1. Risk Management in Regulatory Systems An Introductory Webinar

2. Objectives To get ‘objective evidence’ on the stakeholders’ needs for the establishment of the group; To introduce the needs assessment survey; To examine reference models that were used to prepare the questionnaires; To verify the questionnaires; To improve the models.

3. An overview: regulatory systems Market Business 2 Business 3 Regulator Conformity Assessment Market Surveillance Business N Business risks, incentives, costs Regulator’s risks, incentives, costs Standardization Business 1

4. Scenario 1: risk in business 1 Market Business 1 Business 2 Regulator Conformity Assessment Market Surveillance Business N Business risks Regulator’s risks

5. Scenario 2: chain reaction Market Business 1 Business 2 Regulator Conformity Assessment Market Surveillance Business N Business risks, incentives, costs Regulator’s risks, incentives, costs

6. Risk Management Process

8. The contents Risk Management in: – Technical Regulation – Standardization – Conformity Assessment – Market Surveillance – Business Companies (cooperation with authorities) Basic concepts Reference models Sample questions

9. RM in Technical Regulations: basic principles When risk is a rationale for imposing a regulation, regulation should be adequate to the risk being mitigated and this fact should have objective evidence. There should be no excessive regulation. There should be no insufficient regulation.

10. RM in Technical Regulations: a reference model Risk Identification BusinessRegulatorsMSA Id Methodology for Risk Iden Communicati- on strategy Risk Assessment - Priorities Risk Profile Risk Assessment tools Regulators Determination of a RM strategy Methodology for cost/benefit/ risk An Risk Acceptance Criteria List of risks to be mitigated Technical regulation development plan RegulatorsBusiness Priorities

11. RM in Technical Regulation: a reference model Procedures Development of a technical regulation Regulators Other ways of risk mitigation Risk Acceptance Regulators Business Methodology for management impl risks Management of implemetation risks BusinessRegulators Conformity Assessment Bodies MS Authorities Risks of regulatory failure Risks caused by implementation of TR Technical Regulation Implementation Conformity Assessment Bodies Business MS Authorities Regulators Risk acceptance criteria Business operation Market Surveillance Conformity assessment

12. Sample questions

13. RM in Standardization: basic principles Risks should be considered as an important input into standards development planning process; Comments on the standards should include risk identification, requests for comments should contain a clear methodology on how to identify the risks; Risk management records should prove that risks were addressed when revising a standard.

14. RM in Standardization: a reference model Risks to be mitigatedProject Proposal Risk assessment Deciding on market demand SDO Risk Assessment (of a failure) Project proposal Drafting the standard Risk assessment (impl.) Tech Com Risk Manager Stake holders Requests for risk identification Risk Assessment (of a failure) Draft of a standard Commenting on a draft, including risk ident. Tech Com Risks Comments SDO

15. RM in Standardization: a reference model Requests for risk identification Ris k management records Draft Standart Revising the draft Tech Com Public Comment Public RisksComments Approval and editing Tech Com Risk management records Next Version of a standard Publication SDO Five year review SDO Standard published

16. Sample questions

17. RM in Conformity Assessment: basic principles Conformity Assessment procedures are chosen on the basis of risks related to the products and services. Risk assessment is performed during certification procedures: risk associated with a possible failure of a product is taken into account when devising a sample plan to optimize the conformity assessment costs; in management system certification, non-conformities to the standards are issued on the basis of a proven risk, showing why the nonconformity is important to the business. Assessment of risks related to products is submitted along with technical documentation to conformity assessment bodies.

18. RM in Conformity Assessment: a reference model Risk associated with possible failure of the products Sampling plan Not meeting requirements of a standard A proven risk Risk Assessment Risk Assesment Manufac turer Risk Analysis Developing Technical Documentation Check the connectness of Risk Assessment Manufac turer CAB Devising sampling plan Issuing a nonconformity Product certification System certification

19. RM in Conformity Assessment: a reference model Risks Identification of a special risk Risk identification CE making Conformity Assessment Body

20. RM in Conformity Assessment: sample questions

21. RM in Market Surveillance: basic principles Intensity of Market Surveillance for various products depends on the level of risks that these products present. Risk assessment is an important input for planning of market surveillance processes. Market Surveillance Authorities cooperate with Economic Operators to determine appropriate measures for risk mitigation: manufacturers (importers, distributors) inform Market Surveillance Authorities about the risks and vice versa.

22. RM in Market Surveillance: a reference model Risk identification – products that present a risk Risk Evaluation Market Surveillance Authorities List of products that present a risk Risky products Risks to H&S, Public Interest Cooperation Appropriate measures Economic Operators, MSA Economic Operator Risk identification Information on a risk Determination that a product presents a risk Informing manufacturer or importer and MSA Risk Analysis Distributor MSA, Importer, Mnf

23. RM in Market Surveillance: a reference model Request to provide the information on risks MS Authorities Risk Identification, assesment Distributors Authorities Risk Identification Sending a request Request to provide the information on risks MS Authorities Provision of information Economic operator Determination that a product presents a risk Importer Market Surveillance Authorities Informing manufacturer and MSA Risk Analysis Risk identification Information on a risk Cooperate on any action to eliminate the risk

24. RM in Market Surveillance: sample questoins

25. RM in Business vs. ‘others’: basic principles Business companies actively participate in risk management processes of the regulators. Risk management processes serve as a basis for efficient cooperation between regulators and business companies aiming at implementation of appropriate risk mitigation measures and a balanced level of safety. Application of risk management tools within business companies is essential for successful implementation of risk-based regulation. Risks should be considered in a consistent and systemic way by business companies when making strategic and operational decisions.

26. RM in Business vs. others: a reference model RM standards Risk based regulations Risk Management Records RM for compliance RM standards Business Risk Management Risk Management Records Business Goal-setting regulations Standards Deterministic regulations Compliance Business

27. RM in Business vs. others: a reference model A Risk business can’t manage on its own Risk Management Risk registered Regulation Notifying the Regulator Business Regulator Risk management methodologies, standards Risks that are not a subject to mitigation by regulators Voluntary standards, Frameworks Risk Management Records Identification Risk Management Processes Business

28. The level of risk Time to keep the documents Determination of the period to keep the TD and DoC Manifacturer Risk Assessment Developing of a declaration of Conformity Risk Assessment Manufacturer Risk Management Risk Analysis Check the correctness of Risk Assessment Developing Technical Documentation Risk Management Manifacturer Conformity Assessment Body

29. RM in Business vs. others: a reference model Risk Identification- product that presents a risk Information on a risk Informing MSA (Manufacturer, importer) Risk Analysis Determination that a product presents a risk Market Survelillance Authorities Distributor Importer Manufacturer Importer Distributor Risks presented by a product Carrying out sample testing, keep a register of compaints Manufacturer Importer

30. RM in Business vs. others: sample questions

31. The next steps Filling out the forms of the Survey (with our help) Setting dates and times – when? Could be done on Webex