Doc No.

:QSP-MF-02-F01
Quality Plan N-95 Rev. No.: 00
Date: 25.05.2020

Operation Instrument/ Frequency Person responsible

Process Description AQL Parameters Specifications Sample size Acceptance Criteria Inspection Time Action Plan Record Control
Stages Measuring Aids

As per sampling Fabric Inspection Report (QSP-QA-

Major B GRAMMAGE According Specifications Weighing Scale Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan 10-F01)

Thickness test As per sampling Fabric Inspection Report (QSP-QA-

Critical. THICKNESS According specification Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
instrument plan 10-F01)

As per sampling Fabric Inspection Report (QSP-QA-

Minor. WIDTH According specification L.Scale Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan 10-F01)
FABRIC INSPECTION REPORT
{ a) HP As per sampling Fabric Inspection Report (QSP-QA-
Major A WATER TEST In case of Hydrophobic fabric Manual testing Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
Nonwoven (50 GSM),b)HOT Air plan 10-F01)
Cotton , c) Melt blown (25 30
GSM) & d) Hydrophilic
As per sampling Fabric Inspection Report (QSP-QA-
Nonwoven (35 gsm) } Minor. CORE Proper Winding Visual Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan 10-F01)

As per sampling Fabric Inspection Report (QSP-QA-

Minor. COLOUR As per requirement Visual Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan 10-F01)

As per sampling Fabric Inspection Report (QSP-QA-

Critical. APPREANCE No wrinkles, No core damage Visual Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan 10-F01)

Universal pH solution As per sampling Fabric Inspection Report (QSP-QA-

Critical. pH 5.5- 7.5 pH Every Lot As Per AQL 125 minutes Reject Lot & Inform Supplier Quality controller
test plan 10-F01)

As per sampling Nose Pin Inspection Report (QSP-

Critical. WIDTH 5 ± 0.25 mm Vernier Guage Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan QA-10-F02)

Thickness Meter As per sampling Nose Pin Inspection Report (QSP-

Major A THICKNESS 1.10±0.05 mm Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan QA-10-F02)
Nose Wire/Nose Pin
Manual As per sampling Nose Pin Inspection Report (QSP-
Major A CORE Duel Core Wire Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan QA-10-F02)

Visual As per sampling Nose Pin Inspection Report (QSP-

Minor. COLOUR White Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan QA-10-F02)

As per sampling Elastic band Inspection Report

a) 5±0.25mm Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)
Major B WIDTH L.SCALE
As per sampling Elastic band Inspection Report
b) 4±0.20 mm Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)

As per sampling Elastic band Inspection Report

190% w.r.t a) Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)
Critical. ELONGATION % L.SCALE
As per sampling Elastic band Inspection Report
175% w.r.t b) Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)

As per sampling Elastic band Inspection Report

Incoming Raw Material

Critical. RECOVERY 90% L.SCALE Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)
Elastic Band
1.14±0.05mm w.r.t. a) As per sampling Elastic band Inspection Report
Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)
Major A THICKNESS Thickness Tester

1.14±0.05mm w.r.t. b) As per sampling Elastic band Inspection Report

Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)

Smooth As per sampling Elastic band Inspection Report

Minor. TEXTURE VISUAL Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)

No wrinkles, No dirt, No Damage, No As per sampling Elastic band Inspection Report

Critical. APPEARANCE dust VISUAL Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)

White As per sampling Elastic band Inspection Report

Minor. COLOUR VISUAL Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller
plan (QSP-QA-10-F03)

As per sampling
Major B THICKNESS 0.48mm ± 5% Thickness Tester Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

As per sampling
Minor. length 190 mm ± 5 % Measuring Tape Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

As per sampling
Minor. width 117 mm ± 5 % Measuring Tape Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan
Carton Box / Monocarton As per sampling
Minor. Height 120 mm ± 5 % Measuring Tape Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

gsm cutter, balance,

As per sampling
Major A GSM (g per sqm) 300 ± 5 % calculation according to Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan
formula in report

Visual according to
As per sampling
Major A Printing As per a;pproved sample experience/ as per Every Lot As Per AQL 60 minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan
requirement
As per sampling
Minor. length 185mm ± 5 % Measuring Tape Every Lot As Per AQL 20 Minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

Ploy film
 As per sampling
Minor. width 117 mm ± 5 % Measuring Tape Every Lot As Per AQL 20 Minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan
Ploy film
As per sampling
Minor. thickness As Per P.O. ± 5% thickness meter Every Lot As Per AQL 20 Minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

As per sampling
Minor. GSM (g per sqm) As Per P.O. ± 5% weighing scale Every Lot As Per AQL 20 Minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

As per sampling
Minor. Width 50.8 mm ± 5% Linear Scale Every Lot As Per AQL 20 Minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan
Brown Tape
As per sampling
Minor. Color Brown Viusal Every Lot As Per AQL 20 Minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

As per sampling
Minor. Width 50.8 mm ± 5% Linear Scale Every Lot As Per AQL 20 Minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

Transparent Tape
As per sampling
Minor. Color Transparent Viusal Every Lot As Per AQL 20 Minutes Reject Lot & Inform Supplier Quality controller Raw material Testing Report
plan

In Process Inspection Report QSP-

Major A Dimension As Per Approved Sample Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F04

In Process Inspection Report QSP-

Major A Shape As Per Approved Sample Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F04

No Rough Cutting & No Rough In Process Inspection Report QSP-

Major A Cutting Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
Edges. QA-10-F04

Quality of Ultrasonic Complete Sealing, no see through, In Process Inspection Report QSP-
Critical. Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
Sealing no burn marks QA-10-F04

Width of Ultrasonic In Process Inspection Report QSP-

Major A 4±1 mm L.Scale Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
Sealing QA-10-F04
Rolling & Cutting
Name Description In Process Inspection Report QSP-
Minor. As per Approved Sample Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
Position QA-10-F04

In Process Inspection Report QSP-

Critical. Nose Pin Position In the defined place , in centre Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F04

In Process Inspection Report QSP-

Critical. Nose Pin length 95±2 mm L.Scale Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F04

In Process Inspection Report QSP-

Critical. Nose Pin Placement centre position, in the defined slot Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F04

In Process Inspection Report QSP-

Minor. Surface No Rough & Sharp Surface. Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F04

In Process Inspection Report QSP-

200 ± 5 mm- 5mm elastic 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F05
Length of Elastic Ear
Critical. L. scale Every batch
Bands
In Process Inspection Report QSP-
190 ± 5 mm- 4mm elastic 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F05

In Process Inspection Report QSP-

Ear Loop Major A Position of Sealing On defined place Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F05

Uniform, no burn masks, no see In Process Inspection Report QSP-

Major A Quality of Sealing Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
through QA-10-F05

Strength of Elastic Ear In Process Inspection Report QSP-

Critical. Minimum 2000 GF Push-Pull Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
Bands QA-10-F05

310 ± 5 mm for 5mm elastic - In Process Inspection Report QSP-

L. scale Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
upper QA-10-F06

In Process Inspection Report QSP-

250 ± 5 mm for 5mm elastic- lower L. scale Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F06
Length of Elastic Ear
Critical.
Bands
In Process Inspection Report QSP-
300±5mm for 4mm elastic- upper L. scale Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F06

Head Loop 240 ± 5 mm for 4mm elastic - In Process Inspection Report QSP-
L. scale Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
lower QA-10-F06

In Process Inspection Report QSP-

Major A Position of Sealing On defined place Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F06

Uniform, no burn masks, no see In Process Inspection Report QSP-

Major A Quality of Sealing Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
through QA-10-F06
Strength of Elastic Ear In Process Inspection Report QSP-
Critical. Minimum 2500GF Push-Pull Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
Bands QA-10-F06
Uniform, no burn masks, no see In Process Inspection Report QSP-
Critical. Quality of Sealing Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
through QA-10-F07
In Process Inspection Report QSP-
Major A Width of Sealing 4±1 mm L.Scale Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F07
Edge Sealing Inspection In Process Inspection Report QSP-
Major A Position of Sealing below nose pin Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F07

In Process Inspection Report QSP-

Critical. Strength of Sealing Must not tear Maual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller
QA-10-F07

Sealing/Punching ( Mask,N 95
Critical. number of bags 1 mask each Poly pack Visual Every batch 5 Pcs Per Hour No deviation 60min IF failed raise N.C. & take CAPA Quality controller Online inspection report
Primary packing)

case of deviation, inform the packing in charge

Final packing Major B Total Nos of Pcs 20 pcs per mono box Visual Every batch 5 box pe hour Proper stacking 60min Quality controller Online inspection report
and suggest repacking.
 As per sampling
Major A Shape As per Job Requirement. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Quality of Ultrasonic As per sampling
Critical. Complete Sealing. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
Sealing of R & C plan
Name Description As per sampling
Minor. As per the Job Requirement. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
Position plan
As per sampling
Critical. Nose Pin Position As per Job Requirement. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
As per sampling
Minor. Surface No Rough & Sharp Surface. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
As per sampling
Critical. Quality of Edge Sealing As per Job Requirement. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Strength of Edge As per sampling
Major A As per job Requirement. Manual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
Sealing plan
Position of Edge As per sampling
Major A As per Job Requirement. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
Sealing plan
Quality of Ear
As per sampling
Critical. Loop/Head Loop As per Job Requirement. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Sealing
Position of Ear
As per sampling
Major A Loop/Head Loop As per Job Requirement. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Sealing
As per sampling
Critical. Length of Ear Loop 195±5 mm L.scale Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
As per sampling
Critical. Length of head Loop 310±5mm & 250±5 mm L.scale Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
As per sampling
Critical. Strength of head Loop Min. 2kgF Push Pull scale Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Final Inspection

