4. the Conformity Checking Approach

PROCEDURE FOR THE CONFORMITY CHECKING PROGRAM EXECUTION JUN/07

SUMMARY

1. Introduction 2. Objective 3. Definitions 4. The Conformity Checking Approach 5. Elaboration of the Conformity Checking Program Annual List 6. The Conformity Checking Program Stages 7. Actions

1 INTRODUCTION

The National Institute of Metrology, Standardization and Industrial Quality, INMETRO, is a well- known institution in Brazil, particularly, due to its performance on consumer protection and conformity assessment matters.

INMETRO is a federal institution, funded by the Brazilian Government in chapter of Ministry of Development, Industry and Foreign Trade. INMETRO, within the Brazilian System of Conformity Assessment – SBAC, is the official accreditation body and also a regulatory agency. Under its responsabilities, there is the coordination of mandatory and voluntary certification of products, processes and services focusing on health, safety and environment.

SBAC is a sub-system of the National System of Metrology, Standardization and Industrial Quality. The traditional world-wide mechanisms of conformity assessment are used in Brazil, such as: Certification, Supplier’s Conformity Declaration, Labeling and Testing.

In Brazil, the market surveillance activity must be carried out on Federal level. There are two modalities to follow on the market regulated products with their conformity compulsorily assessed and both are under INMETRO’s responsability: Inspection (based on the package information checking) and Conformity Checking (based on the product intrinsical analysis).

2 OBJECTIVE

This document defines the applicable criteria and establishes the methodology to be used on the implementation of the Conformity Checking Program for products with conformity assessed accordingly to the SBAC.

3 DEFINITIONS

Inspection

It is an activity performed through a network of public organs delegated by INMETRO, which is responsible for the elaboration of inspection’s procedures and the training of the inspectors. The inspection assures that the products available on the market exhibit the SBAC conformity identification mark. In case of identification of products with irregulations, the inspectors are allowed to interdict or arrest, as well as to fine manufacturers or dealers. PAGE PROCEDURE FOR EXECUTION OF THE CONFORMITY CHECKING PROGRAM 02/04

Conformity Checking

It is the verification of the conformity permanence of a product to the specified requirements, with the intention of proving the effectiveness of the Conformity Assessment Program, as well as its constant improvement, with less costs to the society. This activity bears a preventive character and it means to periodically collect samples of conformity assessed products available in market place, in order to verify whether they maintain the characteristics based upon which they were granted to display the SBAC conformity mark.

Conformity Checking Program

It is the execution of the Conformity Checking process and stages applied to a specific product.

4 THE CONFORMITY CHECKING APPROACH

It is a checking modality, following specific steps, such as:

- To select products family to be analyzed, based on a priority list, observing the following criteria: product safety, product history (particularly related to consumers complaints and irregularity indicator on inspection activity) and the conformity assessment mechanism adopted.

- To divulge assay results for the involved actors, protecting manufacturers and/or companies brands, aiming to keep the information confidentiality.

- To take specific measures, based on the results obtained in those analyses, involving manufacturers, importers, notified bodies, testing laboratories and sectoral industry associations.

5 ELABORATION OF THE CONFORMITY CHECKING PROGRAM ANNUAL LIST

The elaboration of the annual list of products submitted to the Conformity Checking, as much as possible, follows criteria, such as: a) Priorities identified within the society, through the Brazilian Committee of Conformity Assessment - CBAC; b) Consumer claims; c) Results of inspection activities; d) Expectations of regulatory agencies; and e) Previous results on Conformity Checking process.

6 THE CONFORMITY CHECKING PROGRAM STAGES

The assignment of the technician responsible for the management of the Conformity Checking Program is defined, whenever possible, observing the adequacy and match of the nature of products with the respective specialization/education area of the manager technician. As far as the product and the manager technician are defined, the development of the Conformity Checking Program is initiated, following stages as described below: PAGE PROCEDURE FOR EXECUTION OF THE CONFORMITY CHECKING PROGRAM 02/04

Program Premises

Each Conformity Checking Program requires specific needs and treatment. The Program manager identifies the standards, the regulation basis related and, if it is necessary, articulates visits to laboratories, plants and/or companies, aiming to deepen the technical knowledge required to evaluate the specific product.

It is a manager’s responsibility the identification of the amount of product manufacturers under mandatory conformity assessment process and also Brazilian testing laboratories accredited by INMETRO for the specific scope, recognized by the International Accreditation Forum – IAF. As well as to set appointments to present the Conformity Checking Program to the SBAC actors mentioned in item 4.

Elaborating the Technical Note

Every single Program requires a specific Technical Note. The responsible manager drafts a document that contains general information about samples collection and delivering to testing laboratories.

The Conformity Checking Program Introduction Meeting

In this meeting, the Conformity Checking Program is presented to all SBAC agents and the subjects regarding the definition, objective, methodology, execution, stages and actions of the Program are well developed. This event is also an opportunity to consolidate the Technical Note.

Collecting Samples

The samples must be collected in the market, following criteria established in the Technical Note.

The definition systematics of manufacturers, brands and models to be checked is made aiming on comprehend, as much as possible, the biggest parcel of the consumer market on national level, considering traditional marketshare leaders, medium and small companies, as well foreign organizations.

It is used as landmark: a) Consumer claims; b) Irregularities historical; and c) Manufacturers geographic dispersion.

Samples must preserve their original characteristics and their transportation shall observe required specifications for such purpose.

Assaying Products

The assay selection is based on the conformity assessment procedure and/or specific standards, evaluating the essential aspects of products related to health, safety and environment. PAGE PROCEDURE FOR EXECUTION OF THE CONFORMITY CHECKING PROGRAM 02/04

The testing laboratories shall certify if the samples had been received in perfect conditios, duly conditioned and conserved with their original packages not violated.

The suppliers and manufacturers take notice of results regarding their products by INMETRO and they have a 10 (ten) days period to submit their comments on testing conclusions.

Testing results are consolidated in a single written report that will be further analyzed. All these stage costs are funded by INMETRO.

7 ACTIONS

Once non-conformities are identified, an analysis of its causes is performed, seeking to define actions for correction and improvement. These improvements may be incorporated into the standards, technical regulations and conformity assessment procedures, as well as implemented in accredited laboratories and bodies or even in the manufacturing sector.

In case when the non-conformity is considered as an intentional one, INMETRO adopts the applicable penalties.

After definition of appropriate actions to be taken, INMETRO invites all SBAC agents for a second round meeting and presents results of the specific Conformity Checking Program. In that ocasion, participants are informed of their responsibilities, possible alternatives and given period of time to present evidences of fulfilment of improvement actions.

It is a responsibility of the Program manager to monitor the course of the implementation of improvement actions and, once the deadline for such actions is expired, INMETRO performs a new Conformity Checking Program season to feedback the conformity assessment system.