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Understanding the Role of Internationally Harmonized Quality Infrastructure in Competitiveness of Agriculture Products
Evangeline C. SantiagoPhilMSTQ MAP Agribusiness
What is QUALITY?
• a degree to which a set of inherent
characteristics “fulfills requirements”
(ISO 9000)
• set of inherent characteristics of
products or process –defined by the
product or process specifications
• fulfills requirement– compliance to
the set of specifications
� Why are we concerned with Quality?
� Satisfaction of clients about the product (value for money)
� Safety of consumers (health)
� Competitiveness (profits)
� How can we ensure that our product has the desired quality?
� Provide a system that will confirm and guarantee that the quality desired is achieved
� National Quality Infrastructure for local competitiveness
� National Quality Infrastructure harmonized to International Quality Infrastructure for global competitiveness
Metrology
Testing
Certification
Accreditation
Testing
Analysis of properties,
ingredients,
characteristics, etc.
Accreditation
Recognition of
technical competence
Standards
Definition of properties,
dimensions, tolerances,
etc.
Certification
Conformity with
requirements defined by
standards
Metrology
Guarantee of exact
and reliable
measurements
Standards
Elements of Quality Infrastructure
Understanding Standards and Technical
Regulations
� Standards- document approved by a recognized body that provides, for common and repeated use, rules, guidelines or characteristics of products or related processes and production methods with which compliance is not mandatory� reproducibility and comparability of
measurements, test results and quality parameters
� industry standards can contribute to cost reduction
Technical Regulations -standards related to safety, health, environment and consumer protection, the enforcement is compulsory, a sovereign task of a nation
National Standards Infrastructure related to the
International Quality Infrastructure (ISO)
Applicable to all products and processes
National Value Chain
National Quality Infrastructure
Regional Standards
International System
FDA
BFAR, BPI
National Standards Body (BPS)FDA, BAFPSNMIS
Participation in Technical
Committees
National Standards
(voluntary)
Technical
compulsory:
Health
Safety
Environment
Consumer
Protection
ISO
International Standards
CODEX Alimentarius
Regulations
NMIS
Notification authority for WTO TBT/SPSPolicy Group DA
Enquiry point for WTOTBS/SPS
BPS
Inquiries
Comments
Notifications
Comments
Common International Standards for Agricultural Products
Process Standards Product Standards
Good Agricultural Process (Primary Production) Good Manufacturing Process (Post Primary Production)
Code of Hygienic Practice in
Slaughtering includes
microbiological tests (Post Primary Production)
Hazard Critical Control Points
(HACCP Management
(Food Safety includes
microbiological tests (Primary and Post Primary
Production)
ISO 9000
(Quality Management )
ISO 14000
(Environmental Management)
1. Physical Specifications (color, size, freshness, odor)
2. Chemical Specifications
a. Composition (% oil, sugar, fats, proteins, carbohydrates)
b. Contaminants
Toxic metals (Cd, Pb,Hg)
Toxic organics (pesticides, antibiotics, additives) Filth
3. Packaging (food grade materials, types of containers
Some Examples of Existing Philippine Technical
Regulations and Standards for Agriculture ProductsStandards Technical
Regulations/Implementation
Basis for Standards
Good Animal Husbandry Practices (GAHP) (BAFPS/ BAI)
(GAHP) Accreditation (Certification )
for export of meat
CODEX Code of Hygiene in Primary Production
AAA (hygiene, animal
health, equipment,
HACCP, cold storage
facilities, microbiological
analysis for )
AAA, AA (hygiene,
animal health, HACCP
cold storage)
A (hygiene, animal health,
cold storage)
(NMIS)
health and physical
attributes for freshness
(NMIS)
AAA
Accreditation (Certification )
for export of meat
AAA, AA, A
Accreditation (Certification)
for regulation of local
market,
allows the meat to be sold
across provinces
