Quality Management System as a part of

Integrated Management System

IAEA, TECHNICAL MEETING

Vienna, December 2014

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IMS implemented and maintained in SE, a.s. meets the requirements of Slovak and EU legislation (Atomic Act), international standards of IAEA and ISO using best practice of different industries and brings useful and effective methods for monitoring company performance and information needed for effective decision making and management.

Integration of management systems on the basis of the QMS in sectors like energy, automotive, aviation is becoming a standard as evidenced by the high rate of implementation among our suppliers and partners.

QMS offers practical tools for management of the company - management review, process approach - clear definition of responsibilities and authorities, internal and suppliers audits, customers satisfaction, etc.

Integrated Management System Executive summary

NR SR Law No. 541/2004 Coll. „Atomic Law“: Part 6, Section 25 Quality Management System: (1) An applicant for permission ... is required to develop, document, introduce, maintain

and review a quality management system, comply with the quality management system documentation, as well as to improve its effectiveness ... ...

(5) Applicant for a authorization and authorization holder is required to ensure financial,

technical and human resources to develop and maintain the quality management system, while these resources must be in accordance with the resources for securing nuclear safety.

(6) The Authority shall issue a generally binding legal regulation stipulating the details of requirements regarding QMS ...

ÚJD SR Decree No. 431/2011 Coll. about quality management system: Text of decree including: Annex No.1 „Quality management system requirements“ Annex No.2 „Requirements for QMS documentation“ Annex No.3 „Scope of approved QMS documentation“ Annex No.4 „Requirements for nuclear facility QA programs“ Annex No.5 „Requirements for quality plans of classified equipment“

Integrated Management System National Legal Requirements

IAEA Recommendation: Safety requirements No. GS-R-3 „The Management System for Facilities and Activities“ Safety guide No. GS-G-3.1 „Application of the Management System for Facilities and Activities“ Safety guide No. GS-G-3.5 „The Management System for Nuclear Installations“

ISO a OHSAS standards:

ISO 9001:2008

ISO 14001:2005

OHSAS 18001:2009

Integrated Management System International Requirements and Standards

License Conditions (Atomic Law

No. 541/2004 Coll.)

LC – Management Systems (Decree

No. 431/2011 Coll.)

LC – Documents, records, authorities and certificates

(D. 431/2011 – Annexes No.2-4) LC – Operational documents

and records (D. 431/2011 – Annex No. 8)

IAEA GS-R-3

GS-G-3.1

Governance (Integration

& Reporting)

Management System Manuals (SE/PISM-100 IMS Manual

NPP Reference/Stage Quality Assurance Programs)

Quality Assurance Program

Documents and Records

Management

Independent

Assessment

(NOS & IMS

Audits –

int./ext.)

Quality Department Manual (SE/PU-70200)

REG

ULA

TO

RY

AU

TH

OR

ITY

A

PP

RO

VA

L

MS

Certificates

ISO 9001

ISO 14001

OHSAS 18001

Integrated Management System License Conditions

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Integrated Management System Definition

Management System

A set of interrelated and/or interacting elements (system) for establishing policies and

objectives and enabling the objectives to be achieved in an efficient and effective way.

(According to IAEA GS-R-3 – The Management System for Facilities and Activities)

One Management System, which ensures the achievement of company goals.

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Standards for management systems (ISO 9001, ISO 14001, OHSAS 18001,

IAEA GS-R-3, ISO 10006, ISO 10007) contain:

Common systematic (generic) requirements for:

Management commitment – policy, goals, management representative

Management review

Documentation and records management,

Non-conformities control, corrective and preventive actions,

Audits,

Staff training, ...

+ Specific requirements of quality management system

( e.g Process approach, Continuous improvement, Customer satisfaction...)

Integrated Management System Integration of standards requirements

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Integrated Management System Quality as the lowest common denominator

Accepting the managerial and

technical requirements, there is also

the set of social and subjective

characteristics and approaches

within the organization designated as

the company culture. Special

meaning has the strong safety

culture described in WANO GL

2006-02.

ISO 9001:2008

IAE

A G

S-R

-3

WANO GL 2006-02

ISO 31001:2009

AND

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Integrated Management System Where standards fulfillment meets stakeholders requirements

Best practice

Costs control

Effectiveness

Efficiency

Certification

of plants and HQ

Compliance with

the Regulatory

Bodies

Requirements

Commitment

to our own

employees

Commitment

on the outside

International

acceptance

High

Level of

Nuclear

Safety

Best practice

Costs control

Effectiveness

Efficiency

Certification

of plants and HQ

Compliance with

the Regulatory

Bodies

Requirements

Commitment

to our own

employees

Commitment

on the outside

International

acceptance

High

Level of

Nuclear

SafetyCertification

of plants and HQ

Compliance with

the Regulatory

Bodies

Requirements

Commitment

to our own

employees

Commitment

on the outside

International

acceptance

High

Level of

Nuclear

Safety

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Commitment of top management for...

continuous improvement

compliance with other requirements

(supervisory bodies, ...)

compliance with legal requirements

(legislation)

Integrated Management System Company policy

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Integrated Management System Main Goals and KPIs

Monitoring and measuring of company performance and effectiveness through the

definition of Main goals and process KPIs as follows:

Benefits for internal and external use:

- Objective tracking and evaluation of

company trim

- Possible comparison with other energetic

companies via benchmark

- Effectiveness of company processes,

review of costs

- Monitoring of tasks and goals fulfillment

Identification

of opportunities for improvement

Back

Integrated Management System Management review

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Contains useful information necessary for decision making and control e.g.: - Customer feedback, - Process performance, - Product conformity, - Status of corrective and

preventive actions, - Changes affecting

company, - Recommendations for

improvement, - Follow-up actions

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Internal audits:

Combined audits of relevant management systems – according to requirements of relevant standard ISO 9001:2008, ISO 14001:2004 a OHSAS 18001:2007, respectively SE, a.s. IMS internal documentation,

40 internal audits performed in 2013 with more than 500 findings.

