Risk Assessment
Process FMEA
Identify manufacturing failure risks and the controls needed to protect product reliability.
Purpose & Benefit
When This Activity Helps
Use during manufacturing transfer, process introduction or after recurring defects. PFMEA supports prevention and detection planning before process weaknesses reach the customer.
Project Information
Typical Inputs
The scope is tailored to the available evidence. Useful inputs include:
- Process flow and manufacturing requirements
- Defect history and known product failure risks
- Current controls and agreed assessment criteria
Engineering Approach
How SPACEREL Supports Your Project
SPACEREL reviews process steps, potential failure modes, causes and product effects with the manufacturing team. Recommended controls are linked to practical verification, ownership and the process control plan.
Documented Outcomes
Typical Deliverables
Deliverables are agreed before work starts and can include:
- PFMEA worksheet and review record
- Prioritised prevention and detection actions
- Recommendations for process controls and verification
Methods & Evidence
Selected References
- IEC 60812: Failure Modes and Effects Analysis
A framework for planning, performing and maintaining FMEA and FMECA.
Project Context
Where This Activity Can Help
Explore the relevant lifecycle stages.