PRODUCT & MANUFACTURING PROCESS AUDIT CHECKLIST Page 1/2

Customer : …………………………………. Part number : …………………………………. Auditor : ………………………………….

Index : …………………………………. Part name : …………………………………. Auditee :

………………………………….
Produc code : …………………………………. Shift : …………………………………. Audit date. :
………………………………….

Dept/Sec Tar. Act. Note, Objectives Evidence

S/N Question / Description
tion Score Score [Document number listed]

Review the effective implementation of the process risk analysis as FMEA

1. RECEIVING
1.1 Is there a revision controlled Work Instruction which contains unique details for receiving? 1
(Score '0' if the unsigned/undated or any hand written instruction morethan 48 hrs old)
1.2 Are Work Instruction readily available to the operator and are they followed sequentially ? 1
1.3 Is there a process to manage un-receivable product/s ? Is the products quarantine ? 1
1.4 Is the receiving area segregated effectively to minimize product contamination ? (painted line, 1
banner notify, color code notification, etc.)
1.5 Does the part arrival verify against supplier invoice, shipping list and Work Instructionll release the 1
good receiving note for part or component?
1.6 Does the received part get a unique receipt number ? The number reflect the parts ? 1
1.7 Does the containment area provide for rejected part received, correlate with the packaging problem, 1
damage, broken or unclear? Score '0' for unclear area.
2. INCOMING INSPECTION
GENERAL
2.1 Is the revision operation controlled Work Instruction for part inspection ? (type and criterion 1
inspection standard is acceptable) review latest BOM
2.2 Is label part identification inspected for correct content ? ( Does the specific traceable labels 1
used) ?
2.3 Is the specific inspection followed when the customer cosigned for critical part ? 1
2.4 Are the parts identify with RoHS compliance label (original) ? 1
2.5 Is the standard AQL determined when took sampling for inspection? 1
2.6 Where the nonconforming parts/comp. located ? Identification required 1
2.7 Is the non-nonconformance part/component identified with label, stamp on unification label 1
information ?
2.8 Is the non-conformance record provided, SCAR and follow-up for closure? 1
2.9 Is the re-inspection, screening, replace or even customer waive recorded ? 1
2.10 Is it record maintain ? The retention record have to declare for limited time 1
A. Appearance
2.15 Is the component RoHS clarify and complete the document, symbol or logo ? (N/A if not required) 1

