Description

  • This inspection is solely for the use and improvement of Bento & Snowfox factories, in preparation for upcoming GMP audits. This inspection should be conducted at a minimum of 1 month away from a GMP audit to ensure there is enough time to implement corrective actions.

    The inspection is divided into sections and are scored accordingly. Scores will reveal the areas each factory needs to improve on, as well as provide trending for factories.

    • All corrective actions must be completed and/ or have target completion dates prior to scheduled audit.
    • This inspection will take several days to complete
    • A score of 95 indicates that the facility is prepared for the GMP audit

    Once the inspection is completed. Print the inspection report and review non-conformances.

HACCP

  • Does the company have a fully implemented and effective food safety plan based on Codex Alimentarius HACCP principles?

  • Principle 1 – Conduct hazard analysis. Please provide photos of hazards established from the HACCP plan.

  • Principle 2 – CCPs. Please provide photos of critical control points established from the HACCP plan.

  • Were appropriate methods used to determine CCPs (i.e. CCP Decision Tree)

  • Principle 3 – do CCPs have established appropriate critical limits? Please provide photos of critical limits established from the HACCP plan.

  • Principle 4 – Establish a system to monitor CCP. Please provide photos of each CCP's logs/forms.

  • Principle 5 – Establish what corrective actions will be taken if CCP is not in control. Please provide photos of corrective actions for each CCP from the HACCP plan.

  • Principle 6 – Establish procedures for verification to confirm that the HACCP is working effectively. Please provide photos of verification procedures established from the HACCP plan.

  • Principle 7 – Documentation concerning all procedure and records appropriate to the principles and their application. Please provide photos.

  • Does at least one member on-site of the food safety team have HACCP training?

  • Please provide photo/s of a valid certificate obtained no longer than 5 years

  • Does the facility have a food safety team established?

  • Are there descriptions and the intended use of the food products being manufactured readily available?

  • Does the facility have a process flow diagram readily available?

  • Interview and observe CCP operators. Are they aware of their role/ responsibility within that CCP? Are they aware of monitoring and corrective action procedures for that certain CCP?

Facility (Building Conditions) & Grounds

Exterior

  • Is the building’s exterior ground and roadway constructed of material that will not cause contamination? (water pooling, big potholes)

  • Surrounding facilities do not pose a risk to ours? (Do they keep their areas tidy, organized, and clean)

  • Does the facility have a designated smoking area?

  • Is there a cigarette receptacle available?

  • Is there proper signage posted?

  • Does the facility have a schedule in place for cleaning the outside perimeters of the building?

  • Is the schedule available, completed and up-to date?

  • Are all doors, windows, and other openings protected against the entry of pests? Check for any openings larger than a dime size. See if there is any light shining through seals.

  • Snapshot of any openings found

  • Is greenery surrounding the facility controlled? Is there regular landscaping scheduled? (grass and weeds trimmed, bushes trimmed) If no is selected; advise plant manager to schedule landscaping

  • Are exterior waste containers kept covered when not in use?

  • Is exterior loading dock & exterior receiving area free of debris and spills?

  • Are bumpers and levelers at the receiving/ loading dock in good repair?

Interior

  • Are handwashing sinks properly located in the facility? (Located upon entry)

  • Are sealants for freezer and cooler doors in good condition? Good condition: no cracks in the caulking, no missing pieces of caulking, no molded caulking (pink or black growth). Include a snapshot of the sealant and specify where it was taken in the notes

  • Are freezer and cooler door curtains in good and cleanable conditions. (No tears, missing pieces, paint residue on them, glue residue, deep scratches etc). Include snapshot of curtains in bad condition and specify the area in the notes section.

Rust

  • Is there any rust observed in the facility?

  • Select yes if rust is found on any of the following. Include a snapshot of rusted area and specify where it was taken in the notes.

  • Freezer and Cool Door Frames

  • Screws, nuts, and bolts

  • Inside cooler and freezer walls

  • Other

  • Are there any missing bolts, screws observed anywhere in the facility?

  • Have they been located?

  • Is there peeling paint or paint chippings observed on walls, and/or ceilings?

  • Include snapshots of peeling paint & paint chippings. List the location in notes or directly on the photo.

  • Is there sufficient light in every room in the facility? Refer to previous months SOP 11-b Internal Plant Audit

  • Are there any lights that are burnt out and need to be replaced in the facility?

  • List the location of lights that are out and/or need to be replaced. Include snapshots if necessary. Forward to plant manager.

  • Are floors in good condition? (Check for any raised flooring, chipped flooring, water pooling beneath flooring)

  • Take a snapshot of floors that are in bad condition. List the location in the notes or directly on the photo.

