Process FMEA draft

Purpose

Expose credible process failure modes and prioritize risk-reduction actions before the control plan or process change is finalized.

Scope

Manufacturing process steps, functions, failure modes, effects, causes, controls, and improvement actions. Excluded: final risk acceptance, production release, and certification of the FMEA.

Data basis

• Process flow, product and customer requirements, defect history, existing FMEA, inspection data, and control descriptions.
• The fixed records, tables, or folders in the skill scope that hold the relevant history or schema.

Result

An FMEA sheet, prioritized action list, and rationale memo linking ratings to evidence.

Quality criteria

• Every process step has a function and at least one relevant failure mode or a stated reason for none.
• Effects, causes, prevention controls, and detection controls are distinct.
• Risk ratings use the configured scale and cite their basis.
• High-priority items have an action, owner or missing owner, and success measure.
• The FMEA and action list contain matching identifiers.

Instructions

Describe failures at the level where a process control can act. Use historical defects and requirements to support occurrence and severity; do not manufacture ratings from intuition without labeling the judgment. Distinguish prevention from detection. Check that proposed controls address the cause or escape path. Compare the draft with the control plan and flag mismatches.

Adapt before use

Keep the source trail close to every conclusion and preserve the difference between a source fact, a calculated value, an assumption, and a recommendation. Use stable identifiers across the document and sheet so a reviewer can move from a summary statement to the underlying row and source. Prefer a complete, transparent partial result over a confident answer built on missing evidence.

• Add the company FMEA form, rating scales, and escalation thresholds.
• Provide process, product, and customer requirement references.
• Define the evidence expected for occurrence and detection ratings.
• Specify owners and review gates for high-risk actions.