As per sampling
Major A Product Dimensions 11± 0.5 X 15.5 ± 0.5 cm L.scale Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Final Inspections N95 Major B As per sampling
Thickness 0.75mm to 1.15 mm Thickness Testor Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Primary & Secondary No damages, no wrinkels, Proper As per sampling
Critical. Visual Every batch As Per AQL 30 minutes IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
Packaging sealing plan
Practical
Performance -
As per sampling
Major A Head Harness External lab test Every batch As Per AQL 10 days IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Comfort - Security
OF fastenings No User Discomfort
Total Inward As per sampling
Critical. External lab test Every batch As Per AQL 10 days IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
Leakage Max Limit ≤ 11 % plan

Compatiblty with No irritant & free from other As per sampling

Critical. External lab test Every batch As Per AQL 10 days IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
Skin adverse plan
Shall not health
burn oreffects
not to
conitune to burn for more As per sampling
Critical. than 5s after removal of External lab test Every batch As Per AQL 10 days IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Flammablity flame
Carbon dioxide
As per sampling
Critical. content of the Shall not exceed and average External lab test Every batch As Per AQL 10 days IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
inhalation Air of 1.0%
Should (by volume)
be adjustable or self
adjusting & shal be As per sampling
Major A sufficiently robust to hold the External lab test Every batch As Per AQL 10 days IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
plan
Head harness mask firmly in psition
Maximum permitted Resistance
Penetration of filter Nacl Paraffin oil As per sampling
Critical. External lab test Every batch As Per AQL 10 days IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
material plan
95 l/min 95 l/min
<6 <6
Maximum permitted Resistance
Inhalation Exhalation
Breathing As per sampling
Critical. 30 l/min 95 l/min 160External
l/min lab test Every batch As Per AQL 10 days IF failed raise N.C. & take CAPA Quality controller Final Inspection (QSP-QA-10-F08)
Resistance plan
0.7 2.4 3.0

In case of deviation, inform the dispatch in

5.5 Grams ± 1 gram , 11± 0.5 X Weighing Scale, linear As per sampling
Minor. Weight, Dimensions Every batch Weighing scale & linear Scale 30 minutes charge and reject the process, inform Quality controller Final Inspection (QSP-QA-10-F08)
15.5 ± 0.5 cm Scale plan
production

As per sampling If deviation , inform dispatch in charge and

Finished/Packaging Product

Minor. Marking Acc to Approved Sample visual Every batch As per customer packing standard 30 minutes Dispatch As per customer packing std
plan segrate box into rejection
Mono Cartoon box
As per sampling Check the box and seal with QC ok. If, not
Major B number of poly packs 20 counting Every batch As per customer packing standard 30 minutes Dispatch As per cutomer packing std
plan acceptable repack and verify the pack

As per sampling Check the box and seal with QC ok. If, not
Minor. 3ply 500 x 410 x 500mm ± 5 % Linear Scale Every batch As per customer packing standard 30 minutes Dispatch As per customer packing std
plan acceptable repack and verify the pack
Corrugated Box
As per sampling Check the box and seal with QC ok. If, not
Minor. Taping Taped properly with brown tape visual Every batch As per customer packing standard 30 minutes Dispatch As per customer packing std
plan acceptable repack and verify the pack

A defect that judgment and experience indicate is likely to result in a condition immediately hazardous to
Critical.
life or health for individuals using or depending upon the respirator
A defect, other than critical, that is likely to result in failure to the degree that the respirator does not
Major A.
provide any respiratory protection, or a defect that reduces protection and is not detectable by the user;
. A defect, other than Major A or critical, that is likely to result in reduced respiratory protection, and is
Major B
detectable by the user;
defect that is not likely to materially reduce the usability of the respirator for its intended purpose, or a
Minor. defect that is a departure from established standards and has little bearing on the effective use or operation
of the respirator

Name Sign Date

Prepared by Paras Mehta 7/22/2020

Review & Approved Mehul Bose 7/22/2020

by
 QUALITY CON
Operation Component/Equipment
Product Description AQL Testing Parameters
Stages Description

Major A Compatibility

Major B Functional Testing

The Components of PCBA Board
(Main Control Board)

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Pipeline and Auxiliary
Materials (Cabels)

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Power Supply Module

 The Power Supply Module
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Breathing System

Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

The Front Panel Assemble of Major B Functional Testing

10.4 Inch Display Screen

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Components of Sheet Metal
Frame
 The Components of Sheet Metal
Frame
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Components of Chassis

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Components of mechanical

Flow Meter
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Anesthesia The Components of Labels

Machine HA1100 Critical. Terchnical Test

Minor. Visual Inspection

 Major A Compatibility

Major B Functional Testing

Vaporizer Sevoflurane

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

AG sensor

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Component of Flush Oxygen

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The assemble of Dual Cylinder

The assemble of Dual Cylinder

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Oxygen Sensor

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Assembly of ACGO Switch

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The Assembly of System Switch

Critical. Terchnical Test

Minor. Visual Inspection

 Major A Compatibility

Major B Functional Testing

The Accessories

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

The components of Oxygen
Nitrous oxide and Air supply
Critical Terchnical Test

Minor Visual Inspection

Major A Compatibility

Major B Functional Testing

Front Cabinet

Critical Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Rear Cabinet

Critical. Terchnical Test

 Rear Cabinet

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Power Supply Board

Critical. Terchnical Test

Minor Visual Inspection

Major A Compatibility

Major B Functional Testing

NIBP Board
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Main Board

Critical. Terchnical Test

Minor. Visual Inspection

 Major A Compatibility

Major B Functional Testing

Distribution Board
Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Fan with wire Connector

Critical. Terchnical Test

Minor. Visual Inspection

Patient Monitor Major A Measuring size

HM1200

Major B Functional Testing

Alarm Speaker with cable

Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Display and Touch Screen

 Display and Touch Screen

Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Battery and Battery Cover

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Parameter Board

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Key Board (Encoder and Knob )

Critical. Terchnical Test

 Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Connecting Cables

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

The Components of Parameter Major B Functional Testing

Connector(ECG ,NIBP,SPO2,
Temperature)
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Bottom Cabinet

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Printer Assembly
 Major B Functional Testing

Printer Assembly

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Power Supply Board

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

ECG Channel Board

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Main Control Board

 Main Control Board

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Front cabinet

Critical. Terchnical Test

Minor. Visual Inspection

ECG Machine
HE1200
Major A Compatibility

Major B Functional Testing

Key board
Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Display & Touch Screen

Critical. Terchnical Test

AW MATERIAL

Minor. Visual Inspection

INCOMING RAW MATERIAL Major A Compatibility

Major B Functional Testing

Printer Head

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

AC-DC Board
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

FRC and Cables

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Battery and Battery Cover

 Major B Functional Testing

Battery and Battery Cover

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Actuator Driver

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Opto Coupler Board

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Bottom Cabinet

Critical. Terchnical Test

 Bottom Cabinet

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Main Board

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Front Cabinet

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

AC/DC Adapter

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility
Cardiac Marker
HIA1100

Primary Laser2
Cardiac Marker
HIA1100
Major B Functional Testing

Primary Laser2

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Printer Assembly (Printer
Head ,Printer Roller& Cover)

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Stepper Motor

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Display and Touch Screen
Display and Touch Screen

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Connecting FRC Cables

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Secondary Laser1

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Front Cabinet

Critical. Terchnical Test

Minor. Visual Inspection

 Major A Compatibility

Major B Functional Testing

Rear Cabinet

Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Battery
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Key Board
Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Display&Touch Screen
 Display&Touch Screen

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Plunger & Srying Clamp

Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Display Board
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility
Syringe Pump
HS100

Major B Functional Testing

Main Board

Critical. Terchnical Test

 Main Board

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Syringe Size Detector Board

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Occlusion Pressure Sensor

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Speaker

Critical. Terchnical Test

Minor. Visual Inspection

 Major A Compatibility

Major B Functional Testing

DC Adapter

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Motor and Gear

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

FRC Cables

Critical. Terchnical Test

Minor. Visual Inspection

 Major A Compatibility

Major B Functional Testing

Main Board

Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Display

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Parameter Board
Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Alarm PCB
 Major B Functional Testing

Alarm PCB

Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Major B Functional Testing

Battery

Critical. Terchnical Test

Pulse Oximeter
HM20

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Front Cover

Critical. Terchnical Test

Minor. Visual Inspection

Major A Measuring size

Adapter
 Major B Functional Testing
Adapter

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Safety Back Cover

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Rear Cover

Critical. Terchnical Test

Minor. Visual Inspection

Major A Compatibility

Major B Functional Testing

Stand Base

Critical. Terchnical Test

 Stand Base

Minor. Visual Inspection

Connectivity
Major A
Placement

Major B Screws Tightness

Wheel Assembly (Stage-I)

