Transcript Slide 1

Welcome to
Shahi Enterprises Ltd.
An ISO 9001:2008 Services Provider Company
UAE Office :
India Office:
205-206, Atmiya Complex,
Maneja Crossing
Vadodara – 390 013
Gujarat, India.
Tel: 9601349008
Email: [email protected]
Website: www.shahienterprises.com
Shahi Enterprises FZE
P.O. Box 31291 Al-Jazeera
Al Hamra, Ras Al Khaimah
United Arab Emirates
Lead Auditor Shiv Shankar
Mobile No. +971 562646057
Email: [email protected]
Website: www.shahifze.com
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Our Branches
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Lucknow, Gorakhpur, Raipur, Kolkatta, New Delhi, Mumbai,
Rajkot,Mehsana, Jamnagar,Ranchi,Dehradoon,
Guhawati Bangalore, Patna, Valsad.
Shahi Enterprises has been established in 2004 as a Quality Consulting firm in India
at Baroda (Vadodara). Shahi Enterprises has grown from a Quality Consulting firm
now become a limited company providing its quality management consulting services
to various parts of India (Gujarat, Maharashtra, Uttar Pradesh, Uttarakhand, and
Chhattisgarh) and started its quality consultancy services at UAE. We have our offices
at Baroda, Lucknow, Mumbai, Guwahati.
Shahi Enterprises Ltd is serving over more than two thousand certified clients
providing them whole range of ISO Certification Consulting Services for ISO 9001,
ISO14001, ISO 18001, ISO 22000, ISO 27001, HACCP, BRC, PED, UL/CE Marking,
API Monogram, Trade Mark, GMP- WHO & Product Up gradation.
Shahi Enterprises Ltd. train and utilize highly capable staff to provide valuable service to
assist our clients to achieve the international recognition and acceptance through the
standard of the quality management system, it would cover systematic approach through
format for:
Purchase order/-monitoring Storage.
Process control/production planning.
Inventory management.
Machine breakdown monitoring.
Neat working place.
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Training management staff.
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We help for subsides for different quality standards from STATE & CENTRAL GOVT.
Quality Up gradation System Subsidy
5% Interest Subsidy
R&D Subsidy
ETP (Environment Treatment Plan)
Foreign Exhibition Subsidy
IT Subsidy
GEB Subsidy
Our Associations have been rewarding in the following areas of activities.
Quality Standard Developments
ISO 14001-2004 Environment Management System
ISO 18001-2007 Occupational Health & Safety Management System
ISO 22000-2005 Food Safety Management System
ISO 27001-2005 Information Security Management System
HACCP – Hazard Analysis and Critical Control Points
BRC - British Retail Consortium
PED - Pressure Equipment Derivative
QUALITY & HR- TRAINING
Product Certification
UL/CE Marking
API Monogram
GMP- WHO & Product Up gradation
Business Development
Franchise and Dealer Management
Project Finance
Liaison and Representation
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ISO’s means "International Organization
for Standardization“
Central Secretariat in Geneva,
Switzerland International federation of
over more than 176 countries
Non-governmental organization
founded in 1947 on the
basis of one member per country
“ISO”, derived from the
Greek word isos, meaning ‘equal”
Published more than 17500
International Standards
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Food is any substance or
material eaten to provide
nutritional support for the
body or for pleasure.
It usually consists of plant
or animal origin, that
contains essential nutrients, such as
carbohydrates, fats, proteins, vitamins, or minerals,
and is ingested and assimilated by an organism to
produce energy, stimulate growth, and maintain
life.
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Food safety is a scientific discipline
describing handling, preparation,
and storage of food in ways that
prevent food borne illness
Concept that food will not
cause harm to the consumer
when it is prepared and/or
eaten according to its
intended use.
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Food safety and Food quality
assurance are increasingly under
the scrutiny of regulators and
consumers
Including raw and semimanufactured foodstuffs and final
products in all principal food
segments
FOOD SAFETY HAZARD
Biological, chemical or physical agent in food, or condition of food,
with the potential to cause an adverse health effect
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Hazard
Analysis
Critical
Control
Point
HACCP IS A SYSTEM WHICH
Identifies
Evaluates and
Controls hazards
which are significant for food safety
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Conduct Hazard Analysis
Determine the critical points
Establish critical limits
Establish a system to monitor to control of the
CCP
Establish the corrective action to be taken when
monitoring indicates that a particular CCP is not
under control
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Assemble HACCP Team
Determine CCPs
Describe Product
Establish Critical Limits for each
CCP
Identify Intended Use
Establish a Monitoring System for
each CCP
Construct Flow Diagram
Establish Corrective Action
On-site Confirmation of Flow Diagram
Establish Verification Procedures
List all Potential Hazards Conduct a Hazard
Analysis Consider Control Measures
Establish Documentation & Record
Keeping
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The ISO 22000:2005 international standard specifies the requirements for a
food safety management system that involves the following elements:
- interactive communication
- system management
- prerequisite programmes
- HACCP principles
It is a Food Safety Management System (FSMS)
that uses a management system approach and HACCP requirements.
