Management system of the regulatory
organisation
VN/RA/01 Task 1&2 Workshop
Hanoi, October 2012
Confidential
Ilari Aro
Ref. to Kaisa Koskinen
STUK
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Content
•
•
•
•
•
IAEA safety standards and guidance
Regulatory processes and procedures
Quality manual
Self-assessment and audits
External assessment
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Requirements for Regulatory Body’s
Management System
• IAEA has published a requirement document GSR Part 1
Governmental, Legal and Regulatory Framework for Safety:
Requirement 19: The management system of the regulatory
body
The regulatory body shall establish, implement, and assess and
improve a management system that is aligned with its safety
goals and contributes to their achievement.
4.14. The regulatory body shall establish and implement a
management system whose processes are open and
transparent. The management system of the regulatory body
shall be continuously assessed and improved.
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Requirements for Regulatory Body’s
Management System
con’t
4.15. The management system of the regulatory body has three
purposes:
(1) The first purpose is to ensure that the responsibilities assigned
to the regulatory body are properly discharged.
(2) The second purpose is to maintain and improve the
performance of the regulatory body by means of the planning,
control and supervision of its safety related activities.
(3) The third purpose is to foster and support a safety culture in the
regulatory body through the development and reinforcement of
leadership, as well as good attitudes and behavior in relation to
safety on the part of individuals and teams.
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Requirements for Regulatory Body’s
Management System
con’t
4.16. The management system shall maintain the efficiency and
effectiveness of the regulatory body in discharging its
responsibilities and performing its functions. This includes the
promotion of enhancements in safety, and the fulfillment of its
obligations in an appropriate, timely and cost effective manner
so as to build confidence.
4.17. The management system shall specify, in a coherent manner,
the planned and systematic actions necessary to provide
confidence that the statutory obligations placed on the regulatory
body are being fulfilled. Furthermore, regulatory requirements
shall be considered in conjunction with the more general
requirements under the management system of the regulatory
body; this helps to prevent safety from being compromised.
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Requirements for Regulatory Body’s
Management System
con’t
• IAEA has published a requirement document GS-R-3
Management Systems for Facilities and Activities’ which is
applicable for RB’s
• IAEA has also published guidance (GS-G-3.1) how to apply
all the requirements
Revision of GS-R-3 General Safety Requirements Part II: GS R
Part II-Leadership and Management for Safety
• Will meet long term structure of SS with General and Specific
Safety Requirements
• Objective and scope are “not” fundamentally changed
– More focus on leadership and responsibility for safety and safety
culture
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IAEA Safety Standards
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Source: Pal Vince
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GS-R-3 Safety Requirements
Chapter 2 Management System
• general requirements
• safety culture
• grading the application of management system requirements
• documentation of the management system
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GS-R-3 Safety Requirements
Chapter 3 Management Responsibility
• management commitment
• stakeholder satisfaction
• organisational policies
• planning
• responsibility and authority for the management system
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GS-R-3 Safety Requirements
Chapter 4 Resource Management
• provision of resources
• individual competence
• infrastructure and work environment
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GS-R-3 Safety Requirements
Chapter 5 Process implementation
• developing processes
• process management
• generic management process
–
–
–
–
–
–
document control
control of products
control of records
purchasing
communication
managing organisation change
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GS-R-3 Safety Requirements
Chapter 6 Measurement, Assessment and Improvement
• monitoring and measurement
• self-assessment
• independent assessment
• management system review
• non-conformances, corrective and preventive actions
• improvement
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GS-G-3.1 Generic Safety Guidance
Thematic guidance for Management Systems
• Application of the Management System for Facilities and Activities
• Generic information and examples to aid understanding and
implementation of Management System requirements
Provides guidance on HOW TO comply with (i.e. to implement) GS-R-3
requirements
• Development of the management system
• Exercise of management responsibility
• Management of Resources
• Development and implementation of processes
• Measurement, assessment and review of performance and of the
management system,
• … etc.
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STUK’s Management System
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Historical Background of
the STUK Management System
• STUK has had a management system and written procedures to
guide staff members from the first beginning of its establishment.
• A systematic approach of the internal quality system was firstly
established at the beginning of 90’s for the regulatory oversight
of nuclear facilities.
• The quality system was based on existed principles and
routines. Good practices were adopted when they were
considered applicable.
• The systematic approach was established voluntarily without
any external pressure.
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Historical Background con’t
•
In 1997, STUK decided to extend the systematic quality approach to
cover all STUK operations.
