FSMS Gap Assessment

• Document No.

• Audit Title

• Conducted on

  Date

• Auditor

• Auditee

• Location Site Name

• Location
  Address

• Auditor sign upon completion

  Sign

Design, Construction & Maintenance

• Floors, walls, ceilings, doors and windows materials are smooth, cleanable, impervious, durable, suitable, clean and in good repair

  Yes

  No

  N/A

• Floors, walls, ceilings, doors and window materials are suitable for food manufacturing premises

  Yes

  No

  N/A

• Overhead walk ways are shielded underneath

  Yes

  No

  N/A

• Product flow / employee traffic patterns are designed to prevent cross contamination

  Yes

  No

  N/A

• Plant schematic showing product and employee flow is available

  Yes

  No

  N/A

• Floors are slopped to trapped drains

  Yes

  No

  N/A

• Premises are connected to sewerage system, sewerage pipes do not pass over or through production

  Yes

  No

  N/A

• Sufficient, leak-proof, labeled waste storage containers available within plant, located to prevent cross contamination. Waste removal at least daily.

  Yes

  No

  N/A

• Air filters present are cleaned or replaced as per maintenance schedule

  Yes

  No

  N/A

• Ventilation is adequate to prevent accumulations of dust, condensation, steam and to remove contaminated air

  Yes

  No

  N/A

• Air used as a processing technique is sourced (intake) and treated (filtered) to reduce sources of contamination

  Yes

  No

  N/A

• SOP and records for checking, cleaning and replacing air filters and for checking air flow and duct cleaning are available

  Yes

  No

  N/A

• Equipment cleaning area is located (and / or cleaning is scheduled) so as to prevent contamination of product and packaging.

  Yes

  No

  N/A

• Drainage in cleaning rooms is adequate

  Yes

  No

  N/A

• Documented SOP and corrective action protocol / records for building inspections is available for review

  Yes

  No

  N/A

Sanitary Facilities

• Sufficient numbers of hand washing stations, conveniently located in processing areas, wash rooms and elsewhere as needed

  Yes

  No

  N/A

• Hand washing stations have hot and cold water, soap dispenser, paper towel or air dryers, waste receptacle, plus sanitizer if required

  Yes

  No

  N/A

• Wash rooms, lunch rooms and changing rooms are well maintained

  Yes

  No

  N/A

• Taps are hands free

  Yes

  No

  N/A

• Hand washing signs are posted

  Yes

  No

  N/A

• Wash rooms are adequately ventilated and do not open directly into processing areas

  Yes

  No

  N/A

• Boot dips are available at entry point to processing areas

  Yes

  No

  N/A

• Lunch rooms and changing rooms are adequately ventilated and do not open directly into processing areas

  Yes

  No

  N/A

• Documented SOP / corrective actions / protocols / records for checking wash room / hand wash / sanitizer / facilities for cleanliness, supplies and sanitizer levels

  Yes

  No

  N/A

Lighting

• Adequate lighting intensity for safety and inspections

  Yes

  No

  N/A

• Lights / windows are adequately shielded against breakages

  Yes

  No

  N/A

General Environment

• Building is not in close proximity to environmental contaminants

  Yes

  No

  N/A

• Surrounding grounds / driveways are free of garbage and debris

  Yes

  No

  N/A

• Surrounding grounds are free of rodent harborage (e.g. overgrown areas / disused items)

  Yes

  No

  N/A

• Sufficient leak proof, covered garbage disposal bins are available

  Yes

  No

  N/A

• Surrounding grounds are adequately drained to prevent pooling of water and or water entry into the building

  Yes

  No

  N/A

General Design, Construction & Maintenance

• Building exterior designed and maintained to prevent entry of pests. Door and windows are screened

  Yes

  No

  N/A

• Air intake is appropriately located and screened against pest entry

  Yes

  No

  N/A

• Roof, walls, doors, windows and foundations are maintained to prevent water leakage

  Yes

  No

  N/A

• Adequate exterior lighting

  Yes

  No

  N/A

• Access doors are designed to prevent unauthorized entry (e.g. self closing, locking)

  Yes

  No

  N/A

• Documented SOP, corrective action protocol, records for exterior building inspections

