TRAINING COURSE

GMP AUDITOR TRAINING

Product Recall Personnel

LL
CA
RE
Complaints Premise

Contract
Manufacturing Equipment
& Analysis

Storage Sanitation
& Hygiene

Audit Production

Documentation Quality Control

CONTENT OF PRESENTATION

I. Introduction
 Objectives
 Description of GMP Audit
 Scope of GMP Audit
 Benefits of GMP Audit
 The key principle of GMP Audit
 The role of GMP Auditor
2. Managing the GMP Audit program
 Process Flow for Managing of an audit program
 Authority of audit program
 Establishing the audit program
 Audit program implementation
 Monitoring and Reviewing the audit program
3. Audit Activities
 Overview of Audit Activities
 Initiating the audit
 Conducting Document Review
 Preparing for On site audit activities
 Conducting on-site audit activities
 Preparing, approving & distributing the audit report
 Completing & Conducting Follow up
4. Audit Format
5. Conclusion
INTRODUCTION
 INTRODUCTION
 Good Manufacturing Practice (GMP) is the part of Quality
Assurance that ensures that products are produced and
controlled consistently and reliably. This consistency of
production and control is essential. It can only come about
by having clear descriptions of the way in which the work
will be done.
 GMP specifically addresses risks of cross-contamination
and mix-up that cannot be fully controlled by testing of the
final product.
 These risks can best be controlled by having a properly
managed system of working that takes them into account.
This means that the quality checking system must be
designed with these risks in mind and set out to find
whether any errors have occurred.
 OBJECTIVES

 To define the activities and requirements of GMP Audit

 To identify the roles and benefits of GMP Audit in a Food

Safety Management System

 To learn how to plan, perform and monitor GMP Audit

 DEFINITION

 “GMP Audit" is an independent examination of a

quality system
 It measures the effectiveness of an organisation's
Food Safety Management System.
 It is a documented and systematic tool
 It should be done periodically by independent and
qualified people
 “Audit" itself is a checking system, NOT a
quality assessment
 As a communication tool of management policies.
All personnel have to understand and do their jobs
well
 ROLES OF AUDIT
 As a powerful tool to measure the effectiveness
of Food Safety Management System

 Evaluates manufacturer’s compliance with GMP

in all aspects related production and quality
control

 Detects any shortcomings in the implementation

of GMP

 Recommend the necessary corrective and

preventive actions
 SCOPE OF GMP AUDIT (1)
 Ensures GMP Audit plan covers all the areas as
per required frequency
 GMP Audit should include all points related to
Following Modules –
- Personal Hygiene
- Cleaning & Sanitation
- Pest Control
- Premises
- Production
- Quality Control

 Ensures corrective actions agreed in last audit should

be reviewed
 SUMMARY GMP
Product Recall Personnel
LL
CA
RE
Complaints Premise

Contract
Manufacturing Equipment
& Analysis

Storage Sanitation
& Hygiene

Audit Production

Documentation Quality Control

 BASIC PRINCIPLES OF
GOOD MANUFACURING PRACTICES

 Part of QA which ensures that products are consistently

produced and controlled to the quality standards appropriate
to their intended use.

 Minimize risks :
• cross contamination
• mix up

 Ensure products/materials are traceable to the original source.

 Product testing is not reliable way to assure product quality.

Should BUILD quality into the product!

 Production and quality control functions should be independent

of each other.
 BASIC PRINCIPLES OF
GOOD MANUFACURING PRACTICES (1)

All manufacturing process are clearly

defined and systematically reviewed.
All necessary facilities/resources for GMP
should be provided :

adequate, qualified and well-trained

personnel
suitable premises and sufficient space
suitable location
good personal hygiene and proper
sanitation
suitable equipment and services
 BASIC PRINCIPLES OF
GOOD MANUFACURING PRACTICES (2)
All necessary facilities/resources for GMP
should be provided :

 clearly defined manufacturing processes

using unambiguous language
 good documentation system
 appropriate storage and transport
 systematic internal quality audit
 proper product recall system
 right handing of complaints
 comprehensive corrective and preventive
action
 BASIC PRINCIPLES OF
QUALITY CONTROL (1)
QC is part of GMP.
QC is concerned with sampling, specification and
testing.
Manufacturer should have a QC department.
QC should be headed by an appropriately qualified
and experienced person.
QC should be independent from production and other
departments.
Ensure that the necessary and relevant tests are
actually carried out.
Ensure that no materials or products will be released
for sale or supply, until their quality have been
evaluated and judged to be satisfactory.
 BASIC PRINCIPLES OF
QUALITY CONTROL (1)

Adequate facilities, trained personnel and approved

procedures should be available for sampling,
inspecting and testing and, where appropriate,
environment monitoring.

