QC chart rev2

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Types of Audit Procedures

luonut Sarah Randquist

Terminology of Microbial Control

luonut Jenny Doriot

1.1 Understand computer storage and data types

luonut Gary Sibbitts

Physical Methods of Microbial Control

luonut Jenny Doriot

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