Transcript Example presentation to the QSTF: INTI Presentation of QMS supporting CMCs in Chemistry

QMS supporting CMCs in
Chemistry
Report to SIM-QSTF
Asunción, April 2013
Scope of this presentation
•QMS supporting CMCs in Inorganic Chemistry (Traces,
Metals in Soil, Water) Laboratories in INTI-Quimica
•QMS supporting CMCs in Organic Contaminants
Laboratories in INTI-Ambiente
Both systems were approved in Santiago, Chile, in
March 2008.
So, a 5-years reapproval is needed.
Ministery of Industry
INTI
Organizational
Structure
INTI
Board of Directors
Advisor Council
Presidency
General Manager
Managers level
Regional
Assistance
Metrology, Quality
And Environment
Commercial
Administration
& Finances
Human
Resources
Assistance to
social industry
International
Cooperation
Special
projects
Deputy managers level
Metrology
Dep. Legal
Metrology
Quality
Environment
Dep. Scientific &
Industrial Metrology
42 R&D centers
Química
Ambiente
…….
…….
Legal
Development
Ministery of Industry
INTI
Board of Directors
Advisor Council
Presidency
Strategic planning and projects
Management reviews Managers
General Manager
Metrology, Quality
And Environment
level
Regional
Assistance
Metrology, Quality
And Environment
Commercial
Administration
& Finances
Harmonization of procedures,
Deputyofmanagers
level
equivalence
results
Crossed audits planning
Inter-comparisons
TechnicalMetrology
training planning Quality
Dep. Legal
Metrology
Metrology
Human
Resources
Assistance to
social industry
Quality
Ambiente
Maintenance of the
Development
Integrated Management
System
Auditors training
Environment
centers
Química
Química
Special
projects
Legal
Dep. Scientific &
Industrial Metrology
Dep. Scientific &
Industrial Metrology
42 R&D centers
International
Cooperation
…….
Ambiente
…….
….
Maintenance of independent QMSs in each center
I. QMS supporting CMCs in
Inorganic Chemistry
INTI-QUIMICA ORGANIZATIONAL CHART
Technical
Management
Program
Metrology Program
in
Chemistry
Outreach and IT and
Administrative
System Division
Resource
Management
Division
Organic Synthesis
Area
Integrated Technical
Support Section
Quality
Organic Technical
Unit
Technology
Assistance
Technical Unit
Inorganic Technical
Unit
Industrial Solvent
Lab
Synthetic Industrial
Product Lab
Pharmaceuticals Lab
Natural Product
Technical Unit
Environmental
Technology and Science
Technical Unit
New Process and
Product
Technical Unit
PNCCC Technical
Unit
Metal and Inorganic
Analysis Lab
Technical Assessment
Lab
Natural
Pharmachemicals
Lab
Water Chemistry Lab
Controlled Release
System Lab
Trace Lab
Pilot Plant Lab
Extractive Process
Lab
Water-Applied
Technology Lab
Cleaning and
Cosmetics Product
Lab
Ecotoxicology and
Microbiology Lab
Industrial Product
Formulation Lab
Fuels Lab
QMS documentation
The file
INTI-Quimica QMS documentation.pdf
contains objectives, scope, responsibilities, organizational charts,
contents of the respective Quality Manuals as well as the lists of
administrative and technical procedures
The Quality Manual is available in
INTI-Quimica QM.pdf
CMCs
Published:
Ap A - INTI Quimica CMCs (approved).pdf
Metal traces in sediments, soils, ores, and particulates
New (under technical review)
Ap A - INTI Quimica CMCs (new).xls
Metals in different matrices
Agreed with the peer reviewer
INTI-Química customer feedback 2012 (survey to 52 users)
Overall performance
45
40
35
30
25
20
15
10
5
very good
goog
regular
bad
no answer
Satisfaction
Fees
Report clarity
Fullfilment
Time
Reliability
Usefulness
Kindness
Access
0
Complaints and non conformities 2012
•No complaints were received in 2012 in INTI Quimica.
32 NCs were detected in 2012 in INTI Quimica. All them were managed and closed
4.2/4.3
4.6.
4.9.
5.2
5.2
5.3
5.4.5.
