Re-Certification FSSC Audit

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FSSC 22000 Audit Report CONFIDENTIAL Document: GP 4133 Issue n°: 14 Page n°: 1 of 22 Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days. Re-Certification FSSC Audit FSSC 22000 Food Safety Management System Audit Report Organisation Gem State Processing, LLC Registered Legal Name (if different to above) NA Site Registration Number NA Address 951 Highway 30 City Heyburn Region Idaho Postcode 83336 Country United States Client Representative Ana Naranjo E-mail [email protected] Site Food Safety Team Leader Ana Naranjo E-mail [email protected]

Transcript of Re-Certification FSSC Audit

Page 1: Re-Certification FSSC Audit

FSSC 22000 Audit Report

CONFIDENTIAL Document: GP 4133 Issue n°: 14 Page n°: 1 of 22

Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Re-Certification FSSC Audit FSSC 22000 Food Safety Management System

Audit Report

Organisation Gem State Processing, LLC

Registered Legal Name (if different to above)

NA

Site Registration Number

NA

Address 951 Highway 30

City Heyburn Region Idaho

Postcode 83336

Country United States

Client Representative

Ana Naranjo E-mail [email protected]

Site Food Safety Team Leader

Ana Naranjo E-mail [email protected]

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FSSC 22000 Audit Report

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Additional Standard(s) (covered in this audit), if any:

NA

Accreditation Body(s) UKAS

Site(s) audited: 951 Highway 30 Heyburn ID 83336 USA

Start and end date of audit:

12.18.2019

12.20.2019

Last Date Previous Audit 11.20.2018

Certificate Expiry Date: 03.20.2020

Total Man Days 3 Previous Audit Type:

Surveillance

Audit Time Justification

NA Hours Spent on Product Realization:

12 hours

Deviation from audit plan and justification

No deviation

No. of FTE Employees:

180 No. of Shifts: 2

No. of HACCP Plans: 2 No. of Production Lines:

3

Food Chain Category:

☐ A I Farming of Animals for Meat/ Milk/

Eggs/Honey

☐ A II Farming of Fish and Seafood

☐ C I Processing of perishable animal products

☐ C II Processing of perishable plant products

☐ C III Processing of perishable animal and

plant products(mixed products)

☒ C IV Processing of ambient stable products

☐ D I Production of Feed

☐ D II Production of Pet Food (ISO/TS22002-6)

☐ D II Production of Pet Food (ISO/TS22002-1)

☐ E Catering

☐ F I Retail

☐ G I Provision of Transport and Storage

Services for Perishable Food and Feed

☐ G II Provision of Transport and Storage

Services for Ambient Stable Food and Feed

☐ K (Bio) Chemical Manufacturer

☐ I Production of Food Packaging and Packaging

Material

Food Sector(s): C4c C4e

Lead auditor: Liang Chen

Team members: NA

Additional attendees and roles:

NA

Scope of certification Dehydration of fresh potatoes into dehydrated and agglomerated potato products.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Exclusions from Scope

NA

Description of Organisation

Gem State Processing, LLC is a potato processing plant that manufactures potato dehydrated products such as potato flakes, flour, dice, shreds.

The facility was established in 2011. It is in the Burley Industrial Park. The plant area included 240,000 square footage for operation, multiple production lines, including Line 1-2 Dehydrated Flake and Flour, Line 3 Dehydrate Slices, Dices and Shreds, Line 10 Bagging, Line 20 Bulk Packaging, Line 45 Agglomeration, Line 70 Totes and Line 80 Cases. The product is packaged in 20 or 25 lbs boxes/ Kraft bags, or totes of 2,400 lbs max. Finished products are stored at this location. The facility supplies some major food manufacturers.

Head Office details NA

AUDIT OBJECTIVES

The objectives of this audit were:

To determine conformity of the management system, or parts of it with audit criteria and its:

- ability to ensure applicable statutory, regulatory and contractual requirements are met, - effectiveness to ensure the client can reasonably expect to achieve specified objectives, and - ability to identify as applicable areas for potential improvement.

1. CURRENT AUDIT FINDINGS AND CONCLUSIONS

NUMBER OF NON-CONFORMITIES

Critical 0

Major 0

Minor 5

This was a process-based audit focusing on significant aspects, risks and objectives required by the standard(s). A sampling process was used, based on the information available at the time of the audit. Methods of assessment included interviews, observation and review of documentation.

The audit team concludes that the organization HAS established and maintained its management system in line with the requirements of the standard and demonstrated the ability of the system to systematically achieve agreed requirements for products or services within the scope and the organization’s policy and objectives.

Based on the result of this audit the audit team recommends that certification be

CONTINUED

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

2. SCOPE OF CERTIFICATION

Has this scope been amended as a result of this audit? NO

3. NON-CONFORMITIES

Minor Non-conformities

Number Clause Details of Non- Conformance

Cause Planned Actions / Corrective Action

Date to Complete Action

1 ISO 22000, 2.1.4.11

Supplier approval in case of emergency

Backup suppliers were not assessed for emergency situations, such as unexpected natural disasters, food safety recall and other supply chain issues. Cargill was the only supplier for Citric Acid. Esseco USA LLC was the only supplier for Sodium metabisulfite.

Failure to properly document

Emergency Action Plan and Crisis Management Plan will be combined to cover all areas.

12.31.2019

2

ISO 22000, 2.1.4.12

Test of Incident Management Procedure

Electricity was the main energy source of the plant. Unscheduled electricity outage was not included in the Emergency Action Plan.

Latest fire drill was conducted on 12.12.2019. While food safety was not considered during the drill.

Failure to properly document

Emergency Action Plan and Crisis Management Plan will be combined to cover all areas.

12.31.2019

3 ISO/TS 22002-1

12.3 Preventing access

Exterior Door 11, which leads to Dissolve Air Floatation (DAF) room, was not properly locked to prevent from potential pest intrusion.

Door was not closing properly

DAF door is locked and not openable. Picture attached.

12.20.2019

4 ISO/TS 22002-1

5.3 Internal structures and fittings

Frame of the door, which connecting Line 1 &2 production area and the chemical room, was found loose.

Door Frame loose

Door to chemical room and been sealed. Picture attached.

12.22.2019

5 ISO 22 000

On 12.13.2019 Line 3 Dehydrator Blancher temperature at 8 am was

It was operator error properly

Production will maintain a minimum of 145

12.31.2019

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

7.5 Establishing the operational PRP’s

recorded as 135 degree F. It was required to maintain at minimum 145 degree F

follow the procedure.

degrees F; Operators were re-trained on the requirements and reasons for the adjustments; and continue to record the processing temperatures.

