Professional Documents
Culture Documents
■ Basics of evaluation
Audit executive
Company name department date of Audit 20 . .
ECN management
Product management of
management 4 equipment 5 (Engineering 9 Conversion score 100
Change
Notification)
Development Improvement
management 6 secondary vender 6 activities 14
Material 1.2 Is there a procedural document for managing long-term inventories and is it operating as a procedure?
1 → Check long-term inventory list and check long-term inventory action(Periodic inspection, disposal, etc.) 1
management
→ Check long-term stock spot in warehouse (Make sure it is operating as per standard))
1.3 Are there standards for the management of parts and materials that require special storage, such as refrigerated
storage, and are they operated according to the procedure? 0.5
→ Identification of special management item and check whether it matches with management condition
1.4 Parts and material management documentation Is inventory and actual inventory periodically checked and operational?
0.5
→ Make sure that the parts and material management documents match the parts,
1.5 Are there procedural documents for raw material, part first-in-first-out management and operating procedures?
subtotal:5 points, rating: (
→ Make sure the warehouse is configured so that the raw materials and parts can be first-in-first-out 1
)point
(Labels, racks, etc.) and storage status
2.1 Is there a documented procedure for managing defective parts, raw materials and operating procedures?
→ Make sure that there is a separate storage area for defective parts and raw materials and that they are not put into the 2
process
2.2 Is there a system that feeds back to the related departments the analysis of the failure case and the results of the
Defective action?
2 product 1
→ Do you analyze the cause of defect parts, products (import / process / shipment), and do improvement activities?
management → Do you report to relevant department heads and chief executive officers?
2.3 Are there procedures for reviewing the processing of defective parts and raw materials and operating procedures?
Are there any special criteria for use? 1
( Identification of operational status through documents (re-inspection, rework, disposal, etc.))
2.4 Are defective parts and materials managed by recording the date, place of occurrence, and details of defect? 1
subtotal:5 points, rating: ( 2.5 Are the responsibilities and authorities for reviewing / approving the processing of defective parts and raw materials
1
)point recorded in the document?
Quality System Audit Check Sheet
No Check-Item Allotment evaluation Notes and
score score Comments
3.1 Are there procedures for the management of packaging, storage and delivery of the product and are they operated according 1
to the procedure?
3 Product
management 3.2 Do you have a safety depository and keep it there to prevent damage and deterioration of the product? 1
3.3 Is there a standard for product loadings and is the standard operated rationally? (Number of loadable layers) 1
subtotal: 4 points, 3.4 Are first-in-first-out for each product lot managed? Is product inventory status and goods issue managed? 1
rating: ( )point
4.1 Check if you have 100% approval, drawings, etc. of the product under development or initial mass production? 1
4.2 Are the approvals and drawings readily filed and easy to find? 1
4 Development → Filing or system, and check the status management
management
4.3 Are the quality failures that occurred during test production and mass production documented and reflected in the
development of new models? 2
→ Check the failure case book and check if it improves on new model
subtotal:6 points, 4.4 Do I find out and solve problems through new product design reviews? 2
rating: ( )point → Check the meeting document and check whether the problem is improved
5.1 There is a procedural document to manage the work standard and it is operated according to the procedure 2
Are job standards managed to be easy to find and use?
5.2 Are the machine, equipment, program and material specifications recorded in the work instruction manual? 1
5.3 Is the work guidance document established and revised managed and approved by the person in charge before issuance, and
the work guidance documented and revised history managed? 1
5 Process control → Ensure that the work instructions are approved by the responsible person
5.4 Are process inspection standards rational and faithful to the standards? 2
→ Inspection cycle, inspection items, inspector level etc.