Sampling by QC personnel & testing by

approved methods.

 Approved test methods.

 Maintenance of QC records & failure investigation records.

 BASIC PRINCIPLES OF
QUALITY CONTROL (2)

 Ingredients comply with regulatory

specification (grade, composition, strength)
 Review and evaluation of production
documentation
 Assessment of process deviations
 Release of batches by authorized person
 Sufficient reference samples of starting
materials and finished products
 OTHER DUTIES OF QC

Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring
QUALITY CONTROL ACTIVITIES

QC should cover the following:

b. Sampling
c. Specification
d. Testing
e. Release procedures
f. Recalls and complaints
g. Decision making in all quality matters
h. Definition of product quality
i. Laboratory operations
j. Release authorization
k. Investigation and reporting
 QA VS QC
 The terms quality assurance and quality control are often used
interchangeably to refer to the actions performed for ensuring the quality
of a product, service, or process.
 Both terms, however, have many interpretations because of the multiple
definitions for the words "assurance" and "control."
 The definitions below, for example, point toward a specific distinction
between these two terms:

Assurance
Assurance = The actact
: The of giving confidence,
of giving the state
confidence, theof Quality assurance : All the planned and
being
statecertain,
of beingor the act of or
certain, making certain.
the act of making systematic activities implemented within the
certain. quality system that can be demonstrated to
provide confidence a product or service will
fulfill requirements for quality.

Control : An evaluation to indicate needed Quality control :The operational techniques

corrective responses; the act of guiding or the and activities used to fulfill requirements for
state of a process in which the variability is quality.
attributable to a constant system of chance
causes.
QUALITY RELATIONSHIP

Quality Management

Quality Assurance

G.M.P.

Quality Control
 BENEFITS OF GMP AUDIT

 Tells you the hygiene standard of area

 Identify the root of a problem and plan for corrective

and preventive actions with timeline

 Achieve better allocation of resources

 Able to avoid potentially big Food Safety Risk

 Learn what an auditors look for

 Continuous improvement
KEY PRINCIPLES OF GMP AUDIT
Approaches towards GMP Audit:
• Independent
• Evidence-based approach

All activities related to Audit should:

• be reviewed by an independent party
• be a self-appraisal system
• have a sampling plan and tracking system
• be open, constructive and effective

Strategies in conducting audit:

• Ask with the basic audit questions about the quality
system in place
• Start with what, why, how, who, where, when
PRINCIPLE OF AN AUDITOR

 Ethical

 Professional

 Fair
Auditing Techniques

Do Don’t
 Stop talking  Judge
 Calm the Auditee  Embellish
 Focus on listening  Inattentive
 Remove distractions  Speak unclearly
 Empathize
 Talk excessively
 Patience
 Hold your temper
 Phrase yes/no
questions
 Question
 Be humble
 Display an attitude
 LISTEN
 Argue
 Criticize
 Answer your question
GUIDANCE WHEN CONDUCTING AN AUDIT

• Auditing should be seen as a positive process not a fault finding

• Audits need to be documented
• Prior to the audit date, an auditor needs to review the quality
system documentation, corrective and preventive actions, and past
audit findings.
• During an audit, an auditor need to see evidences that the
processes are being done in accordance to procedures and policies
GUIDANCE FOR AUDITEE

When being audited:

• Volunteer information
• Report deficiencies and difficulties if you know of any
• Be honest, open and cooperative
• Ensure that underlying causes are identified
• Ask the auditor if you’re not sure
MANAGING GMP AUDIT
 FLOW CHART OF AUDIT
Authority for the audit
programme

