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TRANSCRIPT
30 January 2018
Radziah Mohd Daud
SIRIM QAS International
FOOD SAFETY –
Certification Process, Audit
and Certification
TOPICS
Food safety standards
Certification process
Auditing and challenges
Benefits of certification
Brief changes in ISO 22000 :2018
Established in 1996 as a wholly-owned subsidiary of
SIRIM Berhad
Have been providing conformity assessment services since
the 1970s when these services were provided as a division
of SIRIM Berhad.
Staff strength: 600
No. of certifications issued: more than 9,000
Malaysian based
Local and international clients in countries such as Thailand,
Singapore, Brunei, Indonesia, Vietnam, Myanmar, Korea,
Philippines, China, Taiwan, Japan, India, Sri Lanka, Australia,
New Zealand, Germany and Spain, Finland, Holland
About SIRIM QAS INTERNATIONAL …
ACCREDITATION
(related to Food Safety
Management System
Certification)
•Management System Certification (MS ISO 9001,
MS ISO 14001, OHSAS 18001, MS 1722: Part 1,
HACCP, Food Safety Management System, GMP,
Forest Management Certification),
•Product Certification
•Chain-of-Custody for wood-based products
•Type Approval
Accreditations by STANDARDS MALAYSIA
•Management System Certification (MS ISO 9001,
MS ISO 14001, OHSAS 18001, MS 1722: Part 1,
HACCP, Food Safety Management System, GMP,
Forest Management Certification),
•Product Certification
•Chain-of-Custody for wood-based products
•Type Approval
Accreditations by STANDARDS MALAYSIA
Partnership in IQNet
This means all 30 Certification Bodies IQNet partners
including SIRIM QAS International mutually recognise
the certificates as being equivalent to their own.
Regular and rigorous peer evaluations across the
Network is conducted to ensure confidence in this
mutual recognition
What is IQNet?
IQNet is an international certification entity, formed by more than
30 of the most relevant certification entities of the most important
countries.
Some certification entities involved in IQNet are the following:
AENOR (Spain), AFNOR (France), AIB (Belgium), ANCE, IMNC
(Mexico), APCER (Portugal), CCC, CSIQ (Italy), CQC (China),
CQS (Czech Republic), Cro Cert (Crocacia), DQS (Germany), DS
(Denmark) , ELOT (Greece), FCAV (Brazil) , FONDONORMA
(Venezuela) , HKQAA (Hong Kong), ICONTEC (Colombia),
Inspecta (Finland), IRAM (Argentina) , JQA (Japan) , KFQ (Korea) ,
MSZT (Hungary), Nemko AS (Norway), NSAI (Ireland), PCBC
(Poland), Quality Austria (Austria), RR (Russia), SIQ (Slovenia) ,
SQS (Switzerland), SRAC (Romania) , TSE (Turkey), YUQS
(Serbia), AFNOR, ICCS, DQS, NSAI (USA), etc. .
IQNet Partner List
The purpose of the IQNet certificates
The IQNet certificates are used by companies
and organizations worldwide to testify that they
are certified in a particular standard (as ISO
9001, ISO14001, ISO 22000 or any other).
The IQNet Certified Management
System seal is a logo which the certified
companies usually add with the stamp of
their local certification entity.
These logos are accompanied with the
codes of the standards that they have
certified
The IQ
Net seal
The IQ Net seal
The most common certified standards are the next
ones:
ISO 9001 (Quality) , ISO 14001 / EMAS
(Environment) , OHSAS 18001 (Risk Prevention),
ISO 22000 / FSSC 22000 / BRC / IFS (Food
Security), SA8000 / BSCI / IQNet SR 10
( Sustainability and Corporate Social
Responsibility), ISO 27001 (Information technology
) , BBP / IBEC (Business Excellence), ISO 22301 ,
ISO / TS 16949 (Automotive Industry) , IRIS , TL
9000 , ISO 29001 and other international standards.
Benefits for organisation
IQNet services provide an international passport to global
recognition and worldwide market access.
The IQNet approach simplifies International certification process
and reduces associated costs.
IQNet - Leader in global certification
services
IQNet, through its international network, is the preferred
provider for global certification services and assessments, with
a focus on management systems:
with global resources and capabilities
leading in integrity and competency: accredited by more than
40 accreditation bodies
serving in all business and social sectors
offering to customers a large variety of innovative, value
adding services
IQNet Certificate
All IQNet members have signed the IQNet Multi-Lateral
Agreement (MLA).
This means they mutually recognise the ISO 9001, ISO
14001 and various other certificates of all other IQNet
partner as being equivalent to their own.
IQNet Certificates are the main evidence of this
international recognition. They are provided by all IQNet
certification bodies to their respective customers.
