The previous mock recall was done on 2-Sep-2017, it was class III, and all the affected product identified. Both recalls were completed within one hour.

FSMS Food Defense

1.08.01

Question: Does the company have a documented food defense policy based on the risks associated with theoperation?


Auditor Comments: YES. A food defense management program was available in a document titled "Food DefensePlan for the Garden Wholesale". The program included security of the outside, inside, personnel, and incidentresponse measures.

1.08.02

Question: Is there a current list of emergency contact phone numbers for management, law enforcement andappropriate regulatory agencies?


Auditor Comments: YES. An emergency contact list was prepared and listed 11 emergency response units, 9contractors/ vendors, 7 utilities, and 6 related to facility (insurance, maintenance, etc..

1.08.03

Question: Are visitors to the company operations required to adhere to food defense policies?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. Visitors were required to acknowledge compliance to food defense policies. The auditorwas asked to read the procedure for visitors and sign a log acknowledging its compliance.

GMP General GMP

2.16.01

Question: Is there a designated person responsible for the food safety program?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Lawrence Sutton was responsible for the food safety program at Garden Wholesale.His responsibilities included advise, and creation, maintenance and update of documents to ensure compliancewith food safety requirements.

2.16.02

Question: Are all chemicals (pesticides, sanitizers, detergents, lubricants, etc.) stored securely, safely and arethey labeled correctly?


Auditor Comments: YES. Chemicals were stored in a chemical room dedicated to the storage of sanitationchemicals, and in closets and designated areas in the processing room.

2.16.03

Question: Are "food grade" and "non-food grade" chemicals used, handled and stored in a controlled manner?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Food-grade chemicals were stored in their original containers in a storage roomdedicated to this purpose. Non-food grade chemicals (chemicals used to clean bathrooms) were stored werestored in a smaller room next to the administration office.

of 28

2.16.04

Question: Are signs supporting GMP's posted appropriately?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Reminder signs for hand-washing and use of protective equipment were posted in theemployees break area, the washrooms, and the various entrances to the processing area.

2.16.05

Question: Are the necessary food defense controls implemented in the operation?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. All access doors to the facility were locked, or opened for daily use (receiving orshipping products and entry/exit of personnel) only.

GMP Pest Control

2.17.01

Question: Are products or ingredients free of insects/rodents/birds/reptiles/mammals or any evidence of them?ANY DOWN SCORE IN THIS QUESTION RESULTS IN AN AUTOMATIC FAILURE OF THE AUDIT.


Auditor Comments: YES. All the products inspected during the audit were free from pest contamination. Therewas no evidence of pest activity in them.

2.17.02

Question: Are packaging supplies free of insects/rodents/birds/reptiles/mammals or any evidence of them? ANYDOWN SCORE IN THIS QUESTION RESULTS IN AN AUTOMATIC FAILURE OF THE AUDIT.


Auditor Comments: YES. All the packaging materials inspected during the audit free from pest contamination.There was no evidence of pest activity in them.

2.17.03

Question: Are plant and storage areas free of insects/rodents/birds/reptiles/mammals or any evidence of them?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. The cold storage areas inspected were free from pest activity. There was no evidence ofthem in the floors, walls or ceilings.

2.17.04

Question: Is the area outside the facility free of evidence of pest activity?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. The exterior of the facility was well maintained. There was no tall grass or clutter in theimmediate areas.

2.17.05

Question: Does the operation have a pest control program? ANY DOWN SCORE IN THIS QUESTION RESULTSIN AN AUTOMATIC FAILURE OF THE AUDIT.


Auditor Comments: YES. The Pest Control Program of the operation was contracted to Terminix Pest Control. Abinder with the information related to the program was prepared and maintained.

2.17.06

Question: Are pest control devices located away from exposed food products? Poisonous rodent bait traps are notused within the facility?


Auditor Comments: YES. The pest control devices were installed next to the access doors or in the walls awayfrom products. Baited traps were installed outside.

2.17.07

Question: Are pest control devices maintained in a clean and intact condition and marked as monitored (or barcode scanned) on a regular basis?


Auditor Comments: YES. The pest control devices observed were clean, without damage and were monitoredmonthly by the contractor and monthly in-house.

of 28

2.17.08

Question: Are interior and exterior building perimeter pest control devices adequate in number and location?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. Twenty-one (21) mice devices outside, seventy-one (71) inside, and six (6) fly lights.These numbers seemed appropriate to the size of the facility.

2.17.09

Question: Are all pest control devices identified by a number or other code (e.g. barcode) ?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The pest control devices were numbered, had bar codes attached to them, and asticker posted in the walls for easy identification.

2.17.10

Question: Are all pest control devices properly installed and secured?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. All the pest control devices inspected outside the facility were attached to the floor withpieces of concrete and internally placed in locations where they could not be moved easily.

GMP Storage Areas & Packaging Materials

2.18.01

Question: Are ingredients (including ice), products, and packaging stored to prevent cross contamination (thisincludes iced product pallets stored above pallets of product without adequate protection as well any allergen crosscontamination issues)?


Auditor Comments: YES. Products and materials were stored in groups of the same type and in separate areasto prevent cross-contamination.

2.18.02

Question: Is the storage area completely enclosed?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. The storage areas were completely enclosed. The cold storage rooms were sealed tomaintain the cold temperatures.

2.18.03

Question: Is the facilities use restricted to the storage of food products?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. Only food products were stored in the cold rooms of the facility.

2.18.04

Question: Are rejected or on hold materials clearly identified and separated from other materials?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Materials on-hold or rejected were identified with on-hold tags and stored in a dedicatedarea.

2.18.05

Question: Are raw products, work in progress, ingredients (including ice), finished goods and food contactpackaging within accepted tolerances for spoilage or adulteration? ANY DOWN SCORE IN THIS QUESTIONRESULTS IN AN AUTOMATIC FAILURE OF THE AUDIT.


Auditor Comments: YES. All the materials (food and packaging) inspected were in good quality. There were nosigns of spoilage or adulteration in the products inspected.