Establishing
the GMP audit program
obectives
responsibilitties Plan
resources
procedure and guidance

Implementing GMP audit program competence and

scheduling audits evaluation of
evaluating auditors auditors Do
selecting audit team
Improving the audit directing audit activities
Act Audit activities
programme maintaining records

Monitoring & reviewing

the GMP audit program
monitoring & reviewing
Check
identifying needs for corrective
identifying needs for prevention actions
identifying opportunities for improvement
 RESOURCES FOR AUDIT

Considerations should be given to the following:

 Resources
 Audit techniques
 Processes to achieve and maintain the competency
of auditors and to improve their performance
 Competency and availability of auditor
 Available time for auditing
AUDITING ACTIVITIES
OVERVIEW OF AUDIT ACTIVITES

Planning and scheduling audit

Conducting document review

Preparing for on-site activities

Conducting audit

Prepare audit report

Conducting follow-up
 AUDIT ACTIVITIES
 Forming an audit team and assign roles and
responsibility and agreed on the scope
 Conducting document review

 Review documents (SOPs, audit findings,

corrective action/preventive action, etc.),
check the integrity of the quality system
and various controls are effective

• Preparing for the on-site audit activities

 Preparing audit plan

 Assigning work to the auditors
 Preparing work documents
(eg. audit checklists, sampling plans, forms
for recording information; questionnaires)
 AUDIT DOCUMENTATION

• Audit plan

 should be sent to Auditee prior to audit

activity
 findings from the last audit should be also
mentioned

• Audit note should include

an audit questionnaire

all records and comments during the audit

• Audit report is an

official document to report the audit findings

EXAMPLE OF AN AUDIT CHECKLIST

 Audit format for an audit checklist

Sr. Applicable Type Rating

Section – Personal Hygiene Remarks
No. Yes No PRP FSR A B C D

Almarai Uniform Protocol must be followed

1
by each employee
Smoking / Eating is not allowed inside the
2
manufacturing areas.
All employees must undergone thro
3
Baladiah Medical test
All cuts & grazes on exposed skin shall be
4
covered
Is regular fogging conducted? Are records
5
available for review?
Offices / Workplace shall be kept clean &
6
tidy
Definitions

 PRPs - These are basically the generic controls in any type of food
business operation. These are to be applied in all types of food
business so as to maintain a hygienic environment to reduce the risk
to the Food Safety.

Example – GMP, Calibration, Cleaning & Sanitation etc

 Food Safety Risk – are the conditions where PRPs based on
operational conditions will have direct impact on Food Safety of
Product. These points are critical for Food Safety and should be
control to prevent any hazard to product.

Example – Pest on equipment can lead pest contamination in product,

broken glass, hanging wires on filler can lead to foreign body risk.
Definitions
Abbre # Categories Definitions Score

A Satisfactory Meets the requirement throughout the department 5

Minor Few incidence where department was not able to fulfill the
B 3
Deviation requirements (Based on situation & incidence criticality)

More no of incidences where the department was not able to

fulfill the requirements (Based on situation & incidence
Major
C criticality) 0
Deviation
Corrective Actions not taken place for last audit

A single incidence causing Food Safety Risk to product e.g.

Broken Glass on floor, pest on equipment, Foreign body issue
D Critical -3
Corrective Actions not taken place for consecutive last two
audits
EXAMPLE OF AN AUDIT CHECKLIST

CHECKING LIST FOR GMP ASSESSMENT

Date : Location : Warehouse
Auditor : Auditee :

DESCRIPTION GMP.REF. PARAMETER AUDIT FINDING

Personnel 1.2.1 - Organization structure
5.1.2 - Personnel hygiene
2.1.5 - Training record
Storage area 10.1.1 - Design and layout of defined area
3.1 - Flow of personnel and goods
3.6 - Structure of the storage area, based
3.9 & 3.10 on GMP
3.12.2 - HVAC system
- Record of monitoring parameter
Sanitation 3.1 - Pest record program
- The map of bait
5.3 - The cleanliness of weighing
apparatus
Documentation 4.3 - Record of maintenance and
calibration of weighing apparatus
10.2.2.3 - The effectiveness of label system
10.2.2.1 - Inventory stock control
AUDITING ACTIVITIES (1)

