Title Page
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Plant Name
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Date of Evaluation
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Auditee
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Auditor
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Products
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Reported by
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Plant Location / Place
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Instructions
1. Determine the condition of each item below with either "Pass", "Fail" or "N/A"
2. Add photos and notes by clicking on the paperclip icon
3. To add corrective actions, click on the paperclip icon then "Add Action", provide a description, assign to a member, set priority and due date
4. Complete audit by providing digital signature
5. Share your report by exporting as PDF, Word, Excel or Web Link
ΣΗΜΕΙΩΣΗ: Το πρότυπο αυτό δημιουργήθηκε χρησιμοποιώντας το Google Translate
• Quality Performance Result
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0.2.1 - Rate of Warranty (%)
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0.2.2 - Rate of Customer Complaints (ppm
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0.2.3 - Rate of process defect (Scrap rate+Rework rate) (ppm)
1. Quality Policy & Quality Assurance
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(1) QA System
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1.1.1 - State of Certification
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1.1.2 - Status of internal audit implementation
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1.1.3 - Policy, Target & actual status
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(2) Quality Organization and QA Meetings
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1.2.1 - Quality organization to clarified responsibility and task allocation and QA meetings
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(3) Quality Objectives
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1.3.1 - Status of Target Value (Warr.,PPM, & Internal PPM)
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1.3.2 - Target attainability (Warr.,PPM, & Internal PPM)
2. Analysis on the quality concerns for current products
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(1) Activity for target achievement
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2.1.1 - Existence of Pareto of claim phenomena (monthly / weekly)
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2.1.2 - Consistency between results of defect reduction activity and target values
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2.1.3 - Progress management for defect reduction activity
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(2) Information analysis for warranty claims
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2.2.1 - Obtaining claim information
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2.2.2 - Analysis of information<br><br>• Warranty
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2.2.3 - For the case of product with a few incident on claim<br><br>• Warranty (Claim control in consolidated list / claim tracker to control to reduce)
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(3) Cause analysis of non-conforming parts
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2.3.1 - Standard of Quality non-conformity to analyse
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2.3.2 - Cause analysis of non-conforming parts (warranty, customer complaints, internal process defect)<br><br>• Method, contents and relevance of root cause analysis<br>• 8D reports for internal quality issues <br>• To visit the OEM to analyze the Root cause and take a preventive action
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2.3.3 - Activity for NDF reduction (This line applies for parts subject to warranty issues)
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(4) Prevention of recurrence / deployment
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2.4.1<br>・Warranty<br>・Customer complaints<br>・Process defect
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2.4.2 - Database for past troubles<br><br>・Warranty<br>・Customer complaints<br>・Process defect<br><br>• Management of recurrence asa low effectiveness analysis<br>• Existence of past troubledatabase, confirmation of itsorganization<br><br>Richness in contents of past troubles<br>・Warranty<br>・Customer complaints<br>・Process defect
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2.4.3 - Feedback status of past troubles<br><br>・Process FMEA<br>・Process assurance level evaluation<br>・Control plan<br>・Technical standard
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(5)
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2.5.1 - Methods of progress control for investigation and defect analysis
3. Project Management
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(1) Organization
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3.1.1 - New Model Launch; Standard and Implementation of organization and role / Project team organization; For manufacturing plant only. Project Team organization
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3.1.2 - The standard of changing project member( transfer and resign) ; Standard for handing over project status and lessons learned to the next phase (SOP) and or a new person on the team.
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3.2.1 - For Full evaluation > Feasibility Study
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(3) Supplier Master Schedule and progress meetings
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3.3.1 - Set up of action Items; Set development rank; Milestone management; Progress management
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(4) Phase review and Design reviews
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(2) Feasibility study for full evaluation
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3.4.1 - Milestone management meetings
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3.4.2 - Prevention of problems related to new mechanism and new material. DR member; Follow up on DR results
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3.4.3 - Reccurrence prevention based on past trouble
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3.4.4 - Implementation of countermeasures for past troubles
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3.4.5 - CSCC implementation
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3.4.6 - Management guidance of Initial Products; Initial Product Inspection; Bulletin; Initial Product Management in situations that receiving, process, delivery; Plan and Performance Management of Initial Products
4. Process design nad Pre-production
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(1) FMEA
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4.1.1 - Implementation of countermeasure on design based on evaluation standard.
