FoodSafe Audit 2009.x1x

Rwthrash

Description

Revised 3/15/09FoodSafe Audit 2009.x1Earned Available Comments1.0 Good Manufacturing PracticesPoints Points1.1 A personal GMP practices program is established: P a. GMP policy is defined for employees 4b. GMP audit program 4c. Visitor and contractor guidelines defined 21.2 An associate health policy is documented and established to ensure associates know about and report any big 4 reportable illness as defined in the FDA Model Food Code. These include (1) Salmonella Typhi (2) Shigella sp., (3) Shiga Toxin Producing Escherichia Coli, or (4) Hepatitis A virus.P/R a. Associate health policy is defined 4b. Reporting requirements are defined 4c. Illnesses due to the four causes listed are 4specifically includedd. Symptoms requiring reporting are defined 4e. High risk conditions are defined 4f. Records are maintained 41.3 GMP policy signage shall be posted at all facility entrances and/or GMP zones entrances.O a. Primary associate entrances 4b. Maintenance area entrances 4c. Other side and back entrances 41.4 Personal GMP self-audits are conducted monthly and include corrective action. R a. Audit records 4b. Follow-up corrective actions documented 41.5 All persons in GMP zones shall comply with personal GMPs:O a. Hair restraints are properly worn 4b. No non-cleanable head coverings (caps) 4c. Beard restraints are worn as necessary 4d. No evidence of Gum / ...

Informations

• Publié par: Unyu
• Nombre de lectures: 19
• Langue: English

Extrait

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FoodSafe Audit 2009. x1

Earned Good Manufacturing Practices Points A personal GMP practices program is established: a.GMP policy is defined for employees b.GMP audit program c. Visitor and contractor guidelines defined An associate health policy is documented and established to ensure associates know about and report any big 4 reportable illness as defined in the FDA Model Food Code. These include (1) Salmonella Typhi (2) Shigella sp., (3) Shiga Toxin Producing Escherichia Coli, or (4) Hepatitis A virus. a.Associate health policy is defined b.Reporting requirements are defined c.Illnesses due to the four causes listed are specifically included d.Symptoms requiring reporting are defined e.High risk conditions are defined f.Records are maintained GMP policy signage shall be posted at all facility entrances and/or GMP zones entrances. a.Primary associate entrances b. Maintenance area entrances c.Other side and back entrances Personal GMP selfaudits are conducted monthly and include corrective action. a.Audit records b. Followup corrective actions documented All persons in GMP zones shall comply with personal GMPs: a.Hair restraints are properly worn b.No noncleanable head coverings (caps) c.Beard restraints are worn as necessary d.No evidence of Gum / food / tobacco in use . band and medic alerts allowed when not representing a personal safety issue) f.No false eyelashes or nails / nail polish g.No items in outer pockets above waist All persons in GMP zones shall wear clean and suitable clothing for th work being performed. (e.g., smocks, aprons, gloves, foot coverings or dedicated shoes, etc.): a. Outer garment covering b.RTE food zones c.Handling  restrooms / break d.Handling – outside e.Employees wearing uniforms to and from work wear smocks when working with foods or ingredients.

Personal items are stored away from processing and storage areas. a.Personal storage areas are available b.Personal items in processing area c.Personal items in storage or packaging prep areas. Medical problems are effectively controlled and are not a source of a.Illness (coughing / dripping nose) b.Open lesion / infected woun c.Infectious or communicable diseas Hand washing facilities are available, have clean running water, are stocked, clean and are being used. a.Hand wash water (warm) b.In production  knee or foot pedals c.Paper hand towels d.Bacteriostatic soap e.Dip stations

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

Available Points

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[Supplier] [Location] Page 1 of 12

Comments

Revised 3/15/0

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All persons shall wash and/or sanitize hands and gloves (if required to be worn) before entering exposed product zones  when starting to work, after breaks, after using restrooms, after touching mouth or nose, or when hands/gloves are dirty or contaminated. Hand wash signage is posted appropriately. (e.g., wash before work / after break and when soiled / contaminated) a. Restrooms b. Processing areas Facility and personnel adhere to Good Laboratory Practices that are documented and understood by all responsible for laboratory testing. a.Sufficient work and storage space b. Clean and free of clutter c. No eating, drinking or smoking d. Designated lab coats restricted to lab e. Equipment clean and maintained f. MSDS for housekeeping chemicals All storage containers and/or bottles are properly labeled or color coded.

