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HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
SUPPLIER
AND AND PEST CONTROL
CONTROL
DISTRIBUTION RECALL
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GOOD MANUFACTURING PRACTICES
sets of
principles on
controls,
conditions for
quality and
hygienic
handling/processi
ng/ service of
foods
SANITATION STANDARD OPERATING
PROCEDURES
establishment-
specific sanitation
and hygienic
procedures and
practices
interpretation and
implementation of
GMP by
establishment
HACCP
cGMP SSOP
FACILITIES
Facilities
building
sanitary facilities
lighting
floors, walls, ceilings, doors
ventilation
water supply
waste disposal system
Facilities
Things to consider:
- design Includes programs for
- materials the following:
Building
Must be designed & constructed to
ensure:
- hygienic food handling
- effective cleaning & sanitation
- prevention of entry of pests
- safety of personnel
Facilities
Building
• Location, construction,
maintenance
according to sanitary
design principles With the following
• cleaned on a regular areas:
basis - rest & dining areas
• Lay-out follows a
straight-line process - locker rooms
flow - landscape
garden/trees
- comfort rooms
Facilities
Building
Areas of a Plant:
• Receiving area
• Ingredient storage
area
• Processing area
• Finished product
warehousing area
• Toilet area
Plant Lay-out
Facilities
Main entrance
A simple
factory layout Laboratory Administration
with all
departments
housed within a
single
Production Area EA
compound
Raw
Raw Material Storage FPS
materials
EA = Employee amenities
Final
FPS = Finished Products Storage products
GOOD MANUFACTURING PRACTICES
Raw
materials
Alternative
arrangements Raw Material Storage
of
departments Main
entrance A
under a single
compound Production Area
A = Administration
L = Laboratory L
Finished Product Storage
EA = Employee EA
amenities
Final
products
Facilities
Sanitary Facilities
• Supplied with running water
• Handwashing sink near
processing area & comfort
rooms
• Sinks provided with soap,
nail brush & clean towels
• Facilities for washing &
disinfecting equipment
Facilities
Lighting
• Source: fluorescent light with no
glare & shadow
• Provided with a cover
• Adequate
• Required in food preparation
area, warewashing area,
handwashing stations,
restrooms
Facilities
Floors
• Concrete, kept clean regularly,
free of debris, & properly
drained
• Durable & water resistant
• No cracks, depression, or low
areas
• Drains & gutters carefully
planned & located
Facilities
Walls & Ceilings
• Impervious to moisture, easily
cleanable, smooth & light
colored
• Walls can be tiles, cement
blocks, bricks, concretes &
metals
• Roof is simple, watertight,
sufficiently high, & adequately
vented
• Coving between walls, walls &
Facilities
Doors
• Wide
• Open outward
• Made of corrosion-resistant or
suitable metal with adequate
impact strength
• Self-closing
• With air screen or plastic curtain
Facilities
Ventilation
• Remove obnoxious odors, heat,
& moisture from the plant
• Introduce fresh air, free of any
foreign odors & product
contaminants
• Provide a comfortable
environment for the employees
• Exhaust fan made of rustproof-
coated steel
Facilities
Water Supply
• Sufficient for operations from
adequate source
• Safe & sanitary quality
• Suitable temperature
• Under pressure as needed
• Supplied by a reputable source
Facilities
Waste Disposal
System
• Must meet regulatory
requirements
• Must not cause pollution
problems or create breeding
places for pests
• Sewage system is connected to
the public sewerage system
HACCP
cGMP SSOP
FACILITIES PREMISES
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Premises
• area where the plant
is located and its
Includes programs for
surroundings the following:
cleaning and
sanitation
maintenance and
repair
pest control
Premises
• maintained such that
food is kept from
adulteration and
contamination
• should also consider • location & size must
security and safety support & facilitate
maintenance & sanitary
operations
Premises
Other considerations…
- no domestic animals
- free from garbage/ - free from objectionable
waste odors, smokes, dust &
- free from pollution and other contaminants
dirt - no weeds or grass
- no flooding - concrete roads &
parking space
HACCP
cGMP SSOP
PRODUCTION
FACILITIES PREMISES
EQUIPMENT
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Production
Equipment
• The primary objective is to
prevent adulteration and
contamination of raw materials
and food products with
lubricants, fuel, fragments or
any other foreign matter.
Production
Equipment
constructed & installed in compliance with
sanitary principles
Made of stainless steel/plastic and food-
grade
Made of impervious corrosion-resistant, easily
cleanable, resistant to chipping, & durable
material
Smooth seams on food-contact surfaces
Production
Equipment
installed & kept in manner that supports
preventive maintenance;
replacement of malfunctioning parts;
calibration; and
cleaning schedules
Production
EXAMPLE OF BAD Equipment
TANK
DESIGN
Documents provided
by the supplier to a
client receiving a
product based on
compliance to a set
of specifications
agreed upon
FCC Products,Inc.
106 Naylon Avenue
Livingston, NJ 07039
CERTIFICATE OF ANALYSIS
To:
Lot No:
Quantity:
Product: Apple Cider Vinegar
DESCRIPTION: A composition made from maltro-dextrin, distilled vinegar, and natural flavor. The vinegar is
truly entrapped in a non-hygroscopic matrix.
SPECIFICATIONS: All components of this flavor are approved for use in foods by the
Food & Drug Administration.
Manufacturing Date:
Expiration Date: 18 Months from Manufacturing Date
PERSONAL HYGIENE
Personal Hygiene
Do workers wash their hands before returning to work & after eating
breaks?