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4.1.2 - Implementation of countermeasure on design based on evaluation standard; For Design FMEA & Process FMEA; Feedback status of actual (current) claim to FMEA; Proposal of defect prevention to customers
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(2) Control Plan
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4.2.1 - Rule, Standard to prepare Control plan and how quality characteristics are incorporated in it.
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4.2.2 - Manufacturing actual conditions for quality characteristics
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4.2.3 - Receiving and shipping
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(3) POKA - YOKE
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4.3.1 - Installation Status; Standard to install Poka-yoke
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(4) Equipment & tools commissioning
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4.4.1 - Maintenance procedures and frequency
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(5) Process capability
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4.5.1 - Selection of management items of frequency
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(6) Production trials
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4.6.1 - Trial schedule Control items and targets
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4.6.2 - Trial schedule Control items and targets; Process audit; Production trial results Actions
5. Ramp up activity
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5.1.1 - Setting of action plans; Contents to control
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5.1.2 - To set the target
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5.1.3 - To clarify the condition; the Evidence to set the condition
6. Training
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(1) Operator Training
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6.1.1 - Training plan and result
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6.1.2 - Traning effectiveness evaluation
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6.1.3 - Qualification / Skill authorization
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6.1.4 - Training tool; Training contents
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(2) Operator Skill Evaluation
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6.2.1 - The confirmation of the operation monitoring
7. Shop Floor
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(1) Raw materials and components receiving
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7.1.1 - Receiving Inspection procedure: Does the receiving process contain all confirmation items based on the control plan? Are the results recorded?
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7.1.2 - Is inspected packaging identified with an indication level?
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7.1.3 - If a problem is detected after inspection, is it feedback to sub-supplier?
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7.1.4 - If a problem is detected after inspection, is there a system to prevent the use of non-conformity?
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(2) Check at line start-up
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7.2.1 - Regular quality confirmation<br><br>• Quality check sheet
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7.2.2 - Record of quantitative control item
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7.2.3 - Placement of Poka-Yoke
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7.2.4 - Handling rule for abnormality on Poka-Yoke
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7.2.5 - Poka-Yoke prior to use check sheets
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7.2.6 - Running condition of Poka-Yoke
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7.2.7 - Control on master to check Poka-Yoke (Master which is a basis for Poka-Yoke setting: Leak master, etc)
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(3) Control of Equipment conditions
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7.3.1 - Manufacturing conditions
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7.3.2 - Control of condition setting <br><br>Condition record sheet<br>• Equipment condition check sheet<br>• Prior to use check sheet<br><br>Record the reaction in case of finding non-conformity
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7.3.3 - Condition change management within the tolerance ranges
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7.3.4 - Change over and set up operation
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(4) Process Instructions
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7.4.1 - Update on standards & control documents<br><br>• Confirmation of consistency on standards & Control documents
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7.4.2 - Preparing and storing conditions of standard operation sheets
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7.4.3 - Ideas to help operators' understanding
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7.4.4 Contents of standard operation sheets
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7.4.5 - 3Z assurance sheet prepared,<br><br>• Ideas to help operators' understanding
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(5) 5S
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7.5.1 - 3S condition of Equipments and tools
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7.5.2 - Storing condition of Equipments and tools
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7.5.3 - Controlling dropped goods
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7.5.4 - Control of bringing in personal belongings
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7.5.5 - Control of clothing
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7.5.6 - 5S improvement activity
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7.5.7 - Noise, bad smell, Dust-proof
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7.5.8 - Measures for static electricity
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(6) Part cleanliness and preservation
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7.6.1 - Maintenance of parts, materials and finished products; Deterioration prevention of parts, materials and finished products
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7.6.2 - Container control
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7.6.3 - Control of contamination
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7.6.4 - Control of cleaning agent.
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(7) Inspection of work in process/finished parts
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7.7.1 - Inspection of internal process (Includes functional inspections (Exam), 100% voluntary check in Process)
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7.7.2 - Boundary limit samples
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7.7.3 - Illumination for operation
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(8) Control by SPC sheet (100% inspection is done by Poka Yoke and/or CCD camera with computerized system, skip this item and score 4 pt.)
