Transcript Document

ALL-RUSSIAN SCIENTIFIC RESEARCH INSTITUTE FOR
PHYSICAL-TEHNICAL AND RADIOTECHNICAL MEASUREMENTS
PRESENTATION
to the COOMET QS-FORUM
of the VNIIFTRI
QUALITY MANAGEMENT SISTEM
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VNIIFTRI –
review of activities
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Introducing
VNIIFTRI
VNIIFTRI was founded on 18 February 1955 by
the Decree of the USSR Council of Ministers
No.1063-P on the base of the Central scientific research
office of unified time service, CNII of radiotechnical
measurements, and CNII of physical-technical
measurements
In VNIIFTRI operate:
Scientific Council, Dissertation Council on the
defence of Candidate of Engineering Sciences
and Doctor of Engineering Sciences theses, scientific
seminar and post–graduate studentship.
Total number of VNIIFTRI employees as of
01.05.2003 makes up 1159 workers.
VNIIFTRI is situated in the Moscow region in a place remote from strong sources
of industrial noises
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VNIIFTRI – National
Metrological Institute of Russia
The Federal State Unitary Enterprise
“All – Russian Scientific Research Institute for
Physical-Technical and Radiotechnical
Measurements” is subordinated to the
Gosstandart of Russia. It has the status of
State Research Center of Russia and is one of
the main Centers of National Standards of
Russia.
VNIIFTRI is entrusted with the function of the
Main Metrological Center of the State
Service of Time, Frequency and
Determination of the Earth rotation
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parameters.
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VNIIFTRI ASSIGNMENTS
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Measurements of time, frequency, large lengths; determination of the Earth rotation
parameters;
Temperature and thermophysical measurements in the low temperature range;
Measurements of radiotechnical and magnetic quantities;
Acoustic measurements, telephonometry and audiometry, electroacoustic measurements ;
Underwater acoustic and hydrophysical measurements;
Ultrasonic measurements;
Measurements of ionizing radiation and radioactivity parameters;
Electrochemical measurements (pH-metry, ionometry, conductionmetry) and measurement
of aerosol parameters;
Measurements of material hardness, high pressures, and parameters of construction
materials and constructions;
Measurements of medium, high static and pulse pressures;
Optical and optical-physical measurements .
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VNIIFTRI
ASSIGNMENTS
VNIIFTRI is accredited for:
• Technical competence in the field of calibration of
measuring equipment (reg. No.075);
• Right to conduct calibration works (reg. No.003).
VNIIFTRI is accredited as:
• State center for pattern approval testing of measuring
equipment;
• Testing laboratory of technical means for safety and
electromagnetic compatibility;
• Testing laboratory of explosion – proof measuring
equipment, monitoring devices and automation elements;
• Testing center for medical devices.
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Type of measurement
Containing hydrogen maser
standards of the RF time scale
National
standard
Highest
precisio
n
facility
Secondary
standard
Total
Mechanical measurements
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Measurements of flow rate, capacity,
level, flow parameters
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Pressure and vacuum measurements
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Physicochemical measurements
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Temperature and thermophysical
measurements
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Time and frequency measurements
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10
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Vibroacoustic measurements
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Optical and optical-physical
measurements
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Measurements of ionizing radiation
parameters
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3
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Measurements of electric and
magnetic properties, radio engineering
and radio electronic measurements
National standard of the unit of
electric field
Total:
National special standard of the
unit of pressure
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VNIIFTRI INTRNATIONAL
RELATIONS
VNIIFTRI
AMERICA:
⇨ USA
⇨ Cuba
⇨ Brazil
Europe:
⇨ Great Britain
⇨ Germany
⇨ France
⇨ Italy
⇨ Switzerland
⇨ Poland
⇨ Slovakia
⇨ Hungary
⇨ Lithuania
⇨ Netherlands
Asia:
⇨ China
⇨ India
⇨ Korea
CIS:
⇨ Belarus
⇨ Ukraine
⇨ Kazakhstan
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Legal Base of the VNIIFTRI Activity
⇨ Laws of the Russian Federation :
«On the science and state scientific – technical policy»
«On assurance of measurements uniformity»
«On the protection of consumers rights»
«On technical regulation»
⇨ Decrees of the Government of the Russian Federation:
from 12.12.95 No.113 «On some measures directed to the improvement of
the quality of products and services»
from 12.04.94 No.100 «On organizing of works on standardization,
assurance of measurements uniformity, and certification of products and
services»
Decrees and Documents of the Gosstandard, Ministry of Economy and
other Ministries and Departments
⇨ Normative documents regulating the activities of this institute, the GOSTs,
Procedures, and Normative Documents
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Third COOMET FORUM
2-3 June 2003 .