Certification of Inspection
for regulation of local market
allows meat to be sold within
the province
CODEX
Code of Hygienic Practices of Slaughterhouse
Some Examples of Existing Philippine Technical
Regulations and Standards for Agriculture ProductsStandards Technical
Regulations/Implementation
Basis for Standards
GMP, SSOP and HCCP
practices for fish and
fisheries products
(BFAR)
GMP, SSOP and HCCP
Accreditation (Certification)
for export
CODEX Standards
Code of Good Agricultural
Practice for Fresh
Vegetables and Fruits
(GAPVF)
BAFPS
(GAPVF)
Accreditation (Certification)
for export
FAO GAP, EUREPGAP
Processed Foods
Labeling (Nutritional and
Health Claims)
Packaging and Container
Food Additives
Estimated shelf life
Finished product
specification
Method of manufacture
Certificate of analysis and
method of analysis
(,FDA,DOH)
Registration of the product for
export, import and local retail
Certification of compliance to
standards
CODEX Standards
How is Compliance to Technical Regulations and
Standards Determined
(Example: Meat, Fish, crops, processed foods)
Processes Product
Certification of compliance to a process standard by the regulatory body
(is the certifying body accredited by the Philippine Accreditation Office)
NMIS- no
BFAR-no, (though accredited by EU)
BPI-no
FDA-no
Certificate of Test Results for quality parameters by testing (are the testing done by ISO-17025 accredited Laboratories?)
NMIS-no
BFAR-no
BPI-no
FDA-yes
Accreditation� Accreditation – recognition of the technical
competence of a conformity body or person to carry out specific tasks
� Different Fields that are given Accreditation� Testing and Calibration Laboratories (ISO/IEC 17025)
� Certifying Bodies for QMS (ISO/IEC 17021)
� Certifying bodies for EMS (ISO/IEC 17021)
� Certifying Bodies for Product Certification (ISO/IEC Guide 65)
� Certifying Bodies for Person Certification (ISO/IEC 17024)
� Ensures that MSTQ system works in the
global community
� Establishes Mutual Recognition of
Quality that complies to an agreed
standard
International Quality Infrastructure (IQI)International Quality Infrastructure (IQI)
Process
Farm to Table System
National Quality Infrastructure
STANDARDIZATIONBPS
ACCREDITATIONPhilippine Accreditation
Office
• Products•Processes
CERTIFICATIONNMIS/BAI
METROLOGYNML/MIRDC/private calibration laboratories
Testing laboratories(public/private)
ISO /IEC 17021
And ISO/IEC Guide 65
International System
IQI Application to a Meat Product Value Chain
National Quality System
Products with certificate
Sanitary surveillance
Technical regulationsDept of Agriculture
Animal Farm
Processing
Transport
Meat and Meat
Products
Customer
Good Practices
ISO 9000
HACCPISO 14000
ISO 22000
IAF, ILAC
Traceability •Calibration•Reference Materials
BIPM
intercomparisons
Proficiency tests
ISO/IEC 17025
ISO, CODEX
ISO/IEC 17025
Compliance to Product Specifications
� Calibration – physical measurements� Testing- chemical measurements
� Metrology- science of correct and reliable measurements� important in in quality- related concerns
globalized production with global manufacturers and worldwide local suppliers
� compliance to threshold values of contamination in food products
Physical Measurements
� How to assure that one kilogram of meat in Company A in the Philippines weighs exactly the same in Company B in Singapore?
� Only when the country’s defined structure and measurement hierarchy is harmonized through regional organizations and finally coordinated by the worldwide metrological system, the Bureau International des Poids et Measures- BIPM, with accepted mutual recognition of measurements performed by members
How to assure that 1 kg in laboratory A in Singapore weights exactly the same as 1kg in laboratory B in the Philippines?
1kg
BIMP
1kg
Intercomparison measurements
Philippines Singapore
NMI Accredited Calibration
laboratoriesInternal calibration
laboratoriesCompany A
Measuring Instruments
NMI Accredited Calibration
laboratoriesInternal calibration
laboratoriesCompany B
Measuring Instruments
Trac
eabi
lity
Traceability
1kg in lab A=
1kg in lab B
!