The goal is to provide one internationally recognized standard for a food safety
management system that can be applied to any organization in the food chain.
Food safety relates to presence of food borne hazards in food at the point of
consumption
Food safety hazards can occur at any stage of food chain
Ensured by combined efforts of all in the food chain
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Adequate controls throughout the food chain are essential
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New Family – initiated in 2001
ISO 22000:2005 – Food safety management system Requirements
ISO 22003:2007 - Requirements for bodies providing audit and
certification of food safety management Systems
ISO TS 22004:2005 - Guidance on the application of ISO 22000
ISO 22005 – Traceability in the feed and food chain
ISO/TS 22004:2005 provides guidance on the application of ISO
22000:2005.
ISO 22005:2007 provides requirements for the design and
implementation of a feed and food traceability system.
ISO/TS 22003:2007 sets requirements for registrars that provide
auditing and certification to ISO 22000.
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The standard has the following objectives:
Compliance with the Code– Codex HACCP principles
Provide an auditable standard
Aligned to ISO 9001 and ISO 14001
Provide the communication of HACCP concepts
internationally.
Five Steps:
1. Assemble the HACCP team
2. Describe the product
3. Identify the intended use
4. Construct a flow diagram
5. Confirm accuracy of the flow diagram
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1. Conduct A Hazard Analysis
Plans determine the food safety hazards and identify the
preventive measures
2. Identify The Criticial Points
A point, step, or procedure in a food manufacturing
process
Food safety hazard can be prevented, eliminated, or
reduced to an acceptable level
3. Establish Critical Limits
A critical limit is the maximum or minimum value
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4. Establish Monitoring Procedures
Monitoring activities are necessary to ensure that the
process is under control at each critical control point
5. Establish Corrective Actions
Corrective actions are intended to ensure that no
product injurious to health or otherwise adulterated
6. Establish Record Keeping Procedures
All plants maintain certain documents, including its
hazard analysis and written HACCP plan
Records are needed to show that the critical limits have
been met, and the system is in control.
7. Establish Verification Procedures
Test the end product; verify that the controls are
working as planned
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Clear communication across the entire supply chain
Traceability – identification of an organization's impact on food
safety within the supply chain
Cost reduction due to a more efficient system
Continuous improved business performance in line with the ISO
22000 food safety policy and objectives.
ISO 22000 can contribute to the quality of life in general by:
ensuring safe food
reducing food borne diseases
better quality and safer jobs in
the food industry
better utilization of resources
more efficient validation and documentation
of techniques, methods and procedures
increased profits
increased potential for economic growth and
development
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Clause No.4 - Food Safety Management System
4.1 General Requirement
The organization shall establish,
document, implement and maintain an
effective food safety management system
Communicate appropriate information
Evaluate periodically
4.2 Documentation Requirements
4.2.1 General
Documented statements, procedures
needed by the organisation
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4.2.2 Control of Documents
To approve, review and update documents
To ensure that documents remain legible
and readily identifiable
4.2.3 Control of Records
Records shall be established and
maintained
To provide evidence of conformity to
requirements and evidence of the effective
operation of the food safety management
system.
