Core Questions (GSR Part 1 and GS-R-3) Primary Module ... - STUK

Core Questions (GSR Part 1 and GS-R-3) 

Primary Module : Management System for the Regulatory Body 

QID SQID QTYPE References Primary Question Answer PA 

1 Primary Safety Standards Has the Regulatory Body established and 

Yes No B 

Series No. GS-R- 

3;para 2.1 

implemented a Management System? 

X 

Select ‘Yes’ or ‘No’ above and if desired, enter notes or comments here 

If ‘Yes’ go to: SQID 1.1 

If ‘No’ go to: SQID 1.4 

Otherwise go to: 

QID SQID QTYPE References True Subsidiary Question Next 

Question 

1 1.1 Text Safety Standards 


3;para 2.1 

How has the regulatory body ensured that its 

management system is appropriate for its functions 

and responsibilities and that it is aligned with the 

regulatory safety goals? 

SQID 1.2 

The functions and responsibilities of STUK and regulatory safety goals are stipulated in 

the Finnish legislation (e.g. Radiation Act (592/1991), Nuclear Energy Act (990/1987), 

Act on STUK (1069/1983), and Decree on STUK (618/1997)). 

The regulatory safety goals of STUK are written in the quality policy of STUK (Guide 

STUK 1.1). The directors have committed themselves to follow the quality policy 

requirements and request every STUK employee to do the same. 

The regulatory procedures described in the STUK management system are derived 

from the legislation and the STUK quality policy. The management system and its 

appropriateness and adequacy are assessed and reviewed continuously in many ways 

and amended and improved, if necessary. 


Question 



3;para 2.1 

What are the safety goals of the regulatory body and 

which are the policy documents outlining these goals? 

SQID 1.3 

The basic safety goals of STUK are to protect people, the society, the environment, and 

the future generations from the harmful effects of radiation. The policy document 

outlining further safety goals is Guide STUK 1.1. 


Question 



3;para 2.1 

What are the requirements, standards, guides, models, 

which have been used in the development of the 

management system of the regulatory body? 

PQ 2

The main basis for the management system of STUK is the Finnish legislation, i.e. acts 

and decrees for radiation and nuclear safety, but also acts and decrees giving 

requirements and rules to be followed by all governmental authorities and 

organizations in Finland. 

Further bases for the management system are international standards ISO 9004 and 

ISO/IEC 17025, and the IAEA safety standards concerning management systems of a 

regulatory body. The principles of the EFQM Excellence Model are also applied. 

And last, for a great deal the management system also integrates the experiences and 

good practices that STUK workers themselves have learned working tens of years in the 

field of nuclear and radiation safety – both in Finland and abroad. 

QID SQID QTYPE References False Subsidiary Question Next 

Question 



3;para 2.1 

What are the measures planned to establish an 

integrated management system for the regulatory 

body? 

PQ 2 


2 Primary Safety Standards Does the Management System bring together in a Yes No B 

Series No. GS-R-3;2.3 coherent manner all the requirements for managing 

Safety Standards the Regulatory Body? 


3;para 2.1 

X 






Question 

2 2.1 Text Safety Standards Does the Management System describe the planned SQID 2.2 

Series No. GS-R-3;2.3 and systematic actions necessary to provide adequate 

Safety Standards confidence that all these requirements are satisfied? 


3;para 2.1 

STUK prepares a strategy for a five year period and in the annual planning process the 

goals of the strategy are taken into account (Guide STUK 2.3). The planned and 

systematic actions are presented also in the annual plans. The results of the 

implementation of the annual plans are systematically assessed. 

For its work, STUK has identified and established 11 core processes (Guide STUK 1.2). 

All these core processes have subprosesses. In addition, there are several support

processes. The requirements and working procedures to carry out successfully all these 

processes are described in the Quality Manual of STUK. 

The Quality Manual consists of about 300 separate guides arranged in a hierarchical 

manner: on top, there are the guides addressing the whole STUK, then there are guides 

for the departments of STUK and last, there are guides for laboratories. 

STUK has established systematic measures to assess implementation of the 

management system, including audits, self assessments and management review 

(Guide STUK 1.2). 


Question 



3;para 2.1 

Safety Standards 

Series No. GS-R-3;2.3 

Describe how the regulatory body has identified all 

the relevant requirements applicable to its 

managements system and the regulatory processes 

and activities. 

SQID 2.3 

In 1997, STUK started to develop a coherent management system with various quality 

tools (e. g. self assessments and internal audits) connected to this system. In this 

development phase all relevant processes and activities of STUK were evaluated (Guide 

STUK 1.2). 

STUK´s strategy is compiled every 5 th year and updated annually. In compiling the 

strategy, also a SWOT analysis is made to find the strengths and weaknesses and also 

the opportunities and threats of STUK. When compiling the strategy also the necessary 

actions for the further development of the management system are evaluated. 

Requirements and items to further develop the management system are systematically 

identified in self assessments, internal and external audits and management reviews. 

Further identification is made in active connections with stakeholders and in 

international cooperation. 


Question 



3;para 2.1 



Describe how the Management System identifies and 

integrates the relevant requirements contained in the 

national statutory and regulatory requirements. 

SQID 2.4 

The basic national statutory and regulatory requirements are presented e.g. in the 

Radiation Act (592/1991), Nuclear Energy Act (990/1987), and Act on STUK 

(1069/1983), In addition, the Finnish administrative legislation provides the legal 

framework for the management system. When the management system was 

established and is developed the national statutory and regulatory requirements are 

taken into account. (Guide STUK 1.2). 

Every guide in the STUK quality manual describing the core processes and 

subprocesses gives guidance to STUK employees on how to tackle with the

equirements in legislation and how to impose these requirements on those running 

radiation or nuclear practices. Further, in every guide a reference is made to legislation, 

as far as possible. 

The functions and responsibilities of STUK are also described in the Quality Manual as 

well as the rights and responsibilities of the organizational units (Guide STUK 2.1) and 

personnel (departmental manuals). 


Question 



3;para 2.1 



Does the Management System identify and integrate 

the requirements contained in requirements formally 

agreed with stakeholders? 

SQID 2.5 

Stakeholders for STUK are ministries and other governmental agencies, foreign 

authorities, research organizations, universities, international organizations, citizens, 

media as well as license holders and other responsible parties for the use of nuclear 

energy and radiation. 

STUK has several formal agreements with other governmental organizations, such as 

VTT, IL, and PV. 

STUK makes annually a result agreement with the Ministry of Social Affairs and Health 

for the next year (Guide STUK 2.3). In this plan also needs of other relevant ministries 

are taken into account. 

These agreements are taken into account in STUK’s Quality Manual, e.g. concerning 

purchasing (Guide STUK 4.4) and emergency response (Guide STUK 3.4). 

The needs and requirements of stakeholders are also identified by 

customer/stakeholder satisfaction enquiries and studies (Guide STUK 6.5). The 

identified needs and requirements are integrated into the management system, if 

necessary. However, it must be noted that STUK is a governmental authority. Thus, the 

activities and the management system of STUK are strongly bound to legislation. 

STUK does not have any formal agreements with the license holders. However, STUK 

has continuous contacts with the licensees and other responsible parties (e.g. site 

inspections, meetings, training events). These contacts give understanding for the 

needs of stakeholders. 


Question 



3;para 2.1 




the requirements contained in other relevant IAEA 

Safety Requirements publications? 

SQID 2.6 

Relevant IAEA requirements are identified and integrated in STUK Quality Manual


STUK knows very well the IAEA safety standards concerning the management systems. 

When developing STUK’s Quality Manual the relevant safety standards are taken into 

account. However, the reference to these standards is not generally included in the 

guides of the Manual. 

As regard to emergency preparedness, STUK Quality Manual includes a number of 

guides, the prime guide being the Emergency Preparedness Plan of STUK (guide VA 1). 

This guide says: “Where necessary, STUK will integrate the emergency requirements 

and guides of the IAEA into its guides, especially the Safety Requirements and Safety 

Guides pertaining to preparedness planning and to action to be taken in emergency 

situations”. 

Other guides (SKV 3.5, YTV 7.4, YTV 7.5, YTV 7.6, and YTV 4.7.4) describing the 

preparedness for nuclear or radiation emergencies, reporting data to databases, and 

reviews also mention several IAEA publications. 


Question 



3;para 2.1 




the requirements contained in requirements from 

other relevant codes and standards? 

PQ 3 

The following codes and standards are identified and integrated (Guide STUK 1.2): 

ISO 9001, 9004 

ISO/IEC 17025 

EFQM Excellence Model 

Other codes and standards are also used, but they are discussed in the other modules 

and thematic areas of the IRRS (e.g. transports of radioactive materials). 


Question 



3;para 2.1 



Describe any measures planned to identify and 

address all the applicable requirements under the 

management system of the regulatory body. 

PQ 3 


3 Primary Safety Standards 


3;para 2.2 

Does the Management System of the regulatory body 

ensure that safety is paramount, overriding all other 

demands? 

Yes No B

X 



If ‘No’ go to: PQ 4 



Question 



3;para 2.2 

How does the management system of the regulatory 

body ensure that safety is given due priority in all the 

regulatory activities and decisions? 

SQID 3.2 

The quality policy of STUK (Guide STUK 1.1) states that: “In its activities STUK develops 

and maintains a high-grade safety culture. STUK acts in a way that licence holders and 

stakeholders understand the significance of safety culture and that, in their own 

activities, licence holders give priority to safety.” 

Further, Guide STUK 3.1 (item 4.2) states that: “In its regulatory duties, STUK is obliged 

to recognize the significance of safety in matters handled by it and stress the priority of 

safety. In this way, STUK encourages the enhancement and maintenance of proper 

safety culture in all nuclear and radiation activities.” 


Question 



3;para 2.2 


body ensure that conflicting requirements or opinions 

are dealt with by adequate processes and that the 

regulatory decision-making process is open and 

transparent? 

SQID 3.3 

One of the four values (“cornerstones”) of STUK is openness (Guide STUK 1.1). 

Openness and transparency are included into the basic principles for the regulatory 

control activities (Guide STUK 3.1). All STUK decisions are based on expert judgement 

including hearing all relevant parties, as appropriate. If, however, a customer feels that 

a decision from STUK is incorrect he/she may appeal against the decision. This appeal 

is handled by the court, not STUK (Guides STUK 4.9 and STUK 6.5). 

Another cornerstone of STUK is “courage” which means that any problems and differing 

opinions are openly expressed. Cases of conflicting opinions are dealt with in 

discussions in which a consensus is sought. If a consensus is not found then a person 

with a conflicting opinion expresses his/her opinion in a written document. This 

document is signed by him/her and also by the person making the decision in the case 

concerned. The document is kept in a file together with other documents pertaining to 

this case (Guide STUK 4.9). 

The decisions and procedures of STUK are open to publicity, if not otherwise decided 

by legal grounds. 


Question



3;para 2.2 


body ensure that the objectivity and the adequacy of 

the regulatory review processes are not compromised 

by external pressures? 

SQID 3.4 

The basis for regulatory control activities are presented in Guide STUK 3.1. It lists the 8 

principles that are the universal cornerstones of a good regulatory culture, irrespective 

of the regulatory branch. These principles must be followed also in STUK. Among these 

principles are e.g.: 

legality: All regulatory actions are based on the legislation 

independency: All decisions and actions shall be assessed independently. 

equality: All citizens and responsible parties are treated in an equal manner. 

transparency: All regulatory activities are documented and documents are 

archived. 

Decisions are made only on expert judgement. 


Question 



3;para 2.2 

What are the main policies and principles observed by 

the regulatory body in the performance of its 

regulatory activities in order to ensure the 

independence of its decision-making processes? 

PQ 4 

The regulatory control of the safe use of nuclear energy and radiation is independently 

carried out by STUK based in the Nuclear Energy and Radiation legislation. Other 

governmental bodies cannot take for their decision a matter that has been assigned by 

law to STUK. STUK has no responsibilities or duties which would be in conflict with 

regulatory control. 

Independence is ensured also by adequate competence and resources of STUK. As 

needed, STUK also uses competent technical support organizations such as VTT. 

The basis for regulatory control activities are presented in Guide STUK 3.1. It lists the 8 

principles that are the universal cornerstones of a good regulatory culture, irrespective 

of the regulatory branch. As stated above independence is one of these basic principles. 

A decision must be based on grounds that pertain only to STUK´s duties, not anything 

else. A STUK employee must not work on a case with connections to organizations or 

persons belonging to his/her personal interests. 

Further, Guide STUK 3.1 states (item 4.4) that a STUK employee must restrain 

himself/herself from any such offer or action that might jeopardize the independence 

and objectivity of STUK. 

If any violations are observed in carrying out of the duties of an employee or in his/her 

behaviour STUK will take actions prescribed in Guide STUK 5.8 on neglecting official 

duties.


4 Primary Safety Standards Is the Regulatory Body able to demonstrate the Yes No B 


3;para 2.4 

effective fulfilment of the requirements of its 

Management System? 

X 






Question 



3;para 2.4 

How does the regulatory body review the fulfilment of 

the requirements of its management system? 

SQID 4.2 

Directors and section heads are obliged to supervise the fulfilment of the management 

system in his/her own sector Every STUK employee is responsible for the quality of 

his/her work (Guide STUK 1.2) . STUK employees have to observe the management 

system (Guide STUK 1.1). 

STUK has the following means to review the fulfilment of the requirements of its 

management system: 

Internal audits. The main purpose of the audits is to make clear whether or not the 

STUK processes and tasks are performed according to the requirements of the 

management system (Guide STUK 6.1). 

External audits. The main purpose is the same as above, but sometimes is advisable 

to hear opinions also from experts other than those of STUK itself (Guide STUK 

6.1). 

Management reviews. These reviews try to find out if the management system is 

working as it should (Guide STUK 6.4). 

Self assessments. These assessments try to find out if there is something to be 

improved in the management system (Guide STUK 6.3). 

Customer feedback (Guide STUK 6.5). 

In addition, STUK regularly benefits international peer reviews to assess the 

management system. 


Question 



3;para 2.4 

What is the scope and frequency of the assessments 

performed by the regulatory body in order to 

ascertain whether all the regulatory processes and 

activities are in compliance with the requirements of 

its management system? 

