Pre-requisites Monitoring and Verification Activities

Verification or Monitoring
Purpose Procedure FREQUENCY Who
Food Safety
To ensure GMP policies are being Daily visual audit / QA Daily Operational Quarterly or as
Specialist /
6.1.1 Personnel Practices - followed sheet needed
QC Specialist
personal health, cuts &
lesions, smoking, chewing,
eating and drinking Quarterly or as GMP Audit
To monitor onsite practices Monthly wall-to-wall audit
needed Group

To assure the company clothing

Food Safety
policy is being followed and to assure Quarterly or as
6.1.2 Protective Clothing, jewelry and personal effects policies QA Daily Operational sheet Specialist /
needed
Jewelry and Personal QC Specialist
are being followed
Effects
GMP Audit
To monitor onsite practices Monthly wall-to-wall audit Annually
Group

Sign in/Sign out sheet at front reception

To monitor who is on plant property Quarterly or as
area, required to initial on Receptionist
as a visitor at all times needed
understanding of basic GMPs
6.1.4 Visitors

Quarterly or as Food Safety

To monitor onsite practices Quarterly Food Safety audits
needed Team

To assure personal health and basic

Human
food safety practices are being Medical screening
Resources
6.2 Personnel Processing followed
Practices, hand washing,
GMP's Food Safety
Quarterly or as
To monitor onsite practices QA Daily Operational sheet Specialist /
needed
QC Specialist

Human
To assure all necessary training for Quarterly or as
Training Register Resources /
employees is adequate and current needed
QA Dept
6.3 Training Requirements
6.3 Training Requirements
To assure the quality of the training
Quizzes on training performed & sign-off
performed and demonstrate the Various Trainers
sheets
employees understanding

To establish and maintain accurate Charm Science,

Food Safety
calibrations for equipment critical to Calibration Register PMO Appendix N
Specialist
food safety and food quality Form 2400

To establish and maintain accurate Quarterly assessment of MP2 schedule

calibrations for equipment critical to along with HTST quarterly HTST
food safety and food quality NCDEHNR records
6.4.1 Calibration of
Equipment Protocol
To establish and maintain accurate
Daily calibration Verification of Lab
calibrations for equipment critical to QA
equipment & Production Scales
food safety and food quality

To establish and maintain accurate

Quarterly assessment of PM schedule Facilities
calibrations for equipment critical to
along with quarterly records manager
food safety and food quality

To assure there is an adequate

Review application records and service
program in place to reduce or Food Safety
reports, review sighting logs as well as
eliminate the possibility of Specialist
trend reports
contamination by pests or vermin
6.5.1 Pest and Vermin
Control Daily SSOP sheet for performance of Quarterly or as
To monitor onsite practices QA Dept
duties needed

To monitor pest control vendor

Monthly wall-to-wall audit QA
practices

Quarterly or as
To monitor onsite practices QA Daily Operational sheet QA Dept
needed
To monitor failures in order to
Facilities
6.6.1 Premise and evaluate the effectiveness of the Review of Maintenance Logs
Manager
Equipment Maintenance maintenance program
Program
 6.6.1 Premise and
Equipment Maintenance
Program
To monitor building and grounds Food Safety
Inspection of building and grounds
maintenance Team

To assure processing equipment and

Food Safety
the environment are clean and QA Pre-op inspections
Specialist
sanitary

6.7 Cleaning and

Sanitation Program To monitor and verify effectiveness Listeria Alternative #3 program,
VP of QA
of environmental cleaning sanitation swabs

To monitor and verify effectiveness Listeria Alternative #3 program, Food Safety

of cleaning procedures sanitation swabs Specialist

To assure the daily routine sanitary

Daily SSOP sheet for performance of
condition and waste removal from Quarterly or as
duties / Master Sanitation Sheets / QA Dept
bathrooms, hallways, offices, hand needed
Bathroom Sanitation Log
sinks and dumpsters
Chemical register containing MSDS,
6.7 Cleaning and To assure correct cleaning and
specification sheets and labels for all
Sanitation Program sanitizing agents are used for proper QA Dept
approved cleaning chemicals, daily
soils
sanitizer control form

To assure empty chemical containers Quarterly or as Food Safety

Monthly wall-to-wall audit
are disposed of in a proper manner needed Specialist

To assure the consistent potability of

water, and glycol used in the food Outside
Full chemical analysis of well water
processing operation and lavoratory Laboratory
areas

To assure the consistent potability of

Outside
water used in the food processing Full chemical analysis of well water
Laboratory
operation
6.8 Water Quality
Review well water test results for Water micro analysis results from Outside
coliforms approved laboratory Laboratory
 Backflow Prevention devices Monthly wall-to-wall Audit / QA Daily Food Safety
operating properly Operational Checklist Specialist
Maintenance
PM Program according to the State
Backflow prevention device and/or outside
Plumbing code
contractor
To assure that foreign matter does Pre-startup inspection for foreign Food Safety
not find its way into food products matter in production areas Specialist

To assure that foreign matter does

Metal Detection Program QC Techs
not find its way into food products
6.9 Foreign Matter and
Glass Policy
To assure that foreign matter does Daily / Weekly / Quarterly Sanitation Production
not find its way into food products Sheets & Visual Inspection Personnel

VP of QA to
To assure that foreign matter does delegate to
Glass Control Log
not find its way into food products appropriate
personnel
To assure the correct disposition of
6.9.3 Foreign Material All incidents of foreign matter
product that has been contaminated VP of QA
Incident Management contamination are reported to QA
with foreign matter

