Professional Documents
Culture Documents
Product: Charger
5 100%Critcial Check
Common Wave Soldering
4 100%
Axis Title
3 100%
Mass P...
Outgoin...
Raw Ma...
SMT Pr...
Wave S...
Plug/U...
Moul...
Manual...
Injecti...
LASER ...
Main P...
Ageing...
Reliabil...
Common...
Measur...
Product ...
FG Wa...
IQC
QMS
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Is independent QC responsible person identified/ nominated for handling quality issues / activiti
- Ask for Name, designation.
- Verify the total strength for Quality (Inward, Inprocess, System & Customer Concerns)
Does the procedure covers NC material handling at respective stage of manufacturing process (I
inspection rejection and customer rejection).
- Verify the adequacy of procedure.
- Verify the problem solving method for Inhouse rejection.
Are the Risk and Opportunities addressed for each processes (Business processes) with respect t
of interested parties?
- Verify the risk and opportunity register or equivalent documented information.
- Verify the risk and opportunity register for its adequacy.
Is contingency plan available?
- Verify the contingency plan for all appropriate contingencies.
Are quality objectives defined, established for specific target for each department and function
- Verify the the Quality Objectives.
- Verify the the Quality Objectives for each department/ function.
Does the action plan available to achieve each quality objective of organization?
- Verify the action plan for each quality objectives.
- Verify the management review meeting records.
Does Action plan /8D report available for complaints / issue reported by customer?
- Verify the 8D against the issue listed in customer complaint.
- Verify the document(s) updated for customer complaint.
- Verify the actual action implementation on shopfloor.
Does the supplier having adequate performance for Quality, Delivery, Cost etc.?
- Verify customer rating for last consecutive months
(Not mandatory- checkpoint for newly established facility vendor)
Check if warehouse blocks a direct ray of light and dust inflow prevention equipment is installed
Check if there is a FIFO process ( Production date, quantity etc.) & it is complied?
Check if there is Warehouse Lay-Out map and storage location is marked on it?
Check if electronic, electrical material sensitive to static are storaged with coutermeasure for sta
Check whether fire risky material is separately stored in hazardous substance storing place?
Check if normally 6 monthly periodic inspection is being performd on long-term stock and its ins
Does the supplier set up a warehouse to store the defective goods? Are the defective goods m
Section 3 : Incoming Inspection
Is an Acceptance Inspection for all componenet including PL related components(Electrolytic Co
Have the Color Limit Samples been furnished and maintained?
(Securing Counterparts of each color, Counterpart Sample, Colorimeter Data, Holding Colorime
Is there a controlled list of qualified suppliers ?
Are there trainning and examing programmes for IQC inspectors before beginning work?Are th
Is the operation of the inspectors consistent with the specifications or instructions?
Are the inspection records compile including the part name, model, Lot number, quantity,sampl
Are there standards on giving Penalty or Incentive to the worst or best company after evaluating
Are there efficient systematic controls on non-conforming incoming materials? Is there appropr
Is the functional & Reliability Tests for incoming material done as per SOP?
Is the OQC reports from sub-suppliers maintained and checked per lot
Are there ROHS verification of materials to ensure the compliance with the ROHS?
Are there any location marks or distinctions between the inspected materials and the inspecting
Section 4 : SMT Process
SCREEN PRINT
Are the Metal Masks maintain flatness without dented spots or damages?
Are Squeezes checked periodically in terms of weaing-out or damages?
Is an inspection on Bonding amount and state carried out? (Automatic or Manual)
CHIP MOUNT, REFLOW
Are the capacity and characteristic value of each Component measured, and the samples are ke
(When changing models, Comencing work, changing Reels)
Are the Reflow temperature profiles measured and posted everyday?
Are the Reflow Control Items same as the Work Instruction?
SMD Inspection(Appearance, Function)
Is the soldered state inspected after Reflow? (AOI or Inspection by Naked Eyes)
Are Peel Tests carried out for I/M/F materials, and the samples are kept?
Section 5 : Wave Soldering
Are standardized products used for FLUX and Solder bar ?
Is cooling speed(temperature) suitable ?
Cooling Speed(Prevention of Lead Crack):5~7℃/sec, PBA Cooling Temp.:Below 30 ℃
Is there Improvement actions available for ICT Function Failure due to wavesoldering process
Is there specific gravity and solder application are controlled and measured periodically?
Check the standard of Air Pressure, Nozzle control, and the current condition.
