MODULE 7Food safety plan

Learning objectives

■ Preliminary steps for developing a Food Safety Plan■ A roadmap for building a Food Safety Plan■ Records

Definitions

■ Food Safety Plan– A set of written documents that is based on food safety

principles; incorporates hazard analysis, preventive controls, supply-chain programs and a recall plan; and delineates the procedures to be followed for monitoring, corrective actions and verification.

– Adapted from 21 CFR 117.126■ Food safety system– The outcome of implementing the Food Safety Plan

and its supporting elements

Preventive Food Safety Systems

GMPs and Other Prerequisite Programs

Food Safety Plan

Recall Plan

Hazard Analysis

Process Control

Supply-chain

Program Allergen Control

Sanitation Control

Including procedures formonitoring, corrective actionand verification, as appropriate

Scope of the Food Safety Plan

■ Specific to a facility– Preventive controls specific to a product and process

■ Products may be grouped if hazards and controls are managed generally the same■ Define and address:– Specific product(s) and process(es)– Could be grouped by unit operations– Biological, chemical (including radiological), and

physical hazards

■ Format is flexible■ Contains helpful

information in an organizational format that works for you■ What do I do, how do I

do it, what do I do to minimize the risk to my consumers

EXAMPLE:E.G. Food Company

See Appendix

Main Organizational Sections

1. Background information (optional)

2. Hazard analysis3. Preventive controls*4. Recall plan*5. Implementation

proceduresBackground Inform

ationH

azard Analysis

Preventive Controls

Implem

entation Procedures

RecallPlan

* Required when a hazard requiring a preventive control is identified

Background Information

■ Useful information to organize the plan:“Preliminary Tasks”– Facility overview – Food Safety Team – Product description– Flow diagram (verified)– Process description

Company &

Food Safety Team

Process D

escriptionFlow

D

iagramProduct

Description

BACKGROUND INFORMATION

SECTIONS

Assemble The Food Safety Team■ Management commitment to resources– Supports realistic and executable plan

■ Team approach:– Reduces risk of missing key food safety considerations– Encourages ownership of the plan

■ Individuals with different specialties and experiences– Provides knowledge of daily operations– QA, production, sanitation, maintenance, etc. as applicable

■ “Preventive controls qualified individual” required– Someone within the firm and/or an outside expert– Successfully completed training or otherwise qualified

Preliminary Task:

Food Safety Team’s Responsibilities

Develops, documents, maintains and reviews the

Food Safety Plan

Oversees implementation of the Food Safety Plan

Ensures personnel are trained to carry out their

responsibilities

E.G. Food Company Example

E.G. Food Company is a fictitious enterprise used as an example throughout this course.

Company OverviewE.G. Food Company’s ~150 employees produce egg-based products, including plain omelets, cheese omelets and cheese omelet biscuits. Product is made 5 days a week in one 8 hour production shift, followed by 4 hours for sanitation. Cleaning and sanitizing of all processing equipment is conducted per a master sanitation schedule, which also includes cleaning and sanitizing between different products if needed for allergen control. Municipal water, which is treated and tested per EPA requirements by the city, is used throughout the facility. The company practices hygienic zoning to prevent cooked product exposure to environmental pathogens and employees working in the high hygiene areas wear color coded smocks and dedicated footwear. These employees are instructed on proper hand washing procedures, glove use, and importance of zoning.