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Clause No.5 - Management Responsibility
5.1
Management commitment
Communicating to the organisation
Establishing the food safety policy
Conducting management review
Ensuring the availability of resources
5.2
Food Safety Policy
Top Management shall define, document and communicate its
food safety policy
Top Management shall ensure that the food safety policy as
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a)
Is appropriate to the role of the organisation in the food
chain
b)
Conforms with both statutory and regulatory requirements
with mutually agreed food safety requirements of
customers
c)
Is communicated, implemented and maintained at all levels
of the organization
d)
Is reviewed for continued suitability
e)
Adequately addresses communication
f)
Is supported by measurable objectives
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5.3
Food Safety Management System Planning
Top management shall ensure thata) Planning of the food safety management system
b) Integrity of the food safety management system is maintained
5.4
Responsibility & Authority
Responsibilities and authorities are defined and communicated
within the organisation
b) To ensure the effective operation and maintenance of the FSMS
a)
5.5
Food Safety Team Leader
a)
To manage a food safety team and organise its work
b)
To ensure relevant training and education of the food safety
team members
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c)
To ensure that the FSMS is established, implemented,
maintained and updated
d)
To report to the organisation’s top management on the
effectiveness and suitability of FSMS
5.6
Communication
5.6.1 External Communication
Effective arrangements for communicating witha) Suppliers and contractors
b) Customers or consumers
c) Statutory and regulatory authorities
d) Impact on other organisations
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5.6.2 Internal Communication
The food safety team is informed in a timely manner of
changes
Effective communication with staff concerning food
safety issues
Food Safety team must be swiftly informed relevant
food safety aspects
Updating of FSMS
Management Review
5.7
Emergency Preparedness & Response
Procedures to manage potential emergency situations
and accidents
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5.8
Management Review
5.8.1 General
Include assessing opportunities for improvement and
the need for change to the food safety management
system
Records of management reviews shall be maintained
5.8.2 Review Input
Follow-up actions – from previous management reviews
Analysis of results of verification activities
Changing circumstances that can affect food safety
Emergency situations, accidents and withdrawals
Reviewing results of system-updating activities
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Review of communication activities, including customer
feed-back
External audits or inspections
5.8.2 Review Input
Follow-up actions – from previous management reviews
Analysis of results of verification activities
Changing circumstances that can affect food safety
Emergency situations, accidents and withdrawals
Reviewing results of system-updating activities
Review of communication activities, including customer
feed-back
External audits or inspections
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5.8.3 Review Output
Assurance of food safety
Improvement of the effectiveness of the food safety
management system
Resource needs
Revisions of the organisation’s food safety policy and
related objectives
Clause No.6 - Resource Management
6.1
Provision of Resources
The organisation shall provide adequate resources for the
establishment, implementation, maintenance and updating of
the food safety management system
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6.2 Human Resources
6.2.1 General
The food safety team and the other personnel carrying out
activities shall be competent and shall have appropriate
education, training, skills and experience
6.2.2 Competence, Awareness And Training
Identify the necessary competencies
Provide the training or take other action
Evaluate the implementation and the effectiveness
Ensure that the personnel are aware of the relevance and
importance of their individual activities
Requirement for effective communication
Maintain appropriate records of training and actions
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6.3
Infrastrucutre
Provide the resources for the establishment and maintenance
6.4
Work Environment
Provide the resources for establishment, management and
maintenance
Needed to implement the requirements of the International
Standard
Clause No.7 - Planning And Realization Of Safe Products
7.1
General
Plan and develop the processes needed for the realization of safe
products
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7.2
Prerequisite Programmes (PRPs)
7.2.1 Implement PRPs
Introducing food safety hazards to the product
Contamination of the product
Food safety hazard levels in the product and product processing
environment
7.2.2
PRPs are suitable
Consider and utilize appropriate information
7.2.3
PRPs are effective
Consider and utilize appropriate information
Verification of PRPs shall be planned
Documents should specify how activities included in the PRP(s)
are managed
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7.3 Preliminary steps to enable hazard analysis
7.3.1 General
All relevant information shall be collected, maintained, updated
and documented
Records shall be maintained
7.3.2 Food Safety Team
Combination of multi-disciplinary knowledge and experience in
developing and implementing FSMS
Demonstrate the required knowledge and experience
7.3.3 Product Characteristics
7.3.3.1 Raw materials, Ingredients & Product-Conta Materials
All materials shall be described in the document to the extent to
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7.3.3.2 Characteristic Of End Products
The descriptions shall be kept up-to-date
7.3.4 Intended Use
The reasonably expected handling of the end product
7.3.5 Flow Diagrams, Process Steps And Control
Measures
7.3.5.1 Flow Diagrams
Flow diagrams shall be clear, accurate
and sufficiently detailed
Verified flow diagrams shall be
maintained as records
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7.3.5.2
Description Of Process Steps & Control Measures
The existing control measures, process parameters and/or the
procedures shall be described
7.4
Hazard Analysis
7.4.1 General
The degree of control required
to ensure food safety
Combination of control
measures is required
7.4.2 Hazard Identification & Determination Of
Acceptable Levels
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7.4.2.1 Identify your food safety hazards
The identification shall be based ona) The preliminary information and data collected
b) Experience
c) External information
d) Information from the food chain to food safety hazards