Are the temperature profiles measured and posted everyday? (Shall be same as the Control Sta
Section 6 : Plug/Unit Cable Manufacture
Is the Dipping Time controlled when soldering the Connector by Dipping type?
Is the soldering of Connector inspected by an inspecting method of optimized detecting capabili
Have the PM cycle and items of the molds for molding been established, and are these practiced
Are the Molds maintained by the history cards? (Short No., Repair/Checkup History, etc.)
Is the inspection on the Cable Functions carried out by bending the cables?
Has the detecting capability been secured for Open and Short of the Pins near Plug Cables? (Per
Section 7 : Moulding
Is Machine parameter fixed as per Product Parameter Sheet
Check actual operations meet the ones specified in Work Instruction Sheet.
Check the injection machine and/or its surroundings is kept clean.
If process defect happens, does improvement activity do?
Is defect part's storage box appointed separately?
Check the limit sample are available alongwith Specification Sheet
Check a standard sample (limited sample) is equipped whithin 6 month
Check each operator records and controls the volume of production and/or the number of defe
Does oil temperature of equipment take standard?
Does coolant pressure satisfy regulation water pressure (3~4 kg)?
Check the quantity of injection by mold is controlled.
Check the history of moiuld breakdown and preventive maintenance is recorded in the history c
Check a list of required spare parts by mold is equipped.
Check required spare parts by mold has proper inventory.
Is Mould Preventive maintenance is scheduled as per plan
Check the history of mould breakdown and preventive maintenance is recorded in the history ca
Section 8 : Manual Soldering and Inspection
Are the workers of Solder process those who have been certified?
Has the Manual Solder Process been designated as CTQ process and the Control Items are contr
Is the water in the SPONGE controlled?
Are the Solder Ball, Cold Solder and No Solder inspected when carrying out Appearance Inspecti
Are there any chances of damages inflicted on the PCB and other Components by being touched
Check the defect history and action for size, etc.)
Section 9 : PBA Function Inspection
Is a detecting test conducted periodically for the inspection process? (Suitability of Dummy Test
Is an ICT Inspection conducted?
Is the material quality of PBA Cutting JIG suitable, and are there chances of damages inflicted on
Section 10 : Injection Fusion Splicing (USW)
-. Has a Fusion Process been designated as PL Process?
-. Are Die-Spotting and Gap controlled per fixed time?
-. Is there a preventive control to prevent non fusion spliced products from passing through at w
Section 11 : LASER Printing & MAIN Inspection
LASER Printing
Are the manufacture date and print date identical?
(If different, check the control standard for tracing the Lot and the execution results.)
Are these checked - scratchings/being erased/leaning to the left or right?
Are printing matters veryfied before feeding to the printer?
Are the countermeasures for printing issue applied?
Application of (Use of, S/W for prevention of printing error,vedio monitor just after printing e
MAIN Inspection
Are function inspections conducted for each Input Power?
Is the lifetime of the Connector of a function inspection equipment controlled? (Replacement Cy
Are detecting tests carried out periodically for the inspection process?
(Suitability of Dummy Test Samples, Per Model, Type)
Section 12 : Main Packing
-. Are the empty boxes and packed boxes kept clean, and the product label used before has bee
-. Are production date, manufacture line, model name, etc. on the label same as the product in
-. Has a system been applied which can prevent packing mixed products or putting wrong labels
Section 13 : Ageing Test
Ageing test conducted as per specification
Ageing Test management, tracking input and output are managed and monitor effectively
Ageing rack Pin/Jack replacement cycle defined and monitor as per requirement
Section 14 : Reliability Test
Are reliability test ongoing correctly by test standard?
Are reliability,test equipment are working in good condition?
Have the items about past failure cases been documented, and are they being checked?
Are the Processes of development stage clear, and does each stage have its own standards, and
Test)
Does Quality Department participate from early development stage(Design Validation Stage)?
Have the checklists of failure cases been documented and in operation?
Section 15 : Mass Production Assurance
Is daily process monitoring done model wise & line wise?
Has inspection item been selected not to be omitted important point?
Has processing level of Lot in case of occurring nonconformity been established, and is it being t
Is approved(standard) sample for testing which needs for inspection being equipped?
Is Defective samples managed according to the right criteria?
Has action criteria for relevant Lot been set up in case of out-of-control is occurred in inspection
Is it being checked by process inspection Check sheet regularly?
Are improvement activities carried out for the worst defects by analyzing monitored data and cl
Day Repair and Analysis System
Is defect rate monitoring by making in criteria document?
Has controlling method to prevent mixed defect been established and is it being done?
Has re-verification process been set up and is it being controlled?
