Proficiency Testings (PTs) and Interlaboratory Comparisons (ILCs) for the Department of Calibration Laboratories

Transcription

1 Title Reference Proficiency Testings (PTs) and Interlaboratory Comparisons (ILCs) for the Department of Calibration Laboratories RT-36 Revision 00 Date Preparation Approval Authorization Application date Director of Department Directive Council The President TECHNICAL REGULATIONS RT-36 rev.00 Page 1 of 7

2 CONTENTS 1 INTRODUCTION SCOPE NORMATIVE REFERENCES. 3 4 TERMS AND DEFINITONS. 3 5 DIFFERENT TYPES OF COMPARISONS PARTICIPATION AT COMPARISONS. 5 7 COMPARISONS INDICATING AN UNSATISFACTORY PERFORMANCE ELEMENTS TO BE GIVEN TO ACCREDIA.7 TECHNICAL REGULATIONS RT-36 rev.00 Page 2 of 7

3 1 INTRODUCTION With reference to UNI CEI EN ISO/IEC 17011, paragraph 7.15, the Accreditation Body (AB) shall, during the assessment and during the decision-taking process, take into consideration the participation of Laboratories to proficiency testing or other comparisons as well as the results obtained. ACCREDIA-DT considers the participation of a Laboratory at Proficiency testings or Inter Laboratory Comparisons (ILCs), when available, necessary in order to demonstrate competence regarding each accredited or applicant metrological sector and to ensure the quality of results. 2 SCOPE The present regulation identifies the different types of Proficiency Testings (PTs) and Inter Laboratory Comparisons (ILCs) and describes how results are managed and used by ACCREDIA-DT for the assessment of the technical competences of laboratories and producers of reference materials (RMPs) either accredited or applicant. 3 NORMATIVE REFERENCES The present regulation refers to (when applicable) the following normative documents: EA-2/14 M:2008 Procedure for Regional Calibration ILCs in Support of the EA MLA ; EA 4/18:2010 Guidance on the level and frequency of proficiency testing participation ; EA-1/17A-S1:2014 Supplement 1 to EA-1/17 Criteria for Membership ; ILAC-P9:06/2014 ILAC Policy for Participation in Proficiency Testing Activities ; UNI CEI EN ISO/IEC 17043:2010 Conformity assessment General requirements for proficiency testing ; ISO 13528:2005 Statistical methods for use in proficiency testing by interlaboratory comparisons; UNI CEI EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories ; UNI CEI EN ISO/IEC 17011:2005 Conformity assessment general requirements for accreditation bodies accrediting conformity assessment bodies. 4 TERMS AND DEFINITONS Proficiency testing (PT): evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons (UNI CEI EN ISO/IEC ). Interlaboratory comparison (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 (UNI CEI EN ISO/IEC ). Note: with regard to calibration laboratories both activities are normally referred to in terms of ILCs, whilst regarding RMPs both activities are normally referred to in terms of PTs. Proficiency test item: sample, product, artefact, reference material, piece of equipment, measurement standard, data set or other information used for proficiency testing (UNI CEI EN ISO/IEC ). TECHNICAL REGULATIONS RT-36 rev.00 Page 3 of 7