•
Self assessment of the STUK-QMS has been carried out several times:
– the Finnish Quality Award Criteria (MB), EFQM, ISO 9001 & ISO 9004 (1995
& 2000), IAEA-TECDOC-1090.
•
IRRT Mission was conducted in March 2000 and the Follow-up Mission
in September 2003.
•
IRRS Mission will be conducted in October 2012
•
National laboratory activities of STUK
•
•
ISO 17025 accredited activities
STUK does not have ISO 9001 Certification
– mandate to do work has been granted through the legislation
– no obligation to demonstrate quality management
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Basic framework for the STUK’s Management
System
•
Sound legislation and clearly defined mandate for STUK.
•
Appropriate organisation as well as sufficient human and financial
resources that are built according to the duties and goals of STUK.
•
Clear definition of mission, organisational values, vision and strategy.
•
Clear definition of functions and working processes (still under processing).
•
Clear definition of duties, responsibilities and authorities of each
organisational unit and employee.
•
Quality policy confirmed by the top management.
•
Professional competence covers all necessary key spheres.
•
Most of the staff members have a high quality awareness, motivation and
commitment to continuous improvement.
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Framework for the
quality and safety
management
•regulations
•stakeholders
•nuclear programme
•human and financial resources
•working conditions
•etc.
Quality Documents
Operations
•quality policy
•planning
•managerial guides
•work execution
•work instructions
•assessment and measurement
•work assignments
•improvement and development
•records
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Implementation of the Management System
Prerequisites for quality
and safety management
- Regulations
1. Setting and
- Quality Manuals
updating
- Working environment objectives
- Resources
- etc
4. Improvement and
development
Interactive
cooperation
3. Assessment
and
measurement
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A. Long-term focus
B. Annual focus
C. Day-to-day focus
2. Work execution
Framework of the STUK QMS
Framework for the
Quality and Safety
Management
Quality Manuals available for STUK operations
1.
STUK Quality Manual
- Regulations
Manuals common to different STUK level operations
- Quality Manuals
2. Personnel Administration
- Resources
3. Financial Administration
- Working environment
4. Information Management
- etc
5. Emergency Preparedness
6. Communications
Quality Manuals relating to specific organizational sectors
7. YTV Quality Manual (Nuclear Reactor Regulation (YTO) and
Nuclear Waste and Materials Regulation (YMO))
8. STO Quality Manual (Radiation Practices Regulation)
9. TKO Quality Manual (Research and Environmental Surveillance)
10. HAE Quality Manual (Administration and special units)
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STUK Guides
1. Quality system
STUK 1.1 Quality Policy
STUK 1.2 Description of Quality
system
STUK 1.3 Model of Quality Manual
STUK 1.4 Updating and Distribution
of Quality Manual Guides
2. Organization and
management
STUK 2.1 Rules of Administration
STUK 2.2 Organization
STUK 2.3 Management by results
System
STUK 2.4 Rules of Finance
STUK 2.5 Board of Directors
STUK 2.6 Internal working groups
STUK 2.7 Projects
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3. Core Processes
STUK 3.1 Regulatory control
STUK 3.2 Research
STUK 3.3 Development of Regulations
and Guides
STUK 3.4 Emergency preparedness
STUK 3.5 Shared cost actions
STUK 3.6 Expert services
STUK 3.7 Maintenance of Measurement
Standards (Radiation
metrology)
STUK 3.8 External communications
STUK 3.9 EnvironmentAL Radiation
Monitoring
STUK Guides
4. Support Processes
STUK 4.1 IT Management
STUK 4.2 Financial Management
STUK 4.3 Administration and Internal
Services
STUK 4.4 Procurement
STUK 4.5 Agreements
STUK 4.6 Supervision of STUK’s
equipment
STUK 4.7 Processing and Archiving of
Documents
STUK 4.8 Facilities and Access Control
STUK 4.9 Document Preparation
STUK 4.10 Publicity of Documents and Data
STUK 4.11 Processing of Personnel Data
STUK 4.12 Classification and Processing of
Confidential Documents
STUK 4.13 Employee Inventions
STUK 4.14 Copyrights
STUK 4.15 Use of Radiation in STUK
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STUK 4.16 Radiation Safety Glossary
STUK 4.17 Participation in Standardisation
Work
5. Personnel
STUK 5.1 Principles of Personnel
Administration
STUK 5.2 Competence Management
STUK 5.3 Pay System
STUK 5.4 Equality Plan
STUK 5.5 Co-operation Agreement
STUK 5.6 Internal Communications
STUK 5.7 Safety at work
STUK 5.8 Addressing Failure to Fulfil Official
Duties
6. Quality Management
STUK 6.1 Internal Audits
STUK 6.2 Risk Management
STUK 6.3 Quality Self-Assessment
STUK 6.4 Reviews and Corrective Measures
STUK 6.5 Customer and Stakeholder
Feedback
STUK’s Quality Policy
• Challenged by vision, obliged by values
• Vision
• Values
•
•
•
•
•
•
•
Safety and quality are emphasised in operation
Regulatory oversight ensures safety
Research produces new information
Expert services enhance safety
Communication is active and open
Provision is made for emergencies
Sound prerequisites for operation are provided
•
•
•
•
•
•
•
Quality management
Co-operation between management and personnel
Internal control
Personnel policy
Financial administration
Information technology
Internal services
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YTV Quality Manual
1. Quality system
2. Organisation and leadership
3. Preparation and execution of regulations
4. Regulatory oversight of NPPs
5. Regulatory oversight of nuclear waste and nuclear
materials
6. Decision making and execution
7. Public communications
8. Supportive actions
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Process Approach
• Process approach is widely used
• Processes are divided into main processes and support
processes (internal)
• There are 11 main processes (each containing several
processes and sub-processes) and 8 support processes
(each containing several processes)
• For each process there is a process description (guide) and a
flow-chart
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MANAGEMENT
PERSONNEL
ADMINIST.
