Categories: All - production - sterilization - assembly - storage

by watanabe masanori 2 years ago

114

QC chart rev2

The provided text outlines a detailed quality control and manufacturing process for assembling medical products. It begins with an incoming inspection where resin and purchased parts are checked and sampled based on the Acceptance Quality Limit (

QC chart rev2

QC chart

出荷(この辺はイマイチ。by watanabe)

Test before delivery(入庫。この辺はイマイチ。by watanabe)

Loading and shipping
Make delivery note
Judgement for shipping
NKK judge for sale product or return product to MENV
Make report and send to NKK
Test
take sample

Carton box Packing

Stick sticking plaster
Put product in the carton box
Stick barcode label on the carton box
Print barcode label

Visual inspection before carton box packing

Retaintion sample

Sterilization (Steam)

Storage the finish goods for delivery
Store in aeration area
Sterilize
Pre-conditioning

Sterilization bag Packing

Assy on Conveyor/cell

Inspect leakage (AQL)
Assy Main line & Roll paper
Assy Administration line
Assy Pump (A &V)
Assy infusion line (A & V)
Assy subline (A &V)
Prepare: semi-product, tools

Sub assy

Assy Pressure POD
Inspect height check and leak test
Welding Housing
Auto. Assy
Assemble Rubber button
Roll and inspection
Assemble Heparin line
Prepare: machine, equipment, parts
Assy airless V chamber
inspection
Airless V chamber sub-assy
Prepare: parts
Assy Lock type needle less access port
Inspection
Assy protect cap & cleaning jig
Open the rubber slit
Ultrasonic welding
Apply silicone oil
Slit processing to rubber
Prepare: machine, parts
Sub-Assy
Assy administration line
Assy main line
Assy Sub line
Assy Administration & Pressure line
Assy infusion line/heparin line
Prepare: parts, tubes, semi-product, tools

Part Processing

Print/Sterilization bag
Stick small barcode label on sterilization bag
Print small barcode label
Print on sterilization bag
Prepare: machine stamp mold
Tube cutting
Distribute for the production
Marking tube (counting Qty)
Cutting
Prepare: machine tubes
Annealing
Annealing of parts

Part molding

Extruction
Extude
Prepare resin
Injection
Store & distribute for the production
Inspect AQL

Inspect 100%

Inject
Prepare mold, machine, equipment
Prepare Resin

Incoming inspection

Store and distribute for the production
Test and inspection
Check 100% if necessary
Judge of selection
Purchased parts: Take sample & inspection (By AQL)
Resin: Confirm certification from Supplier

Receiving operation

Resin (PVC,PP,PC,etc.)
Purchased parts