Pre-requisites Monitoring and Verification Activities

Purpose Verification or Monitoring Procedure Who Frequency Records Corrective Action

Food Safety
To ensure GMP policies are being Alert Employee, Alert Supervisor,
6.1.1 Personnel Daily visual audit / QA Daily Operational sheet Specialist / QC Daily QC LAB
followed Disciplinary Action on repeated occurrences
Practices - personal Specialist
health, cuts & lesions,
smoking, chewing,
eating and drinking Alert Employee, Alert Supervisor,
To monitor onsite practices Monthly wall-to-wall audit GMP Audit Group Monthly VP of QA's Office
Disciplinary Action on repeated occurrences

To assure the company clothing

Food Safety
policy is being followed and to Alert Employee, Alert Supervisor,
QA Daily Operational sheet Specialist / QC Daily QC LAB
6.1.2 Protective assure jewelry and personal Disciplinary Action on repeated occurrences
Specialist
effects policies are being followed
Clothing, Jewelry and
Personal Effects
Alert Employee, Alert Supervisor,
To monitor onsite practices Monthly wall-to-wall audit GMP Audit Group Monthly VP of QA's Office
Disciplinary Action on repeated occurrences

To monitor who is on plant Sign in/Sign out sheet at front reception area, Upon entrance of Reception Area / Report non-documented visitors
Receptionist
property as a visitor at all times required to initial on understanding of basic GMPs building QC LAB immediately to management team.

6.1.4 Visitors
Report non-documented visitors
To monitor onsite practices Quarterly Food Safety audits Food Safety Team Quarterly VP of QA's Office
immediately to management team.

To assure personal health and

Human Resource Do not hire. Place employee in non product
basic food safety practices are Medical screening Human Resources At hire date
6.2 Personnel office contact area
being followed
Processing Practices,
hand washing, GMP's Food Safety
Alert employee, Alert Supervisor,
To monitor onsite practices QA Daily Operational sheet Specialist / QC Daily QC LAB
Disciplinary Action on repeated occurrences
Specialist

To assure all necessary training Human Resources /

Human Resources /
for employees is adequate and Training Register Varies VP of QA's Perform Training and Retraining Annually
QA Dept
current office

6.3 Training
Requirements To assure the quality of the
VP of QA's Office /
training performed and
Quizzes on training performed & sign-off sheets Various Trainers Varies Human Perform Training or retraining. Retake quiz.
demonstrate the employees
Resources
understanding
 To establish and maintain
Per manufacturer's
accurate calibrations for Assess reason for non calibration and take
Calibration Register Food Safety Specialist recommended VP of QA's Office
equipment critical to food safety corrective action as necessary
schedule
and food quality

To establish and maintain

6.4.1 Calibration of accurate calibrations for Daily calibration Verification of Lab equipment & Assess reason for non calibration and take
QA Daily QC LAB
Equipment Protocol equipment critical to food safety Production Scales corrective action as necessary
and food quality

To establish and maintain

accurate calibrations for Quarterly assessment of PM schedule along with
Facilities manager Quarterly Maintenance office Evaluate and take corrective action.
equipment critical to food safety quarterly records
and food quality

To assure there is an adequate Take necessary action both for physical

program in place to reduce or Review application records and service reports, repair, change of service, quality or
Food Safety Specialist Weekly QC LAB
eliminate the possibility of review sighting logs as well as trend reports frequency so as to minimize future positive
contamination by pests or vermin results

6.5.1 Pest and Vermin

Control Alert pest control services and/ or perform
To monitor onsite practices Daily SSOP sheet for performance of duties QA Dept Daily QC LAB maintenance for defective protection or
correct poor employee practice

Alert pest control services and/ or perform

To monitor pest control vendor
Monthly wall-to-wall audit QA Monthly QC LAB maintenance for defective protection or
practices
correct poor employee practice

Alert employee, Alert Supervisor,

To monitor onsite practices QA Daily Operational sheet QA Dept Daily QC LAB
Disciplinary Action on repeated occurrences

6.6.1 Premise and To monitor failures in order to

Alter frequency of preventative maintenance
Equipment evaluate the effectiveness of the Review of Maintenance Logs Facilities Manager Quarterly Maintenance Office
to reduce failures
Maintenance Program maintenance program

To monitor building and grounds Correct all defects or deviations and/or

Inspection of building and grounds Food Safety Team Monthly VP of QA's Office
maintenance document reason for non-compliance

To assure processing equipment Review with employee, alert supervisor and

and the environment are clean and QA Pre-op inspections Food Safety Specialist Daily QA Office reclean. Take disciplinary action for
sanitary repeated failure to complete tasks.