 Conducting on-site audit activities

 Conduct opening meeting

 Good communication during the audit

 Roles of escort and observer

 Steps in conducting on site audit:

 Interviews with different personnel

 Carry out both horizontal and vertical audits.
Focus on safety and quality of product.
 Use “Trace-back” method
 AUDITING ACTIVITIES (2)

 Generating audit findings

 Either PRP or Food Safety Risk

 Either conformity or non-conformity

 Sort out isolated or systemic deficiencies

Isolated deficiency:
Tends to happen randomly; no meaningful
pattern; rarely happens

Systemic deficiency:
Could be connected to a particular process,
product, material, person or organisation; shows
pattern; happens more than once
 AUDIT MONITORING
The audit finding can be classified into 2 groups:

• Compliance :
• Satisfactory /Adequate
• Outstanding

Non-compliance :
• Critical deficiency
• Major deficiency
• Minor deficiency
 AUDIT REPORT
 Objectives
 Audit scope
 Identification of trained auditor
 Date and place where the on-site
audit activities were conducted
 Audit criteria and findings
 Conclusions
 AUDIT REPORT

 Only Standard formats can be used for Audit Report

 Usually include name and location of auditee, date of audit,

audit plan, audit observations, classification of non-
compliances, recommendations or expectations

 Should write against a standard

 Focus on deficient conditions and not people

 Include any positive observations

 Keep the audit report simple and clear

 AUDIT REPORT: AN EXAMPLE
Section – Personal Applicable Type Rating
Sr. No. Remarks
Hygiene Yes No PRP FSR A B C D

Offices / Workplace shall be

1 √ √ √ Audit in Blending Room
kept clean & tidy
Do floor drains appear clean,
Audit in Fresh Filling (Drain
2 free from odors and well √ √ √ √
is near to recovery area
maintained?
Smoking / Eating is not
3 allowed inside the √ √ √ √ Audit in any production area
manufacturing areas.
Almarai Uniform Protocol
4 must be followed by each √ √ √ Audit in Down line
employee
All employees must
5 undergone thro Baladiah √ Audit in Outbound
Medical test
Is regular fogging
Audit in RCC Fermentation
6 conducted? Are records √ √ √ √
room
available for review?
Drains shall be fitted with
7 √ √ √ √ Audit in CHP Filling
screens & traps to pest entry
CLOSURE

Follow-up and closing of loop:

• Receive a satisfactory response from auditee and their

commitment to correct for any deficiency
• Ensures CAPA identify the root cause and they are
satisfactory, accomplished and documented
• Timeframe for CAPA is being followed
• Verify and track CAPA by scheduling a follow-up audit
and/or requesting for an updated SOP
CONCLUSIONS

Nobody likes to be
audited………..

It is a means to have
continuous
improvement
GMP Audit Modules

Personnel Hygiene
Waste Management
Premises
Equipments
Cleaning & Sanitation
Production Controls
Quality Controls
Documentation
Good Storage Practices
Good House Keeping
 N

PERSONNEL
HY
O
TI

GI
TA

E
HYGIENE
NE
NI
SA
PERSONNEL HYGIENE (1)

 All personnel must undergo health

examination
 Trained in the practice of personnel hygiene

 Illness or open wounds – not allowed

 Report to supervisors any conditions
adversely affect the product quality
PERSONNEL TRAINING (1)
 Training, in accordance with a written programme for
 all personnel whose duties take them into production;
or
 into control laboratories; and
 for others whose activities could affect the quality of
the product

 On induction and continuing

 on theory and practice of GMP;
 approved by either the head of Production or QC as
appropriate
 training records should be kept
 training before undertaking any new task
PERSONNEL HYGIENE (2)

 Avoid direct contact of operator’s hands and

products including starting/ packaging
materials
 Wear clean Overall or uniform
 Smoking, eating, drinking, chewing and
keeping materials not related to production
not permitted
 Use of protective clothing in production
areas
PERSONNEL TRAINING (2)
 Staff in special areas, e.g.
 working with hazardous materials should be
given specific training
 The concept of QA and its understanding and
implementation should be fully discussed during
training
 Practical effectiveness should be periodically
assessed e.g. assessment tests, number of
rejects, product complaint, return products
REGULATION IN PRODUCTION AREA

 Prohibit use of rings,

earring, and other
jewelries in production
area

 Hair combing is not allowed

in the manufacturing area.