2.18.06

Question: Are all storage areas clean, especially the racking structures, lights, ceilings, floor areas by the wallsand other hard to reach areas?


Auditor Comments: YES. The storage areas (cold rooms) were clean. There was no dirt or residues in the floors.

of 28

2.18.07

Question: Are materials (commodities, packaging, ingredients, processing aids, work in progress, etc.) properlymarked with rotation codes (receipt dates, manufacture dates, etc)?


Auditor Comments: YES. All food and packaging materials were identified with lot numbers and product names tofacilitate their identification and rotation.

2.18.08

Question: Are materials (commodities, packaging, ingredients, processing aids, work in progress, etc.) rotatedusing FIFO policy?


Auditor Comments: YES. All food and packaging materials were rotated based on receiving dates using theinventory management system.

2.18.09

Question: Are storage areas at the appropriate temperatures for the specific products being stored?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. All the products were maintained at the target temperatures, targets were establishedfor the various areas of the facility.

GMP Operational Practices

2.19.01

Question: Does the process flow, facility layout, worker control, utensil control, internal vehicle use, etc. ensurethat finished (processed) products are not contaminated by raw (unprocessed) products?


Auditor Comments: YES. The facility was designed to receive and ship products using the same loading docks,but these operations were conducted at separate times to prevent potential contamination.

2.19.02

Question: Are all exposed materials (product, packaging etc.) protected from overhead contamination (e.g.ladders, motors, condensation, lubricants, walkways, loose panels, degrading insulation, etc.)?


Auditor Comments: YES. All the food materials in the cold storage area were in packages with top-covers or werekept in the shipping/receiving area to prevent overhead contamination.

2.19.03

Question: Are packing and/or processing areas completely enclosed?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. The materials were processed and packed in an enclosed building.

2.19.04

Question: Are production areas clean and well maintained; especially lights, floor areas by the wall andequipment, and other hard to reach areas?


Auditor Comments: YES. The processing and repacking areas were clean, and well maintained. There were nosigns of dirt, or breakages in hard to reach areas.

2.19.05

Question: Is all re-work/re-packaging handled correctly?Possible Points: 0Points Scored: 0Score: N/A

Auditor Comments: YES. Products to be reworked were entered in the system as new product. The reworkactivity was kept in the hold records.

2.19.06

Question: Are raw ingredients examined before use?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The food materials were inspected at receiving by the plant manager or qualityassurance.

of 28

2.19.07

Question: Are finished products coded (carton and unit packaging) for the day of production and displayinginformation to enable proper storage and use of the product within the food supply chain?


Auditor Comments: YES. Each batch of product were identified with a tag that included product name and lotnumbers.

2.19.08

Question: Are foreign material control methods (e.g. metal detectors, metal traps, visual inspection, etc.) in place?Are these systems regularly tested (where relevant) to ensure proper operation?


Auditor Comments: MJ. A metal detector was used to monitor contamination with foreign materials. The probeswere 2 mm Fe, 2.5 mm NFe, and 3 mm SS. But it was monitored once a day only, and the PrimusGFS Guidancerequire it to be monitored every hour.

Auditee Comments: We will begin hourly checks of metal detector. No response at this time since at least3 months orf records are required for review.

CAAccepted?

CB/Auditor Review Comments: MJ. No evidence of corrective action was submitted. No Possible Points: 10

Points Scored: 3

2.19.09

Question: Does the facility use the appropriate test strips, test kits or test probes for verifying the concentrationsof anti-microbial chemicals (product washing water, terminal sanitizers, dip stations, etc) being used and are theyin operational condition?


Auditor Comments: YES. Test strips were used to monitor the concentrations of chemicals in the washing step(peracetic acid), and sanitation activities (quaternary ammonium compounds). The test strips for bothmeasurements were working as intended.

2.19.10

Question: Are hand washing stations adequate in number, appropriate in location, in working order, have warmwater and adequately stocked (e.g. disposable towels, soap, etc.)?


Auditor Comments: YES. A handwashing station with four (4) faucets was installed in a passageway located inthe entrance to the processing area. The faucets were operated with a pedal to prevent contamination of the hands.

2.19.11

Question: Are toilet facilities adequate in number and location and are they adequately stocked (e.g. toilet paper,disposable towels, soap, etc.)?


Auditor Comments: YES. There was a washroom for women with 2 toilets and 1 sink, and one for men with 2toilets, 2 urinals and 2 sinks. The 6 units were sufficient for the maximum of 20 employees working at the sametime in the facility.

2.19.12

Question: Are secondary hand sanitation stations e.g. hand dip, gel or spray stations adequate in number andlocation? Are the stations maintained properly?


Auditor Comments: YES. There were dispensers of hand sanitizers installed next to each hand washing stationin the washrooms and repacking area. All the stations inspected had a sanitizer gel available.

2.19.13

Question: Are foot dip stations adequate in number and location? Are the stations maintained properly?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. There was one foot dip stations in the entrance to the processing area. The station wasfilled with a solution of quaternary ammonium compounds that was operating as intended.

2.19.14

Question: Are single services containers used for their intended purpose only so that potential crosscontamination is prevented?


Auditor Comments: YES. The single-use containers used in the facility were the packaging materials in which thefood materials were transported, and these were sent out for recycling after use.

of 28

2.19.15

Question: Are re-usable containers clearly designated for the specific purpose (trash, raw product, finishedproduct, re-work, ice, etc.) such that cross contamination is prevented?


Auditor Comments: YES. Reusable containers (made of plastic) were used for some products in the form of RPC(Reusable Packaging Containers) and to remove the garbage from the processing and repacking areas. Thereusable containers used in the product were cleaned outside (another company), and the ones used for garbagewere cleaned in-house.

2.19.16

Question: Are food safety measuring devices working properly?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. The test kits used for measuring concentrations of sanitizers working order as inintended and within their expiration date.

GMP Worker Practices

2.20.01

Question: Are workers washing and sanitizing their hands before starting work each day, after using the restroom,after breaks and whenever hands may be contaminated?