Actual points divided by possible points = % fo category

0

Earned Pest Control Points A documented pest control program shall be established and include:

a.A designated PMP (Pest Management Professional) who must be on staff or under contract

b.Defined responsibilities for pest control program at the facility c.Defined schedule of program services appropriate to needs and climate. d.The location of pesticides stored onsite e.A current diagram of trap placemen f.Defined description of station location identification g.Defined monitoring / auditing procedure for pest control activities h.A separate program shall be defined for fumigation processes performed at the facility if applicable. Pest Management Professional is licensed, insured, and certified. a.License from state to perform pest control services in state where service performed b.Insurance is current c. Certification of technician(s) d. Evidence of training for individuals monitoring or applying pest chemicals e. If fumigation is performed, the designated PMP must be licensed to perform these services. PMP service reports, including chemical usage logs, shall be current and available for review. a.Services performed by PMP b.Signs of pest activity documented c.Scheduled followup if necessary d.Monitoring of PMP – audit records e.NonPMP applied pest chemicals f.If fumigation services are performed, records for these services shall be maintained. Pesticides are approved by the appropriate regulatory agency. Handling procedures are on file. a.MSDS b.Sample Label c. FDA/USDA approved d.A facility approved pesticides list, including any pest chemicals applied by nonPMP personnel e. All pesticides are labeled and properly stored.

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

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200

Available Points

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Pesticides shall be used according to label instructions and are applied a.Application of pesticide done according to label

b.Chemicals application must be recorded and include date, concentration, amount, and location c.Current EPA registration information listed There shall be no evidence of outside pest activity. a.No evidence of nesting within 20’ of food production building. b.No evidence of decomposed rodents or animals in bait stations or within 20’ of building perimeter

c.No feeding of animals/pets within 100’ zone There shall be no evidence of inside pest activity. a.No evidence of live animals inside b.No evidence of insects, spiders (webbing) rodents, lizards, ants or birds inside c.No decomposed rodents or animals inside d.No evidence of rodent gnawing e. No evidence of pest or animal excreta All pest control devices shall be located in such a manner as to not contaminate product, packaging or equipment. a.No ILTs within 30' of food or storage areas b. No ILTs within 5' of food or storage areas. c.Light attractant units not over product, ingredients or packaging materials. d.No rodenticide used inside food or storage areas.

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2.9 The number and placement of traps and bait and/or otherinterior treatments shall be documented and effective. O a.Traps interior (25'30') 4 b.Traps < 10' of ext. doors (both sides) 4 c.4Glue boards maintained and dated d.4Traps are functional e. Light bulbs in ILTs are shielded and dated when 4 . 2.10 The number and placement of bait stations and/or otherexterior O a.4Bait stations (30'50') exterior b.4Bait stations are secured c.Bait stations are clean inside 4 d.No old or moldy bait is observed 4 e.4No bag bait is observed f.Bait stations / traps are in proximity of dumpster 4 (<30’) g.Appropriate devices/methods are used in areas of 4 public access or schools nearby. Evidence of food or food contact packaging by pest infestation is evidence of pest control program failure.

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Earned Pre Operational Sanitation Points A master sanitation program shall be established. The documented schedule(s) shall include: a.All food processing and storage zones b.Auxiliary areas are addressed c. Frequency of cleaning is defined Sanitation SOPs shall be defined and include: a.Specific to all areas and equipment listed in the Master Cleaning Schedule b.Cleaning chemical products used Sanitation Records are maintained and include: a.Person assigned to perform cleaning tasks. b.Person verifying effectiveness of cleaning. c.Chemical usage records are available. A CIP program shall be documented. Temperature, pressures and/or flow rates, and cycle times are maintained for automatic cleaning a.Procedures are documented. b.CIP systems are calibrated c. Records

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

200

Available Points

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A preoperative inspection program is established to include daily visual inspection and tear down of equipment as appropriate. Effective a. Documented preop inspection programs are established b.Records are kept and available Sanitation / housekeeping chemicals and sanitizers shall be approved by the appropriate regulatory agency, and data sheets shall be a.Safe and effective for use in food plant b Specimen Labels available Cleanser and sanitizer concentrations and applications shall comply with the sanitation program. a.Concentrations checked b.Appropriate methods and materials used c.Concentrations documented Cleaning practices are effective. Sanitators follow SSOPs. (Attention is given to RTE processing zones and allergens. a.Order, procedure, use  good sanitation b.Cleaning practices follow generally accepted sanitation methods and practices. Sanitation and housekeeping equipment and chemicals shall be properly stored. a.Equipment storage shall be organized b. Chemical storage shall be secured c. Shall not be found storedwith food / pkg. Equipment design and condition shall allow for effective cleaning including: a. Proper weld and seam construction b. No porous food contact surfaces (such as wood)