Critical. Functional Testing

Minor. Visual Inspection

Connectivity
Major A
Placement

Major B Screws Tightness

Mechanical Assembly (Stage-II)

Critical. Functional Testing

Minor. Visual Inspection

Anesthesia
Machine HA1100
Connectivity
Major A
Placement

Major B Screws Tightness

Electronic Assembly (Stage-III)

Critical. Functional Testing

Minor. Visual Inspection

Connectivity
Major A
Placement

Major B Screws Tightness

Pneumatic Assembly (Stage-IV)

 Pneumatic Assembly (Stage-IV)

Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Stage-I

Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Patient Monitor
Stage-II
HM1200
Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Stage-III

Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Stage-I
 Major B Fitting Inspection

Stage-I

Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

ECG Machine
Stage-II
HE1200
Critical. Functional Testing

Minor. Visual Inspection

IN PROCESS INSPECTION

Major A Electrical Connections

Major B Fitting Inspection

Stage-III

Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Stage-I

Critical. Functional Testing

Minor. Visual Inspection

 Major A Electrical Connections

Major B Fitting Inspection

Cardiac Marker
Stage-II
HIA1100
Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Stage-III
Functional
Critical. Test/Surface finish
inspection

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Stage-I

Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Syringe Pump
Stage-II
HS100
Critical. Functional Testing
Syringe Pump
Stage-II
HS100

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Stage-III

Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Stage-I

Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Pulse Oximeter
Stage-II
HM20
Critical. Functional Testing

Minor. Visual Inspection

Major A Electrical Connections

Major B Fitting Inspection

Stage-III
 Stage-III

Critical. Functional Testing

Minor. Visual Inspection

Major A Safety Test

Major B Techninical Test

Anesthesia
QC Stage of Assembled Unit
Machine HA1100

Gas Leakage Test,

Critical. Functional Test, Flow
Test

Minor. Visual Inspection

Major A Safety Test

Major B Techninical Test

Patient Monitor
QC Stage of Assembled Unit
HM1200
 Patient Monitor
QC Stage of Assembled Unit
HM1200

All parameter test,

Critical.
Functional test

Minor. Visual Inspection

Major A Safety Test

Major B Techninical Test

ECG Machine
QC Stage of Assembled Unit
HE1200

Fuctional test of All

Critical.
parameters
FINAL INSPECTION

Minor. Visual Inspection

Major A Safety Test

Cardiac Marker
QC Stage of Assembled Unit
HIA1100
FIN
Major B Techninical Test

Cardiac Marker
QC Stage of Assembled Unit
HIA1100

Gas Leakage Test,

Critical. Functional Test, Flow
Test

Minor. Visual Inspection

Major A Safety Test

Major B Techninical Test

Syringe Pump
QC Stage of Assembled Unit
HS100

Volume test,Occulusion
Critical. Pressure test and
Bolus test

Minor. Visual Inspection

 Major A Safety Test

Major B Techninical Test

Pulse Oximeter
QC Stage of Assembled Unit
HM20

Fuctional test of All

Critical.
parameters

Minor. Visual Inspection

Packaging Inspection
Major A Standard Accessories
Customer demands

Booting Logo,
Major B Branding and Labelling

Anesthesia
Finished Product Inspection
Machine HA1100
Accessories Functional
Critical.
Test

Minor. Visual inspection

Packaging Inspection
Major A Standard Accessories
Customer demands

Booting Logo,
Major B Branding and Labelling

Patient Monitor
Finished Product Inspection
HM1200
Accessories Functional
Critical.
Test
 Patient Monitor
Finished Product Inspection
HM1200

Minor. Visual inspection

Packaging Inspection
Major A Standard Accessories
Customer demands

Booting Logo,
Major B Branding and Labelling

ECG Machine
Finished Product Inspection
HE1200
Accessories Functional
Critical.
Test
FINISHED PRODUCT

Minor. Visual inspection

Packaging Inspection
Major A Standard Accessories
Customer demands

Booting Logo,
Major B Branding and Labelling

Cardiac Marker
Finished Product Inspection
HIA1100
Accessories Functional
Critical.
Test

Minor. Visual inspection

Packaging Inspection
Major A Standard Accessories
Customer demands

Booting Logo,
Major B Branding and Labelling

Syringe Pump
Finished Product Inspection
HS100
Accessories Functional
Critical.
Test

Minor. Visual inspection

 Packaging Inspection
Major A Standard Accessories
Customer demands

Booting Logo,
Major B Branding and Labelling

Pulse Oximeter
Finished Product Inspection
HM20
Accessories Functional
Critical.
Test

Minor. Visual inspection

A defect that judgment and experience indicate is likely to result in a condition immediate
Critical.
individuals using or depending upon the process

A defect, other than critical, that is likely to result in failure to the degree that the equipment doe
Major A.
or a defect that reduces protection and is not detectable by the u

Major B A defect, other than Major A or critical, that is likely to result in fault, and is det

A defect that is not likely to materially reduce the usability of the for its intended purpose, or
Minor.
established standards and has little bearing on the effective use or operation of

Prepared by: Approved by:

Signature: Signature:

Date: Date:
QUALITY CONTROL PLAN
Instrument/
Specifications Frequency Sample size Acceptance Criteria
Measuring Aids

Main board should be compatible with all Measuring Sampling plan as

Test Report
spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

All functions should be proper control,

Main board should be accessible and It Sampling plan as
Cross Check with Test Report
should be operate as intended with all Every Batch per SOP,
Device F/QC/02/07-00
functioning correctly without errors and (SOP/QC/01-00)
malfunctions.

Sampling plan as
Test Report
No any short circuit. Multimeter Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components (SOP/QC/01-00)

Proper Fixedness and compatible with all Measuring Sampling plan as

Test Report
connector of O2,N2O and Air without Scale/Digital Every Batch per SOP,
F/QC/02/07-00
leakage. Vernier caliper (SOP/QC/01-00)

Sampling plan as
Cross check with Test Report
Each hose pipe are function without leaks Every Batch per SOP,
setup device F/QC/02/07-00
(SOP/QC/01-00)

NA NA NA NA NA

Sampling plan as
No any visible defects such as no damage Test Report
NA Every Batch per SOP,
no scratch no cuts and correct port. F/QC/02/07-00
(SOP/QC/01-00)

Power supply board should be Measuring Sampling plan as

Test Report
compatible with holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

Cross check with Test Report
functioning correctly without errors and Every Batch per SOP,
setup device F/QC/02/07-00
malfunctions. (SOP/QC/01-00)
No any short circuit, Input voltage within Sampling plan as
Test Report
range: 100~240V AC Frequency 50/60 Multimeter, Every Batch per SOP,
F/QC/02/07-00
Hz. (SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Proper Fixedness and compatible with all Measuring Sampling plan as

Test Report
connector of breathing circuit without Scale/Digital Every Batch per SOP,
F/QC/02/07-00
leakage. Vernier caliper (SOP/QC/01-00)

Range 1~70 cmH2O, APL Valve rotates Sampling plan as

Cross Check with Test Report
Freely, No greater than 50mL/min, All Every Batch per SOP,
setup device F/QC/02/07-00
functioning correctly without errors. (SOP/QC/01-00)

Sampling plan as
It should be calibrate successfully done Test Report
Gas Flow Analyzer Every Batch per SOP,
and leakage test proper qualified. F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts. (SOP/QC/01-00)

Display Size: 10.4 inch Measuring Sampling plan as

Test Report
Dimension: 272(H) ×278(V) ×18(D) mm Scale/Digital Every Batch per SOP,
F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Display must be show accurate and Sampling plan as

Cross Check with Test Report
timely information and display readable Every Batch per SOP,
setup device F/QC/02/07-00
without error. (SOP/QC/01-00)

No any short circuit. Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors (SOP/QC/01-00)

No any visible defects, fine display Sampling plan as

Test Report
without scratch, no spots inside the NA Every Batch per SOP,
F/QC/02/07-00
display screen. (SOP/QC/01-00)

Measuring Sampling plan as

Proper Fixedness and fit with both casing Test Report
Scale/Digital Every Batch per SOP,
and compatible with Chessis. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA
 NA NA NA NA NA

Sampling plan as
No any visible defects such as no damage Test Report
NA Every Batch per SOP,
no scratch, no spots. F/QC/02/07-00
(SOP/QC/01-00)

Proper Fixedness and fit with both casing Measuring Sampling plan as
Test Report
and compatible with metal frame and Scale/Digital Every Batch per SOP,
F/QC/02/07-00
wheels. Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

No any visible defects such as no damage Sampling plan as

Test Report
no scratch, no spots, internal threads NA Every Batch per SOP,
F/QC/02/07-00
smoothly tightness. (SOP/QC/01-00)

Measuring Sampling plan as

Five Tube Flow Meter should be Test Report
Scale/Digital Every Batch per SOP,
campatible with casing and tubing F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Flow control knob should be clearly Sampling plan as

Cross Check with Test Report
indicate the Gas symbol it controls on the Every Batch per SOP,
setup Device F/QC/02/07-00
flow meter. (SOP/QC/01-00)

The making colours of O2, N2O and Air

Sampling plan as
pressure gauges and flow meters knob Test Report
NA Every Batch per SOP,
should be White, Blue and Black F/QC/02/07-00
(SOP/QC/01-00)
respectively.

