P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin Revisin 1.9 July 26, 2017
P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin TABLE OF CONTENTS TABLE OF CONTENTS... 1 CALA PROGRAM DESCRIPTION PROFICIENCY TESTING POLICY FOR ACCREDITATION... 1 1.0 SCOPE... 1 2.0 BACKGROUND... 1 3.0 POLICY... 1 3.1 Prficiency Testing (PT) Cverage Requirement... 1 3.2 Labratry PT Plan... 3 3.3 Requirements fr Granting Accreditatin... 4 3.4 Requirements fr Maintaining Accreditatin... 4 3.5 Requirements fr Shellfish Testing... 4 3.6 Txiclgy Appendices... 5 3.7 Internatinal PT Participatin... 5 4.0 REFERENCES... 6 Rev 1.9
P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin CALA PROGRAM DESCRIPTION PROFICIENCY TESTING POLICY FOR ACCREDITATION 1.0 SCOPE This plicy applies t all applicant and accredited labratries in the CALA accreditatin prgram. 2.0 BACKGROUND ISO/IEC 17011:2004, Cnfrmity assessment-general requirements fr accreditatin bdies accrediting cnfrmity assessment bdies, is the standard that gverns the peratin f accreditatin bdies such as CALA. This standard (clause 7.15.3) requires CALA t, ensure that its accredited labratries participate in prficiency testing r ther cmparisn prgrammes, where available and apprpriate, and that crrective actins are carried ut when necessary. The minimum amunt f prficiency testing and the frequency f participatin shall be specified in cperatin with interested parties and shall be apprpriate in relatin t ther surveillance activities. Additinally, ILAC P9:06/2014 ILAC Plicy fr Participatin in Prficiency Testing Activities sets ut specific requirements fr accreditatin bdies n the use f prficiency testing activities in the accreditatin prcess fr labratries. This dcument details CALA s plicy n prficiency testing with regard t labratries accredited by CALA. 3.0 POLICY All applicant/accredited labratries shall demnstrate their technical prficiency by their satisfactry participatin in a suitable prficiency testing activity. 3.1 Prficiency Testing (PT) Cverage Requirement The PT cverage requirements are designed t prvide an acceptable level f cverage while, at the same time, taking cst int accunt. As such, the cverage required fr mre cmmnly perfrmed tests, where PT is readily available, is higher than that fr tests that are perfrmed less rutinely. Als, in thse instances where a regulatr specifies the nature and Rev 1.9 Page 1 f 4
P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin level f prficiency testing, these regulatry requirements supersede accreditatin requirements. Where PT is available and apprpriate (e.g., matrix-matched), all analytes appearing in a labratry s Scpe f Accreditatin must t CALA s satisfactin, be supprted by PT. Labratries must treat PT samples as rutine (i.e., defined as the wrk flw and level f effrt fllwed fr the majrity f custmer samples analyzed using the accredited methd). Fr each analyte in the labratry s scpe f accreditatin, the labratry shall select the first ptin that is applicable frm the list belw. If ptin iv, v, r vi is chsen, the labratry must have bjective evidence that a search was cmpleted and that there is n ptin i r ii PT available frm an apprved prvider. If a PT prvider des nt prvide an evaluatin due t data incnsistencies, this will be taken int accunt when determining if PT requirements fr accreditatin have been met. 3.1.1 Optin i If the analyte is cvered within the CALA PT Prgram then the labratry shall use either CALA PT r cmparable PT frm an apprved PT Prvider. Cmparable PT is defined as PT that includes the same number f samples, at the same frequency, as is fund in the CALA PT prgram, and in a ready t analyse frmat (i.e., nt prvided as cncentrates). PT results shall be reprted using the CALA Web-Data-Entry. CALA PT shall be evaluated as per PT15-03 CALA PT Prgram Prcedures. Cmparable PT shall be evaluated using the assigned value frm the PT reprt and the regressin equatins established frm CALA PT; z scres and cmpsite scres shall be determined as per PT15-03 CALA PT Prgram - Prcedures. Unacceptable perfrmance shall be handled as described in