Collaborative Work for Quality Management at...

2013 Fera-JIFSAN Annual Symposium

Washington, June 12 – 13, 2013

Collaborative Work for Quality Management at INFAL

Jorge Eduardo Torroba – PAHO / WHO

Red Interamericana de Laboratorios de Análisis de Alimentos:

RILAA

InterAmerican Network of Food Analysis Laboratories:

INFAL

Perspective

• PAHO / WHO • Health • Food Safety • Technical Cooperation • Networks • Labs

INFAL establishment

Argentina Brazil Bolivia Canadá Chile Colombia Costa Rica Dominican Rep. Guatemala Guyana Honduras Jamaica

México Nicaragua Panamá Paraguay Perú Trinidad & Tobago Saint Vincent Uruguay United States Venezuela

FAO BID ILSI OEA

OIRSA AOAC

December 1997 – PAHO-HQ / Washington D.C. 25 Countries & 6 International Organizations

INFAL mission

promoting food safety and quality in the region of the Americas in order to prevent foodborne diseases, protect the consumers´ health and facilitate trade, fostering and strengthening analytical laboratory development within the framework of programs of food control.

INFAL objectives

• achieve methodological harmonization

• promote the implementation quality management systems (ISO 17025)

• strengthen technical and scientific cooperation among the countries involved in the network

INFAL specific objectives

• develop an information system • facilitate the availability of reference materials and

interlaboratory testing • organize and promote training programs fostering the

interchange of experiences and available resources in the region

• promote national networks of food analysis labs • promote and strengthen the integration of labs to the

programs for food safety and epidemiological survillance

INFAL member laboratories

• voluntary • government labs • maximum 3 laboratories per

country

152 member laboratories from 29 countries

INFAL bylaws

• Assembly (biennial, all labs) • Executive Committee ( 7 labs ) • Technical Groups (all labs) • Advisor Group • ex officio Secretariat (PAHO & FAO) • National Networks ( 13 )

Sub-networks

Labs

Labs

Labs

National Networks Labs

Labs Labs

Labs

INFAL

Country - Labs

Country - Labs

Country - Labs

Country - Labs

Country - Labs

National Networks

Groups

• microbiology • chemical analysis • quality management

Technical:

Management:

• executive committee

Virtual Collaboration Tools

www.panalimentos.org/rilaa

chat

e-learning

forums

web-conferencing

INFAL advisors data base

Guidance for the Implementation of ISO/IEC 17025 Standard

objective

to implement the ISO/IEC 17025 Standard in selected member laboratories by sharing knowledge and experiences from another member laboratories already accredited in certain analytical assays.

preparatory actions

• assays’ selection through forum,

• elaboration of 3 self-evaluation checklists for technical (micro & chemistry) and management requirements,

• approval by 4th assembly (November 2010).

stages

• registration of the labs; • self-evaluation of labs through checklists

elaborated by the INFAL; • training and counseling, as needed; • participation in proficiency testing; • guidance for the resolution of non-

conformities, and • audits to evaluate the degree of the

standard’s implementation.

guidelines

• guidance provided by INFAL must be free of charge;

• advisors’ participation must be completely ad honorem;

• participation in proficiency testing must be free of charge;

• each lab should afford internal implementation costs;

• labs should have adequate access to the Internet to support IT tools.

process

6 INFAL’s member labs with accreditations took the responsibility of counseling 32 labs, from 10 countries, through:

• forums, chat and a web-conference, • 11 live webinars on technical aspects and to

share successful experiences in accreditation of the standard,

• 20 on demand webinars

live webinars • Official Control Techniques: Sampling Criteria and Sample

Collection • Safety in Testing Laboratories • Proficiency testing and quality assurance in food analysis Labs • Measurement Uncertainty • Quality control of microbiology culture media • Implementation of a quality management system to prove

technical competence. Experience of the LABROB/Alimentos, Bolivia

• Successful Experiences in the Accreditation, Reaccreditation and Scope Expansion Process of INLASA / Ministry of Health and Sports, Bolivia

• Implementation Process of the Quality Management System in IIBI, Dominican Republic

on demand webinars

• Quality audits according to ISO/IEC 17025:2005 • Safety in Testing Laboratories • Management of nonconformities in a testing

laboratory based on the requirements of ISO 17025 Standard

• Training on the use of Self-Evaluation Checklists for requirements of ISO/IEC 17025:2005 Standard (amend.: 2006)

• Other specific webinars –available on INFAL’s website– were recommended to each LAB by its advising laboratory.

proficiency testing

• performed for microbiology, physico-chemical and traces elements assays,

• free of charge to all the 32 laboratories admitted in the guidance,

• microbiological PT were organized by CFIA/Canada and SENAI/Brazil;

• physico-chemical PTs by SENAI/Brazil and NFA/Sweden, and traces elements PT by INTI/Argentina

• PTs from INTI and SENAI were funded by PAHO

audits

• 6 auditors were selected, • 3 auditors travel to audit 6 assays in 3 labs

from 3 countries, • for the remaining 6 labs, a “virtual audit”,

through forums and web-conferences, was designed and implemented for 3 labs

results

• 9 labs from 6 countries achieved a high degree of the standard’s implementation on 12 assays;

• some of them are ready to request accreditation to National Accreditation Organism (1 lab got it for 2 assays),

• others should take corrective actions based on guidelines given in each audit report

workload • entire process spent 24 months, while getting started (labs

summon, self evaluation, selection, etc.) took almost 6 months, • 9 web-conference meetings (in order to: harmonize criteria and

work modality of guidance process, prepare in-person audits, design distance audits, assess guidance process and identify learnt lessons ) totalized 23 hours,

• 32 forums gathered 295 “threads” with a total of 1259 “posts”, • entire guidance for each assay has required between 30 and 50

hours of each advising team, • in-person audit took an average of 16 hours/auditor for each

assay, • “e-audits” took 16 hours/auditor per assay, • “live” training contributed 35 hours, • “on demand” training offered 17 additional hours.

guidance’s process assessment

• guidance’s process was viable

• there was a high drop-out rate at all stages

• improvement actions must be taken

improvement actions • labs selection process should be reinforced; • abridge the total period of the guidance process; • limit the guidance to a sole assay per lab to reduce

the workload of institutions; • IT tools’ training should be reinforced; • use of widely-spread web-conference tools should

be allowed, and • improve the communication of the magnitude of the

donation the guidance represents (ideally making a quantification in terms of money)

epilog

this example of the network’s work shows the INFAL as a co-operation mechanism established among governmental food analysis labs in order to strengthen their analytical capacities to support food safety, which operates with scarce resources and based on solidarity

Thank you