Has processing level of Lot in case of occurring out-of-control of process monitoring been establ
Section 16 : Outgoing Inspection
Work Management on Outgoing Inspection
Is an Inspection severity for lots that are out-of-control of process monitoring applied adjusted h
- Check the work standards and Inspection results of lots that are out of process monitoring.
- Check if Lots are Out-of-Control by using Attributes P Control Chart before the Outgoing inspec
Are the Withstanding Voltage and Insulation Voltage inspected based on the the Approval Sheet
Are Check Lists of each new model/destination composed and maintained?
(Pictures can be added for detailed specification.)(AC PLUG, Output PLUG,)
Are Die-Spotting Inspections conducted for products of HOLDR line with approved batteries afte
Is the detecting capability verified regularly at Process/Outgoing Inspection by Dummy Test?
- Check if the verification is carried out in a way that suits the product characteristics.
- Check if the verification is carried out per defect type, and check the cycle of storing and re
When there are Lot failures, are the procedures of corrective measures such as cause analysis/c
Practical Work Management on Outgoing Inspection
Are Random Sampling carried out for the samples needed for the Outgoing Inspection?
- Check if samples are collected from various groups, and collecting samples per hour(ON GO
Are the management standards of approval sheet, inspection standard and inspection result ide
Compare Inspection Items, Inspection Standard Dimensions and Sampling Standards, and chec
Are outgoing inspectors do the inspection from the inspection standard sheets?
Are the measuring equipments used for outgoing inspection maintained well?
(Calibrated Product : Check the Calibration Expiry Date, Self-calibrating Product : Check Self-c
Are all the items of CTF inspected during the outgoing inspection?
- Critical items such as function and appearance, Size, etc.
Initial Lot Management
Is first lot is inspected 100% during the Outgoing Inspection? (Check the Inspection Result Sheet
Is the Reliability evaluation carried out for all the items of initial 1Lot based on the approval shee
(Check if the Reliability Tests have been carried out for all of the new initial 1 Lot items recorded
Are the check Items of process equipment condition, work condition, maintenance state manag
Are the check list items revised when necessary in order to improve the detection capability?
Is the patrol conducted at defined frequency for the entire lines and equipments?
Section 17 : Common Critcial Check
Has a standard of ESD control(Below 100V recommended) been established, and are there regu
Are Earth Rings functioning normally and checked periodically?
Is Job Certification carried out for important worker/inspectors, and periodic educations/evalua
Has a standard of EOS control(Below AC 5V) been established, and are there regularly measured
(EX: Iron, Measuring Machine, Equipments)
Is the grounded state of equipments, measuring machine, worktable and anti-static mat godd, a
Are products kept and handled in an overlapped state?
Are there any chances for products to be damaged by sharp pincettes used in processes?
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 OK, W/H temp/humidity is maintained with in 5
the range for applicable material.
NG, Major dust found in w/h on shelves and
5 boxes 2
5 OK 5
5 OK 5
There is process of FIFO but nor followed as
5 found many Bin cards are not updated in 3
SMT/MI warehouse
5 OK 5
5 Surface Plate NA 2
5 Yes 5
5 Yes Semi-Automatic 5
5 yes 5
5 yes 5
5 yes 5
5 Yes, VI Done & FAI Done 5
5 Yes, by Naked eyes 5
5 Yes, tensile test done 5
5 Yes 5
5 Yes 5
5 Yes, periodically monitored 5
5 Yes 5
5 Yes 5
5 NA 5
5 Yes 5
5 No standards are available for molding m/c 2
5 No maintainence history cards available 2
5 yes 5
5 yes 5
5 Yes 5
5 Yes, ATE Test done 5
5 OK 5
5 Yes 5
5 Yes 5
5 Yes, verified by PQC 5
5 No CAPA Found 3
5 Yes 5
5 Yes 5
5 Yes 5
5 yes 5
5 yes 5
5 yes 5
5 yes 5
5 yes 5
5 Yes 5
5 yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Date of expiry not mentioned on samples 3
5 Yes 5
5 Yes 5
5 Yes 5
5 No such activity done 3
5 Yes 5
5 Lux Level is Low in repair area 4
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
Oscilliscope NA in OQC, but mentioned in OQC
5 report, basic instruments are not available like 2
vernier calliper, spot guage etc.
