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Replacement of Contractor Work to Inhouse Full Process

ISO 13485
COMPLIANCE LEVEL
LINAMAR
IMPLEMENTATION PLANT
100%
INHOUSE OWNERSHIP
RIMS MFG
PROCESS DOMAIN
FIG_04: INHOUSE 3D ROLLING MACHINE PROCESS QUALIFICATION
Stage 1: Rolling Setup
Stage 2: Process Development
Stage 3: Verification Output
Constraint Solved: Sourced personalized design 3D rolling machine to own the rims manufacturing step.
Constraint Solved: Performed full process development meeting strict Cost, Tolerance, Repeatability, and Safety KPIs.
Constraint Solved: Deployed validated IQ/OQ/PQ process under ISO 13485 at Linamar plant.
01 // SITUATION

Sourced, qualified, and fully transitioned a critical rims manufacturing process from an external contractor to an in-house 3D rolling station under ISO 13485.

02 // TASK

Due to high cost, risky dependency, and low-quality results from the external contractor, it was decided to source, purchase, and qualify an inhouse machine and process to fully own a key step of rims manufacturing.

03 // ACTION

Engineered custom 3D rolling machine specifications. Executed rigorous process development, risk mitigation, and IQ/OQ/PQ protocols under ISO 13485 to meet SMART cost, tolerance, and safety criteria.

04 // RESULT

IQ-OQ-PQ was conducted by me under strict ISO 13485 regulation requirements. The process was fully implemented by me at our manufacturer Linamar.

Situation: Sourced, qualified, and fully transitioned a critical rims manufacturing process from an external contractor to an in-house 3D rolling station under ISO 13485.

VERIFIED DELIVERABLES // DOWNLOADS