PQ 5 

The scope and frequency is the following: 

Internal audits (Guide STUK 6.1): This activity is continuous. Every year about half 

a dozen processes or activities are audited pertaining to regulatory work. STUK has 

30-40 internal auditors to do the audits. Some 10-20 persons are interviewed in

these audits yearly. The work, however, is not systematic for all processes. The 

reasons is that STUK has so many duties and tasks and processes that it is not 

possible to audit them all with reasonable frequencies. 

External audits (Guide STUK 6.1) have been carried out approximately once a year, 

e.g. audits by KPMG and VTV 

Management reviews (Guide STUK 6.4): These reviews are carried out every year 

and in all organizational levels of STUK. 

Self assessments (Guide STUK 6.3): These assessments take place every year. They 

are usually arranged in a departmental level, but in addition to this, also offices and 

laboratories arrange them occasionally. 

Customer feedback (Guide STUK 6.5): The stakeholder and media surveys are 

carried out every second year. In addition, it is separately decided if some specific 

customer feedback survey is needed in some sector. The scope of these studies 

varies from questionnaires sent to some tens of customers to some hundreds of 

customers In addition customers may give feedback to STUK any time either by 

phone, mail, e-mail, the internet or fax. 




3;para 2.5 

Does the Management System of the regulatory body 

promote and support a strong safety culture? 

Yes No B 

x 





Question 



3;para 2.5 

Describe how and the extent to which, the regulatory 

body ensures the achievement of a common 

understanding, within its organisation, of the key 

aspects of safety culture. 

SQID 5.2 

The establishment, implementation, assessment and continuous improvement of the 

management system support the planned and systematic performance of regulatory 

activities. By these actions the management system of STUK enhances the safety 

culture in the organization. 

The safety culture aspects have been adopted in the Quality Policy of STUK and Rules of 

Administration (Guides STUK 1.1 and STUK 2.1). 

STUK’s quality policy states that safety and quality are emphasised in operation. STUK 

develops and maintains a high safety culture in its operations. 

Guide STUK 2.1 says: Safety culture followed in the activities of STUK requires always 

that: 

safety significance of the matter or situation to be dealt with at the time is 

recognised 

responsibility related to decisions and resolutions is recognised 

bases of decisions and resolutions are found out and presented

personnel at all levels of the organisation is committed to high quality. 

The bases of quality policy for STUK’s regulatory activities are parts of good regulatory 

culture and independence of the regulatory body. (Guide STUK 3.1). In addition, the 

safety significance of the handled issues shall be recognised and the emphasis on 

ensuring safety shall be given in STUK’s regulatory activities. Thus the development 

and maintaining of proper safety culture is being promoted in all use of nuclear energy 

and radiation practice. 

STUK ensures understanding of the key aspects of safety culture by the following 

methods: 

1) Internal training 

2) Documented basis for the decisions 

3) Communicating the management views and information on important 

decisions in staff briefings 

STUK contributes to the licensees and partners understanding of the importance of 

safety culture, STUK is a service minded organisation. Good service entails STUK 

promptly fulfilling its obligations and engagements as well as paying attention to the 

needs of its customers and stakeholders. 


Question 



3;para 2.5 

Describe any formal means employed by the 

regulatory body to support individuals and teams 

within its organisation in carrying out their tasks 

safely and successfully. 

SQID 5.3 

Responsibilities and authorities of STUK management and staff are documented and 

described in Quality Manuals (STUK Quality Manual, Nuclear Safety: Guides YTV 2.1.1. – 

YTV 2.5 and Radiation Safety (Guides SKV 2.1 – 2.6). 

All the guides (a total of about 300) in the Quality Manuals are written to help the 

individuals and teams to carry out their tasks safely and successfully. STUK also 

strongly supports further training and education and urges its workers to enhance their 

capabilities through continuous training (Guide STUK 1.1). 

Further, in all regular meetings within STUK the individuals may bring forth all kind of 

concerns they have encountered in their work and to discuss these with other team 

members. 

STUK’s management system requires that annual discussions between every employee 

and his/her head are carried out. It is also the duty of every boss to help any worker 

any day in any problem (Guide STUK 2.3). The scope of the discussions include e.g. 

evaluation of the results of the last year, discussions on the plans of the next year, 

training needs, evaluation of the working environment, and possible issues preventing 

successful activities. 

During inspections and in other communication representatives of STUK behave in a 

manner that promotes development of good safety culture in the use of radiation and 

nuclear energy (Guide STUK 1.1). 

STUK has established the following framework for managing its regulatory work (plan-

do-check-act): 

1. Plan; setting and updating objectives. Planning together with staff has two time 

scales, one for strategic planning which is done (cycles for few years 2012- 

2016) and the other for annual action planning. 

2. Do; conduct of work. The work is guided, a comprehensive set of standing 

orders, guides, check lists, work processes and guidance for managing 

processes and procedures that give instructions for all operations, including 

both administration and professional work 

3. Check; Assessment and Measurement. Operations and performance are 

assessed both internally and externally. 

4. Act; Improvement and Development. A general policy: to strive for continuous 

improvement of work processes and regulatory effectiveness. Implementation 

of improvements are based on the results of audits, external assessments, selfassessments 

and evaluations, but development can be started also based on 

other initiatives. Information received from operating and regulatory 

experience is also taken into account 


Question 



3;para 2.5 

Describe measures taken by the regulatory body for 

reinforcing a learning and questioning attitude at all 

organizational levels. 

SQID 5.4 

One of the basic values which guide all operations at STUK is courage (Guide STUK 1.1). 

This means that STUK encourages the attitude that any identified problems and 

personal views are rigorously brought up. Responsibility for decisions is acknowledged, 

and errors are corrected. 

STUK’s management system is based on a continuous improvement principle. This 

involves questioning and learning attitude. The employees are committed to this 

behaviour by means of annual discussions, regular teem meetings, self-assessments etc. 

Individuals are engaged in drafting and commenting internal guidance for regulatory 

activities and managers encourage them to bring up ideas for improvement. 

Further, the employees are responsible for reporting any corrective measures and 

receiving feedback and delivering this to the quality personnel and registers of 

feedback and deviation (Guide STUK 1.1, Guide YTV 1.1). 


Question 



3;para 2.5 

Describe how the regulatory body identifies and 

implements measures for continually developing and 

improving the safety culture within its organisation. 

PQ 6 

The continuous improvement of the management system of STUK supports the safety 

culture and the successful performance of the regulatory activities. 

STUK’s strategic and annual planning are the corner stones for implementation of 

important regulatory activities. Also safety culture aspects are taken into account in the 

strategy and annual plans. The implementation of annual plans is regularly evaluated.

The performance of regulatory activities is continuously evaluated by regular audits, 

self-assessments and management reviews (Guides STUK 6.1, Guide STUK 6.3, and 

STUK 6.4). These assessments include also identification of corrective actions and 

measures. 

The management system models include criteria against which our progress as a 

“quality organization” is assessed. The criteria cover areas like leadership, policy and 

strategy, processes, people, partnerships and resources. Internationally accepted 

criteria sets in assessing the adequacy and effectiveness of a regulatory infrastructure. 

In addition, results of external and evaluations are regularly used for identification for 

opportunities to improve regulatory activities, including safety culture. 

As an example of other assessments STUK has participated a national survey on safety 

culture in organisations in the field of safety or related to high risks (SAFEX). According 

the results STUK’s employees take safety into account in their work in a proper way. 

The results were also discussed with staff in order to seek opportunities to improve 

performance. 




3;para 2.6 

Does the regulatory body apply a graded approach in 

the performance of its regulatory activities? 

Yes No B 

x 





Question 



3;para 2.6 

Describe the bases for determining the graded 

approach with regard to the main areas of regulatory 

activity (e.g. issuance of regulatory requirements, 

review and assessment, inspection and enforcement). 

SQID 6.2 

The nuclear energy and radiation legislation include the principle for graded approach. 

This is seen e.g. in licensing requirements for different type of facilities and activities. 

Accordingly this approach has been taken into account in regulatory activities. 

The basic approach for grading is presented in Guide STUK 1.1 as follows: the 

requirements contained in the decisions are proportional to the matter’s safety 

significance and increase actual quality and safety. A decision can be changed if new 

facts emerge after decision-making giving cause for this. Regulatory actions are 

documented in such a manner that procedures and grounds for decisions are traceable 

afterwards. The implementation of safety culture in STUK’s regulatory activities 

provides that safety significance of the matter or situation to be dealt with at the time is 

recognized (Guide STUK 2.1). 

Graded approach is applied to different STUK’s regulatory activities (Guide STUK 3.1) 

and the quality and process documents of STUK are prepared in consideration of the

graded approach required by the regulatory requirements. The requirements, orders 

and sanctions, which STUK as an authority directs to a responsible party under 

regulatory control, are in a correct and reasonable relationship with the concerning 

defect or non-compliance. In addition, the safety significance of the handled issues shall 

be recognised and the emphasis on ensuring safety shall be given in STUK’s regulatory 

activities. Thus the development and maintaining of proper safety culture is being 

promoted in all use of nuclear energy and radiation practice. 

As regards nuclear power plants and nuclear waste facilities the graded approach has 

specifically taken into account in the safety classification of the systems, structures and 

components (Guide YVL 2.1/ YVL B.2).Graded approach is also applied in regulation of 

nuclear energy activities. All regulatory requirements are based on safety significance 

and it is taken into account in regulatory processes. 

The systems, structures and components important to safety shall be designed, 

manufactured, installed and operated so that their quality level and the inspections and 

tests required to verify their quality level are adequate considering any item's safety 

significance. 

To comply with the above principles, the systems, structures and components of the 

nuclear facility are grouped into Safety Classes 1, 2, 3, 4 and Class EYT (classified nonnuclear). 

The items with the highest safety significance belong to Safety Class 1. 

Safety class determines what quality requirements apply to the facility’s systems, 

structures and components and to their quality assurance. 

The scope of the regulatory control of systems, structures and components is 

determined by safety class. The regulatory control of systems based on safety 

classification is described in Guide YVL 2.0, among others. The inspection and control 

practices for structures and components in Safety Classes 1, 2, 3, 4 and Class EYT are 

described in the respective YVL guides. 

Graded approach used in the regulatory control of radiation practices is described in 

Guide SKV 3.2 (Processing the application for a safety licence). 

In this approach, the radiation appliances and their use are divided into 3 categories 

based on the risk which these appliances and their use may pose on workers and 

members of the public. Category I is the lowest and Category III the highest category. 

In enforcement, the radiation and nuclear energy legislation give graded means to 

STUK. First, STUK can give orders, and if they are not obeyed, then STUK can use 

threats’ of fine and finally fines More specific guidance on enforcement procedures are 

given in internal guides (Guide STUK 3.1, Guide YTV 1.3, Guide SKV 3.7). 


Question 



3;para 2.6 

How is the graded approach applied in the scope and 

depth of regulatory reviews and inspection activities? 

SQID 6.3 

Graded approach is applied to different STUK’s regulatory activities (Guide STUK 3.1) 

Safety significance of each issue to be handled shall be acknowledged and the 

regulatory operations are focused particularly on issues that have real safety

significance. This requires that the regulatory control is continually developed and that 

work contents of each employee are continually self-assessed. (Guide YTV 1.2). 

Documentation for the systems, structures and components of nuclear facilities to be 

sent for STUK’s review takes into account the safety classification. The documentation 

is the most comprehensive for Safety Classes I and II. This means also that STUK’s 

review activities are focused according to safety classes. The Guide YTV 6.1 emphasizes 

that safety significance shall be taken into account in the review of the documentation. 

Safety significance is also taken into account in STUK’s inspections .The basis for 

regulatory inspections is in the legislation and in YVL-guides which both include graded 

approach. Therefore the main inspection resources of STUK are allocated on the basis 

of safety classification (Guides YTV 4.6.1, YTV 4.6.2, YTV 4.5.2, YTV 5.2.1, YTV 4.6.3,). 

Inspection organizations (IO) approved by STUK carry out some inspections in the 

lower safety classes Guides YVL 1.1 and YVL 1.15 and internal guides YTV 4.5.5 and 

YTV 4.5.8) 

STUK has also introduced a risk-based in-service inspections (RI-ISI). In this approach 

also PRA is used for determining safety relevance. 

Documentation for the safety arrangements for the use of radiation to be sent for 

STUK’s review takes into account the Safety Categories. The documentation is the most 

comprehensive for Category III. This means also that STUK’s review activities are 

focused according to Safety Categories (Guide SKV 3.2). 

Risk-based graded approach is applied in inspecting the use of radiation. This means 

that inspection frequencies depend on the risk posed by the activity, ranging from 2 to 

8 years. 


Question 



3;para 2.6 

How is the graded approach reflected in the 

deployment of the regulatory resources across the 

different areas of regulatory activities? 

SQID 6.4 

Graded approach has been taken into account when planning and developing STUK’s 

resources in various regulatory activities in the fields of the use of radiation and 

nuclear energy. This means that the main resources are allocated for the regulatory 

control on nuclear power plants. 

The prioritisation of activities and the most important objectives are set out in the 

strategy and related action programmes. They are taken into account in annual target 

plans. Performance reviews between superiors and employees are an essential part of 

the planning 


As regards nuclear facilities the main resources of STUK are allocated on the basis of 

safety classification. Risk-based categorization of the use of radiation is taken also into 

account in allocation of STUK resources in that area. 

Necessary factors for success of STUK are adequate human resources and professional 

competence in all areas relevant for radiation and nuclear safety. Maintaining and 

developing human capital is supported by maps on competence needs and actual

available competencies within each organizational unit (Guide STUK 5.2). When 

evaluating the competence needs the safety significance of the regulated activities is 

also considered. The original version of maps was developed by the respective units 

with support of consultant, and they contain information on skills and knowledge of 

each person. The competence maps are updated and used for making personal 

development plans, succession planning and recruitment of new staff and planning 

development of human capital in the long term. 


Question 



3;para 2.7 

How is the graded approach applied to the products 

and activities of each process undertaken by the 

regulatory body? Please provide examples from 

different areas of activity. 

PQ 7 

Conduct of work at STUK is guided by the Quality Manuals. The manuals are a 

comprehensive set of orders and guides that give instructions for all STUK`s operations, 

including both administration and professional work. They reflect the graded approach. 

This approach has been taken into account in YVL and ST Guides. 

Regulatory decision making emphasises the substance of the issues, and the 

consistency with the mission of STUK. Essential bases for the decisions and statements 

are presented in writing. Requirements that are presented in connection with the 

decisions are proportional to the safety relevance and increase the actual quality and 

safety (Guide STUK 1.1). 

