1. The management of critical processes and the process continuous improvement are constant opportunities and challenges for most companies. An appropriate processes management is based on performance monitoring of these processes. However, the process performance can be accessed using different approaches, according to the characteristic being monitored. The process perfomance can be accessed, for example, measuring its efficiency or its effectiveness. We can also evaluate the process performance measuring its defects (observed) or defect trends (potential). In the clinical laboratory, for example, we could access the efficiency of a technical process through its "first pass yield” (FPY). The FPY can be obtained checking the percentage of rework (reprocessing for result confirmation, for example) to be completed. For effectiveness obtention, we could access the defects in the products (incorrect results, delays), or assess the errors probability (performance evaluation of analytical methods). Thus, we could to obtain three different metrics to evaluate the performance of a single process. The aim of this study was to evaluate differents approaches available to access technical process performance in clinical laboratory. To compare the process performance calculated by different approaches, we use as example the "hCG" (Human Chorionic Gonadotropin assay) process in our laboratory, expressing the process performance level in sigma-metrics. The data used were FPY (efficiency), delayed laboratory results (observed effectiveness) and Quality Control (QC; potential effectiveness). For FPY calculation, were used as unwanted interventions (rework) in the hCG process: reprocessing for sample dilution, interference that impact on results, transfer of samples for secondary tubes, inadequate samples (with clot, fibrin or bubble), tests reprocessing for results confirmation, repositioning of samples in the analyzer and sample barcodes tag adjust. For potential effectiveness access by QC data, were used: average imprecision in internal QC, average inaccuracy in CAP proficiency test and performance specification based on biological variation. For observed effectiveness access, were considered as defect all the results delivered outside the pre-established target time. The hCG process FPY was higher than 99% (4-sigma). For delayed results, the performance was 5-sigma. CQ performance presented a 6-sigma performance. Analyzing these metrics, we can conclude that hCG process showed adequate effectiveness (time and quality), but with improvement opportunities in its efficiency. We must be careful when using a single metric to evaluate a technical process performance or to obtain the overall performance of a clinical laboratory. Depending on the performance characteristic being evaluated, obtained results may be differents and with comparative reference (benchmark) also differents. Sigma-metrics has often been used as a performance comparison metric between different organizations and processes. This metric also has been used to inform to the market a differentiated performance in terms of quality. For this purpose, we need often more details about the data that provided the performance metric obtaining, allowing to conclude about the validity and usefulness of presented metric. BERLITZ, F. Weinmann Laboratório - Porto Alegre, Brazil fberlitz@weinmann.com.br DIFFERENT APPROACHES TO TECHNICAL PROCESSES PERFORMANCE EVALUATION IN THE CLINICAL LABORATORY ABSTRACT Poster Code: A-84 Session: 04 -Management INTRODUCTION The aim of this study was to evaluate differents approaches available to access technical process performance in clinical laboratory. OBJECTIVES To compare the process performance calculated by different approaches, we use as example the "hCG" (Human Chorionic Gonadotropin assay) process in our laboratory, expressing the process performance level in sigma-metrics. The data used were FPY (efficiency), delayed laboratory results (observed effectiveness) and Quality Control (QC; potential effectiveness). For FPY calculation, were used as unwanted interventions (rework) in the hCG process: reprocessing for sample dilution, interference that impact on results, transfer of samples for secondary tubes, inadequate samples (with clot, fibrin or bubble), tests reprocessing for results confirmation, repositioning of samples in the analyzer and sample barcodes tag adjust. For potential effectiveness access by QC data, were used: average imprecision in internal QC, average inaccuracy in CAP proficiency test and performance specification based on biological variation. For observed effectiveness access, were considered as defect all the results delivered outside the pre-established target time. METHODS AND PROCEDURES RESULTS CONCLUSIONS Analyzing these metrics, we can conclude that hCG process showed adequate effectiveness (time and quality), but with improvement opportunities in its efficiency. We must be careful when using a single metric to evaluate a technical process performance or to obtain the overall performance of a clinical laboratory. Depending on the performance characteristic being evaluated, obtained results may be differents and with comparative reference (benchmark) also differents. Sigma-metrics has often been used as a performance comparison metric between different organizations and processes. This metric also has been used to inform to the market a differentiated performance in terms of quality. For this purpose, we need often more details about the data that provided the performance metric obtaining, allowing to conclude about the validity and usefulness of presented metric. The hCG process FPY was higher than 99% (4-sigma). For delayed results, the performance was 5-sigma. CQ performance presented a 6-sigma performance. The management of critical processes and the process continuous improvement are constant opportunities and challenges for most companies. An appropriate processes management is based on performance monitoring of these processes. However, the process performance can be accessed using different approaches, according to the characteristic being monitored. The process perfomance can be accessed, for example, measuring its efficiency or its effectiveness. Judgements of efficiency are based on some idea of “wastage”. A relatively efficient process either requires fewer inputs or produces more outputs compared to a similar process, to achieve the objectives of the process. In the clinical laboratory, for example, we could access the efficiency of a technical process through its "first pass yield” (FPY). The FPY is the proportion of units that, on average, go through a process first time without defects. In the clinical laboratory, the FPY can be obtained checking the percentage of rework (reprocessing for result confirmation, for example) to be completed. FPY It is calculated from: (DPU=“Defects Per Unit”. It is the average number of defects per unit based on processing a number of units) We can also evaluate the process performance measuring its effectiveness, assessing its defects (observed efficacy) or defect trends (potential efficacy). Effectiveness is very similar to efficiency, but the measure is related to some enterprise objective rather than the technical quality of output. In the clinical laboratory, for effectiveness obtention, we could access the defects in the products (incorrect results, delays), or assess the errors probability (performance evaluation of analytical methods). Thus, we could to obtain three different metrics to evaluate the performance of a single process.REFERENCES GEORGE, M.; ROWLANDS, D.; PRICE, M.; MAXEY, J.; The Lean Six Sigma Toolbook. McGraw-Hill, 2005. PANDE, P.; NEUMAN, R.; CAVANAGH,R. Estratégia Seis Sigma. Qualitymark, 2001. ROTONDARO,R.G. Seis Sigma – Estratégia gerencial para a melhoria de processos. Atlas, 2002. WESTGARD, J.O. Six Sigma Quality design & Control. Westgard Quality Corporation, 2001.