No any visible defects, fine flow display Sampling plan as

Test Report
without scratch, no spots inside flow NA Every Batch per SOP,
F/QC/02/07-00
meter display. (SOP/QC/01-00)

Measuring Sampling plan as

Correct marking and identity with the Test Report
Scale/Digital Every Batch per SOP,
correct size. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

No any visible defects, fine print without Sampling plan as

Test Report
scratch, no spots and correct symbol in NA Every Batch per SOP,
F/QC/02/07-00
position and readable. (SOP/QC/01-00)
Proper Fixedness and fit with both casing Measuring Sampling plan as
Test Report
and compatible with dual vaporizer Scale/Digital Every Batch per SOP,
F/QC/02/07-00
sheet. Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots and , no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)

Measuring Sampling plan as

Proper Fixedness and compatible with Test Report
Scale/Digital Every Batch per SOP,
connector of AG port. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
Cross Check with Test Report
It should be calibrate successfully done Every Batch per SOP,
setup Device F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Gas Flow Analyzer Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots, no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)

Measuring Sampling plan as

Proper Fixedness and compatible with Test Report
Scale/Digital Every Batch per SOP,
connector of AG port. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

“O2+” Switch pressing the rapid

Sampling plan as
oxygenation switch should quickly open Cross Check with Test Report
Every Batch per SOP,
it and releasing it should automatically setup device F/QC/02/07-00
(SOP/QC/01-00)
close it

Sampling plan as
It should be calibrate successfully done Test Report
Gas Flow Analyzer Every Batch per SOP,
and no leakage F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots, no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)

Proper Fixedness and compatible with Measuring Sampling plan as

Test Report
Yoke connector of O2, N2O without Scale/Digital Every Batch per SOP,
F/QC/02/07-00
leakage. Vernier caliper (SOP/QC/01-00)

Sampling plan as
O2 and N2O both Yoke are function Cross Check with Test Report
Every Batch per SOP,
without leaks. setup Device F/QC/02/07-00
(SOP/QC/01-00)
 NA NA NA NA NA

Sampling plan as
No any visible defects such as no damage, Test Report
NA Every Batch per SOP,
no scratch, no bend and no tilt. F/QC/02/07-00
(SOP/QC/01-00)

Proper Fixedness and compatible with Measuring Sampling plan as

Test Report
connector of breathing system without Scale/Digital Every Batch per SOP,
F/QC/02/07-00
leakage. Vernier caliper (SOP/QC/01-00)

Sampling plan as
Cross Check with Test Report
It should be calibrate successfully done Every Batch per SOP,
setup Device F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots and , no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)

Measuring Sampling plan as

Proper Fixedness and compatible with Test Report
Scale/Digital Every Batch per SOP,
ACGO connector and casing of device F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

ACGO switch is turned to the ACGO

Sampling plan as
position the ACGO icon should be display Cross Check with Test Report
Every Batch per SOP,
in the ventilation mode area and alarm setup device F/QC/02/07-00
(SOP/QC/01-00)
message indicating.

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors (SOP/QC/01-00)

Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots, no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)

Proper Fixedness and compatible with Measuring Sampling plan as

Test Report
Systm switch connector and casing of Scale/Digital Every Batch per SOP,
F/QC/02/07-00
device Vernier caliper (SOP/QC/01-00)

Rotate the switch and close circuit for

Sampling plan as
start function in well operated status, Cross check with Test Report
Every Batch per SOP,
Systm switch should be function correctly setup device F/QC/02/07-00
(SOP/QC/01-00)
without errors.

Switch continuity with multi meter Sampling plan as

Test Report
during push button of On/off switch, No Multimeter Every Batch per SOP,
F/QC/02/07-00
short circuit. (SOP/QC/01-00)

Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots, no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)
 Proper Fixedness and compatible with Measuring Sampling plan as
Test Report
Systm switch connector and casing of Scale/Digital Every Batch per SOP,
F/QC/02/07-00
device. Vernier caliper (SOP/QC/01-00)

Sampling plan as
All accessories should be function Cross Check with Test Report
Every Batch per SOP,
without fails setup device F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots, no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)

Proper Fixedness and compatible with all Measuring Sampling plan as

Test Report
connector of O2,N2O and Air without Scale/Digital Every Batch per SOP,
F/QC/02/07-00
leakage. Vernier caliper (SOP/QC/01-00)

Sampling plan as
Gas inlet port assembly are function Cross Check with Test Report
Every Batch per SOP,
without leaks setup Device F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Multimeter Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
No any visible defects such as no damage, Test Report
NA Every Batch per SOP,
no scratch and correct port. F/QC/02/07-00
(SOP/QC/01-00)

Front cabinet should be compatible with Measuring Sampling plan as

Test Report
display, key board and holes screws of Scale/Digital Every Batch per SOP,
F/QC/02/07-00
board place. Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots, no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)

Rear cabinet should be compatible with Measuring Sampling plan as

Test Report
all spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA
 Sampling plan as
No any visible defects, no scratch, no Test Report
NA Every Batch per SOP,
spots, no unwanted parts. F/QC/02/07-00
(SOP/QC/01-00)

Power supply board should be Measuring Sampling plan as

Test Report
compatible with holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

Cross Check with Test Report
functioning correctly without errors and Every Batch per SOP,
setup device F/QC/02/07-00
malfunctions. (SOP/QC/01-00)

No any short circuit, Input voltage within Sampling plan as

Test Report
range: 100~240V AC Frequency 50/60 Multimeter Every Batch per SOP,
F/QC/02/07-00
Hz. (SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Power supply board should be Measuring Sampling plan as

Test Report
compatible with holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

Sampling plan as
Air inflation and deflation should be Cross Check with Test Report
Every Batch per SOP,
function without error setup device F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
No any short circuit of motor and Test Report
Multimeter, Every Batch per SOP,
sinosoidal sensor F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Main board should be compatible with all Measuring Sampling plan as

Test Report
spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

All functions should be proper control,

Main board should be accessible and It Sampling plan as
Cross Check with Test Report
should be operate as intended with all Every Batch per SOP,
setup F/QC/02/07-00
functioning correctly without errors and (SOP/QC/01-00)
malfunctions.

Sampling plan as
Test Report
No any short circuit. Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components (SOP/QC/01-00)
 Measuring Sampling plan as
Distribution board should be compatible Test Report
Scale/Digital Every Batch per SOP,
with holes screws of board place. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

Cross Check with Test Report
functioning correctly, Output voltage Every Batch per SOP,
setup device F/QC/02/07-00
within range and meets (SOP/QC/01-00)

No any short circuit, Input voltage within Sampling plan as

Test Report
range: (14V DC ±2V), Frequency 50/60 Multimeter Every Batch per SOP,
F/QC/02/07-00
Hz. ±2V (SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

Test Report
Size: 60×60×15 mm, Speed: 3200rpm Scale/Digital Every Batch per SOP,
F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
Exhaust Fan functioning correctly Cross Check with Test Report
Every Batch per SOP,
without errors and malfunctions setup F/QC/02/07-00
(SOP/QC/01-00)

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. DC 12 V, 0.08A, 2.4W (SOP/QC/01-00)

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Measuring Sampling plan as

Test Report
Diameter: 50 mm Scale/Digital Every Batch per SOP,
F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
All alarms must trigger correctly and Cross Check with Test Report
Every Batch per SOP,
within range response time setup device F/QC/02/07-00
(SOP/QC/01-00)

No any short circuit, 8 Ohm, 0.5 Watt,

Multimeter, Sampling plan as
94±3 dB, Cable wires continuity with Test Report
Sound level Every Batch per SOP,
multi meter on both end side of F/QC/02/07-00
metter (SOP/QC/01-00)
connectors

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Measuring Sampling plan as

Display size: 12.1”Diagonal, Dimension: Test Report
Scale/Digital Every Batch per SOP,
276(H)×209(V)×10(D) mm F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Display must be show accurate and Sampling plan as

Cross Check with Test Report
timely information and display readable Every Batch per SOP,
setup F/QC/02/07-00
without error. (SOP/QC/01-00)
 No any visible defects, Cable wires Sampling plan as
Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. VCC3.3V, VLED12V (SOP/QC/01-00)

No any visible defects, fine display Sampling plan as

Test Report
without scratch, no spots inside the NA Every Batch per SOP,
F/QC/02/07-00
display screen. (SOP/QC/01-00)

Measuring Sampling plan as

Test Report
Battery Size: 65×44×77 mm Scale/Digital Every Batch per SOP,
F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Batttery meets all required specifications,

Sampling plan as
charge capacity, should be oprate Cross Check with Test Report
Every Batch per SOP,
continuously for 4 hours withuot mains setup F/QC/02/07-00
(SOP/QC/01-00)
supply

Sampling plan as
No any short circuit, Test Report
Multimeter Every Batch per SOP,
DC11.1V/4400mAh/48.84Wh F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and no any liquid, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts, no deformities (SOP/QC/01-00)

Parameter board should be compatible Measuring Sampling plan as

Test Report
with Main board and holes screws of Scale/Digital Every Batch per SOP,
F/QC/02/07-00
board place. Vernier caliper (SOP/QC/01-00)

All alarms must be trigger correctly

Sampling plan as
within range response time, All Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors and setup F/QC/02/07-00
(SOP/QC/01-00)
malfunctions.

