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Conformity of Production EWG-04-02 Risk-based surveillance
Maarten Balk Manager Vehicle Admission & Surveillance Department Assessment & Surveillance
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Agenda Introduction surveillance Facts and implementation
Risk-Based Surveillance Maarten Balk – Risk-based Surveillance
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Surveillance Definitions
Surveillance is defined as collecting information about whether an action or item meets the relevant requirements, it will then form a judgment and the possible related intervention Conformity of Production (COP) is a means of evidencing the ability to produce a series of products that exactly match the specification, performance and marking requirements mentioned in the type approval Maarten Balk – Risk-based Surveillance
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Surveillance Definitions
Market surveillance ensures that products on the market are in conformity with the applicable law Inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or Enforcement: all actions needed to ensure compliance with rules Maarten Balk – Risk-based Surveillance
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Surveillance in the vehicle chain
ENFORCEMENT Maarten Balk – Risk-based Surveillance
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Facts and implementation
RDW is TAA but no MSA Responsible for the surveillance of Conformity of production RDW issues vehicle component and system approvals Number of manufacturers approximately 1800 > 50 countries worldwide Limited number of staff Maarten Balk – Risk-based Surveillance
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Facts and implementation
No specific requirements for excecuting Surveillance on COP Working group harmonization COP on EU level Mutual recognition other Member States Types of Surveillance Audit by RDW Audit by partner (outsourcing) Documentation assessment “Polluter pays” principle Maarten Balk – Risk-based Surveillance
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Risk-based Surveillance
RDW has evaluated the surveillance system Demand of Dutch Government: all surveillance activities Risk-based RDW investigated Risk-based Surveillance (RBS) RISK: The probability of something happening multiplied by the resulting cost or benefit if it does. (change x effect) Maarten Balk – Risk-based Surveillance
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Risk-based Surveillance
The change that a manufacturer is not compliant with the requirements and therfor the product will not comply RDW developed a system based on variables with different weighting factors Result: mutual comparison between manufacturers based on risks. Maarten Balk – Risk-based Surveillance
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Risk-based Surveillance
Risk manufacturer Product risk Frequency of testing Responsible person for cop market Production method Product variaton External NC’s Number of products History Surveillance others intermediary Recalls Type product Culture Quality system experience intermediary Product NC’s OEM / After market Results audits Culture manufacturer Surveillance other TAA Time since latest visit Number of intermediaries Change of failure Effect on failure Land Type Imple-mentation Change of discovering Experiation date Authenticity certificate
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Time since latest visit Surveillance other TAA
Risk-based Surveillance RISK Risk Manufacturer Quality system Type Productrisk History Results audits Product NC’s Recalls Time since latest visit External NC’s Type product Surveillance others OEM / After market Surveillance other TAA Experiation date
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Surveillance other TAA Time since latest visit
EXAMPLE RISK Risk Manufacturer Productrisk 15 25 18 35 62 24 38 50 Score: I.A. performed External NC’s History - Findings: Auditscore 5 - ISO TS 16949 - OEM Supplier - Producing only components Regulation R 42 - Product NC via marketsurveillance Surveillance others Recalls Type product Quality system Product NC’s OEM / After market Results audits Surveillance other TAA Time since latest visit Type Experiation date CS 1 2 3 4 5 6 7
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Risk-based prioritization
Audit perfomed by RDW High Validation Audit perfomed by partner Risk low Document review
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