Confidence in certificate equivalence is founded on regular
and rigorous peer evaluations across the Network.
SIRIM QAS INTERNATIONAL
SCOPE OF SERVICES
RELATED TO FOOD &
BEVERAGE
FOOD AND BEVERAGE
Concerns :
Quality and safety of the food served to customers. Food
safety must be taken into high consideration as this
relates to the health and well being of the customers
Premises where the food is prepared, cooked, served
complies with relevant regulations applicable to food
Food prepared, cooked , served meets customers’
expectations in terms of quality and safety
Need to obtain customers’ confidence in the safety
and quality of food served
- Properly cooked
- uniform colour
- juicy
- meeting customer’s expectation
- tasty
Quality aspects – visual
Food Safety aspects
- Have the frozen chicken been thawed
in a chiller?
- Have all the significant hazards been
processed out?
- Are there contaminants from seasonings
used onto the chicken?
- Adequate cooking temperature & time
to kill the food poisoning bacteria?
- Antibiotics content in the chicken been
checked?
GMP aspects
- Have the cooking utensils been washed and
rinsed to be thoroughly free from sanitisers?
- Have all the hazards (biological, chemical and
physical ) been prevented, eliminated or
reduced to acceptable levels?
- Are the premises and work surfaces clean?
- Do production personnel follow hygiene rules?
- Are the premises free from pest?
- Are equipment suitable and safe for processing
food?
- Are facilties adequate and safe including water,
ice and steam?
STANDARDS
ON
FOOD SAFETY
Good Manufacturing
Practice (GMP)
Hazard Analysis and
Critical Control Point
(HACCP)
Food Safety Management
System (FSMS)
Coverage of each system?
Differences ?
Similarities?
Can comply to one(1) system
and comply to the rest?
Can a single audit cover 3
systems?
Can three (3) certificates be
issued with a single audit?
Compatibility with other
management system standard?
Pre Requisite Programmes
Manage basic conditions and activities of food
premises
Not selected for the purpose of controlling specific
identified hazards but for maintaining a hygienic
production , process and/or handling
Water Documentation & records)
Handling, storage & transportation
Cleaning & personnelhygiene
Premises
Incomingmaterial
Packaging
Equipment
Location
Facilities
Recall
Maintenance & cleaning
CleaningPest control
Waste mgt
Personnel hygiene
Training
PREREQUISITE PROGRAMMES
MS 1514 : 2009 Good Manufacturing Practices
(First revision)
MS 1480:2007(HACCP)
describes the requirements for food safety
according to HACCP system to ensure the safety of
foodstuffs during preparation, processing,
manufacturing, packaging, storage, transportation,
distribution, handling or offering for sale or supply in
any sector of the food chain.
Scope
Scope - GMP & HACCP
Applicable to food processing only
Does not cover upstream (farms), food packaging
material etc
Not readily compatible with other standards e.g,
ISO 9001,
Internal audit and management review separate
but can integrate into one
Documentation of the two (2) systems are different
HACCP
PRE REQUISITE PROGRAMMES(GMP)
7 Principles of HACCP
Principle 1 Conduct a Hazard Analysis
Principle 2 Identify Critical Control Points
Principle 3 Establish Critical Limit
Principle 4 Establish Monitoring Procedures
Principle 5 Establish Corrective Action Procedures
Principle 6 Verification
Principle 7 Record Keeping
Identify CCP step
eg frying
Control
Critical
Limit eg
eg 90ºC
Monitor temp
1 H + 3 W
Take corrective
action if
temp is
deviated
Verification
of corrective
action
Document and
recording
P 1
P 1
P 1
P 2P 3
P 4
P 5P 6 P 7
Identify & evaluate hazards
In RM and processs
SAFE
FOOD
Pre requisite
GMP
MS 1514
HACCP
MS 1480
ISO 22000
Pre requisite
(GMP)
Additional elements in ISO 22000
Laboratory facilities
Boiler chemicals
Compressed air and other gases
corrective maintenance
Selection and management of suppliers
Allergen management
Cleaning in place (CIP) systems
Staff canteens and designated eating
areas
Rework
Warehousing
Food defence, biovigilance, and
bioterrorism
SAFE
FOOD
Pre requisite
(GMP)
Scope
All requirements are generic and are intended to be
applicable to all organisations in the food chain,
regardless of type, size and complexity.
This includes organizations directly or indirectly
involved in one or more steps of the food chain
The standard allows small and/or less developed
organization to implement an externally developed
combination of control measures
Sta
tuto
ry a
nd r
egula
tory
auth
orities
Crop Producers
Feed producers
Primary food producers
Food manufacturers
Secondary food manufacturers
Wholesalers
Retailers, food service operators
and caterers
Producers of pesticides,
fertilizer and veterinary
drugs
Food chain for the production
of ingredients and additives.