STUK also applies graded approach in inspections: in SC 1 and 2 STUK carries out all 

inspections by itself, in lower safety classes IOs or TSOs can be used. 

Graded approach can be applied in authorisation of radiation practices and appliances. 

E.g. dental X-ray appliances used in normal dentist practice are exempted from 

licensing if they meet the requirements specified in Guide ST 3.1. Instead of licensing 

the users and appliances shall be notified to STUK for registration (authorisation by 

registration). 

See SQID 6.2. 


Question 



3;para 2.6 

How does the regulatory body ensure the optimum 

deployment of its resources as to reflect the 

importance of its different regulatory activities? 

PQ 7 

The most important goals of STUK and weighting between its different regulatory 

activities are tackled with in STUK´s strategy, which is compiled every 5 years. These 

weightings and goals are considered in plans made for every year. 

In annual planning resources are allocated to different areas of regulatory activities. 

Based on the detailed work time recording system the real time used is followed and

assessed. 

The management of STUK is responsible for adequate resources in various main 

regulatory activities (regulatory control of safety and security of NPPs, nuclear waste 

management and use of radiation). This is reflected in the organization of STUK (Guide 


Human capital resources are evaluated with maps on competence needs and actual 

available competencies within each organizational unit. The needs are taken into 

account in developing resources in organizational units. 

STUK arranges adequate in-house and external training for staff members. Staff is 

encouraged to attend training on various topics for two weeks every year. Also 

important is on-the job training in teams and with senior staff members. A standard 

initial training course is arranged several times a year for the newcomers. 




3;para 2.8 

Has the regulatory body ensured that its management Yes No B 

system is adequately documented? 

x 






Question 



3;para 2.8 

Does the documentation of the management system 

include the policy statements and the goals of the 

regulatory body? 

SQID 7.2 

Documentation of the management system includes the policy statements and the goals 

of STUK. The Quality Manuals are a comprehensive set of orders and guides 

Quality Policy (Guide STUK 1.1) includes the main policy statements and goals of STUK. 

It provides common understanding of high quality criteria in STUK activities. The 

Quality Policy of STUK sets out the mission, vision, and values and prescribes 

management objectives, quality policy etc. 

STUK’s strategy gives more detailed policy issues and goals of STUK activities. The 

strategy is implemented by the annual plans. 

The Quality Manuals describe the tasks and responsibilities of all organizational units 

and persons, as well as practices of management and internal communication at all 

levels. 


Question



3;para 2.8 

Is the management system of the regulatory body 

described in a single document (e.g. management 

system manual)? 

SQID 7.3 

Generally, the management system is described in STUK Quality Manual (Guide STUK 

1.2). The structure of STUK`s management system documentation has four levels of 

hierarchy: 

a. Quality Policy of STUK (Guide STUK 1.1) sets forth the fundamental 

principles applied in STUK activities. 

b. STUK Quality Manual is a comprehensive set of orders and guides covering 

all STUK`s operations. Main part of the Quality Manual consist of 

description of STUK`s work processes and guidance for managing those 

processes. It also describes the tasks and responsibilities of organization, 

as well as practices of management and internal communications. In 

addition to STUK Quality Manual there are manuals for specific STUK 

activities (financing, personnel, emergency preparedness, information 

technology and communication) 

c. Quality Manuals of Departments. These include more detailed guides and 

procedures. 

d. Detailed guides (working instructions), laboratory handbooks, and 

equipment manuals. 

Quality Manuals of Departments are the following: 

Quality manual of Nuclear Safety (YTV) 

Quality manual of Radiation Practices (SKV) 

Quality manual of Environmental Surveillance (TKO) 

Manual of Administration and non-departmental Units(HAE) 


Question 



3;para 2.8 


include the description of the structure of the 

regulatory body and of the functional responsibilities, 

accountabilities, levels of authority and interactions of 

those managing, performing and assessing work? 

SQID 7.4

The structure of the regulatory body and the functional responsibilities are described in 

management system documentation. 

The Rules of Administration (Guide STUK 2.1) provides the structure of STUK and the 

functional responsibilities of organizational units and decision making rules. Rules of 

Administration are confirmed based on Section 5 of the Decree (618/1997) on 

Radiation and Nuclear Safety Authority. Guide STUK 2.2 describes the organisation in 

more detail. 

Guide STUK 2.3 describes the Management by Results System. The focus in the planning 

of activities is in the quality and effectiveness of the work. The control of activities, the 

evaluation of achieved results and the systematic development of activities are included 

in the Management by Results System. 

At departmental level the Quality Manuals describe the responsibility of the directors, 

Section Heads and Head of laboratories, and basic procedures of the activities and 

instructions of the work of the department. The task and responsibilities of each staff 

member are also included in written documents. In addition, there are more detailed 

guides (working instructions) available. 

Individual audits are carried out by a separately nominated team, consisting normally 

of three persons. A person trained for auditing is appointed as the head of the team. 

Quality Manager appoints the teams based on his/her preparatory discussions. It is 

taken into account in the nomination of a team that nobody taking part in the work is 

auditing his/her own responsibility area (Guide STUK 6.1). 


Question 



3;para 2.8 


include the description of the processes and 

supporting information that explain how work is to be 

prepared, reviewed, carried out, recorded, assessed 

and improved? 

SQID 7.5 

The core processes and main supporting processes are described in STUK Quality 

Manual. More detailed descriptions are given in departmental level Manuals. Based on 

the Quality Manuals professional staff is expected to work on the basis of their own 

knowledge and skills. 


consistency with the mission of STUK (STUK 1.1). Essential bases for the decisions and 

statements are presented in writing. Requirements that are presented in connection 

with the decisions are proportional to the safety relevance and increase the actual 

quality and safety. All the main decisions are signed by two staff members. 

Contributions of the staff members involved in the preparation and review of a decision 

are recorded (either electronically or on paper). 

Assessment and improvement of the work is described in STUK Quality Manual. 

Evaluations are done for example in self-assessments, internal audits and topical 

workshops. The purpose of the assessment is to analyse the operations of work, to 

recognise the strengths and weaknesses of work, to recognise the development targets

at STUK, and expand awareness on increasing importance of the safety culture. 

Agreements on assessments are made in the annual action plans of the Director 

Generals office. 

In addition, the safety reviews related to licence applications of the use of nuclear 

energy and YVL Guides are independently reviewed by Advisory Commission for 

Nuclear Safety (Guide STUK 2.1, YTV 4.1.1) and its subcommittees (RSC, NWSC). 

Similarly, as regards to use of radiation reviews are carried out by Advisory 

Commission for Radiation Safety on ST Guides and on important safety licence 

applications. 


Question 



3;para 2.9 

Explain how it is ensured that the documentation of 

the management system of the regulatory body is 

understandable, legible, readily identifiable and 

available to all the staff of the regulatory body. 

SQID 7.6 

Guidance on preparation of management system guides is given in Guide STUK 1.3. It 

defines the content and structure of guides (general, purpose and scope of application, 

responsibilities, procedures, documentation, references and record). The guides need to 

be written in a clear standard language. 

Responsible persons (Quality Managers) of the department ensure that the guides are 

legible and not in conflict or overlapping with other documentation. The approval 

process of a quality guide includes an independent review (Guide STUK 1.3, Guide YTV 

1.1, Guide SKV 1.2). 

For easy identification, all the guides of Quality Manuals are classified according to the 

unit or departments issuing the guides. The classification is given with an abbreviation 

of letters (STUK, YTV, SKV, TKO etc.). Within a certain class, the guides are further 

divided into numbered groups according to the processes or tasks of the issuing unit. 

So, in STUK there are guides such as STUK 1.1, YTV 4.5, and SKV 3.2 etc. Of course, 

besides these classifications every document also has a name describing the topic of the 

document. 

The documentation of STUK’s management system is available to all staff members in 

STUK’s Intranet in many ways. 

A short notification is made on a new or updated guide. This notification includes the 

essential changes with a few bulletin points. Changes in department specific manual 

guides are notified mainly within the department (Guide STUK 1.4). 


Question 



3;para 2.10 

How does the documentation of the management 

system reflect the characteristics of the Regulatory 

Body and its activities and the complexities of 

regulatory processes and their interactions? 

PQ 8

STUK started in 1997 to develop a coherent management system with various quality 

tools (e. g. self assessments and internal audits) connected to this system. The basic 

idea for preparation of STUK’s Quality Manuals was to reflect the characteristics and 

activities of STUK. In this development phase all relevant processes and activities of 

STUK were evaluated (Guide STUK 1.2). The principle of continuous development was 

adopted in the very beginning of this work. 

The complexity of processes and their interactions has been taken into STUK’s Quality 

Manual. As an example, all the common guidance for the regulatory control activities is 

given in Guide STUK 3.1. In addition, common guidance on financial, personal 

administration, information technology, emergency preparedness and communication 

is given STUK-level guides. More detailed guidance is further given at departmental 

level guides. 


Question 



3;para 2.8 

Describe any measures planned to establish and 

document the management system of the regulatory 

body. 

PQ 8 

Enter notes or comments here 




3;para 3.1 

Does management at all levels in the organisation of 

the regulatory body demonstrate its commitment to 

the establishment, implementation, assessment and 

continual improvement of the Management System? 

Yes No B 

X 






Question 



3;para 3.1 

Explain the involvement of the managers at the 

different levels in the development, implementation 

and improvement of the management system of the 

regulatory body. 

SQID 8.2 

All managers participate in the development, implementation and improvement of the 

management system of STUK as follows for example: 

Management is committed to the implementation of the Management System 

(Guide STUK 1.1) 

Director General is responsible for defining the quality policy in STUK and for 

creating necessary prerequisites for its implementation (Guide STUK 1.2). 

All directors are responsible for applying STUK’s quality policy on their department 

as well as implementing and improving of internal management system (Guide 

STUK 1.2)

It is the responsibility of the head of each organisational unit to see that the valid 

management system is implemented in the unit, the set quality objectives are met 

and that possible deviations and issues requiring corrective actions are properly 

reported (Guide STUK 1.2) 

The guides of STUK’s quality manual are approved by STUK’s director general. 

Directors approve the guides of the Management System guides on their own 

responsibility areas (Guide STUK 1.3) 

Guide STUK 6.4 states that the management reviews shall be carried out annually. As a 

part of these reviews the implementation of the Management System and needs for 

development and improvement are assessed. Directors are responsible for the 

management system reviews on their department. The heads of the units are 

responsible to provide reports for the management review. 

Managers are responsible to arrange annual self-assessments on areas of their 

responsibilities. 


Question 



3;para 3.1 

Explain how the management of the regulatory body 

ensures that adequate resources are allocated for the 

fulfilment of its commitment to the establishment, 

implementation, assessment and continual 

improvement of the Management System. 

SQID 8.3 

Director General has established a permanent working group called Quality Group. 

Members of the Quality Group are nominated by directors and they represent 

departments of STUK and the Quality Manager of STUK acts as a chairperson of the 

group. 

Quality manager is responsible for coordinating for the maintenance and development 

of the management system . Quality manager is also responsible for the internal control 

and establishing and implementing the annual auditing programme. 

The individuals responsible for Management System issues on departmental level are 

also members of the Quality Group 

Directors of the departments allocate resources for implementing, assessing and 

improving the management system on the departmental level in the annual planning. 

Directors nominate process owners for all processes (Guide STUK 1.2). The duties of 

the process owner is to 

follow and analyse the functioning of the process 

develop the process and methods and indicators used to measure the process 

take care that the guides concerning the process are updated. 


Question 



Describe how the senior management of the 

regulatory body develops individual values, 

SQID 8.4

3;para 3.2 

institutional values and behavioural expectations to 

support the implementation of the Management 

System. 

The management group of STUK defined STUK’s vision originally in the strategic 

planning process in 1998-1999. As regards values an inquiry was performed to clarify 

the views of STUK’s personnel on the values. And staff members were encouraged to 

participate the ‘value definition process’. Finally the values were approved by the 

STUK’s management. Since then the vision and the values have been updated as a part 

of the strategic planning process. 

Behavioural expectations of the STUK’s management are published in a separate guide 

(Hyvää päivää –ohje) Guide STUK 5.7 which is available also on STUK’s intranet. Guide 

STUK 5.4 Equality plan gives guidance and rules related to equal and uniform treatment 

of STUK’s employees. 


Question 



3;para 3.2 

Do senior managers of the regulatory body act 

effectively as role models in the visible promulgation 

of individual values, institutional values and 

behavioural expectations? 

SQID 8.5 

Quality policy is signed by the STUK’s management and published in the intranet of 

STUK and on STUK’s webpage( Guide STUK1.1) 

This quality policy statement sets forth the fundamental principles STUK’s management 

considers important and pledges to follow, expecting everyone at STUK to do the same. 

As a means of achieving quality objectives, the management emphasizes good cooperation 

with the personnel. 

The prerequisites for high quality operation include the professional competence, work 

motivation and service mindedness of the personnel. Everyone is expected to assume 

responsibility for the quality of his/her own work. 

The basic values which guide all operations are competence, openness, co-operation 

and courage. Decisions, positions and other measures are based on professional 

knowledge and competence. Actions are open and honest towards both stakeholders 

and citizens as well as in internal communication. Co-operation within STUK is based 

on good working relationships, empowerment and mutual respect. Stakeholders are 

included in the preparation of actions. Identified problems and personal views are 

rigorously brought up. Responsibility for decisions is acknowledged, and errors are 

corrected. 

The values have been actively implemented within STUK. Managers encourage staff 

members to develop their competence and to cooperate extensively. Openness is 

nowadays obviousness in all activities in STUK. STUK and its staff members have during 

years explicitly expressed their position in safety issues . 


Question



3;para 3.3 

Describe how management of the regulatory body, at 

all levels, communicates to individuals the need to 

adopt individual values, institutional values and 

behavioural expectations in order to be able to comply 

with the requirements of the Management System. 

SQID 8.6 

Order STUK 2.3, Attachment 7: Chapter 4.1 gives guidance concerning the discussions 

on performance and results of an organisational unit. Suggested topics in these 

discussions are e.g. repetition of STUK’s mission and values and how the tasks and 

duties of the unit and individuals are linked to STUK’s mission. 

Order STUK 2.3 Performance Management Chapter 4.4 

4.4 Daily management 

In the management system of STUK the following values are emphasised: 

competence 

openness 

courage 

cooperation. 