Yekaterinburg, Russia.
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CONTENS
1 Quality management system documentation
2 Conformity to ISO/IEC 17025 requirements
3 Dynamic of the QMS evolution
4 ISO/IEC requirements that are being implemented
5 Weak and strong points of the QMS
6 Problems in the QMS implementation
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Organizational structure of the VNIIFTRI
Scientific Council
Deputy Director General
On Scientific Work
Metrological Center for Radio Technical
and Magnetic Measurements
Dissertation Council
Director General
Coordination
Council
Quality
Management
System Group
Deputy Director General
On Quality Assurance
IL VSI
Service of the
Main Quality
Manager
Deputy Director General
Chief Engineer
Chief Power Engineer
Chief Power Engineer Service
Testing Laboratory
VNIIFTRI-TEST
Scientific Secretary
Department of Cryogenic Metrology
«Cryomet NIO-2)
Accountant General
Chief Mechanical Engineer
Metrology Center for Heterogeneous
media and physicochemical measurements
CMG SFMI (NIO-3)
Accounting and financial department
Metrology Center for Ionizing Radiation,
CMII (NIO-4)
Planning and Production Section
State Metrology Center for
Hydroacoustical Measurements
(GMCGI)
Personnel staff Department
Center for physicochemical and electric
Measurements CFHEI (NIO-6)
Metrology Center for acousto-optic and
laser optoelectronics
MCAO (NIO-9)
Material and technical Supply Service
Social Maintenance and Housing
Department
Administrative and Economic Department
Legal and International Cooperation
Department
Institute of Metrology for Time and Space
(IMVP)
Service of Chief Mechanical Engineer
Regime and Protection Service
Labor Protection and Technical
Provision Department
Information Protection Department
Measurement Equipment office (BIP)
State scientific and production department
“Potok”
Communications and Signaling
Department
Center for Electromagnetic Measurements
CEMI (Department 200)
Thermal Power Section
Chief Metrologist
Department of general and theoretical
problems of metrology
Department of Scientific and Theme
Planning
(Department 002)
Center for pulse systems
and technologies
(Laboratory 004)
Laboratory for automated processing of
economic information
(Laboratory 106)
Off is
Shipping Department
Dispensary
Departments of scientific and technical
information
Holiday base ‘Bi»
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Science and Engineering Library
Design Documentation Archives
Post – graduate studentship
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VNIIFNRI QMS
Documentation
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Structure of the internal VNIIFTRI
QMS documentation
Quality
Manual
Management
Documents
QMS
guide Documents
Technical procedures
Quality Reports
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VNIIFTRI Quality Manual:
→Corresponds to the requirements of the
GOST P ISO/IEC 7025-2000
→ Main QMS document containing a complete
description of the quality management system
→ Comprises references to documented procedures,
→normative technical documentation
→ Refers to the valid legal standards
→ Is developed by the QMS group, discussed at the
Coordination Council on quality assurance, approved by
the Director General, and put into effect by the order of the
Institute
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VNIIFTRI
management documents
⇒ Orders of the Director General
⇒ Instructions of the higher
management
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VNIIFTRI QMS guide
documents:
￫ regulate and complete requirements and procedures of
individual sections of the Quality Manual;
￫ comprise principles, order and procedure of the work
fulfillment in the frame of the quality management system;
￫ describe responsibilities, powers and interaction of
personnel involved in the activity in the frame of the QMS.
Developed – 7 GD
To be developed– 15 GD
GDs are developed by the QMS group or by ad hoc working
groups
GDs are discussed by the Coordination Counsil on quality
assurance
GDs are approved by the Director General.
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VNIIFTRI technical Procedures
 Procedures and Instructions on the
transfer of measurement units
 Working Procedures and Instruction on
the conduction of calibration and tests
Total: 190 documents
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VNIIFTRI Quality Reports
- Quality Reports – documents, comprising results of
activities on the quality measurements system and
reflecting:
 QMS activity results,
 QMS efficiency,
 QMS evolution.
Quality reports and review results are used by the
VNIIFTRI higher management in the development of
measures on the improvement of quality
management system functioning.
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VNIIFTRI Quality Management System
VNIIFTRI Quality Policy
The aims of VNIIFTRI activity in the field of quality are:
assurance of measurement unity, maintaining of standard base and quality of conducted
metrological works at the level accepted by authoritative metrological and international
organizations. The maintaining of full confidence to the VNIIFTRI activity.
 quality of conducted metrological, certification and other works and services should assure
the full satisfaction of the client’s expectations, and even surpass their demands.
securing, both in this country and abroad, of the VNIIFTRI’s high reputation, achievement of
advantages before the organizations involved in analogous activity.