c. Design allows for thorough cleaning Annual water quality reports shall be on file. (Samples shall be drawn from processing areas of plant)

a.Testing of water quality <13 months b. Potability c.Coliforms d.Heavy metals e.Off flavors and odors Microbiological testing of food contact surfaces shall be in place. The documented program shall include: a.Overall description of program b.Sampling and swabbing procedures c.Lab procedures d. Micro records e. Action limits are defined f. Followup / corrective actions are recorded A training program for the sanitation crew shall be established. a.The training program includes: Training timeline or schedule with annual refresher trainin Defined training methods (How training is erformed Defined ob skill re uirements Defined job safety issues related to sanitation

Defined food safety issues related to sanitation

Trainin effectiveness is verified b.Training records Per em lo e databaseDe artment Matrix or c. Associates observed are adhering to good sanitation methods and practices as defined in training programs.

Actual points divided by possible points = % fo category

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

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Earned Available Operational Sanitation Points Points Operational Sanitation Standard Operating Procedures shall be established. a.Procedures are established 4 b.Monitoring observations are documented 4 c.4Corrective actions are documented d.4Persons doing checks are trained e.4Records are maintained and available. Product changeover control procedures are established including allergen cleaning matrix (as applicable.) a.Records address ingredient issues 4 b.4Records are complete and accurate Procedures for periodic facility inspections (including production areas, nonproduction areas, and surrounding grounds) shall be established. (Refer to 21 CFR Part 110) Records shall be maintained.

a.Documented procedures b.All areas inspected are listed and identified c.Persons doing checks are trained d.Records are maintained and available. e. Followup / corrective actions are documented with effectiveness verified A maintenancerelated food safety program shall be established. Records are maintained. a.Cleaned & Sanitized after maintenance b.Notification to production and/or sanitation / quality control c.Verification of area condition/sanitation d.Reconciling parts by maintenance e.Reconciling tools by maintenance f . Records are complete g.Appropriate maintenance dress / personal hygiene when working in product zones. Only food grade approved lubricants shall be used in food contact areas. a.Food grade lubricants – stored separately from nonfood grade and in such a manner as to avoid potential contamination. b.Grease guns are labeled for food grade or non food grade c.Bulk (buckets / drums) sealed or protected from potential contamination. Housekeeping shall be acceptable for interior of plant including: a.Processing areas b.Storage areas c.Shipping and receiving areas d.Maintenance parts and work areas Housekeeping shall be acceptable for exterior of plant: a.Parking lots b.Dumpster c.Public access areas d.Onsite storage areas Air ventilation through the facility shall be adequate. a. Air borne contaminates are controlled b. Condensate is controlled Waste materials and process build up shall be removed promptly and properly disposed of. a.Trash receptacles b.Production waste materials Break areas, locker rooms, rest rooms, and wash stations shall be maintained in a clean and orderly manner. a.Break area b.Locker rooms c.Restrooms d.Wash stations e.Covered receptacles for sanitary napkins must be in toilet rooms used by females.

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

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[Supplier] [Location] Page 5 of 12

Comments

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5.0

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Doors and openings shall be pest resistant. Cracks and crevices have been sealed. a.Screening b.Doors  weather stripping / sealing c.Dock doors  sealing d.Dock levelers e. No cracks & crevices f.Fan louvers must seal when closed. Facility walls, floors and ceilings shall be in good repair. No temporary repair materials used on continuing basis. a.Walls, floors, ceilings – interior b. Walls, roof leaks  exterior c.No string, tape, wire, cardboard d.No direct contamination of food / pkg. e.Construction areas are properly segregated to protect food zones. Work areas are orderly with tools and processing supplies properly stored. a.Work areas free of clutter b.Tools are properly stored c.All hand tools and knives used in processing areas must be clean and sanitary. d.All hand tools are maintained; are not rusty, and do not have flaking or peeling paint. Idle equipment and spare parts shall be properly cleaned and stored. a.Equipment inside b. Equipment outside Walkways and permanent ladders shall be shielded to prevent potential contamination. a.Unshielded ladder  >1' from product flow. b.Unshielded walkway  >1' from product flow. Forklifts and batteries shall be well maintained and properly stored. a.No leaking batteries b.Batteries are properly stored c. No leaking fluid from forklifts/pallet jacks . stored