Note: This product goes through an extensive drying process at equipment at minimum 250 degree F for several minutes.

Major Non-conformities

Number Clause Details of Non- Conformance

Cause Planned Action

Detail of action completed/evidence reviewed

Date Reviewed

NA

Critical Non-conformities

Number Clause Details of Non- Conformance

Cause Planned Action

Detail of action completed/evidence reviewed

Date Reviewed

NA

Reviewed and Accepted by: Liang Chen Date: 01.06.2020

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

4. PREVIOUS AUDIT RESULTS

The results of the last audit of this system have been reviewed, in particular to assure appropriate correction and corrective action has been implemented to address any nonconformity identified. Where a non-conformance hasn’t been adequately address it has been raised at this audit.

N° _ of __ Grading Details of Non- Conformance Evidence of Conformity Closed

1 Minor Blancher line 3 temperature recorded on the 11/5/18 as 157 F for 19 minutes, limit is 160 F.

Note: This product goes through a extensive drying process at equipment at minimum 250 F for several minutes.

A validation study was conducted by Eurofins Microbiology Lab in Lancaster PA investigating the survival of Listeria monocytogenes on vegetable products after being exposed to a simulated water blanching treatment. It was concluded that 19 minutes at 145 degree F or 4 minutes at 170 degree F could reduce Listeria monocytogenes by over 6.0 logs. Gem State updated the blancher temperature to 145 degree F, after validating the process in the production scale.

Yes

2 Minor Internal audit Dehi Line Process Team 4 indicated in program as done, the documentation was not found.

Internal Audit Schedule was updated and reviewed by auditor.

Yes

3 Minor The plant has several business objectives, it was not found food safety objectives to support the Food safety policy.

Food safety goal of 2019 was established and reviewed by auditor.

Yes

4 Minor Container for rejection of bulk metal detector not identified.

Properly labelled container was observed.

Yes

5. AUDIT ATTENDANCE RECORD – (OPENING, SITE AUDIT, CLOSING)

Name Position Opening Site Audit Closing

Ana Naranjo QA Supervisor x x x

Denicia Martinez QA Assistant x x x

Miguel Rementeria Plant Manager x x x

William Schow General Manager x

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

6. AUDIT SUMMARY

Describe any changes in the management systems since the last audit:

A validation study was conducted by Eurofins Microbiology Lab in Lancaster PA investigating the survival of Listeria monocytogenes on vegetable products after being exposed to a simulated water blanching treatment. It was concluded that 19 minutes at 145 degree F or 4 minutes at 170 degree F could reduce Listeria monocytogenes by over 6.0 logs. Gem State updated the blancher temperature to 145 degree F, after validating the process in the production scale.

Summarise any recalls or withdrawals since the last audit:

No recall or withdrawal since the last audit.

Legal Compliance:

Site complies with FDA 21 CFR.

Use of the logo:

No FSSC or SGS logo used on product.

There should be details here of the documentation sampled, traceability exercise undertaken during the audit as well as those conducted by the site. This section should include all the details of the processes seen during the audit. The checklist documents should simply have the compliance information.

Food Safety Management System Summary

4.0 Food Safety Management System

Food Safety Policy, 8.502, 11.17.2013, covers all products produced at the facility. Hazard analysis was conducted on all raw materials and HACCP Plan was developed and periodically reviewed for its effectiveness. Corrective action was in place for non-conformed raw materials and finished products. Internal audit was conducted annually to review the system. All procedures and records reviewed during this audit showed consistency and presented the Food Safety Management System working effectively. Document Control, 8.301, 01.22.2012, was established which outlined the responsibility of document controller, review, approval, change request and re-approval for revised document. There was document control in different function. Only lead and above employees had access to SharePoint, where all documents were stored. Only QA Supervisor and QA Assistant were authorized to update and upload documents. All procedures and records, including shipping documents, COAs, were retained for 6 years. (Retain samples were kept for 2 years.)

5.1-5.8 Management

commitment

Management Responsibility, 8.501, 02.05.2015, described Management Responsibility for the Food Safety Management System at Gem State Processing. Management Team provides adequate resources needed to implement effectiveness of processes and Food Safety System. Site Quality Team was empowered to ensure that the FSMS was achieving the expected goals aligned with the strategic importance as the potato products.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Daily Production Meeting, Switch-over Meeting, Supervisor and Leads Meeting in place to help achieve Food Safety goals, Customer Complaints (# of case), 2018 actual 36, 33% reduction, 2019 target 25 cases. Site Health, Safety and Human Recourse Team were actively presenting information and communicating requirements on billboards and providing training support and safety tools. Food Safety Policy consists Food Safety compliance, preference & consistency. Policy signed by Plant Manager. Objective for 2019 includes: 33% reduction on Customer Complaints from 2018; Upgrading and enhance S-2 plant security system, which was achieved in 11.29.2018; Passing FSSC 22000 third party audit. Food Safety goals were reviewed and communicated during Management Review meeting. Food Safety goals, Customer Complaints (# of case), 2018 actual 36, 33% reduction, 2019 target 25 cases. The other goals were upgrading and enhance S-2 plant security system and passing FSSC 22000 third party audit. Organization Chart was reviewed. Department Supervisors, including Quality Assurance, Production Supervisor, whose responsibilities and authorities were defined and detailed in their job descriptions. Quality Assurance Supervisor serves as Site Food Safety Team Leader, who was responsible for Site Food Safety Programs and meeting all requirements. Sanitation Supervisor and QA Supervisor were in the Food Safety Team. Consumer Complaint Procedure, 8.1801, 07.11.2018, outlined the steps to be taken in the event of a food safety and quality non-conformity. Communication of complaint to plant was made through emails. The complaints received from Consumer were recorded on SharePoint. Verified puncture bag complaint, PO# 10505966. After investigation it was confirmed due to belt lacing coming off a small section of the belting on the bag flattener. Total complaint received year to date 2019: 27 cases (which including unjustified complaint). Internal communication was made through internal e-mail, skype and meeting such as Daily Production Meeting, Switch-over Meeting, Supervisor and Leads Meeting. Agenda covered included personnel qualification, HACCP, product shipment, non-conformance handling, environmental monitoring, complaint case. Hygiene bill-boards were posted in the hall way to the production area. Topic covered including the cGMP practice. Emergency Action Plan, 8.3109, 08.12.2019, outlined the mode of notification, emergency number to call in event of incident, responsibility of emergency response team, communication to media. Emergency contact list was established for local team and local authority. Scenario identified such as utility interruption, chemical spillage, fire and etc. Product contamination and need for cleaning refer back to Technical Director at Pasco Processing. Latest fire drill was conducted on 12.12.2019. Management Review Quality was conducted annually, recent review for period December 2018 - December 2019, completed on 12.03.2019, showing the follow-up actions for previous reviews inputs and outputs. Projects communicated in the meeting including customer complaints, upgrades of security system was completed.

