Abstract:As a statistical process control model, the CDF-EWMA provides real-time estimation of the fraction of components meeting a regulatory limit. It is capable of detecting developing QC problems before units fail to meet regulatory requirements and is a potential alternative to other QC techniques for monitoring WBC reduction of blood components.
“…In many semi‐automated processes like the production of blood components, the manual steps are critical and person dependent and hence difficult to control and standardize. To assess this type of problem, a control chart depicting the quality control (QC) values may be a useful tool to apply (Perrotta et al 2002; Council of Europe, 2007). The QC data from the blood production have been stored electronically for several years.…”
Introduction of statistical process control in the setting of a small blood centre was tested, both on the regular red blood cell production and specifically to test if a difference was seen in the quality of the platelets produced, when a change was made from a relatively large inexperienced occasional component manufacturing staff to an experienced regular manufacturing staff. Production of blood products is a semi-automated process in which the manual steps may be difficult to control. This study was performed in an ongoing effort to improve the control and optimize the quality of the blood components produced and gives an example of how to meet EU legislative requirements in a small-scale production centre. Data included quality control measurements in 363 units of red blood cells, 79 units of platelets produced by an occasional staff with 11 technologists and 79 units of platelets produced by an experienced staff with four technologists. We applied statistical process control to examine if time series of quality control values were in statistical control. Leucocyte count in red blood cells was out of statistical control. Platelet concentration and volume of the platelets produced by the occasional staff were out of control, which was not the case with the experienced staff. Introduction of control charts to a small blood centre has elucidated the difficulties in controlling the blood production and shown the advantage of using experienced regular component manufacturing staff.
“…In many semi‐automated processes like the production of blood components, the manual steps are critical and person dependent and hence difficult to control and standardize. To assess this type of problem, a control chart depicting the quality control (QC) values may be a useful tool to apply (Perrotta et al 2002; Council of Europe, 2007). The QC data from the blood production have been stored electronically for several years.…”
Introduction of statistical process control in the setting of a small blood centre was tested, both on the regular red blood cell production and specifically to test if a difference was seen in the quality of the platelets produced, when a change was made from a relatively large inexperienced occasional component manufacturing staff to an experienced regular manufacturing staff. Production of blood products is a semi-automated process in which the manual steps may be difficult to control. This study was performed in an ongoing effort to improve the control and optimize the quality of the blood components produced and gives an example of how to meet EU legislative requirements in a small-scale production centre. Data included quality control measurements in 363 units of red blood cells, 79 units of platelets produced by an occasional staff with 11 technologists and 79 units of platelets produced by an experienced staff with four technologists. We applied statistical process control to examine if time series of quality control values were in statistical control. Leucocyte count in red blood cells was out of statistical control. Platelet concentration and volume of the platelets produced by the occasional staff were out of control, which was not the case with the experienced staff. Introduction of control charts to a small blood centre has elucidated the difficulties in controlling the blood production and shown the advantage of using experienced regular component manufacturing staff.
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