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Encoder Connector should be compatible

Measuring Sampling plan as
with Key board and Main board and Test Report
Scale/Digital Every Batch per SOP,
Holes size of screw should be match with F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
front cabinet

Press menu key then open setting

Sampling plan as
function in well operated status and All Cross Check with Test Report
Every Batch per SOP,
switch proper functioning after connect setup F/QC/02/07-00
(SOP/QC/01-00)
the requirement PCB Board

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)
 Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Display & All PCB connectors and Measuring Sampling plan as

Test Report
assessed the flexibility of the cable and Scale/Digital Every Batch per SOP,
F/QC/02/07-00
compatible with pin configuration Vernier caliper (SOP/QC/01-00)

Cables connector should be accessible

Sampling plan as
and It should be operate as intended with Cross Check with Test Report
Every Batch per SOP,
all functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)
and malfunctions

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Parameter Connector should be Measuring Sampling plan as

Test Report
compatible with parameter accessories Scale/Digital Every Batch per SOP,
F/QC/02/07-00
and parameter board connector Vernier caliper (SOP/QC/01-00)

Sampling plan as
It should be function correctly without Cross Check with Test Report
Every Batch per SOP,
errors setup F/QC/02/07-00
(SOP/QC/01-00)

No any short circuit, all wires continuity Sampling plan as

Test Report
with multi meter on both end side of Multimeter, Every Batch per SOP,
F/QC/02/07-00
connectors (SOP/QC/01-00)

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Bottom cabinet should be compatible Measuring Sampling plan as

Test Report
with all spares and screw holes of both Scale/Digital Every Batch per SOP,
F/QC/02/07-00
cabinet, 340(H)×280(V)×70(D) mm Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Printer Assembly should be compatible Measuring Sampling plan as

Test Report
with all spares and screw holes of bottom Scale/Digital Every Batch per SOP,
F/QC/02/07-00
cabinet Vernier caliper (SOP/QC/01-00)
Printer Assembly should be print in both
Sampling plan as
manual and automatic way. Display graph Cross Check with Test Report
Every Batch per SOP,
and results clearly readable on prinout setup device F/QC/02/07-00
(SOP/QC/01-00)
paper

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Power supply board should be Measuring Sampling plan as

Test Report
compatible with holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

Cross Check with Test Report
functioning correctly without errors and Every Batch per SOP,
setup F/QC/02/07-00
malfunctions. (SOP/QC/01-00)

No any short circuit, Input voltage within Sampling plan as

Test Report
range: 100~240V AC Frequency 50/60 Multimeter, Every Batch per SOP,
F/QC/02/07-00
Hz. (SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

ECG board should be compatible with Measuring Sampling plan as

Test Report
Main board and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

All alarms must be trigger correctly

Sampling plan as
within range response time, All Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors and setup device F/QC/02/07-00
(SOP/QC/01-00)
malfunctions.

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Main board should be compatible with all Measuring Sampling plan as

Test Report
spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

All functions should be proper control,

Main board should be accessible and It Sampling plan as
Cross Check with Test Report
should be operate as intended with all Every Batch per SOP,
setup device F/QC/02/07-00
functioning correctly without errors and (SOP/QC/01-00)
malfunctions.
 Sampling plan as
Test Report
No any short circuit. Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components (SOP/QC/01-00)

Front cabinet should be compatible with Measuring Sampling plan as

Test Report
display, key board and holes screws of Scale/Digital Every Batch per SOP,
F/QC/02/07-00
board place, 340(H)×280(V)×35(D) mm Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Key board should be compatible with all Measuring Sampling plan as

Test Report
spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

Press menu key then open setting Sampling plan as

Cross Check with Test Report
function in well operated status and All Every Batch per SOP,
setup device F/QC/02/07-00
switch proper functioning (SOP/QC/01-00)

No any short circuit, all switch continuity Sampling plan as

Test Report
with multi meter during push button of Multimeter, Every Batch per SOP,
F/QC/02/07-00
the given switches (SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

Display size: 7.1”Diagonal, Dimension: Test Report
Scale/Digital Every Batch per SOP,
165(H)×105(V)×6(D) mm F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Display must be show accurate and Sampling plan as

Cross Check with Test Report
timely information and display readable Every Batch per SOP,
setup F/QC/02/07-00
without error. (SOP/QC/01-00)

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. VCC3.3V (SOP/QC/01-00)

No any visible defects, fine display Sampling plan as

Test Report
without scratch, no spots inside the NA Every Batch per SOP,
F/QC/02/07-00
display screen. (SOP/QC/01-00)
 Printer should be compatible with all Measuring Sampling plan as
Test Report
printer assembly and holes screws of Scale/Digital Every Batch per SOP,
F/QC/02/07-00
printer head place. Vernier caliper (SOP/QC/01-00)

Printer Assembly should be print in both

Sampling plan as
manual and automatic way. Display graph Cross Check with Test Report
Every Batch per SOP,
and results clearly readable on prinout setup F/QC/02/07-00
(SOP/QC/01-00)
paper

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects, no artifacts in the Sampling plan as

Test Report
print and no vertical or horizontal lines NA Every Batch per SOP,
F/QC/02/07-00
should appear on the paper (SOP/QC/01-00)

Measuring Sampling plan as

Distribution board should be compatible Test Report
Scale/Digital Every Batch per SOP,
with all connector of related PCB F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

Cross Check with Test Report
functioning correctly without errors and Every Batch per SOP,
setup device F/QC/02/07-00
malfunctions (SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Display & All PCB connectors and Measuring Sampling plan as

Test Report
assessed the flexibility of the cable and Scale/Digital Every Batch per SOP,
F/QC/02/07-00
compatible with pin configuration Vernier caliper (SOP/QC/01-00)

Cables connector should be accessible

Sampling plan as
and It should be operate as intended with Cross Check with Test Report
Every Batch per SOP,
all functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)
and malfunctions

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

Proper shielding to prevent interference

Sampling plan as
from external electrical sources, No Test Report
NA Every Batch per SOP,
frayed wires, No any visible defects such F/QC/02/07-00
(SOP/QC/01-00)
as cuts,

Battery and battery cover dimension Measuring Sampling plan as

Test Report
should be compatibility such as casing Scale/Digital Every Batch per SOP,
F/QC/02/07-00
size of battery. Size: 68×38×75 mm Vernier caliper (SOP/QC/01-00)
 Sampling plan as
The battery should be run continuously Cross Check with Test Report
Every Batch per SOP,
for more than half an hours after charging setup F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
No any short circuit, DC Test Report
Multimeter, Every Batch per SOP,
14.4V/4400mAh/63.36Wh F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and no any liquid, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts, no deformities (SOP/QC/01-00)

Actuator driver should be compatible Measuring Sampling plan as

Test Report
with multiple component such as Gears, Scale/Digital Every Batch per SOP,
F/QC/02/07-00
Belt and Motor Vernier caliper (SOP/QC/01-00)

Actuator driver be smooth movement Sampling plan as

Cross Check with Test Report
and It should be operate as intended with Every Batch per SOP,
setup F/QC/02/07-00
all functioning correctly (SOP/QC/01-00)

NA NA NA NA NA

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Measuring Sampling plan as

It should be compatible with main board Test Report
Scale/Digital Every Batch per SOP,
and holes screws of board place. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
It should be operate as intended with all Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit, Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Bottom cabinet should be compatible Measuring Sampling plan as

Test Report
with all spares and screw holes of both Scale/Digital Every Batch per SOP,
F/QC/02/07-00
cabinet Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA
No any visible defects such as no damage Sampling plan as
Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Main board should be compatible with all

Measuring Sampling plan as
spare parts and Actuator driver and holes Test Report
Scale/Digital Every Batch per SOP,
size of screw should be match with F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
cabinet threads

Sampling plan as
It should be operate as intended with all Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

Front cabinet should be compatible with Test Report
Scale/Digital Every Batch per SOP,
dispay and bottom cabinet. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Measuring Sampling plan as

Adapter should be compatible with Test Report
Scale/Digital Every Batch per SOP,
Device connector. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
It should be operate as intended with all Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)

No any short circuit, 100~240VAC/60VA, Sampling plan as

Test Report
Cable Size: 3Mtr. 50/60Hz, Output Multimeter, Every Batch per SOP,
F/QC/02/07-00
Voltage: 12 V (SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Measuring Sampling plan as

It should be compatible with Device Test Report
Scale/Digital Every Batch per SOP,
connector. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
 The device has auto-scan function and
Sampling plan as
The device inform the message. Cross Check with Test Report
Every Batch per SOP,
Automatically when no control line is setup device F/QC/02/07-00
(SOP/QC/01-00)
detected.