6.0 Resource

management

The plant employs 180 employees, including 12 management positions. The plant area included 240,000 square footage for operation, 6 production lines, including Line 1-2 Dehydrated Flake and Flour, Line 3 Dehydrate Slices, Dices and

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Shreds, Line 10 Bagging, Line 20 Bulk Packaging, Line 45 Agglomeration, Line 70 Totes and Line 80 Cases. Finished products are stored at this location. cGMP for all employees was conducted on 01.18.2019. Personal Hygiene training was conducted on 11.20.2019. Warehouse Supervisor, Phil Frost, was trained on FSPCA Preventive Controls for Human Food on 05.25.2016, Practical Food Safety and HACCP Workshop on 05.07-09.2015, Internal Auditor Workshop on 01.22.2015, Metal Detector Course on 04.17.2012. Plant Manager, Miguel Rementeria, was trained on FSPCA Preventive Controls for Human Food on 05.25.2016. Production Supervisor, Sergio Vigal, was trained on FSPCA Preventive Controls for Human Food on 09.11.2019 QA Supervisor, Ana Naranjo, was trained on FDA Food Defense 101 on 01.19.2017, FSPCA Preventive Controls for Human Food on 03.10.2016, Practical Food Safety and HACCP Workshop on 05.12-14.2015. QA Assistant, Denicia Martinez, was trained on FSPCA Preventive Controls for Human Food on 09.11.2019. Sanitation Supervisor, Heidi Juarez, was trained on FSPCA Preventive Controls for Human Food on 03.10.2016. QA Supervisor, job responsibility, including job function was reviewed. Onboard Training and periodical retraining were defined. Records show that training for personnel was complete. Competence, Awareness, Training, 8.1202, 08.05.2014, outlined that responsibility of management, human resources (HR), in ensuring the competency of trainee, tracking of training program by HR. Training certificate was generated as evidence of training. Food safety training included pest control, allergen, HACCP, cGMP, food Defense, job related safety, hygiene zoning and etc. Sanitation crew was interviewed, Abel Juarez, Frank Reyes. Quiz was used as exit criteria. In addition, on the job demonstration was part of evaluation which conducted by supervisors or managers.

7.0 Planning and

realization of safe

products

Site HACCP Plan was established and periodically reviewed for its effectiveness. It covers physical, chemical, biological hazards of raw materials, packaging materials and processes. All relevant requirements of GMP Codex, rules and guidelines of FDA 21 CFR were recognized. Control measures and corrective actions were in place for the effectiveness of FSMS. Raw material, packaging material description including specifications, storage conditions, intended use and processing conditions, including time, temperature and related information was collected for initiating hazard analysis. Relevant personnel from key functions of the site formed a team and were trained on HACCP requirements. Process Flow Diagram, 09.26.2019, for dehydrated potato flakes & flour, described detailed steps for each process. 25 - 50 lbs Kraft bags or 2,400 lbs totes were used for packaging. Further cooking was instructed. Food Safety Plan for Line 1&2: Dehydrated Flake and Flour, and Food Safety Plan for Line 3: Dehydrate Slices, Dices and Shreds, included hazard analysis for physical, chemical, biological hazards of raw materials, packaging materials and processes. Processing steps included: Receiving, Sizing, Washing, Peeling, Sorting, Slicing, Blanching, Cooking, Drying, UV Conditioning, Grinding as Packaging. Hazard analysis included the risks involving in all processing steps, raw materials and processing equipment. Hazard analysis described risks such as Listeria monocytogenes, Salmonella spp, E. coli, Myco toxin solanine, Pesticides, and physical risk such as metal. Hazard analysis was last reviewed on 09.26.2019.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Process flow diagram was verified during site tour. Process description was accurate. Operational PRP’s/Preventive Controls were defined in Food Safety Plan: oPRP 1. Supply chain preventive control: potato suppliers/growers sent their GFSI certification, such as BRC or SQF or audit report annually; PrimusGFS certificate from Pleasant Valley Potato, Inc, valid from 02.19.2019 to 02.18.2020, was reviewed. PrimusGFS certificate from Mart Fresh Pack LLC, valid from 06.06.2019 to 06.05.2020, was reviewed. Supply Chain Control is Annual. Shipment from a supplier with expired third-party food safety certificate will not be unloaded. Such supplier would be notified. Purchase order would not be sent to a supplier with expired food safety certificate. oPRP 2. Blanching on Line 1&2: blanching potatoes at or above 160 degrees F for 19 minutes minimum, records from January, March, May, July, September and November 2019 were reviewed; oPRP 3. Cooking: cooking temperatures average from 198 to 203 degree F at a retention time of 10 minutes minimum, records from January, March, May, July, September and November 2019 were reviewed; oPRP 4. Blanching on Line 3: blanching potatoes at or above 145 degrees F for 19 minutes minimum, records from February, April, June, August and October 2019 were reviewed; NC#5, On 12.13.2019 Line 3 Dehydrator Blancher temperature at 8 am was recorded as 135 degree F. It was required to maintain at minimum 145 degree F. Product was not affected, as it goes through an extensive drying process with the following set points. Temperature at stage A is set at 223 degree F for zone 1, and 228 degree F for zone 2, for 47 min. Stage B is set at 218 degree F for zone 1, and 225-degree F for zone 2, for 67 min. Stage C is set at 165 degree F for zone 1, and 145 degree F for zone 2, for 70 min. oPRP 5. Sanitation program on Line 1&2, Line 3, Line 10. Sanitation records from 2019 were reviewed and found complete; oPRP 6. Magnets: rare earth magnets were located on top of the fillers. Site defined metal detection was critical control point: verification of metal detector on Line 10 was demonstrated by an employee Phil Frost, who was trained on Metal Detector Course on 04.17.2012 during the plant tour. Metal detection verification records from the second week of July 2019 was reviewed. Records were signed and complete. Hazard analysis, including the flow diagram, process steps, raw material risk assessment, control measures was last reviewed on 09.26.2019. Metal detector, Mettler Toledo, Safeline PowerPhase PRO, on Line 10 serial number 108280, on Line 20 Bulk serial number 109155, on Line 45 serial number 99889, on Line 70 serial number 126608, Rail-car line serial number 109154, were calibrated on 07.05.2019 by Mettler Toledo Service. Rejection system was checked. Pull strength tests on magnet was completed annually on Line 10, Line 70 and Line 80. Latest results from 06.03.2019 and 06.20.2019 were in compliance. Verification on the rejection system of bulk metal detector for rail car was conducted. Record from July 2019 was found complete. Thermometer on blancher and cooker was calibrated annually, certificate of calibration was reviewed.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Moisture Analyzers were calibrated annually. Latest calibration on Ohaus MB120, B628752335, B628752339, B630798985, were conducted on 06.25.2019 by Quality Control Services. Traceability procedure was established, and responsibility was defined under Traceability & Recall Program (PRP) 8.1510, 08.15.2018. A traceability exercise was conducted on below products during the audit, OPC Flake, NAV# 102087, Lot# H08162019, produced on 08.16.2019, total 79,000 lbs, packed in 40 lbs bags. 504 bags of product were shipped on 08.21, 504 bags on 08.30 and 792 bags on 10.04 to Jason Pharmaceuticals. 175 bags were shipped on 10.30.2019 to Anchor Ingredients. All raw materials used in the production was counted for. Unilever, NAV# 103396, DH 1/8*3/4*3/4 dice, produced on 02.17.2019, total 33,560 lbs, packed in 40 lbs cases, 15 cases per pallet. 730 cases were shipped on 02.27, 94 cases on 05.20 and 15 cases on 10.01 2019 to Power Packaging. All raw materials used in the production was counted for. DH Unseasoned Agglomerate, NAV# 102243, Lot# H07162019, produced on 07.16.2019, packed in 2 Totes, total 2,400 lbs. Product was shipped to Power Packaging on 11.01 and 11.04 2019. All raw materials, including potatoes, high oleic canola oil, cardboards, tote liners and dice bins, used in the production was counted for. Production, material used, shipped product were 100% reconciliated. All data was retrieved from ERP system. Raw material traceability target was 100+2%, finished product 100%. Mock recall exercise was conducted twice a year, were completed on 05.09.2019 and 10.03.2019. 1. Dehydrated Potato Flour, NAV Item# 105372, Lot# H04102019, produced on 04.10.2019, total 73,824 lbs, which included 62,500 lbs shipped and 11,324 lbs under quality hold. 2. Dehydrated Potato Flour, NAV Item# 104502, Lot# H08302019, produced on 08.30.2019, total 46,547 lbs, which included 36,000 lbs shipped and 10,547 lbs under quality hold. Positive Release Program, 8.902, 06.04.2018, described the controls to prevent non-conforming products from being released for use. That included all types of ingredients, packaging materials, Work in Progress (WIP) and finished products. Non-conforming raw materials and finished products were stored in designated areas.

