Requirements for a Quality Assurance Programmes at Objects … · · 2014-12-31Requirements for a Quality Assurance Programmes at Objects of Atomic Energy Use ... GOST 12.0.230-2007

Requirements for a Quality

Assurance Programmes at Objects

of Atomic Energy Use

(NP-090-11)

Alexander Smetnik, FSUE VO «Safety»

[email protected]

1

Technical Meeting on Share Experiences and Lessons Learned from the

Application of Different Management System Standards in the Nuclear Industry

15-19 Dec 2014, IAEA, Vienna

mailto:[email protected]

2

• Federal State Unitary Enterprise VO

«Safety» (FSUE VO «Safety») -

Technical Support Organization of the

State Regulatory Body - Federal

environmental, industrial and nuclear

supervision service of Russia

(ROSTECHNADZOR).

INTRODUCTION

3

• MISSION of FSUE VO «Safety» -

Promotion of the safe development of

the nuclear energy system of Russia and

assurance of nuclear and radiation

safety of nuclear facilities under

construction and already built abroad

under Russian designs with the

assistance of Russian organizations in

co-ordination with and under the

direction of ROSTECHNADZOR.

INTRODUCTION

4

INTRODUCTION

MEMBERS

INTRODUCTION

The Nuclear Quality Standard

Association is a nonprofit

association jointly launched by

Areva and Bureau Veritas in

January 2011. Open to all major

nuclear utilities, nuclear

engineering and manufacturers,

NQSA promotes the application

of the NSQ-100 standard, and

sets a nuclear oriented supplier

evaluation process

6

INTRODUCTION

May 2014

BV (France) and FSUE VO «Safety» (Russia)

established a joint venture BV-SAFETY

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NATIONAL STANDARDS

ON MANAGEMENT SYSTEMS

IN RUSSIAN FEDERATION

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NATIONAL STANDARDS ON MANAGEMENT

SYSTEMS IN RUSSIAN FEDERATION

GOST ISO 9001-2011

«Quality management systems.

Requirements».

GOST ISO 9001-2011 is

identical with the standard of

International Organization for

Standardization ISO 9001:2008

«Quality management systems

- Requirements»

9

GOST R ISO 14001-2007

Environmental management

systems. Requirements with

guidance for use

GOST R ISO 14001-2007 is

identical with the international

standard ISO 14001:2004

«Environmental management

systems - Requirements with

guidance for use»



10

GOST 12.0.230-2007 «Occupational safety standards

system. Occupational safety and

health management systems.

General requirements»

GOST 12.0.230-2007 is


International Labour Organization

ILO-OSH 2001. «Guidelines on

occupational safety and health

management systems»



11

GOST R 54934-2012 «Occupational health and safety

management systems.

Requirements»

GOST R 54934-2012 is


Occupational Health & Safety

Advisory Services OHSAS

18001:2007 «Occupational health

and safety management systems -

Requirements»



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source: https://ru.wikipedia.org/wiki/Спрингфилд_(Симпсоны)

ISO 9001

ISO 14001

OHSAS 18001

OTHERS



Organizations implement different management systems

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GOST R 55269-2012

«Organization

management systems.

Recommendations for

building the

integrated management

systems»



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GOST R 55269-2012

Organizations introducing more than one

management system standard must define

common MS elements and, hence,

establish a uniform procedure for each

element.



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GOST R 55269-2012

In practice organizations mostly implement

different management systems step by

step.

In most cases quality management system

implemented first.



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GOST R 55269-2012

As a rule, the following procedures are

the most versatile and easily adaptable to

new systems:

- Document Management;

- Records management;

- Internal audits;

- Management review;

- Corrective and preventive actions.



17

source: https://ru.wikipedia.org/wiki/Спрингфилд_(Симпсоны)

ISO 14001

OHSAS 18001

ISO 9001



Integrated approach

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JSC «PA Electrochemical Plant»



an example

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ROSTECHNADZOR STANDARDS:

FEDERAL NORMS AND RULES

IN THE FIELD OF ATOMIC

ENERGY USE

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ROSTECHNADZOR STANDARD

Design and reliability of systems

(elements) important to safety,

documentation and various types of

works affecting provision of NPP

safety shall be the subject of

activities relating to quality

assurance.

