requirements for the competence of providers of proficiency testing schemes

Requirements for the Competence of Providers

of Proficiency Testing Schemes

ILAC Guide 13:2000– supplementing ISO Guides 43-1 and 43-2

ILAC Guide 13:2000 2

ILAC Guide 13:2000Preamble

– directed to the providers of PT schemes (voluntary basis),– a basis for recognising the competence of providers of PT

schemes by formal compliance withformal 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 17025:2000, applicable to the characterisation, homogeneitycharacterisation, homogeneity and stablilitystablility of the PT test material,

– the responsible organisation for coordinating and providing a PT scheme should ensure compentent compentent performanceperformance (whether carried out by itself or by collaborators).


• Relevant elements of ISO 9000 are included (to eliminate the need for separate recognition for compliance with ISO 9000), accordingly comprising:

– Management System RequirementsManagement System Requirements

– Technical RequirementsTechnical Requirements

but:• ILAC Guide 13:2000 is applicable only for

interlaboratory comparisons for the purpose of PT

ILAC Guide 13:2000Preamble


Management System Requirements The provider of a PT scheme shall:

– establish, implement and maintain a QM QM system appropriate to its scope of system appropriate to its scope of activities activities (incl. type, range, volume of PT schemes provided);

– define and document policy, objectives, policy, objectives, commitmentcommitment 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 ...


Management 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.


Organisation 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.


Organisation 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)


Document 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


Use 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.


Control 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.


Corrective 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.


Corrective actions

identification of QM system problems:– client complaints,– quality control,– test material checking,– statistical evaluation,– observations / supervision,– management reviews,– internal / external audits,


Corrective actions

should include:– cause analysis,– monitoring of corrective actions,– protective action to reduce the

likelihood of nonconformances.


Records

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.


Technical 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.


Internal 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 independent of the activity to be audited audited (if ever feasible).


Management reviews

Senior management shall periodically conduct a review of the PT provider‘s 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.


Technical requirements - Management, Staffing, Training

– coordination and conduct of PT schemes only be undertaken if respective experienceexperience in interlaboratory comparisons and the type of test items is in place,

– competencecompetence in the measurement of the properties to be determined (assignment of values, homogeneity, stability).

Note: – laboratory accreditationlaboratory 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).


Technical 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.


Technical requirements - collaborators / subcontractors:

the PT providerPT 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.


Organisation 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,



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,



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.



The PT provider should: – establish an advisory groupadvisory 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 statisticianstatistician to design and implement a PT scheme and analyse submitted results.


Organisation 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,


Organisation 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.


Organisation 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.


Organisation 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.


Organisation and design - choice of method / procedure:

The PT participants shall normally be permitted to use the test method of test method of their choicetheir 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.


Conduct 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.


Conduct 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.


Conduct 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.


Data 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,


Data 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).


Data 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.


PT 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.


PT 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.


Communication 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.


Confidentiality

The identityidentity of the PT participants shall be confidentialconfidential.

All information suppliedinformation supplied by the participant to the provider shall be treated as confidentialconfidential.

• Note: PT schemes should be designed to ensure that there is little opportunity for collusion and falsification of results.

requirements for the competence of providers of proficiency testing schemes

Documents