audit report - congdon...

NSF Food Safety Certification, LLC - 789 N. Dixboro Road, Ann Arbor, MI 48105, USA

of 28 Audit# - Customer#: 1152000 - C0160019

Auditor:: Patricia Umoren

This report shall not be reproduced in part without the permission of NSF Food Safety Certification, LLC. If you would like to feedback comments on the BRC Global Standard or the audit process directly to BRC, please contact

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Audit Report Global Standard for Food Safety Issue 7: July 2015

1.Audit Summary

Company name Congdon Packing LLC BRC Site Code

1926166

Site name Congdon Packing LLC

Scope of audit Washing, grading, packing of apples and pears in poly bags, cartons and clam-shells. Repacking of apples and pears.

Exclusions from scope

None

Justification for exclusion

N/A

Audit Finish Date 2015-09-17

Re-audit due date 2016-09-24

Voluntary modules included

Modules Result Details

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2. Audit Results

Audit result Certificated Audit grade A Audit type Announced

Previous audit grade A Previous audit date 2014-09-22

Number of non-conformities

Fundamental 0

Critical 0

Major 0

Minor 6





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3.Company Details

Address 1117 S 64th Avenue, Yakima, Washington

Country United States Site Telephone Number

5099457914

Commercial representative Name

Dani Young Email [email protected]

Technical representative Name

Dani Young Email [email protected]

4.Company Profile

Plant size (metres square)

10-25k sq.m No. of employees

51-500 No. of HACCP plans

1-3

Subcontracted processes No

Other certificates held Organic, WSDA (Washington State Department of Agricultural) Good Housekeeping Certificate.

Regions exported to South America Europe Other

Company registration number

FDA X9518

Major changes since last BRC audit

None

Company Description

Congdon Orchards, Inc. is a vertically integrated fruit growing and packing operation located in Yakima, WA, founded in 1904. The facility received, washed, graded, packaged and stored fresh apples and pears. The Congdon property site has 3 buildings about 154,182 sq.ft. total. The three buildings are surrounded by orchards and other properties. There are the packing building, the CA building (composed of multiple control atmosphere rooms) and a building for segregating boxes for shipping with offices. The packing plant currently operates a single shift followed by a full sanitation shift. Cased product is delivered to a sister site six miles away for warehousing and distribution to international and domestic





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4.Company Profile

retail.

5.Product Characteristics

Product categories 05 - Fruits, vegetables and nuts

Finished product safety rationale Chilled < 39 F, Peracetic acid & Chlorine Dioxide wash.

High care No High risk No Ambient high care No

Justification for area Use of decision tree.

Allergens handled on site None

Product claims made e.g. IP, organic

Organic

Product recalls in last 12 Months No

Products in production at the time of the audit

Conventional Pears packaged in Bags, wrapped in paper on trays in cartons and clam-shells.in cartons.





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6.Audit Duration Details

On-site duration 16 man hours Duration of production facility inspection

7 man hours

Reasons for deviation from typical or expected audit duration

N/A

Next audit type selected Announced

Audit Duration per day

Audit Days Audit Dates Audit Start Time Audit Finish Time

2 2015-09-17 08:15 15:15

1 2015-09-16 08:00 17:00

Auditor(s) number(s) Names and roles of others

Auditor Number 233060 Patricia Umoren

Second Auditor Number

233036 Richard Dougherty

Present at audit

Note: the most senior operations manager on site should be listed first

and be present at both opening & closing meetings (ref: clause 1.1.9)

Opening Meeting

Site Inspection

Procedure

Review Closing Meeting

Name / Job Title

Mark Blore/General Manager x x

Dani Young/Technical Manager x x x x

Scott Rosencrance/Operations Manager

x x x





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Non-Conformity Summary Sheet

Critical or Major Non Conformities Against Fundamental Requirements

No. Clause Details of non-conformity Critical or Major? Anticipated re-audit date

Critical

No. Clause Details of non-conformity Anticipated re-audit date





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Major

No. Clause Details of non-conformity Correction Proposed preventive action plan (based on root cause analysis)

Evidence provided document, photograph, visit/other

Date reviewed Reviewed by

Minor

No. Clause Details of non-conformity Correction Proposed preventive action plan (based on root cause analysis)

Evidence provided document, photograph, visit/other

Date reviewed

Reviewed by

1 4.1.3 During the tour of the premises a hole was observed in the ground against the wall near the shipping dock.

The new PM plan has been developed and initiated. Maintenance has been trained to look for these type of maintenance repair issues. Management has reviewed the plan and agrees it is a good starting point. The hole has been sealed.

During internal audit, the hole was an oversight due to location of hole, PM program not developed as it should have been, focused on sanitation instead of PM.

Preventative measures are now in place with the Maintenance staff to conduct the PM inspection on a monthly basis. A monitoring checklist has been developed.

Before and after pictures of hole in shipping dock;Internal/External Maintenance Policy;Preventative Maintenance Inspection Checklist;Management Review Meeting;CAR for PM

03 Oct 2015

PUMOREN

2 4.4.2 The floor in the segregation room and in finished product storage was not in good repair.

PM policy now in place. PM inspection checklist developed and will be conducted on a

Mentality that floors only in production areas were required to

Management Review Meeting attendance Record;Seg room hole

03 Oct 2015

PUMOREN





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In two areas there were loose pieces.

monthly basis. Training has been give to maintenance staff.

be inspected and repaired and deviations monitored. No exterior/interior PM program in place to address repairs just sanitation issues.