Transport and storage
operators
Producers of equipment
Producers of cleaning and
sanitizing agents
Producers of packaging
materials
Service providers
Consumers
Scope – FSMS
Key elements
ISO 22000
Interactive
communication
Management
system
Pre requisite
programmes
HACCP
principles
Control food hazards
PREREQUISITE PROGRAMMES
ISO 22000 :2005 (FOOD SAFETY
MANAGEMENT SYSTEM)
ISO/TS 22002-1 :2009 Part 1: Food Manufacturing
ISO/TS 22002 -2 :2013 Part 2 : Catering
ISO/TS 22002-3 :2011 Part 3 : Farming
ISO/TS 22002-4 : 2013 Part 4 ; Food Packaging
Materials
FSMS Process model
Food safety planning-types
1. Recipe Based Food Safety Plans
or
2. Flowchart Based Food Safety Plans
Food safety planning-types
3. Process Based Food Safety Plans
-involves grouping together menu items that
are processed in the same way eg.
No Cook - Serve salads, sandwiches
Cook – Serve curry , laksa, fried rice
Cook – Chill – Serve potato salad, kerabu
Cook – Chill – Reheat – Serve soups, pasta sauce, gravy
SIRIM QAS INTERNATIONAL
CERTIFICATION SERVICES
RELATED TO FOOD SAFETY
CERTIFICATION PROCESSES OF
GMP, HACCP, FSMS
APPLICATION
STAGE 1
(DOCUMENTATION )
STAGE 2
(COMPLIANCE )
RECOMMENDATION
AWARD OF CERTIFICATE
SURVEILLANCE
Application
Questionnaire
Quotation
DETAILS OF CERTIFICATION PROCESS
• questionnaires will be given
to applicant
• quotation will be issued after
submission of questionnaire
by applicant
• applicant submits application
Stage 1• Audit team will conduct a Stage 1
audit on site focusing on documentation
GMP, HACCP and FSMS System
Stage 2 • Stage 2 audit will be conducted by
audit team upon applicant’s readiness
to verify effective implementation of
GMP, HACCP and FSMS systems
DETAILS OF CERTIFICATION PROCESS
CERTIFICATION• Upon closing of all non
conformities, a recommendation
report will be submitted to the
Certification Panel for approval
prior to issuance of certificates
SURVEILLANCE
AUDIT/
RECERTIFICATION
• Annual surveillance audit will
be carried out to assess
maintenance of the GMP,
HACCP and FSMS
systems annually and a full
system audit will be carried
out once in every 3 years.
DETAILS OF CERTIFICATION PROCESS
COLLABORATION WITH
MINISTRY OF HEALTH MALAYSIA
ON HACCP CERTIFICATION
COLLABORATION DETAILS
SIRIM QAS INT. will:
Handle application
Conduct stages 1 & 2 audits
Effectively verify and resolve all non conformities raised
Recommend to the Certification Panel of SIRIM QAS
International AND to the Approval Panel of Ministry of
Health Malaysia
Conduct annual surveillance . Reports are given to
Ministry of Health for review
QUESTIONNAIRE
APPLICATION
STAGE 1 AUDIT
STAGE 2 AUDIT
RECOMMENDATION FOR
HACCP CERTIFICATION
ISSUANCE OF CERTIFICATE
ANNUAL SURVEILLANCE
ISSUES OF
CONCERN
NON CONFORMITIES
RECOMMENDATION FOR
HACCP CERTIFICATION
ISSUANCE OF CERTIFICATE
SIRIM MIN. OF
HEALTH
3 Years validity 3 Years validity
ANNUAL SURVEILLANCE -
COLLABORATION IN HACCP CERTIFICATION
MOH will conduct one (1) surveillance audit
together with SIRIM QAS International
SIRIM QAS International will conduct surveillance
in the 2nd and 3rd year of certification
Integrating MS 1480: 2007 (HACCP)
with ISO 22000:2005
ISO 22000
Auditing Challenges
7 Principles of HACCP
Principle 1 Conduct a Hazard Analysis
Principle 2 Identify Critical Control Points
Principle 3 Establish Critical Limit
Principle 4 Establish Monitoring Procedures
Principle 5 Establish Corrective Action Procedures
Principle 6 Verification
Principle 7 Record Keeping
Principle 4 Monitoring
7 Principles of HACCP
Principle 1 Conduct a Hazard Analysis
Principle 2 Identify Critical Control Points
Principle 3 Establish Critical Limit
Principle 4 Establish Monitoring Procedures
Principle 5 Establish Corrective Action Procedures
Principle 6 Verification
Principle 7 Record Keeping
7 Principles of HACCP
Principle 1 Conduct a Hazard Analysis
Principle 2 Identify Critical Control Points
Principle 3 Establish Critical Limit
Principle 4 Establish Monitoring Procedures
Principle 5 Establish Corrective Action Procedures
Principle 6 Verification
Principle 7 Record Keeping
Principle 7
Documentation and record keeping
Control of documents and records
Challenges
Lack of understanding on food safety systems
Lack of technical expertise and human resource
Weak or poor Infrastructure especially in kitchens
Food workers lack interest and have a negative attitude toward
food safety programs
Time and effort to develop and implement HACCP /ISO 22000
Excessive volume of Paperwork - inconsistent monitoring of
CCPs
Benefits of Food Safety Systems
implementation
Benefits:
Include: -
Resource optimization - internally and along the food chain
More efficient and dynamic food safety hazard control
All control measures subjected to hazard analysis
Better planning, less post process verification
Improved documentation
.
