W. Steck
Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
QM-Systems for Non-Routine and
(R&D) Analytical Work Accreditation of Non-Routine
Laboratories
Contents
• Introduction
• QM-Systems for R&D
ISO 9001
GLP
EN 45001/ ISO 25
• Combined QM-Systems for R&D
• Accreditation by types of test
• Summary
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
Some Characteristics of NonRoutine or R&D Analytical
Laboratories
• Expanded methodological range
• Complex/multidisciplinary work
• High innovation rate concerning test
items and test methods: permanently
changing analytical tasks
• Large number of test methods
• Modifications of given methods and
development of new methods
• Non-Routine analytical work
• R&D analytical work, e.g.
ad-hoc testing, non-recurring work
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
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Examples for Routine, Non-Routine
and R&D Analytical Work
Routine
Non-Routine
R&D
- Matrix and analyte known; method
known and in use
- Matrix and analyte known; method known,
but rarely performed
- Matrix and analyte known; method
available, but (until now) no experience
with method (verification necessary)
- Matrix and/or analyte new; adaptable
method available (some modification and
revalidation necessary)
- Problem new, no adaptable method
available: Development of new validated
method
- Ad-hoc analysis of new problems
including validation case by case
(analytical working plan, task leader)
- Basic research (research plan, project
management)
- structure elucidation, interpretation of
spectra
R
NR
R&D
Overlap between Routine or R&D with Non-Routine
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
W. Steck
Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
EUROPEAN STANDARD
EN ISO 9001
Quality Systems-Model for quality assurance
in design/development, production,
installation and servicing (ISO 9001: 1994)
ISO 9001 is generic and independent of any
specific industry or economic sector, but it
aims preferably to manufacturing and service
industries.
Scope
This international standard is applicable
in situations when...
a) design is required...
b) ...by adequate demonstration of
suppliers capabilities in design...
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
EUROPEAN STANDARD
EN ISO 9001 Research Design
• On its own not sufficient to demonstrate
technical competence of a testing
laboratory.
• Well practicable to cover non-technical
(non-lab) activities, desk research,
consultancy, basic research for knowledge
development projects, development of
products and processes.
• Suitable for research organisation where
laboratory activities are only part of
research project.
• When applicated to research it should
include "R&D project management" as
primary process.
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
ISO 9001 Design Control
- an Example (Chapter 4.4)
Quality Management in Design Control
Quality Management Directive No. 4
Design contribution to product and process development
Date: 23.06.1998
Revision: 1
Page: 1 of 4
Design contribution to product and
process development
1
2
3
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4
5
Aims
Methods and aids
Procedure
The phases in a development project
Definition of targets and launching the project
Laboratory phase
Pilot plant phase
Production plant phase
Steps to be taken if changes are made in the
requirements imposed on the product or process to
be developed
Verification of the results obtained during the
development work
Responsibilities
Documentation and Retention
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
The OECD Principles of GLP
(Paris1998) Research Design
 GLP is a quality system
concerned with the
organisational process and the
conditions under which studies
are planned, performed,
monitored, recorded, archived
and reported.
 One purpose of GLP is to
promote the development of
comparable quality test data.
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
The OECD Principles of GLP
(Paris1998) Research Design
Pros
• Study Director
• Study Plan
• Knowledgeable personnel in sufficient
number
• Adequate and controlled test equipment with
• - where appropriate - traceable calibration
• Selected Standard Operating Procedures
(SOP's)*
• Validated Computerized Systems
• Evaluation and discussion of results
• Trackability and Repeatability (Reports,
raw data, archive)
• Test Facility Management
• Facilites
• Quality Assurance Programme
* when designed as generic test methods
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
The OECD Principles of GLP
(Paris1998) Research Design
Cons
• Restricted flexibility, too high degree of
details
• Formality superior to proper performance
• Highly bureaucratic
• Excessive Control
• Continuing tendency to excessive
requirements
• Expensive/Unfavourable cost-benefit-ratio
• Not adapted to the needs of chemical
analysis
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
EN 45001 / ISO Guide 25
Research Design
•
•
•
•
•
•
•
Pros
Focusing on technical competence
(Potential for more) Flexibility
Adapted to analytical testing
Higher scope for self-responsibility
Generic test methods applicable
Cons
Continuing tendency to expand
requirements
Professional judgement excluded from
accreditation scope*
__________
*The new standard ISO/IEC 17025 allows the
inclusion of opinions and interpretations in the
test report
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
Development and Research
(Chapter 4 of ISO 9001)
Contents
4.1
Aims and application range
4.2
Definitions
4.3
Responsibilities
4.4
Procedures
4.4.1
Development of test methods
4.4.2
Modification of test methods
4.4.3
Non-Routine testing with respect to
accreditation
4.4.4
Validation of test methods
4.4.5
Use of statistical methods for the validation of
test methods
4.5
Documentation and archiving
4.5.1
Documentation
4.5.2
Archiving
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
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Comparison of QM-Standards for
Non-Routine and R&D Analytical Work
Field
ISO 9001 EN 45001/ GLP
ISO 25
Organisational Process
Project Management
Study Director, Study Plan
+
+
+++
Technical Competence
+(+)
++(+)
+
Staff
+(+)
++(+)
+(+)
Equipment
+(+)
++
+(+)
Facilities
+
+(+)
+(+)
Evaluation and Discussion of
Results/Professional Judgement
-
-
++
Quality Assurance Programme
Audits, Reviews
++
+(+)
++(+)
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
W. Steck
Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
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Application Fields of QM-Systems
Degree of detail
DIN ISO 9000 ff
GLP
EN 45001
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
W. Steck
Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
Combined QM-Systems for
R&D Analytical Work
ISO 17025
Organisational
activities
ISO 9001
EURACHEM/
CITAC
Guide 2
Technical
activities
EN 45001/ISO 25
Technical
activities
GLP
Selected
elements
EN 45001
+
NEN 3417
(SC 03)
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
Accreditation of Non-Routine
Analytical Work by Types of Test
Flexibilisation of the scope of accreditation:
All means to be taken for accreditation not
directed exclusively at the accreditation of
individual test methods.