  Yes

  No

  N/A

• Documented security program in place

  Yes

  No

  N/A

Water, Ice & Steam

• Water quality SOP in place

  Yes

  No

  N/A

• Water, ice and steam are analyzed at a frequency adequate for confirming potability

  Yes

  No

  N/A

• All required permits / approvals are in place

  Yes

  No

  N/A

• Non-Municipal water supplies are treated and tested to ensure potability

  Yes

  No

  N/A

• Water storage facilities are treated and monitored

  Yes

  No

  N/A

• Documented water treatment and testing SOP for non-municipal water supplies. Records include water source sampling, analytical results, analyst and date

  Yes

  No

  N/A

• Documented SOP, corrective action protocol, and records for recirculated water system treatment and testing

  Yes

  No

  N/A

• Documented SOP, corrective action protocol and records for water storage facility treatment and testing

  Yes

  No

  N/A

• Hoses and taps have back flow prevention devices

  Yes

  No

  N/A

• Water pressure / temperature and volume is adequate for all uses

  Yes

  No

  N/A

• If bottling water, access to water source is adequately p[protected

  Yes

  No

  N/A

Incoming Materials

• Incoming food, non-food items, packaging received in area separate from processing area

  Yes

  No

  N/A

• Carriers are inspected for cleanliness, temperature and suitability for food

  Yes

  No

  N/A

• Incoming materials are inspected to ensure they meet specifications: Approved supplier, letter of guarantee, certificate of analysis, master list of ingredients, suppliers available

  Yes

  No

  N/A

• Incoming materials inspected for condition and temperature

  Yes

  No

  N/A

• Receiving temperature log is maintained

  Yes

  No

  N/A

• Lot numbers of ingredients is recorded

  Yes

  No

  N/A

• Allergens are clearly identified

  Yes

  No

  N/A

• Guidelines for rejections are available

  Yes

  No

  N/A

• SOP are in place for cleaning & sanitizing carriers especially bulk tankers

  Yes

  No

  N/A

• SOP for receiving is in place

  Yes

  No

  N/A

• SOP (and records) for returning rejected shipments and how returnable items should be identified

  Yes

  No

  N/A

• Incoming materials are handled to prevent damages or cross contamination

  Yes

  No

  N/A

Storage of Incoming materials and finished products

• Refrigerated storage <4C

  Yes

  No

  N/A

• Frozen storage <18C

  Yes

  No

  N/A

• Chemicals are handled separately from foods to prevent cross contamination and stored in a clearly identified area

  Yes

  No

  N/A

• Allergens are stored separately in clearly identified areas or containers

  Yes

  No

  N/A

• Returns, defective, suspect product is clearly identified and isolated in designated area

  Yes

  No

  N/A

• Stock rotation practiced (incoming and finished product) and there is a documented SOP in place

  Yes

  No

  N/A

• All food is stored off the floor and away from the walls

  Yes

  No

  N/A

Finished Product Control

• Carrier is inspected for cleanliness, temperature, suitability for food

  Yes

  No

  N/A

• Outgoing product is checked for condition and temperature

  Yes

  No

  N/A

Allergen Identification

• Allergen containing raw materials are identified at receiving and marked

  Yes

  No

  N/A

• Colour coded utensils are used for allergens

  Yes

  No

  N/A

• Master list of products / ingredients in each / allergens in each is available

  Yes

  No

  N/A

• Allergen control SOP is in place for transport, receiving, storage and shipping

  Yes

  No

  N/A

• List of allergens is available

  Yes

  No

  N/A

Allergen Production Control

• Allergen control SOP in place for production

  Yes

  No

  N/A

• Sanitation SOP address risk of allergen cross contamination

  Yes

  No

  N/A

• Production sequencing in place to prevent allergen cross contamination

  Yes

  No

  N/A

• Rework SOP in place to prevent allergen cross contamination

  Yes

  No

  N/A

• SOP for staff allergen control training

  Yes

  No

  N/A

Product Labeling & Packaging

• Product labeling meets local requirements

  Yes

  No

  N/A

• All possible allergens in product are declared on the label

  Yes

  No

  N/A

• Documented SOP in place to prevent mislabeling

  Yes

  No

  N/A

• Documented procedure in place to review and update labels

  Yes

  No

  N/A

Supplier Quality Assurance Program

• Letters of guarantee (or certificates of analysis) are available for all incoming materials

