QUALITY ASSURANCE PROGRAMME
GOOD MANUFACTURING PRACTICES
by
Syed Abdul Rahim bin Syed Abdul Rashid
Chief Operations Officer
WHAT IS GOOD
MANUFACTURING
PRACTICES?
procedures to ensure products are
manufactured to meet a certain quality and
safety requirement
 these procedures describe the methods,
equipment, facilities and controls for all
manufactured goods
GOOD MANUFACTURING
PRACTICES
prerequisite program for food quality and
safety plans e.g. HACCP, ISO9000
GMPs -develop,implement, review and
verify:in place and effective
GMP programs ensure HACCP plans focus
on CCPs to produce safe food
MANAGEMENT
RESPONSIBILITIES
• understand the benefits of GMP, its
implementation and coordination
• know the difference between GMPs and HACCP
• know the consequences of not having a good
quality assurance program
• ensure line workers and QC personnel are brought
to a knowledge level commensurate with the
needs of their jobs
MANAGEMENT
RESPONSIBILITIES
• manager communication and employee
training
• provision for food safety system
• facility improvement
• total commitment and involvement
GOOD MANUFACTURING PRACTICES
Programs include:
premise and environment
equipment and utensils
personnel
sanitation facilities and operation
pest control program
supplies
storage and distribution
process control
product recall programs
HOW FOOD CAN BE
CONTAMINATED?
DIRECT CONTACT
FOOD CONTACT SURFACES
NON-FOOD CONTACT SURFACES
SITE OR LOCATION
suitable location
good housekeeping- proper equipment
storage,litter and waste disposal, cut grass
within the vicinity of the plant buildings
or structures
prevent entry or harborage of pests
adequate drainage
general maintenance- roads, yards, and
parking lot
PREMISES
• layout- unilateral flow
• design, construction and maintenance
-sufficient space
-prevent contamination
-facilitate cleaning
-adequate lighting
-adequate ventilation
-adequate screening- protection against
pests
EQUIPMENT
• design, material and construction
- prevent hygienic hazards and permit easy
cleaning
- visible for inspection
- food contact surfaces - corrosion-resistant,
nontoxic, withstand cleaning and sanitizing agents
- seams- smooth, tubular construction
EQUIPMENT (continue)
• non-food contact surfaces clean condition, well maintained
• installation - facilitate easy cleaning
• high risk food storage equipment • fitted with temperature measuring/
recording devices
EQUIPMENT (continue)
• instruments and control
- temperature, pH, acidity, water activity
etc.
- adequate in number
- maintenance, calibration
• compressed air and gases from equipment
- treated to prevent against contamination
DISEASE CONTROL &
MONITORING
•
•
•
•
•
•
•
•
written policy & documented
health questionnaire - upon employment
medical examination
communicable diseases
open lesion - boils, sores, infected wounds
report to supervisors
medical facilities
discourage visitors
PERSONAL HYGIENE
Personal cleanliness
- hygienic practices
Education and training
- appropriate training
Supervision
- assign competent supervisors
PERSONAL CLEANLINESS
• protective outer garments
- clean, light color and change when soiled or
contaminated
• gloves
- disposable gloves, food grade, cotton gloves not permitted
• effective hair restraints
- cover all hair, beard cover
• jewelry
- no loose jewelry, earrings, brooches, rings and wrist watches
PERSONAL CLEANLINESS
• suitable footwear
- shoes, gumboots
• wet (foot bath) or dry lock system
• proper hand wash
• fingernails
- clean and neatly trimmed, polish and
artificial nails not allowed
PERSONAL CLEANLINESS
• no hand cream and other cosmetics, medicines
• no smoking, eating, gum chewing, drinking water or
beverages
• laundry services
• worker welfare
- canteen/cafeteria
- locker room
- toilet & bath
- masjid
HAND WASHING
before start work
after absence from work station
after going to toilet
after handling non-food or raw material
when hands are soiled or contaminated
EDUCATION AND TRAINING
•personnel in-charge
- education and experience
•food handlers and supervisors
- proper food handling techniques and food safety
principles e.g. Food Handling, Hygiene &
Sanitation, GMP, HACCP
•technical training
- understand the processes and assigned tasks
•refresher course & training
- continuos
SUPERVISION
• competent supervisors
• responsible
- assuring compliance by all personnel with all
requirements
• inspection
• employee improvement worksheet
SANITATION FACILITIES
AND
SANITATION OPERATIONS
SANITARY FACILITIES
• Water supply must be :
- sufficient, derived from a sanitary source
- suitable temperature and pressure
- stainless steel or food grade tanks
- conduct sedimentation and
microbiology tests (TPC & Coliform)
SANITARY FACILITIES
• Plumbing
- overhead system - pipe water supply
comes from the top.