Auditor Comments: YES. The employees washed their hands before starting each work session. The employeesinterviewed answered correctly when asked.

2.20.02

Question: Are workers’ fingernails clean, short and free of nail polish?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The fingernails of the employees observed were clean, short and without nail polish.

2.20.03

Question: Is there no sign of any workers with boils, sores, open wounds or exhibiting signs of foodborne illnessworking in direct and indirect food contact?


Auditor Comments: YES. There were no employees observed with boils, sores, open wounds of signs offoodborne illness.

2.20.04

Question: Are workers wearing effective hair restraints?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. All employees wore hair restraints, especially in the repacking and processing areas.

2.20.05

Question: Is jewelry confined to a plain wedding band?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. The use of jewelry was limited to a plain wedding band.

2.20.06

Question: Are all workers wearing outer garments suitable for the operation (e.g. smocks, aprons, sleeves, non-latex gloves)


Auditor Comments: YES. Employees in the repacking area wore hair restraints and gloves. The employees in theprocessing area wore hair restraints, gloves, aprons, smocks, and rubber boots.

2.20.07

Question: Do workers remove protective outer garments e.g. smocks, aprons, sleeves and gloves when on breakand before using the toilets and when going home at the end of their shift?


Auditor Comments: YES. The protective equipment was removed when workers went to the bathrooms orbreakrooms. This activity was observed during the audit.

of 28

2.20.08

Question: Is there a designated area for workers to leave protective outer garments e.g. smocks, aprons, sleevesand gloves when on break and before using the toilets?


Auditor Comments: YES. There were wall hangers next to the employee break room and the washrooms forworkers to leave their protective equipment.

2.20.09

Question: Workers personal items are not being stored in the production and material storage areas?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. There were no personal items from employees stored in the material or packagingstorage areas.

2.20.10

Question: Is smoking, eating, chewing and drinking confined to designated areas?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Eating, chewing and drinking was limited to designated areas. Smoking was limited tooutdoors.

2.20.11

Question: Are all items removed from shirt or blouse top pockets?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. The employees observed during the audit did not have items in their top pockets.

2.20.12

Question: Is there a first aid kit(s) readily available in the facility and adequately stocked?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. There was a first aid kit in the administration area. The first aid kit was stocked withblue metal-detectable Band-Aids and chemicals within expiration dates.

GMP Equipment

2.21.01

Question: Are food contact equipment surfaces free of flaking paint, corrosion, rust and other unhygienic materials(e.g. tape, string, cardboard, etc.)?


Auditor Comments: YES. All food contact surfaces (in the packing and processing area) were made of stainlesssteel, and were free from corrosion, rust or unhygienic materials.

2.21.02

Question: Are non-food contact equipment surfaces free of flaking paint, corrosion, rust and other unhygienicmaterials (e.g. tape, string, cardboard, etc.)?


Auditor Comments: YES. The non-food-contact surfaces of the equipment in the processing lines were clean, andwithout unhygienic materials.

2.21.03

Question: Does equipment design and condition (e.g. smooth surfaces, smooth weld seams, non-toxic materials,no wood) facilitate effective cleaning and maintenance?


Auditor Comments: YES. The equipment surfaces were smooth to facilitate drainage and cleaning.

2.21.04

Question: Are thermometers (independent of thermostat probes) present in all coolers and freezers?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The temperature-controlled rooms had additional thermometers (separate from thethermostat) to monitor and verify temperatures.

of 28

2.21.05

Question: Are all thermometers non-glass and non-mercury?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. All thermometers were operated with metal probes and made of plastic. There were nothermometers made of glass and mercury.

GMP Equipment Cleaning

2.22.01

Question: Are food contact equipment surfaces clean?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. All food contact surfaces inspected were visibly clean.

2.22.02

Question: Are non-food contact equipment surfaces clean?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. All the non-food-contact surfaces in the processing and storage areas were visiblyclean.

2.22.03

Question: Are items (barrels, bins, etc.) that are used to hold or store product clean?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. The items used to handle food materials were visibly clean.

2.22.04

Question: During cleaning are foods and packaging protected from contamination?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. Cleaning operations were conducted at the end of each shift when there was noproduction or products waiting in the plant floor.

2.22.05

Question: Are cooling units including coils in coolers and freezers clean and free of aged, dirty ice?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. All coolers inspected were clean and free from aged and dirty ice.

2.22.06

Question: Are all fan guards dust-free and the ceiling in front of the fans free of excessive black deposits?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The fans in the storage and production areas were dust-free and free from blackdeposits.

2.22.07

Question: Is stored equipment that is not used on a daily basis stored in a clean condition with food-contactsurfaces protected and/or are they retained on cleaning schedules in some manner, even though they are not inuse?


Auditor Comments: YES. There were pieces of equipment stored in the receiving area and these were covered toprevent contamination.

2.22.08

Question: Are all utensils, hoses, and other items not being used stored clean and in a manner to preventcontamination?


Auditor Comments: YES. All utensils observed were hanging in designated areas or stored in cleaning storagefacilities.

of 28

2.22.09

Question: Are maintenance tools that are used in the production and storage areas of the facility clean, sanitaryand corrosion free?


Auditor Comments: YES. The maintenance tools used in the processing and storage areas were clean and ofsanitary design.

2.22.10

Question: Are excess lubricants and grease removed from the equipment?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. There were no signs of excessive lubricants on the various pieces of equipment.

GMP General Cleaning

2.23.01

Question: Are spills cleaned up immediately?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Spills were cleaned up as they occurred, especially if they were of allergens or toxicchemicals.

2.23.02

Question: Are waste and garbage frequently removed from packing and storage areas?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. Garbage bins were emptied out as they filled-up. This activity happened at least once aday.

2.23.03

Question: Do floor drains flow in a manner that prevents contamination (e.g. from high to low risk areas, from highrisk directly to drain system), are they covered, appear clean, free from odors and well maintained?


