Binomial sampling plans for validation and quality control in blood product manufacturing

Transfusion ◽  
2021 ◽  
Author(s):  
Chunrong Cheng ◽  
Boguang Zhen
2005 ◽  
Vol 15 (2) ◽  
pp. 353-366 ◽  
Author(s):  
Peter A. Lachenbruch ◽  
Mary A. Foulkes ◽  
Alan E. Williams ◽  
Jay S. Epstein

2000 ◽  
pp. 233-244

Abstract This chapter provides an introduction to statistical process control and the concept of total quality management. It begins with a review of quality improvement efforts in the extrusion industry and the considerations involved in developing sampling plans and interpreting control charts. It then lays out the steps that would be followed in order to implement statistical testing for billet casting, die performance, or any other process or variable that impacts extrusion quality. The chapter concludes with an overview of the fundamentals of total quality management.


2006 ◽  
Vol 99 (3) ◽  
pp. 993-1001 ◽  
Author(s):  
María Teresa Martínez-Ferrer ◽  
José Luís Ripollés ◽  
Ferran Garcia-Marí

2000 ◽  
Vol 93 (6) ◽  
pp. 1752-1759 ◽  
Author(s):  
R. H. Blank ◽  
G. S. C. Gill ◽  
C. E. McKenna ◽  
P. S. Stevens

1978 ◽  
Vol 24 (5) ◽  
pp. 793-795 ◽  
Author(s):  
M C Steiner ◽  
B A Shapiro ◽  
J Kavanaugh ◽  
J R Walton ◽  
W Johnson

Abstract We describe how to prepare, store, and use a hemolyzed blood product for simultaneous pH, pCO2, and pO2 quality control. Tonometry of the blood product with two oxygen and two carbon dioxide concentrations resulted in consistent and reproducible values during 38 weeks. The resulting pH values were consistent and reproducible, demonstrating the metabolic acid-base stability of the blood product. We conclude that the proper preparation, storage, and use of the product results in consistent, reproducible, and economical quality control for pH, pCO2 and pO2 blood measurements.


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