Benefits (continued):
Saves resources by reducing overlapping system
audits - HOW?
Systematic management of prerequisite programmes
Control focused on what is necessary
Widely applicable because it is focused on end results
Organized and targeted communication among trade partners
(repeated below)
Valid basis for taking decisions
Increased due diligence
Dynamic communication on food safety issues with suppliers,
customers, regulators and other interested parties
CERTIFICATIONS OF FSMS , HACCP
AND GMP AND RELATED ISSUES
Can comply to one(1) system
and comply to the rest?
Can a single audit cover 3
systems?
Can three (3) certificates be
issued with a single audit?
Compatibility with other
management system standard?
Questions Answers
Yes . Implementing ISO 22000
can also ensure the compliance
to GMP and HACCP
Yes. Auditing to ISO 22000 can
cover the GMP and HACCP
auditing
Yes. The expiry dates are also
Aligned
Yes, with other management
system standard e.g. ISO 9001*
ISO 22000: 2005
undergoing revision since 2014
revision undertaken by ISO/TC 34/SC 17/W8
currently, still in draft form –ISO FDIS ( Final Draft
International Standard)
expected to be published by June 2018
IAF will issue communique on transition timelines
from 2005 to 2018 version
FDIS ISO 22000 :2018
•update old and introduce new terms and definitions; Forty-five
(45) definitions are now listed in the FDIS version
•clarify to the end users, the differences of Pre-requisite
Programs (PRPs), Operational Prerequisite Programs (OPRPs)
and Critical Control Points (CCPs)
•provide a clear understanding of the “risk based approach”
•adopt the new High Level Structure (HLS) developed and used
by ISO to allow an easier implementation of an Integrated
Management System
•align with recent developments and concepts in food safety
standards and Codex Alimentarius
Proposal
Stage
Preparatory
Stage
Committee
Stage
(CD)
Enquiry
stage
(DIS)
Finalising
(FDIS)
Approval
Stage
Expected
publication
Nov
2014
Nov
2015
Dec 2016 Jul
2017
Oct
2017
June 2018
Timelines of ISO 22000:2018
FDIS 22000:2018 ISO 22000:2005
:
1.Scope
2.Normative References
3.Terms and Definitions
4.Context of the organization
5.Leadership
6.Planning
7.Support
8.Operation
9.Performance evaluation of
the food safety management
system
10.Improvement
1. Scope
2. Normative References
3. Terms and definitions
4. FSMS
5. Management responsibility
6. Resource management
7. Planning and realization of
safe products
8. Validation , verification
and improvement of the
FSMS
STRUCTURE
Major changes …
Clarification on how the Plan-Do-Check-Act
(PDCA) cycle works by including two separate
PDCA cycles in the standard, that operate one
inside the other.
The first PDCA apply to the management system
while the second PDCA addresses the operations
covering the HACCP principles
CONCEPT OF ISO DIS 22000
Identify external and internal
issues
+Determine the interested parties
and their requirements
Define the scope of the FSMS
of the company
Determine risks
& opportunities
+
Actions taken to
address the risks and
opportunities
(if possible)
FSMS Planning, Implementation,
Monitoring and Verification
ORGANIZATION
LEVEL
OPERATION
LEVEL
EXTERNAL & INTERNAL ISSUES
ISSUES EXTERNAL INTERNAL
POLITICAL
ECONOMY
SOCIAL
TECHNOLOGY
ENVIRONMENT
LEGAL
INTERESTED PARTIES
INTERESTED
PARTIESNEEDS & EXPECTATION (REQUIREMENTS)
CUSTOMER
REGULATOR
SUPPLIER
EMPLOYEES
STAKEHOLDER
Thank you
SIRIM QAS International Sdn. Bhd
www.sirim-qas.com.my