Chemical Measurements
� How can one be assured that the test report of 185 mg/kg ±15mg/kg Tin in canned corned beef submitted by Laboratory A conforms to the CODEX limit of 200mg/kg ?
� Only when the realistic estimate of the uncertainty of measurement depends on the accurate calibration of balance, thermometer, volumetric glasswares and accurate assignment of uncertainty of reference standards used in testing
� If the uncertainty estimate is ± 18mg/kg , then the canned corned beef will no longer conform to the CODEX Limit and maybe rejected in the export market.
Understanding Testing
� many test methods are standardized in order that the results obtained will be comparable and reproducible
� the reliability of tests conducted depends on the correct operation and accuracy of the test and measuring equipment , which are dependent on traceable calibration
� to set up laboratories for all testing required is costly, to use existing specialized laboratories with proper accreditation is more practical
Testing
� third party assessment of the laboratory competence according to a defined criteria by a competent and recognized body is necessary
� third party laboratory accreditation of competence is harmonized and established worldwide
� the criteria for management and technical competence are defined in the international standard ISO-17025
Testing
� Accreditation to ISO-17025, as competence criteria for customers must be demanded irrespectively of whether it is a government or non-government laboratory
� the key criterion “technical competence according to international standards” can and should be recognized by regulatory bodies
Global Harmonization of Conformity
Assessment
�Agreements among nations on mutual acceptability of requirements, assessment methods, inspection or test results
� benefits international trade in general
� reduce or remove so-called technical barriers to trade.
“One stop measurement” to achieve worldwide acceptance
Ideally this means:
• one product one worldwide technical regulation
• one product one worldwide standard
• one product one worldwide measurement
• one product one worldwide test
• one product one worldwide accreditation
Worldwide Product AcceptanceWorldwide Product Acceptance
“ONCE TESTED, EVERYWHERE ACCEPTED!”
Source: C Sanetra, MSTQ Seminar 2005
Where are we now ?Agribusiness: Global Challenges, Opportunities and Competitiveness1 April 2011
Rolando T. Dy, Ph.D.
Executive Director
Center for Food and Agri Business
University of Asia and the Pacific
Benchmarking the Philippines versus ASEAN
� In agri-food export, the Philippines lags miserably. Its export of $4 billion in 2008 was only about 15% of Indonesia's ($31 B), Malaysia's ($28 B) or Thailand's ($34 B). Vietnam has $11B. It is also the only country with a trade deficit.
� On a per farm land basis, the Philippine export intensity was only $340 per hectare in 2008 as compared to $650 for Indonesia, $1,093 for Vietnam, $1,760 for Thailand, and $3,500 for Malaysia.
Country US
Import
Share
(Value)
US
Import
Share
(%)
FDA
Refusals
no. lines
% of
total
FDA
Refusals
China 15.337 5.8 2334 8.6
Thailand 10.649 4.0 709 2.6
Indonesia 9.463 3.6 1071 4.0
Malaysia 4.760 1.8 172 0.6
Vietnam 4.231 1.6 1184 4.4
Philippines 2.996 1.1 650 2.4
US FDA Refusals Among Leading Country Importers, FY 2007-2009
(value of agricultural and seafood in billion US dollars
CRS based on FAS BICO Import Commodity and FDA OASIS Data
Matrix Parameter Matrix Parameter
Black Tiger Shrimp Filth Crispy Roasted Corn Aflatoxin
Yellow Fin Tuna Filth Dried Mackerel Histamine
Smoked Round Scad Insanitary Candy Unsafe Color
Whole Octopus Salmonella, Filth Frozen Tuna Stake Filth
Bittermelon Leaves Pesticides Tuna Spread Transfat
Tamarind Paste Filth Stuffed Milkfish Salmonella
Salted Anchovies Filth, Bacteria Fruit Juice Unsafe Color
Frozen Tuna CubesFilth, Histamine
TransfatTaro Leaves Filth, Transfat
US Detentions/Refusals, 2008US Detentions/Refusals, 2008
