Transcript Implementation of the QM/QC requirements in the laboratiry

“Horia Hulubei”
National Institute for Physics and Nuclear
Engineering - IFIN HH
Implementation of the QM/QC requirements
in the laboratory activity
Dipl.-Eng. Sibila Brancovici
Dr. Emanuela Cincu
Dr. Maria Sahagia
As.I - Luminita Mischie
Implementation of the QM/QC requirements
in the laboratory activity
IFIN-HH has carried out nuclear activities under a Quality
Management System since 1985. As the institute became a
supplier of products and services for Cernavoda Nuclear Power
Plant in 1985 a QA System was created and implemented in
accordance with Romanian nuclear legislation and national
quality norms.
As a result CNCAN (National Commission for Nuclear Activity Control),
Romanian Nuclear Regulatory Body authorized the Institute to
supply products and services to the Cernavoda plant. These
authorized activities were performed under oversight of the
Nuclear Power Plant’s contractors: Canada’s AECL and Italy’s
Ansaldo.
At present IFIN-HH carries out many of its activities under CNCAN’s
licence for Quality Management System
Implementation of the QM/QC requirements
in the laboratory activity
“Horia Hulubei”
National Institute for Physics and Nuclear Engineering- IFIN HH
Organisational chart
Implementation of the QM/QC requirements
in the laboratory activity
IFIN-HH operates a QMS according to Quality Management Norms
(CNCAN), ISO 9001:2000 , ISO/IEC 17025:2000 andGMP.
The modular system of IFIn-HH QMS documents:
 manufacturing QM according to QMN-07;
 manufacturing QM according to ISO 9001 - only for one department
(IRASM);
 manufacturing QM according to GMP, only for one department
(CPR);
 QM for Training Center according to ISO 9001
 decommissioning QM (stage 1) for Nuclear research Reactor
(according QMN-11)
 QM for laboratories according to ISO/IEC 17025.
Implementation of the QM/QC requirements
in the laboratory activity
At present IFIN-HH labs using nuclear analytical techniques are:
 Accredited:
 Lab. ACTIVA-N which performs elemental analysis of metallic by INAA
Analysis lab
Photodosimetry and whole body counter lab’s
On the way of accreditation:
 Lab. for Control of the Environment ;
Metrology and Testing Laboratory for Ionising Radiation;
 Lab. for Radionuclide Metrology.
There are also 4 labs which will start soon to implement ISO/ IEC
17025.
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Implementation of the QM/QC requirements
in the laboratory activity
 The laboratory managers understood:
 the QMS implementation is indispensable for the survival of
an analytical laboratory;
the advantages of having an official certificate about proper
performance in compliance with international standards;
 an accreditation helps to persuade customers and to credit
analytical methods;
 the implementation of QMS / Quality Control System can be
decisive for the perspective of analytical labs, for competition
of nuclear methods.
Implementation of the QM/QC requirements
in the laboratory activity
Management’s goal is to establish a comprehensive QMS according
to ISO/IEC 17025 and to assist labs to approach the national nuclear
Regulatory Body and the national accreditation Body.
Policy Statement
Our General Director have written a quality policy statement
stipulating the commitment of the management in implementing and
continually improving the Quality management System, for all
specific activities carried out in the institute in compliance with: law
111 of 1996 on the safe performance of Nuclear Activities, republished
in 1998, and revised and supplemented by law 193 of 2003 and:
Implementation of the QM/QC requirements
in the laboratory activity
 Quality management Norms (CNCAN);
 ISO 9001:2000;
 ISO / IEC 17025:2000;
 GMP.
The management is committed to ensure the personnel and
financing that are necessary for implementing and maintaining a
Quality Management System.
At each laboratory the managers have also written a Policy Statement
stipulating the commitment of the management in implementing and
continually improving the Quality Management System.
Implementation of the QM/QC requirements
in the laboratory activity
The action plan for implementation of ISO/IEC 17025 in every lab
includes the following steps:
 training of staff for specific tasks, but also in QM/QC principle and
practice.
 Very important: it is necessary to train staff members to function
as internal auditors, becouse they became aware of QMS. Labs keep
the records for training.
 Elaboration of QMS documents for lab according to the reference
documents.
QMS for a lab is a component part of general QMS of IFIN-HH.
IFIN-HH QM describes the general organisation of IFIN-HH and gives
principles for the QMS within the institute.