E.G. Food Company Example

Food Safety Team

Name PositionApplicable Training(Records are in personnel file)

I.N. Charge Plant Manager In plant trainingF.S. Leader*

QA Manager FSPCA class

E.F. Ency Production Supervisor

In plant training

I.M. Clean Sanitation Supervisor

In plant training

P.H. Books*

Consultant, PH Books Consulting Service

M.S. & Ph.D. in Food Science and FSPCA lead instructor

*Preventive controls qualified individual

Describe the Product and Its Distribution■ The product names(s)■ Important food safety characteristics of the

product, if any (e.g., pH, aW, preservatives)■ Ingredients■ Packaging type ■ Shelf life■ Storage and distribution

Preliminary Task:

Describe the Intended Use and Consumers■ Intended use and reasonably foreseeable unintended use■ Intended consumers (e.g., general public, infants, elderly)– These groups are more susceptible to foodborne illness:■ Infants and young children (infant formula or baby/toddler foods)■ Elderly persons (foods prepared for nursing homes)■ Pregnant women (foods targeted toward young women)■ Immune-suppressed persons (special diets for medical settings)

■ Labeling instructions relevant to food safety

Preliminary Task:

E.G. Food Company Example

PRODUCT(S) Omelet – Plain, Cheese and Cheese Biscuit PAGE X of YPLANT NAME: E.G. Food Company ISSUE DATE 09/20/2015ADDRESS: 360 Culinary Circle, Mytown, USA SUPERSEDES 08/06/2015 Product Description, Distribution, Consumers and Intended UseProduct Name(s) Omelet – Plain, Cheese and Cheese BiscuitProduct Description, including Important Food Safety Characteristics

Frozen, cooked egg omelet, with or without cheese filling and a wheat biscuit bunpH 7.1 - 7.9, water activity >0.98, no preservatives

Ingredients Plain: Eggs, milk, pan release oil, saltCheese: Eggs, milk, cheese, pan release oil, saltCheese Biscuit: Eggs, milk, cheese, biscuit, pan release oil, salt

Packaging Used Paperboard trays wrapped with plastic wrap and inserted in a corrugated case.

Intended Use The product is considered ready-to-eat, but is typically heated to hot holding temperatures (135°F (57°C)) or above for palatability. Heating is typically conducted using microwaves, convection oven, or induction.End user may thaw at refrigeration temperatures overnight to reduce cooking time. End users may also add toppings or fillings.Sold for foodservice applications.Potential abuse: Some establishments may hold thawed product for longer than the recommended 24 hours.

Intended Consumers General public

Shelf Life 1 year frozen

Labeling Instructions Keep frozen or thaw under refrigeration (<41°F (5°C)) for <24 hours before cooking.

Storage and Distribution Frozen

Approved:Signature: F.S. LeaderPrint name: F.S. Leader

Date:April 11, 2015

See example plan: page A3-4

Develop a Flow Diagram and Describe the Process■ Flow diagram is an important tool to describe the process■ Include all the process steps within the facility’s control ■ Include reworked product, by-product and diverted

product, if applicable■ Develop a written description for each step in the flow

diagram

Preliminary Task:

Receiving packaging[labeled carton, tray, plastic

wrap]

Receiving shelf stable

ingredients[pan release oil, salt]

Receiving refrigerated ingredients [liquid

pasteurized eggs, pasteurized milk, cheese]

Receiving frozen ingredients

[prebaked biscuits]

¯ ¯ ¯

Packaging storage[labeled carton, tray, plastic

wrap]

Ambient ingredient

storage[pan release oil, salt]

Refrigerated ingredient storage

[liquid pasteurized eggs, pasteurized milk, cheese]

¯ ¯Labeled carton

assemblyMix ingredients [liquid

pasteurized eggs, pasteurized milk, salt]

¯Cook

[liquid pasteurized eggs, pasteurized milk, salt, pan release oil]

¯Assemble, wrap tray

[cheese or biscuit may be added]¯

Spiral freeze¯

Metal detection¯

Fill, weigh, label¯

Frozen storage¯

Frozen distribution

Omelet Flow Diagram E.G. Food Company Example

Preliminary Task: Verify the Flow

DiagramWalk the floor and sign

and date diagram

E.G. Food Company Example

Process Description – Plain, Cheese and Cheese Biscuit OmeletReceiving Ingredients and Packaging:Ingredients and raw materials are purchased from reputable suppliers that comply with internationally recognized food safety and quality systems. For each ingredient, the same brand is used consistently to minimize variation. Ingredients are stored according to manufacturers’ recommendations when specified.Receiving packaging: Corrugated shippers, paperboard trays and plastic wrap are received in bulk. Specifications require food grade material for trays and plastic wrap that is compatible with frozen storage of food products. Receiving shelf stable ingredients:

