P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
Typical Non Routine Analysis (NRA) and
Research and Development (R&D)
Situations
1
•
Question unclear
• Sample and matrix unknown
• Method new or unproven
• Deviation of concentration range
•
Synthesis and materials R&D
• Process development
• Analytical R&D (techniques / method)
• "Trouble shooting" (e.g. quality control, production )
•
Academia
• Industry and Commerce
• Government and public services
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
2
Sample
Sampling
Sample preparation
Analysis (method)
RA NRA /R&D
• • • •
• • • •
• • • •
• • • •
• • • • Confirmation of data
Validation / MU* (•) • • •
Preparation of RM** (•) • • •
Evaluation of results
Reporting of results
(•) • • •
• • •
Interpretion / Comments (•) • • •
•
* Measurement Uncertainty
** Reference Materials
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
3
Many unknowns
• Sample, matrix
• Problem, answers
• Methodology
• Resources
Require EXTRA effort
(Quality Assurance, QA)
• Planning of task and performance
• Execution and control of work
• Evaluation of work and results
Extent depends on
• Complexity
• Degree of novelty
• Expenditure and duration
• Risks and consequences
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P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
4
Requirements
• usefulness of results
• valid and reproducible data
• compliance with cost and time limits

= Fit for purpose
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P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
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• Projects are problem solving tasks
• Many uncertainties
• Flexible planning with alternatives
• Efficiency requires planning and structuring of work
• Much QA effort: technical + organizational
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
6
Combination of elements
PROJECT MANAGEMENT (PM)
+
QUALITY MANAGEMENT (QM)
Scientist: Manager of the Unknown
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
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Project
1. Something that is contemplated, devised or planned; plan; scheme
2. A large or major undertaking, esp. one involving considerable money, personnel and equipment
3. A specific task of investigation, esp. in scholarship
4. Educ. an educational assignment necessitating personal initiative on the part of a student
Task
1. A definite piece of work assigned to a person
2. Any piece of work
3. A matter of considerable labor or difficulty
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
8
EURACHEM/CITAC Guide CG2 ”Quality
Assurance for Research and Development and
Non Routine Analysis", Chapters 7.1, 7.2, 7.3
Phase 1: Preparation and planning before work
• definition of task and project design
• project design and research plan
• resource management of task
Phase 2: Work in progress
• progress review / monitoring analysis
• data verification
• changing direction
Phase 3: Work is completed
• achievement review
• reporting, technology transfer and publication
• archiving
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
Task Definition + Project Design
9
Analysis and Definition
• Understand, analyse, define problem and review of literature, goals
• Experience
• Sampling, sample / matrix, analyte
• Methods, accuracy, validation, RM
• Dates of preliminary results, completion
• Decision points (date, result, expense)
• Resources, subcontraction
• Confidentiality, intellectual property
• Archiving
• Exploitation
Tool: Questionnaire
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
Project Design and Research Plan
10
Defines
Goals: Intermediate goals
Decision points / milestones
Answers / results
Tactics: Task
Workpackage (WP)
Resources: Personnel
Equipment
Time:
Total / WP
Start
Intermediate dead lines (WP)
End
Tools: flow-chart, bar-chart, critical path method
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
Task Definition + Project Design
11
Organization of Task Environment
• Scope
• Objectives
• Resources
• Costing
• Milestone planning
• Contract control
• Financial control
• Change management
• Customer liaison
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
1. Preparation and Planning
Project Design and Research Plan
12
Resource Management
• Define authority and responsibility
• Set tasks and time table
• Involve all personnel
• Secure availability (resource, time)
• Monitoring system
• Communicate and consult
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
Record and Verify
Document
• Lab work, observations
• Lab data and print-outs
• Progress, difficulties
• Unsuccessful work
• Deviations from plan
• Ad hoc changes
• Organisational aspects
Verify and validate
• Consistency with literature
• Plausible with experience
• Reproducibility of results
• Check data with RM / model substances
• Reproduction of work
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
13

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
Progress Review
Monitor
• Results, problems
• Deviation from plans
• Expense
• Time schedule vs. achievement
Reports, meetings
• Irregular intervals
• Milestones / dates
• Workpackage
• Major problem
Decide and report
• Change / modify plan
• Stop / go
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
14

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
Reporting
Presentation in reports, SOP, publications
• Comprehensible
• Enable reproduction of work
• Document trueness (validation, MU)
• Problems, dangers
15
Achievement review
• Usefulness of results
• Quality of work
• Gained experience
• Compliance with expense
• Satisfaction of client
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
Archiving + Reporting
Secure storage
• Note books
• Data recordings
• Samples
• Reference samples
Requirements
• Legal / regulatory (contents, length, safety)
• Customer / external agency
• Verification
• Validation
• Proficiency testing with samples
• Duplication of work
• Technology transfer, publication
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000
16

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
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• Analyse problem
• Plan and organise work
• Work and monitor results
• Verify and validate data
• Document activities and results
• Report and review
• Archive documents and samples
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000

P. Radvila Concepts of Quality Management and Quality Assurance in
Analytical Research Projects and Non Routine Analysis
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Q-Key elements ISO/IEC 17025 Management
Requirements Tools
Analyse
• Plan and Organise
• Work and Monitoring
• Verify and validate
• Document
• Report and Review
• Archive
Management
Technical
PM
+
QM
QA in NRA and R&D is TQM !
B. Neidhart, W. Wegscheider (Eds.): Quality in Chemical Measurements © Springer-Verlag Berlin Heidelberg 2000