5.5 Is there a cause analysis, prevention of recurrence, and history management in case of a defect in process inspection? 3
5.6 Is the process failure collected and analyzed on a daily basis and data managed? 1
5.7 Are Worst defects in the production process improving? And is it preventing you from recurring? 1
subtotal: 12 points, 5.8 Are there production line-stop standards, and are the line stop criteria reasonably set and operating as per standards? 1
rating: ( )point
Quality System Audit Check Sheet
No Check-Item Allotment evaluation Notes and
score score Comments
6.1 Are there procedural documents for instrumentation and facility management that require calibration and are they operated 1
according to the procedure? → Check procedure and execution status
Measuring
6 Instrument 6.2 Do you have an instrument management list and are all instruments calibrated? 1
Management 6.3 Do each meter have a history card and is the history managed? 1
6.4 Are test facilities that are not capable of calibration and calibration performed self-inspection? 1
subtotal: 5 points, 6.5 Instrument calibration status (IQC, PQC, OQC, Reliability test instrument check) 1
rating: ( )point → Check calibration label, check compliance with validity period
7.1 Do you manage the status of equipment that requires preventive maintenance? 1
7 management of 7.2 Is there a standards document for preventive maintenance for each facility and is the maintenance item reasonable? 1
equipment
7.3 Are the preventive maintenance plans for each facility established and operating as planned? 2
subtotal: 5 points,
rating: ( )point 7.4 Do you have proper spare parts for each facility and manage the status? 1
8.1 Is there a procedure for selecting a secondary vendor and is it operating according to the procedure? 1 -
8.2 Are secondary Vendors selected by following the vendor selection process?
- Confirmation of selection result of newly registered company (company evaluation result, manufacturing quality process chart, 1
organization chart, etc.)
secondary vender 8.3 Is the secondary Vendor status periodically Up-Date?
8 Management 1
- Second Vendor Status Table Up-date status check
8.4 Is there procedural documentation for the secondary vendor evaluation and is the content substantial? 1
- Confirmation of the evaluation of the company (whether the evaluation of the process or system for the company is faithful)
8.5 Does the 2nd Vendor Year Audit Plan have been established and is undergoing evaluation as planned? 1
- Confirmation of performance against plan
subtotal: 6 points, 8.6 Audit Does the issue indicate that the countermeasures are followed up? 1
rating: ( )point - Confirmation of Audit results, countermeasures against problems and confirmation of measures to prevent recurrence
Quality System Audit Check Sheet
No Check-Item Allotment evaluation Notes and
score score Comments
9.1 Raw materials Is the IQC inspection standard established and tested as per the standards?
- Confirmation of approval documents, inspection manuals, inspection items of supplier shipment inspection certificate, 2
etc.
9.2 Inspection, no inspection (management inspection) Is there a selection criteria? 0.5
9 IQC
9.3 Does IQC have an improvement measure in case of failure, and does the recurrence prevention activity operate?
- Confirmation of non-acceptance management document → Confirmation of same defect occurrence → Confirmation of 1
establishment of countermeasure for preventing recurrence
9.4 Do you manage the quality performance of each supplier (IQC , PQC failure)? (Quality trend management) 1
subtotal: 5 points, 9.5 Does the IQC inspection standards manage enactment and revision histories? (Including inspection standard) 0.5
rating: ( )point
10.1 Does the OQC process include Sampling Plan, AQL, Test Equipment, Test Conditions, etc. and operate according to 1
the procedure? → Check the inspection status
10.2 Is the inspection item set to an objective item that includes the customer approval document and requirements? 3
10 OQC 10.3 Does the OQC inspection carry out the history management of quality reject products? 1
10.4 Are customer complaints included in the OQC inspection report?
- Is the customer complaint checked as an important item when testing OQC? 2
Check the customer complaint document and check whether it is included in the inspection certificate
subtotal: 8 points, 10.5 Does the OQC inspection standards manage enactment and revision histories? (Including inspection standard) 1
rating: ( )point
11.1 Does Engineering Change Notification work well with our company?
ECN management -When Engineering Change occurs, do you report all of them to our company and obtain approval? 3
(Engineering Change
Notification) - ECN Managed Document Confirmation (ECN Notification and Reply Rate Management)
11
11.2 Engineering Change Schedule, Changed Shipment Schedule, etc.? 1
- design specifications,
parts, and work 11.3 Engineering Change Initial production (change / new) Will you inform us by labeling at shipment? 2
changes 11.4 Is the secondary vendor ECN management process built and managed? 1
subtotal: 9 points, 11.5 Has the inspection standard of the inspection standard and the inspection certificate changed in case of a design 2
change in our company?