- carry sufficient water
- provide adequate floor drainage
- no back flow, cross - connection between
sewage/waste water and water for
manufacturing food
- non-rust material
- 1 1/2 days water supply (reserve)
SANITARY FACILITIES
• Sewage disposal
- adequate and proper
• Toilet facilities
- adequate, easily accessible
- good repair at all times
- self closing doors
-do not open where food is exposed to airborne
contamination
- main door
- not wood, away from processing area
- clear and proper signs
SANITARY FACILITIES
• Hand washing facilities
- adequate,essential location
- hand cleaning and sanitizing agents provided
- paper towels or drying devices
- foot or knee operated or sensor
type taps
- warm running water
- proper refuse bin (foot operated)
SANITARY FACILITIES
• Rubbish and offal disposal
- conveyed, stored and disposed
properly
- avoid accumulation of waste
- easy cleaning
SANITARY OPERATIONS
General maintenance
- buildings, fixtures and
other facilities
- utensils and equipment
Cleaning & sanitation materials
and toxic materials storage
Pest control
SANITARY OPERATIONS
• Written Instructions
• a Planned Cleaning Schedule
• Cleaning Schedule should have details on
- the equipment/area cleaned
- name of person in charge
- frequency
- method
- type of detergent and
sanitizer
SANITARY OPERATIONS
• Dismantle Instructions
(equipment)
- safety precautions
- standard
- person who check, record
and verify
CLEANING PROGRAMME
• a planned schedule of how, when and where
cleaning will be done
• include written instructions giving details of:
the frequency,
the method,
the strength,
type of detergent and sanitiser to be used,
any variations,
how to dismantle the equipment for cleaning,
method of application
CLEANING METHODS
The are 5 cleaning methods:
•
•
•
•
•
manual
soak
pressure
foam
in-place cleaning
DETERGENTS &
SANITISING
 Types of detergents
• acidic detergents
• alkali detergents
 Methods of sanitising
• steam sanitising
• hot-water
• chemical sanitising eg halogens, Na
hypochlorite, chlorine releasing comp. ,
quaternary amm. comp., phenolics and
other surfactants (acid anionics etc)
CLEANING PROCEDURE
• dry clean the entire area
• wet all equipment by hosing with lowpressure water at a temperature less than
45 °C
• apply a suitable detergent
• rinse off detergent
• apply sanitiser to all surface
• rinse off surfaces with hot water at 82 °C
• drain off all water on equipment and floors
CLEANING REMOVABLE
EQUIPMENT
• dry clean
• hose with warm water
• immerse individually in hot water (55-60°C)
containing a detergent or detergent/sanitiser
• after soaking 20 mins scrub all surfaces and rinse
clean with warm water
• if only detergent is used than repeat step above
and rinse off with water (82°C)
• place all equipment in such a manner that
surfaces are not touching and allows to air-dry
HOW CLEAN IS CLEAN
Two types of determination
• organoleptic test - general appearance
• microbiological test
replica or contact method eg agar
slice method, rodac plates and cellulose tape
swab method eg agar plate swab and
rinse method
CLEANING AND SANITIZING
MATERIALS AND TOXIC
MATERIAL STORAGE
• free from contamination, safe, adequate
• compliance- supplier certification,
examination
• identified, held and stored to protect
against contamination
• separate locked rooms or cabinets
PEST CONTROL
• control of insects, rodents, birds or other
vermin
• effective, on-going written program
• trained personnel or professional pest
control
• regular inspection
• layout-bait or trap station
PEST CONTROL
• rodenticides, fumigants, insecticidesapproved by the authority, instruction on
usage, dosage, collection of dead pests
• proper measures to prevent crosscontamination
• inspection, action, record and verify
• guard and watch dogs (tied or caged)
• do not feed or encourage stray animals
WHAT ARE THE SIGNS OF
INFESTATION?
