Title: Requirements for the Competence of Providers of Proficiency Testing Schemes
1Requirements for the Competence of Providers of
Proficiency Testing Schemes
- ILAC Guide 132000
- supplementing ISO Guides 43-1 and 43-2
2ILAC Guide 132000Preamble
- directed to the providers of PT schemes
(voluntary basis), - a basis for recognising the competence of
providers of PT schemes by formal compliance with
a set of internationally acceptable requirements
for PT planning and implementation, - based on ISO Guide 43-1 and on relevant elements
of ISO/IEC 170252000, ? applicable to the
characterisation, homogeneity and stablility of
the PT test material, - the responsible organisation for coordinating and
providing a PT scheme should ensure compentent
performance (whether carried out by itself or by
collaborators).
3ILAC Guide 132000Preamble
- Relevant elements of ISO 9000 are included (to
eliminate the need for separate recognition for
compliance with ISO 9000), accordingly
comprising - Management System Requirements
- Technical Requirements
- but
- ILAC Guide 132000 is applicable only for
interlaboratory comparisons for the purpose of PT
4Management System Requirements
- The provider of a PT scheme shall
- establish, implement and maintain a QM system
appropriate to its scope of activities (incl.
type, range, volume of PT schemes provided) - define and document policy, objectives,
commitment to ensuring and maintaining the
quality of all PT aspects, i.e. - homogeneity, stability, equipment calibration,
method validation, statistical procedures,
performance evaluation, storage transport,
reporting ...
5Management System Requirements
- The provider of a PT scheme shall have a Quality
System covering - aims, scope statistical design, format
- operational procedures, preparation and issuing
of reports - policies on confidential and ethical procedures,
handling of complaints - computing and information systems
- collaboration subcontracting
- participation fees
- use of scheme results
- role and responsibilities of Technical Quality
Manager PT coordinator.
6Organisation and Management
- Requirements for providers of PT schemes
- managerial technical personnel with the
resources needed - management and personnel free from commercial or
other pressures - policies and procedures to ensure the protection
of confidential information and proprietary
rights - policies and procedures to avoid involvement in
activities that might diminish confidence in
competence, impartiality, judgement, integrity.
7Organisation and Management
- Requirements for providers of PT schemes
- define organisation and management structure,
inter-institutional relations, etc. - specify responsibilities, authorities, have a
technical management, appointed Quality
Technical Manager (deputy, if applicable)
8Document Control
- establish and maintain procedures to control all
documents - approval and issue
- unique identification
- authorised editions available where essential
- periodical document review and withdrawal of
obsolete documents - review of document changes
- request, tender, contract review
- records of reviews
9Use of collaborators
- PT provider shall have procedures for evaluating
and selecting collaborators.
Procurement of services and supplies
- PT provider shall have procedures for the
selection of services and supplies - to use adequate services and supplies
- equipment, consumables not to be used until
inspected, calibrated, verified for compliance.
10Control of non-conforming activities
- procedures shall ensure
- designated responsibilities
- actions in case of nonconformities
- evaluation of significance
- work halted, if necessary
- remedial action
- complete records maintenance of nonconformities
- corrective actions promptly followed.
11Corrective actions
- policies and procedures shall ensure
- appropriate personnel for implementing corrective
actions - appropriate corrective actions to eliminate
causes - document and implement any required changes to
operational procedures.
12Corrective actions
- identification of QM system problems
- client complaints,
- quality control,
- test material checking,
- statistical evaluation,
- observations / supervision,
- management reviews,
- internal / external audits,
13Corrective actions
- should include
- cause analysis,
- monitoring of corrective actions,
- protective action to reduce the likelihood of
nonconformances.
14Records
- PT provider shall establish and maintain
procedures for - identification, collection, indexing, access,
storage, maintenance, disposal, retention, - quality and technical records, including
- legibility, retrievability, suitable environment
for storage, prevention of damage, deterioration,
loss.