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Printer Assembly should be compatible Measuring Sampling plan as

Test Report
with all spares and screw holes of bottom Scale/Digital Every Batch per SOP,
F/QC/02/07-00
cabinet Vernier caliper (SOP/QC/01-00)

Printer Assembly should be print in both

Sampling plan as
manual and automatic way. Display graph Cross Check with Test Report
Every Batch per SOP,
and results clearly readable on prinout setup F/QC/02/07-00
(SOP/QC/01-00)
paper

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Motor and Gear should be compatible

Measuring Sampling plan as
with other Gears and connector and holes Test Report
Scale/Digital Every Batch per SOP,
size of screw should be match with F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
cabinet threads

Motor and Gear should be smooth

Sampling plan as
movement and It should be operate as Cross Check with Test Report
Every Batch per SOP,
intended with all functioning correctly setup F/QC/02/07-00
(SOP/QC/01-00)
without errors

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Display and Touch screen should be

Measuring Sampling plan as
compatible with display board and Main Test Report
Scale/Digital Every Batch per SOP,
board, Size: 7.4 Inch, Dimension: F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
170(H)×110(V)×6(D)mm

Display must be show accurate and Sampling plan as

Cross Check with Test Report
timely information and display readable Every Batch per SOP,
setup F/QC/02/07-00
without error. (SOP/QC/01-00)
 Sampling plan as
Cable wires continuity with multi meter Test Report
Multimeter, Every Batch per SOP,
on both end side of connectors. F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, fine display Sampling plan as

Test Report
without scratch, no spots inside the NA Every Batch per SOP,
F/QC/02/07-00
display screen. (SOP/QC/01-00)

Display & All PCB connectors and Measuring Sampling plan as

Test Report
assessed the flexibility of the cable and Scale/Digital Every Batch per SOP,
F/QC/02/07-00
compatible with pin configuration Vernier caliper (SOP/QC/01-00)

Cables connector should be accessible

Sampling plan as
and It should be operate as intended with Cross Check with Test Report
Every Batch per SOP,
all functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)
and malfunctions

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

Proper shielding to prevent interference

Sampling plan as
from external electrical sources, No Test Report
NA Every Batch per SOP,
frayed wires, No any visible defects such F/QC/02/07-00
(SOP/QC/01-00)
as cuts,

Measuring Sampling plan as

It should be compatible with Device Test Report
Scale/Digital Every Batch per SOP,
connector. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

The device has auto-scan function and

The device inform the message.
NA NA NA NA
Automatically when no control line is
detected.

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Measuring Sampling plan as

Front cabinet should be compatible with Test Report
Scale/Digital Every Batch per SOP,
display and holes screws of board place. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)
Rear cabinet should be compatible with Measuring Sampling plan as
Test Report
all spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Measuring Sampling plan as

It should be compatibility with casing of Test Report
Scale/Digital Every Batch per SOP,
battery, Size:(67mm×56mm×12mm) F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
The battery should be run continuously Cross Check with Test Report
Every Batch per SOP,
for more than seven hours after charging setup F/QC/02/07-00
(SOP/QC/01-00)

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and no any liquid, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts, no deformities (SOP/QC/01-00)

Key board should be compatible with all Measuring Sampling plan as

Test Report
spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

Press menu key then open setting Sampling plan as

Cross Check with Test Report
function in well operated status and All Every Batch per SOP,
setup F/QC/02/07-00
switch proper functioning (SOP/QC/01-00)

No any short circuit, all switch continuity Sampling plan as

Test Report
with multi meter during push button of Multimeter, Every Batch per SOP,
F/QC/02/07-00
the given switches (SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

Display size: (2.8”Diagonal), Test Report
Scale/Digital Every Batch per SOP,
Dimension: 60(H) × 45(V) × 5(D)mm F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Display must be show accurate and Sampling plan as

Cross Check with Test Report
timely information and display readable Every Batch per SOP,
setup F/QC/02/07-00
without error. (SOP/QC/01-00)
 No any short circuit, Cable wires Sampling plan as
Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects, fine display Sampling plan as

Test Report
without scratch, no spots inside the NA Every Batch per SOP,
F/QC/02/07-00
display screen. (SOP/QC/01-00)

Plunger and Clamp should be compatible Measuring Sampling plan as

Test Report
with cabinet and All holes screw size Scale/Digital Every Batch per SOP,
F/QC/02/07-00
should be match with cabinet threads Vernier caliper (SOP/QC/01-00)

Sampling plan as
It should be operate as intended with all Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)

Measuring Range 26kPa~130kPa and

Sampling plan as
Occlusion pressure should be change Test Report
Multimeter, Every Batch per SOP,
(0~100%) on display icon according to F/QC/02/07-00
(SOP/QC/01-00)
push button

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Measuring Sampling plan as

It should be compatible with main board, Test Report
Scale/Digital Every Batch per SOP,
dispay and holes screws of board place. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Display must show accurate and timely Sampling plan as

Cross Check with Test Report
information or errors and display Every Batch per SOP,
setup F/QC/02/07-00
readable (SOP/QC/01-00)

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Main board should be compatible with all

Measuring Sampling plan as
spare parts and Actuator driver and holes Test Report
Scale/Digital Every Batch per SOP,
size of screw should be match with F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
cabinet threads

Sampling plan as
It should be operate as intended with all Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)
 No any visible defects, dry solder, Sampling plan as
Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

It should be compatible with Syringe Test Report
Scale/Digital Every Batch per SOP,
push handle and cabinet screw threads F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Syringe size:2ml, 5ml, 10ml, 20ml, Sampling plan as

Cross Check with Test Report
30ml, 50ml (Automatically identify of Every Batch per SOP,
setup F/QC/02/07-00
syringe size according to use syringe) (SOP/QC/01-00)

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

it should be compatible with plunger Test Report
Scale/Digital Every Batch per SOP,
cabinet and Main board F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Plunger should be accessible and It Sampling plan as

Cross Check with Test Report
should be operate as intended with all Every Batch per SOP,
setup F/QC/02/07-00
functioning correctly without errors (SOP/QC/01-00)

Measuring Range 26kPa~130kPa and

Occlusion pressure should be change Sampling plan as
Test Report
(0~100%) on display icon according to Multimeter, Every Batch per SOP,
F/QC/02/07-00
push button,Automatically detect (SOP/QC/01-00)
occlusion pressure

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

Measuring Sampling plan as

Test Report
Diameter: 50 mm Scale/Digital Every Batch per SOP,
F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
All alarms must trigger correctly and Cross Check with Test Report
Every Batch per SOP,
within range response time setup F/QC/02/07-00
(SOP/QC/01-00)

No any short circuit and closed circuit,

Resistance value 8 Ohm, Beep and low Sampling plan as
Test Report
resistance readings should be coming on Multimeter, Every Batch per SOP,
F/QC/02/07-00
multi meter or indicating continuity (SOP/QC/01-00)
between corresponding pins.

Sampling plan as
Test Report
No any visible defects NA Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)
 Measuring Sampling plan as
It should be compatible with Device Test Report
Scale/Digital Every Batch per SOP,
connector F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
Adopter meets all required specifications, Cross Check with Test Report
Every Batch per SOP,
Three pin plug C type connector setup device F/QC/02/07-00
(SOP/QC/01-00)

No any short circuit, Cable wires

Sampling plan as
continuity with multi meter on both end Test Report
Multimeter, Every Batch per SOP,
side of connectors. Cable Size: 1.5Mtr. F/QC/02/07-00
(SOP/QC/01-00)
50/60Hz, 100~240V AC, 0.5Amp.

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Motor and Gear should be compatible

Measuring Sampling plan as
with other Gears and connector and holes Test Report
Scale/Digital Every Batch per SOP,
size of screw should be match with F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
cabinet threads

Motor and Gear should be smooth

Sampling plan as
movement and It should be operate as Cross Check with Test Report
Every Batch per SOP,
intended with all functioning correctly setup F/QC/02/07-00
(SOP/QC/01-00)
without errors

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Display & All PCB connectors and Measuring Sampling plan as

Test Report
assessed the flexibility of the cable and Scale/Digital Every Batch per SOP,
F/QC/02/07-00
compatible with pin configuration Vernier caliper (SOP/QC/01-00)

Cables connector should be accessible

Sampling plan as
and It should be operate as intended with Cross Check with Test Report
Every Batch per SOP,
all functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)
and malfunctions

No any short circuit, Cable wires Sampling plan as

Test Report
continuity with multi meter on both end Multimeter, Every Batch per SOP,
F/QC/02/07-00
side of connectors. (SOP/QC/01-00)

Proper shielding to prevent interference

Sampling plan as
from external electrical sources, No Test Report
NA Every Batch per SOP,
frayed wires, No any visible defects such F/QC/02/07-00
(SOP/QC/01-00)
as cuts,
Main board should be compatible with all
Measuring Sampling plan as
spare parts and Actuator driver and holes Test Report
Scale/Digital Every Batch per SOP,
size of screw should be match with F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
cabinet threads

Sampling plan as
It should be operate as intended with all Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors setup F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

Dimension: 55(H)×85(V)×5(D) mm, Test Report
Scale/Digital Every Batch per SOP,
3.1”Diagonal, F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Display must be show accurate and Sampling plan as

Cross Check with Test Report
timely information and display readable Every Batch per SOP,
setup F/QC/02/07-00
without error (SOP/QC/01-00)

Sampling plan as
VCC3.3V, VLED05V, LB121S03-TL04 and Test Report
Multimeter, Every Batch per SOP,
No any short circuit F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, fine display Sampling plan as

Test Report
without scratch, no spots inside the NA Every Batch per SOP,
F/QC/02/07-00
display screen. (SOP/QC/01-00)

Parameter board should be compatible Measuring Sampling plan as

Test Report
with Main board and holes screws of Scale/Digital Every Batch per SOP,
F/QC/02/07-00
board place. Vernier caliper (SOP/QC/01-00)

All alarms must be trigger correctly

Sampling plan as
within range response time, All Cross Check with Test Report
Every Batch per SOP,
functioning correctly without errors and setup F/QC/02/07-00
(SOP/QC/01-00)
malfunctions.

