Introductionseafoodhaccp.cornell.edu/blackboard/module11/pdfmod11/...Introduction Welcome to Module 11. In this Module we’ll learn about the 7th and final Principle of HACCPÑ Record

Seafood HACCP Alliance Training Course 11-1

IntroductionWelcome to Module 11. In this Module we'll learnabout the 7th and final Principle of HACCP—Record Keeping. Accurate record keeping is anessential part of a successful HACCP program.

So let's find out what records are needed in aHACCP system, and what information must beincluded in your HACCP records. There are 19pages, 2 interactive HACCP Plan Form worksheets,and 4 questions in this Module.


Why Are Records Needed?Records are important for a variety of reasons.They document that the critical limits have beenmet, and that appropriate corrective actions weretaken when the critical limits were not met, as wellas other components of the HACCP system.Likewise, they provide a means of monitoringtrends so that adjustments or modifications to theprocess can be made as necessary to prevent lossof control. Additionally, there are specificregulatory requirements for HACCP records in theFDA's Seafood HACCP Regulation.

What Types of Records areNeeded?There are four categories of records that need tobe kept as part of the HACCP system. Theseinclude:

1.The HACCP plan and the supportdocumentation used in developing the plan.

2.Records of CCP monitoring results.

3.Records of corrective actions.

4.Records of verification activities.

Let's take a look at each one of these categoriesseparately.


The HACCP Plan FormThe HACCP Plan Form is the record that is typically used to document the firm'sHACCP plan. Examples of this Form have been used as the interactive worksheetsfor our hypothetical firm, the ABC Shrimp Company, in each of the last 4 modules.The HACCP plan must be made available to inspectors and should be kept withthe firm's other HACCP records.


Support DocumentationSupport documentation should also be kept with the HACCP plan. Thesedocuments should include all of the information and data that was used to developthe HACCP plan. This includes the Hazard Analysis Worksheet (Modules 5 and 6),and other data including documents used to help you establish your critical limitssuch as publications, scientific studies, and correspondence with consultants orexperts.


Support Documentation (continued)Examples of critical limit support documentationmay include:

• Data to establish the adequacy of a cookingprocess used to destroy bacterial pathogens.

• Data to establish the adequacy of otherbarriers for bacterial pathogen growth such astime and temperature limits during storage.

• Data used to establish batch processparameters such as the salt concentration,product size, brining time, and brinetemperature necessary to achieve the correctwater phase salt in smoked fish products.

• Letters, reports, or correspondence fromprocessing authorities, food science experts,consultants, laboratories or other sources thatwere used to establish critical limits.

Other support documents for your HACCP systemcould also include:

• A list of the HACCP team members and theirresponsibilities.

• Prerequisite programs such as your company'sSanitation Standard Operating Procedures.

• A summary of preliminary steps taken in thedevelopment of the HACCP plan.

• The Process Flow diagram.

• A Process Flow Narrative.

• The FDA Hazards and Controls Guide.


Records of CCP Monitoring ResultsHACCP monitoring records are primarily keptto demonstrate that significant food safetyhazards have been controlled at CCPs. Theserecords provide the information needed todetermine if critical limits have been met orviolated. Timely review of these records by aHACCP trained individual ensures that theCCPs are being controlled in accordance withthe HACCP plan (see Module 10). Monitoringrecords also provide a means by whichregulators can determine whether a firm is incompliance with its HACCP plan.

Monitoring records can also help firmsidentify and track trends in their process. Bytracking the values recorded on monitoringrecords, an operator or manager candetermine if a process is approaching its

critical limit. Trends can be identified throughrecord review to make necessary processadjustments. If adjustments are made before thecritical limit is violated, processors can reduce oreliminate the labor and material costs associatedwith corrective actions.

Monitoring information should be recorded at thetime the observation is made. False or inaccuraterecords filled out before the operation takes placeor ones that are completed later are illegal andinappropriate for a HACCP system.


Developing Monitoring RecordsProcessors need to develop their own monitoring records. Each record should bedesigned in a format that will allow the person conducting monitoring activities towrite down the actual monitoring observations or measurements at the frequencyspecified in the HACCP plan. They should also clearly identify the firm, time anddate, who conducted the monitoring, who reviewed the results, and the date ofreview. Checklists are not adequate unless the actual measurement orobservation is recorded.