8.0 Validation,

verification and

improvement of the

FSMS

Food Safety Team was from multiple function such as QA, Production, Warehouse and Sanitation. Validation of preventive controls, equipment calibration was observed as complete. Food Safety Management System included final product release, defined monitoring, characteristic/classification, sampling, inspection method, specifications for verification, also defined corrective actions in case non-conformance occurs. Product verification recorded under NAV system by Quality Assurance, i.e. sensory evaluation, physical and microbiological examination. On the blanching and cooking process, a validation study was conducted by Eurofins Microbiology Lab in Lancaster PA investigating the survival of Listeria monocytogenes on vegetable products after being exposed to a simulated water blanching treatment. It was concluded that 19 minutes at 145 degree F or 4 minutes at 170 degree F could reduce Listeria monocytogenes by over 6.0 logs. Gem State updated the blancher temperature to 145 degree F, after validating the process in the production scale.

Measurements, such as balance, thermometer were managed properly.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Scale including load cell, truck scale were registered on Master scale list.

Magnet pull strength was measured by QA annually. Moisture analyser in the lab calibrated annually. Metal detectors were calibrated annually.

Internal Audit Procedure, 8.1700, was established. Internal audit conducted annually, each function being audited through a calendar year. Internal Audit Schedule 2019 and records were complete and reviewed.

Continual improvement at the facility is managed in accordance with internal audits and management reviews. Management Review Quality was conducted annually, recent review for period December 2018 - December 2019, completed on 12.03.2019, showing the follow-up actions for previous reviews inputs and outputs. Projects communicated in the meeting including customer complaints, upgrades of security system were completed.

Additional Requirements findings

2.1.4.1 Management of Services

The facility kept documented agreement with service providers, such as utility services and pest control service providers. Water supplier by City of Burley. Water was treated by water softener, Reverse Osmosis in-house. Solid waste was collected by Total Waste Services. Invoice/statement from 2019 were verified. By-products such as potato peels was picked up by Chris Drakos Enterprises. Service Agreement was verified. Boiler chemicals were supplied by ChemTreat. FDA approved boiler chemicals were supplied by ChemTreat. Pest control service was provided by Sprague. Scope of service was signed on 05.30.2018. All raw materials and final products were stored within the facility, no contracted warehoused was used. Transportation was arranged and scheduled by suppliers and customers.

2.1.4.2 Product Labelling Product label content was reviewed by QA Supervisor Ana Naranjo, and Plant Manager Miguel Rementeria and approved by Technical Director at Pasco Processing, which was the Corporate office. Labels were generated at the site, QA Dept. conducted label inspection for any undeclared allergen. Site raw material label were observed as legible with raw material information. Product labels reviewed label control verified during site tour, i.e. Flake in totes, ingredients declaration on product bag label and pallet labels were accurate and NAV tag.

2.1.4.3 Food Defence Food Defense plan was last reviewed on 12.11.2019. Plant Manager was appointed as Food Defense Team Leader. Broad Mitigation Strategies included sections of the facility, measures, response and plan. Vulnerability assessment was conducted based on process steps with severity scores and mitigation suggestions. Food Defense team was from multiple function such as QA, Production, Warehouse and Sanitation. Receiving of potatoes, truck number, driver’s name, Outbound Ticket number, bin number, sample weight and inspected information were recorded on Tare Work Sheet. Outbound Ticket recorded gross and tare weight, truck number of delivery trucks. Product or material condition were inspected. Receiving of raw materials other than potatoes was recorded on Incoming Ingredient & Material / Packaging Report. Visitor need to sign in at main entrance and with ID verification by reception. Chemicals, including cleaning agent, sanitizers and boiler chemicals, were observed stored at dedicated area with access control. Visitor was provided with ID badge escorted by plant personnel all the time. Computers were password controlled. Staff need access card to enter facility. In addition, utility room was access controlled. The premise was under security surveillance and fenced. Bulk receiving for potatoes and raw materials was locked after 5 pm, when no receiving was scheduled on the same day.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Food Fraud and Vulnerability, 8.3103, 06.07.2018, outlined that risk assessment based on accessibility and vulnerability for broad mitigation and establishment of food defense plan. Food defence plan was established with defined control measure and monitoring frequency. Food defence was part of food safety training on 10.01-10.03.2019. The plant has the respective FDA registration approval, registration number 19955121100.