USFDA-OASIS
EU Rapid Alert (Rapid Alert System for Food
and Feed 2006-2008)Date Cause of Alert Date Cause of Alert
29 Jan 2008 Cadmium in Sardines in Tomato Sauce
5 Oct 2007 Cadmium in canned sardines
5 Nov 2007 Histamine in Canned Tuna oil
22 Aug 2007 Cadmium in canned sardines
14 Nov 2007 Histamine in Yellow fin Tuna
9 Nov 2006 Cadmium in canned sardines
8 Oct 2007 Histamine in Fresh chilled Slices of Tuna
23 Mar 2006 Histamine in canned tuna
NationalValue Chains
Applicable
to all
products
and
processes
InternationalQI - System
Certification
- products
- processes
Metrology
- Calibration
- Reference Materials
Standardization
Accreditation
Testing
Laboratories
National Quality Infrastructure (NQI) and Value Chains
Government
& Private
Laboratories
DA/BAFPS
DOH/FDA
DTI/BPS
FDA, BFAR,
NMIS
DTI/PAO
ITDI/NML
While the NQI is not completely harmonized to the IQI,
What can agribusiness do to enhance its global
competitiveness ?
� US and Japan market- rely heavily on inspection at border and testing for compliance to standards
� Exporters to use ISO-17025 accredited laboratories for testing
� Exporters to use the National Process Standards that are available (GAHP, GMP, HACCP,GAPVF)
While the NQI is not completely harmonized to the IQI,
What can agribusiness do to enhance its global
competitiveness
EU market – relies more on the system of accreditation of the national competent authority and certification of compliance of exporters to EU regulations for food safety
� Exporters to use ISO-17025 accredited laboratories for testing
� Exporters to lobby for competent authorities to be accredited by PAO to ISO 17011 and ISO Guide 65 for certifying bodies
.
Sources of Competitive AdvantageAgribusiness: Global Challenges, Opportunities and Competitiveness1 April 2011
Rolando T. Dy, Ph.D.
Executive Director
Center for Food and Agri Business
University of Asia and the Pacific
� The key sources of competitive advantage are: factor endowment; productivity and costs; and economies of scale
1. Factor endowments include natural resources (land, water and coastline).
2. Productivity and cost drivers cover the quality of business climate, infrastructure, and institutions.
3. Economies of scale matters in terms of supply of raw materials for processing as well as finished products for exports.
MSTQ NQI-
MSTQ NQI- Harmonized to IQI
industry
reg agency
consumer competitiv
eness
industry
reg agency
consumer
globally-acceptable
Product C
ertific
ates
safe and re
liable products
National Notification Authority
and Enquiry Point
National Notification Authority
� a single government authority responsible for the implementation of notification procedures and to notify approved technical regulations to the TBT or SPS Secretariat at WTO in Geneva
Enquiry Point
� a single body responsible for the provision of answers and documentation to all reasonable questions from interested members
April 2012
Chocolate mallows Unsafe color FDC yellow #5
Fish sauce No registration as
manufacturer of low acid food or acidified food
Frozen raw whole
cleaned octopus
Salmonella
Salty candy filthy
Frozen tuna steak filthy
Dried herring Insanitary packing
Corn snacks Unsafe color FDC yellow
#5
Adobo mix melamine
Tamarind fruit filthy
April 2005
Sandwich spread Unsafe color FDC yellow
#5
Chillites (hot pepper in jars)
No registration as manufacturer of low acid
food or acidified food
Frozen/ raw shells on shrimps
filthy
Dried mango Excess sulfite
Fish sauce No registration as
manufacturer of low acid food or acidified food
Refusals of Products from the Philippines
Reliable and recognized national laboratory infrastructure
National Metrology Institute (NMI)NML at DOST
National IndustryRegulatory AgenciesNeeds reliable calibration and test results
Accredited calibration laboratoriesPublic or Private
Accredited testing laboratoriesPublic or Private
National Accreditation Body PAO
Traceability
Accreditation
Traceability