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