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Risk Management in Regulatory Systems

Risk Management in Regulatory Systems. An Introductory Webinar. 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;

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Risk Management in Regulatory Systems

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  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 Standardization Regulator Conformity Assessment Market Surveillance Regulator’s risks, incentives, costs Market Business 1 Business 2 Business 3 Business N Business risks, incentives, costs

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

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

  6. Risk Management Process

  7. 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 Business Regulators MSA Communicati-on strategy Methodology for Risk Iden Id Risk Identification Risk Assessment tools Risk Profile Risk Assessment -Priorities Regulators Methodology for cost/benefit/risk An Risk Acceptance Criteria Priorities Determination of a RM strategy Regulators Business List of risks to be mitigated Technical regulation development plan

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

  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 SDO Risk assessment Risks to be mitigated Project Proposal Deciding on market demand SDO Risk Assessment (of a failure) Project proposal Drafting the standard 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 Comments Risks Risk assessment (impl.)

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

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

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

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

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

  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 Risk based regulations Goal-setting regulations RM standards RM standards RM for compliance Risk Management Business Business Risk Management Records Risk Management Records Deterministic regulations Standards Compliance Business

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

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

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

  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

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