Several factors influence the success or failure of management. Essential factors are for 

example: 

consistency and the manager’s own example 

management team work and result unit meetings 

open discussions (participative management) 

constructive feedback and encouragement 

knowledge of operational environment and field of activities, with future prospects 

knowledge of the expectations of interest groups 

good connections with organisations and persons essential to the activities. 

The head of an organisational unit shall 

be responsible for planning of the activities and finance of his/her unit 

be responsible for the efficient and appropriate use of his/her unit’s resources 

avoiding overloading 

be responsible that adequate time is reserved for unexpected duties during the 

year 

take care of that the cooperation and flow of information required by the unit’s 

duties are arranged in an appropriate way 

be responsible for the training of the personnel and maintaining the working 

conditions of his/her unit 

be aware of the development of his/her responsibility area and follow changes in 

the environment essential for the development. 


Question 



3;para 3.4 

Describe how and the extent to which, management at 

all levels of the regulatory body fosters the 

involvement of all individuals in the implementation 

and continual improvement of the Management 

System. 

SQID 8.7 

The management is committed to the implementation of the Management System and

expects the same from all of the personnel (Guide STUK 1.1) 

In addition to assessment and improvement of STUK’s actions also the Management 

System of STUK is updated, assessed and continually improved. This includes especially 

assessment and improvement of accessibility and user-friendliness of the Management 

System as well as assessment of structure and guidelines. 

In addition to the evaluation and improvement of operations, the Management System 

is also maintained, evaluated and improved continuously. Improvement of the Management 

System pays particular attention to the structure of the system (also to the structure 

of manuals and guides), availability and evaluation and improvement of user interfaces. 

Each manager is responsible for the internal implementation and development of the 

management system in his/her area of responsibility. This especially includes 

• Definition of the operational organisation and work processes 

• Commitment of units and staff to quality consciousness and to the 

management sys-tem 

• Emphasis on quality criteria in management and development 

• If necessary, the appointment of people responsible for monitoring, reporting 

and developing the performance of the management system. These people are usually 

also members of the quality group. 

The implementation of Management System is independently assessed by annual audit 

programme and internal inspections. Annual self-assessments are carried out in STUK 

(Guide STUK 6.3). The main focus of these assessments is to identify measures for the 

improvement of the management system. All individuals are encouraged to participate 

into self-assessments and also to bring up other improvement ideas. 

Guide STUK 1.2 Each employee in STUK is responsible for the quality of his/her own 

work. This also includes cooperation and active transfer of information, when the task 

or matter in question requires it. 

The head of an organisational unit is responsible for taking care of that the employees 

of his/her unit continuously have reasonable duties essential from the viewpoint of the 

organisational unit’s objectives and that the employees have possibilities to work 

efficiently and in a way of good quality Therefore, the employees shall have good 

possibilities 

to get sufficient information on matters related to duties and working conditions 

to discuss and to get support in matters related to duties 

to get sufficiently information on training possibilities and on other occasions 

related to the increase of expertise 

to make proposals for the development of his/her duties and STUK’s activities 

(Order STUK 2.3). 

Personnel has the right and the responsibility to report to the management on the work 

related problems or other factors that have a negative impact on the working 

conditions or work motivation (Guide STUK 5.1) 


Question 

8 8.7 Text Safety Standards How does senior management of the regulatory body PQ 9


3;para 3.5 

ensure that it is clear when, how and by whom 

decisions are to be made? 

All relevant information is gathered and used when a decision is being prepared. An 

essential part of the process is extensive communication between the experts 

participating in the preparation. The principal reviewer is familiar with the relevant 

regulations, STUK´s general policies and previous decisions in similar cases. If 

necessary, research or advisory opinions are ordered from external experts to support 

decision making (Guide STUK 1.1). 


consistency with the mission of STUK. Essential bases for the decisions and statements 

are presented in writing. Requirements that are presented in connection with the 

decisions are proportional to the safety relevance and increase the actual quality and 

safety. A decision can be changed if additional arguments presented later on give a good 

reason for a new decision. Regulatory activities are recorded with a goal in mind, that 

the manner of processing and the basis for the decision can be traced if necessary 


Legislation defines matters on which STUK makes the decisions and regulatory guides 

(ST Guides and YVL Guides) give detailed guidance regarding issues or matters which 

need application of STUK’s decision. 

Order STUK 2.1 gives a list of matters and defines by whom the decisions shall be made. 

More detailed guidance on decision making is given in guides YTV 2.1.1 (YTO), 

YTV 2.3.1.(YMO), SKV 2.5 (STO). 

According to the Act on administrative procedures (434/2003 Section 23) 

a matter shall be considered without undue delay. 

upon request, the authority shall supply the party with an estimated time of issue 

of a decision and respond to queries as to the progress of the consideration of the 

matter. 

STUK’s Management System includes several guides as regards reviewing and filing of 

documents sent to STUK or prepared by STUK. 


9 Primary Safety Standards Does the senior management of the regulatory body Yes No B 


3;para 3.6 

take the expectations of the stakeholders into 

consideration in the activities and processes of the 

management system while ensuring that safety is 

given priority in all regulatory activities? 

X 






Question 



Describe how the expectations of stakeholders are 

considered by senior management in the activities and 

SQID 9.2

3;para 3.6 

interactions in the processes of the Management 

System. 

The expectations of stakeholders are taken into account when STUK’s strategy, action 

programmes for core processes and annual plans are prepared. STUK actively collects 

feedback through meetings, surveys and interviews from all interested parties. For 

regulatory control of nuclear facilities regular meetings are held between STUK and 

licensees top management. Special outage meetings are arranged before and after 

outages at NPPs, in which the licensee’s and STUK’s needs and experiences are 

discussed. Feedback is also received in conducting regulatory control of activities and 

facilities. 

During the preparation process of the regulatory guides they are circulated for 

comments to the interested parties such as licensees and operators. The STUK guide 

extranet, which opened in the summer of 2010 (https://ohjeisto.stuk.fi), makes 

publicly available drafts of the YVL Guides, ST Guides and VAL Guides under 

preparation or revision. (Guides STUK 3.3, YTV 3.2 and SKV 10.1). 

According to (Guide STUK 6.5) all stakeholder and customer inquiries are planned as a 

part of action programmes for core processes and the realization is included in annual 

plans. Inquiries can also be contracted to an outside company. Results are inputs for the 

management review. If necessary, corrective measures are taken 

Guide STUK 6.5 includes also guidance on rectification and notification processes. 

Dissatisfaction towards STUK operations can be expressed either in writing or orally. 

The primary place for reacting towards rectification and notifications is the appropriate 

organizational unit. If a customer requests e.g. that a change should be made to a 

statement or an order presented in the inspection protocol, he/she is asked to prepare 

a justified rectification request in writing. The same procedure is followed when a 

customer argues that essential facts require that a change should be made in a STUK 

decision. 


Question 



3;para 3.6 

Explain how it is ensured that actions aimed at 

enhancing stakeholder satisfaction would not 

compromise regulatory functions and responsibilities 

for safety. 

PQ 10 

When identification actions based on feedback from stakeholders it is always carefully 

taken into account that they are in compliance with regulatory functions and 

responsibilities for safety. 

The final decisions on actions taken on the basis of stakeholder feedback are always 

taken by STUK. According to Guide STUK 3.1 one of the main principles is the legality. 

In addition, the safety significance of the handled issues shall be recognised and the 

emphasis on ensuring safety shall be given in STUK’s regulatory activities. 




3;para 3.7 

Has senior management developed the policies of the 

Regulatory Body? 

Yes No B 

X






Question 



3;para 3.7 

How has it been ensured that these policies are 

appropriate to the activities of the Regulatory Body? 

SQID 10.2 

The functions and responsibilities of STUK as a regulatory body are stipulated in the 

Finnish legislation: 

Radiation Act (592/1991) and the decrees based on it 

Nuclear Energy Act (990/1987) and the decrees based on it 

Act on STUK (1069/1983) and the decree on STUK (618/1997). 

STUK’s policies and strategy are derived directly from the legislation. STUK policies are 

presented in the quality policy of STUK (Guide STUK 1.1). The directors have 

committed themselves to the quality policy expecting every STUK’s worker to do the 

same. 

In the Guide STUK 3.1 the main principles for regulatory activities are presented. They 

are : legality, openness, independence, equality, relativity, verifiability, efficiency and 

effectiveness and service-minded 

The regulatory procedures described in STUK’s management system are based on the 

legislation and they are inline with STUK’s quality policy. The management system and 

its appropriateness and adequacy are assessed and reviewed continuously and 

amended and improved, if necessary. 


Question 



3;para 3.7 

How it is ensured that the regulatory policies are 

made known to all the staff of the regulatory body and 

are properly followed and implemented? 

SQID 10.3 

STUK ensures by many means that all the staff are aware of the policies and that they 

are followed and implemented: 

Management System guides are available to all STUK’s employees in intranet 

always when STUK’s policies are revised all of the staff members of STUK are 

widely informed 

STUK’s Management System is presented to the newcomers in the initiation 

training (responsibility of the superior; Guide HA 3.2 Attachment 1) 

managers’ duty is to see to that the regulatory policies and procedures are properly 

followed 

Order STUK 2.3, Attachment 7: Chapter 4.1 gives instructions concerning the

discussions on performance and results of an organisational unit. Suggested topics in 

these discussions are e.g. repetition of STUK’s mission and values and how the tasks 

and duties of the unit and individuals are linked to STUK’s mission. 

Through STUK’s annual audit programme it is ensured that the Management System is 

implemented correctly (Guide STUK 6.1). A premise is that the person who makes the 

solution has the necessary knowledge; he/she is familiar with the safety regulations 

and follows the general policy of STUK. 


Question 



3;para 3.7 

How are the regulatory policies communicated to the 

interested parties, including the public? 

PQ 11 

Guide STUK 1.1 This is how we operate - quality policy of STUK and the strategic plan 

for a five year period covering all of STUK’s operational areas are published on STUK’s 

website. 

STUK publishes ST guides for regulation of the radiation practice and YVL guides for 

regulation of the use of nuclear energy. The regulatory principles concerning oversight 

of radiation and nuclear safety are presented in these regulatory guides (YVL and ST 

Guides). The preparation process of these regulatory guides includes hearing of the 

interested parties i.e. licensees and operators. Representatives of the licensees 

participate in the working groups established for the ongoing revision project of YVL 

Guides. The STUK Guide extranet, which opened in the late summer of 2010 

(https://ohjeisto.stuk.fi), makes publicly available drafts of the new regulatory guides 

under preparation or revision. All published regulatory guides are available on STUK’s 

website. 


Question 



3;para 3.7 

Describe any measures planned to develop regulatory 

policies. 

PQ 11 



11 Primary Safety Standards Has the senior management established and 

Yes No B 


3;para 3.8 

implemented goals, strategies, plans and objectives 

that are consistent with the policies of the Regulatory 

Body? 

X 




Otherwise go to:


Question 



3;para 3.9 

How has the senior management ensured that the 

goals, strategies, plans and objectives of the 

Regulatory Body are developed in an integrated 

manner so that their collective impact on safety is 

understood and managed? 

SQID 11.2 

STUK has established an integrated planning system. STUK’s strategy is updated every 

fifth year and presents the most important goals and the prioritization of the activities. 

Action programmes for all core processes are derived on the basis of STUK’s strategy. 

Annual action plans based on the strategy and action programmes are prepared, and 

more detailed work plans needed for its implementation are prepared for all of the 

organisational units and employees. Performance reviews conducted by each of the 

superiors and his/her subordinates are an essential part of the planning. 

Order STUK 2.3 gives instructions for the strategic planning, annual planning of 

activities, the evaluation of achieved results and the systematic development of 

activities. 


Question 



3;para 3.10 

How does senior management ensure that measurable SQID 11.3 

objectives for implementing the goals, strategies and 

plans are established through appropriate processes 

at various levels in the Regulatory Body? 

STUK has established measurable objectives for implementing strategies and plans. 

These are presented in the STUK’s annual result plan (Guide STUK 2.3) 

Result agreements for departments are done by Director General and the Directors. 

Within their responsibility areas the Directors sign the result agreements with the 

heads of each unit. 

The personal performance targets for each employee are agreed upon in a result 

discussion with the manager. 

Result agreements include objectives that relate to products or results which are to be 

achieved. In defining the results, special attention must be paid to the fact that the 

fulfilment of the results can be measured at the end of the planning period. 

Director General confirms the budget for departments and for result units working 

directly under Director General. 

Detailed instructions on the annual planning process are given annually by specific 

order of the Director responsible for that process. 

In defining objectives, the following criteria must be taken into account: 

realism; the objectives must be achievable 

challenges; the objective level must be adequate, meaningful and encouraging 

verifiability; the results have to be able to be verified by measuring or evaluating so

that the fulfilment of the results can be followed; mere doing is not sufficient as an 

objective (e.g. the effects of radiation are studied). 

In the planning of result objectives it has to be taken into account that unexpected new 

duties emerge during the year. 

In the result agreement, the most essential development plans of the unit in question 

are also presented. These kinds of development projects are for example projects 

launched for increasing the efficiency of activities or for enhancing quality. The projects 

are presented so that their implementation can be verified. 

The planning of human resources is also an essential issue in the preparing of the result 

agreement. 


Question 



3;para 3.11 

How does the senior management ensure that the 

implementation of the plans is regularly reviewed 

against the objectives and actions are taken to address 

deviations from the plans where necessary? 

PQ 12 

The implementation of the plans is regularly reviewed on all organization levels. 

At each level the implementation status is evaluated at least semi-annually. Depending 

on nature of functions of the units evaluation can be done more frequently. All 

departments report the implementation status to the Deputy Direct General in August 

and January. In the end of each year all departments prepare a report on 

accomplishment of its objectives. 

STUK prepares an annual report on its activities for the Ministry of Social Affairs and 

Health and for the State Auditor’s Office. It is prepared according to the Decree on the 

State budget. In this report especially the accomplishment of objectives included in 

STUK’s result agreement is evaluated. The annual report is also a document for closing 

of the accounts. In addition to the Decree on the State budget, the instructions given by 

State Treasury are taken into account in preparing the report. 

The accomplishment of personal result objectives is evaluated in connection with result 

discussions. If the result objectives are not achieved at all or partially achieved, reasons 

influencing are analysed and corrective measures are considered. 


