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QMS Quality Management System
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Are the quality assurance policy and quality goal set up for all employees to understand?
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Is a quality responsible person assigned with the responsibility and authority clarified?
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Is the quality goal developed in each organization in the company to <br>set up and understand practical goal and action plan for each organization?
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Does the quality goal result in customer satisfaction?ss
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Is achievement level for the quality goal checked periodically?
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Can all the employees access the quality goal as well as its achievement level?
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Is the analysis of achievement level for the quality goal and customer <br>satisfaction reflected in the further activities? (reflection in corrective measures, <br>setting up of the next goal and action plan, etc.)
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Are internal quality meetings periodically held to report achievement level to <br>the top management and to follow up the progress from the top management?
Market Quality
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Is a certain rule / procedure (such as time limit) available to dispose of market complaints / defective information? Is a contact person clarified?
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Are major quality accidents or quality risk information such as PL accidents reported to top management for corrective action? (Is the procedure clearly defined by the regulation?)
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Is a market quality goal defined?
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Are manufacturing history / used parts and materials traceable from market quality information? Is a certain measure available to identify products when disposing in market and customers?
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Is market quality information distributed to the related departments (especially manufacturing department) promptly and accurately? Is a certain system available to review, implement and develop temporary / permanent measures in the related department?
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Is a corrective measure taken based on the analysis resulting from investigating true cause in the organization using market defect research / analysis?
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Is the effect verification in the company for corrective measures against market complaints / defect information?
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Are monitoring of market quality and effect verification for corrective measures implemented?
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Is FMEA revised based on market defect research / cause analysis, corrective measures and its effect verification to reflect QCS or operational procedure?
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Is quality information statistically analyzed and developed to the related departments to utilize for quality improvement activities and to reflect in design / development?
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Are the contents of corrective measures for market complaints and defect information documented and stored?
Design Management
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Is a quality assurance system available to cover the plan, design / development and manufacturing?
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Is the design management / audit system available to clearly define the checking items in each intermediate stage to check the consistency between the schedule and actual progress in each stage.
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Do only the authorized persons design the products? Is a person in charge and a approver clarified? Are the criteria available to measure designers' abilities to place the right person in the right place?
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Does design management system verify that developed products satisfy all the requirements?
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Is the latest version of the design records and related documents stored for utilization?
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Is a certain system available to verify mass-production design? Are mass-products verified to satisfy the quality confirmed at product design?
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Is a certain system available to verify production design? Is production design verified to realize product design and ensure building quality into the product design (how to manufacture)?
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Is a certain system available to verify production equipment (measuring instruments / jigs and tools included)? By manufacture / processing / inspection based on the production design, is the assurance verified to realize product design?.
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Are defect / fault cases accumulated to reflect in the design?
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Are potential defect causes analyzed by FTA / FMEA to reflect in design? Are FTA / FMEA revised based on defects appeared or evaluation results?
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Is design guidance concerning product safety available and is its adequacy verified from the product safety perspective in the design control and inspection system?
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Are reliability evaluation items, reflecting the assumed use (including misuse), available to verify safety / reliability for evaluation?
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Are the reliability test items or judgment criteria reviewed depending on customer quality requirements or market requirements change? Are the test validation / acceleration factor, etc. reviewed compared to market quality performance?
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Are defects occurred in design evaluation including reliability evaluation analyzed in the organization surely to reflect the countermeasure in design / production?
Change Control <br>
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Is a certain change control system available according to design management as for design and process change? Are verification methods and a approver clarified depending on the contents of change (level)?
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Is definition of the change clarified? (material / facility / operation / person / location, etc.)
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Is the change implemented only after reporting to and obtaining approval from customers under a certain system?
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"Are risks (failures) which occurred due to the change analyzed by FMEA to assess safety and reliability and verify that there are no failures?
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(Were any failures which occurred due to the change avoided based on the result?)"
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Is purpose of the change achieved to verify to achieve the quality goal?
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Is a certain rule available to identify products that implemented change? (product management system, etc.)
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Is a certain system available to transfer contents of the change surely to the necessary departments?
Shipping Quality Assurance
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Are the organization / authority / responsibility defined to assure shipping quality? Does the authorized person approve the quality inspection result to control shipment?
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Is a certain system available to allow shipment of only products that passed the inspection? (identification management)?
