Quality Management in the Blood Bank

I. Quality

A. Commonly Used Quality Terms (AABB)

  • Explain the following terms:

    • Biovigilance

    • Calibration

    • Change Control

    • Control Chart

    • Near-miss Event

    • Process

    • Process control

    • Qualifications

    • Quality Assurance

    • Quality control

    • Quality indicator

    • Quality management

    • Requirement

    • Specifications

    • System

    • Validation

B. Quality Forms

C. Organizations / Accrediting Body

  • Compliance programs evaluation states how effective the facility meets regulatory

    and accreditation requirements (Usually

    every _____ years)

D. Quality Building Blocks

  • Explain/Differentiate the different terms under quality management (3).

E. Risk Assessment

F. Need to Memorize

II. Quality Building Blocks

A. Quality Control

  • What do we do in quality control?

B. Quality Assurance

  1. QA Indicators

  • What are the QA indicators?

C. Quality Management System

  • Explain what is quality management system.

III. QMS Essentials

A. Organization

B. Facilities and Safety

C. Personnel

D. Equipment

E. Purchasing and Inventory

F. Process Management

  • What is/are SOPs?

G. Documents and Records

H. Information Management

I. Non-conformance Management

  • What is non-conformance management about?

J. Assessments

  • What is the best assessment tool?

K. Continual Improvement

  • What is PDCA?

IV. Cost of Quality

  • What are the four basic costs?

  • What are the good costs and bad costs? Then differentiate them.