5.4.6.
5.6.
Documentation / QMS
Suppliers
Nonconforming works
Job descriptions
Non authorized person
Facilities
Method validation
Uncertainty
Use of non-calibrated equipment
Total
20
1
1
1
2
1
4
1
1
32
INTI-Química internal and crossed audits
Management Audit
Auditor: Gladys Mastromónaco (INTI-SAI)
Date: Sep 28-2012
This audit revealed 5 non-conformities, all resolved to date.
Internal Technical audits (2011-2012)
The following procedures were audited (September 2011)
Determination of Cr in acid solutions (PAAMet-02). Auditor: Pablo Álvarez
Non-conformities: 1 – solved
Determination de nitrites in calibration solutions. Auditor: Mabel Puelles
Non-conformities: 3 – solved
Reports and corrective actions in: INTI
Quimica internal and crossed audits.pdf
Note: Considering that, during 2012, a peer review was held to all the methods related to
CMCs, no internal audits were performed then.
INTI-Química Management review
Date: October 2012
Details in: INTI-Quimica MR.pdf
Summary of topics treated:
Summary of preliminary reports
Evaluation of the Period: Policy and Procedure Revision . Audit Results .
Independent Entity Evaluations - Interlaboratory Comparison Results Change in Volume
and/or Type of Work Customer Feedback - Claims Staff Training
Evaluation of Objectives from the previous review
Improvement objectives for the new period:
•
•
•
•
expanding the scope of methods
acquire the necessary equipment to expand the range of internal calibrations
optimize maintenance, verification and equipment calibration management.
activities towards tuning up viscosity measurements
INTI-Química Peer Review
Date:June 25‐27 2012,
Reviewer:. Heidi Goenaga‐Infante, LGC (UK).
Scope: stated CMCs in Ap A
Report: INTI Quimica PR report.pdf
Results: The reviewer has mentioned 19 recommendations. All of them were
considered and actions were defined and were or are being executed.
Actions taken in: INTI-Quimica Action Plan.pdf
INTI-Química Peer Review
Attestation (extracted from the report)
“The INTI has the capabilities and competences to carry out the services it is
claiming to deliver to its customers in the scope of the CIPM MRA.
The quality system, as far as it could be reviewed, is in compliance with
ISO/IEC 17025 and covers the near future claimed CMCs.
No Non-Compliances have been found, however a few minor non-compliances
have been observed. Those are detailed in further sections of this report. A
number of recommendations for further improvements are, therefore, added in
the peer review report.”
INTI-Química CMCs vitality
Evidences included in file:
INTI-Quimica vitality evidences.pdf
Summary:
•Participation in working groups at CCQM, SIM
•Stays at other NMIS
•Participation in international technical seminars or congresses
•Organizattion of 2 Training courses at INTI-Chemistry during 2010 (by NMI experts)
•Organization of 3 proficiency tests in the country (traceability dossemination)
• Harmonization of Measurements at different INTI Centres
II. QMS supporting CMCs in
Organic Contaminants
INTI- Ambiente structure
Technical
Director
Secretary
Technical Unit
Coordination
Office
Head of Quality
Laboratory
Management
Test
Operators
Analysts
Support Staff
QMS documentation
The file
INTI-Ambiente QMS documentation.pdf
contains objectives, scope, responsibilities, organizational charts,
contents of the respective Quality Manuals as well as the lists of
administrative and technical procedures
The Quality Manual is available in
INTI-Ambiente QM.pdf
INTI-Ambiente customer feedback 2012
A random sample of 15 users was extracted. The survey results were
presented and discussed in the management review
INTI-Ambiente NC 2012
3 customer complaints were received in INTI Ambiente in the last period. All of
them are related to mistakes in the report of results. Corrective actions were
implemented and verified
22 NC were received. All of them were managed according the procedures and
closed. In the following tabke, a classification by matters can be shown
4.2/4.3
Documentation / QMS
8
4.4
Contract review
2
4.14
Audits
1
5.2
Lack of training
1
5.3
Facilities
1
5.4.5.
Method validation
1
5.4.6.
Uncertainty
1
5.6.
Traceability
1
5.4.7.
Data Control
1
5.9.