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Are disposal method and reporting route for non=conformity of shipping quality defined and implemented? (Is a certain rule available to retroactively take measures against the products that have already completed inspection?)
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Are inspection items / method for shipping quality inspection ruled to verify the contents assure the customers quality requirements? (such as unit of assurance)
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Are periodical reliability tests conducted after start of mass-production to monitor stability and variation of the quality?
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Are the records to assure shipping quality stored under a rule?
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Is a certain system available to stop shipment when abnormality occurs in the process?
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Is sampling store ruled?
Process Management
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Is the production design process ruled for building quality into the process such as QC process flowchart? Is a certain system available to develop to operation / inspection / facility operation procedure, etc., to manage?
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Based on risk review result of product design and production design / equipment verification and performance in the past, is an important process defined and managed under a certain system?
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"Are criteria / checking items / responsibility in process start up / trial / shift to the mass production clarified?
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Is a certain system available to separate trial products from products? "
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Are initial fluid management (handling of the products, identification included) , result verification and approval ruled?
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"Is analysis of defects in the process ruled?
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Are defects occurred in the process classified and analyzed to utilize for improvement?"
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Is the traceability of used parts and materials, process history (manufacturing date and time / equipment / operator / quality records / repair, etc.) ensured under a rule? (lot management rule, etc.)?
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Is management of environmentally related substances ruled?
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Whether there is a mechanism to process defect rate, management of one-pass rate, to take advantage?
Abnormality Management
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Is a certain rule available to define and manage abnormality? (Is a certain rule available to stop production process depending on the contents of abnormality?)
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"Is a certain rule available to dispose of / analyze abnormality? (detection / reporting / dispose / verification / approval / reporting to customers, etc.)
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Is abnormality ranked by its degree and is a countermeasure defined depending on the contents?"
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Are abnormalities related to product safety such as PL accidents reported to the top management immediately and notified to customers?
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Is disposal rule for abnormality implemented on the analysis result of abnormality? Is a certain system available to verify the effect of the disposal and countermeasure?
Measuring Instrument Management
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Is management procedure for measuring instruments / jigs and tools ruled? (such as classification of instruments / tools, management frequency)
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Are measuring instruments / jigs and tools are identified, managed and calibrated according to the schedule after they are verified in advance they satisfy the required specification? (measuring instrument managements system and its actual operational situation)
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Is measuring instrument management traceable?
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Is a certain disposal specified for the products when the measuring instruments / jigs and tools turn out not to satisfy the requirements?
"Procurement Quality Assurance <br>(OEM / ODM included)"
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Are certain criteria / system available to evaluate / authorize suppliers so that they are selected based on the evaluation result? Are suppliers periodically evaluated?
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Is a certain rule / system available to authorize materials / parts / products, etc. procured from suppliers?
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Is a "Basic Transaction Agreement" concluded with suppliers to clarify defect liability and product liability?
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Is a "Quality Assurance Agreement (Contract)" concluded with suppliers to oblige them to control changes (prior approval) and control abnormalities (notification)?
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Are quality requirements clearly presented to suppliers? (such as purchasing specifications / inspection specifications, clarification of inspection criteria, rejection rate (definition of epidemic, clarification of abnormality (MFFR, etc.) and others
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As for procurement items concerning safety (products that may cause fire or harm people), is the safety requirement presented to suppliers and have their design and making been verified?
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Is a certain rule available to verify the materials / parts / products, etc. procured from suppliers satisfy the quality requirements? (incoming inspection rule, etc.)
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"Is a certain rule available to dispose of non=conformity such as materials / parts / products procured from suppliers?
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Is disposal of in conforming products defined? (in conforming products disposal rule, etc.)?"
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Does the business transaction with suppliers comply with the related laws / official regulations?
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Are suppliers verified to manage environmentally related substances?
Outsourcing Management
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Is a certain rule / system available to verify the ability of manufacture / process of subcontractors when subcontracting whole or a part of the production / process?
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Are organization and responsibility / authority clearly defined to manage subcontractors?
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Does the business transaction with subcontractors comply with the related laws / regulations?
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Is a certain system available to verify that subcontractors manage the environmentally related substances in their operational contents and in the manufacturing process and implemented? (prohibited materials are clearly defined?)