The achievement of these aims are secured by:
Aspiration after the quality level of scientific-technical products, conducted works and
services, securing the leading position at the internal and world markets;
Creation of the institute structure securing financial stability and economic well–being of its
employees;
Rational combination of state, market and social aspects in the economic activity of the
enterprise;
Organization of the quality management work providing clear regulated responsibilities of
the whole personnel from the Director General to an employee.
Signed by the Director General of the Institute.
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VNIIFTRI Quality Management System
To realize quality policy VNIIFTRI has in its disposal:
 necessary legal, organizational, procedural, normative and
technical documentation;
 necessary modern standard base and auxiliary facilities;
 rooms provided with the necessary conditions for performing
verification, calibration and tests;
 learned custodians of standards;
 highly skilled personnel.
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Correspondence of the VNIIFTRI
QMS to ISO/IEC 17025
requirements
Management requirements
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Organization and responsibility
VNIIFTRI activity is realized in accordance with its
organizational structure .
Top management responsibility
Director General:
 performs the guidance of the whole VNIIFTRI activity;
 bears the responsibility for the QMS functioning and improvement;
 determines quality policy, aims, and commitments that creates a legal basis for QMS
functioning by means of approval and signing of normative and organization–managing
documents;
 appoints a management representative on quality and empowers him with the
corresponding commission;
 allots necessary financial and material resources for QMS functioning.
Deputy Director General on Quality - Management representative :
 secures the development, implementation and maintaining in working condition of
QMS processes;
 submits reports about QMS processes;
 maintains relations with other organizations on the QMS-connected questions.
Coordination Council on Quality is VNIIFTRI board consultative body, coordinating the
work of all the VNIIFTRI structural subdivisions participating the QMS.
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Control of QMS documentation
Control of QMS documentation is carried out in
accordance with the requirements of the following
QMS guide documents:
 ND QMS 4.2-01-03 “Control of internal QMS
documents”
 ND QMS 4.2-02-03 “Control of external QMS
documents”
ND QMS 4.2-03-03 “Control of quality records”
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Service to clients
Metrological services :
•dissemination of National standards ,
• verification of measuring equipment,
• calibration of measuring equipment,
• metrological expertise of normative documents,
• certification of measuring equipment.
Testing:
• type approval testing of measuring equipment,
• testing of explosion-proof measuring and monitoring equipment,
and automation elements,
• testing of technical means for safety and electromagnetic
compatibility,
• testing of medical devices.
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Correspondence of the VNIIFTRI
QMS to ISO/IEC 17025
requirements
Technical requirements
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Personnel qualification
The requirements to the professional education, training, skills
and experience are regulated by ND QMS 6.2-01-03 “Personnel
certification and raising the level of its skill”
 Approval of scientific custodians for national standards,
secondary standards, highest precision facilities is carried out in
accordance with the GOST 8.372-80, GOST 8.525-85 and MI
2626-2000
 Certification procedure for measuring equipment verification
officers is defined by the metrology rules PR 50.2.012-94
In the institute there are:
⊳
29 learned custodians of national standards
⊳
17 learned custodians of secondary standards
⊳
19 learned custodians of highest precision facilities
⊳
43 experts in the certification of measurement procedures
⊳ 172 verification officers for all the fields of the accreditation
scope
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Calibration and measurement routines
In the works on measurements, calibration, verification and testing
the subdivisions use:
 Normative documents determining verification methods and
facilities, testing methods, calibration procedures (GOST, MI)
 Quality management system procedures
GD QMS 7.5-02-03 “Routines of verification and calibration of
measuring equipment”,
GD QMS 7.5-03-03 “Routines of type approval testing”
 Documents determining general technical requirements for the
measuring equipment to be calibrated (specifications, regulations,
standards, including international ones, etc.)
Normative documentation is registered in a subdivision and its cardindex is maintained. The realization of the controlled normative
documentation is responsibility of the subdivision chief, whereas the
QMS group is responsible for QMS GD. The documentation for the
measuring equipment to be tested is kept in the subdivision.
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Quality data control
Quality data include:
 internal audit reviews and management
review results;
 data on correction and preventive actions;
 data on working standards verification;
 data on standards comparison results.