Ensure that deviations caught by maintenance on inspections are related on to management for corrective action. Corrective actions generated will be reviewed for completion as turned in and will also be reviewed during quarterly Management Meetings.

in floor before and after pictures;Exterior/Interior Maintenance Policy;Preventative Maintenance Inspection form;Floor in Transfer Room before and after

3 4.7.1 The documented preventative maintenance program addresses equipment, but does not include the interior or exterior of the building.

New PM Exterior/Interior Policy developed and implemented. PM Monthly Checklist developed. Maintenance Staff has been trained.

Current program did not cover exterior and interior except for sanitation inspections.

Maintenance staff will conduct inspection on monthly basis. If deviation is identified they will notify immediate supervisor for corrective action. CAR will be audited

Management Review Meeting;PM Policy;Training for Maintenance on PM program and checklist; Exterior/Interior Maintenance Checklist

03 Oct 2015

PUMOREN





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within 14 days for closure. Management will review these corrective actions on quarterly basis.

4 4.8.9 One employee was found chewing gum in the segregation room and another eating in the shipping area.

Refresher training has been given to both employees. Stressed that they are to eat in designated areas only and not in production areas. Verbal warning has been given by supervisor. Progressive discipline will be put in place to ensure they know that Congdon is committed to their Food Safety Program.

Father and son have been with Congdon for several years. The father is 85 years old and has been working here since he was 17. Difficult sometimes to change mentalities. Food Safety is still relatively new at Congdon.

Refresher training has been given. Prerequisites will be emphasized to all employees at the next employee monthly meeting.

Refresher training for eating in designated areas only.

03 Oct 2015

PUMOREN

5 4.9.1.1 The approved chemical list is incomplete. Hydrated lime use in the control atmosphere room was not on the list and the SDS was missing.

Got on line for SDS for hydrated lime. Hydrated lime has been put on chemical list and refresher training given to all employees purchasing products.

Hydrated Lime used in CA rooms and was overlooked as a chemical that required monitoring as it would not come in contact with product in any way. Lime is used to take CO2 out of the room once the room

Refresher training on SDS and monitoring of chemicals;SDS hydrated lime;CAR on lime not on list and no SDS;CA room chemical list

03 Oct 2015

PUMOREN





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Comments on non-conformities

has been unloaded. SDS was thought to be on hand however. Was not.

No product will be purchased without current SDS. Any new product will be added to chemical list for monitoring.

6 5.4.2 The vulnerability assessment that was completed on 8/27/15 was incomplete. There were identified questions for the assessment, but few answers.

Researched vulnerability issues on line extensively and came up with a good vulnerability assessment. Reviewed by all management and agreed this was a much better starting place for us.

First vulnerability assessment, a new assessment for us, just was not detailed enough and was really not complete.

Will continue to review this assessment in quarterly management meetings to see if improvements will be required or if it is working for us. Revisions will be made as needed.

Management Review Meeting;CAR for vulnerability;Vulnerability Assessment

03 Oct 2015

PUMOREN





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Voluntary Modules Non-Conformity Summary Sheet





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Detailed Audit Report

Details of non-applicable clauses with justification

Clause reference

Justification

3.5.4 Outsourced processing is not conducted in this facility.

3.5.4.1 Outsourced processing is not conducted in this facility.




3.9.4 The facility does not conduct rework.

4.3.5 The facility is not high-risk.

4.3.6 The facility is not high-care

4.3.7 The facility does not have ambient high-care areas.

4.3.9 There were no temporary structures observed.

4.4.4 There are no high-risk or high-care areas.

4.4.6 The facility did not have suspended ceiling or roof voids.

4.4.13 There are no high-risk.

4.5.3 Non-potable water is not used.

4.7.5 There are no high-risk or high-care areas.

4.8.4 The site is not high-risk area.

4.8.5 There were no high-care areas.

4.9.4.1 Products are not packed into glass or other brittle containers at this facility.



4.10.1.1 The facility does not have foreign body detection and removal equipment.




4.10.2.1 The facility does not have filters and sieves.

4.10.2.2 The facility does not have filters and sieves.

4.10.3.2 The facility does not have metal detectors and X-ray equipment.






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4.10.4.1 The facility does not have magnets.

4.10.5.1 The facility does not have optical sorting equipment.

4.10.6.1 The site does not pack into glass, cans or other rigid containers.

4.10.6.2 The site does not pack into glass, cans or other rigid containers.

4.11.7.1 No CIP systems were used.



4.13 The site noted that there was no disposal of trademarked materials and no food was set aside for animal feed.

4.13.1 The site noted that there was no disposal of trademarked materials and no food was set for animal feed.

4.13.2 The site noted that there was no disposal of trademarked materials and no food was designated for animal feed, charity or employees.