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes, PQC is designated for same 5
5 Not measured 3
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes 5
5 Yes, all are as per spec sheet 5
5 Yes 5
5 Yes 5
5 Yes 5
5 No sharpness observed 5
5 No sharpness observed 5
5 No Gap is observed 5
5 No Spark is generated 5
5 Yes 5
Yes, inspection is performed as per given
5 parameters 5
5 OK 5
5 Found Major dust on pallets 2
5 OK 5
5 OK 5
5 Storage locations are marked but no layout map 2
of w/h is present
5 OK 5
5 OK 5
5 NO CMR taken for Static charge 2
5 OK 5
5 OK 5
5 OK 5
5 OK 5
Risk
Remarks
Level
No Risk
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Very High
High
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Very High
High
Moderate
Low
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Low
High
No Risk
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High
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No Risk
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Moderate
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Moderate
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High
No Risk
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No Risk
No Risk
Annexure 3 - Key Personal contacts
Name of the Supply Partner
Location/Address
Products Supplied
Key Personal Contacts
Functional Role Manager Contact Details
Name Leo
Designation CEO
Comericial/Business Development
Phone number 8287808124
Email Leo@mywisepower.com
Name William
Designation VP
Factory Operations Head
Phone number 8287800331
Email William@mywisepower.com
Name Mike
Designation R&D Director
Product Design
Phone number
Email Mike@mywisepower.com
Name Alvin
Designation Manager
Product Quality
Phone number
Email Alvin@mywisepower.com
Name Sunil
Designation DM
Quality FAE
Phone number 78360 60141
Email Sunil@mywisepower.com
Name UmaKant
Designation IQC leader
Raw material/Supplier Quality
Phone number
Email Manisha@mywisepower.com
Name Gaurav Shukla
Designation VP
Production & Delivery
Phone number 8448781557
Email gaurav@mywisepower.com
Name Vikas
Designation Process Engg
Industrial Engineering
Phone number 7065171820
Email vikas@mywisepower.com
Name Gagan
Designation DM
Lean Six Sigma & Continual Improvement
Phone number 85868 97291
Email Gagan@mywisepower.com
Personnel Name
Production Size/Layout
Product Description
Production Capability
Production Capacity
Actual UPH/Line
Expiration Date
Engineering Manager
Production Manager
Factory Manager
QA/QC Manager
No.
2017
Yes
1500 Sqmt
3million
500 Sqmt
50
10
26
26000
130000
3.4
Capacity Quantity
12
50
8
10
on the Product.
CAPA for Findings VENDOR :
PART :
Check if warehouse blocks a direct ray of light and dust inflow prevention equipment is NG, Major dust found in w/h on shelves and 1. Work define each warehouse operator Warehouse/Shubham
2 and make the 5S check sheet. Open 4/10/2021
installed? boxes 2. curtain at stairs area and lift area.
& Vinay
Storage locations are marked but no layout Map will be initiated to supplier by Warehouse/Shubham
4 Check if there is Warehouse Lay-Out map and storage location is marked on it? Open 4/12/2021
map of w/h is present warehouse and admin & Vinay
Check if electronic, electrical material sensitive to static are storaged with coutermeasure Racks will be grounded and for m/p new
Warehouse/Shubham
5 No countermeasures are taken for static charge apron, cap, sleepers & gloves will be Closed 4/3/2021
for static? given
& Vinay
Material placed in very bad condition and Stationary items will be placed at Warehouse/Shubham
6 Check whether fire risky material is separately stored in hazardous substance storing place? mixed with stationary defined lockers Closed 4/6/2021 & Vinay
Does the supplier set up a warehouse to store the defective goods? Are the defective Marking will be initiated and close on Warehouse/Shubham
7
goods marked clearly and treated regularly? No special area alloted Monday
Closed 4/5/2021
& Vinay
Are there trainning and examing programmes for IQC inspectors before beginning work? Examination done in form of practical
8 Trainings done but no exam taken operations i.e. Dummy test
Open 4/3/2021 IQC-QA/ Umakant
Are the records kept?
