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training programme
On
ISO 22000:2005
(FOOD SAFETY MANAGEMENT SYSTEM)
SESSION-1
Audit planning
Audit process
Role play
Course Objectives
UPON SUCCESSFUL COMPLETION OF
THIS COURSE YOU WILL:
Be able to prepare for, report on,
Planning Audits
Collecting and
Conducting Audits
Verifying evidence
defect nonconformity
Non-fulfillment of a Non-fulfillment of a requirement
requirement related
to an intended or
Specified use Understand the difference
Conformance legal
with audit = Compliance
criteria
Food laws
Foods Acts applicable in India under different
Ministries
• Ministry of health and family welfare
Hazard Recognition
Severity of consequence
SUBSTAINTIAL GMPs and GHPs are applied, special measures for keeping the risks
within tolerable limits are applied. The effect is controlled through
measurements and if necessary the process is considered as a CCP
INTOLERABLE The process is controlled as a CCP
Hazards Classification
Biological
Chemical
Physical
Biological Hazard
Visible:Birds,Flies,Mosquitoes,Rats/
rodents, pet animals etc.
Invisible: Microbes like Bacteria,
Viruses, mold and yeast, fungus
etc.
Sources of Hazards-
Biological
• Raw materials
• Animals
• Environment
• Staff
Sources of Hazards-
chemicals
• Veterinary Medicines
• Fertilizers
• Packaging chemical compounds
• Hazardous gases
• Cleaning and disinfection
detergent
Sources of Hazards-
Physical
• Glass
• Metal particles
• Hair
• Nail
• Stones
• Dust/ Dirt
• Equipment
• Facilities
• Raw material
• Packages
• Environment
• Personnel
• Ionizing radiation
Session-4
approval
Changes and current revision status
clearly identified
4.2.2 Control of
documents
Relevant version available at points of ue
Documents remain legible and reaily
identifiable
Documents of external origin are
identified and their distribution controlled
Prevent use of obsolete documents, and
identify if retained
4.2.3 Control of records
Maintained to demonstrate
conformance to requirements and
the effective operation of the Food
SMS
System-level procedure for
identifying, storage, retrieval,
protection, retention times and
disposal
5. Management responsibility
5.1 General
Top Management to provide evidence
of its commitment to development
and implementation of the Food SMS
&continually improving its
effectiveness
How???
Top management training
school
Show food safety is supported by
business Objectives
Communicating the importance of
meeting
customer/statutory/regulatory
requirements
Establishing the food safety policy
Holding management reviews
Ensuring availability of resources
5.2 Food safety policy
Top management to ensure it:
Is appropriate to the role of organization in food
chain.
Confirms with both statutory and regulatory and with
changes
Responsibility and
authority
Top management to ensure that R&D
are defined and communicated
All personnel have the responsibility
to report problems with the Food
SMS to identified person(s).
That designated personnel shall
initiate and record action.
Food safety Team Leader
Manage a Food system team
Ensure relevant training and
education of team
Ensure the Food SMS is established,
implemented, maintained and
updated
Reporting effectiveness and
suitability to top management
5.6 Communication
External communication
Supplier and contractors
Customers or consumers
Statuary and regulatory authorities
Other impacted organization on Food
SMS
Known food safety hazards, needed to
be controlled by other organizations.
Communication (cont.)
Internal communication
Food safety team is informed of
changes in food SMS.
Food safety team shall ensure the
updating of the Food SMS.
5.7 Emergency
preparedness and
response
Procedure to manage potential
emergency situation and accidents
that can impact food safety
Role of the organization in the food
chain
5.8 Management review
Top management reviewing Food
SMS to ensure suitability,
adequacy & EFFECTIVENESS
Defined intervals
Is there a need to amend the Food
SMS, food safety policy.
5.8 Management
review(cont.)
Review information to:
Follow up issues from previous reviews
data Experience
External information
Intended use
Flow diagram
Process step
Control measure
Verification planning
Verification activities shall confirm that
PRP are implemented
Input hazard analysis is updated
Effective of operational PRP and HACCP
plan
Hazard levels are within acceptable level
Other procedure are implemented and
effective
7.9 Traceability system
Traceability system for product lot
and their relation to batch of raw
material, processing and delivery
record
Able to identify incoming material
from immediate suppliers and
initial distribution route of end
product
7.10 Control of
nonconformity
Corrections
Identify and assessment affected end
product to determine proper handling
Review of the corrections carried out
Corrective actions
control measures
To verify and improve the food
SMS
8.2 Validation of control
measure combinations
Validate the control measures are
capable to control the Hazards
Modify the control measures, as
necessary.
