Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...

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AABB Accreditation

� 1998 AABB Inspections move to AABB assessments

� Inspectors become assessors

� Assessors are resources for facilities

� Inspections become system audits

�� Deviations become non non‐conformances

conformances

� Response to non‐conformance includes:

� Immediate corrective action

� Root Cause Analysis

� Long term plan

Recommendations
Info

AABB Accreditation � 1998 AABB Inspections move to AABB assessments � Inspectors become assessors � Assessors are resources for facilities � Inspections become system audits �� Deviations become non non‐conformances conformances � Response to non‐conformance includes: � Immediate corrective action � Root Cause Analysis � Long term plan

Quality

Page 1 and 2: Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQ
Page 3 and 4: A Horse named Jim � In 1901 a ser
Page 5 and 6: Early Regulations ‐ 1903 � Issu
Page 7 and 8: World at War � American Red Cross
Page 9 and 10: Court Cases 1960‐1970 � Violati
Page 11 and 12: National Blood Policy � 1972 Pres
Page 13 and 14: Bureau of Biologics Regulation �
Page 15 and 16: HIV and the Blood Supply � 1980
Page 18 and 19: FDA Guideline � Intended to be us
Page 20 and 21: Quality Control � Several dimensi
Page 22 and 23: Quality System Essentials � 1997
Page 27: Questions

Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQM/OE Director ...

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