Report to SIM-QSTFAsunción, April 2013
QMS supporting CMCs in
Chemistry
QMS supporting CMCs in
Chemistry
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.
INTI Organizational
Structure
Ministery of Industry
INTI
Board of Directors
Presidency
Advisor Council
General Manager
Metrology, Quality And Environment
Metrology Environment
Dep. Legal Metrology
Dep. Scientific & Industrial Metrology
Managers level
Deputy managers level
42 R&D centers
Química Ambiente ……. …….
Special projects
Legal
Development
Regional Assistance
Human Resources
Administration & Finances
International Cooperation
Assistance to social industry
Commercial
Quality
Maintenance of the Integrated Management SystemAuditors trainingHarmonization of procedures,
equivalence of resultsCrossed audits planningInter-comparisonsTechnical training planning
Strategic planning and projectsManagement reviews
Metrology, Quality And Environment
Metrology
Dep. Scientific & Industrial Metrology
centers
Química Ambiente ….
Quality
Maintenance of independent QMSs in each center
Ministery of Industry
INTI
Board of Directors
Presidency
Advisor Council
General Manager
Metrology, Quality And Environment
Metrology Environment
Dep. Legal Metrology
Dep. Scientific & Industrial Metrology
Managers level
Deputy managers level
42 R&D centers
Química Ambiente ……. …….
Special projects
Legal
Development
Regional Assistance
Human Resources
Administration & Finances
International Cooperation
Assistance to social industry
Commercial
Quality
I. QMS supporting CMCs in Inorganic Chemistry
INTI-QUIMICA ORGANIZATIONAL CHART
Technical Management
Organic Technical Unit
Quality
Program
Metrology Program in
Chemistry
Inorganic Technical Unit
Technology Assistance
Technical Unit
Natural Product Technical Unit
Environmental Technology and Science
Technical Unit
New Process and Product
Technical Unit
PNCCC Technical Unit
Metal and Inorganic Analysis Lab
Trace Lab
Industrial Solvent Lab
Synthetic Industrial Product Lab
Pharmaceuticals Lab
Technical Assessment Lab
Pilot Plant Lab
Fuels Lab
Natural Pharmachemicals
Lab
Extractive Process Lab
Water Chemistry Lab
Water-Applied Technology Lab
Ecotoxicology and Microbiology Lab
Controlled Release System Lab
Cleaning and Cosmetics Product
Lab
Outreach and IT and Administrative
System Division
Resource Management
Division
Integrated Technical Support Section
Organic Synthesis Area
Industrial Product Formulation 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).pdfMetal traces in sediments, soils, ores, and particulates
New (under technical review) Ap A - INTI Quimica CMCs (new).xls Metals in different matricesAgreed with the peer reviewer
INTI-Química customer feedback 2012 (survey to 52 users)
0
5
10
15
20
25
30
35
40
45
Acc
ess
Kin
dn
ess
Use
fuln
ess
Re
liab
ility
Tim
e
Fu
llfilm
ent
Re
po
rt c
lari
ty
Fe
es
Sa
tisfa
ctio
n
Overall performance
very good goog regular bad no answer
Complaints and non conformities 2012
• No complaints were received in 2012 in INTI Quimica.
4.2/4.3 Documentation / QMS 204.6. Suppliers 14.9. Nonconforming works 15.2 Job descriptions 15.2 Non authorized person 25.3 Facilities 1
5.4.5. Method validation 45.4.6. Uncertainty 15.6. Use of non-calibrated equipment 1
Total 32
32 NCs were detected in 2012 in INTI Quimica. All them were managed and closed
INTI-Química internal and crossed audits
Management AuditAuditor: Gladys Mastromónaco (INTI-SAI)Date: Sep 28-2012This 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 – solvedDetermination 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
INTI-Quimica vitality evidences.pdf
Evidences included in file:
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
0
20
40
60
Fa
cil
ida
d
de
ac
ce
so
Am
ab
ilid
ad
de
l …
Uti
lid
ad
d
el …
Co
nfi
ab
ili
da
d d
el …
Tie
mp
o
de
…
Cu
mp
lim
ie
nto
…
Cla
rid
ad
d
el …
Va
lor
de
l a
ran
ce
l
0
20
40
60
80
100A
cc
es
s
Kin
dn
es
s
Us
efu
lne
ss
Re
liab
ility
Tim
e
Fu
llfill
me
nt
Cla
rity
Fe
e
Performance (%)Low
Regular
Good
A random sample of 15 users was extracted. The survey results were presented and discussed in the management review
INTI-Ambiente NC 2012
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
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
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 - 2012Auditor: Gladys Mastromónaco (INTI-SAI)Date: Sep 28-2012This audit revealed 1 non-conformity, resolved to date.
Technical auditScope: 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
INTI-Ambiente vitality evidences.pdf
Evidences included in file:
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
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
Note on the dissemination of traceability in Chemical Metrology:
Thank you!
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