Records – Implementation

The second type of records are implementation records. Implementation records demonstrate that the food safety system is operating as planned. They provide evidence that the activities were completed and are effective.

Implementation records include the operational data from activities; this information was collected during actual production, and provide the proof that you are supplying safe food to your customers. Example forms are shown here and can be downloaded from the Appendix, or you can use your own to capture the results of monitoring, corrective actions, and other activities, such as:

• Preventive control monitoring data
• Corrective actions taken
• Verification activities
• Supply-chain program implementation
• Training

The implementation records can be listed in a “Records” column on the Process Preventive Control form.

Verification of Process Preventive Control for aflatoxin

PROCESS PREVENTIVE CONTROLS
PRODUCT:							PAGE 1 of ___________
FACILITY:							ISSUE DATE:
ADDRESS:
Process Control	Hazard(s)	Critical Limits	Monitoring				Corrective Action	Verification	Records
			What	How	Frequency	Who
Roasting	Non-sporeforming pathogens such as Salmonella	Minimum roasting time: 25 minutes	Length of roast cycle	Measure time-in to time-out with stop watch and metal test unit run through oven	Beginning of shift and after any adjustment	Roaster operator	If roasting is interrupted, product is held and evaluated to determine if it can be reprocessed. If a processing parameter was not met, reprocess batch using alternate validated process; identify root cause and determine actions needed to address it; conduct training as needed to prevent recurrence. Also, segregate and evaluate product, rework or discard as appropriate.	Operator verifies the roaster bed depth, temperature and roasting time are accurate and operating properly during the processing run once each day during morning shift. QA manager reviews and initials records within a week of preparation and compares performance with past results to determine trends. Maintenance manager ensures that roster and monitoring equipment are calibrated. Finished product tested for Enterobacteriaceae once every 2 weeks. Salmonella is analyzed if hygiene Enterobacteriaceae counts are found to be out of specification.	Roasting log, including time, temperature and depth records. Recording device calibration records Corrective action logs Validation study establishing roasting parameters
		Bed depth ≤2 inches	Bed depth leveling bar height	Leveling bar height is set at 2 inches high at oven inlet	Check at startup and end of day
		Oven temperature ≥300 degrees F. Note: to achieve 5 log reduction of Salmonella	Oven air temperature	Recording thermometer at the coldest locations (i.e., inlet and outlet of oven)	Continuous with visual check of recorded data at startup and once per day at each location

FSPCA, (2016). PC Course Instructor Guide V1.2, page 17.

Basic information that should be on all records includes:

• Name of record
• Name and location of facility
• Date and time where applicable
• Measurement or observation
• Product identification
• Signature or initials of persons performing monitoring 
• Signature or initials of person reviewing record

Monitoring records are used to document that food safety hazards have been controlled.

Monitoring Records

ALLERGEN LABEL CHECK MONITORING LOG
COMPANY OR FACILITY NAME:				FACILITY LOCATION:
PRODUCT:
Parameters: All finished product labels must declare the allergens present in the formula
Date	Time	Lot Code	Lot Number	Proper Label Applied		Line operator (initials)
				Yes	No
[ Example ]
	[ Example ]
		[ Example ]
Verification Reviewer Signature:				Date of Review:
Date issued:				Supersedes issue:

DAILY COOKER MONITORING LOG
COMPANY OR FACILITY NAME:				FACILITY LOCATION:
PRODUCT:
Date	Time	Lot Code	Lot Number	Proper Label Applied		Line operator (initials)
				Yes	No
[ Example ]
	[ Example ]
		[ Example ]
Verification Reviewer Signature:				Date of Review:
Date issued:				Supersedes issue:

Corrective Action Records

Information that should go on a corrective action record includes:

• Product identification
• Volume on hold
• Deviation description
• Actions taken to prevent recurrence
• Final disposition of product
• Evaluation of testing results if relevant
• Corrective action verification

CORRECTIVE ACTION
Date of Record: 6 February 2016		Lot Number: AY123
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 label. 4. 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 taking action: Mr. P.K. Lead
Amount 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: Ms. Sandy Lane	Sandy Lane		Date: 20 February 2015

Verification Records

Verification records should include:

• Verification of monitoring and corrective action records
• Calibration and accuracy checks of process-monitoring instruments
• Product testing
• Environmental monitoring
• Supply-chain program verification
• Reanalysis

QUARTERLY THERMOMETER CALIBRATION LOG
COMPANY OR FACILITY NAME:			FACILITY LOCATION:
PRODUCT:
Verification: Check each thermometer quarterly against a thermometer traced to a recognized standard. Temperature must be +/- ___ degrees from the standard.
Date of calibration	Instrument number(s)	Method of calibration	Calibration results	Within specification		Line operator initials
				Yes	No
[ Example ]
	[ Example ]
		[ Example ]
Reviewer signature:				Date of Review:
Date issued:				Supersedes:

Validation Records

Examples of Validation Records might be:

• Process validation records
• In-plant studies
• Research studies
• Journal articles
• Industry or regulatory guidance