LOOK OUT FOR
 smell
 droppings
 smears
 path
 part of body
 damage
 maggots
HOW PESTS GET INTO THE
PREMISE?






deliveries- raw material
attracted by smell of food
encouraged by employees
cracks, gaps, holes
drainage system
windows, doors, ventilation
PEST CONTROL
• maintain good housekeeping
• all employees trained to recognise pest
infestation signs and procedures on how
to prevent and control them
• premise kept in good repair
• traps kept clean and in good repair
• proper hygienic practices
• practice good stock rotation
• screens at doors, windows, and other
outlets
SUPPLIES
•
•
•
•
raw materials and other ingredients
inspect, segregate, clean, store
receiving area away from processing area
inspection upon receipt, storage and
before use
• wash and clean- contaminant and
minimize deterioration
• store under proper condition
• compliance with requirements
SUPPLIES
• Requirements
- level of microorganisms
- other hazards
- physical specifications
- packaging
- temperature
Supplier Quality Assurance (SQA)
• Compliance with requirements verified
by a planned and managed Supplier
Quality Assurance (SQA)
• SQA
- agreed specifications
- audits
- Certificates of Analysis
Supplier Quality Assurance (SQA)
Specifications
• develop good customer-supplier
relationship
• accepted criteria (quality and safety)
• define all factors
• limits/tolerance level
Raw Material Specification
• detail of
supplier
• description of
raw material
• tolerance limits
• microbiological
criteria
• sampling plans
• labeling
requirements
• storage and
distribution
conditions
• pack type,size and
quantity
Supplier Audit
• all raw materials, priority to high-risk
raw materials
• trained and experienced personnel/third
party auditors
• twice a year
Supplier Audit
co.,
add.,ownership
 history
 production site
 types of products
adopt any food
safety system
on-site/contract
laboratories
 pest control
programs
 good personnel
hygiene practices
 specifications of
all products
 training
 transportation
Certificates of Analysis
(CA)
• confirm raw materials have been
sampled
• meet all criteria
• prepared by competent laboratories
Packaging Material
•
•
•
•
•
•
•
comply with specification
inspected, sampled and tested
protected
no adverse interaction
stand up to subsequent treatment
provide necessary characteristics and integrity
carry information required
PROCESS CONTROL
all operations conducted in accordance
with adequate sanitation principles
quality control operations
overall sanitation
production procedures- do not contribute
contamination from any source
testing methods- chemical, microbiology
and extraneous material
contaminated or suspect food
Raw materials and other
ingredients
inspected
 stored
 washed or cleaned
 not contaminated
 holding identification

MANUFACTURING
OPERATIONS
food manufacturing -control physical
factors and manufacturing operations
measures to destroy or prevent growth of
undesirable microorganisms
work in progress
effective measures to protect finished
food
MANUFACTURING
OPERATIONS
adulterated food
mechanical manufacturing steps
heat blanching
batters, breading, sauces, gravies,
dressings and other similar preparations
hard foreign objects- sieves, traps, metal
detectors, magnets, etc.