The accreditation of types of tests - which is
based primarily on measurement principles
instead on specific test methods only - is one
possibility for flexibilisation of accreditation.
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
Testing Fields, Types of Test,
Test methods
Testing fields
Sizable sectors distinguished by common
fundaments of a technical, methodological or trained
related nature.
For example:
• Chemical and physico-chemical analysis
• Biological investigations
• Application tests
• Safety tests
• Medical laboratory diagnostics
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
Testing Fields, Types of Test,
Test Methods
Types of test
Sector of a testing field with similar technicalmethodological features, with comparable calibration,
validation and training principles. Types of test may
be defined on a technology or application related
basis.
For example:
Testing field
Types of test
Chemical and
physico-chemical
analysis
Mass spectroscopy
NMR spectroscopy
UV/VIS-Flourescence
spectroscopy
IR/Raman-spectroscopy
Atomic spectrometry
Gas chromatography
Migration
Waste Water Analysis
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
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Accreditation of Non-Routine
Analytical Work by Types of Test
Some features:
Testing laboratories are given the opportunity
to introduce/develop new test methods within
the approved type of test or of modifying
existing methods without having to obtain
approval from the accreditation authority in
each invidual case in advance.
It allows confirmation of the competence of
Non-Routine analytical activities on the basis
of general work (e.g. generic test methods).
Making the scope flexible with respect to
methodology used does not necessarily
imply making it flexible with respect to the
test items.
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
W. Steck
Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
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Accreditation by Types of Test
Proofs of competence:
Competent technical staff
Knowledge and experience concerning measurement
principles, methodology, technology, technical range,
science, test items and validation
Documented competence like specific test methods,
generic test methods, SOPs for non-routine analysis,
SOPs related to types of test, scientific reports, test
reports and others
Adequate and controlled/calibrated equipment
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
W. Steck
Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
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Accreditation of Type of Tests Strategy
for Selection of Test Methods for GC
Technique
Sample
application
split injection
splitless
injection
cold-oncolumn
injection
temperature
programmed
vaporization
Headspace
GC
Pyrolysis GC
Thermo
desorption
...
Separation
Evaluation
method
Detection
capillary
column
flame
ionization
internal
standard
packed
column
thermal
conductivity
external
standard
column
coupling
...
mass
selective
standard
addition
element
specific
area-%
nitrogen
specific
thermal
energy
analyzer
electron
capture
...
isotopic
dilution
...
Application field
analyte/matrix
(working range)
purity control for
release of raw
materials and
final products
(> 90 g/100 g)
impurities in chemical
products
( 0.01 – 10 g/100 g)
residual monomers
e.g. VC in PVC
( ng/g - µg/g)
N-nitrosamines
in air (µg/m 3)
Enantiomer
separation
...
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
W. Steck
Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
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QM-Systems for Non-Routine
and R&D Analytical Work Accreditation of
Non-Routine Laboratories
Summary
I.
In its current, non-modified version no single QM-System
can be recommended as beeing the most suitable for
monitoring the quality of Non-Routine
and R&D Analytical work.
II. Combining the technical focus of EN 45001/ISO 25 with
organisational and R&D project management elements
taken e.g. from GLP or ISO 9001 has proven as fit for
purpose.
III. Using the types of test approach the accreditation
according to EN 45001/ISO 25 has become flexible
enough to deal not only with Routine but also
successfully with Non-Routine and R&D Analysis.
IV. Non-Routine / R&D Laboratories have already been
accredited in Europe according to the schemes II. or III.
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
W. Steck
Quality Systems for Non-Routine and R&D Analytical Work Accreditation of Non-Routine Laboratories
Accreditation of Non-Routine
Laboratories
Publications concerning flexible accreditation
1. EAL-P 10, Edition 1, February 1997, The Scope of Accreditation
and Consideration of Methods and Criteria for the Assessment of
the Scope of Testing.
2. DACH GmbH, Technische Mitteilung, No. 3, Februar 1997,
Flexibilisation of the Scope of Accreditation, Accreditation of Type
of Tests
3. F. Eggimann, J. Morkowski: An adaptable modular QA-system of
a large multi-discipline testing laboratory. Proc. of the 1st Eurolab
Symposium, January 28 to 30th, 1992, p. 24-34.
4. F. Eggimann, J. Morkowski: A modular approach for the
assessment of the competence of a testing laboratory in a
specific testing field. Proc. of the 1st Eurolab Symposium,
January 28-30, 1992, p. 501-515.
5. F. Eggimann, R. Fischbach, J. Thies: Experiences with the
modular assessment of conformity and competence of a testing
laboratory. 2nd Eurolab Symposium, Testing for the years 2000,
Florence, Italy, April 94.
6. EURACHEM/CITAC Guide 2, 1998, Annex C
7. Steinhorst, Accred Qual Assur (1998) 3: 294
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
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