Implementation of the QM/QC requirements
in the laboratory activity
Some general procedures of IFIN-HH are applicable to lab such as:
internal audit, management review, purchasing.
QM - Quality Manual
QM
SP - System procedures
SP
SOP - Standard Operational
Procedures
SOP
QM and SP - describe the lab’s organization and QMS it self.
Implementation of the QM/QC requirements
in the laboratory activity
In QM it is specified that lab’s QMS is a component part of the general
QMS of IFIN-HH.
QM’s content is in compliance with ISO/IEC 17025.
QM and SP ensure the conformity with each chapter of ISO/IEC 17025.
It as recommended to draw up a list of cross-reference to clauses in
ISO/IEC 17025 .
SOP - give detailed information about the way to do the work and
check it.
Implementation of the QM/QC requirements
in the laboratory activity
Another documents relating to quality management are:
 documents containing data that are essential for operating the
QMS and for carring out the laboratory work, such as:
inventory of system documents and forms;
lists of instruments and equipments, technical reports on the
validation of new methods;
reports from tests;
quality records of findings and recommendations from
management review, non-conformance reports, corrective
action reports established as a result of internal/external
audits, reports on audits performed on suppliers or
subcontractors;
quality plans.
Implementation of the QM/QC requirements
in the laboratory activity
Implementation of QMS
QMS has to be put in place and / or have be to developed.
 Documents are already available and usable;
 lab’s quality manager guides the process of implementation and
supervices it ;
 during the process of implementation it is verified the compliance
with the requirements of ISO/IEC 17025 and deficiences are
corrected;
 the necessity of modifications in QMS documents or elaboration
of new documents (procedures, instructions);
Implementation of the QM/QC requirements
in the laboratory activity
the necessity of more training of staff;
 non-conformances
in QM of instruments (related to the current
status and performance of equipment);
 the necessity of developing of methods and equipment that are
more sensitive and efficient, etc.
 the necessity of improving of environmental conditions, of
archiving conditions, procurement, etc.
CONCLUSION: Implementation of QMS is a continuous process.
Management internal improvement
 it is achieved by internal audit and management review.
Implementation of the QM/QC requirements
in the laboratory activity
Internal audit
According to the IFIN-HH procedure “Internal Audit” audit are planned
and executed in accordance with an annual internal programme.
IFIN-HH has an audit team including trained auditors in an IAEA
Programme in the ISO/IEC 17025 implementation in IFIN-HH, some of
them are also certified as internal auditors in the ISO 9001
implementation by TUV - THURINGEN.
Audits are usually scheduled by the QM department for one year
cycle to include every department/lab, if need be, activities at
subcontractors.
Implementation of the QM/QC requirements
in the laboratory activity
Management Review
According to the procedure at the level of IFIN-HH, “Management
Review”, cod AC-PS-08-00. Periodically IFIN-HH management reviews
institute’s suitability and effectivness of QMS.
The input of the review:
 quality policy and the objectives of the QMS
 the results of the external and internal audits
 clients’ feedback
 the results of the corrective or preventive actions
 reports from managerial personnel
 changes in the organizational structure or changes regarding to
the type of the work
Implementation of the QM/QC requirements
in the laboratory activity
 Different
activities: resources, training of the personnel, quality
control activities, market studies.
The output of the review
An Improvement Programme of QMS (strategy goals, objectives and
deadlines for coming period). Findings from management review are
recorded in Management Review Report and QMS Improvement
Programme.
CONCLUSIONS
 By embarking on the IAEA RER 2/004 Regional Project, IFIN-HH has
started to bring its QMS into the line with the requirements of ISO/IEC
17025 in 2001;
 At present IFIN-HH has a good experience in implementing ISO/IEC
17025;
Implementation of the QM/QC requirements
in the laboratory activity
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IFIN-HH has implemented this standard in 4 lab’s which are
accredited by CNCAN or RENAR;
There are still 4 lab’s which started this process;
QM/QC is a concept of gradual improvement of performance for
the benefit of analytical laboratories.
Implementation of the QM/QC requirements
in the laboratory activity
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Weak points:
 Internal audit in 2005
 Equipment is not up-to-date
 Lack of market studies
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Strong points:
 Inereasing of number of our lab’s involved in INFRAS - NATIONAL
PROJECT regarding to ISO/IEC 17025
 A low no of complaints from our clients
 Participation of our lab’s in international intecomparisons.