Risk%20Management%20in%20Regulatory%20Systems

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Risk Management in Regulatory Systems

• An Introductory Webinar

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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.

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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
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Scenario 1 risk in business 1
Regulator
Conformity Assessment
Market Surveillance
Regulators risks
Market
Business 1
Business 2
Business N
Business risks
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Scenario 2 chain reaction
Regulator
Conformity Assessment
Market Surveillance
Regulators risks, incentives, costs
Market
Business 1
Business 2
Business N
Business risks, incentives, costs
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Risk Management Process
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Risk Management Process
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The contents

• Risk Management in
• Technical Regulation
• Standardization
• Conformity Assessment
• Market Surveillance
• Business Companies (cooperation with authorities)
• Basic concepts
• Reference models
• Sample questions

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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.

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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
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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
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Sample questions
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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.

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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.)
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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
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Sample questions
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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.

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

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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
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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
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RM in Market Surveillance sample questoins
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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.

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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
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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
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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
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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
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RM in Business vs. others sample questions
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The next steps

• Filling out the forms of the Survey (with our
  help)
• Setting dates and times when?
• Could be done on Webex