Actual points divided by possible points = % fo category

Food Safety Practices

0

Earned Points

The twelve steps of HACCP or other regulatory authority shall be established: a. HACCP team assembled b. Food and its distribution is described a.Intended use of food and its consumers is described b.A flow diagram which describes the manufacturing processes is defined c. Flow diagram verified by HACCP team d.Hazard analysis conducted for each product or group of products e.CCPs determined f.Critical limits are established g.Monitoring procedures are established h.Corrective actions are established and nonconformities are documented i.Verification procedures are established j. Recordkeeping and documentation procedures are established A periodic review / reassessment procedure for HACCP plan shall be established. a.Frequency b.Responsibility c.Corrective action d. Review records

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

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250

Available Points

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All employees shall receive documented training in food safety programs (e.g., HACCP). Training program must be documented and training records kept per employee. Training shall include: a.Personal hygiene b.GMPs (21 CFR, Part 110) c.Cleaning and Sanitation procedures d.Their role in food safety (e.g. HACCP): / monitors / verifier Technicians ram mana emen Pro e. Training effectiveness is verified CCPs shall be monitored according to documented procedures with appropriate actions taken and recorded. An audit program is established. a.Monitoring per plan b.Correlate to production records c. Documented HACCP audit d. Documented corrective actions e. A deviation log or similar record is maintained. Employees shall be aware of CCPs and critical limits in their areas and take a ro riate action. a.CCP awareness b. CCP critical limits c. CCP corrective action steps Measures shall be taken to prevent cross contamination. a.Raw vs. cooked b. Ingredient controls There shall be no actual or potential instances of product adulteration observed. Foreign material control methods shall be used and shall be evaluated to ensure proper operation. a.Metal detector monitoring includes 316 series stainless steel. b. Monitoring includes beginning and ending of each processing shift. c.Corrective actions are documented d.Positivere ection/beltshutoffdeviceuse e.Bandaids are metal detectable f.A log of foreign material / metal found in product or packaging is maintained. g.Action plan is defined for when test fails. h. Testing records are available for review. i. Metal detector test by auditor functions properly (deduct 3 points if detector fails and corrective actions are taken immediately). Facility shall establish procedures to prevent foreign material contamination from water when water is used as an ingredient or cleaning food contact surfaces. a.Filtration device(s) b.Record of checks A written glass policy shall be established. Lights and other breakable a.Written Policy addresses key areas for broken lass incident Guidelines  Glass re lacement uideline  Glass dis osal uideline  Purchasin uideline ection Receivin ins  Lost e lassecontact lenses or broken e b. Light shields are in place c.No Breakable materials in production, storage or

A procedure for finished product testing of critical food safety attributes (e.g., micro) is defined. ●Written procedures address actions to be taken when food safety critical limits are exceeded.

Actual points divided by possible points = % fo category

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

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220

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Product Receiving, Tracing, & Recall

Earned Points

Procedures shall be established for lot coding all raw materials and finished products a.Raw material lot codes are defined  When supplier lot codes are used, definitions of su lier lot codes are available. b.Finished product lot codes are defined All raw materials and finished products shall be lot coded a.Raw material lots are coded b.Finished product lots are coded c.Codes are legible and follow procedure (See 6.1) A list of approved suppliers is maintained.

Suppliers for all food ingredients and packaging materials are required a.Procedure requiring audits is defined. b.Evidence of audits is available for all food ingredient and packaging suppliers on the approved supplier list. Specifications are defined for all ingredients and packaging materials. Key attributes to be checked during receiving are identified as either part of the specification or in separate quality control documents. Ingredients and packaging materials are verified for quality control upon each receipt. a.Procedures for verifying quality of ingredients are defined. b.Procedures for verifying quality of packaging materials are defined. c.Records for verifying quality of all ingredients received are maintained. d.Records for verifying quality of all packaging materials received are maintained. Ingredients and materials are analyzed on a regular frequency by an internal or external laboratory to ensure they meet specification criteria Ingredients and materials are received with Certificates of Analysis (COA) and/or Certificates of Guarantee (COG). a.Procedure is defined b.COA and/or COG records are maintained Steps required for tracing ingredients and finished products in the event of a recall shall be defined. Documented SOPs shall include: a. Steps defined for tracing ingredients b. Steps defined for tracing finished products c. Records needed for tracing are identified d. Backup processes if computers fail are defined. A Recall Policy shall be defined which includes: a.Classification of Product Recalls b.Recall team list (represents various areas) c.Recall team role and responsibilities e.Reconciliation procedures e.Product disposition guidelines f.Record keeping procedures. g.Product restocking guidelines. h.Termination of Recall i.Copies of applicable regulatory directives. j.Flow chart of recall processes Auditee demonstrated their ability to conduct a product recovery test of finished product to the auditor during the audit. 100% of finished product was tracked to the first external customer. Product was tracked within two hours to the first external customer. A test of product recovery processes shall be conducted annually from raw material to distribution. a.Test conducted within last 13 months. b.Results are documented Ela sed time to determine location

