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Ventilator Production Quality Control Plan Full

The document outlines a comprehensive quality control process for product assembly, detailing stages from material receipt to product release. It specifies inspection methods, acceptance criteria, test equipment, responsible personnel, and control methods for nonconformities. Each stage requires 100% inspection to ensure compliance with standards and specifications.

Uploaded by

Mostafa Khaled
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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93 views6 pages

Ventilator Production Quality Control Plan Full

The document outlines a comprehensive quality control process for product assembly, detailing stages from material receipt to product release. It specifies inspection methods, acceptance criteria, test equipment, responsible personnel, and control methods for nonconformities. Each stage requires 100% inspection to ensure compliance with standards and specifications.

Uploaded by

Mostafa Khaled
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
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Stage Check Point

Material Receipt Verify component type, quantity, and specs

Pre-Assembly Cable routing, solder joint quality

Pre-Assembly QC Connector fit, visual check

Assembly Assembly torque, parts alignment

Final QC Visual appearance, part integrity

Performance Testing Tidal volume delivery, alarm accuracy

Labeling & Packaging Label accuracy, packaging integrity

Product Release Document check, final sign-off


Inspection Method Frequency

Visual + Spec Sheet + Barcode Scan 100%

Visual + Soldering Standard 100%

Visual + Fit Gauge 100%

Torque Tool + Visual 100%

Visual + Touch 100%

Flow Analyzer, Pressure Gauge 100%

Visual + Label Checklist 100%

QA Checklist Review 100%


Acceptance Criteria

Components match the Bill of Materials (BoM)

All components are assembled in accordance with ap

Assembled parts are verified against Work Standards

Final integration is done without deviation from the

No visible defects

Tidal volume ±10%, alarms trigger <5s

Label legible, box sealed

All tests passed


Test Equipment

Spec Sheet, Scanner

Ratchet Spanner Wrench, Adjustable Wrench, Loxeal (Thread Locker), Automatic Screwdriver, Machine Screw Vice, Allen

Gas leakage test rig, Soap solution, Torque Wrench, Tube blanking fitting, Cleaning cloth, Citrex H4 gas flow analyz

Automatic Screwdriver, Allen key, MAEXUS Flexible Drill Bit Extension, Explore Flexible Extensions for Drills, Flexible Sh

Reference Sample

Patient Circuit, Citrex H4 Flow Analyzer, Air Compressor, Oxygen Cylinder, Quick Lung Ingmar adult

Label Template, Tape

QA Forms, Software
Responsible Person Record / Document Name

Warehouse Inspector Material Receiving Log

pre-Assembly Technician Pre-Assembly phase

QC Engineer QC report

Assembly Technician Assembly phase

QC Engineer Final Visual QC Sheet

Tester Performance Test Log

Packaging Operator Label & Pack Report

Factory Manager Final Release Form


Control Method Type Reaction to Nonconformity (Rework)

Visual/Document Quarantine and return to supplier

Functional Fit, Dimensional Check Rework or replace cables

Visual/Gauge Adjust or replace connector

Visual, Leakage, Tightening, Continuity Retorque or reassemble

Visual Inspection Reject or touch-up

Performance Simulation Recalibrate or reject unit

Visual/Label Repack or relabel

Document Review Hold release until issue resolved

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