Session 2 Objectives

Change Control
• Define change control
• Describe factors that make individuals resist change
• Describe ways to help manage change
• Describe the benefits of managing changes
• Describe project management as a tool for managing change

Materials Management
• Discuss the regulatory requirements for materials management
• Define critical supplies and services
• Describe elements of managing critical supplies and services
• Describe elements of managing nonconforming supplies
• Outline the elements of a supplier qualification program

Process Improvement
• Define regulatory requirements for process improvement
• Define process improvement
• List the common steps involved in process improvement methods
• Identify available tools for process improvement and how and when to use them

Quality and the Customer
• Describe:
    – Customer service system
    – Alignment of the system with the customer
    – Being a customer focused organization
    – Role of quality within customer relationships

Quality Monitoring
• Define a Quality Indicator (QI)
• Understand how to select a QI
• Identify measurement tools for data collection
• List priorities that determine which QI are monitored
• Identify requirement for tracking QI’s
• Recognize difference between benchmarking and establishing thresholds
• Determine the criteria for ongoing monitoring of QI

Resources
• List the blood bank regulations that govern human resources
• Describe key principles to follow in helping adults learn
• Examine various methods to deliver training
• Examine various methods for performing competency testing

Risk Management
• Define risk management
• Describe types of risks and potential losses in blood centers
• Apply basic risk management techniques and components to blood center operations

Soft Skills
• Outline basic facilitation skills
• Lead a team and facilitate a meeting
• Build consensus
• Communicate effectively
• Utilize negotiation skills
• Identify elements of effective teams / meetings

Registration and Licensure
• Describe when and how to complete an FDA registration
• Identify when and how to submit Blood License Applications (BLAs)
• List the three categories of submission
• Describe how and when to submit labels for approval
• Identify the uses of a comparability protocol