Proficiency testing (PT) evaluation of the participant performance against pre-established criteria by means of interlaboratory comparisons.

Transcription

1 1. Proficiency testings REFERENCE DOCUMENTS RENAR P-04 Policy on the use of proficiency testing and inter-laboratory comparisons in accreditation; SR EN ISO CEI 17011:2005 Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies; SR EN ISO CEI 17025: 2005 General requirements for the competence of testing and calibration laboratories; SR EN ISO CEI 17020: Conformity assessment Requirements for operation of various types of bodies performing inspection SR EN ISO CEI 17043:2010 Conformity assessment - General requirements for proficiency testing; EA and ILAC documents related to the field ( and DEFINITIONS AND ABBREVITATIONS Definitions: Proficiency testing (PT) evaluation of the participant performance against pre-established criteria by means of interlaboratory comparisons. Interlaboratory Comparisons (ILC) - organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions. Bilateral proficiency testing determining the proficiency of the laboratory to carry on tests/calibrations by examining a test item which is accurately characterized and presented to the laboratory within an accreditation procedure. Test items can be provided by an evaluator or a third party Participation RENAR requests the accredited laboratories or in process of accreditation to participate in PTs in order to demonstrate and monitor the laboratory performance to carry on tests/calibrations in the field for which accreditation was requested/granted Before, during and after the participation at PTs, the laboratory shall take into consideration all relevant aspects regarding the adequacy to the scope of the PTs. This includes: selection of the PTs, planning, execution, results review, defining and implementation of corrective/preventive actions, process documentation and archiving the documents.

2 A laboratory which wishes to participate at PT has to review the following two aspects: if there are PTs in the laboratory field of activity; if the PT is relevant for the laboratory field of activity When assessing the relevance of the PT there shall be taken into account at least the following: a) the competence of the PT provider: the provider may be accredited by against the requirements of SR EN ISO CEI 17043; if the laboratory recourse to a PT provider which is not accredited it s necessary to carry on and document its own evaluation of the provider (art 4.6 of ISO IEC and ISO 15189). b) if the participation to a certain PT is useful for the assurance of the test/calibration/analysis competence. Note: RENAR does not take into account the participation and results to PTs for which laboratory can not prove the usefulness of PT in demonstrating its competence. c) in case there are many very similar PTs, the laboratory shall take into consideration the effectiveness and efficiency of its choice. d) if the proficiency testing is compatible with the testing/ calibration/ daily analysis of the laboratory; Note: Can be analyzed at least the following: elements analyzed usually by the laboratory (e.g. Cu, Ag, Hg) by comparison with the elements proposed by the organizer (e.g. Ag, Al, Hg); product analyzed by the laboratory (e.g. dog food) by comparison with the product proposed by PT (ex. animal feed); the usual concentration level for laboratory (ex mg/kg) by comparison with the concentration proposed by PT (e.g mg/kg); testing method used by the laboratory comparing to the method proposed by PT; laboratory type (e.g. first party laboratory) by comparison with the type of laboratory proposed by PT (e.g. any type of laboratory first, second or third party). e) if the number of rounds carried on in a PT is sufficient to demonstrate competence in test/ calibration; f) characterization of the item subject to PT Participation of CAB to the PT organized by EA are mandatory no matter they are accredited or in process of accreditation PT participation frequency RENAR has established a PT minimum participation frequency through its Policy, P-04. The accredited CABs participate at PTs if there are any available and relevant, according to their PT participation plan.

3 In order to establish the participation frequency when preparing the PT participation plan, the laboratory shall take into account at least the following: 1. RENAR s requirements on the PT participation frequency approved by Policy P-04 available on RENAR s website; 2. PT participation frequency requested by the normative documents issued by the authorities in the respective field; 3. objectives of the laboratories (e.g. fulfillment of the eligibility criteria in case of medical laboratories, fulfillment of requests of competent authorities in case of CABs which carry on specific activities or are notified; 4. extension of activity; modifications of the scope out of different reasons, changes in the personnel structure, etc.); 5. number of participations and the results of the previous participations (unsatisfactory results, disputable results etc.) In the fields where the minimum level of participations is established by the authorities, the accredited laboratories and the laboratories in process of accreditation shall fulfill that level RENAR requests laboratories to define their PT participation frequency on the basis of a documented risk analysis, taking into account the possibility of obtaining results which are not conforming to the specific requirements of the accreditation field. This takes into consideration especially: the number of tests/ analysis/ calibrations or carried on measures; the possibility of using the results of a PT for the evaluation of the proficiency of a group of tests which involve the similar measurement techniques and/or referring to the group of products; the number of persons directly involved and the frequency of changing the personnel; the level of training and general experience of personnel; access or not to the traceability sources (national standards, certified reference materials); the level of exigency of the results depends on their final use RENAR can impose a higher participation frequency or specific application rules for specific technical sectors Where there are not available any PTs, the laboratories are requested to demonstrate the validity of tests/ calibrations/ analysis they are carrying on by other means such as: use of reference standards or materials (certified), comparison of the results obtained using other means, systematic evaluation of the factors which are influencing the result, evaluation of results uncertainty on the basis of the scientific understanding of the theoretical principles and of own experience etc In case there are not available PTs, concerning the way the quality of results of tests/ calibration/ analysis is assured, the laboratories are requested to present at least the following records referring to: regularly use of certified reference materials/ quality control using secondary reference materials, replicate tests/ calibrations using the same methods or