4.13.3 The site noted that there was no disposal of trademarked materials and no food was set for animal feed.

4.14.3 The site does not undertake its own pest control.

4.16.3 Products are transported at ambient temperature.

4.16.6 The site does not employ third party truck contractors.

5.1.3 The site does not conduct trials. Products are sold whole.

5.2.3 There are no such claims.

5.3.5 There are no allergens associated with these products.

5.3.6 The facility is allergen free.

5.3.7 There are no such claims made.

5.3.8 There are no allergens associated with these products.

5.5.2 Product liners or bags are not used for ingredients or work in process.

5.6.2.2 The facility does not have a lab.

6.2.4 There are no on-line vision equipment.

7.2.4 There are no metal detectors.

7.4.4 There are no high-care or high-risk areas.

1.0

Senior management commitment





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1.1

Senior Management Commitment and continual improvement

The site has a documented policy statement signed by the General Manager, Mark Blore, on 8/13/15 and posted in the employee break room. The policy states their commitment to supply safe quality foods that meet regulatory and customer requirements. It is communicated during orientation and HACCP meetings. During the management review meeting the company decided to redefine their objectives to be more measurable. Some KQI’s are 1) Reduce the number of trouble reports (complaints) by 20%. 2) Zero tolerance on non-comformances (wrong label, PLU and etc). 3) Achieve an A rating on the BRC audit. The objectives are communicated during their monthly employee meetings. Employees know when the site has gotten a non-comformance that relates to their work. These new objectives were set in July and will be revised if needed. Management meets weekly but will document meetings monthly. Minutes for 2015/04/06, 2015/07/06 and 2015/08/27 were reviewed. On 2015/8/27 the management review meeting was conducted in which internal corrective action, food safety fundamentals, KQI, customer audit scores, complaints, resources, grower certificates, and revised forms for cold storage were discussed. From the meeting they decided to reset the KQI. The team signed and kept minutes of the meeting. The monthly employee meeting is a forum that enables employees to bring food safety, legality and quality issues to the attention of senior management. A tour of the facility revealed that management has invested in providing resources to maintaining the requirement of the BRC standard. Several areas in the plant which had been improved were pointed out as improvements made due to previous non-conformances. This facility was kept neat and well maintained as noted during the tour. The technical manager and the team are kept inform of scientific and technical advances in the industry through the USDA, WSDA, FDA, EPA, sales agents, WSU, NSF and the University of Washington. A colored copy of the BRC Global Food Safety Issue 7 was noted during the audit and referred to several times. This re-certification audit was conducted before the expiration date listed on the facility's current BRC Certificate. Both the General Manager and Operation Manager were present at the opening and closing audit meetings. The five minor non-conformances identified at the 2014 BRC audit were observed to be resolved and the applied corrective action effective.

1.2

Organisational structure, responsibilities and management authority

The site has an organization chart that demonstrates the management structure of the company. It shows the Technical Manager as having a dotted line to the CEO/President of the company and reporting to the General Manager. She has been given the food safety/quality responsibility and oversight of the BRC standard. On her team are the Assistant Technical Manager and Laboratory Technicians. There are job-specific training program such as QC refresher training and those training administered by the chemical company. The positions have documented job descriptions and work instructions. The operations manager facilitates the monthly meetings with an interpreter. There is a separate flow chart that lists the back-up for each position.

2.0

The Food Safety Plan – HACCP





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HACCP Team: The HACCP team is composed of 19 members. The team is led by Dani Young who is the Technical Manager and was trained by WSU on April 19 -21 2010. The back-up person is the new Technical Manager Assistant. The team is multi-disciplinary comprised of the Technical Manager, Assistant Technical Manager, General Manager, Operations Manager, Food Safety assistants, Sanitation, Production (Line Supervisors, Packing Supervisors, and Sorting Supervisor), HR, Maintenance and more. The HACCP team leader conducted refresher training for the HACCP team on 2015/ 8/13. The manual contains pre-requisite programs and amendments to the program.

Product Description: This site washes and packages conventional and organic pears and conventional apples. Products can be packaged in containers such as poly bags, cartons and clam-shells for distribution to international and domestic retail. The interior of the corrugated cardboard boxes can include paper trays and paper wrappers. Cased product is then staged for deliver to a sister site, six miles away for warehousing. The products packaged are intended for all consumer groups and the shelf life is 9 months or less.

Process Flow Steps: There is one process flow chart that identifies the process steps. The flow chart was verified on the production floor on August 13, 2015. Some of the steps include receiving packaging materials and chemicals, receiving fruit, incoming water, fresh water rinse, washing with soap, pre-sort table, removal of culls, box taper, finished product cold room storage. Products are refrigerated for quality preservation.

Hazards: Each one of the processing steps identifies the associated hazard. Microbiological hazards include e. coli, Salmonella and listeria. Physical hazards include damage, rodent activity, glass, extraneous material, insects, loose objects, light fixture and more. Chemical hazards include pesticides and cleaning chemicals.

CCPs and Critical Limits: There are 2 CCPs - chlorine dioxide (CIO2) measured by oxidation reduction potential (ORP) with operating limits <665 - >1200 mV. The CLO2 is also monitored in ppm at a range of 3-10. CCP 2 is peracetic acid with critical limits of <55 - >80ppm. Both reagents are applied with a spray bar in different areas.

Validation Method of CCPs: Various literature were used to validate the HACCP plan, which is based in Codex principles. There are research papers in the folder with extensive documentation on the use of chlorine dioxide and peracetic acid on pathogen inactivation. CCPs are supported by research from the Washington State University and University of California, Davis.

Monitoring and Corrective Actions: The product is rejected when the results are outside the critical limits. Non-conforming products are investigated and released by operations manager and technical manager. Monitoring is conducted prior to the 7am start-up, every hour and five minutes prior to shut down of the production line. Results are documented on various forms such as Chlorine Dioxide Chemical Log and Sani-Date (peracetic acid) Chemical Log. Testing is conducted by the laboratory technician who has been in the position for over 7 years. He was interviewed several times and found very knowledgeable. Records for August 10, 18 and 27, 2015 were reviewed and found complaint. Records are reviewed prior to release and trained Food Safety Assistants sign off on hazard forms.