Are workers informed of proper handwashing procedures?
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Personal Hygiene
Management’s Responsibility
• To evaluate employee training program,
ask these questions:
– Did the training produced results on the job?
– If intended results ere not produced, why not?
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Personal Hygiene
Management’s Responsibility
• Hiring the right employees
• Using task analysis to determine the food safety
and sanitation requirements for each job
• Establishing employee rules
for personal hygiene
• Supervising and training employees
in good personal hygiene and
food safety practices
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…Personal
Hygiene
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HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CHEMICAL PERSONAL
CONTROL HYGIENE
Chemical Control
• Follow appropriate
segregation, labeling,
use & storage
procedures of food &
non-food chemicals
HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
Cleanliness and
Sanitation
Effective management of sanitation
programs includes education,
participation & proper delegation of
responsibilities among employees
Written detailed plans, procedures,
schedules & checklists regarding
cleaning & sanitizing of food & non-food
processing equipment & facilities
Evaluation of existing cleaning
procedures
Detailed program of control for storage
& use of cleaning & sanitizing chemicals
Cleanliness and
Sanitation
FOOD PLANT SANITATION IS EVERYONE’S
CONCERN!
TOP
MGT.
MIDDLE
MANAGEMENT
Sanitation Plant
Manager Manager
HRD
QA
Manager
Manager
Safety
Production Manager
Manager
HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING
AND
DISTRIBUTION
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Warehousing and
Distribution
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…Warehousing and
Distribution
Lot Identification
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…Warehousing and
Distribution
Lot Identification
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…Warehousing and
Distribution
Storage Principles
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…Warehousing and
Distribution
Storage Principles
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…Warehousing and
Distribution
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…Warehousing and
Distribution
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…Warehousing and
Distribution
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Traceability and Recall
System which
implements proper
coding or labeling of
raw materials and
finished products in
the anticipation of
circumstances which
will require complete
traces of product
retrievals
Traceability and Recall
Intermediaries:
Wholesalers/brokers/
Exports Imports
repackers/exporters/
importers
Shippers
Growers Processors
RECALL
- It is a firm’s voluntary removal of product
from trade or consumer channels (e.g.
importers or manufacturers) to protect the
public from consuming adulterated or
misbranded products
Traceability and Recall
RECALL
any corrective action by a company
needed to protect consumers from
potentially adverse effects of a
contaminated, adulterated, or
misbranded product
Traceability and Recall
RECALL
- It may be an alternative detention or
seizure of adulterated or misbranded
product
- Does not include a market withdrawal or
stock recovery
a Successful Recall Process
• Planning ahead
• Acting quickly
• Effective communication during a
recall
• Recall assessment
Traceability and Recall
Market withdrawal
• Used when a minor violation
is not subject to legal action
Precautionary Hold
• Product suspected of
adulteration/ contamination
restricted for use, held & labeled
pending confirmation of test
results, risk assessment, etc.
Complaint Source
Government Agency Vendor/
Vendor Product Recall
Obtain Manufacturer
Customer Withdrawal Y Batch Info Distributor
Consumer Distribution
Lot Number Broker
Employee Reversal
Container Label Customer
Routine Lab Results needed
Caterer
Other
N
Formally notify customers thru mail or phone call:
1. Product number/ volume produced
2. Batch number, lot number, production date,
spec number
3. Container label
4. Reasons for recall/ withdrawal
Handle as appropriate
5. Manufacturing location
6. Location of distribution
7. Number of cases sent to locations
8. What is its brand
Product Recall/Hold/Withdrawal
9. What to do with products
Communication Flow Chart10. Notify authorities as appropriate
Traceability and Recall
Recall
Classifications
• Class 1 – health hazard situation where there is a
reasonable probability that use of the product will
cause serious adverse health consequences or
death
ex. E. coli O157:H7 in ground beef
• Class 2 – health hazard situation where there is a
remote probability that use of the product will
cause adverse health consequences
ex. Histamine (undeclared)
• Class 3 – health hazard situation where the use of
the product will not cause adverse health
consequences
ex. GRAS (undeclared), excess water
Traceability and Recall
Depth of Recall
1. Consumer level (consumer)
2. Retail level (retail stores)
3. User level (hotel, restaurants)
4. Wholesale level (between manufacturer & retailer)
Health Hazard
Evaluation
• Nature of the violation or defect
• Occurrence of illnesses or injuries
• Likelihood that illnesses may result
• Type of illnesses or injuries that may result
• Procedure to determine the need for a recall
Traceability and Recall
Recall Notice Report
(RNR)
• Provide consumers & public health community
with information related to product in question
• Posted in Regulation Agency Recall website
• Electronically distributed to public health &
inspection program officials throughout the
country with the date & recall case numbers
Parts of RNR
• Specific product recalled with identifying codes
• Name of recalling firm, contact person & phone
nos.
• Quantity of product recalled
• Reason for recall, how & when it was discovered
Traceability and Recall
Recall Notice Report
(RNR)
HACCP
cGMP SSOP
INGREDIENTS
FACILITIES PREMISES EQUIPMENT AND
RAW MATERIALS
CLEANLINESS
CHEMICAL PERSONAL
AND
CONTROL HYGIENE
SANITATION
WAREHOUSING TRACEABILITY
SUPPLIER
AND AND
CONTROL
DISTRIBUTION RECALL
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Supplier Control
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…Supplier Control
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…Supplier Control
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Pest Control