risk management in regulatory systems an introductory webinar
TRANSCRIPT
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;• To verify the questionnaires;• To improve the models.
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
Scenario 1: risk in business 1
Market
Business 1
Business 2
Regulator Conformity Assessment
Market Surveillance
Business N
Business risks
Regulator’s risks
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
Risk Management Process
Risk Management Process
The contents
• Risk Management in:– Technical Regulation– Standardization– Conformity Assessment– Market Surveillance– Business Companies (cooperation with authorities)
• Basic concepts• Reference models• Sample questions
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.
RM in Technical Regulations: a reference model
Risk Identification
Business Regulators MSA
IdMethodology 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
Regulators Business
Priorities
RM in Technical Regulation: a reference model
Procedures
Development of a technical regulation
Regulators
Other ways of risk mitigation Risk Acceptance
Regulators
BusinessMethodology for management impl
risks
Management of implemetation
risksBusiness Regulators
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
Sample questions
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.
RM in Standardization: a reference model
Risks to be mitigated Project ProposalRisk assessment
Deciding on market demand
SDO
Risk Assessment (of a failure) Project proposal
Drafting the standard
Risk assessment (impl.)
Tech Com Risk Manager
Stakeholders
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
RM in Standardization: a reference model
Requests for risk identification
Ris k management records Draft Standart
Revising the draft Tech Com
Public Comment Public
Risks Comments
Approval and editing Tech Com
Risk management records
Next Version of a standard
Publication SDO
Five year review SDO
Standard published
Sample questions
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.
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
Manufacturer
Risk Analysis
Developing Technical
Documentation
Check the connectness of
Risk Assessment
Manufacturer
CAB
Devising sampling plan
Issuing a nonconformity
Product certification
System certification
RM in Conformity Assessment: a reference model
Risks
Identification of a special risk
Risk identification
CE making
Conformity Assessment
Body
Conformity Assessment
Body
RM in Conformity Assessment: sample questions
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.
RM in Market Surveillance: a reference model
Risk identification – products that present a risk
Risk Evaluation
Market Surveillance Authorities
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
Distributor
MSA, Importer,
Mnf
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
Importer
Market Surveillance Authorities
Informing manufacturer
and MSA
Risk Analysis
Risk identification
Information on a risk
Cooperate on any action to
eliminate the risk
RM in Market Surveillance: sample questoins
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.
RM in Business vs. others: a reference model
RM standards
Risk based regulations
Risk Management Records
RM for compliance
RM standards
BusinessRisk
Management
Risk Management Records
Business
Goal-setting regulations
Standards
Deterministic regulations
Compliance Business
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
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
Business
The level of risk
Time to keep the documents
Determination of the period to
keep the TD and DoC
Manifacturer
RiskAssessment
Developing of a declaration of
Conformity
Risk Assessment
Manufacturer
Manufacturer
Risk Management
Risk Analysis
Check the correctness of
Risk Assessment
Developing Technical
Documentation
Risk Management
Manifacturer
Manifacturer
Conformity Assessment
Body
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
RM in Business vs. others: sample questions
The next steps
• Filling out the forms of the Survey (with our help)
• Setting dates and times – when?• Could be done on Webex