3.0

Food safety and quality management system





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3.1

Food safety and quality manual

The food safety and quality manual is compiled in folders kept in the conference room and on the company server. Employees have to notify management when they need to review the manuals. It is organized in sections and clauses of the BRC standard. The food safety and quality manual was reviewed mainly in July to reflect the changes in version 7 of the BRC standard. All forms needed for in-process monitoring are given to employees as needed. All procedures and work instructions are clearly legible, unambiguous, in English and Spanish. Documents reviewed included the policy statement, the recall policy, allergen policy and more.

3.2

Documentation control

Documents & Data Control revision 8 dated 2015/07/25 details the document control policy. The revision history is shown at the bottom of the page and contains the latest revision, number, approval and description of changes. The technical manager is responsible for all documents and forms used by the organization to support the BRC Standard.

3.3

Record completion and maintenance

Records reviewed were legible, maintained in good condition and retrievable. Records were maintained manually. Records are maintained on site for 2 years and stored remotely thereafter. Records are compiled into daily, weekly and monthly piles for storage. Records reviewed included- daily (In-line QC Apples and pears, Dump tank check, Fruit Receiving Log, In-line QC Inspection, QC Final Packaging Inspection and more), weekly (Penetrometer Calibration, Scale Calibration, Pre-operational Checklist and Employee Monitoring) and monthly (Maintenance lube log and Level of Chlorine Going into Well).

3.4

Internal audit

The company has a schedule program to conduct internal audits throughout the year in which all activities are covered at least annually. The internal audit of the BRC Standard was conducted on 2015/08/13. The audit reports include conformances as well as non- conformances, corrective actions, a responsible party for correction as well as a due date. Non-conformances are logged, assigned and investigated. Root causes are captured on Corrective Action Reports. The audit covering the scope of the BRC Standard is conducted by an independent auditor. Corrective actions covering the BRC standards were corrected according to the timescale. Various audits are conducted more frequently. For example security checks and chemical inventory are conducted daily. Knife/scissors/box cutter and tape gun inspection, Hard plastic/metal glass inspection and Temperature of control atmosphere room checks are under the weekly checks. There are documented audit covering the factory environment and processing equipment on a daily basis. Those include - Daily Plant Exterior, Site Security, Maintenance Pre op checklist and Employee Monitoring log. Inspections are carried out by the supervisors and forms are verified by the technical group. Daily records for August 10, 18, and 27, 2015 were reviewed. Weekly in-process checks reviewed include week of August 3, 10, 17 and 24, 2015.

3.5

Supplier and raw material approval and performance monitoring





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3.5.1

Management of suppliers of raw materials and packaging

Congdon Packing has a Supplier Evaluation and Management policy that assessed the risk of raw and packaging materials. A list of certified growers was reviewed. The majority of apples and pears are sourced from company owned orchards. Contract growers undergo Good Agricultural Practices (GAP) audits conducted my Congdon Technical Services Department. A documented receiving policy outlines the approval and ongoing monitoring process of incoming loads to manage risks to raw material quality and safety. Using the QC Receiving Log, the US grades are recorded, product quality and truck condition. Pictures of substandard products are taken and products placed on hold. Two suppliers of ingredients and packaging from the facility tours were picked at random and documentation establishing their approval status was requested. Their GAP audits and continuing letters of guarantee were on file. Packaging materials are purchased from brokers. Information to enable the approval of the packaging manufacturers is on file in the form of continuing letter of guarantee. There are no exceptions to the supplier approval process because the site has back-up suppliers.

3.5.2

Raw material and packaging acceptance and monitoring procedures

A documented Receiving Policy outlines the approval and ongoing monitoring process of incoming loads to manage risks to raw material and packaging quality and safety. Using the QC Receiving Log the US grades are recorded, product quality (example damage and infestation) and truck condition are determined and bin tag is verified. Pictures of substandard products are taken and products placed on hold as needed. Incoming product suppliers are verified on the list of growers and packaging supplier list. Packaging acceptance is based on continuing letter of guarantee.

3.5.3

Management of suppliers of services

A documented procedure for the approval and monitoring of suppliers of services dated 2015/8/27 was reviewed. It contains description of services, their evaluation, review date and specification. A contract service list was on file. The pest control company and the waste management company were found on the list as names were noted during the facility tour. Not all contract service company had contract on file as some were based on a purchase agreement. These services did not pose food safety risks.

3.5.4

Management of outsourced processing

Outsourced processing is not conducted in this facility.

3.6

Specifications

Raw material and finished product specifications for this site are limited to pears and apples of various US grade standards and packaging materials. The raw material specification was date 2013/7/13. There has been no change since. The list of packaging specification was also reviewed. Finished product specifications include those for specific customers which is made available to QC either in book form or written in their in-process sheet. The site was noted as adhering to regulatory and customer requirements.





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3.7

Corrective action

A documented procedure for handling and correcting failures identified in the food safety and quality system was reviewed. The Technical Department is responsible for managing corrective action. There is a log use to document failures identified. The log includes root cause analysis and was required to be verified to close. Corrective action reports for pest control issues, internal audits and previous BRC audits were reviewed.

3.8

Control of non-conforming product

During the senior management review meeting the site established a zero tolerance on non-conforming product. The policy and the list of non-conforming products were reviewed. Non-conforming products are tagged and sent to the sister plant for repack and regrading. During the resorting and grading process products are separated for sale, for juicing, canning or waste. The containers are tagged appropriately. The operations manager has responsibility over non-conforming products and the technical manager maintains the policy.