Auditor Comments: The floor drains were installed at the center of the processing area, had baskets to catchmaterials, were covered, and did not have signs of contamination or bad smells.

2.23.04

Question: Do high level areas including overhead pipes, ducts, fans, etc. appear clean?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. The overhead structures of the facility in the processing and storage areas were visiblyclean.

2.23.05

Question: Are plastic strip curtains maintained in a good condition, kept clean and mounted so that the tips arenot touching the floor?


Auditor Comments: YES. There were plastic strips in the doors connecting the cold rooms with the repackingand shipping and receiving areas. The plastic strips were clean and off the floor.

2.23.06

Question: Is safety equipment for the sanitation crew adequate, in good condition and stored to prevent crosscontamination to raw products, work in progress, ingredients, finished goods or packaging?


Auditor Comments: YES. The safety equipment for the sanitation crew included non-latex rubber gloves, apronsand boots. These pieces of equipment were in good conditions and stored in the chemical storage area.

2.23.07

Question: Is cleaning equipment available and stored properly?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. Most cleaning equipment was stored in the chemical storage room, and there weresome brooms and shovels hanging on the walls of the different areas to facilitate cleaning by operators.

of 28

2.23.08

Question: Is cleaning equipment identified in order to prevent potential cross contamination issues e.g. production,maintenance, outside, restroom equipment?


Auditor Comments: YES. Four (4) colors were used to classify the tools based on the area of use: red forwholesale, black for processing, green for repacking, and blue for receivng. Equipment was identified with a pieceof tape attached to them.

2.23.09

Question: Are all items used for sanitation appropriate for their designated purpose (e.g. no steel wool, metalbristles, etc.)?


Auditor Comments: YES. All items used for sanitation were made of plastic to prevent product contamination withother type of physical contaminant.

2.23.10

Question: Are toilet facilities and hand-wash stations clean?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. All the toilet facilities and hand washing stations inspected were visibly clean.

2.23.11

Question: Are worker break facilities clean, including microwaves and refrigerators? No rotting or out of datefoodstuffs?


Auditor Comments: YES. The employees break-room was clean, including the refrigerators and microwavesinstalled.

2.23.12

Question: Is the maintenance shop organized - i.e. equipment and spares stored in a neat and tidy fashion?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The maintenance shop was in a separate area of the building. The area was keptorganized and clean.

2.23.13

Question: Are internal transport vehicles (e.g. forklifts, bobcats, pallet jacks, trolleys, floor cleaners, etc.), clean,do not emit toxic fumes and being used in a sanitary manner?


Auditor Comments: YES. The forklifts and power jacks used in the operation were electrically operated.

2.23.14

Question: Are shipping trucks clean and in good condition?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The shipping trucks observed during the audit were clean and in good conditions.

GMP Buildings and Grounds

2.24.01

Question: Are all lights in the facility that could potentially contaminate raw materials, work in progress,ingredients (including ice), finished goods, equipment or packaging shielded to protect product from contaminationin the event of breakage?


Auditor Comments: YES. All the lights in the storage areas were coated with protective films or plastic tubing.

2.24.02

Question: Has the facility eliminated or controlled any potential metal, glass or plastic contamination issues?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. All the lights in the facility were coated with protective films or plastic tubing.

of 28

2.24.03

Question: Has the facility eliminated the use of wooden items or surfaces?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The only wooden items used in the facility were pallet skids, and these were coated toprevent contamination with shattering.

2.24.04

Question: Is there adequate lighting in the packing and storage areas?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The packing and storage areas were well-lit. The labels and the product could be easilyinspected.

2.24.05

Question: Is ventilation adequate to control dust, condensation, odors and vapors?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. The ventilation of the storage and processing areas was adequate. There was noaccumulation of odors, vapors or condensation.

2.24.06

Question: Are floor surfaces in good condition, with no standing water, no debris trapping cracks and are theyeasy to clean?


Auditor Comments: YES. The floor surfaces were clean and in good conditions, there were no major cracks orstanding water.

2.24.07

Question: Are the floor drains where they are needed for drainage and cleanup?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. There were floor drains at the center of the processing and repacking areas to facilitatedrainage of water. Especially next the to processing equipment.

2.24.08

Question: Are doors to the outside pest proof?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. Exterior doors had self-closing devices and the loading docks were sealed to preventpest contamination.

2.24.09

Question: Are dock doors fitted with buffers to seal against trucks?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. The loading docks had buffer seals to maintain temperature chain and prevent pestcontamination.

2.24.10

Question: Are dock load levelers and shelters maintained in a good condition, pest proof and debris free?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. The dock load levelers did not have signs of pest contamination or food debris.

2.24.11

Question: Are exterior walls free of holes to exclude pests? Are pipes, vents, air ducts designed and protected inorder to prevent pest entry e.g. by using fine mesh?


Auditor Comments: YES. The exterior walls were in good conditions. There were no holes or damage that couldallow pest contamination.

of 28

2.24.12

Question: Are interior walls and ceilings free of cracks and crevices to prevent pest harborage and allow propersanitation?


Auditor Comments: YES. The interior walls and ceilings were in good conditions. There were no cracks or visibledamage.

2.24.13

Question: Do false ceiling areas have adequate access to allow for inspection and cleaning?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. There were no false ceilings in the production areas. The only false ceiling installed inthe facility was in the administration offices, and this could be easily inspected if needed.

2.24.14

Question: Is an 18" (46cm) internal wall perimeter being maintained within the facility, with adequate access tothese wall perimeters thereby allowing inspection and cleaning ?


Auditor Comments: YES. An internal wall perimeter of at least 18" was maintained with an internal short-wall ofbricks (1 meter high) was kept in the production and storage areas. The product and equipment could be inspectedeasily.

2.24.15

Question: Is the exterior area immediately outside the facility free of litter, weeds and standing water?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The exterior of the facility did not have signs of standing water, weeds or litter.

2.24.16

Question: Are control measures being implemented for the storage of pallets, equipment, tires etc. (i.e. out of themud, pipe ends capped, stacked to prevent pest harborage, away from building perimeter)?


