PPAP Process

Our systematic approach helps clients seamlessly transition from prototype to full-scale production, ensuring successful additive manufacturing for regulated industries.

LEVEL 1: Get the Baseline - Define Regulatory & Performance Requirements

• • Define material requirements, tolerances, mechanical performance, and surface finish expectations.
  • Identify regulatory requirements (FDA, ISO 13485, AS9100, IATF 16949, etc.).
  • Document initial process parameters, key control factors, and risk considerations (DFMEA/PFMEA).

LEVEL 2: Design & Process Feasibility

• • Produce a small batch (typically 1-5 parts) based on the existing design for initial evaluation.
  • Validate fit, function, and surface finish, identifying potential failure modes.
  • Document initial process settings, print orientation, and post-processing methods.
  • Conduct preliminary risk assessment for production scalability.

LEVEL 3: Process Optimization & Validation

• • Produce revised design samples focused on dimensional accuracy, consistency, and repeatability under real-world conditions.
  • Perform first article inspection (FAI) and document Cpk/Ppk (process capability indices).
  • Validate mechanical properties and post-processing impact (color, surface finish consistency, structural integrity).
  • Conduct process capability study (5-100 parts) to establish statistical process control limits.
  • Implement design refinements for manufacturability & scalability.

LEVEL 4: Pre-Production Validation & Scalability Testing

• • Document key process parameters to ensure repeatability & traceability.
  • Run pre-production validation with a pilot batch (10-25% of full production volume).
  • Confirm consistent performance under scaled conditions.
  • Identify and document any adjustments before transitioning to full production.

LEVEL 5: Release for Series or Batch Production

• • Components are manufactured at the required production volumes with verified repeatability.
  • Full PPAP documentation package (Control Plan, FAI, Process Flow, Capability Studies, etc.) is completed and submitted.
  • Any design or process changes require re-validation per established change control processes.

Efficiency & Cost Savings – Avoid costly design or production failures through iterative validation.

 Predictable Quality – Ensure components meet industry and regulatory expectations before scaling.

 Process Reliability – Documented workflows ensure repeatability and traceability for production needs.