2.16 Is the component discrepancy verify with component spec/standard? Broken, bend, chipping, etc 1
conform with the standard?
B. Mechanical ('NA' if not required)
2.17 Is the dimension are measuring correctly ? 1
2.18 Is the Tools/equipment calibrated/ verified ? 1
2.19 Is the measurement appropriate the specification (mechanical. draWork Instructionng) ? 1
2.20 Is the part inspect from broken, bent, shrunk, short molded, etc ? 1
3. Incoming store
3.1 Is there a revision controlled Work Instruction contains unique details for WH operations ? 1
3.2 Does this system control FIFO (First In First Out) methodology ? 1
3.3 Does the material storage in the right place and maintained data with ERP system or even manual 1
recorded?
3.4 In case the MSD/ESD part/component manner as a void damage, is the part component storage 1
properly and identified ?
3.5 Does the warehouse use the FIFO/FEFO operation ? 1
3.6 If parts are returned from production to the warehouse do they go back through Incoming inspection 1
and update the quantity?
3.7 Is the humidity and temp. met the part/component ambient specification? 1
4. Mold maintenance
4.1 Is there a revision controlled Work Instruction contains unique details for technician? 1
4.2 Are the mold maintenance activities as defined schedule or standard? (Check evidence) 1
4.3 Are the repairing/maintenance recorded and retention? 1
4.4 Is the communication conducted when the nonconforming find? 1
4.5 Is the customer defect/complaint (if any) summaries and highlighted? 1
4.6 Is the risk point highlighted and trained to technicians? 1
4.7 Are the using chemical conform with Customer requirement? (N/A if not required) 1
5. Production
A. Top up and drying
5.1 Is there a revision controlled Work Instruction contains unique details for technician/operation? 1
5.2 Is the material in Hopper/Dryer match with requirement? 1
5.3 Are the parameter set up on hopper/dryer conform with standard? 1
5.5 Area material and product traced by manufacturing date/lot code? 1
5.6 Is the communication conducted when the nonconforming find? 1
A. Injection process
5.8 Are the machine actual status identify with the indication? 1
5.9 Are the Master condition registered and updated? 1
5.11 Are the injection machine parameter monitored and conform with Master condition sheet? 1
5.12 Are the vertification complete with:
a) Mold cleaning and grease check sheet 1
 Dept/Sec Tar. Act. Note, Objectives Evidence
S/N Question / Description
tion Score Score [Document number listed]
b) Daily machine check sheet 1
c) Mold traveller 1
5.13 Are all WIs conform with control document standard? Avaiable for using and access? 1
5.14 Are the work layout clear and indicated? 1
5.15 Are products packaged follow Packing standard sheet? 1
5.13 Production history be recorded? 1
5.14 Trouble history be recorded? 1
5.15 Have FA/EA sample or not? 1
Dept/Sec Tar. Act. Note, Objectives Evidence
S/N Question / Description
tion Score Score [Document number listed]
6. Inspection in process
6.1 Is the controlled Inspection standard displayed for the inperator? 1
6.2 Is the controlled FA sample? 1
6.3 Is the controlled setting jig/inspection jig? 1
6.4 Is the inspection data completed and vetified? 1
6.5 The evidence of inspection skill for checking part? 1
6.6 Calibrate measurement equipment? 1
6.7 Daily control measurement equiment? 1
7. Packing

7.1 Is there working standard or instruction for packing? 1

7.2 Does operator comply following standard? 1
7.3 Is there evidence about implementing standard? 1
7.4 Is there regulation about controlling output production? 1
7.5 Is there regulation about non-confirming product in packing process? 1
7.6 Is there treament method for non-confirming product in packing process? 1
8. OUT GOING INSPECTION

8.1 Is the controlled Work Instruction displayed for the operator at OQA inspection station ? 1
8.2 Is the operator inspect the critical point, location, assy. based on the Work Instruction? 1
8.3 Is the Customer spec. involved at the inspection instruction? (if available) 1
8.4 Does the AQL inspection established and appropriate with model inspected ? 1
8.5 Is the customer defect/complaint (if any) summaries and highlighted ? 1
8.6 Is the unit inspect under the proper light, magnifying or microscope define on Work Instruction the 1
product requirement ?
8.7 Take the minimum sampling for verify the products met requirement: 1
a) Is the Label serial attached properly ? 1
8.8 Is the communication conducted when the nonconforming find ? CAR, NCR, etc. 1
8.9 Inspect the passed boards with minimum sampling quantity, and check the rejected boards (if 1
available)
8.10 In case of Rework submission, Is the OQC perform the 100 % inspection ? 1
Score '0' for sampling use.
8.11 Does the data inspected per sampling record and maintained for traceability retained 1
9. Finished good store