Salt: Received in 10-pound bags from our distributor. Specifications require food grade salt.Pan release oil: The pan release oil contains soybean oil, soy lecithin and natural flavor. It is received from our distributor in 10-gallon jugs.

See Appendix 3: Food Safety Plan for full information

Preliminary Tasks SummaryActivity Outcome1. Assemble the food safety

teamManagement commitment for resources and training

2. Describe the product and its distribution

Information for hazard analysis

3. Describe the intended use and consumers of the food

4. Develop a flow diagram and describe the process

Organizing framework for hazard analysis

5. Verify the flow diagram Essential to assure accuracy

Hazard Analysis - Required

■ Drives decision-making for the controls that must be included in the Food Safety Plan

Hazard

AnalysisPreventive Controls

Recall Plan

HAZARD ANALYSISSECTION

Implem

entation Procedures

Hazard DefinitionsHazard■ Any biological, chemical (including radiological), or physical agent that has the potential to cause

illness or injury.

Known or reasonably foreseeable hazard ■ A biological, chemical (including radiological), or physical hazard that is known to be, or has the

potential to be, associated with the facility or the food.

Hazard requiring a preventive control■ A known or reasonably foreseeable hazard for which a person knowledgeable about the safe

manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.

Sources of Information■ Publications:– Hazard Analysis and Preventive

Controls for Human Food training curriculum

– Peer reviewed literature– Trade association publications

■ FDA Hazards and Control Guidance– Seafood HACCP Hazards and Controls

Guidance– Juice HACCP Hazards and Controls

Guidance– Food Safety Preventive Controls for

Human Food Hazards and Controls Guidance (in development)

■ Reliable Internet Sites– FSPCA website– FDA website– Other U.S. agency resources■ Centers for Disease Control and Prevention

■ FoodSafety.gov

■ U.S. Department of Agriculture

– International agency resources, e.g.,■ Canadian Food Inspection Agency

■ Codex Alimentarius Commission

■ European Food Safety Authority

– Trade association websites

(1)Ingredient

/ Processing

Step

(2)Identify potential

food safety hazards introduced,

controlled or enhanced at this

step

(3) Do any potential

food safety hazards require

preventivecontrol?

(4)Justify your decision for

column 3

(5) What preventive

control measure(s) can be applied to

significantly minimize or prevent the food

safety hazard?Process including CCPs,

Allergen, Sanitation, Supply-chain, other preventive control

(6)Is the

preventive control

applied at this step?

Yes No

Yes No

Cook[eggs, milk, salt, pan release oil]

B Survival of vegetative pathogens such as Salmonella

X Thorough cooking is required to kill vegetative pathogens

Process Control – Cooking to achieve a lethal temperature

X

E.G. Food Company Example

PRODUCT: Omelet – Plain, Cheese and Cheese Biscuit PAGE X of ZPLANT NAME: E.G. Food Company ISSUE DATE mm/dd/yyADDRESS: 360 Culinary Circle, Mytown, USA SUPERSEDES mm/dd/yy

Haz

ard

Ana

lysi

s Fo

rm

PRODUCT: Omelet – Plain, Cheese, and Cheese Biscuit PAGE X of Y

PLANTNAME

E.G. Food Company ISSUE DATE 2/13/2016

ADDRESS 360 Culinary Circle, Mytown, USA SUPERSEDES 9/20/2015

(1)Ingredient/ Processing

Step

(2)Identify

potential food safety hazards

introduced, controlled or enhanced at

this step

(3) Do any

potential food safety hazards

require a preventive

control?