 Prohibit use of artificial

eyelash, synthetic nail, and
other beauty accessories that
can fall into the products.
 PERSONNEL WITH ILLNESS

Personnel should be instructed and

encouraged to report to their
immediate supervisor when they
are ill or when they see any
conditions that may adversely
affect the product quality.
 PROPER ATTIRE
All authorized personnel entering the
production areas should practice good
personal hygiene including wearing of
proper attire, suitable headwear and
footwear.

To avoid cross contamination,

personnel should not move between
areas producing different products.
 SAFETY ATTIRE

• Avoid direct physical contact with

the product to protect from
contamination.
Dust mask
• Personnel should wear protective
attire when working with
hazardous materials

smoke mask

gloves goggles moustache &

beard cover
VISITOR OR UNTRAINED PERSONNEL

 Must be given information in advance,

particularly about
personal hygiene; and
protective clothing requirements
 Must be accompanied and closely
supervised at all times
BENEFITS – Personnel Hygiene

For personnel :
To prevent contamination risk that effect personnel health

For product :
To prevent contamination of the products
To maintain the high standard of product quality

For company :
To save on cost, avoid reworks and rejects
To avoid consumer complaints
To avoid potential product recall

For consumers :
To get safe and good quality product
WASTE MANAGEMENT

Waste material should be placed in suitable

container and regularly collected for disposal
outside the production areas.
Regular & timely collection of garbage
Garbage bins must be properly covered
at all times
No food wrapper to be thrown in garbage
cans inside the production area
Do not use product shipping cases
as garbage bins
 WASTE MATERIALS HANDLING

 All waste materials should be properly handled

 Should be stored properly and in a safe place

 Toxic and flammable materials should be stored

in a suitable designed, separated and enclosed
area
 Should not be allowed to accumulate
PREMISES
PREMISES DESIGN (1)
The design of the premises depends on the
manufacturing activities. However, in general
terms, all areas should be designed in such a way
that prevents the build-up of dirt and dust.

The plant facilities shall:

 provide sufficient space for equipment and
storage of materials as necessary for the
maintenance of sanitary operations and safe
production.
 provide adequate lighting, ventilation or control
equipment to minimize contamination.
 have an effective pest control program.
 check pests and pest infestation on a regular
basis.
 provide, where necessary, adequate screening
or other protection against pests.
PREMISES DESIGN (2)
Buildings / facilities should be so constructed that :
 floors, walls, and ceilings may be adequately
cleaned and kept clean, and kept in good repair;
 floor must be hard, smooth and impervious,
sloping sufficiently towards a drain thus
allowing cleaning with water;
 the grounds shall be kept in a condition that
will protect the product against
contamination, and to include proper
storage of equipment, removing litter and
waste;
 drains are kept to a minimum amount. Their design
must prevent the possibility of back-flow. Open
channels should be easy to clean and sanitize.
PREMISES DESIGN (3)
In addition:

 There must be a written cleaning and

sanitization procedure indicating who is
responsible for its execution, the materials used
and methodology. The procedure should be
appropriate to the area being cleaned.

 There should also be a written record of

cleaning that has been performed.

 There should be maximum protection against

the entry of insects or other animals. For
loading bays in particular, there needs to be
protection against the weather and flying
animals.
Air curtain
 CLOSED DOORS & WINDOW

 Facilities must be well maintained to

prevent any contamination to get into
the production area.

