The Lifecycle of a Change Control Program – Phase 2: Evaluate


The process of the change control lifecycle begins with Phase 1 – Propose, in which a need for change is identified and developed, as shown in Figure 3. Once all of the information is recorded on the change request document (we covered this in detail in our course on Phase 1 of implementing a change control program), the change request is completed and submitted to a change control committee (CCC) and Quality Assurance (QA). During Phase 2 (Evaluate), the details of the CCC/QA evaluation are recorded, along with the signatures of all who participated.

Curriculum for this course:
Program Introduction
Overview 1 min 01 secs
Learning Objectives 1 min 31 secs
Glossary 1 min 21 secs
Introduction to Phase 2: Evaluate
Phase 2/Step 2: Guidelines on Evaluation of the Change Control Request 1 min 05 sec
Phase 2: Roles – Subject Matter Experts 1 min 10 secs
Roles: The Change Control Committee 1 min 05 secs
Roles: The Quality Unit’s Role in Evaluation 1 min 42 secs
Change Control Evaluation 1 min 50 secs
Documenting the Change Request Approval/Denial 1 min 24 secs
Steps in Approving a Change Request 1 min 58 secs
Change request Part III – Tasks, Responsibilities and Scheduling 1 min 13 secs
Final Assessment

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