(General regulations on ensuring safety

of nuclear power plants (OPB -88/97))

General safety requirements

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The operating organization of the NPP provides

development and execution of quality assurance

programs at all stages of NPP service life and to

this end elaborates the general quality assurance

program and performs supervision of the

activities by organizations executing works or

rendering services to the NPP (survey, design,

engineering, research, construction, erection

organizations, suppliers of systems and elements,

NPP equipment manufacturing plants etc).

(General regulations on ensuring safety of nuclear

power plants (OPB -88/97))


22


Organizations performing works and

rendering services for the operating

organisation of the NPP develop specific

quality assurance programs concerning

relevant types of activities within the frame

of the general quality assurance program.

(General regulations on ensuring safety of

nuclear power plants (OPB -88/97))


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QUALITY ASSURANCE - activities

planned and systematically carried out

and aimed at following the established

order in executing works on creating and

operating the NPP and achieving results

satisfying the requirements imposed on

them. (General regulations on ensuring

safety of nuclear power plants (OPB -

88/97))

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«REQUIREMENTS TO THE QUALITY

ASSURANCE PROGRAMS FOR NUCLEAR

FACILITIES»

NP-090-11

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NP-090-11

superseded in July 2013 and combined:

NP-011-99«Requirements to the quality assurance program for

nuclear power plants»;

NP-041-02 «Requirements to the quality assurance program for

nuclear fuel cycle facilities»;


research nuclear facilities»;


marine nuclear power units».

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NP-090-11

Quality assurance program (QAP) -

a document which defines the set of

organizational and technical

arrangements for safety assurance

affecting safety of a nuclear facility.

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NP-090-11

QAPs for nuclear facilities are comprised of:

1) general QAP, which applies to all the works

and services related to the safety of a nuclear

facility during all life-cycle stages;

2) specific QAPs of the organizations that carry

out activities related to the safety of a nuclear

facility at a particular life-cycle stage and (or)

when they fulfill a licensable activity in the

field of atomic energy use.


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NP-090-11 content:

I. Purpose and Scope of Application

II. General Provisions

III. Requirements to Content of Quality

Assurance Programs

IV. Requirements to Content of the Sections

of QAPs

Appendix: Terms and definitions


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NP-090-11 content:

The general QAP shall have the following content:

• Scope of application;

• Quality policy;

• Organizational activities;

• Personnel management;

• Documentation management;

• Management of procurement of equipment, components,

materials, semi-finished products, software tools and

services;

• Non-conformance management;

• Audits (inspections).


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NP-090-11 content:

The specific QAP shall have additional to general QAP

sections:

• Design (engineering) control;

• Production activity;

• Metrological support;

• Quality assurance of software tools and calculation

techniques;

• Reliability assurance.


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NP-090-11 content:

Personnel Management

The section shall contain information on the management

procedure of the personnel involved in performance and

verification of works falling under the QAP, during the

stages of selection, recruitment, training, qualification

maintaining, advanced training and admission to

unsupervised work.

A description shall be given of the procedures providing

for the following:

• forming and maintaining the organization's safety

culture.


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Differences between GS-R-3, ISO 9001:2008

and NP-090-11:

Established

Integrated management system requirements (GS-R-3);

Quality management system requirements (ISO 9001);

Quality assurance activity requirements (NP-090-11);


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and NP-090-11:

Objective

To achieve and enhance safety (GS-R-3);

To enhance customer satisfaction (ISO 9001);

Priority of safety assurance for nuclear facilities (NP-

090-11);


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and NP-090-11:

Basic principle

Management system is based on the process approach

(GS-R-3);

Quality management system is based on the process

approach (ISO 9001);

Set of requirements for the specific activity of

organization (NP-090-11);


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and NP-090-11:

Describe interactions

Organization and interested parties, suppliers (GS-R-3);

Organization and customers, suppliers (ISO 9001);

Organization and customers, suppliers, higher

organizations, supervision authorities (NP-090-11);


36


and NP-090-11:

Main document

Description of the management system (GS-R-3);

Quality manual (ISO 9001);

Quality assurance program (NP-090-11);


37

Thank you!

Documents

Requirements for a Quality Assurance Programmes at Objects … · · 2014-12-31Requirements for a Quality Assurance Programmes at Objects of Atomic Energy Use ... GOST 12.0.230-2007