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Requirements for a Quality
Assurance Programmes at Objects
of Atomic Energy Use
(NP-090-11)
Alexander Smetnik, FSUE VO «Safety»
smetnik@vosafety.ru
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
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• 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
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
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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
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»
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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»
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
10
GOST 12.0.230-2007 «Occupational safety standards
system. Occupational safety and
health management systems.
General requirements»
GOST 12.0.230-2007 is
identical with the standard of
International Labour Organization
ILO-OSH 2001. «Guidelines on
occupational safety and health
management systems»
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
11
GOST R 54934-2012 «Occupational health and safety
management systems.
Requirements»
GOST R 54934-2012 is
identical with the standard of
Occupational Health & Safety
Advisory Services OHSAS
18001:2007 «Occupational health
and safety management systems -
Requirements»
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
12
source: https://ru.wikipedia.org/wiki/Спрингфилд_(Симпсоны)
ISO 9001
ISO 14001
OHSAS 18001
OTHERS
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
Organizations implement different management systems
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GOST R 55269-2012
«Organization
management systems.
Recommendations for
building the
integrated management
systems»
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
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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.
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
15
GOST R 55269-2012
In practice organizations mostly implement
different management systems step by
step.
In most cases quality management system
implemented first.
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
16
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.
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
17
source: https://ru.wikipedia.org/wiki/Спрингфилд_(Симпсоны)
ISO 14001
OHSAS 18001
ISO 9001
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
Integrated approach
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JSC «PA Electrochemical Plant»
NATIONAL STANDARDS ON MANAGEMENT
SYSTEMS IN RUSSIAN FEDERATION
an example
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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
21
ROSTECHNADZOR STANDARD
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))
General safety requirements
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ROSTECHNADZOR STANDARD
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))
General safety requirements
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ROSTECHNADZOR STANDARD
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))
24
ROSTECHNADZOR STANDARD
«REQUIREMENTS TO THE QUALITY
ASSURANCE PROGRAMS FOR NUCLEAR
FACILITIES»
NP-090-11
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ROSTECHNADZOR STANDARD
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»;
NP-042-02 «Requirements to the quality assurance program for
research nuclear facilities»;
NP-056-04 «Requirements to the quality assurance program for
marine nuclear power units».
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ROSTECHNADZOR STANDARD
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.
27
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.
ROSTECHNADZOR STANDARD
28
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
ROSTECHNADZOR STANDARD
29
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).
ROSTECHNADZOR STANDARD
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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.
ROSTECHNADZOR STANDARD
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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.
ROSTECHNADZOR STANDARD
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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);
ROSTECHNADZOR STANDARD
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Differences between GS-R-3, ISO 9001:2008
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);
ROSTECHNADZOR STANDARD
34
Differences between GS-R-3, ISO 9001:2008
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);
ROSTECHNADZOR STANDARD
35
Differences between GS-R-3, ISO 9001:2008
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);
ROSTECHNADZOR STANDARD
36
Differences between GS-R-3, ISO 9001:2008
and NP-090-11:
Main document
Description of the management system (GS-R-3);
Quality manual (ISO 9001);
Quality assurance program (NP-090-11);
ROSTECHNADZOR STANDARD
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