PT15-03 CALA PT Prgram - Prcedures and P02-01-CALA Prgram Descriptin. It is cmmn in sme PT studies t nly add 60% f the published analytes t any individual sample. In this case, the labratry shall reprt results as indicated in the PT Prvider instructin with respect t lw level data. 3.1.2 Optin ii If the analyte is nt cvered within the CALA PT Prgram, but is ffered in the catalgue f an apprved PT Prvider, the labratry shall participate in at least tw studies per year, with a minimum f ne sample per study. The utcmes f each study shall be reprted using the CALA Web-Data- Entry system. Unacceptable perfrmance shall be handled as described in PT15-03 CALA PT Prgram - Prcedures and P02-01-CALA Prgram Descriptin. Rev 1.9 Page 2 f 6
P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin It is cmmn in sme PT studies t nly add 60% f the published analytes t any individual sample. In this case, the labratry shall reprt results as indicated in the PT Prvider instructin with respect t lw level data. 3.1.3 Optin iii This ptin is n lnger valid. 3.1.4 Optin iv If ptin i and ptin ii are nt applicable, the labratry shall participate in at least ne frmal study per year frm a PT Prvider (e.g., NAPT, New Yrk State, EPA, etc.). These studies shall be examined during site assessments. If frmal acceptable/unacceptable flags are nt assigned t PT studies, the labratry shall establish criteria fr acceptable perfrmance and act accrdingly. 3.1.5 Optin v If ptins i, ii r iv are nt applicable, the labratry shall participate in at least ne less frmal inter-labratry study per year (e.g., inter-labratry cmparisns amngst a multisite labratry chain). These studies shall be examined during site assessments. If frmal acceptable/unacceptable flags are nt assigned t PT studies, the labratry shall establish criteria fr acceptable perfrmance and act accrdingly. 3.1.6 Optin vi If ptins i, ii, iv, r v are nt applicable, the labratry shall develp and implement a prcedure t demnstrate analyst prficiency. Prcedures include, but are nt limited t, inter-analyst cmparisns, analysis f a blind reference material, r matrix spikes. While this prcedure shuld cnsider bias r accuracy, it is understd that fr sme empirical and physical tests, a reference material may nt be available. These studies shall be examined during site assessments. The labratry shall establish and peridically review criteria fr acceptable perfrmance, and act n unacceptable flags. 3.2 Labratry PT Plan 3.2.1 Submitting a PT Plan A labratry seeking accreditatin fr any analyte shall submit a PT Plan t CALA detailing hw they are ging t cmply with the CALA PT requirements. A cmpleted Scpe f Testing Template that is included in the appendices f the applicatin dcuments (e.g., P04-03 CALA Applicatin fr New Accreditatin), is the frm in which a labratry cmmunicates its PT Plan fr any new methd. Upn review by CALA, and any required clarificatin, CALA and the labratry shall agree t the plan. Rev 1.9 Page 3 f 6
P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin 3.2.2 Ntificatin f Change The labratry shall ntify CALA f any changes t their PT Plan. 3.3 Requirements fr Granting Accreditatin Prir t gaining accreditatin fr an analyte, a labratry shall cmplete, t CALA s satisfactin at least ne prficiency testing activity as per 3.1 abve. The labratry must demnstrate successful participatin fr all analytes where ptins i and ii PT are available, regardless f the percentage f cverage in multi-analyte appendices (e.g., ICP r GC). Fr new (applicant) labratries, it is strngly recmmended that ne rund f PT is cmpleted prir t the initial site visit. 3.4 Requirements fr Maintaining Accreditatin Subsequent t accreditatin, the labratry shall demnstrate technical cmpetence fr each analyte n the scpe f accreditatin as per 3.1 abve with the fllwing clarificatins: 3.4.1 50% Cverage per Appendix Fr multi-analyte appendices (e.g., ICP r GC), labratries are nt required t seek additinal PT fr all analytes n an n-ging basis if at least fifty percent f the analytes in the appendix are cvered by any cmbinatin f PT. If a labratry uses an apprved prvider t meet the requirements in sectin 3.1, it shall reprt all analytes ffered by the prvider fr the rdered sample if it is n their scpe f accreditatin, regardless f whether the fifty percent mark has been reached. 