MANUFACTURING
OPERATIONS
filling, assembling, packaging and other
operations
water activity
pH- 4.6 or below
ice- safe
non-human food- animal feed or inedible
products
STORAGE
• all raw materials and other supplies
inspected upon receipt or unloading
• end products inspected prior loading
• storage area designed and constructed to
protect against contamination
STORAGE
Raw materials
• proper conditions (temperature,
humidity)
• frozen raw materials kept at - 4OC or
below (do not allow thawing)
• appropriate stock rotation
• pest control programs
Raw materials(continue)
•
•
•
•
•
•
sufficient space
cleaning and sanitizing programs
labelled (batch no., date-marked)
well ventilated
adequate lighting (110 lux)
building, all equipment, vehicles and
fixtures maintained
End Products
• stored and handled to prevent
deterioration
• returned, defective products identified
and isolated
• stock rotation
• adequate lighting
• pest control programs
• cleaning and sanitizing programs
• well ventilated
End Products
• High risk food:
- refrigerated foods at 2-4 0C or
below
- frozen foods in frozen state
- hot foods at 60 0C or above
- heat treating acid foods in
hermetically sealed containers
(ambient temperature)
INSPECTION
ELEMENTS TO CONSIDER
freshness
temperature
colour
odour
contamination
infestation
packaging
labelling
Non Food Chemicals
• kept in dry, well ventilated, locked room
• separate from food handling areas
• stored in clean, clearly marked
containers (secondary containers)
• trained personnel (handle & dispense)
• fire appliance
TRANSPORT
 inspected (damage, infestation etc.)
 cleaned and sanitized
 properly loaded, arranged and
unloaded
 constructed with suitable material
 temperature control
 security precautions
Product complaints
Product recall programs
PRODUCT RECALL
PROCEDURES
written and tested product recall program
written recall procedures
- person responsible- recall team
- step-by-step procedures described
- product traceability- product coding
- distribution records
- means of notifying customers, retailers
or wholesalers
- means of coordinating recall with
regulatory agencies
PRODUCT RECALL
PROCEDURES
take the complaint and obtain
information (forms and procedures)
do not admit liability
evaluate the complaint
- small token
- involve regulators, outside advisors
thorough investigation
Product Recall Procedures
(continue)
means of notifying the regulatory agency
- reason of recall
- product identification
- total amount of recalled product
- areas of distribution
be cooperative
Product Recall Procedures
(continue)
Regulatory agency may:
 take samples
 prevent the sale of product
 require medical and lab examinations of
employees
 exclude suspect employees from food
handling duties
 order the facility to be closed
Product Recall Procedures
(continue)
• deal with the media
• regular analysis, summarizing and
review of reports
• take proper preventative measures
• avoid recurrence
CORRECTIVE ACTIONS
Recalled product may be:
 disposed
 reworked
 quarantined
DOCUMENTATION
 define materials, operations and
products
 record and communicate information
 reduce risk of errors arising from oral
communication
 defect product traceability
 permit investigation
DOCUMENTATION
 GMP manual
 Structure:
- Quality Manual
- Operating Procedures
- Support Documentation
DOCUMENTATION STRUCTURE
Quality
Manual
Operating
Procedures
Support Documentation
DOCUMENTATION
 Quality Manual
policy statements on the way a company
intends to carry out its business
 Operating Procedures
what a company does and how it achieves
stated policies
 Support Documentation
how a company carries out what it says it
does (in detail)
DOCUMENTING
PROCEDURES
• what we do
• defines process by which a task is carried
out
• Structure:
Objectives and scope
Definitions and references
Responsibilities
Procedure details
SOP
(Standard Operating Procedures)
•
•
•
•
•
what to do, who does it and when
not static; continuously adjusted
simple
training aid
prevent ‘subject-to-change-withoutnotice’ situation
• provide written standard for audits
• effective;detail,simplicity and practicality
SUPPORT DOCUMENTS
•
•
•
•
•
•
•
•
Working Instruction
Codes of Practice
User Manuals
Technical Documentation
Job Description
Job Specification
Forms
Checklists
THANK
YOU