Corrective Action Reports - CALA

1 November 22/23, 2004 CAEAL PT Workshop1 ACLAECAEALC orrective Action ReportsWhy are they important?November 22/23, 2004 CAEAL PT Workshop2 ACLAECAEAL For laboratories reporting unsatisfactoryresults, the laboratory accreditation bodyshould have policies to:a) Have the laboratory investigate andcomment on its performance within anagreed time-frame. ISO/IEC Guide 43-2 November 22/23, 2004 CAEAL PT Workshop3 ACLAECAEALR emedial Action Each time an accredited lab receives a failing PTscore (<70) for any given parameter, a CARshowing the completed Action items must CAEAL PT related Policy # 7 November 22/23, 2004 CAEAL PT Workshop4 ACLAECAEAL Improves the quality of laboratory data. Minimizes inclusion of poor data in PTprogram. Demonstrates a commitment to of Corrective Action ReportsNovember 22/23, 2004 CAEAL PT Workshop5 ACLAECAEAL HeaderCAEAL PROFICIENCY TESTING PROGRAMCORRECTIVE Action REPORT (CAR) FORMJ anuary 2004 StudyMEMBERSHIPNO:123 MATRIX:Water (Inorganic)LABORATORY:ABCTEST GROUP:C-01 CONTACT:John DoePARAMETER:AlkalinityTELEPHONENO:(555) 555-5555 APPENDIX SuspensionCorrective Action ReportNovember 22/23, 2004 CAEAL PT Workshop6 ACLAECAEAL Section AADETAILS OF PROFICIENCY TESTING FAILURE/ANALYSISCONDITIONS:(identify analyst, instrument, analytical technique, samplepreparation, media type etc.

2 Jane DoeRadiometer VIT90, ABU80, SAC90 Automated titationResults biased highSigned (labrepresentative)John DoeDate:April 6 2004 Corrective Action ReportNovember 22/23, 2004 CAEAL PT Workshop7 ACLAECAEAL Section B: Root cause identifiedBCORRECTIVE Action PLAN: (identify root cause and Action to prevent reoccurrence)Investigated: Analytical QC, training, regent preparation, method validation, calculations, reporting, ..Root Cause: Air bubble occasionally observed in acid delivery line. Resulted in high estimate of Action : Modify SOP to require two empty/fill cycles rather than flush cycle in Completed By:Jane DoeDate:April 4 2004 Signed (labrepresentative)John DoeDate:April 6 2004 Corrective Action ReportNovember 22/23, 2004 CAEAL PT Workshop8 ACLAECAEAL Section B: Root cause not identifiedBCORRECTIVE Action PLAN: (identify root cause and Action to prevent reoccurrence)Investigated: Analytical QC, training, regent preparation, method validation, calculations, reporting,volume and weight traceability, sample storage, sample Cause: Unable to clearly identify a root Action : Closely monitor performance of method over next three months.

3 Participate inadditional QC Completed By:Jane DoeDate:April 4 2004 Signed (labrepresentative)John DoeDate:April 6 2004 Corrective Action ReportNovember 22/23, 2004 CAEAL PT Workshop9 ACLAECAEAL Section CCACCEPTANCE OF Corrective Action PLAN/ REQUIRED FOLLOW-UP:More evidence required? (Y)Due Date:April 30 2004 DetailsRequested clarification on Corrective clarification on April 18 2004. Clarification Visit required? (N)Revoke Accreditation? (N)Signed (CAEAL representative)Ken MiddlebrookDate:April 23 2004 Signed (Advisory Panel)representative)Date:_____Correctiv e Action ReportNovember 22/23, 2004 CAEAL PT Workshop10 ACLAECAEAL Incomplete/Unacceptable CAR Further information requested. Advisory panel may be involved. Site visit may be requested Status advanced to next Action ReportNovember 22/23, 2004 CAEAL PT Workshop11 ACLAECAEAL No CAR submitted or unacceptable CAR Warning notice given. Status advanced to next Action ReportNovember 22/23, 2004 CAEAL PT Workshop12 ACLAECAEALD iscussio