2021 - Modified DD2977: A Simple Alternative to Process Failure Mode Effect Analysis

Scope and purpose of modified DD 2977; product realization processes, administrative processes, and service processes for which a simpler approach is suitable and for which the customer does not require formal PFMEA
Key definitions (commonality between DD 2977 and PFMEA)
Controls
Failure mode, failure cause (formerly mechanism), and failure effect
Occurrence and Detection (PFMEA) and Probability (DD 2977)
Severity (both systems)
Risk Level (DD 2977) and Action Priority (PFMEA)
Procedure for Modified DD 2977 (enhanced with PFMEA methodology)
Structure and Function Analysis; what are the process steps, and what are their deliverables?
Failure and Risk Analysis; how can the process steps fail to achieve their objectives? What controls, if any, remove or mitigate these risks? What is the resulting initial risk level?
Optimization; how can the failure effect be removed, or the failure causes disabled? What new or improved controls can be installed for this purpose? What is the resulting residual risk level?
Documentation (organizational knowledge), and share lessons learned with related processes.
Risk Assessment Review. PFMEA is not a once-and-done activity; it must be reassessed in response to changes in the process (management of change issue). The same applies to the modified DD 2977. Whenever anything is new or changed, it introduces the risk of unforeseen consequences to the process.