rating: ( )point
Quality System Audit Check Sheet
12.3 Are user complaints documented and delivered to the process (production / outsourcing)? 2
12 Improvement 12.4 Has the work standards / inspection standards for preventing recurrence of user complaints been revised? 2
activities
12.5 Is it self-checking and recording whether the improvement measures are applied? 1
12.7 Do you receive and manage measures to prevent recurrence of secondary Vendor failures? 1
subtotal:14 points, 12.8 Is the quality report (IQC / Process / OQC / Uesr complaints etc.) reported to the CEO? 3
rating: ( )point
13.1 Do you carry out reliability tests on development and production parts? 1
13.2 Development and mass production components When the reliability test fails, does the cause analysis and 2
countermeasure prevent recurrence?
13.3 Do you manage performance against the annual reliability test plan? 1
13.6 Does the reliability test standard and the actual test conditions match? 1
13.7 Do you improve the parts already delivered to the mother company when the reliability test fails? 3
And do you notify the parent company of the problem of the reject?
subtotal: 15 points, 13.8 Have test conditions been revised for the purpose of enhancing detection capability or improving part reliability? 2
rating: ( )point
2. Production process management Audit
Finished product 7
management
Injection Mold approval
18 Spray 22 Conversion score 100
Management document
11
management
Part (product) 7.3 Are the process control items specified in the approval document of the part (product) 2
compliant?
7 approval document
management 7.4 Is the important management point for each material specified in the approval document of 2
the part (product) executed? (Data confirmation)
7.5 Is there a procedure to evaluate the parts (product) approval documents on their own?
And do they test? 2
(Reliability test, assemblability verification and type synthesis verification)
subtotal: 11 points, 7.6 Do you use materials only from approved suppliers? 2
rating: ( )point
3. Production process management Audit
[PRESS]
■ Basics of evaluation
Audit executive
Company name department date of Audit 20 . .
Evaluation allotment evaluation Evaluation allotment evaluation Evaluation allotment evaluation Evaluation allotment evaluation
process score score process score score process score score process score score
approval
Raw material Total evaluation
management 9 Press processing 16 document 11 score 60
management
3.4 Is EDGE, FLASH, BURR managed in a safe condition for human body? 1
3 PRESS processing 3.5 Is the marking clear and readable and not missing? (Identification tracking) 1
3.6 Does the TAP exchange cycle comply? (Check the exchange date) 2
3.8 Are TAP Missing Automatically Detected and Automatically Inspected for Wear Failure? 1
3.10 Is welding TIP exchanged on the basis of exchange cycle? (Check the daily report) 2
subtotal: 16 points, 3.11 Are the Welding strength tested in accordance with the standards? 2
rating: ( )point
4.1 Is the plating and coating thickness measured according to the standard? 2
4 Plating, painting 4.2 Do you obtain data from other suppliers when you do not have a measuring device? 1
4.3 Are plating and coating adhesion tests carried out? (TAPE TEST, etc.) 2
Allotmen
evaluation Notes and
No Procedure Check Point t
score Comments
score
5.1 Do you have approval documents for parts (products)? (Number of items held / Total number of
1
items)
5.2 Does the approval document of our company's part (product) agree with the approval document of
the supplier part (product)? 2
5 document 5.3 Are the process control items specified in the approval document of the part (product) compliant? 2
management
5.4 Is the important management point for each material specified in the approval document of the part
(product) executed? 2
(Data confirmation)
5.5 Is there a procedure to evaluate the parts (product) approval documents on their own?
2
And do they test? (Reliability test, assemblability verification and type synthesis verification)
subtotal: 11 points,
7.6 Do you use materials only from approved suppliers? 2
rating: ( )point