Auditor Comments: YES. There was no storage of used equipment and transportation materials in the back of thebuilding.

2.24.17

Question: Are pallets inspected to separate and replace dirty or broken pallets?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. Broken pallets were discarded at receiving or prior to shipping.

2.24.18

Question: Is the area around the dumpster/cull truck/trash area clean?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. There was one garbage dumpster located in the front of the building and theirsurroundings were clean.

2.24.19

Question: Are outside garbage receptacles and dumpsters kept covered or closed?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The garbage and recycling dumpsters were located in the back of the building and werecovered with a lid.

2.24.20

Question: Are all water lines protected against back siphonage?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The water used in the operation was potable (city water) and the water lines wereprotected with a backflow prevention device.

2.24.21

Question: Is the on-site laboratory (where appropriate) completely enclosed and separated from production andstorage areas?

Possible Points: 0Points Scored: 0Score: N/A

Auditor Comments: N/A. There was no on-site laboratory in the operation.

of 28

GMP Chemical Files

2.25.01

Question: Are copies of all Safety Data Sheets (detergents, sanitizers, pesticides, etc.) on file and fullyaccessible at all times with clear indexes?


Auditor Comments: YES. A SDS binder was available in the chemical storage area. All the chemicals used forsanitation and maintenance were included in this binder.

2.25.02

Question: Are there copies of specimen labels for chemicals used, where the full label is not immediatelyaccessible e.g. rodent chemicals, product sanitizers?


Auditor Comments: YES. Chemical labels were kept attached to the containers. The barrels with the cleaningand sanitizer chemicals have them attached.

2.25.03

Question: Is there a chemical inventory and/or usage log?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. A Weekly Chemical Inventory Check was maintained and included 27 chemicals to betested.

2.25.04

Question: Are there specific Standard Operating Procedures (SOPs) for the changing and testing of water and icesystems e.g. washing flumes, hydrovacuums, hydrocoolers, ice making machines, ice injectors, etc.?


Auditor Comments: N/A. There was no water or ice treatment in the operation.

GMP Pest Control Documentation

2.26.01

Question: Is there a documented pest control program, including a copy of the contract with the exterminationcompany (if used), Pest Control Operator license(s) (if baits are used) and insurance documents?


Auditor Comments: YES. The pest management program was contracted to Terminix. The insurance wasprovided by Acord until 1-Jan-2018. The contractor was licensed by the State of Florida Department of Agricultureand Consumer Services with a Business License (until 30-Apr-2018), and the applicators (14) as Inspectors withsome specialized qualifications (until 30-Apr-2018) . The contract included visits every 2 weeks and were on call 24hours. Exterior and interior mice traps (2 types), fly lights (UV with pheromone-glue).

2.26.02

Question: Is there a schematic drawing of the plant showing numbered locations of all traps and bait stations, bothinside and outside the plant?


Auditor Comments: YES. A diagram indicating the locations of the traps was available. There were twenty-one(21) mice devices outside, seventy-one (71) inside, and 6 fly lights.

2.26.03

Question: Are service reports created for pest control checks detailing inspection records, application records, andcorrective actions of issues noted (in-house and/or contract)?


Auditor Comments: YES. Service reports were computer based and included recommendations on sanitation incritical areas (i.e. garbage dumpster). Only one mice was caught outside, most activities were bait replacementsbecause of outdoor pest activity.

GMP Operation Monitoring Records

2.27.01

Question: Does the facility have incoming goods (raw products, ingredients and packing materials) inspectiondata?


Auditor Comments: YES. Records of receiving were kept in a Receiving Form, and the information collectedincluded list of products, is the trailer dirty, any unusual odor, holes to the exterior, evidence of rodents/insects,evidence of tampering, is rear door unsecured, hazardous chemicals, lock, seal, receiving product temperature.

of 28

2.27.02

Question: Are there inspection logs on incoming trailers for rodents and insects, cleanliness, holes andtemperature control?


Auditor Comments: YES. Records of receiving were kept in a Receiving Form, and the information collectedincluded list of products, is the trailer dirty, any unusual odor, holes to the exterior, evidence of rodents/insects,evidence of tampering, is rear door unsecured, hazardous chemicals, lock, seal, receiving product temperature.

2.27.03

Question: Are there records for the necessary process monitoring activities (e.g. pH, water temperature, metaldetection, labeling, heating processes, etc.) showing the monitoring frequencies, results and where necessary thecorrective actions?


Auditor Comments: N/A. There were no additional processes other than storage and distribution.

2.27.04

Question: Are there records (with corrective actions) that show anti-microbial (e.g. free chlorine, ORP, peraceticacid) strength testing of wash water and ice solutions prior to start up and throughout the production runs?


Auditor Comments: MJ. There were 2 washing systems (steps) in the processing area and both utilized peraceticacid (Tsunami) as anti-microbial at a concentration of 30 to 80 ppm. But there were no records of monitoring theconcentration of the first wash, and the second wash was monitored every 4 hours (required every 30 minutes).

Auditee Comments: We will seek to begin continuous monitoring of PAA levels in wash. No response atthis time since at least 3 months orf records are required for review.

CAAccepted?


Points Scored: 3

2.27.05

Question: Are there records (with corrective actions) that show anti-microbial strength testing of hand/foot/tool dipstations? Are there stock check and replenishment records for gel and spray stations?


Auditor Comments: YES. The concentration of quaternary ammonium compound was measured weekly andrecorded in a "quaternary sanitizer ppm log". The strips were manufactured by Hydrion (QT-40).

2.27.06

Question: Is there a tool accountability program for knives and similar cutting hand tools used in the productionarea?


Auditor Comments: YES. There were some knives used in the processing area, but these were kept in a closedstainless steel box, and accounted for every day in the pre-operational inspection log.

2.27.07

Question: Is there a daily pre-operation inspection log?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The pre-operational inspections were recorded in a Daily Pre-Operations Log thatincluded 32 areas to be inspected prior to use.