√
 Doors and windows must always be kept
closed at all times in the production
area. Screens must be installed on
windows or any other openings. X

X
SANITATION &
CLEANING
CLEANING PRINCIPLES
Cleaning and sanitation is a key consideration when
designing premises and equipments to operate in a Food
industry.
Proper cleaning plays an important role. The methods used
to establish a clean manufacturing environment vary from
company to company. The goal is always the same, to
acquire the level of cleanliness to maintain a high product
quality while minimizing costs.
To understand the concept of cleanliness, it is necessary to
define some common words used in the industry. Most
important are the words clean,
clean sanitation,
sanitation hygiene,
hygiene and
sterile.
sterile
CLEANING PRINCIPLES
 Cleaning operations shall be performed in a manner to
prevent contamination of materials and products.
 Cleaning practices can be divided by :
 “deep cleaning”,
 “housekeeping cleaning”, and
 “maintenance cleaning”.
 All cleaning compounds and sanitizers shall be properly
labelled and stored in a locked compartment, away from
production and storage areas.
 Cleaning equipment and tools shall be supplied and be
readily available for use. All cleaning equipments shall be
maintained and stored in such a way as not to
contaminate product or equipment.
BENEFITS – Sanitation & Cleaning
For personnel :
To prevent contamination risk that effect personnel health

For product :
To prevent contamination of the products
To maintain the high standard of product quality

For company :
To save on cost, avoid reworks and rejects
To avoid consumer complaints
To avoid potential product recall

For consumers :
To get safe and good quality product
PROCESS CONTROL
 NO EATING, DRINKING & SMOKING

 “No Eating”, “No Drinking”, “No Smoking”, and

“No Chewing Gum” policy shall be strictly
implemented as well as no spitting on the floor.
 Food shall not be kept in production, warehouse or
laboratory area.

No Eating,
No Drinking
No Smoking
 PREVENTION OF CONTAMINATION
 Prevention of contamination should be done in every
step of manufacturing processes
 Type of contaminant can vary, starting from dust,
gases, vapors, spray, residues from equipment, insect,
microbes, or may come from operators clothing.
 Area where some susceptible products are processed,
such as neutral pH product should be monitored
periodically for its microbial content.
 Cross-contamination should be avoided through proper
application of preventive measures
 Measures to prevent cross-contamination and their
effectiveness should be checked periodically .
WEIGHING & MEASUREMENT

 Weighing should be carried out :

- in defined areas
- using calibrated equipment.
 All weighing and measurement carried
out should be:
- recorded
- counter checked
 IN-PROCESS CONTROL
 Done within the production area and by production people
and/or Quality Control
 Should be recorded and done as per approved/written SOP
 Sampling done to verify:
 physical aspects (weight, volume, amount, etc)
 text on labels
 other performance requirements
 Sampling maybe conducted based on need :
 during processing activity
 during packaging (filling & packing) activities :
 random,
 sequential, or
 statistical
 Samples taken away from the packaging line should not be
returned if containers were opened
 Record of in-process control should be part of the
Production Run.
 CALIBRATION
 To maintain the accuracy and precision of test equipment at all
times.
 To ensure highest level of confidence in all measurement that
affect materials disposition decision, with unbroken chain of
traceability to national standard.
 To determine whether the equipment is still fit for its intended
purpose.
 It is based on the comparison of a primary standard or
instrument of known accuracy with another equipment (to be
calibrated)
 It is used to detect, correlate, report or eliminate by adjustment
of any variation in the accuracy of the equipment being
calibrated.
EQUIPMENT CLASSIFICATION

 Critical equipment:
 Direct measurement that affect the final
product quality
 Measurement on critical process parameters in
the process specification such as Pasteurizer

 Non critical equipment:

 Indirect measurement that will not directly
affect the final product quality
 Shall be maintained based on company
maintenance schedule
GOOD HOUSEKEEPING PRACTICES
GOOD HOUSEKEEPING PRINCIPLES

A well-planned, well-executed and controlled cleaning and sanitation

programme for rooms, machines and equipment is very important to
achieve a hygienic standard.
Cleaning and sanitation alone
will not assure a hygienic
standard in production. Process
hygiene as well as personal
hygiene are important factors.