2.1.4.4 Food Fraud Prevention

Food Fraud was evaluated in Food Defense Plan, which was last reviewed on 12.11.2019. Potential of vulnerability, i.e. metal contamination, was identified. Risk assessment was based on likelihood and consequences. Supply chain control, including raw material suppliers, was approved by Supplier Management Program, 8.901, 06.13.2017, at Pasco Processing. Material inspection was conducted at site level upon material receiving, information was recorded on Tare Work Sheet and Incoming Ingredient & Material / Packaging Report, which were verified during document review. Food Fraud Plan was reviewed once a year for new suppliers and existing suppliers. Supplier survey was used to collect information for supply chain risk assessment. Site Quality Assurance Supervisor was interviewed. All suppliers have GFSI food safety certifications, such as BRC and SQF, or in the processing being certified during vendor assessment. Vulnerability assessment was part of hazard study for raw materials and processing.

2.1.4.6 Management of Allergens (for categories C, I and K only)

Allergen Management Policy, 8.420, 02.04.2015, described how the site handles any potential allergens. The control measure was based on sanitation, identification of allergenic material, cleaning of shared utensil. It applied to visitor and all employees. Staffs were trained on allergen handling. At raw material warehouse, it was observed that allergenic material was properly identified with type of allergen and stacked at assigned location. No material spillage was observed. Allergen validation was conducted on Sodium metabisulfite.

2.1.4.7 Environmental monitoring (for categories C, I and K only)

Microbiological Environmental Monitoring Program, 8.3070, 01.06.2018, described regular swab tests on APC, Coliforms, Listeria species and Salmonella by internal Micro-Lab and third-party lab. Verification of cleaning and sanitation was conducted. Food contact surfaces, such as conveyor belts, product contact utensils, were swab-tested weekly for APC and Coliforms. Non-food contact surfaces, such as equipment supports, frame outside the tunnels, control panels, were swab-tested bi-weekly for Listeria species and Salmonella. Non-product contact areas within a room that were remote from product contact surfaces, such as drains, floors, ceilings, were swab-tested bi-weekly for Listeria species and Salmonella. Areas that were outside food production, such as restrooms, break rooms, were swab-tested bi-weekly for Listeria species.

2.1.4.8 Formulation of products (for sub-category DII, pet food for dogs and

cats only)

NA

2.1.4.9 Management of natural resources (for category A only)

NA

2.1.4.10 Product Release Procedure (only for food chain categories C, I, G and

K).

NAV Instructions for Releasing and Holding Products, 8.1251.1, 02.04.2015, described releasing products through the NAV software. Positive Release Program, 8.902, 06.04.2018, described the controls to prevent non-conforming products from being released for use. That included all types of ingredients, packaging materials, Work in Progress (WIP) and finished products.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Quality Department was responsible for Non-conforming product hold release. Hold release records included investigation and disposition of products.

2.1.4.11 Supplier approval in case of emergency (only for food chain categories C, I, G and K).

Supplier Management Program, 8.901, 06.13.2017, outlined the approval process of suppliers of ingredients, additives, packaging and other materials used in the processing and packaging of potato products. NC#1, Backup suppliers were not assessed for emergency situations, such as unexpected natural disasters, food safety recall and other supply chain issues. Cargill was the only supplier for Citric Acid. Esseco USA LLC was the only supplier for Sodium metabisulfite.

2.1.4.12 Test of Incident management procedure (only for food chain categories C, I, G and K).

Emergency Action Plan, 8.3109, 08.12.2019, outlined plan implementation when there was a reporting fire and emergency situation such as emergency number to call in event of incident, responsibility of emergency response team. NC#2, Electricity was the main energy source of the plant. Unscheduled electricity outage was not included in the Emergency Action Plan. Latest fire drill was conducted on 12.12.2019. While food safety was not considered during the drill.

2.1.4.13 Traceability of final products (only for food chain

categories C, D, I, G and K).

Traceability procedure was established, and responsibility was defined under Traceability & Recall Program (PRP) 8.1510, 08.15.2018. Recall team was established. All final products had a unique code identification for customers to identify product. Traceability Exercises were conducted by quality assurance team during the audit: 1. OPC Flake, NAV# 102087, Lot# H08162019, produced on 08.16.2019, total 79,000 lbs, packed in 40 lbs bags. 504 bags of product were shipped on 08.21, 504 bags on 08.30 and 792 bags on 10.04 to Jason Pharmaceuticals. 175 bags were shipped on 10.30.2019 to Anchor Ingredients. All raw materials used in the production were counted for. 2. Unilever, NAV# 103396, DH 1/8*3/4*3/4 dice, produced on 02.17.2019, total 33,560 lbs, packed in 40 lbs cases, 15 cases per pallet. 730 cases were shipped on 02.27, 94 cases on 05.20 and 15 cases on 10.01 2019 to Power Packaging. All raw materials used in the production were counted for. 3. DH Unseasoned Agglomerate, NAV# 102243, Lot# H07162019, produced on 07.16.2019, packed in 2 Totes, total 2,400 lbs. Product was shipped to Power Packaging on 11.01 and 11.04 2019. All raw materials, including potatoes, high oleic canola oil, cardboards, tote liners and dice bins, used in the production were counted for. Exercise of traceability of final products was successful as Production, material used, shipped product were 100% reconciliated.

2.1.4.14 Procurement of animals, fish and seafood (only for food chain category CI)

N/A None of these raw materials were used at this site.

2.1.4.15 Animal Inspection Process (only for food chain category CI)

N/A No animal raw materials were used at this site.