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

Available Points

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[Supplier] [Location] Page 8 of 12

Comments

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Product location % Product in inventor reconcileh sicall c. Standards for processing shrink or gain have been determined by product code d.Areas for improvement identified. e.Corrective actions documented. f.Test results reviewed by recall team. g. A product recovery test procedure shall be defined including responsibilities and frequency of testing.

Recall Crisis Communication Plans for Product Recoveries shall be defined and conform to regulatory requirements a.Communication plans are documented b.Regulatory issues are addressed c.Customer issues are addressed d.Current 24/7 contact lists are available e.Management training has been conducted

Actual points divided by possible points = % for category

0

Earned Food Defense Points A food defense team and food defense management coordinator is identified. a.Each food defense team member shall have clearly established food defense duties and responsibilities. A documented fooddefense risk assessment shall be established. This risk assessment should include:

a.Identifying of potential risks threats and opportunities. .Anm nfhn i lri kf rh potential threat or opportunity identified. c.Corrective actions are documented and reviewed by management for effectiveness. Procedures are established to ensure physical security of facility. Outside security should include: a.Plant boundaries shall be established and secured and appropriately posted. b.Outside lighting shall be sufficient to allow detection of unusual activities. c.Outside storage tanks for hazardous materials, chemicals and potable water shall be secured. d.Entries into establishment shall be established, controlled and require positive identification. e.Vehicles of visitors and including contractors are identified.

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

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200

Available Points

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Procedures are established to ensure physical security inside facility. Security shall include: a.Restricted areas inside clearly marked and secured. b.Access to central controls for airflow, water systems, electricity, and gas restricted and secured.

c.Updated layout schematics available at strategic and secured locations in the plant.

d.Disposal procedures for reagents, hazardous materials and live cultures of bacteria comprehensive and secure. Security procedures shall be established for storage security and include: a.Controlled access for all product, ingredient, and packaging material storage areas.

b.Bulk receiving lines have locks or tamper evident seals.

c.Access to hazardous chemical storage areas or rooms are secured.

Procedures are established to ensure shipping and receiving security. Security shall include:

a.Outgoing shipments are sealed with tamper evident numbered seals. Numbers are included on shipping documents. Provisions are made for partial loads and multiple drop shipments.

b.Incoming shipments of ingredients and packaging are sealed with tamperproof, numbered seals. Seal numbers are shown on shipping documents. When partial load shipments are received and seals are not  , secured upon arrival. c..Packaging integrity of all incoming shipments shall be examined at the receiving dock for evidence o tampering. d.Loading docks are secured to avoid unverified or unauthorized deliveries. Procedures are established to ensure personal security. These shall include: a.Controlled entry into the plant during non processing hours by contractors and visitors.

b.New hires are subjected to prehire screening and/or background checks before hiring. c.Orientation training on security procedures is given to all employees.

Actual points divided by possible points = % for category

FoodSafe Audit 2009.xo Copyright 2009 ll Rights Reserved

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100

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Earned Available Comments 8.0 Allergen Controls Points Points Allergens and food sensitizers include but are not limited to: peanuts, tree nuts, eggs, egg based products, dairy or dairy based products, soy or soy based products, wheat or wheat based products, crustacean and fish. Additionally, FD&C Yellow #5, FD&C Yellow #6, sulfites, autolyzed yeast, hydrolyzed protein and MSG.

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An assessment has been performed and documented to determine if any allergens or food sensitizers are used within the facility. A listing of allergens is maintained identifying name of and classification of allergen or food sensitizer. Standard Operating Procedures are defined forhandling allergens and food sensitizers to prevent cross contamination. Rework procedures address allergens and food sensitizers. Records identify when allergens are included in products being reworked. Associates receive training regarding control of allergens and food sensitizers. Training is documented and effectiveness of training is measured. Ingredient labels on all incoming ingredients are inspected for allergens or food sensitizers. Incoming labels for finished products with allergens or food sensitizers are inspected for accuracy.

Allergen ingredients are identified and/or segregated.

Actual points divided by possible points = % for category

FoodSafeAudit2009.xo Copyright2009 ll Rights Reserved

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Auditor:xxxxx