External audits:

Audit of SE, a.s. suppliers’ quality management systems – according to requirements of ISO 9001:2008 and Atomic Act,

39 suppliers audits performed in 2013.

Third party (independent) audits:

Certification and Supervisory audits,

Regulatory bodies inspections

Customers evaluation,

Peer reviews and missions (WANO, OSART), ...

Integrated Management System Adequacy and compliance audits

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Integrated Management System Process-Structure-Document

To have in mutual compliance the setting of processes, valid organizational structure (including the responsibilities and competencies decomposition) and approved documentation.

Processes

Organizational Structure

Documentation

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INPUTS

Fuel

SOURCES

Staff Facilities

OUTPUTS

Power

energy, heat

Ancillary

services

IMS Documentation

LIMITS

Customer requirements

Integrated Management System Process approach in SE, a.s.

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Procedure of management, performance, evaluation and improvement

of processes according to the scheme:

Plan Determine the objectives and processes necessary for the delivery of results in compliance with customer’s requirements and organisation’s policies.

Do Implement (carry out) the processes.

Check Monitor and measure the processes and product, compare them with the policies, objectives and requirements for the product and report the results.

Act Carry out the activities for the continuous improvement of process performance.

Integrated Management System Deming’s PDCA cycle of improvement

CONTINUOUS

IMPROVEMENT

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The main goal of business success is to keep a customer.

Process approach is based on customer orientation with the aim to achieve the satisfaction of external and internal customers.

External and internal customers have to be exactly defined so that the quality criteria of products can be established and consequently the customer satisfaction recognized.

Evaluation of customer satisfaction (both internal and external) is one of the sources for company efficiency measurement and significant input within IMS continuous improvement.

Integrated Management System Customer satisfaction

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To realize each repeated type of work, activity and process, in the same way and same

quality, it is necessary to describe it and to notify (familiarize).

STANDARDIZATION AND CONTINUOUS IMPROVEMENT

The managers (direct superiors) are:

responsible for familiarization with IMS documentation,

obliged to keep records about familiarization.

Note:

Cross-sectional documentation – all employees have to be familiarized

Documentation necessary for performance of functions’ activities – direct superior of employee is obliged to specify these documents

Other documents related to functions’ activities – according to direct superior decision

Integrated Management System Documentation - Requirements

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Integrated Management System Documentation - Pyramid

Declarative documents important from

the top management point of view

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Integrated Management System Documentation (Working group matrix)

Type of Document Director

General DD 20000 DD 70000

DD

Managers of DG

Division

Directors

21000

22000

DP Managers Manager

70200

Manager

10400 Head of

Unit

Documents Issued from SE-HQ Level

ZPZK S O O - - - - - - -

SE ISM Manual S O O - - - - - - -

Directive S O* O - S** O* - O - -

Methodical Guide - - S*/O S*/O S**/O - S/O O O** -

Department Handbook - - - - - - S - - -

Guide - - - - - - S O - O

GD Order S O O O - - O O - -

Regulation - - - S O - O O - -

Announcement - - - S - - S O - -

Documents Issued from the Level of Plant

EPZK - - - - S O O O -

Plant ISM Manual - - - - - S O O -

Directive - - - - - S O O -

Methodical Guide - - - - - - S O O

Department Handbook - - - - - - S - -

Guide - - - - - - S O O

Plant Director Order - - - - - S O O -

Announcement - - - - - S S - -

Matrix of IMS documentation recommendation and approval:

S - Approves document S* - approves selected MNA within its process S** - approves common SM and MNA issued for NPP (EBO, EMO), KE (ENO, EVO, VE), TE (ENO, EVO) as part of Process 3. Operation O - Recommends a document O* - recommends SM in Process 3. Operation O** - recommends selected MNA

In line with Company’s Vision, Mission and Integrated Policy:

“To promote high level of safety culture, environmental protection and reliability through

the continuous improvement of SE Integrated Management System and to provide both, corporate and site management, with independent information from audits to be

strategically applied to improve performance.”

Quality Department Our Mission

2014 – New Governance & Oversight Model

Nuclear Oversight

WANO

(Peer

Review)

OSART

External

ÚJD (Inspections)

Health & Safety (Inspections)

Regulation & Enforcement

External Oversight

Internal

Oversight

Self Assesment

Audits & IMS Procedures

Health & Safety,

(Internal Control)

Internal Audit

NSAC

Line management

assessment

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Clearly Defined Responsibilities & Authorities

ONE team with clear division of responsibilities:

(NOS, IMS and Health & Safety, Environment)

Corporate (HQ): - Governance & Oversight

- Methodical Guidance

- Reporting- (external)

- Best Practice sharing

Power Plants: - Execution & Reporting (internal)

- Inspections & self assessment

- Plant Managament Support

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Improvement of IMS Audits in 2014

• Better Coordination between IMS, NOS & IA

completed

• Reduction of IMS Audits

completed

2013 Plan 2014 Plan

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• Value added to: - Governance & Oversight

- Operation

- Procurement

• Requires commitment from Operation,

and support from all divisions. 23

Questions?

Thank you for your attention.