Buildings / facilities should be

so constructed that clean and
unclean processes and products
do not mix.
The cleaning program must be performed regularly, dependent on the
demand for cleaning in the specific areas. The requirements for
cleaning have to be defined before establishing the cleaning program.
GOOD HOUSEKEEPING ADVANTAGES

• A Clean Workplace is High in QUALITY;

• A Clean Workplace is High in PRODUCTIVITY;
• A Clean Workplace Keeps COSTS Down;
• A Clean Workplace Saves TIME;
• A Clean Workplace Ensures EFFICIENT Delivery;
• A Clean Workplace Provides HEALTHY environment;
• A Clean Workplace is SAFE for people to work in;
• A Clean Workplace is High in MORALE.

Before cleaning program After cleaning program

 5 S: WORKPLACE ORGANIZATION

SEIRI (CLEARING UP):

Remove what is not needed and keep what is needed
SEITON (ORGANIZING):
Place things in a such way that they can be easily
reached whenever they are needed
SEISO (CLEANING):
Keep things clean and polished; no trash an dirt in
workplace
SEKETSU (STANDARDIZING):
Maintain cleanliness after cleaning-perpetual cleaning
SHITSUKE (SELF DICIPLINE):
Commitment, a typical teaching and attitude towards
any undertaking to inspire pride and adherence to
standards established for the four components
 5 S: WORKPLACE ORGANIZATION

Benefit of 5S implementation :
• reduce inventory,
• efficient on workplace usage,
• reducing time for searching
material and finished goods,
• keep workplace clean and tidy,
• improve working condition,
• reduce work accident,
• increase discipline,
• follow procedure etc.
GOOD STORAGE PRACTICES
 REQUIREMENT OF GSP

To ensure that when the end product reaches

the consumer, it is of good quality and safe to
use.
 MATERIAL REQUIREMENTS (1)

 All incoming materials should be

quarantined immediately after receipt until
they are released for use in production
 Raw materials should be stored under
appropriate condition.
 Storage condition should be controlled,
monitored and recorded
MATERIAL BASIC REQUIREMENTS (2)
 Storage of materials should be orderly to avoid
mix up and cross contamination
 Ensure that there is an effective system in
controlling stocks
 Ensure that consumption of starting materials
follows :
 FIFO ~ First-In-First-Out, or
 EEFO ~ Earliest Expiry, First Out.
MATERIAL BASIC REQUIREMENTS (3)

 Personnel in charge of raw material purchase

should have sufficient knowledge of the
materials, products and suppliers of the materials
 Raw materials should be purchased from qualified
suppliers. Raw materials should have approved
specification and deliveries are accompanied with
a certificate of analysis.
 it is suggested to purchase raw materials directly
from manufacturers or appointed distributors .
 MATERIAL VERIFICATIONS
 Starting materials should be checked and verified for
their conformity to specifications and be traceable to the p
roduct.
 Samples of raw materials should be physically checked for
conformity to specifications prior to release for use. Raw
materials should be clearly labeled .
 All materials received should be clean and checked for
appropriate protective packing to ensure no leakage, perfo
ration or exposure to environment.
 Deliveries of raw materials that do not comply with
specification should be segregated and disposed according
to standard operating procedures
STOCK MANAGEMENT & CONTROL

 receiving & identity inspection

 storage & stock control
 product release, repackaging &
transportation
 product disposal
RECEIVING & INSPECTION (1)

All deliveries should be checked:

 containers are not damaged

 quantity of deliveries
 labels
 suppliers name & address
 RECEIVING & INSPECTION (2)

 product information
 product name, batch no
 manufacturing/expiry date,
 storage requirements:
 Stack on pallets
 Use standard pallets

wooden pallets should be free from

pest
 Interlocking pattern of the box for
stability
 STORAGE & STOCK CONTROL

 systematic storage system

 sufficient passage way for easy movement
 inspection / checking
 apply stock card

 proper labeling
 scheduled stock check or count

Identification labels
 PRODUCT RELEASE

 To follow FIFO / FEFO system

 Recheck before delivery
 Monitor goods condition during
transport and at delivery
 RETURNED GOODS

Available written procedure:

 segregation of returned goods
 labeling of returned goods
 investigations & evaluations on:
quality and safety
 REJECTED/DAMAGED GOODS

Apply written procedure:

 segregation of returned goods
 labeling of returned goods
 investigations & evaluations on:
 quality, and
 safety
 disposal of goods