8.3 control of measuring &
monitoring
To ensure valid results, devices are:
Calibrated/adjusted prior to use or at
implemented
Planned based on status, importance and
previous results
Independent auditors? Dept. Audit (cross)
Documented procedure
Follow-up
8.4.2 Evaluation of
individual verification
results
Systematic evaluate the individual
results of planed verification
Take action to achieve the require
conformity
8.4.3 Analysis of results of
verification activities
Analysis the results of verification
activities, incl. internal/ External audit
To confirm overall performance of system.
To identify need for updating/ improving
the Food SMS
To identify trends of potential unsafe
products information for internal audit
To provide evidence the effectiveness of
correction and corrective action
8.5 Improvement
8.5.1 Continual improvement
Continually improve Food SMS
Planning
Corrective actions
Stage 1
Second internal audit and management review
Stage 2
Review documentation, including:
FSMS policy
HACCP plan
GMP,GHP,PRP,OPRP
Legal and other requirements
Preparation
Audit plan
Check list
Information to brief team
Communicate with client
Session 7
Audit Process and Planning
Audit stages
Report Preparation
Closing Meeting
The Audit process
Internal Audit are performed to verify
Formal assessment of hazard analysis
Process flow diagrams
Prerequisite programmes
Document review
5 main audit trails:-
Organization
GMP and PRP
Legal Compliance
Hazard Analysis, CCPs, Control Measures, Monitoring,
Corrective and preventive actions
Verification
Reasons for Conducting
Internal Audits
To examine the Food Safety
Management System for
improvements
To ensure ISO 22000, and all other
compliance
To meet regulatory requirements
Auditing Procedure
Audit activities are required to be documented in a
procedure that will address
A statement of responsibility
Contract requirements
Preliminary visit
required
Administration requirements
Planning
The audit team must be supplied with
copies of
The specification
The programme
Allocation of individual audit areas
Audit policies and practices
Planning
Facilities and Administration
The audit team may require hotel
accommodation, secretarial
support and throughout the audit a
separate room, so they can discuss
findings and prepare reports
Lunch should preferably be light,
Work Experience
Training
Auditing Experience
Auditing skills
Auditor Attributes
Desirable Undesirable
• Fact finding > Fault Finding
• Polite > Rude
• Persistent > Lazy
• Decisive > Indecisive
• Prepared > Unprepared
• Honest > Dishonest
• Unbiased > Biased
• Communication > Un communicative
• Ethical > Un ethical
A Good Auditor’s
Attributes
Focused
Diplomatic
Versatile
Time Manager
Open Minded
Fast Thinker
Self Reliant
Observant
3 Most Important Qualities
Persistence:
Ability to overcome difficulties and maintain planned
course of action inspite of setbacks
Flexible outlook:
Ability to see things from different points of view and
adapt to changing circumstances
Perceptiveness:
Ability to grasp the problem quickly but without
Jumping to conclusions
Responsibilities of an Audit
Communicate and clarify Audit Requirements
Execute the audit in compliance with the audit
plan
Adhere to Audit plan Arrangements
Record the Audit Findings
Record the Non Conformities along with
agreement with the auditee
Maintain Audit documents and records
Cooperate with Audit Team members
Prepare summary of own audit findings
Inform Lead Auditor incase of any concerns
during the audit.
Responsibilities of a Lead
Auditor
Assistance in selection of audit team
Manage audit team and overall process of
the audit
Prepare audit plan and applicable checklists
Liaison with auditee
Coordinate with the other auditors for
seamless audit process
Compile and present the audit report
Ensure timely follow-up of the corrective
actions
Responsibilities of an
Auditee
Understand, define and publicize scope and objective of
the audit
Provide guide/escorts to the audit team
Arrangement of resources required for the conduct of
the audit
Provide access to facilities/system/documents/records to
auditors during the audit
Extend cooperation to auditor
Carryout Root Cause analysis for non conformity
detected.
Determine and take corrective action without undue
delay.
Audit Techniques
a) Ask questions
b) Examine objective evedence
c) Observe activities
d) Listen to reactions
e) Record findings
Forward Trace – An audit which follows the natural flow of a product or
service process
Backward Trace – An audit which traces records back through the system
Audit Techniques
DESIGN HORIZONTAL
VERTICAL
HORIZONTAL
PURCHASING
HORIZONTAL
PRODUCTION
HORIZONTAL
TRAINING
result
Question Technique
Yes/no Questions
Often elicit dead end answers- you gain
answers
Explanations questions
Useful for comparing interfaces
Objective Evidence
Try to establish:
That authorised documents are in use
removed
That good housekeeping is practiced
Audit name
Completed