  Yes

  No

  N/A

• Supplier approval process is in practice

  Yes

  No

  N/A

Approved Supplier Records

• List of approved suppliers is available

  Yes

  No

  N/A

• Master list of ingredients is available with specification sheets for each

  Yes

  No

  N/A

Product Specifications

• Product specifications are available indicating ingredients and sub-ingredients

  Yes

  No

  N/A

• Product specifications are monitored through evaluation of product

  Yes

  No

  N/A

Equipment Design & Installation

• All equipment is food grade presenting no hazard to product

  Yes

  No

  N/A

• Equipment is designed to ensure clean ability

  Yes

  No

  N/A

• Equipment is accessible for cleaning

  Yes

  No

  N/A

• Equipment allows for proper drainage

  Yes

  No

  N/A

• Where needed equipment is directly exhausted to the outside to prevent accumulations of condensation

  Yes

  No

  N/A

• Equipment specifications are available

  Yes

  No

  N/A

Food Contact Surfaces

• Food contact surfaces are smooth, non-corrosive, non-absorbent, non-toxic, free from chips, cracks, crevices and pitting

  Yes

  No

  N/A

• Utensils used for food, for allergens, for non-edibles are clearly identified by colour coding

  Yes

  No

  N/A

• Chemicals, paints or lubricants used on food contact surfaces are food grade

  Yes

  No

  N/A

Equipment Maintenance & Calibration

• Documented preventative maintenance schedule is available and includes lists of equipment, maintenance procedures and frequency of checks

  Yes

  No

  N/A

• Maintenance schedule is followed

  Yes

  No

  N/A

• Maintenance records are complete

  Yes

  No

  N/A

• Working calibration equipment is available and / or off-site calibration is available

  Yes

  No

  N/A

• Documented, validated calibration SOP is place especially for critical monitoring equipment

  Yes

  No

  N/A

• Calibration records are complete and current

  Yes

  No

  N/A

• Repair program is in place including names and contact numbers of repair personnel or company

  Yes

  No

  N/A

In House Hygiene Policy

• Written hygiene policy includes:

  Yes

  No

  N/A

• Hand washing technique

• Proper use of disposable gloves

• Correct way to wear hair restraints

• Removal of Jewelry

• Correct way to wear uniform

• No personal items

• No eating / chewing / drinking in food production area

• Documented illness and injury policy includes:

  Yes

  No

  N/A

• Not working with food if suffering from or carrying infectious disease

• Cuts shall be covered completely with a water proof covering

• Employees shall advise management if they have a disease communicable through food

• There is an SOP for hand washing available

  Yes

  No

  N/A

Visitor Food Safety & Hygiene

• Visitor food safety & hygiene policy is posted

  Yes

  No

  N/A

• Visitor policy includes:

  Yes

  No

  N/A

• Sign in and wear ID

• Wear protective clothing when applicable (i.e. hair restraint, coverall, boots, safety gear)

• How access is controlled and limited to relevant areas only

Food Safety & Hygiene Training

• A documented training program for food safety and hygiene includes:

  Yes

  No

  N/A

• Skills and knowledge objectives

• Importance of food safety & hygiene

• Training methods and materials include professional training if required

• Skills knowledge is evaluated and updated frequently

  Yes

  No

  N/A

• Hygiene training records are on file

  Yes

  No

  N/A

• Training program is reviewed at set intervals and updated as needed

  Yes

  No

  N/A

Technical Training

• Documented training program for technical skills (critical processes and operation of equipment, monitoring, sanitation, calibration, maintenance, general plant knowledge) includes:

  Yes

  No

  N/A

• Skills & knowledge objectives

• Importance of task

• Detailed SOP for tasks

• Critical Limits, monitoring procedures, corrective actions, record keeping and verification for CCPs and monitoring SOPs