Monitoring records must contain the following information:

• Title of monitoring record,

• Firm name and location,

• Date,

• Time of observation or measurement

• Product identification (e.g. product type, package size, processing line and lotor product code, where applicable),

• Actual observation or measurement,

• Operator's signature or initials,

• Reviewer's signature or initials, and

• Date of review.


Examples of CCP Monitoring RecordsCCP monitoring records should be designed to capture information thatdemonstrates that the critical limit has been met. They should be available in thegeneral area where monitoring occurs and should be filled out when monitoringobservations or measurements are taken. Examples of CCP monitoring recordsmay include:

• Storage cooler temperature records for temperature-sensitive ingredients, in-process materials, and finished products where time/temperature control isnecessary to ensure product safety.

• Receiving records for temperature sensitive products, bivalve molluscanshellfish, or certain products received directly from fishermen or aquaculturefarms.

• Brine records that include the salometer reading (salt level), amount of fish,volume of brine, size or thickness of fish, brining time, and temperature atthe brining step in smoked fish processing which is used to establish a barrierto bacterial pathogen growth in the finished product.

Let's look at examples of the monitoring records for ABC Shrimp Company's twoCCPs—the Cooker and the Weigh/Pack/Label steps. The monitoring record for theWeigh/Pack/ Label step is shown below. Note that all of the required informationdescribed on the previous page has been incorporated into these monitoringrecords.

Example 1—Pack-Room Inspection Record for Weigh/Pack/Label CCP

This figure can also be seen on page 118 of the blue HACCP Training manual.


Example 2—Shrimp Cooker Log for Cooker CCPABC Shrimp has chosen to conduct continuous temperature monitoring using arecording thermometer, and to conduct manual time and temperature checksevery hour. The cooker operator checks the continuous recording chart every hourto confirm that the critical limit was continually met since the last manual check.Time checks are performed by using a stop watch to determine how long it takesa block to move through the steam tunnel. A comparison between a mercury-in-glass (MIG) thermometer and the continuous recording thermometer is madedaily.


The results of hourly observations on 3/4/96 are recorded on the "Shrimp CookerLog" shown above. This record shows that a deviation occurred at 4:28 p.m.,triggering a corrective action (the corrective action record is shown on the nextpage). Note that during the 5:01 p.m. temperature check, the recordingthermometer was reading lower than the MIG (Mercury in Glass) thermometer.This condition is acceptable as long as the two instruments are as close aspossible, but the temperature recording device should not be higher than the MIGthermometer.


Records of Corrective ActionProcessors must also develop a corrective action record to document critical limitdeviations and describe:

1. how control of the process was re-established, and

2. how the affected products were evaluated, and

3. the results of this evaluation, and

4. the disposition of the affected products.

Corrective action records should reflect the nature of the deviation, the firm nameand location, date of the report, and the individuals responsible for the correctiveaction and for reviewing it.

An example and one possible format for a Corrective Action Report for the ABCShrimp Company is shown below. It contains all of the elements that should beincluded in this type of record. This Corrective Action Report was completed as aresult of critical limit deviation that was recorded on the Shrimp Cooker Log record(previous page) at 4:28 pm on Line 1 for Lot Number 053.



Records of Verification ActivitiesA variety of different verification and validation records may be needed dependingon the procedures identified in your HACCP plan. Again, you will need to developyour own verification records. Each of these records should contain the sameelements necessary for monitoring and corrective action records including the firmname and location, date, actual verification measurement or observation, andwho conducted the verification procedure, who reviewed it, and the date of thereview.

Examples of the types of verification records that may be needed includes recordsthat document:

• Modifications to the HACCP plan (e.g., changes in ingredients, formulations,processing, packaging and distribution methods etc.);

• Calibration of all monitoring equipment (e.g. thermometers, salometers, pHmeters etc);

• Processor audit records verifying supplier compliance with guarantees orcertifications;

• Results of periodic in-process and finished product microbiological, chemicaland physical tests if applicable;

• Results of in-house inspections or on-site inspections by experts;

• Results of equipment evaluation or challenge tests.

• Results of process validation studies such as temperature distribution studiesfor thermal processes.


Examples of Verification RecordsAn example of an equipment calibration verification record for the ABC ShrimpCompany is shown below.


The Equipment Calibration Log is used to record the results of the quarterlycalibration of the MIG thermometers used on the cookers. All monitoringequipment such as thermometers should be checked against a standard. In somecases, this standard may be a boiling water bath or an ice slush, depending uponthe instrument and the accuracy requirements for the critical limit beingmonitored. Note that on the 6/12/95 calibration, the thermometer was 1°F abovethe standard thermometer. This could have an impact on the previously producedproduct and could have resulted in critical limit deviations. These should beevaluated, and appropriate corrective action should be taken and recorded.