3.9

Traceability

The site is able to trace raw and packaging material through all stages of processing to shipping to the sister plant and to the final destination. Their computer system along with maintenance of appropriate records allows them to trace back to the block on the farm. A traceability exercise was conducted the day of the audit using the shipment out on August 27 2015. 194 bins of Bartlett Pears were pulled from storage for processing on August 27, 2015. Documentation indicates that a total of 4,098 cases were boxes. 3,364 boxes were shipped and 734 cases were still on hand. The breakdown showed the percent designated for 3rd grade, juicing, US Grade 1 and fancy. The detail info collected for the mock recall included lot number (1580203), grower, bins received in pounds, inventory transaction, shipped box report and customer list. 100% of the product was accounted for. To track packaging the company maintains a “Packaging Material Usage Log”. The Congdon traceability system is tested annually and includes a traceability test on raw materials, packaging materials, and finished product. The site conducted their trace on Bartlett Pears on 2015/8/25 and achieved a 100% recovery. Traceability is maintained on repacked items (rework).

3.10

Complaint handling

The plant trouble report is detailed on a policy titled Product/Customer Complaints last revised on 2015/7/18. Complaints are received and directed to the Marketing branch from the customers. It is logged and trended by types of complaints. Food safety related complaints are reported to the technical manager and handled on a timely fashion. There has not been a significant increase in any complaints. Complaints are reported to relevant staff during the monthly employee meetings.

3.11

Management of incidents, product withdrawal and product recall





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Incident Traceability for Recall dated 2015/7/26 details the management of incidents and product recall. It is led by the Technical Manager. A mock test of the recall system was conducted at least annually (August 25, 2015), with 100% reconciliation. The recall policy included the management team, with contact information for on- and off-site, detailed list of roles and responsibilities, external resources and recall steps. No recalls have occurred to date. The policy included notification to the CB within three working days.

3.12

Customer Focus and Communication

The site maintains a book of customer specifications for the QC inspections. Some of the specific customer requirements are listed on in-process sheets use during the inspections. Customer spec goes first to the marketing group and this info is related to the production team. The site demonstrated how they meet a specific customer requirement. Congdon must make sure they source from approved suppliers designated by the customer.

4.0

Site standards

4.1

External standards

The facility is located in the city of Yakima, Washington where the surrounding area is either commercial or orchard land. The external grounds were well maintained and designed to prevent contamination and enable safe production of food. The facility is composed of three primary buildings and a standalone maintenance shop in a trailer. There is a warehouse/ CA room building, warehouse/shipping dock/office building and a processing building. Within the warehouse segregated areas have been designed with refrigeration cool rooms for produce, dry storage for paper goods and packaging. Landscaping around the main entrance is well kept with rock/gravel around the back side of the building and asphalt paved roads into the facility and the parking lots (truck & employee car). The facility conducts a plant exterior cleaning/monitoring activity to ensure external areas do not present a food and quality safety risk.

4.2

Security

The facility has a documented and implemented assessment of the site security last revised 2015/07/26. The assessment of the site was conducted on 2015/08/27 to assess chemical, security, water, threats from staff, suspicious activities, health issues, visitors and more. The facility has controlled access to the building, chemical storage and maintenance area. It is federally registered with FDA under Bioterrorism Preparedness and Response Act. Employees are trained and encouraged during orientation to question any stranger walking the property. All employees carry the company issued identification card.

4.3

Layout, Product Flow and Segregation

Layout, Product Flow & Segregation Policy outlines the floor design and various areas within the warehouse area. Consideration to minimize risk of product contamination has been taken into account when designating the location of the repackaging tables. Physical barriers are in place, temperature control appropriate to the commodity's QC specifications.





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There is a logical product, personnel and activity flow. A series of site maps have been developed to outline the process. There are maps of zones, water route, travel route, waste, material (packaging/ingredients), personnel and other maps required by this standard. Visitors must log in in the office and report to the manager on site or call the Technical Manager. No temporary structures were observed. There are no high-care or high-risk areas within the warehouse/re-repack zones thus all areas are low risk.

4.4

Building fabric Raw material handling, preparation, processing, packing and storage areas

The facility is constructed of aluminum walls; no exterior windows are in the warehouse/ re-pack areas. Interior windows, offices within the warehouse, are shatter coated. The building walls and floor were in good condition except the floor in the segregation/finished product storage. There were trench drains and no pooling water was observed and waste water is discharged into the Yakima waste water system. There was no observation of condensation or dust. Overhead doors had strip curtains, when in use. There were no suspended ceilings. Overhead lighting units are either equipped with shields or shatter coated bulbs. There were large lights at the inspection belts. Floors are constructed of sealed concrete The location of the insect light traps did not pose a food safety issue and was fully protected from breakage. Adequate ventilation was provided. There were no high-care or high risk processing areas. All areas were identified as low risk.

4.5

Utilities – water, ice, air and other gases

Facility uses well water for handwashing, processing and cleaning of facility/equipment. A map of well lines was available. There were backflow preventers and check valves in place. Water test results were on file for microbiology and chemical testing. Water chemistry testing results were for front line valve, hand wash station and bathroom sink on 2015/8/19 and 2015/1/29 by a third party lab. A water distribution plan was available. Water was treated with automated chlorination system. Water was monitored daily by the Food Safety Assistant and tested by third party contractor monthly to ensure potable, as all water was required to be potable. No ice was used or made. There was no storage, holding or recycling of water and no steam was used in the process. Compressed air was used for cleaning and was filtered. The filter was changed annually by third party service provider.