2.1.4.16 Slaughter Time and Temperature (only for food chain category CI)

N/A None of these raw materials were used at this site.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

2.1.4.17 Use of Feed Ingredients (for food chain categories DI and DII only).

NA

2.1.4.18 Packaging with a functional effect on food (only for food chain category I)

NA

2.1.4.19 Materials transported in the same vehicle (only for food chain category I).

NA

2.1.4.20 Medical Screening (only for food chain category I).

NA

2.1.4.21 Food contact and claims (only for food chain category I).

NA

PRP Summary

Summary of PRP compliance 4. Construction and layout of buildings The building was located in an industrial area with paved roads and few plants without external source of contamination. The exterior wall and roof were maintained in a clean status with no potential pest sabotage. Interior walls were built with smooth concrete, set on concrete flooring. It was protected from spill, moisture or forklift damages, plus easier to clean. There was no roof leaking or potential damage from leakage observed at the time of the audit.

Building was enclosed to prevent external contamination.

Receiving and loading docks were concrete paved. Vegetation near the proximity to premise was well maintained. Staff and visitor parking were paved.

5. Layout of premises workspace

The facility was overall maintained in a good and sanitary condition. No potential contamination nearby. Premise was trimmed and well maintained with no potential pest harborage. Adequate drainage system was put in place and no stagnant water was observed.

The facility was mainly focus on refrigerated pasta, sauces and cookie dough. Adequate space was available in production areas for equipment, piping and operation. Traffic between warehouse and processing areas were well designed to avoid cross contamination. Raw materials and personnel flow were properly managed.

All rolling gates, walls, ventilation, floors, roof and drains etc. were clean and well

maintained.

NC#4, Frame of the door, which connecting Line 1 &2 production area and the

chemical room, was found loose.

Equipment was properly located with adequate space for piping, raw material containers, operation and cleaning.

QA lab and Microbe lab which conducted physical and microbiological testing, were located outside of production area. Labs were well maintained.

Vending machine located in staff break room which away from production.

Packaging material was protected with external wrapping and placed on pallet. Materials were found with identification with allergen status. Loose material was identified with ID tag too. It was noted that the raw material carton was placed on board lined wooden pallet. Cleanliness of raw material warehouse was found acceptable. The cleaning agent, boiler chemicals at chemical room was identified with labels.

6. Utilities – air, water, energy

Monitoring of utility quality was documented in FSMS. The program was robust and comprehensive. Program was managed by Utility team and QA.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Water Supply Policy, 7.604, 06.12.2018, described the water systems at Gem State.

Water supplier by City of Burley. Water was treated by water softener, Reverse Osmosis in-house. Semi-annual water test conducted on 01.09.2019 and 07.09.2019 by Magic Valley Labs for heavy metals, such as arsenic, cadmium, lead, mercury, chromium, copper, and cyanide, radium 226 & 228 and Coliforms. Lab reports were verified. Free chlorine was monitored on RO water.

Steam-peeling equipment used steam.

Monthly micro testing, including Total Coliform and E.coli, were conducted on City

water by City of Burley. Verified report on 11.20.2019.

Boiler chemicals were supplied by ChemTreat.

FDA approved boiler chemical ChemTreat BL1302, BL1253, BL4356, BL124 for boiler water treatment, BL1553 for steam line treatment, RL9909 for RO treatment, P817FG, P834E, P891L for water clarification/solid conditioning. Boiler water analysis was conducted weekly on feed water for conductivity, pH, hardness, iron and copper. Report from 11.13.2019 was verified.

Conductivity on boiler was monitored by maintenance daily.

Ventilation Policy, 7.601, 08.01.2013, described the requirement on clean air at the facility. Minimum efficiency reporting value, MERV, rating for HVAC was 11. Intake and exhaust air ducts were observed clean. Filter in Air Makeup Unit, AMU, was

changed monthly based on PM schedule. Latest change was on 12.12.2019.

APC, Petrifilm, 3M, lot# 334CDL, expiration on 10.18.2020;

E.coli / Coliform, Petrifilm, 3M, lot# 334YWK, expiration on 01.31.2021;

Staphylococcus (STX), Petrifilm, 3M, lot# 418319140C, expiration on 11.17.2020;

Rapid yeast & mold, Petrifilm, 3M, lot# 33545N, expiration on 02.07.2021, for the

microbiology lab;

Yeast & Mold 3-day, Petrifilm, 3M, lot# 33358M for the production areas.

Microbiology Grade Sheet, Environmental testing, Air sampling, was conducted monthly. Yeast and mold in processing area, warehouse holding area, Line 10 Packaging area, Line 45 Agglomeration, Line 50 Packaging was monitored. Record from recent inspection on 05.06.2019 and 12.03.2019 was verified.

Compressed Air Policy, 7.610, 08.01.2012, described the requirements for compressed air.

Solid particulate < 0.5 ppm by weight;

Particulate filtration greater than 3.0 micron at 100% efficiency, 0.1-3.0 microns at 99.98% efficiency;

Oil removal: 2 ppm = 0.1 ppm out, 10 ppm = 0.05 ppm out;

Food grade oil was used. Air compressors was listed on the preventive maintenance list.

Records from 01.06 and 10.02.2019 were verified.

Lighting Policy, 7.603, 01.19.2012, defined the lighting requirements for general working areas, process areas, packaging area and warehouse with minimum of 10

foot candles.

Lighting was observed sufficient in storage areas, production areas, agglomerate production, flake packaging, agglomerate packaging. All lights were protected with shatter proof sleeves or equipped with shatter proof bulbs.

7. Waste disposal

Waste Disposal Policy, 7.710, 06.12.2018, outlined the responsibilities and requirements for general waste, including by-products and office waste.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Waste containers in processing areas were found clean and maintained. No algae were observed in docking area at the time of audit. Waste water was treated before releasing to industrial drains by DAF unit, which controlled/removed total solids (TSS), BOD, phosphorus, ammonia and other pollutants. Flock from DAF was collected to waste room. Starch water from steam-peeling and rinsing was separated by cyclone system and collected as by-product for non-food purpose.

Surrounding exterior waste collection was found satisfactorily. Liquid waste was directed to DAF system. Exterior building was free of cutter and waste.

Solid waste was collected in a dumpster and picked up by Total Waste Services weekly. No hazard waste generated at the facility. Invoice/statement from Total Waste from 02.28, 04.30, 06.30, 08.31 and 10.31.2019 were verified.

Rejected potato during processing, whole or sliced, was collected. By-products such as potato peels was picked up by Chris Drakos Enterprises for feed purpose.

Monthly collection bills 04.01, 06.01, 08.01, 10.01 and 12.01.2019 were verified.

