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Risk Management in Regulatory Systems

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Risk Management in Regulatory Systems An Introductory Webinar – PowerPoint PPT presentation

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Title: Risk Management in Regulatory Systems


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
Regulator
Conformity Assessment
Market Surveillance
Standardization
Regulators risks, incentives, costs
Market
Business 2
Business 3
Business N
Business 1
Business risks, incentives, costs
4
Scenario 1 risk in business 1
Regulator
Conformity Assessment
Market Surveillance
Regulators risks
Market
Business 1
Business 2
Business N
Business risks
5
Scenario 2 chain reaction
Regulator
Conformity Assessment
Market Surveillance
Regulators 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
Methodology for Risk Iden
Communicati-on strategy
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
Business operation
Market Surveillance
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
Risks to be mitigated
Project Proposal
Risk assessment
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
Risks
Comments
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
List of products that present a risk
Distributor
Risk identification
Risk Evaluation
Market Surveillance Authorities
Risky products
Informing manufacturer or importer and MSA
Distributor
Cooperation
Economic Operators, MSA
Information on a risk
Risks to HS, 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
Market Surveillance Authorities
Risk Analysis
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 cant manage on its own
Voluntary standards, Frameworks
Notifying the Regulator
Business
Risk Management Processes
Risk registered
Business
Changing -developing a regulation
Regulator
Risk Management Records
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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