(4)Justify your decision

for column 3

(5) What preventive control

measure(s) can be applied to significantly minimize or prevent the food safety

hazard?Process including CCPs,

Allergen, Sanitation, Supply-chain, other preventive

control

(6)Is the

preventive control applied

at this step?

Yes No Yes NoReceiving frozen ingredients – biscuits *

C Allergen –wheat

X Wheat is an allergen that must be labeled to inform consumers. Allergen cross-contact with other products must be controlled becausesome products do not contain wheat.

Allergen Control –allergen labeling at other steps

Sanitation Control – at a subsequent step to prevent allergen cross-contact

X

E.G. Food Company Example Hazard Analysis Form

(1) Ingredient/ Processing

Step

(2)Identify potential food safety

hazards introduced, controlled or enhanced at this step

(3) Do any

potentialfood safety

hazards require a

preventive control?

(4)Justify your decision for

column 3

(5) What preventive control

measure(s) can be applied to significantly minimize or

prevent the food safety hazard?

Process including CCPs, Allergen, Sanitation, Supply-

chain, other preventive control

(6)Is the

preventive control

applied at this step?

Yes NoYes No

Assemble, wrap

B Introduction of environmental pathogens such as L. monocytogenes

X Recontamination may occur if sanitation control is not in place.

Sanitation Controls –prevent recontamination

X

C Allergen cross-contact from other products handled at this step; e.g., Cheese Omelet Biscuit

X Biscuits could introduce wheat allergen to other products without control

Sanitation and Allergen Controls –prevent cross-contact

X

Hazard Analysis Worksheet PRODUCT: Omelet – Plain, Cheese and Cheese Biscuit

PAGE X of Y

PLANT NAME E.G. Food Company ISSUE DATE mm/dd/yy

ADDRESS 360 Culinary Circle, Mytown, USA SUPERSEDES mm/dd/yy

E.G. Food Company Example

Hazard Analysis

PRODUCT: Omelet – Plain, Cheese and Cheese Biscuit PAGE 10 of 36

PLANT NAME E.G. Food Company ISSUE DATE mm/dd/yyyy

ADDRESS 360 Culinary Circle, Mytown, USA SUPERSEDES mm/dd/yyyy

E.G. Food Company Example

(1)Ingredient/ Processing

Step

(2)Identify potential

food safety hazards introduced,

controlled or enhanced at this step

(3) Do any

potentialfood

safety hazards

require a preventive control?

(4)Justify your decision

for column 3

(5) What preventive

control measure(s) can be applied to

significantly minimize or prevent the food

safety hazard?Process including CCPs,

Allergen, Sanitation, Supply-chain, other preventive control

(6)Is the

preventive control

applied at this step?

Yes No Yes No

Receiving refrigerated ingredients –pasteurized process cheese

B Vegetative and sporeforming pathogens such as Salmonella,pathogenic E. coli, L. monocytogenes and C. botulinum

X Pathogens listed were identified as significant by ICMSF (2005) in process cheese. These hazards must be controlled when the cheese is made.

Supply-chain Control – approved supplier and 3rd party supplier audit by a qualified auditor

X

Preventive ControlsPreventive Controls are REQUIRED if a hazard is determined to be known or reasonably foreseeable

Process preventive controls– Critical Limits (Validation)– Monitoring– Corrective Actions

Food allergen preventive controls– Accurate labeling– Cross-contact prevention

Sanitation preventive controls– Environmental pathogens– Cross-contamination, cross-contact

Supply-chain preventive controls– Supplier agreements– Supplier verification (audits, testing)– Receiving records (COAs)

Other preventive controlsProcess

Food AllergenSanitation

PREVENTIVE CONTROLS

REQUIRED based on Hazard Analysis

Supplier /Other

Process Preventive Control ExamplePRODUCT: Omelet – Plain, Cheese, Cheese Biscuit PAGE 1 of X