4.6

Equipment

Equipment required for washing sorting and packaging of whole pears and apples included a bin dump lift, water flume, spray bars, sorting tables, dryers, conveyors, packaging tables and weighing scales. Equipment was observed to be well maintained, included on the sanitation schedule and sanitation verification swab program. Sanitation and verification records were examined at random for the month of August and September were found to be complete. A daily pre-op inspection and maintenance PM was performed on all equipment to ensure all was suitable for use. There are letters of guarantee for items such as brushes for food contact.





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4.7

Maintenance

Equipment Maintenance policy revised 2013/8/12 details the PM program and contains daily, weekly and monthly schedule. The equipment is inspected and serviced daily by the maintenance manager before production. In addition, production conducts a pre-operation daily. Results are located on forms such as Production Line Mechanic Clean-up log and Maintenance Lube Log. Temporary repairs are documented on a Temporary Repair Sheet and logged to track completion and to ensure timely resolution. Documented hygiene procedures are in place to ensure that tools, equipment, and maintenance materials are removed from the production line and returned to the shop at the completion of a job. The log for the week of 2015/08/24 was reviewed. Food grade lubricating oil were neatly stored, labelled and locked in the maintenance shop and were not found in production. The maintenance shop is located in a separate building/trailer, and is well kept and organized.

4.8

Staff facilities

Staff facilities were sufficient in number and maintained in good and clean condition. All employee that want lockers were provided one. The facility has two break rooms and toilet that open into a hall way. The breakroom is equipped for employee and reminds staff to wash hands. GMP stations are maintained at the entry points to the production building. GMP stations contain hair & beard nets, aprons and hand sanitizer dispensing units and gloves. Hand washing facilities are located just inside the production entrance. Hand washing stations are fitted with hands-free taps with appropriately hot and cold water, liquid soap, and single-use disposable paper towels. Signs are in place to remind employees to wash hands. Smoking is not allowed on site and the facility is low risk.

4.9

Chemical and physical product contamination conRaw material handling, preparation, processing, packing and storage areas

The facility has procedures to control chemical and physical contamination of raw material during storage, handling, preparation and packing. Chemical Policy last revised on 2015/8/31 and Glass and Brittle Plastics Control Policy revised 2015/8/3 cover this topic. There are facility inspections that help control these hazards such as the brittle glass audit, pre-op inspection, the wood policy and the employee GMPs.

4.9.1

Chemical control

Policy last revised on 8/31/15 covers chemical control. There are two list of chemicals one for production and another for maintenance. Usage for chemical list for production is monitored daily. SDS was requested for 4 chemicals and 3 were found.





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Strongly scented or taint-forming chemicals were not observed.

4.9.2

Metal control

The facility had conducted a metal hazard analysis. There are metal found in the belts and staples used as bin tags. A Knife and metal policy was revised on 2015/08/31 and periodic inspections are completed.

4.9.3

Glass, brittle plastic, ceramics and similar materials

A Glass and Brittle Plastics Control Policy revised 2015/8/31 has been implemented at the facility and includes weekly documented audits. Records were reviewed for week of August 17, and August 24, 2015. This work is conducted by maintenance and it contains a detail list, notification of management and inspection/release for any breakage.

4.9.4

Products packed into glass or other brittle containers

Products are not packed into glass or other brittle containers at this facility.

4.9.5

Wood

A Wood Control Policy has been implemented and includes visual monitoring of pallet conditions and monitoring of wood debris during GMP audits. Wood was evaluated as part of the HACCP Hazard Analysis. Incoming pallets are inspected by receiving personnel.

4.10.1

Foreign body detection and removal equipment

The facility does not have foreign body detection and removal equipment.

4.10.2

Filters and sieves

The facility does not have filters and sieves.

4.10.3

Metal detectors and X-ray equipment

Congdon had a foreign material control policy. The evaluation included a risk analysis for the use of metal detector. The risk to consumer was low thus they elected to not install a metal detector on the line. The facility does not cut products. They wash and package only.





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4.10.4

Magnets

The facility does not have magnets.

4.10.5

Optical sorting equipment

The facility does not have optical sorting equipment

4.10.6

Container cleanliness – glass jars, cans and other rigid containers

The site does not pack into glass, cans or other rigid containers.

4.11

Housekeeping and hygiene

The company has an in-house sanitation team that carry out the sanitation program. The documented program included a master sanitation schedule and detailed sanitation procedures for all equipment and included the requirements of the clause. Training of sanitation employees was through a "buddy" system. Cleaning tasks were documented on Daily or Weekly record. Chemical concentrations were checked and documented daily by CCP operator. This record was reviewed and found in range. Prior to building start-up in September, a Pre-Start Cleaning was performed. Cleaning of the storage rooms was recorded on the Cleaning and Fogging Log. House keeper cleans the rest rooms and the lunch room and their instruction is in both English and Spanish. Records for week of August 17, 2015 were reviewed. The Pre-op Inspection was conducted by Supervisor prior to start up visually. ATP testing was conducted weekly by Food Safety Assistants and a separate swab schedule included quarterly swabbing of food contact and non-food contact surfaces. Both testing methods had defined limits of acceptability.

4.11.7

Cleaning in place (CIP)

No CIP systems were used.

4.12

Waste/waste disposal

During the resorting and grading process products are separated for sale, for juicing, canning or waste. Waste & Disposal policy outlines Waste streams. The waste contract service provider is licensed by the city of Yakima. The waste collection areas were observed to be clean and well-maintained during this assessment. No waste accumulation was noted. The waste containers were





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appropriately labelled/covered and trash bin were not found overflowing.