9.1 Is the controlled Work Instruction displayed for the operator at packaging station ? 1
The packaging list established ? .
9.2 Is the any method to maintain packing area to ward off messy or disarrangement ? 1
At least the FIFO or chain link system is provided.
9.3 Does the packing material (box/carton, bubble bag, antistatic bag, etc) part number listed on the 1
Work Instruction or standard operating procedure ?
9.4 Review the packing, does the packing met requirement ? (check the units inside box with minimum 1
sampling)
a) Is carton box correct (part number, size) ? 1
b) Is the bubble bag, antistatic bag correct and present ? 1
c) Is the board direction correct inside box ? 1
d) Is the label box correct i.e. model name, part name, customer name, quantities, date, signet ? 1
e) Are the actual quantities appropriate with label ? 1
f) Is the label patched after the unit insert ted and before selaed the box ? 1
f) Is the packaging sealed properly ? 1
9.5 Is the loose box notified and recorded ? 1
a) Is the support part/material determined for loose box and documented ? 1
9.6 Does the packaging result recorded and maintain ? 1
The retention time may required for tracebility of customer feedback or complaining.
10. Delivery
10.1 Is there procedure for preparing goods before delivery? 1
10.2 Is there standard/instruction for preparing goods before delivery? 1
10.3 Is there assignment for PIC who prepare goods before delivery? 1
10.4 Is PIC trained and do they undertand regulation, WI, WS…? 1
10.5 Is it easy to check positions of goods in stock and delivery history? 1
10.6 Is there regulation about non-confirming product in preparing process? 1
10.7 Is there treament method for non-confirming product in preparing process? 1
11. Customer-specific requirement
Are SPC done on special characteristics requirements? 1
Are special characteristics under statistical control? 1
Did you inform to customer any out of control condition of special characteristic? 1
Are used measurement equipments acceptable (MSA less than 10%)? 1
1
1
1
1
MAXIMUM SCORE 109
OBTAINED SCORE 0
 Dept/Sec Tar. Act. Note, Objectives Evidence
S/N Question / Description
tion Score Score [Document number listed]
OBTAINED % 0%
PASSED % 85%
OUT COME Fail

Note for Out Come :

- Pass (Result ≥ 85%) ; When the requirements reached base appropriate with audit checklist
- Conditional Approval (Result < 85% and ≥ 75%); When the some actual are not met requirements and
the Corrective action is required to close and Work Instructionll review upon CAR's submitted.
- Fail ; If the requirement base audit checklists cannot reach the minimum score and need to re-audit for finding
after the corrective action done within time constraint not over into next schedule
 PRODUCT & MANUFACTURING PROCESS AUDIT CHECKLIST Page 1/2

Customer : …………………………………. Part number : …………………………………. Auditor : ………………………………….

Index : …………………………………. Part name : …………………………………. Auditee :

………………………………….
Produc code : …………………………………. Shift : …………………………………. Audit date. :
………………………………….

Dept/Sec Tar. Act. Note, Objectives Evidence

S/N Question / Description
tion Score Score [Document number listed]

Review the effective implementation of the process risk analysis as FMEA

1. RECEIVING
1.1 Is there a revision controlled Work Instruction which contains unique details for receiving? 1
(Score '0' if the unsigned/undated or any hand written instruction morethan 48 hrs old)
1.2 Are Work Instruction readily available to the operator and are they followed sequentially ? 1
1.3 Is there a process to manage un-receivable product/s ? Is the products quarantine ? 1
1.4 Is the receiving area segregated effectively to minimize product contamination ? (painted line, 1
banner notify, color code notification, etc.)
1.5 Does the part arrival verify against supplier invoice, shipping list and Work Instructionll release the 1
good receiving note for part or component?
1.6 Does the received part get a unique receipt number ? The number reflect the parts ? 1
1.7 Does the containment area provide for rejected part received, correlate with the packaging problem, 1
damage, broken or unclear? Score '0' for unclear area.
2. INCOMING INSPECTION
GENERAL
2.1 Is the revision operation controlled Work Instruction for part inspection ? (type and criterion 1
inspection standard is acceptable) review latest BOM
2.2 Is label part identification inspected for correct content ? ( Does the specific traceable labels 1
used) ?
2.3 Is the specific inspection followed when the customer cosigned for critical part ? 1
2.4 Are the parts identify with RoHS compliance label (original) ? 1
2.5 Is the standard AQL determined when took sampling for inspection? 1
2.6 Where the nonconforming parts/comp. located ? Identification required 1
2.7 Is the non-nonconformance part/component identified with label, stamp on unification label 1
information ?
2.8 Is the non-conformance record provided, SCAR and follow-up for closure? 1
2.9 Is the re-inspection, screening, replace or even customer waive recorded ? 1
2.10 Is it record maintain ? The retention record have to declare for limited time 1
A. Appearance
2.15 Is the component RoHS clarify and complete the document, symbol or logo ? (N/A if not required) 1