6.7 Cleaning and To monitor and verify Take appropriate action to increase
Sanitation Program effectiveness of environmental Listeria Alternative #3 program, sanitation swabs VP of QA Monthly VP of QA's Office frequency and/or cleaning methods to gain
cleaning consistent negative results
 Sanitation Program
To monitor and verify
effectiveness of cleaning
procedures
To assure the daily routine
sanitary condition and waste
removal from bathrooms,
hallways, offices, hand sinks and
dumpsters
6.7 Cleaning and
Sanitation Program To assure correct cleaning and
sanitizing agents are used for
proper soils
To assure empty chemical
containers are disposed of in a
proper manner
To assure the consistent potability
of water, and glycol used in the
food processing operation and
lavoratory areas
To assure the consistent potability
of water used in the food
processing operation
6.8 Water Quality
Review well water test results for
coliforms
Backflow Prevention devices
operating properly
PM Program according to the
State Plumbing code
To assure that foreign matter does
not find its way into food products
To assure that foreign matter does
not find its way into food products
6.9 Foreign Matter and
Glass Policy
Reclean equipment as necessary and retest
Listeria Alternative #3 program, sanitation swabs Food Safety Specialist Weekly QC LAB
till test result is negative before startup
Daily SSOP sheet for performance of duties /
Master Sanitation Sheets / Bathroom Sanitation QA Dept Daily QC LAB Reclean to sanitary condition.
Log
Chemical register containing MSDS, specification
sheets and labels for all approved cleaning QA Dept Continuous QC LAB Refrain from using chemicals not approved
chemicals, daily sanitizer control form
Alert employee, Alert Supervisor,
Monthly wall-to-wall audit Food Safety Specialist Monthly VP of QA's Office
Disciplinary Action on repeated occurrences
Notify QA and take appropriate action to
Full chemical analysis of well water Outside Laboratory Yearly VP of QA's Office
regain negative test results
Notify QA and take appropriate action to
Full chemical analysis of well water Outside Laboratory Yearly VP of QA's Office
regain negative test results
Work with Maintenance and regional QA to
Water micro analysis results from approved
Outside Laboratory Monthly VP of QA's Office determine severity of out-of-specification
laboratory
and take corrective action.
Monthly wall-to-wall Audit / QA Daily
Food Safety Specialist Monthly QC LAB Malfunctioning devices will be replaced
Operational Checklist
Maintenance and/or Backflow preventers that fail the annual test
Backflow prevention device Annually VP of QA's office
outside contractor will be repaired, replaced and retested
Pre-startup inspection for foreign matter in
Food Safety Specialist Daily QC LAB Remove foreign matter prior to startup
production areas
Document and report findings on forms
provided. Alert supervisor and QA
Metal Detection Program QC Techs Daily QC LAB immediately to any debris that may be
considered hazardous to food safety and/or
food quality
6.9 Foreign Matter and
Glass Policy
To assure that foreign matter does
not find its way into food products
To assure that foreign matter does
not find its way into food products
To assure the correct disposition
6.9.3 Foreign Material
of product that has been
Incident Management contaminated with foreign matter
To maintain an approved list of
suppliers to assure formulas,
quality, labeling and
specifications are maintained
6.10.1 Approved
Supplier Program
Annual review of COA compliance, inspection of
Monitoring of the consistency and
ingredients and/or packaging at receipt along with
reliability of suppliers
any ingredient and/or packaging noncompliances
To assure the consistency and
6.11.1 Transport and
preservation of quality during
Delivery transport to the customer
To assure continuous sanitary
conditions both in and around the
processing facility
6.12.1 Waste
Management and
Disposal To assure the daily routine
sanitary condition and waste
removal from bathrooms,
hallways, offices, hand sinks and
dumpsters
Risk assessment for new
6.13 Allergen Control
ingredients that may contain
Program allergens
Daily / Weekly / Quarterly Sanitation Sheets & Report to VP of QA in writing for corrective
Production Personnel Weekly QC LAB
Visual Inspection action as necessary
VP of QA to delegate to Report to VP of QA in writing for corrective
Glass Control Log Daily QC LAB
appropriate personnel action as necessary
All incidents of foreign matter contamination are QA documents failures and takes corrective
VP of QA Continuous QC LAB
reported to QA action Per Product Hold Policy
In the event a non approved supplier ships
materials in, QA must be immediately
Approved Supplier register containing
notified and take corrective action to either
specifications, risk analysis and maintains VP of QA Annually VP of QA's Office
reject shipment or place product/ingredient
approved COA procedure
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.
VP of QA Annually VP of QA's Office
Take necessary action up to and including
supplier elimination and replacement.
Alert employee, refresh or retrain, Alert
Receiving / Shipping Receiving /
Transportation Visual Checksheets Daily Supervisor, Disciplinary Action on repeated
Dept Shipping Offices
occurrences
Correct and remedy conditions, alert
employee responsible, alert employee
QA Daily Operational sheet Food Safety Specialist Daily QC LAB
supervisor and disciplinary action on
repeated occurrences
Daily / Weekly Master Sanitation Sheets Production Personnel Daily QC LAB Reclean to sanitary condition
Immediate corrective measures, embargo or
Risk assessment for ingredients containing place On Hold any suspect ingredient or
HACCP Team Annually VP of QA's office
allergens / Vendor Approval Program product until a determination can be made
regarding disposition of the material