4.13

Management of Surplus Food and Products for Animal Feed

During the resorting and grading process products are separated for sale, for juicing, canning or waste. Products for juicing and canning are sent off-site. The site noted that no food was designated for animal feed.

4.14

Pest control

Sprague is the pest control service provider for Congdon. The pest control program was reviewed on 2015/7/16. There are interior pest devices, external bait station and insect light traps that are inspected monthly and supplemented by trained internal inspector that monitor the interior traps. There are up to date PCO licenses (with Washington State Department of Agriculture) for both the operators and the company. The PCO received their GMP training on 2015/11/14. The folder contains signed maps (2015/01/09), usage log, targeted pest, SDS, service reports and more. There is a quarterly trending and the last trending was 2015/07/16. The bulb was last changed on 2015/05/16. A review of the service report revealed that applicable recommendations of the PCO were carried out. September, August and May service reports were reviewed. No evidence of past or current pest infestation was noted during this assessment.

4.15

Storage facilities

The facility has a warehouse manual that ensure the integrity of the products within the site. There are 10 CA rooms set at 30 F with electronic temperature recording devices. The other storage rooms are set at 34-36 degrees. They were calibrated on 2015/09/15 using ice water. Records reviewed for week of 2015/08/24 and 2015/01/09. The other 2 rooms are monitored 2 times daily manually. Temperatures were within range. Packaging materials that are stored outside are well covered and are inspected before they are taken inside for use. The storage facility was well kept and no boxes were found on the floor or in the 18” inspection path against the walls. All finished products are log into their warehouse management system and reports are run to pull the oldest product for sales. Raw materials are placed directly into CA storage before use. Products are refrigerated for quality.

4.16

Dispatch and transport

Transport and Delivery policy revised on 2013/8/15 covers dispatch and transport. All finished products were transfer on trucks at ambient temperature to the sister site for storage. Refrigeration is only for quality and the distance to the storage site is about 10 minutes. These trucks are owned by the company. Trucks condition is inspected and documented before loading. This form was review for the trace exercise and during the facility tour. Before transfer a pallet tag is placed on the pallet for traceability. Washing of truck was performed monthly and recorded on the Truck Wash log. Cleaning of forklifts was documented daily and recorded on the daily forklift record.

5.0

Product control





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5.1

Product design/development

Packaging policy revised 2015/8/15 outlines how packaging is managed. The company grades and packs fresh apples and pears. Changes in packaging are initiated by the marketing company. Email notification of new packaging type and specifications were forwarded to Technical Manager and added to the packaging binder after reviewing and approval. There was no new packaging introduced in the last year. Apple and pear nutrition fact sheets are on file. Labelling requirements for US and Canada were stated. Product shelf life is per industry standards and no trials are required.

5.2

Product Labelling

Labelling of Products of Incoming policy revised 2015/04/21 guides product labelling. Each QC station gets the pack-out schedule that would state the grade, conventional vs organic, name of the plant/orchard, variety, lot number, PLU and more. The in-line QC, finished product QC and shipping QC all inspect products to meet with the customer requirements and labelling. When there is change in labelling there are supervisors on each station to check info and relate changes to QC. Three boxes per pallets are checked to confirm with the labelling before products is shipped. No nutritional claims are made and the finished product types and formulation do not change.

5.3

Management of allergens

The allergen policy revised 2014/08/26 guides the allergen management. A documented risk analysis is found with the HACCP plan. There were no allergens used or stored on site. Employees were trained on proper hand washing procedures prior to returning to work from break. Allergen awareness training form part of the orientation training.

5.4

Product Authenticity, claims and chain of custody

The facility is certified (September, 2015) Organic through the WSDA- Washington State Department of Agriculture. Organic products are identified at all time from the orchard harvest to receiving, processing and finished product storage. Organic product is run prior to conventional non-organic product. Only organic pears are handled in this facility. The vulnerability assessment was conducted on 2015/08/27 and another on 2015/09/17 using the Product Authenticity Claim & Chain Custody policy dated 2015/09/06. The products are not identified as being at particular risk of adulteration or substitution as the organic identity is maintained throughout the operation.

5.5

Product Packaging

Packaging SOP revised 2015/8/15 guides the product packaging process. An up to date list was found on file titled Packaging Material Register 2015-2016. Continuing letters of guarantee were requested for three packaging materials found during the facility tour and they were all provided. Product liners are not used.





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5.6.1

Product inspection and testing

There are QC stations with different policies that outline the inspection and testing conducted at each station by the production team. Those include Receiving/Shipping QC (bin weights, bin tags, pressure, brix, size and more), in-line QC (defects, grade, brix, organoleptic, weights, codes, PLU, size, and more) and finished product QC (code, grade, size, pack types, PLU, barcode). Products are constantly pulled for inspection by the stations. The work is verified and reviewed by a member of the technical group. The company uses industry standard for shelf life.

5.6.2

Laboratory testing

Export Chemical Restriction policy revised 2015/4/9 covers testing for maximum residue level. Testing is conducted both for export and NOP. Every lot and variety (small growers are checked at random) is test for MRL and results are submitted to the Technical Manager for review. Results were reviewed and found in range. Other laboratory testing included quarterly environmental swabbing and monthly water testing, when in operation by external laboratory. All results were reviewed by Technical Manager. Lab results were on file and confirmed schedule. Pathogen testing was conducted by outside laboratory. Laboratory accreditation certificate were available for Cascade Analytical (2015/11/30). Accreditation included approved methods.