3.4.2 Reprting Results fr Optin i and Optin ii If the labratry is using PT cmparable t CALA PT (ptin i) r ptin ii PT, the first study in a calendar year shall be cmpleted and reprted by July 31. The secnd study in the year shall be cmpleted at least fur mnths after the first study and be reprted by December 31, f the same year. 3.4.3 Onging Surveillance CALA shall have a surveillance prcedure whereby it requests cpies f the fficial PT reprts frm a randm selectin f labratries. Failure t submit these reprts, r any evidence f falsificatin f PT data shall result in suspensin f the affected analyte(s). As well, labratries using nn-cala ptin i PT may be requested t prvide cpies f PT instructin sheets frm the apprved prvider t demnstrate that they are being prvided as ready t analyze samples. Labratries using ptin ii may be further requested t prvide cpies f crrective actin reprts as demnstrated evidence that crrective actins are carried ut when necessary. 3.5 Requirements fr Shellfish Testing If pursuing accreditatin fr shellfish prduct testing under the Canadian Shellfish Sanitatin Prgram (CSSP), participatin in the USFDA prgram is mandatry. Rev 1.9 Page 4 f 6
P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin 3.6 Txiclgy Appendices Very few txiclgy tests have fficial PT testing available that meets either ptin i r ii. Mst txiclgy PTs will be cnducted as either ptins v r vi. Fr ptin v and vi PTs it is imprtant t establish acceptability criteria prir t testing. A minimum f ne (1) sample is required annually. Labratries must demnstrate prficiency fr a minimum f ne f the test species, where there is mre than ne species listed under a methd. It is preferable that different species are used in the annual demnstratin f prficiency, if pssible. The txiclgy PT must match the matrix and test duratin and include the standard txicity endpints f results that are reprted by the lab. Fr example, fr a 14-day Hyalella azteca survival and grwth sediment test, the results reprted at the end f the test are % survival and weight f rganisms. It is nt acceptable t cnduct a PT using a 4-day test with a txicant in water where the endpint is nly the LC50 r % survival and des nt evaluate the grwth endpint. Examples f acceptable PT fr Hyalella culd be: a) tw analysts r tw labs analysing the same lab prepared sediment sample that has been split (i.e. spiked with txicant), b) an analyst cnducting a spiked sediment sample and cmparing the result t a knwn r literature txiclgical value that is based n the same reference methd that was used fr the prficiency testing, c) tw labs r analysts analysing a field cntaminated sample that has been split and d) tw labs r analysts analyzing a cntrl sediment r sil. Ptential acceptance criteria culd be: a) tw test results must have endpints within a defined percentage (reasnable fixed value culd be based n the uncertainty f bilgical respnse), b) bth analysts r labs classify a sample crrectly as txic (as defined by the methd), c) fr multi-cncentratin test the tw LCxxs/ECxxs are nt statistically different. 3.7 Internatinal PT Participatin Labratries in the accreditatin prgram may be required by CALA t participate in internatinal PT studies, in rder t meet Mutual Recgnitin Arrangement (MRA) requirements. Such participatin is ver and abve the PT ptins required fr cntinued accreditatin. Rev 1.9 Page 5 f 6
P02-03 CALA Prgram Descriptin Prficiency Testing Plicy fr Accreditatin 4.0 REFERENCES ILAC P9:06/ 2014 ILAC Plicy fr Participatin in Prficiency Testing Activities. P02-01 CALA Prgram Descriptin. P02-02 CALA Prgram Descriptin Fee Schedule. P02-04 CALA Prgram Descriptin PT Catalgue. P02-05 CALA Prgram Descriptin - List f Apprved PT Prviders. PT15-01 - CALA PT Prgram Scheme. PT15-02 CALA PT Prgram Plicies. PT15-03 CALA PT Prgram Prcedures. A118 - Labratry Prficiency Testing Plan. Rev 1.9 Page 6 f 6