7.4.2.2 Consider your hazard environment
Consideration shall be given toa) The steps preceding and following the specified operation
b) The process equipment, utilities/services and surroundings
c) The preceding and following links in the food chain
7.4.2.3 Specify Acceptable Hazard Levels
Established statutory and regulatory requirements
Customer food safety requirements
The intended use by the customer and other relevant data
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7.4.3
Hazard Assessment The degree of control
Conducted to determineEach food safety hazard shall be evaluated
Elimination or reduction to acceptable levels is essential to the
production of a safe food
7.4.4
Selection & Assessment Of Control Measures
An appropriate combination of control measures shall be selected
Capable of preventing, eliminating or reducing the food safety hazards
7.5 Establishing The Operational Prerequisite
Programmes (PRPs)
Food safety hazard to be controlled by the programme
Control measure
Monitoring procedure
Corrections and corrective actions
Responsibilities and authorities
Records monitoring
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7.6 Establishing The HACCP Plan Food safety
7.6.1 HACCP Plan
The HACCP plan shall be documented for each identified
critical control point (CCP)
7.6.2 Identification Of Critical Control Points (CCP)
CCP shall be identified for the control measures identified
7.6.3 Determination Of Critical Limits For Critical
Control Points
Critical limits shall be established, determined, measureable,
documented, based on subjective data, supported by instructions
or specifications and/or education and training
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7.6.4 System For The Monitoring Of Critical Control
Points
A monitoring system shall be established
Demonstrate that CCP is in control
All scheduled measurements or observations relative to the
critical limits
7.6.5 Actions when monitoring results exceeds critical
limits
Planned corrections and corrective actions to be taken
Specified in the HACCP Plan
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7.7 Updating Of Preliminary Information & Documents
Specifying The PRPs & The HACCP Plan
The organisation shall update the followingProduct characteristic
Intended use
Flow diagrams
Process steps
Control measures
7.8 Verification Planning
Shall define the purpose, methods, frequencies and responsibilities for
the verification activities
7.9 Traceability System
Shall be able to identify incoming material from the immediate
suppliers and the initial distribution route of the end product
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7.10 Control Of Non-conformity
7.10.1 Corrections
A documented procedure must be established and maintained
7.10.2 Corrective Actions
Identify and eliminate the cause of detected non-conformities
To prevent recurrence and to bring the process or system back
into control
7.10.3 Handling Of Potentially Unsafe Products
7.10.3.1 General
The food safety hazard have been reduced
Reduced to identified acceptable levels
Meets the acceptable levels
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7.10.3.2 Evaluation For Release
The monitoring system demonstrates the control measures
Combined effect of control measures
Results of sampling, analysis and/or other verification activities
7.10.3.3 Disposition Of Nonconforming Products
Reprocessing or further processing
within or outside the organisation
Destruction and/or disposal as waste
7.10.4 Withdrawals
To enable and facilitate the complete and timely withdrawal of lots
of products which have been identified as unsafe
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Clause No.8 - Validation, Verification & Improvement
Of The Food Safety Management System
8.1 General
The food safety team shall plan and implement the processes
needed to validate control measures
8.2
Validation Of Control Measure Combinations
Selected control measures are capable of achieving the intended
control of the food safety hazard
8.3
Control Of Monitoring & Measuring
Specified monitoring and measuring methods and equipments are
adequate to ensure the performance of the monitoring and
measuring procedures
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8.4 Food Safety Management System Verification
8.4.1 Internal Audit
Planned intervals to determine the food safety hazards
Conforms to planned arrangements
Effectively implemented and updated
8.4.2 Evaluation Of Individual Verification Results
Existing procedures and communication channels
The conclusions of the hazard analysis, the established
operational PRPs and the HACCP Plan
The PRPs
The effectiveness of human resource management and of
training activities
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8.4.3 Analysis Of Results Of Verification Activities
Analyse the results of verification activities, including the
internal and external audits
8.5 Improvement
8.5.1 Continual Improvement
Top management shall ensure that the organisation continually
improves the effectiveness of the food safety management
system
8.5.2 Updating The Food Safety Management System
Input from communication, external as well as internal
Suitability, adequacy and effectiveness of FSMS
Output from the analysis of results of verification activities
Output from management review
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1. The quality must state …………….
 Commitment to quality
 The quality objectives support it
2. What to do when things go wrong? What action
should be taken?
 Corrective action
3. Food business operators, implement and maintain
food safety management procedures based on
______________
 The principles of HACCP
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4. Negative attributes such as spoilage, contamination
with filth, discoloration, off-odors relates to

Food quality
5. Is HACCP approach is an important preventive
approach?
 Yes
6. HACCP plan to identify the corrective actions to be
taken if a critical limit is met.
This statement is correct or not
 No
7. The process of finding evidence for the accuracy of
the HACCP system
 Validation
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9. If verification does not demonstrate conformity
with the planned arrangements. Which following
actions may be taken?
 Review of existing procedures and communication
channels.
 Review of the conclusions of the hazard analysis, the
established OPRP(s) and the HACCP plan.
 Review of the PRP(s)
 Review of the effectiveness of human resource
management and of training
10. While analysing the results of verification
activities, which results are also included?
 Internal as well as external audit
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we
care
with
quality
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For
More
Detail
Visit our website
www. shahifze.com
www.shahienterprises.com
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