Question 



3;para 3.8 

Describe any measures planned to ensure adequate 

implementation of the management system of the 


PQ 12 


QID SQID QTYPE References Primary Question Answer PA



3;para 3.12 

Has the senior management of the Regulatory Body 

taken the ultimate responsibility for ensuring that the 

Management System is established, implemented, 

assessed and continually improved? 

Yes 

X 

No B 






Question 



3;para 3.12 

Describe formal activities of the senior management of SQID 12.2 

the regulatory body that are intended to fulfil its 

responsibility for ensuring the establishment, 

implementation, assessment and continuous 

improvement of the management system. 

STUK established its first comprehensive Quality Management system in 1997-98 

covering all activities in STUK. However since 1970’s special management guidance 

have been issued both at STUK level and at departmental level. 

Guide STUK 1.2 describes generally STUK’s current integrated Management System. In 

the Management System e.g. the organization of STUK, core and support processes, 

assessment and continuous improvement including audit processes and management 

reviews are described. 


Question 



3;para 3.13 

Is specific responsibility and authority for 

coordinating the development and implementation of 

the management system, for reporting on the 

performance of the management system and the need 

for improvement, and for resolving any potential 

conflicts between requirements, assigned to an 

individual reporting directly to senior management? 

SQID 12.3 

Duties of STUK’s Quality Manager include participating in the maintenance and the 

development of the management system and coordinating self-assessments, 

management reviews, internal audits and inspections, customer satisfaction inquiries, 

other studies and feedback. 

STUK’s quality Manager reports directly to the Senior Management and is the 

chairperson of STUK’s Quality Group. 


Question 



3;para 3.13 

What are the arrangements in place to identify and 

resolve any potential conflicts between the 

requirements within the management system? 

SQID 12.4

Identification of potential conflicts is possible in internal audits of the management 

system and also in other evaluation procedures of the activities or the management 

system. Staff members are encouraged to announce their findings on potential conflicts 

between requirements to the STUK’s register for non-conformances and deviations. 

Potential conflicts between requirements are discussed in the Quality Group and 

resolved at appropriate level. 

Guide YTV1.1 Drafting and updating YTV guides, Chapter 3 states that the compiler of a 

guide shall check that the contents of the guide do not conflict with other YTV Guides, 

STUK Guides and Orders or any general state’s administrative rules and regulations. 

According to Guide SKV 1.2 persons responsible for the quality issues of the 

department (SKV guides concern Radiation Practices Regulation and Non-ionizing 

Radiation Surveillance) shall check that the contents of the guide do not conflict with 

other Management System guides 


Question 



3;para 3.14 

What are the measures in place to ensure that the 

regulatory body retains overall responsibility for the 

management system when an external organization is 

involved in the work of developing all or part of the 

management system? 

PQ 13 

Currently N/A 


Question 



3;para 3.12 

Who has the overall responsibility for the 

management system of the regulatory body? Explain 

the functional relationships between this person or 

organisation and the Regulatory Body. 

PQ 13 


13 Primary Safety Standards Has the senior management determined and provided Yes No B 


3;para 4.1 

the resources necessary to establish, implement, 

assess and continually improve the management 

system? 

X 






Question



3;para 4.1 

How has the senior management determined the 

amount of resources necessary to carry out the 

activities of the regulatory body and to establish, 

implement, assess and continually improve the 


SQID 13.2 

The management of STUK is responsible for adequate resources in various main 

regulatory activities (regulatory control of safety and security of NPPs, nuclear waste 

management and use of radiation). This is reflected in the organization of STUK (Guide 


A Management by Results System is in use in STUK. The focus in the planning of 

activities is not only in goals but also in the quality and effectiveness of the work. The 

follow-up of activities, the evaluation of achieved results are also covered by the 

Management by Results System. Within the system objectives and timelines as well as 

resource allocation for all activities are determined. STUK 2.3 

The most important goals of STUK and weighting between its different regulatory 

activities are tackled with in STUK´s strategy, which is compiled every 5 years. These 

weightings and goals are considered in annual plans. 

In annual planning resources are allocated to different areas of regulatory activities. 

Based on the detailed work time recording system the real time used is followed and 

assessed. One part of annual planning is human resource plan, all departments prepare 

HR-plan for next coming year and also a long-term one for next five years. These plans 

are approved by DG. 

For implementing, assessing and improving the management system STUK has a 

comprehensive system. Internal auditing of STUK’s activities is described in Guide 

STUK 6.1, self-assessment in Guide STUK 6.3 and management reviews and corrective 

actions are described in Guide STUK 6.4. These activities shall be included in annual 

plan of departments and independent units and also resources shall be allocated. 

Further more STUK has a Quality development group which coordinates 

implementation and development of STUK’s quality policy, drafts of annual plan for the 

quality management, supports departments in development of their quality 

management and follows the development of general quality management systems in 

domestic and international and takes necessary initiatives to for improvement in STUK. 


Question 



3;para 4.2 

Explain any arrangements in place for the 

management of knowledge as a resource of the 


PQ 14 

Competent and co-operative people are a fundamental success factor in STUK 

operations. The third basic element of success, motivation, can also be derived from the 

competence and co-operation (Guide STUK 5.1). 

Goals for knowledge management are included in STUK’s Strategy. In connection with

the annual planning HR-plans for the next and forthcoming years are established. 

Necessary factors for success of STUK are adequate human resources and professional 

competence in all areas relevant for radiation and nuclear safety. Maintaining and 

developing human capital is supported by maps on competence needs and actual 

available competencies within each organizational unit (Guide STUK 5.2). When 

evaluating the competence needs the safety significance of the regulated activities is 

also considered. The original version of maps was developed by the respective units 

with support of consultant, and they contain information on skills and knowledge of 

each person. The competence maps are updated annually and used for making personal 

development plans, succession planning and recruitment of new staff and planning 

development of human capital in the long term. 

STUK arranges adequate in-house and external training for staff members. Staff is 

encouraged to develop their competence by i.e. training on various topics for two 

weeks every year. Also important is on-the job training in teams and with senior staff 

members. A standard initial training course is arranged several times a year for the 

newcomers. And managers are responsible for developing initial training programmes 

for each newcomer. 

In order to capture main knowledge of retiring and staff leaving STUK the managers 

interview them (Guide STUK HA 3.5). One item in these interviews is how knowledge 

has transmitted. STUK has also recruited new staff 6-12 months before retirement of 

experienced staff and in these cases the senior expert has taken part in the in-the-jobtraining. 

Information technology enhances the efficiency of STUK’s operations. Information 

systems are user-friendly, reliable and mutually compatible. Data security is well 

organised. (STUK’s Quality Policy) 

STUK provides knowledge and information for staff through internal website 

(SANTRA). STUK information management system uses the electronic SAHA-system 

(case management and document management systems). E.g. the VASARA-system 

(regulatory control for the use of radiation) and TARKKA-system (inspection protocols 

and records related to the regulatory control of the use of nuclear energy) are 

connected to the SAHA system. 

In case STUK needs support or more knowledge on a specific topic relevant for safety, it 

can use TSOs, other external consultants to support the development of in-house 

knowledge. 


Question 



3;para 4.1 

Describe any measures planned to determine and 

provide the resources necessary to establish, 

implement, assess and continually improve the 

management system. 

PQ 14 


QID SQID QTYPE References Primary Question Answer PA



3;para 4.4 

Has the senior management ensured that individuals 

are competent to perform their assigned work and 

that they understand the consequences for safety of 

their activities? 

Yes 

X 

No B 






Question 



3;para 4.3 

How has the senior management of the regulatory 

body determined the competence requirements for 

individuals at all levels? 

SQID 14.2 

The Management System of STUK provides requirements for competence management. 

According to STUK’s Quality Policy the personnel’s competence is systematically 

developed taking into account the needs of the organization and the wishes of the 

individuals. Everyone’s obliged to maintain professional skills as presupposed by their 

duties. Those aiming at an expert’s career are valued as highly as those interested in 

managerial duties (Guide STUK 1.1) 

Prerequisite for STUK staff in all regulatory functions is a university degree. In general 

there is no formal qualification for specific duties such as regulatory staff members in 

Finland. As regards inspectors for the use of radiation qualification for the radiation 

safety officer is required. 

All governmental organizations have a competence classification for duties. 

Accordingly, STUK has established a competence classification system taking into 

account the specific requirements for regulatory duties, Guide STUK 5.3. When new 

staff is recruited the specific competence requirements are defined for each duty in 

question. The tasks for each employee are defined based on his/her education and 

existing competence. 


Question 



3;para 4.3 

What are the arrangements made by the regulatory 

body for recruiting individuals with appropriate 

education, skills and experience? 

SQID 14.3 

When new staff is recruited the specific competence requirements are defined for each 

duty in question. Prerequisite for STUK staff in all regulatory functions is a university 

degree. The tasks for each employee are defined based on his/her education and 

existing competence. The internal guidance for recruitment process is described in 

Guide HA 3.1 and guidance on competence classification is given in Guide STUK 5.3. 

STUK’s recruiting processes are describer in Guide STUK 5.1. When a person resigns or 

retires from STUK’s service, or moves to another position within STUK, it shall always 

be firstly considered, if his/her old task could be taken care of by rearranging tasks 

without adding any new personnel.

If an open vacancy is decided to be filled, an advertisement of the open vacancy is 

published. The job description of the position to be filled is always defined before 

declaring the vacancy for applying. Job description is defined and based on recognition 

of human resources made in annual planning. An application process is always used 

when the position in question concerns an official position and usually also when a 

periodical official is being filled. The advertisement is published in an appropriate way 

and extent so that as many as possible such persons that are interested in the position 

are notified. 

The advertisement is always published so that STUK’s all own employees are notified 

from the open vacancy. Furthermore, the advertisement is published in a public media 

that is STUK’s internet site and governmental electric recruitment system with broad 

circulation, unless there is a good reason for limiting the search to an internal search 

within STUK. A good reason would, for example, be that STUK already has a well 

experienced and suitable person in a periodical employment relationship for the 

position. 

The starting point for recruitment is appointing the best candidate. When a position is 

being filled, maintenance of personnel’s balanced age structure and equality among the 

sexes are taken into account. When a final selection has to be made between two or 

more equally well suited candidates, the possibility to promote internal job rotation is 

taken into account and thus a suitable candidate already employed by STUK is 

favoured. When a person is chosen for a management position, leadership skills are 

required. An aptitude test can be used, when choosing a person. Information on new 

employees is published in the weekly bulletin “Viikkis”. 

STUK also has a close co-operation with universities and provides summer job and 

graduation job opportunities for students. 


Question 



3;para 4.3 

What are the arrangements for providing training for 

the staff of the regulatory body in order to achieve and 

maintain the required level of competence and 

proficiency and to ensure that they are aware of the 

importance of their activities and of the way in which 

these contribute to the achievement of the objectives 

of the organisation? 

SQID 14.4 

STUK provides training for its own personnel in order to achieve and maintain required 

level of competence. 

STUK’s Personnel Unit (HEP) organizes general initial training for the newcomers and 

provides basic information of how STUK acts. In addition initial training related to job 

description and tasks of a newcomer is organized by each manager. . 

STUK establishes annually a common training programme. This programme covers the 

areas such as project management, emergency preparedness, legislation, language 

skills, general working skills and regulatory practises and culture, human relations 

skills, leadership, financial administration, IT-skills (Guide STUK 5.2). In addition all 

departments provide annually specific training for their own staff members.

As a part of annual discussion between manager and employee also training needs shall 

be covered. The basis for planning the training program include the current and 

planned tasks of the each section and outcome targets set for them as well as the 

capabilities of the existing personnel and its required level of knowledge and skills. 

When the training program is planned, attention is also paid to the special needs of the 

ageing personnel. 

The head of the section is responsible for making sure that the necessary preconditions 

are arranged for those working for the section to develop their professional knowledge 

and skills, and to receive training that is necessary for the operations of the section. 

Development of the professional knowledge and skills as well as of acknowledgement 

of personal development needs is, however, ultimately the responsibility of each 

individual. Guide STUK 5.1 

Matching these objectives – on the one hand the objectives of the section and on the 

other the personal development needs – is done in the annually held personal 

development discussions (See also SQIDs 14.4 and 14.5). After the discussions and after 

the training needs of each person have been agreed upon and documented, they are 

gathered together and a departmental program for the development of professional 

knowledge and skills is drawn up. A separate, annual budget is allocated for the 

training. 

STUK encourages its personnel to develop its professional skills and to expand its 

competence to new tasks as well (STUK 5.2). One factor that is taken into account in the 

recruitment process is the advancement of internal job rotation. STUK grants leave of 

absence for the purpose of working for another employer, if working elsewhere 

develops competence in STUK related tasks and the execution of the unit’s tasks doesn’t 

become considerably more difficult as a consequence. 

STUK supports its personnel in its studies on his/her own terms, when the new 

knowledge also benefits the work. Possible working time and task arrangements can be 

settled with the closest foreman. STUK can also participate in the studying expenses. 

(HA 3.6 and HA 3.7) 

In order to develop experience and competence of the personnel STUK is ready for 

paying the expenses, and either whole or part time salary, for a fixed-term work with a 

foreign organisation, if the bases for this are considered adequate. 


Question 



3;para 4.4 

What are the measures taken by the senior 

management of the regulatory body in order to ensure 

that all individuals have the suitable skills, knowledge 

and experience needed so that they are competent to 

perform their assigned work? 

SQID 14.5 

STUK’s Quality Policy states that the prerequisites for high quality operation include 

the professional competence, work motivation and service mindedness of the 

personnel. Everyone is expected to assume responsibility for the quality of his/her own 

work. Further 

the personnel’s competence is systematically developed taking into account the needs

of the organization and the wishes of the individuals. Everyone’s obliged to maintain 

professional skills as presupposed by their duties. Those aiming at an expert’s career 

are valued as highly as those interested in managerial duties. 

The top management is responsible for adequacy of resources and, therefore, the 

conditions for organizing staff development. Accordingly the management has 

established the necessary prerequisites for systematic training. This covers initial 

training, annual common and specific training, training outside STUK as well as 

arrangements for personal development. 

In annually discussion held with each staff member staff’s existing competence and 

skills are indentified (competence mapping by OSKAR) as well as the views and wishes 

of the necessary competence development. Competence development can be a general 

enhancing the capacity or maintaining and developing the expertise. 


Question 



3;para 4.3 

What are the arrangements for measuring the 

effectiveness of the actions taken to achieve and 

maintain the competence of the staff of the regulatory 

body? 

PQ 15 

STUK assesses systematically how annual plans have been realized. (Guide STUK 2.3). 