Waste Disposal Policy described drain and drainage. No drains flowed from contaminated areas into clean areas. No overflow was observed during the plant tour.

No issue on exterior drain.

8. Equipment suitability, cleaning and maintenance

Preventative Maintenance Plan, 7.1600, 06.12.2018, described the preventive

maintenance at the facility.

Equipment Suitability, Cleaning and Maintenance, 7.810, 06.12.2018, described the program in place to prevent food contamination due to design, cleaning and

maintaining equipment.

Equipment throughout the facility was designed to allow cleaning and maintenance, built with stainless steel. Equipment, such as Steam-peel, blancher and cooker, was found in clean condition and well maintained. Equipment was sanitized at daily basis.

Sanitation Team was dedicated for cleaning and sanitizing equipment.

Cleaning and Sanitation program was in place. Processing Sanitation Report included areas such as Infeed and Peeler, Halo Sorter/Cutting Area, Bypass, Blancher, Cooker, Drums and Pit. Detailed description of cleaning and sanitation was listed. Time of cleaning was recorded by sanitation team on daily bases. Two sanitation

teams worked on 12 hours shifts covered 24 hours operation.

Sanitation records from 2019 were reviewed as complete.

Sanitation was verified by swab testing. 3M Quick Swab, lot# 29019, expiration on 10.22.2020 for zone 1.

EZ-Reach Polyurethane Sponge sampler, EZ-10LET-PUR, lot EZ-13164, expiration on 07.30.2020, for zone 2, 3 and 4.

Product contact surface and equipment was made with stainless steel. Blancher, cooker and covers were also made with stainless steel.

Temperature controls were properly conducted and monitored as required by preventive control, blanching on sliced potatoes. For Line 1 and Line 2 blancher minimum set temperature as 165 degree F. For Line 3 blancher minimum temperature set point was 145 degree F. Temperature was recorded every 2 hours by operators.

Process Control for Blanchers and Cookers from 06.01 to 12.11.2019 was reviewed.

Non-conformity was raised under ISO 22000, 7.5: NC#5, On 12.13.2019 Line 3 Dehydrator Blancher temperature at 8 am was recorded as 135 degree F. It was required to maintain at minimum 145 degree F.

Cleaning and Sanitation program exercised. Verification of cleaning carried out through swab test.

Cleaning verification was reviewed by Sanitation Supervisor.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Compressed Air maintenance records from 10.09.2019, by Rogers Machinery Company, was verified. Work order included filter replacement, micron coalescing replacement, lubricant,

Food grade lubricant LubriPlate SFL-2 was used at the facility.

AMU filter change for Dehydrator #1 and #2 on 12.12 and 12.17.2019; AMU filter change for Processing #1 and #2 on 12.12.2019 were verified.

Preventive maintenance was managed and executed by Maintenance Team.

Supplier Management Program, 8.901, 06.13.2017, was established.

9. Management of purchasing materials

Raw material and packaging material purchasing was managed by Corporate. The facility purchased only from corporate approved suppliers, which maintained in the NAV system. QA Supervisor explained the supplier approve process, which involved risk assessment. Survey was usually part of the supplier approval process. GFSI scheme were required from a potential material supplier.

Potatoes were mainly supplied by companies owned fields. Supplier management program was in place for approving suppliers of other ingredients and packaging materials.

On-time deliveries, non-conforming rates, quality levels delivered, and pricing were

assessed continuously. Record was maintained at the time of receiving.

Spec for each raw material and requirements for packaging materials were maintained. Current third-party food safety certificate was required from a supplier. Receiving inspection and sampling were conducted by QA. Supplier COA to verify conformity with

specified requirements prior to acceptance or use. Testing was conducted by QA.

10. Measures for prevention of cross contamination

Materials and employee traffic pattern was defined in all areas, including processing

area, warehouse.

Prevention of cross contamination were managed by segregation in material storage, transport, preparation, product processing and employee movement, which were maintained well during the time of audit.

Microbiological Environmental Monitoring Program, 8.3070, 01.06.2018, described regular swab tests on APC, Coliforms, Listeria species and Salmonella by internal Micro-Lab and third-party lab. Verification of cleaning and sanitation was conducted. Food contact surfaces, such as conveyor belts, product contact utensils, were swab-tested weekly for APC and Coliforms. Non-food contact surfaces, such as equipment supports, frame outside the tunnels, control panels, were swab-tested bi-weekly for Listeria species and Salmonella. Non-product contact areas within a room that were remote from product contact surfaces, such as drains, floors, ceilings, were swab-tested bi-weekly for Listeria species and Salmonella. Areas that were outside food production, such as restrooms, break rooms, were swab-tested bi-weekly for Listeria species.

Allergen Management Policy, 8.420, 02.04.2015, was established to protected from unintended allergen cross contact by cleaning and line change-over.

Sodium bisulfite was identified as allergen and stored segregated in allergen cage.

Foreign Material Control, 8.1000, 01.02.2019, described control of foreign material, including rules for each type of foreign material risk.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Metal as foreign matter was controlled by magnets and metal detector. Glass and Brittle plastic control was established which outlined the glass breakage handling such as notification to QA, holding of affected product, recording of glass incident. Lighting at warehouse were shielded.

Annual glass audit was conducted on 01.16.2019 through the whole plant.

11. Cleaning and sanitizing

Facility, including warehouse, processing areas and packaging areas was found in clean condition. Equipment was cleaned and sanitized at set interval. Dedicated sanitation team covered 24 hours operation.

Cleaning agents, such as Chlorchem and Chlorquat, were used for food contact

surfaces and utensils. Cleaning tools were stored in designated place.

Cleaning and Sanitation program was in place. Two sanitation teams worked on 12 hours shifts covered 24 hours operation. Sanitation records from 2019 were reviewed as complete.

Visual inspection conducted and documented by operator, and further verified by supervisors. ATP, Listeria species and Salmonella swab test was used to verify effectiveness.

12. Pest Control

Pest Control Program, 8.1212, 06.11.2018, was established, and outlined the responsibility of QA Supervisor on implementation of program, close door policy to prevent pest entrance. Document and reports were maintained online by W.B. Sprague. Routine meeting was conducted with pest control to review the trend. Any

pest finding by site will be discussed with Sprague.

Site engaged Sprague as pest controller. Scope of service was signed on 05.30.2018. Frequency of service was defined in schedule. Inspection service: weekly service for interior, monthly for exterior; for ITLs, monthly from December to March and weekly during rest of a year. Documentation such as insurance, business license, issued by

State of Washington, were found updated.