• Training methods and materials include professional training when required

  Yes

  No

  N/A

• Skills and knowledge are evaluated and updated

  Yes

  No

  N/A

• Technical training records are on file

  Yes

  No

  N/A

• Training program is reviewed at set intervals and updated as needed

  Yes

  No

  N/A

• Comprehensive training program for all employees

  Yes

  No

  N/A

Sanitation Program

• Master cleaning schedule is available and includes in-process, daily, weekly, monthly, annual and periodic cleaning tasks and projects

  Yes

  No

  N/A

• Documented SOP is available for all tasks and areas relevant to food safety

  Yes

  No

  N/A

• Documented SOP includes chemicals, concentration required, water temperature / pressure and contact time

  Yes

  No

  N/A

• Chemical dilutions are controlled

  Yes

  No

  N/A

• Premises are in a sanitary condition

  Yes

  No

  N/A

• Pre-operational and in-process sanitation checks / inspections are made to verify cleaning

  Yes

  No

  N/A

• Routine verification monitoring (observation or micro testing) is done

  Yes

  No

  N/A

• Sign-off sheets are available for cleaning / monitoring / verification of sanitation tasks

  Yes

  No

  N/A

Pest Control Program

• A documented pest control program includes:

  Yes

  No

  N/A

• Name of persons responsible for pest control

• Name and contact information of pest control company on the contract licence

• Description of the pest control measures taken on the premises

• List of chemicals used, MSDS, import licences (where necessary) concentrations, locations where applied, method and frequency of application

• Schematic map showing the location of pest control devices

• Monitoring of pest control devices (person responsible and frequency)

• Use of poison bait is prohibited inside the facility

• No evidence of pest activity in premises

  Yes

  No

  N/A

• Only approved pest control chemicals are used

  Yes

  No

  N/A

• Service reports are on file and detail what was done, what chemicals were used, and any corrective actions taken or required

  Yes

  No

  N/A

Complaint Handling

• Customer complaints are documented and investigated using root cause analysis

  Yes

  No

  N/A

• Records are maintained regarding follow up and corrective actions taken

  Yes

  No

  N/A

• Documented SOP for handling complaints is available

  Yes

  No

  N/A

• Customer complaint form is available for customers

  Yes

  No

  N/A

Recall System

• Key persons are responsible for recall and their roles

  Yes

  No

  N/A

• Master plan of ingredients and supplier contact information is available

  Yes

  No

  N/A

• Master list of finished products and customer contact information is available

  Yes

  No

  N/A

• Documented methods to identify, locate and control recalled product (finished product and recalled raw materials)

  Yes

  No

  N/A

• Ingredient traceability is through lot numbers or codes

  Yes

  No

  N/A

• Finished product traceability is through lot numbers or codes

  Yes

  No

  N/A

• Mock recalls are performed and documented for finished product recall

  Yes

  No

  N/A

• Mock recall is performed and documented for raw material recall

  Yes

  No

  N/A

• Corrective actions regarding recalls are documented

  Yes

  No

  N/A

• Records of production, inventory and distribution by lot are available

  Yes

  No

  N/A

• Codes identify establishment, day, month and year of production

  Yes

  No

  N/A

• If packing for private label owners, lot ID allows for distinguishing each private label product

  Yes

  No

  N/A

• Codes used and their meaning is available

  Yes

  No

  N/A

Recall Notification

• Names and contacts for those who are required to be notified in the event of a recall are available

  Yes

  No

  N/A

• Amount of affected product produced (inventory and distributed)

  Yes

  No

  N/A

• Product name, size, code or lot numbers of affected product are recorded

  Yes

  No

  N/A

• HACCP Team in place

  Yes

  No

  N/A

• Written commitment from management regarding PRP and HACCP program

  Yes

  No

  N/A

• HACCP Team leader is adequately trained

  Yes

  No

  N/A

• HACCP team members responsibilities are delegated in the SOP

  Yes

  No

  N/A

• Product back ground form is completed for each product group or process

  Yes

  No

  N/A

• For each product a list of ingredients with sources / suppliers identified for each and all allergens associated with product are identified

  Yes

  No

  N/A

• For each process a plant schematic showing all equipment, product flow and employee flow is available

  Yes

  No

  N/A

• For each process a process flow diagram is completed

  Yes

  No

  N/A

• Hazard Analysis work sheet is completed for each product group / each process

  Yes

  No

  N/A

• For each process all BCP hazards are identified and described for each process step, including cross contamination and equipment hazards