Examples of Verification Records (continued)The type of verification records needed will vary depending on the process and theprocedures identified in the HACCP plan. For some processors, laboratory tests areused to periodically verify that effective controls are in place at certain CCPs. In thissituation, these laboratory reports are a verification record. Examples of laboratoryreport records for ABC Shrimp Company are shown below.


The A-One Laboratory Report for 6 batches of shrimp shown above is an example of averification record that gives the results of finished product laboratory tests for totalplate count (TPC), coliform bacteria, and the bacterial pathogens: Escherichia coli,Staphylococcus aureus and Salmonella. It's important to keep in mind that there aresituations when the results of a verification activity would necessitate a correctiveaction. For example, this laboratory report shows a positive Salmonella result in Batch1. It would be appropriate for the processor to hold any of the affected lot that is stillin storage and recall any of the product that was no longer under the processor'scontrol. Then the processor could re-cook or destroy the lot. It would also beappropriate to re-evaluate the HACCP plan and its implementation to determine howthis hazard (Salmonella contamination) could have occurred.


Examples of Verification Records (continued)The A-One Laboratory Report for sulfite residuals shown below could also be averification record for the ABC Shrimp Company. This report documents thatsulfite levels in raw materials were less than 10 ppm.



Equipment or Process Validation RecordsThe Cooking Equipment Validation Letter shown below is a record of the initial testthat confirms that the temperature throughout the cooking equipment is at orabove the critical limit when the equipment is properly operated. In this case,professionals from the "Seafood Processing Research and Extension Unit of yourState University" checked the temperature distribution in the cooker and theinternal temperature of a range of shrimp sizes. The results verified that thispiece of thermal processing equipment is capable of delivering the time andtemperature treatment needed at this CCP. All thermal-processing equipmentshould be tested to verify that its performance meets the requirements of theprocess.



Reviewing RecordsMonitoring records for CCPs and critical-limitdeviations must be reviewed in a timely manner byan individual with adequate HACCP training. TheFDA Seafood HACCP regulation requires that allmonitoring and corrective action records bereviewed by an individual who meets the trainingrequirement of the regulation within 1 week of theday that the record is made. All records should besigned or initialed and dated by the reviewer. Thisis a verification activity designed to ensure thatmonitoring and corrective action results show thatcritical limits have been consistently met andappropriate corrective actions have been takenwhen necessary. This is discussed in detail inModules 10 and 12.

Computerized RecordsComputerized records are an option for recordkeeping. When using computerized records,controls must be implemented to ensure thatrecords are authentic, accurate and protected fromunauthorized changes. These records must alsoensure the integrity of the electronic data andsignatures. To view current FDA regulations andpolicies for electronic records and signatures visitthis web site: http://www.fda.gov/ora/compliance_ref/part11/Default.htm.


Tools to Help You Develop Record Keeping ProceduresThere are tools and sources of information available to help you decide what recordkeeping procedures are appropriate and when certain activities such as the calibrationof monitoring devices should be conducted. The FDA Hazards Guide contains guidanceinformation designed to help you develop appropriate record keeping procedures.Specifically, Step #17 in each of the chapters that cover the species and processrelated hazards contains guidance to help you establish appropriate record keepingprocedures. For some hazards there may be more than one example of appropriaterecord keeping procedures. It's important that you select a procedure that isappropriate for your operation and your HACCP plan.

Other resources may also be useful to help you establish procedures for recordkeeping. Outside experts, auditors, consultants or food testing laboratories may alsoplay a role in certain record keeping activities.

Completing the HACCP Plan formThe names of the monitoring records that will be used at each CCP should be enteredin the final section (Column 10) of the HACCP Plan Form.


ABC Shrimp Company ExampleYou will need to return to Module 11 (page 11-17) via the Internet to go throughthe interactive portion of this Module.

Have fun!


Check Your Knowledge

Now you need to return to Module 11 via the Internet.

Click through the text pages until you get to the Check YourKnowledge page (page 11-18). Submit your answers beforemoving on to Module 12.

Good Luck!

Documents

Introductionseafoodhaccp.cornell.edu/blackboard/module11/pdfmod11/...Introduction Welcome to Module 11. In this Module we’ll learn about the 7th and final Principle of HACCPÑ Record