Loading dock at receiving and finished goods shipping were found close fitting.

Facility doors towards exterior were secured providing no pest entry.

NC#3, Exterior Door 11, which leads to Dissolve Air Floatation (DAF) room, was not properly locked to prevent from potential pest intrusion.

No pest sighted at material storage area and processing areas.

Pest control mapping was found updated. The pest control devices were found functioning and at designated location as per mapping. Service report on April 2019, 12.12.2019. Trend was plotted continuously on mice and rodents. Exterior rodent trap #239 at the rail car loading dock was replace.

No pesticide was used in premise.

13. Personnel hygiene and employee facilities

Personal Hygiene and Employee Facilities, 8.1310, 04.19.2018, described the expected level of personnel hygiene and facility cleanness.

As for visitor and contractor, they required to wear hair net/bread net, hard-hat, ear-plugs, lab coat, safety shoes, no jewelry.

Hand-wash stations, soap, tissue paper, sanitizer were equipped throughout the facility.

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Staff break room was equipped with vending machine.

Workwear, hair-net, beard-net for male workers if necessary, ear-plugs, hard-hat and safety shoes were used by all employees entering production and warehousing areas.

cGMP Policy, 8.305, 08.01.2018, described that staff required to report to superior in event with illness symptom.

Metal detectable bandage was required to cover the cut.

Employees were found complied to the hygiene requirements during the whole time of the audit.

No issues was observed during the plant tour.

14. Rework

There was rework on flake and flour for density or peel defect.

Designated area for materials to be reworked.

Quality approval by QA Supervisor after reworked.

15. Product recall procedures

Product recall and withdrawal was managed under Traceability & Recall Program (PRP) 8.1510, 08.15.2018..

All data was retrieved from ERP system. Raw material traceability target was 100+2%, finished product 100%. Mock recall exercise was conducted twice a year, were completed on 05.09.2019 and 10.03.2019.

1. Dehydrated Potato Flour, NAV Item# 105372, Lot# H04102019, produced on 04.10.2019, total 73,824 lbs, which included 62,500 lbs shipped and 11,324 lbs under quality hold.

2. Dehydrated Potato Flour, NAV Item# 104502, Lot# H08302019, produced on 08.30.2019, total 46,547 lbs, which included 36,000 lbs shipped and 10,547 lbs under quality hold.

There was no product recall or withdrawal since the last FSSC22000 audit.

Recall program was established with recall team, regulatory contact, actions to take for various levels of recall.

16. Warehousing

Warehouse, 6.161, 06.11.2018, described the program in place to protect the products and supplies from any type of contamination.

Warehouse Supervisor was responsible for the operation.

Trailer inspection was conducted to ensure the truck was fit for transportation and do not introduce the hazard to product.

Product was stacked on pallet with proper pallet tag for identification.

Product was staged at ambient temperature warehouse. No leak or issues was observed during the plant tour.

Trailer condition such as pest, cleanliness, product appearance was inspected prior to loading. No issue was sighted on truck condition. Pre-loading Inspection from 05.23 and

11.26.2019 were verified.

17. Product information/consumer awareness

Product label content was reviewed by QA Supervisor Ana Naranjo, and Plant Manager Miguel Rementeria and approved by Technical Director at Pasco Processing.

Sample label for potato flour, spec 32242, net 50 lbs bag was verified. Label was ink-

jet printed at the site.

18. Food defence, biovigilance and bioterrorism

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

Food Defense plan was last reviewed on 12.11.2019, outlined that risk assessment based on accessibility and vulnerability for broad mitigation and establishment of food defense plan.

Seal no. was inspected during outbound. Product or material condition were inspected. It was recorded in tally sheet. Visitor need to sign in at main entrance and with ID verification by security guard. Chemical was observed stored at dedicated chemical room with access control. Visitor was provided with ID badge escorted by plant personnel all the time. Computer was password controlled. Staff need access card to enter facility. The premise was under CCTV surveillance on the building and fenced. Supervisors and sanitation team had access to that room.

Key processing steps and Control measures:

Receiving, Sizing, Washing, Peeling, Sorting, Slicing, Blanching, Cooking, Drying, UV Conditioning, Grinding as Packaging.

During the audit the control of the following key processing steps and operational prerequisite programs (oPRPs) and CCP(s) were verified. All oPRPs and CCP’s should be verified.

Control measure

Short description (process step)

Food safety hazards to be controlled

Monitoring procedure and critical limit

Verified during audit

oPRP: Supply chain preventive control

Potatoes, processing aids/additives, liner bags/boxes, totes.

Potatoes from growers without Good Agricultural Practices

Suppliers/growers providing GFSI certification, such as BRC or SQF or audit report annually.

YES

oPRP: Blanching

Blancher Line 1&2 Biological hazard: listeria, listeria monocytogenes, salmonella E. coli or any type of pathogens.

Blanching potatoes at or above 160 degrees F for 19 minutes minimum.

YES

oPRP: Cooking

Cooker Biological hazard: Pathogens can be re-introduced through contamination

Cooking temperatures average from 198 to 203 degree F at a retention time of 10 minutes minimum.

YES

oPRP: Blanching

Blancher Line 3 Biological hazard: listeria, listeria monocytogenes, salmonella E. coli or any type of pathogens.

Blanching potatoes at or above 145 degrees F for 19 minutes minimum.

YES

oPRP: Sanitation

Sanitation Biological hazard: Pathogens can be re-introduced through contamination

Applying sanitizing agent.

YES

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Please note: In the event of the certificated organization becoming aware of legal proceedings with respect to product safety or legality, or of a product recall, SGS MUST be notified within 3 working days.

oPRP: Magnet

Rare earth magnets were located on top of the fillers to inspect metal pieces

Physical hazard: Metal foreign material

Magnets are inspected every 2 hours to verify any foreign material, metal.

YES

CCP: Metal detection

Metal detector Physical hazard: Metal foreign material

Final products passing through metal detector.

YES

Customer Feedback/Complaints Customer complain procedure was in place. 27 complaints were received, mainly on product quality, not on food safety.

Customer feedback is recorded and monitored by:

Quality assurance.

Complaints on food safety No food safety complaints.

Other feedback received Mainly on product quality, color or clumping.

Where required by regulation, were the appropriate authorities advised? NA

Was action taken as follows:

To restore conformity as quickly as practicable? NA

To prevent recurrence? NA

To evaluate and mitigate any adverse product safety risks? NA

To ensure satisfactory interaction with other components of the FSMS? NA

To assess the effectiveness of the corrective measures adopted? NA