  Yes

  No

  N/A

• Risk analysis (severity of risk) is done as part of the hazard analysis

  Yes

  No

  N/A

• Control, measures are identified for each hazard

  Yes

  No

  N/A

Control Points

• CCPs are identified

  Yes

  No

  N/A

• For each identified hazard a determination is made as to whether it is fully controlled by a PRP or a CCP

  Yes

  No

  N/A

• A CCP decision tree is used to justify

  Yes

  No

  N/A

• Critical Limits are identified for each CCP

  Yes

  No

  N/A

• Reliable sources / data / expertise used to determine critical limits, i.e. validation by HACCP team. Sources are documented

  Yes

  No

  N/A

• CLs state specifically what standard must be met at the CCP

  Yes

  No

  N/A

• CLs can be accurately and consistently observed and measured

  Yes

  No

  N/A

• Monitoring procedures are identified for each CCP

  Yes

  No

  N/A

• Monitoring procedures are defined in the SOP and include equipment used, frequency, persons responsible and records

  Yes

  No

  N/A

• Monitoring method, equipment validated by HACCP team

  Yes

  No

  N/A

Record for Control of Operation

• Batch reports completed for product

  Yes

  No

  N/A

• All critical limits are monitored and records completed

  Yes

  No

  N/A

Deviations / Corrective Actions

• Corrective action plan in place for each CCP

  Yes

  No

  N/A

• Corrective action report forms are available and include confirmation that the problem was addressed

  Yes

  No

  N/A

• Detailed SOP is available for each corrective action for each possible deviation from CL at CCP

  Yes

  No

  N/A

• Triggers for corrective actions are accurately defined

  Yes

  No

  N/A

• Extent of authority to take corrective action is clearly defined

  Yes

  No

  N/A

• Amount of product included in the corrective action is clearly defined and mean of identifying affected product is defined

  Yes

  No

  N/A

• Disposal of affected product is clearly described with appropriate SOP

  Yes

  No

  N/A

Verification Procedures

• Verification methods are identified for each CCP

  Yes

  No

  N/A

• Verification methods are validated

  Yes

  No

  N/A

• Verification of monitoring is done by someone other than persons doing the monitoring

  Yes

  No

  N/A

• Verification of monitoring is done at appropriate frequency

  Yes

  No

  N/A

• Monitoring records are available

  Yes

  No

  N/A

• Corrective Action records are available

  Yes

  No

  N/A

• Verification records are available for checking

  Yes

  No

  N/A

• Training records are available for checking

  Yes

  No

  N/A

Verification of the HACCP System

• HACCP plan requires annual verification of systems, records, staff evaluations, PRPs, CCPs, on-site observations and external audit

  Yes

  No

  N/A

• Annual verification of PRPs, CCPs (& CL monitoring), HACCP preliminary steps, supplier review, certification, monitoring and CA

  Yes

  No

  N/A

• Verification of performance of system checks, testing equipment for CCPs / PRP, sampling, testing for hazard control efficiency

  Yes

  No

  N/A

• Review of validation data

  Yes

  No

  N/A

• Records and follow up on inadequacies found in system checks or audits

  Yes

  No

  N/A

• Prompt correction for inadequacies

  Yes

  No

  N/A

• Procedures in place to repeat verification to ensure inadequacies were corrected

  Yes

  No

  N/A

• Audit records are completed and signed off

  Yes

  No

  N/A

HACCP System Records

• HACCP study and plan is available (preliminary documents needed to write the HACCP Plan)

  Yes

  No

  N/A

• CCP monitoring templates are available, and follow a controlled document procedure

  Yes

  No

  N/A

• Process deviation corrective action template is available, and follows a controlled document procedure

  Yes

  No

  N/A

• HACCP team meetings are recorded

  Yes

  No

  N/A

• Hold / Release memos are adequately designed and appropriate

  Yes

  No

  N/A

• Hold / Release documents are authorized only be top management

  Yes

  No

  N/A

• Validation data is documented

  Yes

  No

  N/A

• Verification and audit records are available for checking

  Yes

  No

  N/A