To maintain an approved list of

Approved Supplier register containing
suppliers to assure formulas, quality,
specifications, risk analysis and VP of QA
labeling and specifications are
maintains approved COA procedure
6.10.1 Approved Supplier maintained
Program
Annual review of COA compliance,
inspection of ingredients and/or
Monitoring of the consistency and
packaging at receipt along with any VP of QA
reliability of suppliers
ingredient and/or packaging
noncompliances
To assure the consistency and
6.11.1 Transport and Receiving /
preservation of quality during Transportation Visual Checksheets
Delivery Shipping Dept
transport to the customer

To assure continuous sanitary

Quarterly or as Food Safety
conditions both in and around the QA Daily Operational sheet
needed Specialist
processing facility
6.12.1 Waste Management
and Disposal
6.12.1 Waste Management
and Disposal To assure the daily routine sanitary
condition and waste removal from Production
Daily / Weekly Master Sanitation Sheets
bathrooms, hallways, offices, hand Personnel
sinks and dumpsters

Risk assessment for ingredients

6.13 Allergen Control Risk assessment for new ingredients
containing allergens / Vendor Approval HACCP Team
Program that may contain allergens
Program
ies

Frequency RESPONSIBILITY Records Corrective Action

Maintenance and Lab

Daily QC LAB Alert Employee, Alert Supervisor, Disciplinary Action on repeated occurrences
Tech

Maintenance and
Monthly Instrumentation VP of QA's Office Alert Employee, Alert Supervisor, Disciplinary Action on repeated occurrences
Services, Inc

Maintenance and
Daily Instrumentation QC LAB Alert Employee, Alert Supervisor, Disciplinary Action on repeated occurrences
Services, Inc

Maintenance and
Monthly Instrumentation VP of QA's Office Alert Employee, Alert Supervisor, Disciplinary Action on repeated occurrences
Services, Inc

Upon
Maintenance and JA Reception Area / QC
entrance of Report non-documented visitors immediately to management team.
King & Co. LAB
building

NCDENR&
Quarterly VP of QA's Office Report non-documented visitors immediately to management team.
Maintenance

Maintenance/Outside Human Resource

At hire date Do not hire. Place employee in non product contact area
Service Contractor office

Maintenance and Lab

Daily QC LAB Alert employee, Alert Supervisor, Disciplinary Action on repeated occurrences
Tech

Human Resources /
Varies Perform Training and Retraining Annually
VP of QA's office
 VP of QA's Office /
Varies Perform Training or retraining. Retake quiz.
Human Resources

Per
manufacture
r's Lab Tech., Supervisor VP of QA's Office Assess reason for non calibration and take corrective action as necessary
recommende
d schedule

Assess reason for non calibration and take corrective action as necessary

Daily QC LAB Assess reason for non calibration and take corrective action as necessary

Quarterly Maintenance office Evaluate and take corrective action.

Take necessary action both for physical repair, change of service, quality or
Weekly QC LAB
frequency so as to minimize future positive results

Maintenance and Lab Alert pest control services and/ or perform maintenance for defective protection or
Daily QC LAB
Tech correct poor employee practice

Alert pest control services and/ or perform maintenance for defective protection or
Monthly QC LAB
correct poor employee practice

Maintenance and Lab

Daily QC LAB Alert employee, Alert Supervisor, Disciplinary Action on repeated occurrences
Tech

Quarterly Engin Maintenance Office Alter frequency of preventative maintenance to reduce failures
 Monthly SQF VP of QA's Office Correct all defects or deviations and/or document reason for non-compliance

Review with employee, alert supervisor and reclean. Take disciplinary action for
Daily SQF QA Office
repeated failure to complete tasks.

Take appropriate action to increase frequency and/or cleaning methods to gain

Monthly VP of QA's Office
consistent negative results

Weekly QC LAB Reclean equipment as necessary and retest till test result is negative before startup

Maintenance and Lab

Daily QC LAB Reclean to sanitary condition.
Tech

Continuous SQF QC LAB Refrain from using chemicals not approved

Maintenance and
Monthly Instrumentation VP of QA's Office Alert employee, Alert Supervisor, Disciplinary Action on repeated occurrences
Services, Inc

Yearly VP of QA's Office Notify QA and take appropriate action to regain negative test results

Yearly VP of QA's Office Notify QA and take appropriate action to regain negative test results

Work with Maintenance and regional QA to determine severity of out-of-specification

Monthly VP of QA's Office
and take corrective action.
 Monthly QC LAB Malfunctioning devices will be replaced

Annually VP of QA's office Backflow preventers that fail the annual test will be repaired, replaced and retested

Daily Lab QC LAB Remove foreign matter prior to startup

Document and report findings on forms provided. Alert supervisor and QA

Daily QC LAB immediately to any debris that may be considered hazardous to food safety and/or
food quality

Weekly QC LAB Report to VP of QA in writing for corrective action as necessary

Daily QC LAB Report to VP of QA in writing for corrective action as necessary

Continuous QC LAB QA documents failures and takes corrective action Per Product Hold Policy

In the event a non approved supplier ships materials in, QA must be immediately
notified and take corrective action to either reject shipment or place
Annually VP of QA's Office
product/ingredient On Hold until such time the supplier qualifications can be
evaluated

Upon evaluation of risk, send warning letter and place product or ingredient On Hold.
Annually SQF VP of QA's Office
Take necessary action up to and including supplier elimination and replacement.

Receiving / Shipping Alert employee, refresh or retrain, Alert Supervisor, Disciplinary Action on repeated
Daily
Offices occurrences

Correct and remedy conditions, alert employee responsible, alert employee

Daily Q QC LAB
supervisor and disciplinary action on repeated occurrences
 Daily SQF QC LAB Reclean to sanitary condition

Immediate corrective measures, embargo or place On Hold any suspect ingredient or

Annually VP of QA's office
product until a determination can be made regarding disposition of the material