Sampling plan as
Test Report
No any short circuit Multimeter, Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

Alarm PCB should be compatible with main Test Report
Scale/Digital Every Batch per SOP,
board and casing F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)
 Sampling plan as
All alarms must be trigger correctly Cross Check with Test Report
Every Batch per SOP,
within range response time setup F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
Test Report
No any short circuit Multimeter Every Batch per SOP,
F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects, dry solder, Sampling plan as

Test Report
misaligned component, solder bridges, NA Every Batch per SOP,
F/QC/02/07-00
solder joints are intact with components. (SOP/QC/01-00)

Measuring Sampling plan as

Test Report
Size: (30×45×7)mm, Cell type Scale/Digital Every Batch per SOP,
F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Batttery meets all required specifications,

Sampling plan as
charge capacity, should be oprate Cross Check with Test Report
Every Batch per SOP,
continuously for an hour withuot mains setup F/QC/02/07-00
(SOP/QC/01-00)
supply

Sampling plan as
2×3.7V/1000mAh, Lithium Ion/ DL3210, Test Report
Multimeter Every Batch per SOP,
Resistance value within range ≤100mΩ F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and no any liquid, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts, no deformities (SOP/QC/01-00)

Front cabinet should be compatible with Measuring Sampling plan as

Test Report
all spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Cable Size: 1Mtr. , Diameter: 5 mm Measuring Sampling plan as

Test Report
PVC Insulated Cable, Adopter size: Scale/Digital Every Batch per SOP,
F/QC/02/07-00
(60×60×40)mm Vernier caliper (SOP/QC/01-00)
 Sampling plan as
Adopter meets all required specifications, Cross Check with Test Report
Every Batch per SOP,
Two pin plug and USB setup F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
100~240V AC/200mA, 50/60Hz, Test Report
Multimeter, Every Batch per SOP,
Output Voltage: 5V/1.2Amp. F/QC/02/07-00
(SOP/QC/01-00)

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Measuring Sampling plan as

Safety cover should be compatible with Test Report
Scale/Digital Every Batch per SOP,
device and charging port place. F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Rear cabinet should be compatible with Measuring Sampling plan as

Test Report
all spare parts and holes screws of board Scale/Digital Every Batch per SOP,
F/QC/02/07-00
place. Vernier caliper (SOP/QC/01-00)

NA NA NA NA NA

NA NA NA NA NA

No any visible defects such as no damage Sampling plan as

Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

Measuring Sampling plan as

It should be compatible with charging Test Report
Scale/Digital Every Batch per SOP,
point of device F/QC/02/07-00
Vernier caliper (SOP/QC/01-00)

Sampling plan as
Cross Check with Test Report
Hold the Device vertical position Every Batch per SOP,
setup device F/QC/02/07-00
(SOP/QC/01-00)

Sampling plan as
No any short circuit, Output Voltage Test Report
Multimeter, Every Batch per SOP,
within range: (5V ±1V) F/QC/02/07-00
(SOP/QC/01-00)
No any visible defects such as no damage Sampling plan as
Test Report
no scratch no spot and correct port, no NA Every Batch per SOP,
F/QC/02/07-00
unwanted parts (SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit. (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)
 Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)
 Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)
 No any misconnections, Proper Sampling plan as
As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)
 Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

No any misconnections, Proper Sampling plan as

As per Work
connected both end sides and No short Multimeter, Every Batch per SOP,
Instruction
circuit (SOP/QC/01-00)

Sampling plan as
As per Work
Screws tightness & no gaps allows Torque wrench Every Batch per SOP,
Instruction
(SOP/QC/01-00)
 Sampling plan as
As per Work
All PCB Working Device Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Sampling plan as
As per Work
No any visible defects NA Every Batch per SOP,
Instruction
(SOP/QC/01-00)

Dielecric and current leackage test meets Electrical Safety Sampling plan as
As per COA,
with IEC60601-1/IS13450-1 Standard for Analyzer, HV Every Batch per SOP,
F/QC/03/03-00
electrical safety Tester (SOP/QC/01-00)

Input voltage within range: (100~240V

Multimeter, Sampling plan as
AC) 50/60Hz , Groundind impedance As per COA,
Electrical Safety Every Batch per SOP,
≤100 mΩ and No any short circuit. F/QC/03/03-00
Analyzer (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

VT Mini and Gas As per COA,
features functioning correctly without Every Batch per SOP,
Flow Analyser F/QC/03/03-00
errors and malfunctions (SOP/QC/01-00)

No any visible defects, Correct labels with Sampling plan as

As per COA,
the correct position, No loose parts and NA Every Batch per SOP,
F/QC/03/03-00
screws (SOP/QC/01-00)

Dielecric and current leackage test meets Electrical Safety Sampling plan as
As per COA,
with IEC60601-1/IS13450-1 Standard for Analyzer, HV Every Batch per SOP,
F/QC/03/03-00
electrical safety Tester (SOP/QC/01-00)

Input voltage within range: (100~240V

Multimeter, Sampling plan as
AC) 50/60Hz , Groundind impedance As per COA,
Electrical Safety Every Batch per SOP,
≤100 mΩ and No any short circuit. F/QC/03/03-00
Analyzer (SOP/QC/01-00)
It should be operate as intended with all Spo2 Functional Sampling plan as
As per COA,
features functioning correctly without Tester, Vital Sign Every Batch per SOP,
F/QC/03/03-00
errors and malfunctions Simulator (SOP/QC/01-00)

No any visible defects, Correct labels with Sampling plan as

As per COA,
the correct position, No loose parts and NA Every Batch per SOP,
F/QC/03/03-00
screws (SOP/QC/01-00)

Dielecric and current leackage test meets Electrical Safety Sampling plan as
As per COA,
with IEC60601-1/IS13450-1 Standard for Analyzer, HV Every Batch per SOP,
F/QC/03/03-00
electrical safety Tester (SOP/QC/01-00)

Input voltage within range: (100~240V

Multimeter, Sampling plan as
AC) 50/60Hz , Groundind impedance As per COA,
Electrical Safety Every Batch per SOP,
≤100 mΩ and No any short circuit. F/QC/03/03-00
Analyzer (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

As per COA,
features functioning correctly without ECG Simulator Every Batch per SOP,
F/QC/03/03-00
errors and malfunctions (SOP/QC/01-00)

No any visible defects, Correct labels with Sampling plan as

As per COA,
the correct position, No loose parts and NA Every Batch per SOP,
F/QC/03/03-00
screws (SOP/QC/01-00)

Electrical Safety Sampling plan as

Verify compliance with relevant As per COA,
Analyzer, HV Every Batch per SOP,
standard IEC 60601 for Electrical Safety F/QC/03/03-00
Tester (SOP/QC/01-00)
 Multimeter, Sampling plan as
Specifications According to Test report As per COA,
Electrical Safety Every Batch per SOP,
and No short circuit F/QC/03/03-00
Analyzer (SOP/QC/01-00)

Input voltage within range: (100~240V

Sampling plan as
AC) 50/60Hz , Groundind impedance As per COA,
Controller Every Batch per SOP,
≤100 mΩ and No any short circuit. F/QC/03/03-00
(SOP/QC/01-00)

No any visible defects, Correct labels with Sampling plan as

As per COA,
the correct position, No loose parts and NA Every Batch per SOP,
F/QC/03/03-00
screws (SOP/QC/01-00)

Dielecric and current leackage test meets Electrical Safety Sampling plan as
As per COA,
with IEC60601-1/IS13450-1 Standard for Analyzer, HV Every Batch per SOP,
F/QC/03/03-00
electrical safety Tester (SOP/QC/01-00)

Input voltage within range: (100~240V

Multimeter, Sampling plan as
AC) 50/60Hz , Groundind impedance As per COA,
Electrical Safety Every Batch per SOP,
≤100 mΩ and No any short circuit. F/QC/03/03-00
Analyzer (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

Infusion pump As per COA,
features functioning correctly without Every Batch per SOP,
Analyser F/QC/03/03-00
errors and malfunctions (SOP/QC/01-00)

No any visible defects, Correct labels with Sampling plan as

As per COA,
the correct position, No loose parts and NA Every Batch per SOP,
F/QC/03/03-00
screws (SOP/QC/01-00)
Dielecric and current leackage test meets Electrical Safety Sampling plan as
As per COA,
with IEC60601-1/IS13450-1 Standard for Analyzer, HV Every Batch per SOP,
F/QC/03/03-00
electrical safety Tester (SOP/QC/01-00)

Input voltage within range: (100~240V

Multimeter, Sampling plan as
AC) 50/60Hz , Groundind impedance As per COA,
Electrical Safety Every Batch per SOP,
≤100 mΩ and No any short circuit. F/QC/03/03-00
Analyzer (SOP/QC/01-00)