PLANT NAME: E.G. Food Company ISSUE DATESUPERSEDES

mm/dd/yymm/dd/yyADDRESS: 360 Culinary Circle, Mytown, USA

Process Control Hazard(s)

Critical Limits

Monitoring

Corrective Action Verification RecordsWhat How Frequency Who

Cook Vegetative pathogens such as Salmonella

Omelet surface temper-ature is ≥158°F (70°C) instan-taneousbefore transfer to assembly table

Omelet surface temper-ature is ≥158°F (70°C)

Infrared surface thermo-meter

Each cook station, 4 times per shift, about every 2-3 hours

QA tech-nician or designee

Hold product back to the last good check and evaluate -rework, discard, or release.Determine root cause – retrain or correct as appropriate.

Review of Cook Log, Corrective Action and Verification records within 7 working daysDaily accuracy check for thermo-meter

Annual calibration of thermo-meter

Cook Log – cook temp by QA technicianCorrective Action recordsVerification records, including Validation study

Allergen Preventive Control ExamplePRODUCT: Omelet - Plain PAGE 1 of X

PLANT NAME: E.G. Food Company ISSUE DATESUPERSEDES

mm/dd/yymm/dd/yyADDRESS: 360 Culinary Circle, Mytown, USA

Allergen Control Hazard(s) Criterion

Monitoring Corrective Action Verification RecordsWhat How Frequency Who

Receiving packaging (labeled carton)

Undeclared allergens –egg, milk, soy (wheat in biscuit only)

All finished product labels must declare the allergens present in the formula per listing

Ingredient listing and allergen informa-tionmatches product

Visual check of carton label to match product formula

Before release to production

Label coordi-nator

If label is incorrect, reject labels and return to supplier or destroy. Identify root cause and conduct training as needed to prevent recurrence

Review of Label verification, Corrective Action and Verification records within 7 working days

Allergen Label Verifica-tionlisting;Allergen Label Verifica-tionlog;Corrective Action records;

E.G. Food Company Example

Sanitation Preventive Controls:Hygienic Zoning

Non-manufacturing areas• Maintenance shop, offices, employee

areas, waste disposal

Transition areas• Entry rooms, locker rooms that enter

onto basic GMP areas, etc.

Basic GMP areas• Raw, receiving and storage

Primary pathogen control area – CONTROLLED ACCESS• Cooked, pasteurized or RTE products

exposed to the environment

Sensitive/high hygiene area –RESTRICTED ACCESS• Products for sensitive populations

such as infants

Differentiates facility hygiene requirements to minimize product cross-contamination, e.g.,

Example Hygienic Zoning Map

Hall

Sh

ipp

ing

& R

ece

ivin

g

Ma

in-

ten

an

ce

Me

ch

a-

nic

al

Offices

Lab

Non-manufacturing, Transition, Basic GMP, Primary pathogen control area –

CONTROLLED ACCESS

En

try a

rea

Me

n’s

Ro

om

Wo

me

n’s

Ro

om

Hall

Refr. Ingr.

Storage

Ambient

Ingr. Storage

Packaging

Storage

Frozen

Storage

Cook Area

Assemble, Wrap Area

Ca

rto

n

Asse

mb

ly

Fill, la

be

l

Me

tal

De

tect

Spiral Freeze

Mix Room

Utensil and Small

Equipment Cleaning

Room

Ha

llH

all

Ha

ll

E.G. Food Company Example

Assemble, Wrap Table SanitationPurpose: Cleaning and sanitizing of the assembly and wrapping table is important to remove potential allergens and reduce microbial cross-contamination or recontamination with environmental pathogens that may impact product safety.Frequency:

Cleaning: At lunch break, after Cheese Omelet Biscuit production, at the end of daily production.Sanitizing: Before operations begin, at lunch break, after Cheese Omelet Biscuit production, and at the end of daily production.