2.27.08

Question: Has a documented risk assessment been performed to ensure that any food safety hazards relevant tofacility location and adjacent land use are identified and controlled?


Auditor Comments: YES. A risk assessment of the use of adjacent land was prepared as part of the food defenseprogram. The facility was surrounded by other food warehouses, a logistics company and green areas.

2.27.09

Question: Is there a current certificate of inspection for backflow prevention assemblies on water lines into thefacility?


Auditor Comments: YES. The backflow prevention device was inspected by JEA Environmental Services. Abackflow preventer test report was prepared on 19-Dec-2016.

of 28

2.27.10

Question: Is there documented evidence of the internal audits performed to the audited operations, detailingfindings and corrective actions?


Auditor Comments: YES. A "Monthly GMP self-audit" was used to monitor the GMPs monthly, and the last timethey were completed was in 1-Jun-2017, and 1-May-2017. The documents and HACCP plan were reviewedannually as part of the preparations for management review.

GMP Maintenance & Sanitation Files

2.28.01

Question: Does the facility have a preventative maintenance program and a documented schedule?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. A Master Maintenance Schedule was prepared and listed evaporators, pallet jacks,forklifts and trucks. All the pieces of equipment were inspected monthly.

2.28.02

Question: Is there a log of maintenance work or repairs ordered and is it signed off on work completed?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. The maintenance records were kept in a form that listed all units of equipment andwhat to be inspected on them (room temp, fans/belts, feeding rate, drains, vibration noise, thermometer checked).

2.28.03

Question: Are there logs showing that equipment is cleaned and sanitized after maintenance work has beencompleted?


Auditor Comments: YES. The maintenance records included a section that asked for sanitation of equipmentafter maintenance or repair.

2.28.04

Question: Is there a written cleaning schedule (Master Sanitation Schedule) that shows what and where is to becleaned and how often?


Auditor Comments: YES. A Master Cleaning Schedule was prepared and listed 8 areas to be cleaned every day,and these were initialed by the people responsible for cleaning them. There were also areas to be cleaned monthlyand annually.

2.28.05

Question: Are there written cleaning procedures (Sanitation Standard Operating Procedures) for the facility and allequipment?


Auditor Comments: YES. There were around 36 SSOPs for cleaning the various areas and pieces of equipment.

2.28.06

Question: Are sanitation logs on file that show what cleaning was done, when and who carried out the cleaning?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. The sanitation records were maintained in the Master Cleaning Schedule. Checkmarksand initials were added to the schedule acknowledging completion of the cleaning task.

2.28.07

Question: Are there documented procedures and completion records for clean-in-place (CIP) activities, whereapplicable (e.g. cleaning re-circulating water systems such as washing flumes, ice injectors, hydrocoolers, icemakers, etc.)?


Auditor Comments: YES. A "Clean In Place" Procedure was available for the wash tanks and listed the use ofquaternary sanitizers and tools to clean the tanks.

of 28

2.28.08

Question: Is there a routine program and written procedure to validate sanitation effectiveness using rapid postsanitation checks, e.g., ATP measurements?


Auditor Comments: MJ. An ATP testing program was established and included monitoring the sanitation of 3zones daily and 1 zone monthly. But the program was implemented using Protein Residue Test swabs fromHygiena and it is intended to monitor all organic materials.

Auditee Comments: Will have just received a Neogen Accupoint biolum tester. No response at this timesince at least 3 months orf records are required for review.

CAAccepted?


Points Scored: 1

2.28.09

Question: Is there a log indicating that floor drains are cleaned on a regular basis (minimum daily in wet and fresh-cut production areas)?


Auditor Comments: YES. The cleaning of the drains was listed as weekly in the non-contact surface logs (SSOP-4000 R2). The drains were cleaned daily, but sanitized every week.

2.28.10

Question: Are there records showing cooling units are serviced and cleaned at least every 12 months or morefrequently as required?


Auditor Comments: YES. The cleaning of the cooling units was conducted by a contractor (St Johns Air). Thelast servicing of the units was on 29-Jan-2017.

2.28.11

Question: Is there a documented glass management policy and procedure (including company glass policy, glassbreakage procedure and where necessary glass register)?


Auditor Comments: YES. A procedure titled "Glass/ Brittle Plastic Breakage Procedure" was prepared andincluded instructions for putting product on hold and cleaning breakages. The procedure was complemented with aGlass and Plastic Directory, and a monthly check.

GMP Worker Documentation

2.29.01

Question: Are there records of new worker food safety (GMP) orientation training (with topics covered andattendees) and are all workers required to sign the company’s food safety hygiene and health policy?


Auditor Comments: YES. New employees were trained on GMPs at the beginning of their term, and wererequired to sign a training log that included the GMPs.

2.29.02

Question: Are there logs of ongoing worker food safety education training with topics covered and attendees?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. A "Employee Training Log" was prepared to refer to the training files. There were 88employees listed, and the topics included GMP, Allergens, Sanitation, and Safe Driving.

2.29.03

Question: Is there a documented training program with training logs for the sanitation workers including bestpractices and chemical use details?


Auditor Comments: YES. Employees conducting sanitation activities were trained on sanitation and use ofchemicals. The last training session on sanitation was on 1-Feb-2017.

of 28

2.29.04

Question: Are there written procedures in place that require food handlers to report any cuts or grazes and/or ifthey are suffering any illnesses that might be a contamination risk to the products being produced? (In the US,auditors can check procedure/policy but not actual records).


Auditor Comments: YES. The GMPs listed that the employees had to report any cuts, grazes or illnesses totheir immediate supervisor as they occurred.

2.29.05

Question: Are there written sickness reporting and return to work procedures?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. Employees were required to bring a Doctor's release to be able to return to work after aserious illness. Minor illnesses were evaluated by their supervisor.

2.29.06

Question: Is there an worker non-compliance/disciplinary action procedure (verbal confirmation accepted)?Possible Points: 3Points Scored: 3Score: Total Compliance

Auditor Comments: YES. Employees were given a series of warnings before dismissal. The warnings were verbalor written depending on the nature of the problem.

