NPI Quality Leadership:
- Participate in DFM reviews to ensure design for manufacturability, reliability, and quality.
- Ensure quality requirements are clearly defined and implemented throughout product development lifecycle.
- Ensure product and process readiness prior to production release.
- Serve as Quality representative in all New Product Introduction (NPI) projects.
2. Risk Management & Quality Assurance:
- Lead and facilitate risk management activities including:
+ PFMEA
+ DFMEA
- Ensure risks are identified, mitigated, and controlled before production launch.
- Drive preventive quality approach rather than reactive correction.
- Risk analysis and mitigation planning.
3. Process Development and Validation:
- Ensure proper implementation and approval of:
+ Quality standards for new products."
+ Inspection Plan.
+ Control Plan.
+ Work Instructions.
- Ensure manufacturing process capability and stability before mass production.
- Review and approve validation activities including IQ, OQ, PQ.
4. Design Transfer & Production Readiness:
- Support pilot build, NPI Build, and production ramp- up activities.
- Ensure effective and compliant transfer from engineering to manufacturing.
- Ensure all quality deliverables are completed prior to pilot and mass production.
5. Customer Quality Interface for NPI:
- Support customer audits, technical discussions, and quality reviews.
- Ensure customer quality expectations and requirements are met.
- Act as quality interface with customers during NPI phase.
6. First Article Inspection (FAI / FAIR):
- Ensure First Article Inspection (FAI) is planned, executed, and approved prior to production release.
- Review and approve First Article Inspection Reports (FAIR) to verify compliance with:
+ Specifications.
+ Critical dimensions and characteristics.
+ Assembly drawings.
+ BOM.
+ Customer drawings.
- Coordinate with Engineering, Manufacturing, and Supplier Quality to resolve any FAIR discrepancies.
- Ensure FAIR approval is completed prior to pilot build exit or mass production release.
- Ensure ballooned drawings and full traceability between drawing requirements and inspection results.
- Maintain FAIR documentation as part of Device History Record (DHR) or product quality records.
7. Continuous Improvement & Lessons Learned:
- Support root cause analysis and corrective action during development phase.
- Improve NPI quality performance and reduce launch risk.
- Drive lessons learned from NPI into future projects.
