RECORD‐KEEPING PROCEDURES FOR HUMAN FOOD

WAFP WorkshopMatt MathisonJune 9, 2016

Record‐keeping Procedures Objectives

• What records are required• General information required on records• Implementation record requirements and examples

• How to conduct a record review• Record retention and availability

21 CFR Part 117 – Subpart F

21 CFR Part 117 – Subpart C

What Records Are Required?

IMPLEMENTATION RECORDS

Implem

entation Records

What Records Are Required?

Food Safety Plan

• Hazard analysis• Preventive controls

Process preventive controls Allergen preventive controls Sanitation preventive controls

• Supply‐chain program requirements

• Recall plan• Monitoring procedures• Corrective action procedures• Verification procedures

What Records Are Required?

Implementation Records

• Preventive control monitoring data

• Corrective actions taken• Verification (if applicable) 

activities• Validation documentation (if 

applicable)• Supply‐chain program 

implementation• Applicable training

IMPLEMENTATION RECORDS

Implem

entation Records

PRODUCT:        Pepper jack Cheese PAGE 1 of X

PLANT NAME: Best Cheese Company ISSUE DATESUPERSEDES

mm/dd/yymm/dd/yyADDRESS:  123 Main Street, Monterey, USA

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

Owner / Agent In Charge Must be Informed

• 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 managementinformed of changes

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

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

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 Log Example

Form 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: AY123

Date 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:

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

Thermometer Accuracy Record ExampleForm Title: Daily Thermometer Accuracy Verification LogFirm Name: Firm Location:Product Identification: Verification: Check each thermometer daily for accuracy. Temperature must be  xF from the standard.Date  Time Instrument 

NumberBoiling Water Check

Within Specification (Yes/No)

Line Operator (Initials)

Verification Reviewer Signature: Date of Review:Date issued: dd/mm/yy Supersedes issue: dd/mm/yy

Thermometer Calibration Record Example

Form Title: Quarterly Thermometer Calibration LogFirm Name: Firm Location:Product Identification: Verification: Check each thermometer quarterly against a thermometer traced to a recognized standard. Temperature must be x°F from the standard.Date of Calibration

Instrument Number(s)

Method of Calibration

Calibration Results

Within Specification(Yes/No)

Line Operator (Initials)

Verification Reviewer Signature: Date of Review:Date issued: dd/mm/yy Supersedes issue: dd/mm/yy

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 

Record Review ExampleCorrective Action FormDate of Record:  6 February 2015 Code or Lot Number: AY123

Date 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:  Sig N Ture Sig N Ture P.K. Lead  Pat K Lead

Amount of Product Involved in Deviation: XXXX 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: F.S. Leader Fred S. Leader

(Name and Signature)

Date of Review: 13 Feb 2015

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

Food Safety Plan Reanalysis ChecklistReason for reanalysis:

Task

Date Reviewedand 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

Employee Training Record• Records could be kept in individual personnel files and summarized for easy access as follows:

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

Record‐keeping Summary

• Required records include the Food Safety Plan and implementation records, as appropriate to the control: Monitoring records, corrective action records, verification 

records, supply‐chain assurances, training records

• Records must be permanent, recorded at the time the activity occurred and identify the facility, date, time (as appropriate) and appropriate signatures

• Records must be verified and must be accessible upon request by the regulatory authority

• Organized and accessible records facilitate implementation, audits and inspections

Questions