2.29.07

Question: Are visitors and contractors required to sign a log stating that they will comply with the operation'spersonal hygiene and health policies?


Auditor Comments: YES. Visitors and contractors were required to abide by the operation personal hygiene andhealth policies. The auditor was asked to sign and complete a log acknowledging this issue.

GMP Testing/Analyses Records

2.30.01

Question: Are there records of routine equipment microbiological testing?Possible Points: 5Points Scored: 1Score: Major Deficiency

Auditor Comments: MJ. A laboratory testing schedule and results were prepared and listed 2 food contactsurfaces to be tested quarterly. The laboratory reports listed < 10 per swab for Aerobic Counts, Coliforms andListeria, but the analysis was not done according to Primus GFS guidance requirements (weekly).

Auditee Comments: Wev will begin submiting weekly samples to the lab. No response at this time since atleast 3 months orf records are required for review.

CAAccepted?


Points Scored: 1

2.30.02

Question: Are there records of routine environmental microbiological testing?Possible Points: 5Points Scored: 1Score: Major Deficiency

Auditor Comments: MJ. Microbiological analysis of environmental samples was being conducted quarterly, andthe results suggested low bacteria counts. But the analysis was not being conducted at the frequency required bythe PrimusGFS Guidance (quarterly).

Auditee Comments: We will begin conducting these tests at the Primus GFS frequency. No response atthis time since at least 3 months orf records are required for review.

CAAccepted?


Points Scored: 1

of 28

2.30.03

Question: Are there routine microbiological tests on water used in the facility (sampled from within the facility)?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Water samples were analyzed quarterly. The last analysis was conducted on 6-Jul-2017 and the sample resulted in absent coliform and E. coli.

2.30.04

Question: Are there routine microbiological tests on ice used in the facility (either produced in-house orpurchased)?


Auditor Comments: N/A. There was no ice used in the facility.

2.30.05

Question: Are routine tests (e.g., microbiological, moisture, etc.) performed on compressed air that is useddirectly on food and food contact surfaces?


Auditor Comments: N/A. There was no compressed air used in food contact surfaces in the facility.

GMP Temperature Controlled Storage & Distribution Logs

2.31.01

Question: Are there records of final product temperature checks for temperature sensitive product?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Temperature logs of pulp thermometer were available and these were monitored daily.The last record was entered was in 19-May-2017.

2.31.02

Question: Are there temperature logs for the packing room (if refrigerated)?Possible Points: 0Points Scored: 0Score: N/A

Auditor Comments: N/A. The processing and packing areas were temperature controlled but not refrigerated.

2.31.03

Question: Are there temperature logs for storage rooms?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. Records of monitoring temperature of storage rooms were kept in the Shift TemperatureReading form. The form included 11 coolers, the breezeway, and docks. The temperatures were recorded by themorning and the night shifts.

2.31.04

Question: Are there records of shipping truck temperature checks, indicating that the truck was pre-cooled prior toloading?


Auditor Comments: YES. Records of shipping temperature checks were maintained in the Driver's Manifest, andthe information included pre-loading temperature.

2.31.05

Question: Are there sanitary condition logs for shipping trucks (cleanliness, trailer condition, odor, etc.)?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Records of shipping were maintained in the Driver's Manifest, and the informationincluded lists of product, pre-loading temperature, padlocked, load time, loaders name, evidence of tampering,holes to the exterior, hazardous chemicals, evidence of insects/ rodents, and trucks needs cleaning/ odor.

GMP Allergen Control

2.32.01

Question: There are no allergen risks handled or stored within production and storage areas?Possible Points: 0Points Scored: 0Score: No

Auditor Comments: NO. There were two types of allergens managed in the operation: dairy and eggs.

of 28

2.32.02

Question: Has a documented allergen management plan been developed?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. An allergen management SOP was prepared and listed the instructions for segregatingproduct and cleaning up allergen spills.

2.32.03

Question: Are there adequate storage controls (separation, identification etc.) that ensure that allergens are notcontaminating other materials?


Auditor Comments: YES. Allergen containing foods were only stored in designated areas.

2.32.04

Question: Is there a dedicated production line or adequate clean down and production procedures that preventallergen cross contamination?


Auditor Comments: N/A. Allergen containing products were not repacked or processed in the facility.

2.32.05

Question: Are utensils and work in progress storage containers identified in order to prevent allergen crosscontamination?



2.32.06

Question: Does re-work handling take into account the issues associated with allergen containing products?Possible Points: 0Points Scored: 0Score: N/A


2.32.07

Question: Are workers trained with respect to allergen risks and the facility allergen cross contamination controls(including hand washing between production runs) and are there records of this allergen training?


Auditor Comments: YES. Employees were trained in allergen management and cleanup. The last trainingsession was in 1-Feb-2017.

2.32.08

Question: Are all products manufactured on site, labeled correctly with respect to allergens?Possible Points: 5Points Scored: 5Score: Total Compliance

Auditor Comments: YES. All products containing allergens were maintained in their own package, and thepackage listed the name of the allergen.

HACCP Preliminary Steps

3.01.01

Question: Is there a team responsible for the HACCP program at the operation, with a leader assigned and ifapplicable, for the development, implementation and on-going maintenance of the HACCP system?


Auditor Comments: YES. The HACCP team included the Director of Operations, Operations Manager, FoodSafety Manager (Lawrence Sutton), and the Production Supervisor.

3.01.02

Question: Is there documented evidence that the HACCP team members have being trained on HACCPprinciples?


Auditor Comments: YES. Lawrence Sutton was trained by North Carolina State University in a course titled"Introductory Course for Development of HACCP" in the Spring 2017, and HACCP principles for fresh produce andindustries on 18-Jan-2016. The rest of the HACCP team and all personnel (45 people) were trained on HACCPbetween Jan-Jun-2016. The training was complemented with a quiz.

of 28

3.01.03

Question: Does a product description exist for the products produced?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. A description of the processed products was prepared and included food safetycharacteristics, customer/ consumer use, packaging, target market, labeling instructions, distribution and storagecontrols, an shelf-life. The description was accompanied with a list of 150 products.