This assessment covers also the realization of training and competence development 

programmes. 

In the annual discussion with each staff member the most important topics are the 

realization of the objectives, agreement on future objectives and the needed resources 

as well as personal development needs. When the realization of the set objectives is 

assessed, both appreciative and critical feedback shall be communicated directly. STUK 

2.3 

Departments maintain competence maps. Maps of personal competence (OSKAR) are 

updated in annually. In the case of possible rise in the level of expertise is recognized it 

is registered in the competence map. 

STUK carries out every second year a survey on staff wellbeing. This survey includes 

also questions on training and competence development. 


Question 



3;para 4.4 

Describe any measures planned to implement 

adequate arrangements for ensuring the competence 

of all the staff members involved in safety related 

regulatory activities. 

PQ 15 

Enter notes or comments here




3;para 4.5 

Does senior management determine, provide, 

maintain and re-evaluate the infrastructure and the 

working environment necessary for work to be 

carried out in a safe manner and for requirements to 

be met? 

Yes No B 

X 






Question 



3;para 4.5 

How have the infrastructure and the working 

environment necessary for the regulatory work to be 

carried out safely and efficiently been determined, 

provided, maintained and re-evaluated? 

PQ 16 

STUK provides high standard infrastructure and working environment to its staff. Staff 

has opportunity to influence their work and working conditions (Guide STUK 1.1). 

The personnel’s well-being is looked after by available means. Meaningful duties and 

the chance to develop one’s own work and STUK’s operational processes helps 

maintain work motivation. Everyone is given a safe work environment and the support 

of the work community. 

STUK follows the principles of early support to incipient problems in wellbeing. It is 

considered intolerable that anyone should be treated inappropriately and in a 

discriminatory manner. Workload and the exactingness of duties are kept at a level that 

facilitates management of own work. 

Based on the Finnish legislation on occupational health and safety STUK has established 

own arrangements. Occupational health center is available for all STUK staff members 

(Guide STUK 5.7). Ergonomic aspects have also been taken into account in the working 

environment. Additional arrangements cover many other areas such as a gym, support 

to physical exercise and cultural activities and saunas are available for staff. 

STUK has assessed risks related to occupational safety. The overall results were good. 

However, some small improvements have been implemented on the basis of the latest 

assessment. STUK has nominated a group which follows the development on 

occupational safety (Guide STUK 5.7) 

Flexitime enhances co-ordination between work and personal needs as well as 

efficiency at work; and so does the possibility of carrying out, independently outside 

STUK, tasks requiring special concentration. 

The most staff members have permanent contracts with STUK and the annual number 

of people leaving STUK is small. STUK promotes carrier planning and possibilities to 

move from one post to another (Guides STUK 5.1) 

Financial administration uses appropriate systems and guides. STUK promptly attends 

to income and expenditure as well as bookkeeping.

Management accounting produces reliable, real-time information on STUK’s operations 

and their costs. Operations subject to a charge are priced based on exact cost 

calculations. The reporting system provides each organizational unit with real-time 

information on the resources available to it. 

Information technology enhances the efficiency of STUK’s operations. Information 

systems are user-friendly, reliable and mutually compatible. Data security is well 

organized. 

Infrastructure and working environment are subjects in the surveys on the staff 

wellbeing. Survey results show that staff is satisfied. Infrastructure and working 

environment are discussed also in annual discussions with each staff member and in 

management reviews. Self assessment practice is also one tool for staff members to 

influence their own working environment. 


Question 

15 15.2 Text Safety Standards Describe any measures planned to ensure that the PQ 16 


3;para 4.5 

infrastructure and the working environment 

necessary for regulatory work to be carried out safely 

are adequately determined, provided, maintained and 

re-evaluated. 


Core Questions (GSR Part 1 and GS-R-3) 

Primary Module : Management System for the Regulatory Body 


16 Primary Safety Standards Has the regulatory body identified and developed the Yes No B 


3;para 5.1 

processes of its management system necessary to 

achieve goals, provide the means to fulfil all 

regulatory responsibilities and enable regulatory 

activities to be performed in an effective and efficient 

manner? 

X 






Question 



3;para 5.1 

Describe how the regulatory body has identified and 

developed its management system processes 

(including planning, implementation, assessment and 

continuous improvement). 

SQID 16.2 

STUK’s Management System processes are described in STUK Manual. STUK 

established its Quality Management System already in late 90’s. All procedures were 

defined and described in 1998. In the beginning of 20 century processes were identified

and process descriptions were published. After the IAEA published GS-R-3 in 2006 

STUK carried out self-assessment between its’ Quality System and IAEA requirements. 

All general management system processes, but managing organizational change, were 

present in STUK’s QMS even thought the structure of manual differs from the structure 

of GS-R-3. 

Chapter 3 describes STUK’s core processes, chapter 4 supporting processes including 

general management system processes such as procurement, administration, document 

management, Provision of recourses are described in chapter 5 and planning and 

follow-up of activities in chapter 2 and improving processes are included in the chapter 

6 of Management System. 


Question 



3;para 5.2 

How have the sequence and interactions of the 

processes been determined? 

SQID 16.3 

The process chart is shown in STUK 1.2 appendix 4. The core processes are presented 

in STUK 1.2 appendix 2 and support processes in appendix 3. 

The sequence and interactions of processes under the core processes are presented in 

the guides concerning the processes. For example the interactions of processes, under 

the core process regulatory control of radiation practice (presented in STUK 3.1), are 

presented in guide SKV 1.1 appendix 2. 


Question 



3;para 5.3 

Describe how the methods that ensure effectiveness of SQID 16.4 

both the implementation and the control of the 

processes have been determined and implemented. 

The Guide STUK 1.2 (Description of the Quality System) and it’s appendixes describes 

how the processes are managed, shortly: 

Every process has owner 

Every process has chart and description 

The actions for every process are presented in some guide 

Process measures are monitored 

STUK 1.3 (Contents of the Quality Manual Guides) describes how the guides should be 

handled. 

See also the answer to SQID 16.15. 


Question 



Have the processes of the management system of the 

regulatory body been documented? 

SQID 16.5

3;para 5.4 



The core processes are documented in guides STUK 3.1-3.9. The support processes are 

in guides STUK 4.1- 4.17. The processes under these are documented in department 

level quality manuals (YTV, SKV, TKO). 


Question 



3;para 5.4 



How have the responsibilities and authorities for the 

development of the processes been assigned? 

SQID 16.6 

The process owner is responsible for the development of process. Guide STUK 1.2 

(Description of quality system) states: 

Owners are appointed for each process. The role of the process owner is: 

To monitor and analyse the performance of the process 

To develop the process, and the methods and indicators used to measure it 

To ensure that the instructions regarding the process are up to date. 


Question 

16 16.6 Text Safety Standards Have the inputs, process flow and outputs of each SQID 16.7 

Series No. GS-R-3;5.6 process been identified? 



3;para 5.4 

Some but not all process descriptions include inputs, outputs and process flow. The 

processes and their outputs, measures and owners are listed in appendixes 2 and 3 of 

STUK 1.2. Process flow charts are presented in appendixes of guides (STUK 3.1-3.9 and 

STUK 4.1-4.17) concerning the processes. See also the answer to SQID 16.4. 


Question 

16 16.7 Text Safety Standards How have the applicable requirements for each SQID 16.8 

Series No. GS-R-3;5.6 process been identified and specified? 



3;para 5.4 

The main requirements for STUK’s actions are presented in STUK’s Quality Policy

(Guide STUK 1.1). It states that the legality of processes is confirmed from top to 

bottom. The requirements are stated in the guides in question. 


Question 



3;para 5.4 



Describe the extent to which there is effective 

interaction between interfacing processes. Please give 

examples. 

SQID 16.9 

Many of processes in STUK’s Management System have interactions with each other. In 

most cases the interaction is between core processes and related processes as well as 

between processes and related procedures. 

To large extent for example in regulations process (guide STUK 3.3) and in the 

processes under the core process regulatory control of radiation practice (interactions 

presented in guide SKV 1.1 appendix 2). The support processes are also largely 

overlapping to other processes. 

Projects can have participants from different department and/or process and that of 

course increase interactions as well. 


Question 



3;para 5.5 

Describe how the activities and interfaces between 

different individuals or groups involved in a single 

process are planned, controlled and managed to 

ensure effective communication and clear assignment 

of responsibilities. 

SQID 

16.10 

The management is presented in Guides STUK 2.1 (Regulation for Organisation and 

Management), STUK 2.2 (Organisation), STUK 2.3 (Management by Results System 

Description). Generally the result unit head is responsible that the individuals in a 

process can work in effective manner as stated in STUK 2.3: 

This Guide presents STUK’s management by results system. The management by 

results system is applied to all STUK tasks. 

The principles presented in Chapter 4.4 of the order apply not only to the heads of the 

result units but also to all possible managers who have direct subordinates and who are 

responsible for specified functions. Chapters 4.2 and 4.3 of the Guide also apply to such 

line managers when separately agreed. 

In addition to above mention line organisation management, for specific tasks the 

director general can assign work groups to ensure effectiveness, especially for actions 

concerning several result units as stated in guide STUK 2.6 (Permanent and Temporary 

Work Groups). 

Tasks can be also managed with forming a project as stated in guide STUK 2.7 (Project

Management). 


Question 



3;para 5.6 

Describe arrangements that ensure the 

documentation for each process is consistent with 

other relevant documents and specifies the records 

required to demonstrate that the process results have 

been achieved. 

SQID 

16.11 

In the guide of each process it is described how the documentation and records should 

be kept. The records of core processes are listed in STUK 1.2 appendix 2 and support 

processes in appendix 3. 

The word processor has templates to which all documentation is done (e.g. own 

template for management system guides). 


Question 



3;para 5.4 



How have the process measurement criteria been 

established and what are the arrangements for 

monitoring and reporting on the performance of the 

processes? 

SQID 

16.12 

The measurement criteria for each process are presented in the process description of 

relevant guide. The performances of processes are described in annual reports and 

there are reviewed at Management group meetings as stated in Guide STUK 2.5 

(Management Group). The Performance is also monitored yearly at STUK level and 

department level at management reviews as stated in Guide STUK 6.4 (Management 

Reviews and Corrective actions). 


Question 



3;para 5.6 

How are improvements in processes determined and 

promoted? 

SQID 

16.13 

Guide STUK 2.3(Management by Results: System description) states how the annual 

and strategic planning is managed. The flow-chart of the process is in appendix 2. The 

quality Management guides (STUK 6.1- STUK 6.5) states how the performance 

evaluation is done. 


Question 

16 16.13 Text Safety Standards Describe how each process, including any subsequent SQID


3;para 5.6 

changes to it, is aligned with the goals, strategies, 

plans and objectives of the regulatory body. 

16.14 

See answer to SQID 16.1 


Question 



3;para 5.6 

How are the responsibilities and authorities for the 

development of the processes assigned within the 


SQID 

16.15 

STUK 1.4 (Updating and Distributing the Quality Manual) states the responsibilities of 

management system development. Process owners are responsible for the 

development of processes (see SQID 16.5). 


Question 



3;para 5.7-8 

What verification activities and evaluations are 

conducted to confirm the adequate performance and 

ensure the effectiveness of each process and how are 

the responsibilities for verification specified? 

SQID 

16.16 

The principles of internal and external evaluations are presented in Quality 

Management guides (STUK 6.1-6.5). 

The process owner is responsible for the development of process as stated in Guide 

STUK 1.2 (Description of quality system). The quality manager and quality group also 

participates in the verification. 

The internal audits are arranged according to audit plan. Roughly 10-20 audits are 

arranged yearly. Also external auditing is required to some activities, see SQID 16.16. 

Large scale independent evaluations that have been done during past decade are for 

example IRRT 2000 and follow-up 2003, IPPAS 2008, Research evaluation 2005 and 

2010. 


Question 



3;para 5.7-8 

What are the processes and activities within processes 

for which independent verification activities are 

required? 

SQID 

16.17 

Finnish Accreditation organization FINAS is carrying out annual assessments in STUK’s 

accreditated laboratories and similarly Center of metrology and accreditation (MIKES) 

is assessing DOS -laboratory.

STUK’s activities are also subject to external control. State auditors and State Audi-tor’s 

Office are external national auditing bodies. State Auditor’s Office carries out annual 

audits in governmental offices and independent audits as regards legality and 

expediency. The European Union’s Court of Auditors and Commission audit projects, 

which have been financed by the European Union. As considered necessary, STUK uses 

in addition other external evaluations on its activities. Detailed information is 

presented in the Guide STUK 6.1. 


Question 



3;para 5.9 

How it is ensured that the work performed in each 

process is carried out in accordance with approved 

current procedures and instructions that are 

periodically reviewed to ensure their adequacy and 

effectiveness? 

SQID 

16.18 

The performance evaluation is arranged, including the internal and external auditing, 

as stated in SQID 16.15 and 16.16. 


Question 



3;para 5.10 

How is the control of processes contracted to external 

organizations identified and addressed in the 


PQ 17 

STUK has contracted on few processes to external organizations. The outsourcing is 

done via procurement under EU legislation and main requirements are included in the 

legislation. STUK has also internal guidance for procurement Guides STUK 4.4 and YTV 

6.2. Guidance for contracts and agreements is given in the Guide STUK 4.5. In addition 

Guide YTV 6.6 includes guidance for auditing technical support organizations. 




3;para 5.12 

Does the regulatory body have a process for the 

control of documents? 

Yes No B 

X 

The principles of document control are described in guide STUK 1.3 and 1.4 

and in department level quality manuals. Guide STUK 4.9 gives more 

guidance on handling of documents and Guide STUK 4.10 on publicity of 

documents and information. 

More detailed guidance for document management in nuclear regulation is 

given also in Guides YTV 6.1 and YTV 6.5. 

If ‘Yes’ go to: SQID 17.1




Question 



3;para 5.12 

How is it ensured that document users are aware of, 

and use the appropriate and correct documents? 

SQID 17.2 

Guide STUK 1.4 (Updating and Distributing the Quality Manual) states how the 

documentation is handled. 

The documentation is in kept electronic case management system SAHA, in which only 

the approved version of guide can be accessed. From the STUK’s intranet SANTRA there 

is a link to that valid guide. Paper versions of guides are not distributed, only the signed 

paper version is kept in registry as stated by in guide STUK 4.7. 