Are there standards on giving Penalty or Incentive to the worst or best company after Grading system start according lot
9
evaluating Companies, and are there application results? No standards defined basis
Open 4/3/2021 IQC-QA/ Umakant
10
Are there efficient systematic controls on non-conforming incoming materials? Is there Appropriate system is followed but No 8D 8D report will be submitted by supplier Supplier has submitted 8D
Closed 4/6/2021 IQC-QA/ Umakant
appropriate documentation? report found for IQC rejected lots to IQC reports
11 Is the functional & Reliability Tests for incoming material done as per SOP? Reliability testing done but Report NA Reliabilty report already completed Closed 4/5/2021 IQC-QA/ Umakant
12 Is the OQC reports from sub-suppliers maintained and checked per lot OQC Reports recd. But record not maintained Report will send each incoming Closed 4/5/2021 IQC-QA/ Umakant
Are there any location marks or distinctions between the inspected materials and the
14
inspecting materials? Inspection pending area not marked Marking Will be done by IQC 4/5/2021 IQC-QA/ Umakant
17 Are the Molds maintained by the history cards? (Short No., Repair/Checkup History, etc.) No maintainence history cards available History cards will be hanged on m/c 4/5/2021 Engineering/ Vikas
Cable QA
5S will be done everyday at each stage
19 Check the injection machine and/or its surroundings is kept clean. 5S not OK by operator
4/12/2021 PQC/Deepak &
Praveen
Cable Production/
21 Is defect part's storage box appointed separately? No Separate box identified Separate Box will be identified 4/5/2021
Vinay
Cable QA
Approved Limit sample will be hanged
22 Check the limit sample are available alongwith Specification Sheet No limit sample found on each stage
4/5/2021 PQC/Deepak &
Praveen
Cable QA
updated and Approved Limit sample will
23 Check a standard sample (limited sample) is equipped whithin 6 month No limit sample found be hanged on each stage
4/5/2021 PQC/Deepak &
Praveen
24
Check the history of mould breakdown and preventive maintenance is recorded in the No maintainence history cards available History cards will be hanged on m/c 4/5/2021 Engineering/ Vikas
history card and then controlled.
Check the history of mould breakdown and preventive maintenance is recorded in the
29
history card and then controlled. No maintainence history cards available History cards will be hanged on m/c 4/5/2021 Engineering/ Vikas
Are detecting tests carried out periodically for the inspection process? Laser QA
31 No Dummy test performed Dummy test will be performed now 4/5/2021
(Suitability of Dummy Test Samples, Per Model, Type) PQC/Praveen
Are improvement activities carried out for the worst defects by analyzing monitored data
33
and classifying them into several classes? (Cycle : Minimum once a week) No such activity done Data will be shared by production 4/6/2021 Production/Gaurav
34 Has controlling method to prevent mixed defect been established and is it being done? Lux Level is Low in repair area Closed 4/3/2021 Repair Process- Vinay
When there are Lot failures, are the procedures of corrective measures such as cause OQC- QA/Gautam &
36
analysis/countermeasure establishment conducted as regulations? CAPA not found for rejected lot in OQC CAPA will be asked for pending lots 4/5/2021
Praveen
Are the measuring equipments used for outgoing inspection maintained well? Oscilliscope NA in OQC, but mentioned in OQC
37 (Calibrated Product : Check the Calibration Expiry Date, Self-calibrating Product : Check report, basic instruments are not available like Closed 4/3/2021 OQC- QA/Gautam &
Praveen
Self-calibration History, compare the results of calibration.) vernier calliper, spot guage etc.
Is first lot is inspected 100% during the Outgoing Inspection? (Check the Inspection Result OQC- QA/Gautam &
38 Inspection done but data NA Closed 4/3/2021
Sheet, Appearance, Charachteristics, Functions) Praveen
Has a standard of ESD control(Below 100V recommended) been established, and are there Data will be shared by Engineering while
39 Not measured regularly 4/5/2021 Engineering/ Vikas
regularly measured results? NC verification audit
Has a standard of EOS control(Below AC 5V) been established, and are there regularly
All Area is ok but soldering iron machine
41 measured results? Not measured results regularly is NG, Need to purchase new
4/12/2021 Engineering/ Vikas
(EX: Iron, Measuring Machine, Equipments)
Is the grounded state of equipments, measuring machine, worktable and anti-static mat
42
godd, and checked periodically? Not checked periodically Closed 4/3/2021 Engineering/ Vikas
Is there a documented system for planned maintenance covering all items of equipment and
43
plant which are critical to product safety, legality, and quality? Yes No such document found Closed 4/3/2021 Engineering/ Vikas
44
Are preventative maintenance schedules and maintenance records available showing that No records and schedule available Closed 4/3/2021 Engineering/ Vikas
the maintenance is carried out regularly and on schedule?
Do machines, equipment, fixtures, tools and measurement equipment appear to be clean in 5S will be done everyday at each stage
45 5S not good 4/5/2021 Production/Gaurav
good condition and well maintained? by operator
Storage locations are marked but no layout Map will be initiated to supplier by Warehouse/Shubham
47 Check if there is Warehouse Lay-Out map and storage location is marked on it? map of w/h is present warehouse and admin
Open 4/12/2021
& Vinay