Transcript Technical requirements Sampling Analysis Reporting of the results

Technical requirements
 Sampling
 Analysis
 Reporting
of the results
Quality
 Selecting
analytical procedures suitable for
answering the analytical questions (good
science)
 Performing
the selected tests in a
traceable manner, according to clear and
transparent procedures under proper
conditions (good QA system)
The Laboratory Process
Report
Laboratory
Sample
Intermezzo
 Participant
discussion on critical
aspects after receipt of the sample,
prior to analysis
Sample
The Laboratory Process: Sampling
Registration
Labelling
Receipt
Disposal
Identification
Temperature control
Storage
Protection
Sampling
( ISO 17025:2005, 5.7, 5.8 )
Sampling plan and procedures:
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Statistically based appropriate
Deviations required by customer are recorded
and reported
Recording data as sampling procedure,
identification of sampler, sampling location,
statistics as appropriate
Abnormalities of samples are recorded
Secure storage -> further investigations or
return to service
Laboratory Process
 Participant
discussion
the analytical process
Laboratory
Sample
Analyzing the laboratory
Equipment
Reference standards
Method validation
SOP
Quality Control
Calibration
Uncertainty of measurement
Traceability
Equipment - 1
(ISO 17025:2005, 5.5)
 Identification
 Maintenance
plan
 Calibration according to plan and use
 Records are maintained from checks,
calibration, maintenance, defects
Equipment - 2
(ISO 17025:2005, 5.5)
 Adequate
equipment is required for the
correct performance of tests, meets
specifications (IQ, PQ, OQ)
 Equipment is operated by authorized
personnel
 Up-to-date instructions are present for use
and maintenance
Equipment - 3
(ISO 17025:2005, 5.5)
 Equipment
out of laboratory or calibrated
is tested first for correct functioning before
returning to service
 Calibration state is controlled and if
verification checks of calibration are
needed they are carried out
Equipment - 4
(ISO 17025:2005, 5.5)
 Handling
of defect equipment
 If calibration results in correction factors
procedures are available to ensure that
copies (computer software) are correctly
updated
 Safeguarding from adjustments (hardware
and software) which invalidates results
Test and calibration methods and
method validation -1(ISO 17025:2005, 5.4)
 Use
of appropriate methods within its
scope (handling samples and estimation
measerements uncertainty)
 Preferably use of methods published in
international, regional or national
standards
 Appropriate method is chosen/advised by
laboratory
Test and calibration methods,
method validation - 2 (ISO17025:2005, 5.4)
 Laboratory–developed
methods are
planned activities and assigned to
qualified personel with adequate
resources
 Plans are updated and communicated as
development proceeds
 Validation of non-standard methods is
required
Test and calibration methods,
method validation – 3 (ISO17025:2005, 5.4)
 Validation
is the confirmation by
examination and the provision of objective
evidence that the particular requirements
for a specific intended use are fulfilled
 Validation
is required for non-standard
methods, standard method used outside
their scope or modified methods
Test and calibration methods,
method validation - 4 (ISO17025:2005, 5.4)
 Validation
items:
 Uncertainty of results, detection limit,
selectivity, linearity, limit of repeatability,
reproducibility, robustness against external
influences, interference from the matrix of
the sample object
 Validation shall be relevant for the
customer needs
Test and calibration methods,
method validation – 5 (ISO17025:2005, 5.4)
 A procedure
has to be applied to estimate
the uncertainty of measurements for
calibrations: reference is Guide to the
Expression of Uncertainty of Measurement
 Use knowledge and experimental data
(validation,quality controls, profiency tests)
Assuring the quality of
test/calibration results
(ISO 17025:2005, 5.10)
Resulting data are recorded and trend analysis (if
practicable by statistics) carried out:

regular use of reference materials/and or internal quality
control
 Interlaboratory comparison (profiency tests)
 Replicate tests using the same or different methods
 Retesting of retained items
 Correlation of results for different characteristics of an
item
 Planned action is undertaken when data are OOS,
correction of problem and prevention being reported
Uncertainty of measurement
Random effects:
 Short term fluctuations, temperature, pressure,
humidity
 Variability of measurer
Systematic effects:
 Offset measuring instrument
 Drift between calibrations
 Personal bias reading analogue scale
 Uncertainty value reference standard
Intermezzo
Participant
discussion
Closing the books, critical points
for reporting data
Laboratory
Sample
Report
The Laboratory Process
Certificate
Reporting results -1
(ISO 17025:2005, 5.10)
 The
laboratory has to report all requested
information to the customer
 Results are reported with complete
information about laboratory, customer,
sample data, used method, authorizing
personnel
 A simplified report is allowed for internal
customers or if agreed with the customer
Reporting results - 2
(ISO 17025:2005, 5.10)
 Where
necessary for interpretation of
results deviations are given
 Where relevant compliance or noncompliance statement is given
 If applicable estimated uncertainty of
measurement
 Identification of results from
subcontractors
Reporting results - 3
(ISO 17025:2005, 5.10)
 Electronical
transmission of results is
allowed
 Opinions and interpretations are out of
accreditation, clearly marked and the
basis has to be documented
 Admendments are marked as supplement
to original test report, or if a new report is
necessary shall refer to the original report