Question 



3;para 5.12 

How is it ensured that all individuals involved in 

preparing, revising, reviewing or approving 

documents are competent to perform these tasks and 

have access to appropriate information on which to 

base their inputs or decisions? 

SQID 17.3 

Generally all documents are available to everyone as stated in guide STUK 4.10 

(Publicity of Documents and Information), the exceptions are listed in Guides STUK 

4.12 (Processing of Confidential Documents) and STUK 4.11 (Handling Personal data). 

Guide STUK 4.9 states how the preparation of documents in handled. 

Persons are familiarized to new tasks as stated in Guide HA 3.2. The head of result unit 

is responsible that individuals are competent to perform their tasks. 


Question 



3;para 5.12 

How is it ensured that changes to documents are 

reviewed and recorded and are subject to the same 

level of approval as the documents themselves? 

PQ 18 

The updates of guides go through same procedure as new guide. Only minor changes in 

appendixes are allowed without formal approval (signature). 




Are specifications for the products of regulatory 

activities (review and assessment reports, inspection 

Yes No B 

X

3;para 5.14 

and audit reports, regulatory documents, licences, 

certificates of approval and authorizations, etc.) 

defined in accordance with established standards and 

incorporate the applicable requirements? 

STUK has used ISO9000 standard series and IAEA requirement documents 

as a basis when developing its Management System and regulatory guides. 

In the development of regulatory guides also other established standards 

have been used, such as IEE, ASME etc. 





Question 



3;para 5.14 

Describe how products of regulatory activities that 

interface or interact with each other are identified and 

controlled. 

SQID 18.2 

Main products of regulatory activities are all documented in document management 

and achieving systems and they are always available when relating issues are handled. 

The activities of records management and archive are described in details in Guides 

HAE 3.5 and guidance for document management is presented in Guides STUK 4.7, 

STUK 4.9, STUK 4.10 and STUK 4.12. 

In addition STUK has internal guidance (Guide YTV 6.1) for inspectors that the preparer 

examines the documents submitted and clarifies the background to the case using 

SAHA (document management system) for example. 


Question 



3;para 5.15-17 

Describe the extent of arrangements in place that 

ensure all the products of regulatory activities and 

processes are verified in accordance with specified 

requirements. 

SQID 18.3 

STUK has well defined processes for documents submitted by authorized organizations 

(Guides STUK 4.7, STUK 4.9, STUK 4.10, STUK 4.12, SKV 3.4, SKV 11.1, YTV 6.1 and YTV 

6.5). All these guides include also verification. In most regulatory decisions at least two 

people are connected to the work. For inspections at nuclear facilities STUK uses 

electronic inspection protocol system (TARKKA) which also required verification. 

In addition STUK monitors, measures and evaluates its activities by many means ( for 

example Guides STUK 6.1 , STUK 6.3 and STUK 6.5 ) 

QID SQID QTYPE References True Subsidiary Question Next



3;para 5.18 

How is it ensured that products do not bypass the 

required verification activities? 

Question 

SQID 18.4 

STUK’s decisions are usually signed by two staff member, presenting officer and 

decision maker. This ensures that products of regulatory processes are not bypassing 

verification activities. 

In addition the products of regulatory activities (review and assessment reports, 

inspection and audit reports) are followed by management surveys (Guide STUK 6.4). 


Question 



3;para 5.19 

What are the arrangements in place to ensure the 

identification of the products for their proper use and 

ensure their traceability? 

SQID 18.5 

STUK’s Management System includes clear guidance to ensure the traceability of 

products (Guide STUK 4.7). The proper use in STUK is also included in the same Guide. 


Question 



3;para 5.20 

What are the arrangements in place to ensure prevent 

loss, deterioration or inadvertent use of products? 

PQ 19 

STUK’s Management System includes clear guidance to ensure prevent of loss, 

deterioration and inadvertent use of products (Guide STUK 4.7). In addition STUK’s 

document management System SAHA has procedures for user management and IT unit 

is responsible for taking back-ups of all data in STUK’s systems. 


19 Primary Safety Standards Has the regulatory body ensured that records are Yes No B 


3;para 5.21 

specified in the process documentation and that they 

are controlled? 

X 






Question 

19 19.1 Text Safety Standards What are the arrangements to ensure that all records SQID 19.2


3;para 5.21 

are readable, complete, identifiable and easily 

retrievable? 

Arrangements to ensure that all records are readable, complete, identifiable and easily 

retrievable are described in Guide TI 5.2 (Back-ups and restoration of the back-up 

data). This Guide includes guidance for back-up activities, back-up storages, curing 

period and restoration. 

STUK has also established recovery plans for major IT-incidents. 


Question 



3;para 5.22 

How are retention times of records established to be 

consistent with statutory requirements and 

knowledge management obligations of the regulatory 

body? 

SQID 19.3 

Guide STUK 4.7 Handling and filing of the documents describes procedures for 

documents archived, the principles for archiving are described in STUK’s Document 

Management Plan (THS): 

which documents shall be archived in STUK’s end archive 

which documents shall be archived in department’s archive 

what are the retention times in different document categories 

Documents which don’t have any special value as describing document on STUK’s 

activities or administration are not archived. 


Question 



3;para 5.22 

Is media used for records suitable to ensure that the 

records are readable for the duration of the retention 

times specified for each record? 

PQ 20 

Basic requirements for media used for archiving are given in Act on Archives 

(831/1994). 

Detailed guidance for suitable media is given in the Guide STUK 4.7. Only media 

suitable for archiving shall be used for Documents which are archived for a long time or 

constantly. Documents which are essential for STUK’s activities shall be archived in 

archives which complies special security requirements. 


Question 



3;para 5.14 

Describe any measures planned to establish a process 

for the control of records. 

PQ 20





3;para 5.23 

Does the regulatory body ensure that its suppliers of 

products are selected on the basis of specified criteria 

and that their performance is evaluated? 

Yes No B 

X 





Question 



3;para 5.24 

How are purchasing requirements developed and 

specified in procurement documents? 

SQID 20.2 

Requirements are specified in the document STUK 4.4 Purchasing, whish is based on 

the Act for Public Contracts (348/2007) and related EU directives. Specific guidance for 

using technical support organizations are given in Guide YTV 8.1 and Guide 8.5 gives 

guidance on auditing TSOs. 


Question 



3;para 5.24 

How is it ensured that evidence that products meet 

the requirements is available to the Regulatory Body 

before the products are used? 

SQID 20.3 

Act for Public Contracts and related Guide STUK 4.4 gives detailed specifications of the 

product in the invitation for and assessing of tenders. Detailed requirements are also 

given in JYSE (Term of agreement for public contracts) which are mandatory in all 

public procurement. 


Question 



3;para 5.25 

Are the requirements for reporting and resolution of 

non-conformances specified in the procurement 

documents? 

PQ 21 

See SQID 20.2. 

QID SQID QTYPE References False Subsidiary Question Next



3;para 5.23 

Describe any measures planned to establish a process 

and the criteria necessary for selecting and evaluating 

the suppliers of products. 

Question 

PQ 21 



21 Primary Safety Standards Is information relevant to safety, health, 

Yes No B 


3;para 5.26 

environmental, security, quality and economic related 

goals communicated to individuals in the Regulatory 

Body and, where necessary to other stakeholders? X 






Question 

21 21.1 Text Safety Standards How is information relevant to safety, health, 

SQID 21.2 


3;para 5.26 

environmental, security, quality and economic related 

goals communicated to individuals in the Regulatory 

Body and, where necessary to other stakeholders? 

Goals are described in the document STUK 1.1 Quality policy 

Radiation and Nuclear Safety Authority (STUK) is a regulatory authority, research 

institution and expert organisation, whose mission is to prevent and restrict any 

harmful effects of radiation. 

The ultimate quality objective of operations is to keep the radiation exposure of the 

Finnish citizens as low as reasonably achievable (ALARA principle) and to prevent 

radiation and nuclear accidents with a very high certainty (Safety As High As 

Reasonably Achievable or the SAHARA principle). The key indicators of the quality are 

also the confidence of the general public in STUK’s ability to perform the task it has 

been entrusted with, and the radiation and nuclear energy users’ views on the 

significance of STUK’s operations in enhancing safety. 

The basis for high-quality operations is the Quality System, which is sustained by 

manuals guiding these operations. High quality is achieved through the professional 

competence of the personnel, high working motivation and service orientation. 

STUK’s management commits itself, in the course of its own work, to complying with 

the Quality System it has endorsed and to improving the quality of operations. From the 

personnel the management expects work results of high quality and the bringing 

forward of any quality problems that have been acknowledged during everyday work. 

STUK makes information available for interested parties and stakeholders at STUK’s 

website. 


Question 

21 21.2 Text Safety Standards Describe the formal and informal communication PQ 22


3;para 5.27 

mechanisms concerning implementation and 

effectiveness of the management system between the 

various levels and functions of the regulatory body. 

STUK uses both formal and informal communication concerning implementations and 

effectiveness on the Management System. All reports relating Management System are 

available for staff in SAHA and most on STUK’s intranet (SANTRA) as well. Also all 

registers are open for staff. 

STUK’s annual report includes a chapter on management system and improvement 

actions and information on safety related improvements on Management System is 

given in Regulatory Oversight on Nuclear Safety in Finland –report which is also 

published annually. 

STUK director general reports regularly on latest improvements and findings on 

Management System in his informative meetings for staff. 


Question 



3;para 5.26 

Describe any measures planned to ensure adequate 

communication arrangements relating to the 

implementation and effectiveness of the management 

system. 

PQ 22 





3;para 5.28 

Does the regulatory body have in place a process for 

the management of its organisational changes? 

Yes No B 

X 





Question 



3;para 5.28 

Describe arrangements in place that ensure 

organisational changes are properly evaluated, 

classified according to their importance and justified. 

PQ 23 


Question 

22 22.2 Text Safety Standards Describe any plans to establish adequate PQ 23


3;para 5.28 

arrangements for the management of organisational 

change. 

At the moment STUK’s Management System does not include process for managing 

organizational change. STUK has already decided to complete it according to GS-R-3 

requirements. However, department of nuclear reactor regulation carried out an 

organizational change in the beginning on the year 2008 and that change was evaluated 

before to it was realized and it was also assessed afterwards . 




3;para 6.1 

Does the regulatory body monitor and measure the 

effectiveness of its management system to confirm the 

ability of the processes to achieve the intended results 

and to identify opportunities for improvement? 

Yes No B 

x 





Question 



3;para 6.1 

Describe the arrangements for monitoring and 

measuring the effectiveness of the management 

system of the regulatory body to confirm the ability of 

the processes to achieve the intended results and to 

identify opportunities for improvement. 

PQ 24 

STUK monitors and measures the effectiveness of its Management System by various 

means Opportunities for improvement for STUK’s Management System and activities 

are systematically identified by means of 

self-assessments of quality and internal surveys related to them 

stakeholder feedback 

customer satisfaction surveys 

annual result discussions 

internal audits 

external or internal benchmarking. 

Once the opportunities for development have been identified, corrective measures are 

taken to improve the quality of the operations. 

The measures taken are described in the following guides: 

STUK 6.1 Internal auditing 

STUK 6.2 Risk management 

STUK 6.3 Quality self assessment 

STUK 6.4 Management Reviews 

STUK 6.5. Customer and stakeholder feedback 

Internal audits are regarded as an essential part of assessment and improvement of the 

Management System. STUK’s Quality Manager prepares annual programme for internal 

audits with the Quality group, departments and units can make their own suggestions 

on the activities and functions that should be included to the programme. Quality

manager is also responsible for the execution of the programme. 

All departments shall carry out self-assessments on annual basis. The criteria such as 

EFQM and CAF (Common Assessment Framework) and the focus (full-scope or single 

process or function) of self-assessment is decided in STUK’s board of Directors. 

Management reviews are carried out regularly. The top management assesses the 

effectiveness and functionality of STUK’s management system in a review performed 

annually. The department management assesses the effectiveness and functionality of 

the department’s management system in a review performed annually. And a review 

comparable to the departmental management review is also arranged for 

Administration and ICT Administration and units reporting to the Director General. In 

reviews ISO9000 series requirements for management system review are used as a 

basis. 

STUK collects feedback from interested parties in many means: 

To investigate the satisfaction of customers and interested parties with STUK's 

operations 

To investigate the demands, needs and expectations of customers and interested 

parties 

To gather views in order to improve operations 

To focus the interest of staff on customers and interested parties 

To communicate to customers and interested parties that their views and opinions 

are appreciated. 

Non-conformances, recommendations and suggestions detected in any of assessment 

activities are registered and corrective actions are followed up by managers. 


Question 

23 23.2 Text Safety Standards Describe any measures planned by the regulatory PQ 24 


3;para 6.1 

body to establish arrangements for monitoring and 

measuring the effectiveness of its management 

system. 





3;para 6.2 

Does senior management and management at all 

other levels in the regulatory body carry out selfassessment 

to evaluate the performance of work and 

the improvement of the safety culture? 

Yes No B 

x 





Question 



Prior to this IAEA methodology for self-assessment, 

how has senior management and management at all 

SQID 24.2

3;para 6.2 

other levels in the regulatory body carried out selfassessment 

to evaluate the performance of work and 

the improvement of the safety culture? 

Continuous improvement is a fundamental principle in all STUK’s activities (Guide 

STUK 1.2). One of the means used for seeking opportunities for improvement is selfassessment, 

which must be carries out in all organizational levels. Procedures, 

responsibilities and objectives for self-assessments in STUK are described in the Guide 

STUK 6.3. The objectives for self assessments are as follows: 

• To analyse the operations of STUK and its various units 

• To identify the strengths and weaknesses of the operations of STUK and its various 

units 

• To compare STUK against the best corresponding organisations and their success 

factors 

• To identify areas for development in STUK and its various units 

• To increase awareness of the importance of quality in operations. 

In addition the STUK’s senior management holds an annual seminar which includes the 

senior managements’ self-assessments. 

Despite of the broad scope of self assessments in STUK safety culture has not been 

included in these assessments in a systematic way in the past. The department for 

Nuclear Reactor Regulation (YTO) carried out safety culture self assessment in 1999- 

2000 and some actions to improve systematic approach to safety culture were taken on 

the basis of the results. YTO has also participated twice to national survey on safety 

culture and safety management in organizations on nuclear field (SAFEX). 


Question 



3;para 6.2 

What guidelines are used by the managers in the 

performance of self-assessments and what is the 

frequency of the self-assessments performed? 