Who: Sanitation team memberProcedure:

Note: Blue cleaning tools are to be used ONLY for cleaning after a cheese biscuit run to reduce the potential for unintentional allergen transfer.Cleaning1. Remove unused packaging material to an area at the end of the shift to prevent it from getting wet. Cover it during the

lunch clean up.2. Remove gross soil with a squeegee.3. Wipe table surface with a clean cloth dipped in ABC cleaning solution (Y oz. per gallon).4. Rinse table with clean water. Detergent remaining on the surface can inactivate the sanitizer.Sanitizing1. Spray table surface with 200 ppm quaternary ammonium compounds solution, ensuring that entire surface is

covered.2. Allow table to air dry, about 5 minutes. Contact time required per label – 1 minute.

Monitoring (at frequency indicated above):Inspect table for residual soil and cleanliness. Record on Daily Sanitation sheet.Use test strip to measure the quat concentration BEFORE application. Record on Daily Sanitation sheet

Corrections:If residual soil is observed on the table, reclean and sanitize.If quat is not at the proper concentration, make a new solution.

Records: Daily Sanitation SheetVerification: Supervisor reviews and signs Daily Sanitation Sheet within 7 working days

PRODUCT: Omelet – Plain, Cheese and Cheese Biscuit PAGE 21 of 36PLANT NAME: E.G. Food Company ISSUE DATE

SUPERSEDESmm/dd/yyyymm/dd/yyyyADDRESS: 360 Culinary Circle, Mytown, USA

E.G. Food Company Example

Easy to read text is in Appendix 3

Supply Chain Program General Requirements

When applicable, verify a supply-chain-applied control applied by an entity other than your supplier

Document supplier verification activities

Conduct supplier verification activities

Determine supplier verification activities

Use approved suppliers

Recall Plan

■ Required when a hazard requiring a preventive control is identified ■ What to do when

something goes wrong■ See Chapter 15

Recall Plan

RECALL PLAN

Implem

entation Procedures

Recall Classifications

■ Actions taken by a firm to remove a violative product from the market– Class I recall: reasonable probability of serious adverse

health consequences or death– Class II recall: may cause temporary or medically

reversible adverse health consequences or where the probability of serious adverse health consequences is remote

– Class III recall: not likely to cause adverse health consequences

■ May be conducted on a firm’s own initiative, by FDA or state request, or by FDA or state order

Recall Plan Requirements

■ Required for any food with a hazard requiring a preventive control

■ Must be written■ Must describe steps to take and assign responsibility

to:– Notify direct customers and consignees– Notify the public, when appropriate– Conduct effectiveness checks– Execute disposition of food

■ Test the recall system – Mock Recall

Define and Assign Responsibility

■ Define details of each step in the recall process and person responsible for each item– Scope of recall (product and quantity)– Regulatory agency communication (FDA and state)– Recall initiation– Customer notification– Information and data compilation (effectiveness check)– Document gathering– Securing inventory of affected lot(s) in your control– Product disposition (destruction, reconditioning,

reworking, relabeling, diversion)– Documentation

Corrective Action Related to Recalls

■ Reanalysis of the Food Safety Plan is required■ May result in:– Modification of the Food Safety Plan– Retraining to enhance implementation effectiveness– Other actions to prevent recurrence of the problem

■ Maintain a log of decisions made throughout recall■ After recall is completed, conduct review meeting

Implementation Procedures■ Preventive control

monitoring data■ Corrective actions taken■ Verification (if applicable)

activities■ Validation documentation

(if applicable)■ Supply-chain program

implementation■ Applicable training

IMPLEMENTATION PROCEDURES

Implem

entation Procedures

Basic Information on Records■ Name of record■ Name and location of facility■ Date and, when appropriate, time of activity documented■ Actual measurement or observation taken, as applicable■ Product identification, if applicable■ Signature or initials of the person performing the

monitoring activity■ Signature or initials of the person reviewing the record, and

date of the review

General Requirements for Records

■ Form– Original, true copies or electronic

■ Content– Actual values or observations – Accurate, permanent (e.g., in ink) and legible– Real time recording– Adequate detail