PROCESS
MAPFINANCIAL
DATA
ADMINIST.
ADMINIST.
SUPPORT
PROCESSES
CUSTOMER AND SOCIETY NEEDS
REGULATORY CONTROL OF NUCLEAR WASTE MANAGEMENT
REGULATORY CONTROL OF NON-PROLIFERATION OF NUCLEAR WEAPONS
REGULATORY CONTROL OF THE USE OF RADIATION
METROLOGY
RESEARCH
ENVIRONMENTAL SURVEILLANCE
EXPERT SERVICES
EMERGENCY PREPAREDNESS
RULE MAKING
OUTCOMES OF CORE PROCESSES
REGULATORY CONTROL OF NUCLEAR POWER PLANTS
COMMUNICATION
COMPETENCE
INTERNAL
SERVICES
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SURVEYS
SUPPORTING
REGULATORY
ACTIVITIES
DEVELOPMENT
OF
EMERGENCY
PREPAREDNES
S
SUPPORT
PROCESSES
Nuclear reactor regulation
Rule Making
Oversight of
New Power
Plant Projects
and Plant
Modifications
• Legislation
• YVL-guides
• Int. statements
Decision
Making and
Enforcement
• Document handling
• Contracted services
• Enforcement
Inspection
programmes
• Periodic inspection
programme (KTO)
• Inspection programme
for construction (RTO)
• Inspections required in
YVL-guides
Safety Analysis Oversight of
and Assessment Operations
• Conceptual design of
the plant
• Conceptual design of
the systems
• Systems design
• Components and
structures design
• Manufacturing and
construction
• Validation and
suitability
• Inspections of
components and
structures
• Commissioning
• Modifications
• Deterministic safety
analysis
• Compliance with
tech specs
Oversight of
Management in
Regulated
Organisations
•Probabilistic safety
analysis (PRA)
• Incidents
• Safety management
• Outage
management
• Management systems
and QMS
• Maintenance and
ageing management
• Training and
qualification of
personnel
• Safety performance
indicators; analysis
and feedback
• Fire Protection
• Radiation protection
• Emergency
preparedness
• Security
• Operational
experiences
• Manufacturers of
nuclear pressure
equipments
• Nuclear liability
• Event investigation
• Testing- and
inspection
organisations
Safety Assessment
• Statement for decision-in-principle, construction and operating license, periodic safety review
• Annual assessment of the safety of NPPs
• Safety assessment required in CNS
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Setting and updating objectives
1. Management objectives are set in two time scales:
–
–
strategic planning – cycles of four years
annually
2. Implementation of the STUK Strategy is supported with more detailed
Action Plans
–
–
Action Plans are written for each of the 12 STUK’s Result Areas by the persons
responsible for the respective areas
Regulation of Nuclear Power Plants is largest of these Result Areas.
3. The input for the strategic plan comes from three main sources:
– information on future plans and programs of the main stakeholders
–
–
such as NPP licensees, users of radiation, Finnish Government and European
Union
a SWOT-analysis of other known and potential changes in the
operating environment (SWOT = strengths, weaknesses, opportunities, threats)
improvement and development needs indicated by the systematic
assessment and measurement
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Setting and updating objectives ....