15Technical records
- PT provider shall establish and maintain a
records system for - measurent observations,
- appropriate calculations,
- derived data (statistical treatments, uncertainty
budgets), - results from participants,
- scheme reports.
16Internal audits
- PT provider shall conduct internal audits
- with a predetermined schedule and procedure,
- addressing all elements of the QM system,
including the test item preparation, - at the responsibility of the technical manager to
plan and organise, - by trained and qualified personnel who are
independent of the activity to be audited (if
ever feasible).
17Management reviews
- Senior management shall periodically conduct a
review of the PT providers QM system and PT
scheme procedures. - The review should take account of
- reports of management and supervisory personnel,
- outcome of recent internal audits and assessments
by external bodies, - feedback from participants,
- other relevant factors.
18Technical requirements - Management, Staffing,
Training
- coordination and conduct of PT schemes only be
undertaken if respective experience in
interlaboratory comparisons and the type of test
items is in place, - competence in the measurement of the properties
to be determined (assignment of values,
homogeneity, stability). - Note
- laboratory accreditation to ISO/IEC 17025 for
appropriate tests will satisfy the requirement of
competence, - if no laboratory accreditation is in place other
factors should be considered (e.g. own laboratory
performance in appropriate PT schemes).
19Technical requirements -Management, Staffing,
Training
- appropriate managerial personnel,
- measurement of the properties of interest to be
supervised by a technically competent manager, - levels of qualification for the key positions
defined, - sufficient personnel with the necessary
education, training, experience, - staff be sufficiently trained,
- maintenance of up-to-date training records.
20Technical requirements - collaborators /
subcontractors
- the PT provider is required
- to demonstrate that the collaborators technical
competence is sufficient for the assigned tasks, - that work be placed with a competent laboratory,
- that the competence of the collaborator is
assessed, - that details of the methodology, results,
outcomes of monitoring are available and
appropriately maintained.
21Organisation and design - planning
- before commencement, a documented plan should be
in place, including - name and address of the PT provider, coordinator,
collaborators and other personnel involved, - nature and purpose of the scheme,
- procedure for selection (if applicable) and the
number and identity of expected participants, - the manner in which test items are to be
obtained, checked, distributed,
22Organisation and design - planning
- before commencement, a documented plan should be
in place, including - description of the information to be supplied to
participants (pre-notification) and the time
schedule for the various phases, - target dates / deadlines,
- frequency / dates upon which test items are to
be distributed (for ongoing schemes), - information on methods / procedures needed to
perform the tests, - outline of the statistical analysis to be used,
including determination of assigned values and
outlier detection techniques,
23Organisation and design - planning
- before commencement, a documented plan should be
in place, including - a description of the data or information to be
returned by the participants, - the basis of performance evaluation,
- the extent to which test results / conclusions
based on the outcome of the scheme are to be made
public.
24Organisation and design - planning
- The PT provider should
- establish an advisory group of technical
specialists with detailed experience in the
relevant field the responsibilities should
include the complete design and arrangements of
the PT scheme, - have (or have access to) a statistician to design
and implement a PT scheme and analyse submitted
results.
25Organisation and design preparation of test
items
- The PT provider should provide procedures and
resources for - material selection,
- maintaining a suitable environment for
preparation and testing of test material, - material preparation, measuring, testing,
equipment calibration, measurement methods, - assessing material homogeneity / stability,
- adequate storage facilities and conditions,
- adequate packaging / labelling / transport /
distribution,
26Organisation and design - preparation of test
items
- The PT provider should provide procedures and
resources for - statistical analysis of test results and
assigning values of measurands / associated
uncertainties, - adequate reporting service to participants.
27Organisation and design - homogeneity and
stability testing
- The PT provider shall
- use a random selection of samples to assess the
homogeneity of the PT material, - have a documented assessment procedure in
accordance with an acceptable statistical design
(e.g. analysis of variance under repeatability
conditions), - assess homogeneity after the test material has
been packed, and before distribution to
participants (as far as applicable), - determine PT values periodically (over a range of
applicable storage conditions), - demonstrate that test material is sufficiently
stable without significant changes throughout the
PT scheme.