  • Are floors made of material that is easily cleaned?

  • Are floors designed in a way that allow water to easily flow into a drain?

  • Is water pooling observed within the facility? If yes, include a snapshot and the list the location in the notes section.

  • Are ceilings, and ceiling tiles in good condition?

  • Are walls made of material that can be easily cleaned?

  • Are water leaks observed? Check hoses, beneath sinks, dishwasher, rice washer, check for water pooling

  • Are any roof leaks observed? Are proper measures taken to ensure food is not contaminated by roof leak

  • If a leak is observed is there a work order in place?

  • Does the processing facility have sufficient ventilation to reduce steam and condensation?

  • Does the facility preform a monthly audit that evaluates interior and exterior conditions?

  • Are inspections and corrective actions up to date?

Personnel

Employees

  • Are all employees trained on proper cGMPs?

  • Does the facility have a hygiene requirement program that includes clothing, hair restraints, jewelry, and illnesses?

  • Are signages posted somewhere in the facility?

  • Do employees know how to wear hair restraints (hairnets) properly? Covering ears and all hair.

  • Are employees wearing beard nets properly? Covering the entire bottom half of the face.

  • Are employees washing hands prior to donning gloves?

  • Are employees following proper hand wash procedures (water, soap, lather for 20sec, rinse)

  • Are employee glove stations (or glove boxes) maintained and in clean condition?

  • If glove boxes are dirty and contaminated they should be removed & discarded. Plant managers and supervisors need to remind employees to keep glove stations clean.

Visitors

  • Are visitors made aware of the hygiene requirements prior to entering the processing plant?

  • Do visitors follow the proper hand wash procedures?

Employee Common Area and Uniform

  • Personal lockers are to be free from food, processing area utensils, and dirty ppe (such as dirty cutting gloves, or dirty metal detector gloves)

  • Check personal lockers

  • Do employees know not to keep food in their lockers or changeroom?

  • Are there signages that state no food is allowed in lockers or change rooms posted?

  • Create and post signages that state no food is allowed in lockers or change rooms

  • Are there allergen alert signages posted in lunchrooms and common areas?

  • Create and post signs that clearly identify allergens (Include translations if necessary)

  • Are lunchrooms floors in clean conditions? (check corners, behind doors, behind fridge)

  • Is the lunchroom sink and counter in clean conditions?

  • Are the paper towel and soap dispensers fully equipped?

  • Are employee uniforms (lab coats) stored in a segregated area and in a way that prevents contamination?

  • Are there sufficient uniforms (lab coats) for everyone to change into if they were to get dirty?

Equipment & Utensils

  • Is there a checklist to control any glass/plastic brittle equipment’s or items in the facility? (Check: Covers for thermostats, covers for alarms, electrical panel cover, etc.)

  • Are the non food-contact surfaces (NFCS) of equipment used in food handling made of materials that can be easily cleaned? (Are NFCS made of stainless steel, non corrosive steel, cleanable materials?) If the NFCS of equipment is not made of appropriate material list the equipment in notes.

  • Include a snapshot of the NFCS of equipment that is not made of appropriate material

  • Are the food-contact surfaces (FCS) of equipment besides Sushi Robot, Crab Mixer, Nigiri Machine, Rice Sheeter easily cleanable and are in good condition? Check for rust and/or deep gashes. Include a snapshot of the equipment.

  • Examine each table used in the facility. Are tables free of rust and uncleanable deep gashes? In the notes specify the table # that had rust and deep gashes.

  • Include snapshots of tables that are not in good condition. List their location and table # (if they are numbered)

  • Are cleaning equipment stored in a way that prevents contamination? (i.e: mops hung to dry, hanging into drip tray)

  • Include snapshots of cleaning equipments not being stored properly

  • Are there standard cleaning procedures for when products / equipment are broken?

  • Select equipment that is present at your facility and inspect them for cleanliness and condition. Include photos of equipment that is not compliant.

  • Crab Mixer

  • Inside of crab mixer

  • Controls (Buttons, Electrical cord, Switches)

  • Outer part of crab mixer

  • Rice Sheeter

  • Controls (Buttons, Electrical cord, Switches)

  • Rice Dispenser & Rice Sheeter

  • Rolling pins, strong shafts, etc

  • Underneath

  • Other

  • Shimadzu (Sushi Robot)

  • NFCS

  • Controls (Buttons, Switches, Control Panel, Electrical Panel, Electrical cord)

  • Rice Dispenser

  • Meat Dispenser

  • Rolling pins (small, large, all sizes of the white rolling pins)

  • Other

  • Nigiri Machine

  • Controls (Buttons, Switches, Electrical Cord, Screen)

  • Rice Dispenser & pieces

  • Nigiri pieces and holder

  • Metal Detector

  • Controls (Buttons, Switches, Electrical Cord, Screen)

  • Belt

  • Other

  • Labeller

  • Controls (Buttons, Switches, Electrical Cord, Screen)

  • Belt

  • Other

  • Inspect the pH meter/s in the facility. Is it in good condition and working as intended?