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Control of data on the electronic media
To control the data on verification
calibration and testing of measuring
equipment, the preparation works is
being carried out in this institute on the
implementation of the automated
measuring system (AMS) “Metrcontrol”
(order No. 29 of Gosstandard from
06.02.2002)
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Policy of uncertainties implementation:
Procedure of measurement uncertainty assessment is used:
• by the execution of international, key, regional, and bilateral comparison of
national standards and by the compilation of calibration and measuring
capabilities,
• by the calibration of measuring equipment, including working standards.
The concept of measurement uncertainty covers:
• reports on standards comparison results,
• publications on standards comparison,
• calibration certificates of measuring equipment,
• development of new and revision of acting metrological normative documents
(in case of need).
Uncertainty in measurement is used in accordance with the requirements of:
• Guide to the expression of uncertainty in measurement (BIPM, IEC, ISO,
OIML, etc.),
• MI 2552 “GSI. Application of the guide to the expression of uncertainty in
measurement”,
• 01-001-2002 « Principles of using the concepts «measurement uncertainty »
and «measurement error», implemented in VNIIFTRI by the order No. 249
from 06.11.2002 г.
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VNIIFTRI PARTICIPATION IN INTERNATIONAL
COMPARISONS ACTIVITIES
Assignment
KCDB code
Type
Quantity
Status
Time of
comparison
Length
BIPM.L-K10
Key
Frequency
In progress
1988
Ionizing radiation
and radioactivity
BIPM.RI(I)-K4
Key
Absorbed dose in
water
In progress
1993
Acoustics,
ultrasound and
vibrations
CCAUV.A-K1
Key
Sound pressure
CCAUV.A-K3
Key
Sound pressure
Is being planned
2003-2005
CCAUV.U-K1
Key
Sound pressure
In progress
1999-2001
CCAUV.W-K1
Key
Sound pressure
In progress
1999-2001
COOMET.AU V.A-K1
Key
Sound pressure
In progress
2001-2002
CCEM.RF-K1.c.W
Key
Energy
Draft A preparation
1997-1999
CCEM.RF-K9
Key
Excess noise ratio
Measurements are finished
1998-2000
CCEM.RFK10-.CL
Key
Energy
In progress
2000-2002
CCEM.RF-K15.CL
Key
Attenuation
Finished
N/A
CCEM.RF-K18.CL
Key
Noise temperature
Finished
2001-2002
CCEM.RF-K19.CL
Key
Attenuation
Finished
2001-2003
CCEM.RF-K20
Key
Electric field strength
In progress
1999-2002
EUROMET.EM-S6
Additional
Electric field strength
Draft A preparation
1997
Mass and related
quantities
CCM.P-K11
Key
Pressure
In progress
1981-1989
Amount of
substance
CCQM-K9
Key
pH 7.0
Draft A preparation
1999-2000
CCQM-K17
Key
pH 4.1
In progress
2001
Temperature
CCT-K1
Key
Temperature
Draft A preparation
1997-2001
Electromagnetics
and radio technical
measurements
Draft A preparation
1999-2001
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Complaints
In the Section 4.8 of the VNIIFTRI Quality Manual and GD QMS 8.5-02-03
“Corrective and Preventive actions” the procedures are stipulated for the
resolution of complaints, received from clients, that provide for :




order of registration and maintaining of complains;
review of complaint causes and the estimate of complaint category;
development and realization of corrective actions;
monitoring of the actions taken in accordance with the results of complaints
resolution .
In 2002, the following claims were laid:
- on the shape of verification mark - 1;
- on the date of formalization of financial documents on measuring equipment
verification - 3;
- on delays in the approval of a verification schedule of measuring equipment
for types of verification not covered by the institute accreditation scope – 2.
Claims are received by the chief metrologist department for review and
corrective actions and forwarded to the structural subdivision for registration in
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corresponding registers by authorized persons.
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Internal audits
The aim of internal audits in VNIIFTRI is the determination
of the QMS functioning efficiency.
In the course of audit:
 Results of the elimination of nonconformities are analyzed.
 Sufficiency of the documents, assuring the QMS functioning,
is determined.
Execution of procedures on the control of documents and data is
checked in accordance with the following documents:
- GD QMS 4.2-01-03 «Control of QMS internal documents»
- GD QMS 4.2-02-03 «Control of QMS external documents»
- GD QMS 4.2-03-03 «Control of QMS quality records »
The audits are conducted:
internal - by a group of VNIIFTRI auditors,
external – by detached bodies.
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Internal audits
 The internal audits of the VNIIFTRI quality management
system are conducted in accordance with the requirements of
GD QMS 8.2-01-03 «Order of internal audit conduction ».
