EWG-04 -02 Conformity of Production Risk-based surveillance Maarten Balk Manager Vehicle Admission & Surveillance Department Assessment & Surveillance
Agenda § § § Introduction surveillance Facts and implementation Risk-Based Surveillance Maarten Balk – Risk-based Surveillance
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
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
Surveillance in the vehicle chain ENFORCEMENT Maarten Balk – Risk-based Surveillance
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
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
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
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
Risk-based Surveillance Risk manufacturer Product risk Frequency of testing Responsible person for cop Production method market Product variaton History Surveillance others OEM / After market intermediary experience intermediary Number of intermediaries Time since latest visit Land Implementation Type Authenticity certificate Product NC’s Culture manufacturer Results audits Surveillance other TAA Recalls Type product Culture Quality system External NC’s Number of products Experiation date Change of failure Effect on failure Change of discovering
Risk-based Surveillance RISK Risk Manufacturer Productrisk External NC’s History Surveillance others Quality system OEM / After market Product NC’s Results audits Surveillance other TAA Recalls Type product Time since latest visit Type Experiation date
EXAMPLE RISK Risk Manufacturer Score: Productrisk 62 50 38 24 18 15 25 35 0 I. A. performed - Findings: Auditscore 5 - ISO TS 16949 Type product - OEM Supplier - Producing only components - Regulation R 42 History Surveillance others Quality system OEM / After market Results audits Surveillance other TAA External NC’s Time since latest visit Recalls Product NC’s - Product NC via marketsurveillance Type Experiation date CS 0 1 2 3 4 5 6 7
Risk-based prioritization High Audit perfomed by RDW low Risk Validation Audit perfomed by partner Document review
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