4 different methods, retesting or recalibration of the items kept, results correlation for different characteristics of an object Where there are available PTs, RENAR requests the accredited laboratory to document the motivation concerning its rejection to participate to PTs Criteria for selecting PT providers RENAR gives the laboratory the freedom to choose the PT scheme which satisfies the selection criteria from , the PT provider being considered a service provider (ISO article 4.6) RENAR can request the laboratory to participate in a certain PT scheme, when it is considered necessary based on the different issues arising from accreditation Analysis of results obtained by the laboratory following the participation to PT When determine its performance, the laboratory shall take into consideration at least the following: compliance with the PT performance criteria and undertaken corrective actions (short term assessment); after participating in one or more PTs, comparison of its current performance with the previous ones (long term assessment) The laboratory should also study the general performance of all participants to PT. The questionable results obtained by the laboratory, when the majority of the participants obtained satisfactory results, it should be considered by the laboratory unsatisfactory, in contrast to obtaining satisfactory results for when a significant number of participants obtained poor results In case of questionable results, the laboratory examines the causes and possible consequences and undertakes corrective actions. These measures shall include both the review of the test reports/ calibration certificates/ analysis bulletins which may be affected and already sent to the clients and, on the other hand, technical, corrective/preventive measures which shall ensure that the PT results satisfy the client expectations Corrective actions If the participant laboratory appreciates its performance as being unsatisfactory, it shall undertake corrective actions/corrections, according to its own procedures for treating the nonconformities The laboratory shall verify if the corrective actions/corrections were efficient Data requested by RENAR on PT Annually, in the first trimester, until the 31 st of March of each year, the accredited laboratory shall send to RENAR, to Proficiency Testing Manager, the situation regarding its

5 participation and PT results from the previous year (even in case the laboratory did not participate in any PT shall fill in the form F-08-PR-14 List of participations and results obtained in PT/ILC and send it to RENAR) On RENAR s request, the laboratory shall send a communication concerning the participation situation, the obtained results and actions undertaken following its participation to the respective PT Proficiency Testing Manager maintains records concerning the level of participations of the laboratories to PTs The records regarding the performances of the laboratory to PT are maintained in the laboratory accreditation file by the Lead Assessor. 1.7 Actions in case of unsatisfactory results In case a laboratory obtains unsatisfactory/ questionable results following its participation to a PT (including the situation of receipt of interim results) it shall: use its own procedure for treating the non-conformities, establishing the causes which led to the results and undertake the necessary corrections, corrective actions, respectively preventive. These measures shall include a reexamination of the test reports/ calibration certificates which can be affected and have already been sent to the clients and as well the technical measures with corrective and preventive character which guarantees the client s expected quality of the reported results from now on. when the keeping under control the test/ calibration/analysis is not demonstrated either by proficiency testing or by other means available to laboratories, the laboratory is not able to deliver results under accreditation and if the situation persists it is necessary to notify RENAR in that respect Evidence of closing the non-conformity can be a new participation with satisfactory results, to similar available PT RENAR can request additional participation to PT if: there are doubts on the technical competence of the laboratory; the results obtained at PT does not satisfy the defined performance criteria; the corrective actions undertaken following the finding of non-conformities were not efficient or there are no evidences of checking their efficacy; there were made significant changes in the management system, personnel, infrastructure or accreditation scope Sanctions In case the information related to the participations and results obtained to PT are not available or sent to RENAR, the CAB shall be warned about this situation. The CAB shall send the requested information within an established deadline. In case the CAB does not send the requested information, a commission is established to analyze the situation. The commission is composed of LA, PTM and LAD. The commission proposes the sanctions and decision follows.

6 Table no. 1 Situations SANCTIONS First deviation Repeated 1 Unjustified non-attendance at PT Warning Suspension 2 Unsatisfactory results at PT without being followed by: presenting the analysis evidences and undertaken measures (Warning) Extraordinary assessment (additional) or suspension, as it is the case, depending on the risk analysis conclusions Suspension 3 Intentional reporting of false results or false by omission Accreditation withdrawal In case the laboratory is not sending to RENAR the information on the participation to PTs (the annual report also in case of the participation with unsatisfactory results), the Proficiency Testing Manager collaborates with the Accreditation Director with view to the current situation of the records regarding the PT and the above mentioned sanctions from Table 1, point 1 shall be applied Taking into account the testing/calibration and the history of the raised non-conformities, the Lead Assessor proposes: when there are unsatisfactory or questionable results obtained for the first time, RENAR s procedure for additional monitoring of the laboratory shall be applied and/or request its participation of RENAR to witnessed bilateral PT or at similar PT; when unsatisfactory results repeated (subsequently or not) of maximum three times, RENAR s procedure for suspension of accredited test/calibration, of the scope or of the entire accreditation applies, depending on their level of impairment due to the appeared situation; when unsatisfactory results repeated (subsequently or not) more than three times, RENAR s procedure for suspension of accredited test/calibration, of the scope or of the entire accreditation applies, depending on their level of impairment due to the appeared situation. If a laboratory can prove the participation with satisfactory results to two subsequent PTs, following those mentioned before, on the same or similar type of sample, the Lead Assessor can propose the lifting of suspension.