Computerized Records

■ Must be equivalent to paper records and hand written signatures■ An electronic record-keep system must:– Be authentic, accurate and protected– Provide accurate and complete copies of records– Protect records for later retrieval– Limit access to authorized individuals– Provide a secure record audit trail– Be reviewed by a trained individual

Implementation Records■ Monitoring records for preventive controls■ Corrective action records■ Verification records, when required– Validation– Verification of monitoring and corrective action– Calibration of monitoring and verification instruments– Product testing– Environmental monitoring– Records reviews– Reanalysis

■ Supply-chain program and supporting documentation■ Training records, as appropriate

Monitoring Records

■ Records used to document that food safety hazards have been controlled by preventive controls■ Information required:– Standard information required for all records– Signature or initials of the individual reviewing the

record, and date of the review

Periodic Monitoring of Cooking Example

Form Title: Daily Cooker Temperature LogFirm Name: Firm Location:Product Identification: Critical Limits: Date Time Line

Number, Lot Code

Cooker Temp (°F)

Cook Time (minutes)

Critical Limit Met (Yes/No)

Line Operator (Initials)

Verification Reviewer Signature: Date of Review:

Date issued: dd/mm/yy Supersedes issue: dd/mm/yy

Periodic Monitoring of Continuous Temperature Record

2/3-2/

9

2014

1

CJ

CJ

CJ CJ

CJ

CJ

CJ

See corrective action 2/5/2014CJ

E.X. Company123 Happy LaneProductivity, USA

Temperature Chart(Cooler #1)2/3 – 2/9/2014

Temperature limit met?Yes/No _________

Reviewed by: ___________Review date: ___________

Back of chart

Allergen Label Check Monitoring LogForm Title: Allergen Label Check Monitoring LogFirm Name: Firm Location:Product Identification: Parameters: All finished product labels must declare the allergens present in the formula:

Product A: list allergensProduct B: list allergens

Date Time

Lot Code Lot Number

Proper Label Applied (Yes/No)

Line Operator (Initials)

Verification Reviewer Signature:

Date of Review:

Date issued: dd/mm/yy Supersedes issue: dd/mm/yy

Corrective Action Records

■ Records that document the root cause and corrective actions taken in response to a deviation from the Food Safety Plan

■ For each event, information required includes:– Product identification and volume on hold, if applicable– Description of deviation from parameters– Actions taken to prevent recurrence– Final disposition of product– Evaluation or testing results, if relevant– Corrective action verification

Corrective Action ExampleCorrective Action FormDate of Record: 6 February 2015 Code or Lot Number: AY123Date and Time of Deviation: 2:15 pm, 5 February 2015 Description of Deviation: Labels for product A were applied to product B because the operator selected the wrong stack of labels. The issue was discovered by the operator loading packages into cases.Actions Taken to Restore Order to the Process: 1. Production was halted when error was discovered. 2. Product was segregated back to the last good check.3. Product was relabeled with the correct label4. Line operator was retrained on how to check the label before placing a new stack on the

line and the importance of doing so. The procedure was emphasized with all operators as a teachable moment.

Person (name and signature) of Person Taking Action: P.K. Lead Pat K LeadAmount of Product Involved in Deviation: 50 cases

Evaluation of Product Involved with Deviation: All relabeled product was double checked to ensure that the correct label was in place.