 To execute QMS internal audits, a group of auditors,
selected from the institute structural subdivisions, was trained
at courses and seminars.
 To conduct the audit, a group of auditors is formed that
include:
 representative of the QMS group,
 auditors from other subdivision competent in the field of
activity of the subdivision to be audited.
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Schedule of internal audits conduction
Point of GOST P
ISO/IEC 17025
Months
Subdivision
01
02
03
04
05
06
07
08
09
10
Х
MCRMI
Х
Х
NIO-3
Х
Dep. 200
Dep. 001
Group of auditors
Х
Group of auditors
Х
Group of auditors
Х
IMVP
NIO-9
Group of auditors
Group of auditors
NIO -4
NIO-6
12
Group of auditors
Cryomet
GMCGI
11
Auditors surname, name,
patronymic and position
Х
Group of auditors
Group of auditors
Х
Group of auditors
Х
Group of auditors
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Corrective and preventive actions
The need in the conduction of corrective actions is determined
by:
• results of clients’ complaints review,
• results of internal and external audits,
• indexes of the efficiency of QMS functioning.
The need
by:
• analysis
• analysis
• analysis
in the conduction of preventive actions is determined
of information about service quality
of guide documents,
of the QMS functioning.
The activity on the conduction of corrective and preventive actions
is carried out in accordance with the GD GMS 8.5-02-03 “Corrective
and preventive actions”
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Management reviews
VNIIFTRI higher management once in a year conducts a review
of the quality management system functioning, determines the
necessity of introduction of changes or corrective actions aimed
at the improvement of effectiveness of the system used in this
institute.
QMS review includes:
⇒ review of the efficiency of internal audits,
⇒ review of clients’ complaints,
⇒ review of the prospective needs in the changes of the QMS
documents,
⇒ determination of the necessary quantity of personnel to be
trained.
Deputy Director General on quality organizes the works on the
QMS review and reports preparation. He presents the yearly
report on quality to the Director General and Coordination
Council on quality.
The QMS group reviews the QMS functioning and presents a
report to the Deputy Director General on quality .
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ISO/IEC17025 requirements that are being
implemented
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•
Several procedures reflecting that requirements of the
ISO/IEC17025 standard are at the stage of coordination, approval,
and implementation:
GD QMS 6.2-01-03 «Personnel certification and raising the level of
its skill»
GD QMS 7.2-01-03 «Review and conclusion of contracts»
GD QMS 7.4-01-03 «Control of purchases»
GD QMS 7.5-05-03 «Rules of measuring equipment and test
equipment maintenance»
GD QMS 7.5-07-03 «Rules of storage and transportation of products»
GD QMS 7.6-01-03 «Control of measuring and test equipment»
GD QMS 8.3-01-03 «Control of nonconforming equipments (services)»
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Evolution dynamics of the
VNIIFTRI QMS
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Evolution stages of the VNIIFTRI
QMS
1979 – Implementation of the product complex quality
management system (KSUKP)
1998 – Decree on the creation of the quality system
corresponding to the GOST P ISO 9001-96 requirements
2000 – Implementation of the ISO/IEC17025-2000
standard
2002 – Adoption by the Institute management of the
decision on the evolution of the VNIIFTRI QMS in
accordance with the GOST P ISO/IEC17025-2000
standard
2003 – Adoption by the Institute management of the
improvement of the QMS and development of additional
guide documents for correspondence with the GOST P
ISO/IEC 17025-2000 и GOST P ISO 9001-2001
requirements
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STRONG and WEAK
SIDES of the VNIIFTRI
QMS
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QMS implementation problems and
the ways of their solution
Revision of the Quality manual in correspondence with the GOST P
ISO/IEC 17025 standard requirements. Drawing of subdivision and service
personnel in the realization of tasks, principles and rules of the QMS
functioning
Creation of the structure of the QMS guide and work bodies:
- Coordination Council on quality
- QMS group
- appointment of QMS responsible officers in the subdivisions
- personnel training in the institute
Intensification of the works on uncertainty implementation
The guide document 01-001-2002 “Principles of the conceptions
“measurements uncertainty” and measurements error” has been
developed
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Strong sides
• Experience of participation in international,
regional and other comparisons of standards
• High commitment to and the independence of
the management and personnel in the
fulfillment of the work conducted
• Securing of the financial stability
• Increasing of the client’s confidence
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Weak sides
• Scanty influx of young specialists
• Limited resources for maintaining and keeping of
standards
• Social–psychological aspect of QMS implementation
• Invitation of experts from subdivision for the
development of QMS documents at the expense of
their basic professional activity
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