2.16 Is the component discrepancy verify with component spec/standard? Broken, bend, chipping, etc 1
conform with the standard?
B. Mechanical ('NA' if not required)
2.17 Is the dimension are measuring correctly ? 1
2.18 Is the Tools/equipment calibrated/ verified ? 1
2.19 Is the measurement appropriate the specification (mechanical. draWork Instructionng) ? 1
2.20 Is the part inspect from broken, bent, shrunk, short molded, etc ? 1
3. Incoming store
3.1 Is there a revision controlled Work Instruction contains unique details for WH operations ? 1
3.2 Does this system control FIFO (First In First Out) methodology ? 1
3.3 Does the material storage in the right place and maintained data with ERP system or even manual 1
recorded?
3.4 In case the MSD/ESD part/component manner as a void damage, is the part component storage 1
properly and identified ?
3.5 Does the warehouse use the FIFO/FEFO operation ? 1
3.6 If parts are returned from production to the warehouse do they go back through Incoming inspection 1
and update the quantity?
3.7 Is the humidity and temp. met the part/component ambient specification? 1
4. Mold maintenance
4.1 Is there a revision controlled Work Instruction contains unique details for technician? 1
4.2 Are the mold maintenance activities as defined schedule or standard? (Check evidence) 1
4.3 Are the repairing/maintenance recorded and retention? 1
4.4 Is the communication conducted when the nonconforming find? 1
4.5 Is the customer defect/complaint (if any) summaries and highlighted? 1
4.6 Is the risk point highlighted and trained to technicians? 1
4.7 Are the using chemical conform with Customer requirement? (N/A if not required) 1
5. Production
A. Top up and drying
5.1 Is there a revision controlled Work Instruction contains unique details for technician/operation? 1
5.2 Is the material in Hopper/Dryer match with requirement? 1
5.3 Are the parameter set up on hopper/dryer conform with standard? 1
5.5 Area material and product traced by manufacturing date/lot code? 1
5.6 Is the communication conducted when the nonconforming find? 1
A. Injection process
5.8 Are the machine actual status identify with the indication? 1
5.9 Are the Master condition registered and updated? 1
5.11 Are the injection machine parameter monitored and conform with Master condition sheet? 1
5.12 Are the vertification complete with:
a) Mold cleaning and grease check sheet 1
 Dept/Sec Tar. Act. Note, Objectives Evidence
S/N Question / Description
tion Score Score [Document number listed]
b) Daily machine check sheet 1
c) Mold traveller 1
5.13 Are all WIs conform with control document standard? Avaiable for using and access? 1
5.14 Are the work layout clear and indicated? 1
5.15 Are products packaged follow Packing standard sheet? 1
5.13 Production history be recorded? 1
5.14 Trouble history be recorded? 1
5.15 Have FA/EA sample or not? 1
Dept/Sec Tar. Act. Note, Objectives Evidence
S/N Question / Description
tion Score Score [Document number listed]
6. Inspection in process
6.1 Is the controlled Inspection standard displayed for the inperator? 1
6.2 Is the controlled FA sample? 1
6.3 Is the controlled setting jig/inspection jig? 1
6.4 Is the inspection data completed and vetified? 1
6.5 The evidence of inspection skill for checking part? 1
6.6 Calibrate measurement equipment? 1
6.7 Daily control measurement equiment? 1
7. Packing