4 Measurement audits: calibration of a measurement standard or measurement instrument, whose calibration parameters are known, by a laboratory exclusively and entirely in the presence of the technical assessor during the on-site assessment. On-site experimental assessment: assessment involving one or more calibrations in the presence of the technical assessor who verifies the proper application of technical procedures, knowledge of the state of the art and the capacity of the laboratory to apply correct professional practices. If possible, the results of the calibrations are compared with the results of previous ones on the same measurement standard or instrument. 5 DIFFERENT TYPES OF COMPARISONS Interlaboratory comparisons or proficiency testing are performed in certain main cases as follows: 1. PTs and/or ILCs proposed by independent and competent organizations; ACCREDIA-DT accepts the following organizations as providers of PTs and/or ILCs: Providers of proficiency testing (PTPs) accredited by ABs signatory to the EA or ILAC agreements of mutual recognition for calibration and testing scopes; National Metrological Institutes and Designated Institutes signatory of the CIPM MRA agreements (e.g., in Italy, INRIM and ENEA-INMRI). ACCREDIA-DT also accepts as providers of PTs and/or ILCs, provided they have the necessary qualifications from the Laboratory concerning operations in conformity with the requirements of UNI CEI EN ISO/IEC 17043, such organizations that are present: on the EPTIS website at the address on the list managed by the EA LC working group on ILCs for calibrations and published in the reserved area of ACCREDIA s website for calibration Labs (the list can also be obtained on request to the ACCREDIA-DT Secretariat). 2. PTs and/or ILCs organized by EA, by APLAC or offered within the ambit of regional and International cooperation; ACCREDIA-DT, following EA-2/14 M: 2008 or equivalent APLAC documents, chooses one or more Labs on the basis of the metrological sectors for participation at regional and international ILCs. 3. Measurement Audit; If there are no providers of PTs and/or ILCs available for certain metrological sectors, the Laboratories shall nevertheless keep records of research conducted so as to be able to prove their unavailability. In such circumstances ACCREDIA-DT accepts the request for a measurement audit. Note: Labs may request a measurement audit to verify the effectiveness of corrective actions (CAs) resulting from negative results of participation at PTs and/or ILCs. 4. On-site experimental assessments; In cases where the performance modalities of a laboratory turn out to be the most relevant for a correct calibration and in cases where the calibration uncertainty of the measurement instruments or systems have a calibration uncertainty due basically to the instrument or system itself, ACCREDIA-DT accepts the request for an on-site experimental assessment. TECHNICAL REGULATIONS RT-36 rev.00 Page 4 of 7

5 6 PARTICIPATION AT COMPARISONS In order to demonstrate its technical competence and conformity with point 5.9 of UNI CEI EN ISO/IEC 17025:2005 a Laboratory shall take part in comparisons as described in point 5 of the present document regarding every metrological sector and/or every accredited or applicant production method. Participation at a PT and/or ILC may be requested by ACCREDIA-DT on the basis of the rules of the metrological sector or of the EA or ILAC requirements. For example, a Lab accredited for measurements with ionized radiations shall undergo a measurement audit at every surveillance. For calibration Labs positive results of participations are used by ACCREDIA-DT to confirm the Calibration and Measurement Capabilities (CMCs). Therefore, each time the calibrated item and the measurement method permit it, in providing the results, the Laboratory shall not declare an uncertainty value which is greater than the accredited or required CMCs. Participation at a PT and/or ILC is necessary, with an indication that the performance was positive (absolute normalized error E n 1 for all measurement points and/or suitable and effective CAs) for each metrological sector: - during the phase of first accreditation and of extension, before they are granted; - at least once during the accreditation cycle, before the granting of renewal; except for the sector of ionized radiations for which participation at PTs and/or ILCs is expected at each surveillance; - on the request of ACCREDIA-DT during the resumption of activities following self-suspension, as described in RG-13. In cases of a request for measurement audit and/or experimental on-site assessment (points 3 and 4 of chapter 5) upon the presentation of the application for accreditation/extension/renewal, the Laboratory shall submit for assessment by ACCREDIA-DT the elements set out in point 8 of the present document. The assessment of the items requested may be concluded: - with a negative outcome, in which case the process is repeated; - with a positive outcome, in which case ACCREDIA-DT organizes the on-site assessment, depending upon receipt of the certificate of calibration of the measurement instrument/standard, where applicable. Subsequently, during the performance of the on-site assessment, the technical assessor prepares a comparison report containing, if possible, the normalized error E n, calculated on the basis of the comparisons of the calibration carried out on-site with the previous calibration results of the same instrument or measurement system (UNI CEI EN ISO/IEC 17043, B3). The Laboratory shall prepare a suitable program of participation at comparisons, review it periodically, update it and monitor its performance so as to demonstrate that the scope of accreditation has been covered throughout the accreditation cycle. In the program the requests for measurement audits and on-site experimental assessments shall be provided for, to be done on-site during the phase of renewal. Participation at PTs and/or ILCs cannot be replaced systemically by the conduct of measurement audits. ACCREDIA-DT, applying EA-2/14 M:2008, requests that the chosen Laboratories participate at regional ILCs, enabling them, in cases of satisfactory performances, to update their program of participation at comparison in terms of exoneration from ILCs programmed for sectors covered by the competent regional circuit. TECHNICAL REGULATIONS RT-36 rev.00 Page 5 of 7