3.01.04

Question: Has the process(es) been flow charted in sufficient detail to completely describe the process or producthandling/processing steps and has the flow chart(s) been verified?


Auditor Comments: YES. A process flow chart was prepared and included 18 steps. The first 7 steps wererelated to receiving and storage, and the last steps to processing (trimming, cutting, peeling).

HACCP Development of the HACCP Plan

3.02.01

Question: Has a documented hazard analysis for the process been conducted, showing the various types ofhazard, their likelihood of occurrence and their associated severity? A ZERO POINT (NON-COMPLIANCE)DOWNSCORE IN THIS QUESTION RESULTS IN AUTOMATIC FAILURE OF THIS AUDIT


Auditor Comments: YES. A hazard analysis was completed and included 14 steps, each step listed the potentialhazards, justification, possible control measures, and if it was a CCP.

3.02.02

Question: Have CCPs been developed? If answer is YES, continue with next question. If answer is NO, the rest of"Module 3 HACCP" is not applicable. If the auditor detects that one or more CCPs have been omitted, then theauditor should score down a Zero Point, Non-Compliance under 3.02.01. If the auditor thinks that CCPs have beenadded that should be omitted, then the auditor should note the issue under 3.02.03.

Possible Points: 0Points Scored: 0Score: Yes

Auditor Comments: YES. One CCP (washing of processed product) was considered necessary in the operation.

3.02.03

Question: Have CCP decisions been made with documented justification and where CCPs are noted have theybeen developed to control the hazards identified in the hazard analysis step?


Auditor Comments: YES. The decision for selecting a CCP was taken using a CCP Decision Tree. A table withthe 4 major groups of hazards (pathogens, foreign materials, chemicals and radiological) was prepared, and theCCP was selected because it was considered that the control measure did not prevent, eliminate or reduced therisk of the hazard.

3.02.04

Question: Have CCP critical control limits been established with the support of relevant sources of information orby validation documentation?


Auditor Comments: YES. The critical limits were 30-80 ppm of peroxyacetic acid, and the product should not bewash for least than 90 seconds.

3.02.05

Question: Have monitoring requirements and frequencies been determined for the CCPs?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. Frequencies for monitoring were established, the HACCP plan stated that the washingstep should be monitored every 4 hours.

3.02.06

Question: Have specific responsibilities been assigned for the monitoring, recording and corrective actionmanagement of each CCP?


Auditor Comments: YES. The production supervisor, QA/QC and food safety manager were responsible formonitoring, and recording corrective actions.

3.02.07

Question: Have standard operating procedures (SOPs) been created for the monitoring process of the CCPs,which would include how to carry out the monitoring activities?.


Auditor Comments: YES. The procedure for monitoring the washing step was described in the HACCP plan in theCCP summary.

of 28

3.02.08

Question: Have Corrective Action procedures for the CCPs been established, including a detailed action plan foroperators to follow if the limits are not met and plans to adjust the process back into control?


Auditor Comments: YES. Corrective Actions were listed in a section called CCP development of the plan, andlisted that if the solution of Tsunami falls outside the Critical Limit thresholds during any testing cycle the washingactivities will be halted until the chemical levels are adjusted.

3.02.09

Question: Have recording templates (recording forms) been developed for monitoring the CCPs?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. A form titled "Fresh cuts HACCPs" was used to record CCP monitoring. The formincluded date, time, and ppm of peroxyacetic.

3.02.10

Question: Have verification plans and schedules been developed for each CCP?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. Verification activities included daily ATP swabbing, weekly and monthly self audits.

3.02.11

Question: Are changes in the process, equipment, ingredients etc., causing timely reviews of HACCP systems,including hazard analysis, CCP decisions, CCP records and staff training?


Auditor Comments: YES. Changes in the processing arrangements, new materials or new products wereincorporated in the HACCP plan as they occurred.

3.02.12

Question: Is there evidence recorded for HACCP training to all plant workers, including training for CCP operators?Possible Points: 10Points Scored: 10Score: Total Compliance

Auditor Comments: YES. The HACCP team and all personnel (45 people) were trained on HACCP between Jan-Jun-2016. The training was complemented with a quiz.

HACCP Execution of the HACCP plan on the Plant Floor

3.03.01

Question: Are all of the documents noted in the HACCP plan in place for real time monitoring of the CCPs?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. The forms used for recording the monitoring of CCPs were observed being used in theprocessing area.

3.03.02

Question: Are the CCP monitoring activities and frequencies in compliance with the plan?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. The CCP was being monitored according to plan (every 4 hours).

3.03.03

Question: Do CCP operators understand basic HACCP principles and their role in monitoring CCPs? (Interviewoperators to verify).


Auditor Comments: YES. The production supervisor was interviewed on HACCP and CCPs and answered thequestions correctly.

3.03.04

Question: Are CCP monitoring records signed off (or initialed) by the operator(s) who are carrying out andrecording the CCP check?


Auditor Comments: YES. The CCP monitoring records were signed by the production supervisor and approved bythe food safety manager.

of 28

3.03.05

Question: Are corrective actions detailed in writing when the failure of a CCP occurs?Possible Points: 15Points Scored: 15Score: Total Compliance

Auditor Comments: YES. Corrective actions were recorded in the CCP monitoring form if they occurred. Therewas not too much variation in the CCP measurements.

3.03.06

Question: Are the CCP records reviewed and signed off daily by the quality control supervisor and/ormanagement?


Auditor Comments: YES. The CCP monitoring records were also signed by the Food Safety Manager every day.

3.03.07

Question: Is any other CCP verification performed (apart from daily record verification) according to the HACCPPlan?


Auditor Comments: YES. The chemical application pumps were also calibrated by the chemical supplier to verifytheir accuracy.

of 28