7.1 Is there working standard or instruction for packing? 1

7.2 Does operator comply following standard? 1
7.3 Is there evidence about implementing standard? 1
7.4 Is there regulation about controlling output production? 1
7.5 Is there regulation about non-confirming product in packing process? 1
7.6 Is there treament method for non-confirming product in packing process? 1
8. OUT GOING INSPECTION

8.1 Is the controlled Work Instruction displayed for the operator at OQA inspection station ? 1
8.2 Is the operator inspect the critical point, location, assy. based on the Work Instruction? 1
8.3 Is the Customer spec. involved at the inspection instruction? (if available) 1
8.4 Does the AQL inspection established and appropriate with model inspected ? 1
8.5 Is the customer defect/complaint (if any) summaries and highlighted ? 1
8.6 Is the unit inspect under the proper light, magnifying or microscope define on Work Instruction the 1
product requirement ?
8.7 Take the minimum sampling for verify the products met requirement: 1
a) Is the Label serial attached properly ? 1
8.8 Is the communication conducted when the nonconforming find ? CAR, NCR, etc. 1
8.9 Inspect the passed boards with minimum sampling quantity, and check the rejected boards (if 1
available)
8.10 In case of Rework submission, Is the OQC perform the 100 % inspection ? 1
Score '0' for sampling use.
8.11 Does the data inspected per sampling record and maintained for traceability retained 1
9. Finished good store

9.1 Is the controlled Work Instruction displayed for the operator at packaging station ? 1
The packaging list established ? .
9.2 Is the any method to maintain packing area to ward off messy or disarrangement ? 1
At least the FIFO or chain link system is provided.
9.3 Does the packing material (box/carton, bubble bag, antistatic bag, etc) part number listed on the 1
Work Instruction or standard operating procedure ?
9.4 Review the packing, does the packing met requirement ? (check the units inside box with minimum 1
sampling)
a) Is carton box correct (part number, size) ? 1
b) Is the bubble bag, antistatic bag correct and present ? 1
c) Is the board direction correct inside box ? 1
d) Is the label box correct i.e. model name, part name, customer name, quantities, date, signet ? 1
e) Are the actual quantities appropriate with label ? 1
f) Is the label patched after the unit insert ted and before selaed the box ? 1
f) Is the packaging sealed properly ? 1
9.5 Is the loose box notified and recorded ? 1
a) Is the support part/material determined for loose box and documented ? 1
9.6 Does the packaging result recorded and maintain ? 1
The retention time may required for tracebility of customer feedback or complaining.
10. Delivery
10.1 Is there procedure for preparing goods before delivery? 1
10.2 Is there standard/instruction for preparing goods before delivery? 1
10.3 Is there assignment for PIC who prepare goods before delivery? 1
10.4 Is PIC trained and do they undertand regulation, WI, WS…? 1
10.5 Is it easy to check positions of goods in stock and delivery history? 1
10.6 Is there regulation about non-confirming product in preparing process? 1
10.7 Is there treament method for non-confirming product in preparing process? 1
11. Customer-specific requirement
11.1 Are SPC done on special characteristics requirements? 1
11.2 Are special characteristics under statistical control? 1
11.3 Did you inform to customer any out of control condition of special characteristic? 1
11.4 Are used measurement equipments acceptable (MSA less than 10%)? 1
MAXIMUM SCORE 105
OBTAINED SCORE
OBTAINED %
PASSED % 85%
OUT COME
 Dept/Sec Tar. Act. Note, Objectives Evidence
S/N Question / Description
tion Score Score [Document number listed]
Note for Out Come :
- Pass (Result ≥ 85%) ; When the requirements reached base appropriate with audit checklist
- Conditional Approval (Result < 85% and ≥ 75%); When the some actual are not met requirements and
the Corrective action is required to close and Work Instructionll review upon CAR's submitted.
- Fail ; If the requirement base audit checklists cannot reach the minimum score and need to re-audit for finding
after the corrective action done within time constraint not over into next schedule