  • If the pH meter is not working properly as well as not in good condition. Remove and replace the meter with a new one.

  • Are pH buffers for calibration available and near the area of testing?

  • Check the expiry date. Are the pH buffers valid and within the expiration date?

  • Remove and Replace expired buffers with new ones.

  • Are there unopened buffers readily available?

  • Order more pH buffer from the warehouse. Always make sure to have a backup bottle.

Pest Control Program

  • Are all pest traps in good condition? In the notes, specify which traps are not in good condition – if any.

  • Does the facility have an up-to-date pest trap map that shows where all glue traps, and pest traps should be located?

  • Does the facility have a pest control program established and implemented at the facility?

  • Scope of service (includes frequency of visits and target pests)

  • License and insurance for contracted company

  • License and/or training for personnel responsible for prevention tasks

  • Is an accurate pest trap map that shows the location of all permanent and temporary pest traps readily available?

  • Are SDS for pest control chemicals used in the facility available?

  • Are pest control inspection reports available?

  • Are all recommendations from the Pest Control Company closed?

  • Is there a pest trap present in every location listed on the map?

  • Include a snapshot of location that is missing a trap. Record the pest trap number.

  • Is there any evidence of pest activity within the facility?

  • Are all exterior traps in good condition?

  • Are they located according to the pest trap map?

  • Do all possible entrances to the facility have pest traps?

Processes & Controls

  • Are reasonable precautions taken to ensure that production is protected from contamination of any sort?

  • How is the pH of acidified rice being verified?

  • Does the facility have a hold and release program?

Allergens

  • Does the facility have an allergen management program established? Program should include signs posted around the facility as well as a verification of incoming material ingredients

  • Is there proper signage?

  • Are allergens clearly identified?

  • Are equipment colour coded?

  • Are allergens properly segregated when stored?

  • Are there effective methods established when there is an allergen change-over?

  • Are allergens being identified and segregated in all stages of processing? If there are signs please create and post signs to clearly identify allergens. Implement corrective actions to segregate allergens

  • Does the facility have methods in place for verifying that change-over processes have been followed for allergen to non-allergen?

  • Ask a random employee for the allergens found in the facility. Do employees have knowledge of which ingredients contain allergens and which do not? If employee is not aware of the allergens present in the facility record their name in the notes and schedule an SOP 8: Allergen training

  • Which allergens are present within the facility?

Chemicals & Chemical Storage

  • Are all chemicals being used for their intended use?

  • Where and how were chemicals not being used for their intended use?

  • Do all chemicals spray bottles and buckets have manufacturer labels added onto them?

  • Add a manufacturer label to all unlabelled bottles and buckets. Contact Ecolab technician for labels if none are available

  • Are chemicals being stored in a First-In-First-Out (FIFO) manner? (This is to ensure chemicals are used before expiry)

  • Are chemical concentrations verified prior to usage?

  • Are chemical testing strips present in all appropriate areas where there are chemical dispensers?

  • Check the expiration date on the chemical testing strips. Are the chemical testing strips expired or not expired?

  • Discard and replace expired test strips

  • Are chemical testing strips opened and in-use?

  • If chemical test strips are present but not opened. Speak to the person responsible for verifying chemical concentrations

Cleaning & Sanitation

  • Does the company have and follow a master cleaning schedule? Is it readily available?

  • Refer to SSOP binder. Do SSOPs include all areas, equipment, and frequency of cleaning?

  • Are sanitation activities performed by trained and designated personnel only?

  • Are there sanitation schedules in place for items and areas that cannot be cleaned on the daily basis?

  • Are there cleanliness verification procedures in place?

  • Are there records of cleaning verification procedures (ATP log)

  • Are cleaning utensils colour coded?

  • Is there signage describing the colour codes? If there are no signs that indicate colour coding schemes please create and post signs.

  • Are cleaning utensils segregated from each other? For instance, table squeegees separate from brushes. If cleaning equipment is not being properly stored properly, cleaning staff and/or sanitation staff need to be reminded and re-trained on proper cleaning utensil storage

  • Are foot baths present at every entry into the processing plant?

  • Are foot baths in good condition? (Check for leaks and tears)

  • If foot bath is in bad condition, order and replace with a new one

  • Are garbage cans clean and in good condition?