Quality Control
1
5.10
Report of results
4
Total
22
INTI-Ambiente crossed audits 2012
Management Audit
Audit Criteria: QMS requirements in ISO/IEC 17025: 2005
Leader Auditor: Bioq Gladys Mastromónaco
Date: Sep 30/31 - 2012
Auditor: Gladys Mastromónaco (INTI-SAI)
Date: Sep 28-2012
This audit revealed 1 non-conformity, resolved to date.
Technical audit
Scope: Aromatic hydrocarbons in metanol (PE 10.39 V2.)
Leader Auditor: Bioq Gladys Mastromónaco
Auditor Team: Lic. M. Alejandra Rodríguez (technical expert) - Lic. Pablo Sánchez
(Observer)
Date: Dec 11 2012
This audit revealed 4 non-conformities, all resolved to date.
Reports and corrective actions in: INTI Ambiente crossed audits.pdf
INTI-Ambiente Management Review
Date: September 2012
Summary in: INTI-Ambiente MR.pdf
Improvements proposed for 2013:
•Improve the supplier evaluation procedure
•Improve or implement an effective procedure for the treatment of queries directed to the
Centre so that they can become a source of information and feedback to Laboratories.
•Train all the employees in complaint reception and management.
•Establish procedures to make reagent and equipment purchases for Analytical Service
Coordination Laboratories easier and faster.
General Objectives 2013
•Strengthen and expand current metrology capacities based on the start up of the
National Metrology Plan.
•Reinforce Quality Management notions in the Centre's Technical Assistance areas.
•Produce at least two new Standard Materials.
•Expand the scope of the QMS with, at least, 5 new tests.
Peer review in Ambiente
Date: July 2012
Reviewer: Mariana Arce Osuna, CENAM
Report in: INTI Ambiente PR report.pdf
Scope: stated CMCs in Ap A
Results: The reviewer has mentioned 2 non conformities and 21
recommendations.
Actions taken in:
INTI-Ambiente Action Plan.pdf
Extracted form the Executive summary of the peer review report):
The results generated by INTI in key comparisons and pilot studies are in
general satisfactory, although there are examples in which it became clear that
more experience is still needed. However, since the activities in chemistry in
INTI still in development and moreover the metrology concepts in
measurements in chemistry are not well understood for all staffs, still necessary
to include within INTI training program all base chemical metrology concepts. It
is observed that Research and Development of Special Organic Contaminants
of INTI is making very good progress in the right direction.
The Research and Development of Special Organic Contaminants have a large
amount of chemical analysis equipment available. The facilities are similar to
those in other national metrology institutes. They are suitable for the current
activities.
In general, the measurement methods applied are adequate. Measurement
uncertainty evaluation is based on the GUM and related EURACHEM
documents.
Extracted form the Executive summary of the peer review report (II)
In some cases the claimed uncertainty seems to be on the optimistic side and
should be reconsidered, of course taking into account the results of pilot studies
and other bilateral comparisons and in particular of key comparisons. Thorough
method validation is still necessary addressing all potential uncertainty
components.
Taking into account some reconsideration as mentioned above, the claimed
calibration and measurement capabilities as proposed to become published in
the Appendix C of the CIPM MRA are acceptable and seem to be reliable.
CMCs vitality
Evidences included in file:
INTI-Ambiente vitality evidences.pdf
Summary:
 Participation in working groups at CCQM, SIM
 Participations in CCQMK79, CCQM P129, CCQMK55, CCQMK95, AFRIMET
QM-K27
 Stays at other NMIS
 Participation in international technical seminars or congresses
 Organization of national proficiency tests
Note on the dissemination of traceability in Chemical Metrology:
Up to now, the metrological traceability in services related to INTI CMCs is
mainly disseminated by means of
o analytical services to samples supplied by customers, or
o assignation of reference values in proficiency tests
Additionally, INTI is beginning to produce, certify and offer reference
materials. Up to know, they are mainly related to measurements in which no
CMCs can be stated (for instance, quality of milk parameters)
The reviewers have strongly encouraged us to increase this option for CMCs
services
In that way, ISO Guide 34 is being implemented. Our intention is to have a peer
review in the following months and to present the results in the next QSTF
meeting
Thank you!