4. Annual planning is started with guidance given by the management,
based on
– Strategic Plan
– need of development identified from the feedback loop
– plans and expectations of stakeholders
5. Planning process goes firstly top down involving meetings of
organizational units and then bottom up through systematic face-toface discussions at all levels between the supervisors and their
subordinates.
6. Annual work plan provides performance and development goals for
each person, for each organizational unit, and for the entire STUK.
Among the goals are
– output of the work
– development of the work processes
– development of the staff knowledge and skills
7. Performance goals and annual targets of STUK are written in an
agreement that the management signs with the Ministry of Social
Affairs and Health.
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Conduct of works (work execution)
1. Quality Policy – management view on high quality in each of the main
work areas
2. Tasks and responsibilities of all organizational units and persons;
Cross-organisational working is preferred (team working between
organisational units without involving supervisors regularly in this team
working);
3. Practices of management and internal communications at all levels
4. Descriptions of STUK’s work processes and guidance for managing
those processes
5. Comprehensive set of standing orders, guides, and procedures that
give instructions for all STUK’s operations, including both administration
and professional work
6. Each employee has just one organisational position but several roles in
doing work; Each employee is responsible for a work of his/her own;
The high quality of work is important to achieve at the first attempt in
order to avoid unnecessary loading of other workers.
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Assessment, Measurement and Improvement
Internal assessment
–
–
–
–
–
systematic follow-up of achievements against the agreed annual targets
cross-audits conducted by staff members according to annual audit programme
self-assessment carried out in internal workshops
annual upper management reviews
staff surveys every two years (on staff engagement, motivation, satisfaction,
etc.), and
– annual Report to the Ministry on work results and developments, including
assessment against agreed targets and other performance indicators.
External assessments are conducted by international and national peers,
including the following:
– regulatory activities were evaluated by an IAEA’s IRRT mission in year 2000
and a follow-up in 2003
– IRRS mission in Finland October 2012
– IPPAS mission in Finland in summer 2009
– Assessment of research activities
– one or two topical audits every year by external experts who are working on
similar issues.
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Assessment of stakeholder interfaces
1.
Annual agreement and discussions between STUK and the Ministry of
Health and Social Affairs
2.
Thesis on the co-operation between STUK and Finnish utilities
3.
Independent study on the Finnish regulations whether they are too
prescriptive or not
4.
Annual post-interviews with the selected utility staff members are conducted
relating to the Inspection Programs
5.
Investigation of selected operational events/issues (the latest one: Violations
of and exemptions from the TechSpecs); except utility operations also STUK
operations are investigated in these reviews
6.
A number of complaints from the stakeholders are followed
7.
A general follow-up of the mass media
EFQM definition of “Stakeholders”:
•
“All those who have an interest in an organisation, its activities and its
achievements. These may include customers, partners, employees,
shareholders, owners, government, and regulators.”
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Face-to-face discussions
•
Face-to-face discussions (supervisor/subordinate discussions; summingup discussions) is a mandatory process in STUK. Each supervisor
shall conduct at least once a year a discussion separately with each of
his/her subordinates.
•
In addition to reviewing the results of the ongoing year and
determining the targets of the forthcoming year, the discussions shall
cover the following topics:
•
training
•
work satisfaction
•
co-operation satisfaction
•
mutual feedback.
•
The contents and principles have been described in the Guide STUK
2.3.
•
Main results of these discussions are utilised in the Management Review
and in drawing up an Annual Action Plan.
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Management review
•
Management review carried out in the end of each year both at departmental
and STUK levels has been experienced very useful.
•
The below list is composed of data included in Annual Management
Review:
•
Actions agreed in the previous management review (backlog of
recommendations)
•
Conclusions of supervisor/subordinate discussions
•
Summary Reports on overall assessment of different regulatory sectors
(rule making, safety analyses, performance indicators etc.)
•
Self-assessment reports (based on EFQM Business Model)
•
Internal and external audit reports
•
Assessment reports relating to STUK/stakeholder interactions
•
Outcome of the development seminars
•
Conclusions of the leadership enquiries
•
Reports of quality deviations
•
Stakeholder feedback (complaints and positive feedback from the
stakeholders including other departments and top management).
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Conclusions
•
An honest top management commitment (important that talks and
actions comply with each others) is a key factor of effective QMS
implementation;
•
High motivation of the staff and the top management to achieve
objectives is of vital importance;
•
Clear rules of the game obligate staff members but also protect them
in case of confusions;
•
Awareness of good management tools (EFQM, Balanced Scorecard,
SWOT analyses, information management etc.) create effective
means to manage activities and to lead people;
•
Transparency (internal guides are submitted to the operators for
information) gives a good basis for co-operation with the regulated
organisations.
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