It should be operate as intended with all Sampling plan as

Spo2 Functional As per COA,
features functioning correctly without Every Batch per SOP,
Simulator F/QC/03/03-00
errors and malfunctions (SOP/QC/01-00)

No any visible defects, Correct labels with Sampling plan as

As per COA,
the correct position, No loose parts and NA Every Batch per SOP,
F/QC/03/03-00
screws (SOP/QC/01-00)

Every Batch Sampling plan as

Robust enough protect device/ Customer As per PDI,
NA Every unit per SOP,
specs F/STR/02/01/01-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
Company logo, No any visible defects NA Every unit per SOP,
F/STR/02/01/01-00
100% (SOP/QC/01-00)

User interface and alarms functionality, Every Batch Sampling plan as

VT Mini and Gas As per PDI,
all intended funtions correctly as Every unit per SOP,
Flow Analyser F/STR/02/01/01-00
customer expectations and as per order 100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
No any visible defects NA Every unit per SOP,
F/STR/02/01/01-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

Robust enough protect device/ Customer As per PDI,
NA Every unit per SOP,
specs. F/STR/02/01/04-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
Company logo, No any visible defects NA Every unit per SOP,
F/STR/02/01/04-00
100% (SOP/QC/01-00)

User interface and alarms functionality, Spo2 Functional Every Batch Sampling plan as
As per PDI,
all intended funtions correctly as Tester, Vital Sign Every unit per SOP,
F/STR/02/01/04-00
customer expectations and as per order Simulator 100% (SOP/QC/01-00)
 Every Batch Sampling plan as
As per PDI,
No any visible defects NA Every unit per SOP,
F/STR/02/01/04-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

Robust enough protect device/ Customer As per PDI,
NA Every unit per SOP,
specs F/STR/02/01/02-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
Company logo, No any visible defects NA Every unit per SOP,
F/STR/02/01/02-00
100% (SOP/QC/01-00)

User interface and alarms functionality, Every Batch Sampling plan as

As per PDI,
all intended funtions correctly as ECG Simulator Every unit per SOP,
F/STR/02/01/02-00
customer expectations and as per order 100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
No any visible defects NA Every unit per SOP,
F/STR/02/01/02-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

Robust enough protect device/ Customer As per PDI,
NA Every unit per SOP,
specs F/STR/02/01/03-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
Company logo, No any visible defects NA Every unit per SOP,
F/STR/02/01/03-00
100% (SOP/QC/01-00)

User interface and alarms functionality, Every Batch Sampling plan as

As per PDI,
all intended funtions correctly as Test Controller Every unit per SOP,
F/STR/02/01/03-00
customer expectations and as per order 100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
No any visible defects NA Every unit per SOP,
F/STR/02/01/03-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

Robust enough protect device/ Customer As per PDI,
NA Every unit per SOP,
specs F/STR/02/01/05-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
Company logo, No any visible defects NA Every unit per SOP,
F/STR/02/01/05-00
100% (SOP/QC/01-00)

User interface and alarms functionality, Every Batch Sampling plan as

Infusion pump As per PDI,
all intended funtions correctly as Every unit per SOP,
Analyser F/STR/02/01/05-00
customer expectations 100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
No any visible defects NA Every unit per SOP,
F/STR/02/01/05-00
100% (SOP/QC/01-00)
 Every Batch Sampling plan as
Robust enough protect device/ Customer As per PDI,
NA Every unit per SOP,
specs F/STR/02/01/09-00
100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
Company logo, No any visible defects NA Every unit per SOP,
F/STR/02/01/09-00
100% (SOP/QC/01-00)

User interface and alarms functionality, Every Batch Sampling plan as

Spo2 Functional As per PDI,
all intended funtions correctly as Every unit per SOP,
Simulator F/STR/02/01/09-00
customer expectations and as per order 100% (SOP/QC/01-00)

Every Batch Sampling plan as

As per PDI,
No any visible defects NA Every unit per SOP,
F/STR/02/01/09-00
100% (SOP/QC/01-00)

ly to result in a condition immediately hazardous to life or health for

Abbreviation
or depending upon the process

to the degree that the equipment does not provide any tangible protection,
AQL Acceptab
otection and is not detectable by the user;

at is likely to result in fault, and is detectable by the user; SOP Standard O

ity of the for its intended purpose, or a defect that is a departure from
COA Certific
ng on the effective use or operation of the Medical Device

PDI Pre-Disp
 Doc. No.: QCP/QA/01-00
Supersedes: None
Effective date: 01.02.2023
Next Rev.date: 01.02.2025

Inspection
Action Plan Person responsible Record Control
Time

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
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02 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
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02 min Approved/Rejected/H Quality controller F/QC/02/07-00
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03 min Approved/Rejected/H Quality controller F/QC/02/07-00
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05 min Approved/Rejected/H Quality controller F/QC/02/07-00
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10 min Approved/Rejected/H Quality controller F/QC/02/07-00
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02 min Approved/Rejected/H Quality controller F/QC/02/07-00
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03 min Approved/Rejected/H Quality controller F/QC/02/07-00
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05 min Approved/Rejected/H Quality controller F/QC/02/07-00
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10 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

 NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
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Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

 Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

 Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

NA NA Quality controller F/QC/02/07-00

NA NA Quality controller F/QC/02/07-00

Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
03 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
10 min Approved/Rejected/H Quality controller F/QC/02/07-00
old
 Pass/Fail
02 min Approved/Rejected/H Quality controller F/QC/02/07-00
old

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework
 Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
10 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework
 Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework
 Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework
 Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework
 Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

Pass/Fail
05 min Quality controller F/QC/03/06-00
Approved/Rework

If funtional parameter
not matched as per the
defined perameter,
15 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
15 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
15 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
15 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.
 If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.
 If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.
 If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
10 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

If funtional parameter
not matched as per the
defined perameter,
05 min Quality controller F/QC/03/03-00
Hold the device and
rework process will
do.

Pass/Fail Quality
05 min Approved/Rejected controller/Store F/STR/02/01/01-00
Replaced/Hold Incharge

Pass/Fail Quality
03 min Approved/Rejected controller/Store F/STR/02/01/01-00
Replaced/Hold Incharge

Pass/Fail Quality
15 min Approved/Rejected controller/Store F/STR/02/01/01-00
Replaced/Hold Incharge

Pass/Fail Quality
02 min Approved/Rejected controller/Store F/STR/02/01/01-00
Replaced/Hold Incharge

Pass/Fail Quality
05 min Approved/Rejected controller/Store F/STR/02/01/04-00
Replaced/Hold Incharge

Pass/Fail Quality
03 min Approved/Rejected controller/Store F/STR/02/01/04-00
Replaced/Hold Incharge

Pass/Fail Quality
10 min Approved/Rejected controller/Store F/STR/02/01/04-00
Replaced/Hold Incharge
 Pass/Fail Quality
02 min Approved/Rejected controller/Store F/STR/02/01/04-00
Replaced/Hold Incharge

Pass/Fail Quality
05 min Approved/Rejected controller/Store F/STR/02/01/02-00
Replaced/Hold Incharge

Pass/Fail Quality
03 min Approved/Rejected controller/Store F/STR/02/01/02-00
Replaced/Hold Incharge

Pass/Fail Quality
10 min Approved/Rejected controller/Store F/STR/02/01/02-00
Replaced/Hold Incharge

Pass/Fail Quality
02 min Approved/Rejected controller/Store F/STR/02/01/02-00
Replaced/Hold Incharge

Pass/Fail Quality
05 min Approved/Rejected controller/Store F/STR/02/01/03-00
Replaced/Hold Incharge

Pass/Fail Quality
03 min Approved/Rejected controller/Store F/STR/02/01/03-00
Replaced/Hold Incharge

Pass/Fail Quality
10 min Approved/Rejected controller/Store F/STR/02/01/03-00
Replaced/Hold Incharge

Pass/Fail Quality
02 min Approved/Rejected controller/Store F/STR/02/01/03-00
Replaced/Hold Incharge

Pass/Fail Quality
05 min Approved/Rejected controller/Store F/STR/02/01/05-00
Replaced/Hold Incharge

Pass/Fail Quality
03 min Approved/Rejected controller/Store F/STR/02/01/05-00
Replaced/Hold Incharge

Pass/Fail Quality
10 min Approved/Rejected controller/Store F/STR/02/01/05-00
Replaced/Hold Incharge

Pass/Fail Quality
02 min Approved/Rejected controller/Store F/STR/02/01/05-00
Replaced/Hold Incharge
 Pass/Fail Quality
05 min Approved/Rejected controller/Store F/STR/02/01/09-00
Replaced/Hold Incharge

Pass/Fail Quality
03 min Approved/Rejected controller/Store F/STR/02/01/09-00
Replaced/Hold Incharge

Pass/Fail Quality
10 min Approved/Rejected controller/Store F/STR/02/01/09-00
Replaced/Hold Incharge

Pass/Fail Quality
02 min Approved/Rejected controller/Store F/STR/02/01/09-00
Replaced/Hold Incharge

Abbreviations:

Acceptable Quality Limit

Standard Operating Procedure

Certificate of Analysis

Pre-Dispatch Inspection