5.7

Product release

The Operations Manager verifies all processing parameters were in conformance to operating limits at the end of each production run. This was confirmed by examination of production records.

6.0

Process control

6.1

Controls of operations

The company demonstrated control over all operations in the packing facility. Process monitoring was documented through the following systems: • QC Receiving Inspection • Sorting/Grading/Cull inspection • QC In-line inspection • Net weight check • QC Finished Product Inspection • Lot changeovers Procedures were in place in the event that reagent levels were outside of critical limits; hold/release procedure would be initiated. In addition to the two CCPs monitored by the CCP station, other control points were monitored. The level of PAA (55- 80ppm) was monitored in the dump tank. The in-line QC was checking fruit pressure and brix hourly. Changeovers were documented by Supervisors and in-line QC. Records review was for August 10, 18 and 27, 2015.





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6.2

Labelling and Pack Control

Labelling and Packaging are monitored continually by the supervisors and at each QC station. There are documented policies for each QC stations. There is one production line with multiple products of different grades and labels/boxes. The boxes are stamped on line. Stamped boxes are verified for accuracy. The in-line label check include PLU verification, code, net weight, grade, size, barcode, box description, type of bottom, country of origin, customer specific requirement, conventional vs organic and more. Labels are checked against the production schedule at the beginning and continuously. When there is a change on the line it is documented on the changeover form, the old package is removed and communicated to the QC stations by the supervisors.

6.3

Quantity-weight, volume and number control

All products were packaged based on weight. Net weight checks were performed on each retail unit. Box weights were checked continually for net weight compliance by QC inspectors. All products were packaged and labelled as per customer and regulatory requirements. Product for sale in Canada included French requirements. Scales are verified daily by the QA team and calibrated by a third party annually.

6.4

Calibration and control of measuring and monitoring devices

Calibration and control of measuring & monitoring devices outlines the equipment within the facility that require calibration and states verification frequencies of these activities and the responsible party. The penetrometer, pH meter, refractometer and scales are checked daily internally for accuracy or calibrated. Records reviewed were for August 10, 18 and 27, 2015. The contract service provider for chemicals used in washing products calibrates the ORP system. The CA room thermometers are calibrated yearly. All records were on file.

7.0

Personnel

7.1

Training: raw material handling, preparation, processing, packing and storage areas

Congdon Packing has a well-documented, comprehensive and implemented training program that include GMPs, Personal hygiene, Food Safety, Chemical control, Allergen control awareness, HACCP, prevention of foreign matter contamination, QA/QC SOP training and other job specific training. The training policy was dated for 2013/8/21. An electronic training matrix divided into work areas is used to track training need of all employees in the different departments. New employees training include food safety, HACCP, GMPs, personal hygiene, allergens, and prevention of foreign matter contamination. Employees are trained on these topics during the first day of work when the season starts thus they may be trained up to three times during the year as they are rehired. Refresher training is conducted when a non-conformance is identified for an employee/s. Non-conformances can be identified during observations from management, process improvements and during record reviews. Training is conducted in English and Spanish. Competency is determined through observations by supervisors. An interview of the technician conducting CCP testing revealed that he is competent and knowledgeable on his duties. He was observed several times during the facility audit. All employees are considered temporary but all employees are trained by the Congdon





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Packing. Training records include the person training, date, topic, signature of attendee and the duration of training. Training records for two people picked at random during the facility tour was confirmed. From the metrics, training on Food defense was conducted on 2015/08/03, GMPs on 2015/08/11, Job instruction on Taiwan Inspection on 2015/08/12 and allergen on 2015/08/04.

7.2

Personal hygiene: raw material handling, preparation, processing, packing and storage areas

Food Safety Fundamental Personal Hygiene last revised 2015/9/13, a comprehensive policy of 43 pages was on file. A review of the policy revealed that it covers appropriate details as required by the BRC Standard clause 7.2. Employees are trained upon commencement of work. As a refresher the policy is reviewed yearly. Visitors and contractors sign the GMP policy. The facility does have blue coloured metal detectable plaster but does not have metal detectors in the plant. The GMP policy prohibits personal medicine in production areas and the warehouse.

7.3

Medical screening

Food Safety Fundamental Personal Hygiene last revised 2015/9/13, a comprehensive policy of 43 pages was on file. The policy reflects added emphasis in the code to outline cases where employees, visitors and contractor must communicate any potential food borne illnesses to management. The GMP Policy signed by visitors reminds visitors to disclose information on communicable diseases. Supervisors and other management monitor people for signs of communicable diseases and employees, visitors and contractors are required to communicate when they may be suffering from or have been in contact with an infectious disease. 911 is used when expert medical advice is required.

7.4

Protective clothing: employees or visitors to production areas

There are no high-care or high-risk areas in this facility. Protective clothing in sufficient number, issued to employees includes blue gloves, hairnets, bear nets and white disposable apron. Uniforms are provided to maintenance. The uniforms are cleaned by an approved vendor and documentation to the effectiveness of cleaning of the uniforms is on file. During orientation employees are made aware of protective clothing. Visitors and contractors are briefed through the visitor’s GMP Policy and by their escort. Adherence to the protective clothing is monitored by supervisors on the production floor and documented daily. During the site tour the employees were observed following the glove/apron policy and wearing slip-resistant footwear. Employees completely covered their hair.