28Organisation and design - statistical design
- The PT provider shall
- document the statistical model and data analysis
techniques to be used, - describe the reasons for the model selection,,
- ensure that the statistical treatment is carried
out in accordance with the prescribed procedures
(i.e. ISO Guide 43-1), - give careful consideration to trueness,
precision, assigned value, confidence level,
outliers, homogeneity, stability.
29Organisation and design - choice of method /
procedure
- The PT participants shall normally be permitted
to use the test method of their choice
(consistent with routine procedures). - Details of the methods used should be requested
from the participants, to permit comparisons and
comments on the results obtained by different
test methods.
30Conduct of PT schemes -instruction to the
participants
- The PT provider shall
- inform participants in due time about the
intention to conduct a PT scheme, - give detailed documented instructions to all
participants (influencing factors, storage
conditions, test procedure, timing, etc.), - give specific instructions on recording and
reporting of results (units, number of
significant figures, e.g. based on dry weight or
as received, etc.), - instruct participants to treat PT samples in the
same manner as routine samples.
31Conduct of PT schemes - materials handling and
storage
- The PT provider / collaborator shall
- identify, preserve, segregate all test material
and test items to avoid contamination, - ensure adequate packaging and secure storage,
- assess conditions of stored / stocked items and
materials at specified intervals during storage.
32Conduct of PT schemes - packaging, labelling,
distribution
- The PT provider shall
- control packaging and marking processes,
- ensure that labels are securely attached to the
packaging and remain legible and intact within
the period of use.
33Data analysis and interpretation of PT scheme
results
- Appropriate data analysis and records require
- adequate data processing equipment,
- a description of all data processing equipment
established and maintained, - the role and responsibility of a person
designated for the effective operation of the
data processing system, - data processing equipment and software be
validated according to documented procedures
before use,
34Data analysis and interpretation of PT scheme
results
- Appropriate data analysis and records require
- received results be promptly recorded and
analysed by appropriate documented statistical
procedures, - documented criteria and procedures for dealing
with results inappropriate for statistical
evaluation, - documented criteria for determining whether test
items are not suitable for evaluation
(inhomogeneity, instability, contamination).
35Data analysis and interpretation of PT scheme
results
- Evaluation of performance (if required)
- overall performance against prior expectation,
- variation within and between laboratories,
- comparison with previous schemes or published
precision data, - variation between methods / procedures,
- possible sources of errors,
- suggestions for improving performance,
- comments, recommendations, conclusions.
36PT scheme reports
- A PT report shall be comprehensive, clear with
data on the distribution of the results of all
participants, including - name and address of the provider, persons
involved in the design and conduct of the scheme, - date of issue of the report,
- clear identifcation of the report,
- description of items, materials, details of
sample preparation, homogeneity testing, - participation codes and test results,
- statistical data and summaries, assigned values,
acceptability ranges, graphical displays, - traceability, uncertainty of assigned values.
37PT scheme reports
- A PT report shall include (where appropriate)
- comments on particpants performance by the
provider and technical advisers, - details / reference to the scheme protocol,
- advice on the interpretation of statistical
results. - Report shall be made available to the
participants within a specified time table.
38Communication with participants
- The PT provider shall provide detailed
information to potential partipants (form of
scheme protocol, how to apply, scope, fees,
policies). - Prompt advices in writing in the case of changes
in scheme design and operation. - Feedback from particpants be encouraged for the
active contribution to the development of the
scheme.
39Confidentiality
- The identity of the PT participants shall be
confidential. - All information supplied by the participant to
the provider shall be treated as confidential. - Note PT schemes should be designed to ensure
that there is little opportunity for collusion
and falsification of results.