  • Replace damaged & bad condition garbage cans

  • Are areas prone to collect moisture free of condensation? (rice cooking room, entrance of coolers, cooler curtains, by warehouse area entering the processing area, where temperature changes occur)

  • List the areas that are not free of condensation.

  • Include a snapshot of areas that have condensation.

Receiving & Shipping

Receiver Checklist

  • Observe the receiver during receiving process. Do receivers check the shipping truck for the following, before unloading?

  • Cleanliness

  • Truck temperature either 4°C or -18°C

  • Is there a thermostat in the vehicle?

  • Integrity of truck (are there holes, pest activity, spillage)

Multiple Choice Questions for Receiver

  • Conduct a short interview with the facility receiver. Ask the receiver the following multiple choice questions and input their answers.

  • Maximum time products are permitted to stay in the shipping area?

  • Temperature of refrigerated products

  • Temperature of frozen products

  • Are COAs required for raw materials upon receiving?

  • Is there a protocol in place when COAs are not available upon receipt?

  • Is there any documentation that shows COAs have been reviewed?

  • Are there protocols in place for incoming damaged material?

  • Is the receiving and shipping area in clean conditions?

Food Defense

  • Does the facility have controls in place for intentional adulteration of foods

  • Does the facility have documented controls for food defense?

  • Are doors secured and monitored to prevent or control unauthorized entry?

  • Are entrances and processing areas equipped with surveillance cameras?

Documentation

  • Review the following Documentation for the past 3 months with the Document Control as a guide. When reviewing documentation verify that all forms and inspections are:
    • All located
    • Contain the correct & appropriate information
    • Have corrective actions for non-compliances
    • Have all signatures

Cleaning and Sanitation

Pre-operational Checklist

  • Is this inspection currently being conducted at your factory?

  • Is there are an inspection for each day?

  • Dates of missing inspections

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all corrective actions have signatures and have they been implemented?

Chemical Usage Verification

  • Are chemical concentrations being checked, verified, and recorded?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Sanitation Task Logs (Daily/Weekly/Monthly)

  • Are these forms currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

SOP 2-1c: Washroom Cleaning Log

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

Special Cleaning Log

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Post Operational Checklist

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Pest Control

Internal Pest Trap Inspection Log

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4

SOP 4-1a: Cooked Rice Quality & Safety Control – pH (CCP1)

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-1b: WIP Time & Temperature Control (CCP6)

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-1c: WIP Time & Temperature Control (CCP5)-Bowls

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-2: Finished Product Temperature Control (CCP4)

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-3: WIP & Production Log

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-4: Seafood Thawing Control (CCP2)

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-5a: In Process Weight Control

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-5b: Finished Product Weight Control

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-5c: Blade verification

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

SOP 4-6: Labelling Control (CCP3)

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Ordering, Receiving, Shipping

Material Receiving Log

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Label Receiving Log

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Delivery Van Maintenance

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Daily Delivery Log

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Third-Party Transportation Log

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Equipments

Weekly Equipment Calibration Record – Thermometers

  • Is this form/inspection currently used at your factory?

  • Is there are an inspection for each week?

  • Dates of missing inspections

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all corrective actions have signatures and have they been implemented?

Weekly Equipment Calibration Record – Balances/Scales

  • Is this form/ inspection currently used at your factory?

  • Is there are an inspection for each week?

  • Dates of missing inspections

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all corrective actions have signatures and have they been implemented?

Daily Equipment Calibration Record – Metal Detector

  • Is this form/ inspection currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Glass and Brittle Plastic Registry (Weekly)

  • Is this form currently used at your factory?

  • Is there are an inspection for each week?

  • Dates of missing inspections

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all corrective actions have signatures and have they been implemented

SOP 6-5b – Glass and Brittle Plastic Registry (Monthly)

  • Is this form currently used at your factory?

  • Is there are an inspection for each month?

  • Dates of missing inspections

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all corrective actions have signatures and have they been implemented?

Labelling

Date Coding Control

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Ingredient Label Verification

  • Is this form currently used at your factory?

  • Is there are an inspection for each month?

  • Dates of missing inspections

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all corrective actions have signatures and have they been implemented?

Documentation & Internal Plant Auditing

Internal Plant Audit for Manufacturing Facilities

  • Is this form/inspection currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

  • Do all non-compliances have CAPs?

  • Which non-compliances need CAPs (date & non-compliance)

Corrective Action Plan

  • Is this form currently used at your factory?

  • Are all forms available?

  • Which dates are missing?

  • Are all inspections completed and verified (Digital and/or Paper)?

Steritech

Steritech Portal

  • Are all corrective actions closed?

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