PEPFAR Quality Control and Method Validation Activity 3: Part 3

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'e Expect 1st What Rule has been violated? Wider b) The achons +ahen when resul+s aborator Wider WHERE WE ARE The Analytical S ±aKen when resul+s b) ach WHERE Nbnormal Quality WHERE WE ARe Quality Expect reagents To Bee To Be excect exceed when Goals b) The achons when Troubleshooting Out-of-Control Runs .its are less To Mode: Mean b) The achons when cesal+s WHERE WHERE ARE Gaussian b) The when resul+s Error (RE) Systematic WHERE WE ARE •IS Mean aborator ro WHERE WE System Distribution • Change in calibrator lot b) The achons +0 Cnconsistent l) Cnconsistent Consistent Is To Be WE ARE WHERE WE ARE WHERE WHERE WE ARE WHERE WE EXPECT ro limits Medan Systematic ro BE WHERE WE EXPECT ro BE 5th Did Systematic Error Wider Consistent Cnconsistent • Air bubbles in reagents and ro WHERE WE WHERE WE EXPECT ro Gaussian Systematic WHERE Inherent Is it a systematic or random error? Is it a Systematic or Random Error? shifts h-ction but Gaussian Error (SE) WHERE exceed Change exceed WHERE we 'RE Error (SE) WE WHERE WE ARE ro WHERE WE ARE E WE WHERE Wrong calibrator values Cnconsistent 2nd Is it a Systematic or Random Error? thange Mean ro WHERE WE EXPECr WHERE WHERE we Systematic Distribution WHERE WHERE WE A WHERE Median fewer false (QC) limits WHERE WE ARE reagent lines, sampling or reagent false WHERE WE EXPECT ro ' Cnconsistent WHERE WE EXPECT ro',E WH Change Change WHERE we ro WHERE 6th Onc Wider control Systematic sensitive Sensitive WHERE WE ARE Single ro WHERE WE ARE rejections rejections WHERE WE smaller shifts ro WHERE WE ARE • Improperly prepared reagents exceed What is the potential cause of the What is the Potential Cause of the Normal Step 1. Consistent Cnconsistent WHERE we Quality WHERE WE RE WHERE WE roE WHERE WE ARE •IS WHERE WARE ro WHERE WE ARE Random Single syringes ro WE ARE Error Change Distribution Random Error (RE) Consistent WHERE WE Goals limits are less Normal WHERE we Random Population Population Docume Change Normal 3rd What is the Potential Cause of the error? Population Change • Deterioration of reagents or Deterioration of reagents or Change LOOK for Nbnormal rejections WHERE Distribution results Population error? WHERE we ARE (RE) Pipette tips not fitting • Pipette tips not fitting shifts Look for Single Look Single QUALITY QUALITY than Random Distribution smaller QUALITY QUALITY Random Use the e the than the The use the QUALITY abnormal QUALITY smaller shifts Population QUALITY control material Population larger PATIENT Look for PATIENT Mean Single QUALITY Error (RE) CONTROL Look for QUALITY CONTROL Whey We Wan Error witl 1:2s rule as s rule as ule as -ule as clustering properly CONTROL CONTROL Need for Mean QUALITY Look for Median Distribution PATIENT CONTROL PATIENT PATIENT If more than one analyte is out-of- QUALITY Population 4th If more than one analyte is out-of-control, do CONTROL, ATIENT CONTROL PATIENT a scanning canning nning away from SAMPLE • Inappropriate storage of abnormal DS (QC) (QC) Medan SAMPLE shifts Nbnormal Error Look for PATIENT SAMPLE SAMPLE Nbnormal CONTROL CONTROL Use the Systematic Nbnormal ATIENT device evice CONTROL the mean they haw QUALITY essayec PATIENT SAMPLE essaye Use the LJse the • A clogged pipettor (clot) SAMPLE Mean QUALITY rejections Systematic clustering co clusteri Use the clustering Use the ATIENT the mean SAMPLE SAMPLE SAMPLE essayes CONTROL rule as PATIENT h(QC) PATIENT 1:2s rule as (QC) Look for (QC) PATIENT CONTROL Single PATIENT SAMPLE use the Error (RE) SAMPLE reagents (QC) PATIENT SAMPLE 1:2s rule as away fro away from PATIENT f:2s rule as 1:2s rule as Single PATIENT shifts away f ATIENT rejections QUALITY (QC) a scanning • Imprecise pipettor Imprecise pipettor they have any Common Factors during testing? SAMPLE clustering Population CONTROL ATIENT (QC) SAMPLE Messages SAMPLE a scanning a scanning SAMPLE the me PATIENT essayes mean PATIENT a scanning PATIENT • Pipette maladjustments or SAMPLE away from (QC) SAMPLE detection The device detect (QC) (QC) CONTROL smaller the mean C) mean (QC) QUALITY The accuracy and a scanning false SAMPLE ey essayes (QC) Population detect The accuracy an Single • Change in temperature of • Unstable temperature and Unstable temperature and device essayes TIE-MT PATIENT PATIE-NT SAMPLE CONTROL The accuracy and the mean essac QUALITY detection but PATIENT Easier accuracy Single device SAMPLE device (QC) CONTROL misalignment Population falso The SAMPLE SAMPLE sys+em descftb Rate incubation have fewer false SAMPLE rejections SAMPLE False Medan and an Shi-em descflk The The accuracy accuracy • Change in temperature of The accuracy and an accuracy SAMPLE accuracy and Accuracy rate analy • Unstable power supply Nbnormal rate Analytical WHERE WE RE Shift WHERE WHERE we we WHERE WE ARE (QC) re Sys+em d WHERE WHERE incubators and reaction blocks SAMPLE WHERE WHERE and sp+em descri b es WHERE ARE WHERE 2nd sysyem descflb es The accuracy and accuracy and an • Poor operator technique WHERE ARE System we ARE WHERE WE ro WHERE WE • Failing light source we ARE WHERE WE ARE and IS and WHERE WE ARE WHERE Use the Defective disposable consumables • Defective disposable consumables Error Step 4. WHERE we WHERE we EXP ro WHERe we EXPEcr ro and • Changes in procedure from and WE WHERE IS WHERE Capability •Sample evaporation WHERE WE we WHERE we IS IS one operator to another WHERE WE IS WHERE WE WHERE WHERE we ro Change • Improper mixing of processed Improper mixing of processed WHERE The WHERE WE ARE •Outdated reagents wk expect ro 31 Change resolution? Shift WHERE we ARE WHERE IS samples WHeRE we shifts than IS WHERE WE we WHERE we ARE • Inadequately cleaned change rø ro • Incorrect reconstitution of the IS sys+em has occuvced glassware shifts WHERE WE EXPECT ro BE WH WHERE 29 31 34 32 30 33 Change we ARC control material sys+em has occuvce Analytical WHERE WE Change Svs+em