Final Disposition of Product: Released

Reviewed by (Name and Signature): Date of Review:Date issued: dd/mm/yy Supersedes: dd/mm/yy

Verification Records

■ As appropriate for the nature of the preventive control and its role in the food safety system, document the results of:– Validation studies – Verification of monitoring and corrective action records– Accuracy checks and calibration of process-monitoring

instruments– Product testing– Environmental monitoring– Supply-chain program verification– Reanalysis

Validation Records, When Applicable

■ Potential information used to support decisions made in the Food Safety Plan– Process authority validation records – In-plant studies or challenge studies– Information on emerging hazards– Recognized academic or research institution studies– Peer reviewed journal articles– Industry or regulatory guidance documents– Lack of customer and consumer complaints related to

food safety

Product Testing and Environmental Monitoring Records■ Applies to microbiological and chemical tests specified as

verification activities in the Food Safety Plan ■ Keep original record from laboratory– Name of lab– Sample identification (including date sampled)– Location of sampling (e.g., finished product, in-process, etc.)– Date of test– What you are testing for– Method used– Results per unit volume (e.g., per gram, per milliliter, or per

unit of analytical unit for presence absence)■ Format can vary considerably

Employee Training Records

Form Title: Employee Training RecordEmployee Name: Name Hire Date: dd/mm/yyyy

Employee Training Course Location Date CompletedFSPCA Food Safety Preventive Controls for Human Food course

Local University Extension November 15, 2015

Sanitation in the processing plant, 4-hour course

Chemical supplier in house February 28, 2015

Good manufacturing practices (GMPs) online course

Cornell University Distance Learning Center

March 15, 2015

Allergen labels and cleaning control procedures

On the job training March 1, 2015

Date issued: dd/mm/yy Supersedes: dd/mm/yy

Record Retention and Availability

■ Required records must be retained at least 2 years■ Records that must be retained, e.g., at the facility – Food Safety Plan– Records on general adequacy of equipment and processes

used, including scientific studies– Electronic records considered onsite if they can be

accessed onsite■ Other than the Food Safety Plan, records may be

stored offsite IF accessible within 24 hours■ All required records must be made available to

regulatory personnel upon oral or written request

■ The Food Safety Plan must be signed and dated by owner, operator or agent-in-charge– Upon initial completion– After modifications are

made■ Intent is to keep

management informed of changes

EXAMPLE:E.G. Food Company

See Appendix

Food Safety Plan Reanalysis ChecklistReason for reanalysis:

Task

Date Reviewed

and initials

Is Update Needed? (yes/no)

Date Task Completed

Signature or Initials of

Person Completing the

TaskList of Food Safety Team with individual responsibilities Product flow diagrams Hazard analysis Process Preventive Controls Food Allergen Preventive Controls Sanitation Preventive Controls Supply-chain ProgramRecall PlanUpdated Food Safety Plan implementedUpdated Food Safety Plan signed by owner or agent in chargeReviewer Signature: Date Review:Date issued: dd/mm/yy Supersedes: dd/mm/yy

HACCP Plan vs. Food Safety PlanElement HACCP Plan Added in Food Safety Plan

Hazard analysis Biological, chemical, physical

Chemical hazards to include radiological; consider economically motivated hazards

Preventive controls CCPs for processes Process CCPs + controls at other points that are not CCPs

Parameters and values

Critical limits Parameters and minimum/maximum values (= critical limits for process controls)

Monitoring Required for CCPs Required as appropriate for other preventive controls

Corrective actions or corrections

Corrective actions Corrective actions or corrections, as appropriate

Verification For process controls As appropriate for all preventive controls; supplier verification required when supplier controls a hazard

Records For process controls As appropriate for all preventive controlsRecall plan Not required in the

planRequired when a hazard requiring a preventive control is identified

Food Safety Plan Overview Summary■ A written Food Safety Plan, specific to the facility, is

required to include a hazard analysis■ When hazards requiring a preventive control are identified,

the following are required, as appropriate:– Preventive controls ■ Process, food allergen, sanitation, supply-chain and others determined

through the hazard analysis process

■ A recall plan– Implementation procedures■ E.g., validation studies and monitoring, corrective actions and verification

procedures

■ The format is flexible