PQ 25 

STUK has internal guidance on self assessments (Guide STUK 6.3). It states that SFS- 

ISO-standards and the excellence model (EFQM) have been taken into account in all self 

assessments, however the internal guidance allows also other references to be used. 

Self assessments are carried out annually in all organizational levels 


Question 



3;para 6.2 

Describe any plans to establish arrangements for 

managers at all levels to perform self-assessments. 

PQ 25 

. 


25 Primary Safety Standards Does the regulatory body have arrangements for Yes No B


3;para 6.3 

independent assessments to be conducted regularly? 

x 






Question 



3;para 6.3 

Describe any independent assessments conducted to 

evaluate the effectiveness of processes in meeting and 

fulfilling the goals, strategies, plans and objectives of 

the regulatory body. 

SQID 25.2 

As described in STUK’s Management System independent assessments are carried out 

regularly. Several international peer reviews have been carried out, such as: 

The IRRT-mission in 2000 and the follow-up mission in 2003 

International evaluation of the research activities of the Finnish Radiation and 

Nuclear Safety Authority in 2000, 2006 and 2011 

Ippas-mission (security in the use of nuclear energy and radiation) in 2009, and its 

follow-up mission in 2012 

EU-27 Regulators Peer Review: Effectiveness of STUK’s Regulatory Infrastructure 

for Waste Safety in 2009 

In addition core activities and related processes and procedures have been evaluated 

by KPMG. 


Question 



3;para 6.3 


determine the adequacy of work performance and 

leadership within the regulatory body. 

SQID 25.3 

As a part of continuous improvement of STUK’s activities Director STUK’s top 

management called KPMG to carry out independent assessment on processes and 

procedures in emergency preparedness, nuclear reactor regulation and radiation 

sources regulation. The aim for this was to assess the effectiveness of these procedures 

as well the effectiveness of interval auditing. 

The scope of these assessments were: 

how processes and procedures were organized 

external and internal guidance 

documentation 

risk management 

planning, monitoring and reporting 

Recommendations and suggestions made by auditors were taken into account in 

further development on Management System and processes.


Question 



3;para 6.3 


evaluate the safety culture of the regulatory body. 

SQID 25.4 

The department for Nuclear Reactor Regulation (YTO) carried out safety culture self 

assessment in 1999-2000 and some actions to improve systematic approach to safety 

culture were taken on the basis of the results. 

YTO has also participated twice to national survey on safety culture and safety 

management in organizations on nuclear field (SAFEX). 


Question 



3;para 6.3 


identify opportunities for improvement in the 

regulatory body's facilities, resources, functions and 

activities. 

SQID 25.5 

Identification of opportunities for improving STUK’s facilities, resources, functions and 

activities have included in all international peer reviews. See 25.1 


Question 



3;para 6.4 

Is an organisational unit within the regulatory body 

responsible for conducting independent assessments? 

If so, describe how it is ensured that the unit has 

sufficient authority for discharging its responsibilities. 

SQID 25.6 

STUK has nominated a Quality Manager reporting to directly to the Director General. 

Director General is responsible on organizing internal auditing. The Quality Manager is 

responsible for the efficient organising of internal audits. 

All departments nominate their representatives to assessment expert pool. These 

experts are trained to carry out internal audits and some on them have LeadAuditor 

qualification as well.. 


Question 



3;para 6.5 

Has it been ensured that individuals conducting 

independent assessments do not assess their own 

work? 

SQID 25.7 

When nominating audit groups for individual audit it is taking care that auditors are 

independent and that none is assessing their own work nor processes on their own 

responsibility (Guide STUK 6.1)


Question 



3;para 6.6 

Describe how senior management evaluates the 

results of independent assessments, takes any 

necessary actions, and records and communicates 

their decisions and reasons. 

PQ 26 

The results of independent assessments are reported without any unnecessary delay 

after each assessment and the results are evaluated by managers and directors 

responsible for activity assesses. Depending on findings the actions needed are decided 

either immediately or they might be included in special action plan. The results are also 

discussed in the management reviews. 


Question 



3;para 6.3 

Describe any measures planned to establish 

arrangements for independent assessments of 

regulatory body facilities, resources, functions and 

activities to be conducted regularly. 

PQ 26 





3;para 6.7 

Are management system reviews conducted at 

planned intervals to ensure the continuing suitability 

and effectiveness of the management system and its 

ability to enable the accomplishment of the objectives 

of the regulatory body? 

Yes No B 

x 






Question 



3;para 6.7 

What is the scope and frequency of the management 

system reviews? 

SQID 26.2 

According to Guide STUK 6.4 management system review are carried out annually. 

Some department have decided to perform it twice a year. 

The scope of review depends on the level. At STUK level following issues are reviewed: 

results of activities (incl. audits) 

feedback from interested parties

process performance and product conformity 

status of preventive and corrective actions 

follow-up actions from previous management reviews 

changes that could affect the Management System 

recommendations for improvement 

At the departmental and unit level the scope is broader and the list of issues that shall 

be included the review is more detailed. 

Detailed instructions are given in the Appendix 1 of the Guide STUK 6.4. 


Question 



3;para 6.7 

How do the management system reviews make use of 

outputs from all forms of assessment? 

SQID 26.3 

Outputs from all forms of assessment are taken into account in management system 

review. The results of self assessments and independent assessments as well as 

internal and stakeholders feedback and reports of relevant organizational unit are 

discussed during the review. (Guide STUK 6.4.). 


Question 



3;para 6.7 

How do the management system reviews cover and 

address the results delivered and objectives achieved 

by the regulatory body and its processes? 

SQID 26.4 

As indicated above the reports of relevant organization unit are discussed during the 

review. 


Question 



3;para 6.7 

How do the management system reviews cover and 

address the non-conformances identified and the 

corrective and preventing actions taken to solve them? 

SQID 26.5 

According to Guide STUK 6.4 non conformances, corrective and preventive actions shall 

be discussed in management system review in all units. 

Minor corrective actions which are decided by a director or head of the unit, are made 

as soon as possible. For significant actions a responsible person or a working group is 

nominated and schedule is fixed or a special project is established. (Guide STUK 6.4) 


Question 

26 26.5 Text Safety Standards How do the management system reviews take account SQID 26.6


3;para 6.7 

of lessons learned from other organisations? 

According to STUK’s Quality Policy STUK continuously develops its activities, giving 

particular emphasis to effectiveness and efficiency. As a part of this STUK also is 

actively seeking opportunities to learn from other organizations. Though Management 

System does not include a fixed procedure for benchmarking and for learning from 

others, whenever good practices of other organizations have been recognized, they are 

implemented also in STUK. 


Question 



3;para 6.7 

How do the management system reviews address the 

opportunities for improvement? 

SQID 26.7 

The identification of opportunities for improvement is elementary part of In the end of 

each review an evaluation of management system and the necessary improvements are 

discussed and recorded in the review report. 


Question 



3;para 6.7 

How do the management system reviews identify 

weaknesses and obstacles and thereafter evaluate 

these obstacles in order to remedy the weaknesses in 

a timely manner? 

SQID 26.8 

Weaknesses and obstacles are identified in management system review but also by 

independent assessments and risk analysis. The decisions for actions needed for 

remedy are made by case-by-case. 


Question 



3;para 6.7 

How do the management system reviews identify 

whether there is a need to make changes to or 

improvements in policies, goals, strategies, plans, 

objectives and the processes? 

PQ 27 

Need to make changes to or improvements in policies, goals, strategies, plans, 

objectives and the processes is always discussed in management review. And the 

reports of management reviews are used as input for annual and strategic planning. 


Question 

26 26.9 Text Safety Standards Describe any measures planned for performing PQ 27


3;para 6.7 

management system reviews to ensure the continuing 

suitability and effectiveness of the management 

system and its ability to enable the accomplishment of 

the objectives of the regulatory body. 





3;para 6.11 

Does the regulatory body have arrangements for the 

management of non-conformances within its 


Yes No B 

x 






Question 



3;para 6.11 

Describe how non-conformances are defined in 

relation to the activities and processes of the 

regulatory body and the arrangements in place to 

identify non-conformances, determine their causes 

and take remedial actions to prevent their recurrence. 

SQID 27.2 

STUK emphasizes that non-conformances shall be indentified as early as possible. 

Procedures for identification and handling of non-conformances are described in 

Guides STUK 6.1, 6.3, 6.4, 6.5. All employees are encouraged to bring up nonconformances 

and opportunities for improvement. 

Depending on the matter corrective and preventive actions shall be defined either 

immediately or latest at management system review. 

In addition Guide STUK 1.2 refers to work satisfactory inquiries and external 

assessments. Staff can bring up non-conformances also in these surveys. 

STUK has established a register for feedback and non-conformances in intranet. All 

audit and assessment findings, non-conformances, ideas for improvement, feed-back 

from interested parties and initiatives made by staff members are recorded in the 

register. Also all actions taken are documented in the system. 


Question 



3;para 6.12 

How are processes and products that do not conform 

to specified requirements identified, segregated, 

controlled, recorded and reported at an appropriate 

level of management within the regulatory body? 

SQID 27.3 

Guide STUK 6.5 describes the ways STUK processes gathered information. Corrective

actions are defined based on the severity of the non-conformances. The responsibilities 

for corrective actions are defined in the same guide. 

The procedures for corrective and preventive actions are described in the Guide STUK 

6.4. It describes how and in which depth findings are dealt with in the organization. 

See also SQID 27.1. 


Question 



3;para 6.12-14 

How are corrective actions for eliminating nonconformances 

in regulatory activities or processes 

determined and implemented? 

SQID 27.4 

Guide STUK 6.3 outlines the procedure how areas for improvement are identified in 

self-assessments. Measures for improvement based on the results of the selfassessments 

are scheduled and responsible parties are defined. 

Guide STUK 6.1 describes how the findings and results of internal audits are reported, 

dealt with and followed through. 

See also SQID 27.1. 


Question 



3;para 6.14 

Describe preventive actions taken to eliminate the 

causes of potential non-conformances in regulatory 

activities or processes. 

SQID 27.5 

STUK addresses high quality of work and decisions. A prerequisite for this is competent 

staff with good knowledge on regulatory processes and procedures i.e. clear guidance 

how to carry out the work. According to Management System processes, procedures 

and internal guidance shall be assessed regularly and as a part of this assessment also 

potential non-conformances should be identified. 

In addition Guide STUK 6.5 describes how customers or other stakeholders can 

respond to STUK’s decisions or give feedback on STUK’s actions, products or nonconformances. 

All feed-back shall be documented and any corrective or preventive 

actions needed shall be attached. 

See also SQID 27.1 


Question 



3;para 6.15 

Describe arrangements for monitoring and reporting 

the status and effectiveness of all corrective and 

preventive actions to the management at an 

appropriate level in the organisation. 

SQID 27.6

Arrangements and guidance for monitoring and reporting status and effectiveness are 

presented in STUK’s intranet (Follow-up registers - Seurantarekisterit). Also Guides 

STUK 6.5 and STUK 6.4 give detailed guidance. 


Question 



3;para 6.16 

Describe arrangements in place to identify any 

potential non-conformances that could detract from 

the organization's performance. 

PQ 28 

Potential non-conformances shall be discussed in self-assessments and in management 

reviews 


Question 



3;para 6.11 

Describe any measures planned to establish 

arrangements for the management of nonconformances 

within the management system of the 


PQ 28 




3;para 6.17 

Does the regulatory body have arrangements in place 

for the improvement of its management system? 

Yes No B 

X 






Question 



3;para 6.17 

Describe how opportunities for improvement of the 

management system are identified and how actions to 

improve the processes are selected, planned and 

recorded. 

SQID 28.2 

STUK seeks actively opportunities for improving quality and effectiveness of its 

activities. The principle of continuous improvement is included in STUK’s Quality 

Policy: STUK continuously develops its activities, giving particular emphasis to 

effectiveness and efficiency. Activities focus on matters essential for radiation and 

nuclear safety. 

The quality of STUK activities is evaluated by self-assessments and external

assessments. The functionality of processes is ensured by internal audits. External 

assessments provide an independent view of, and a reference point for, operations. 

Activities and their results are systematically measured. An important criterion of 

quality is how the users of radiation and nuclear energy see the activities STUK takes to 

promote safety; and so is society’s trust in STUK’s ability to attend to the task entrusted 

to it. 

All directors are responsible for the work conducted under their domain in accordance 

with target plans agreed upon with the director general. Quality manuals determine 

decision-making responsibilities at the various organisational levels. 

Underlined in the management process is an active interaction between the 

management and personnel as well as every employee’s right and responsibility to 

actively develop his/hers own task. The personnel are adequately informed 

According to STUK’s Management System opportunities for improvement shall be 

identified in all assessments of Management System, in management reviews and staff 

members are encouraged to bring up their ideas. After all assessments the results are 

discussed and necessary actions are decided. A responsible person is nominated or a 

working group is established and a schedule is fixed. The actions are recorded on the 

follow-up database (Guide STUK 6.1). Also the internal and external feedback and as 

well as internal initiatives are recorded in the same database (STUK 6.5). 


Question 



3;para 6.18 

Describe the extent of arrangements to ensure that 

improvement plans are supported by the provision of 

adequate resources. 

SQID 28.3 

The major improvements and the necessary personal and financial resources are 

included in annual plans. Minor improvement which requires only limited resources 

can be done without delay. The basis for this is in Guide STUK 2.3: 

The management by results system also includes control of activities, assessment of the 

results achieved and systematic development of activities. Management by results links 

activities to time, the available resources and the agreed results objectives. 

Further the result agreement also presents the key development plans for the unit in 

question. For example, these can include projects launched to increase the effectiveness 

of activities or improve quality. The projects are presented so that their realisation can 

be verified. Another key issue when preparing the result agreement is planning of 

human resources 


Question 



3;para 6.18 

How are the actions for improvement monitored 

through to their completion and what are the 

arrangements for checking the effectiveness of the 

improvement? 

n/a

The progress of improvements is recorded in the database and it is discussed during 

the management reviews. Minor progress of minor improvements can also be checked 

in annual discussions between managers and their staff. 

The effectiveness of improvement is assessed also in management reviews but there is 

no systematic approach to check the effectiveness of them. 


Question 



3;para 6.18 

Describe any measures planned by the regulatory 

body to ensure its management system is 

continuously improved. 

n/a 

Enter notes or comments here

Core Questions (GSR Part 1 and GS-R-3) Primary Module ... - STUK

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