6 For the preparation and revision of the program the Laboratory shall consider, for each sector, at least, the following factors: the minimum frequency of participation given in the present document, in the general regulations, in the national and international technical standards and in the applicable EA and ILAC rules; the results obtained from previous participations at comparisons; the frequency and the entity of actions deriving from internal controls of the management system of technical activities, in particular those permitting the identification, quantification and monitoring of any systematic deviation (such as nonconformities, corrective actions, preventive actions deriving from calibrations and metrological confirmation). the results of assessments by second or third parties; circumstances or factors of the Lab which could justify a modification to the usual frequency of participations; the availability of providers of PTs and/or ILCs. The participation program shall be sent to the ACCREDIA-DT Technical Officer:: - during the phase of application for accreditation/renewal/extension; - in cases of modification to the program; - upon request by ACCREDIA-DT. The program is considered an integral part of the technical documentation annexed to the application for accreditation/renewal/ extension and it is evaluated by ACCREDIA-DT as an additional part of the document analysis. For this assessment the Lab shall provide to ACCREDIA-DT the elements as described in point 8 of the present document. The evaluation and any changes to a previous program (and positively evaluated by ACCREDIA-DT) is not a part of maintenance activities. 7 COMPARISONS INDICATING AN UNSATISFACTORY PERFORMANCE If the results of a Laboratory are not satisfactory (with normalized error En > 1 in one or more measurement points) in a PT or ILC, it shall act as set down in its own internal procedure for the management of NCs and, if applicable and/or necessary, proceed with a self-suspension regarding the specific metrological sector. The Lab shall also evaluate the impact with respect to past activities and transmit to ACCREDIA-DT within 3 months from receipt of the results, the evidence of the treatment, the implemented CAs and the modalities for verifying their effectiveness. As a verification of the effectiveness of implemented CAs, ACCREDIA-DT recommends participation at the first due PT and/or ILC, and it reserves the right to oblige the Lab to participate if the evidences provided were not satisfactory or the modality planned for the verification of effectiveness was not adequate. If this is the case, during the phase for the maintenance of accreditation, the CSA-DT is informed of the negative outcome and it decides regarding any subsequent actions to be taken (e.g. modification of the periodicity of the surveillances). Ineffective treatment of unsatisfactory results is a cause of suspension of accreditation of the Laboratory in the specific metrological sector. TECHNICAL REGULATIONS RT-36 rev.00 Page 6 of 7

7 8 ELEMENTS TO BE GIVEN TO ACCREDIA The table shows the elements that the Lab shall provide to ACCREDIA-DT, both in the phases of the presentation of the application for accreditation/renewal/extension and in the phase of the programming of assessment activities. Type of comparison (see point 5) 1 PTs / ILCs proposed by independent providers 2 PTs / ILCs organized by EA, by APLAC, or provided within the ambit of regional and international cooperation Elements to be given to ACCREDIA by the Lab Programming phase Name of provider of PTs / ILCs item of the PT / ILC Identification of the PT / ILC Application phase Name of provider of PTs / ILCs Object of the PT / ILC Identification of the PT / ILC Evidence of participation and/or results 3 Measurement Audit An indication of the planned application to ACCREDIA-DT is sufficient Evidence of the records of research carried out by the Lab showing the unavailability of PT / ILCs. Instrument chosen by the Lab to be used for the measurement audit. Provider of the certificate of calibration for the instrument chosen and/or copy of the certificate of calibration of the instrument. 4 On-site experimental assessment An indication of the planned application to ACCREDIA-DT is sufficient Evidence of the records of research carried out by the Lab showing the unavailability of PT / ILCs. Instrument chosen by the Lab to be used for the onsite experimental assessment. (if available) provider of the certificate of calibration for the instrument chosen (if available) copy of the certificate of calibration of the instrument TECHNICAL REGULATIONS RT-36 rev.00 Page 7 of 7