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7.8.2 - Action when control chart shows abnormality
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7.8.3 - Management of process defect performance
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(9) Special characteristics
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7.9.1 - Identification of critical safety parts and Critical characteristics
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7.9.2 - Management of critical safety parts and critical characteristics
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7.9.3 - Special Process Management
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(10) Management of non-conforming parts
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7.10.1 - Handling of Nonconforming parts and record.
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7.10.2 - Identification of Nonconforming products; At Products Line side, Sub line side, Part return site ex.) Return part Cage
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7.10.3 - Abnormality control of supplied parts from customer control
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7.10.4 - Claim Treatment
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7.10.5 - 8D list
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(11) Treatment of non-conforming parts (by rework, disassembly, repair, replacement, re-assembly, re-useetc.)
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7.11.1 - Handling rules for rework
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7.11.2 - Rework operator
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7.11.3 - Rework record
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(12) "Unusual "product and equipment situations
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7.12.1 - Handling abnormality; Information of abnormality analysis; Communication; Verifications for recurrence prevention of abnormality; Definintion of abnormality; Definintion of abnormality
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(13) Internal Auditing, Improvement activity , and Sub-supplier 8D management
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7.13.1 - Process Quality current state understanding
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7.13.2 - Process defect reduction activity
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7.13.3 - Continuous check on countermeasure
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7.13.4 - Lateral deployment of countermeasures
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7.13.5 - Daily improvement activity QRQC
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7.13.6 - Small group improvement activity; Action plan QCC
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(14) Control of delivery process
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7.14.1 - Production change over; Similar products control for finished products, reworks, and at delivery area
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7.14.2 - Odd part control
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7.14.3 - First-in first-out control of components and finished goods
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7.14.4 - The management of packing specification
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(15) Storage of work in process/ finished parts
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7.15.1 - Container labeling; Applies to production order labels, work in process labels, Finished Goods labels and Warehouse or Shipping labels
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7.15.2 - Location control; Applies to: Parts Depository, Line side storage, Shelves for components, WIP locations, Finished goods locations.
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(16)Traceability
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7.16.1 - Traceability of critical/Special parts
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7.16.2 - Lot Management; Traceability for general parts
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(17) Maintenance of equipment and Dies
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7.17.1 - Periodical inspection
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7.17.2 - Management of consumables; TOOLING - consuming tools conditions and follow-upApplies to blades, drills, copper tips, die cast tooling
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7.17.3 - Chokotei control ("Chokotei" means short time stop. Interruption time is not over 10 minutes, not over 3 times/month)
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(18) Calibration of gauges/measurement instruments Gauges/measuring instruments
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7.18.1 - Storing of measuring equipments; The usual check of measuring equipment ; Protection on calibrated equipments
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7.18.2 - Measurement; calibration environment control
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7.18.3 - Management of calibration on measuring equipment
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7.18.4 - Expiration date identification
8. Change Management
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(1) Process / plant / sub-supplier change management
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8.1.8 - Confirmation of processes sufficient. Please show the file of process change sheets of the previous year.
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8.1.2 - Risk evaluation - for planned and sudden change.
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8.1.3 - Updating of documents for a change
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8.1.4 - Comparison before and after the change
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8.1.5 - Status of each change
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8.1.6 - Control of change in operator (new operator)
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8.1.7 - Control of infrequent production
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8.1.8 - 4M Change training
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(2) Design (Product) change management
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8.2.1 - Between end of Design and SOP standard rule to manage design change and influence on DR and prototype evaluation. Confirmation of design (Product) change after SOP is appropriate.
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8.2.2 - Design notes managemant
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8.2.3 - Design change risk identificaition
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8.2.4 - Are FMEA, control plan and process instructions up-dated?
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(3) Control of change at sub-suppliers
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8.3.1 - Change / Modificationin formation Tier 2':- Process / plant change request- Design (product) change request
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8.3.2 - Definition of change; Management of process changes; Record of process change
9. Sub-Supplier Management
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(1) Sub-supplier sourcing and quality assurance contracts
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9.1.1 - Procedure and Method to select the supplier
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9.1.2 - Quality control Manual for supplier
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(2) Sub-supplier project management
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9.2.1 - Procedure to manage suppliers
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9.2.2 - Risk Evaluation for supplier
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9.2.3 - Project control of Supplier activity
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(3) Sub-supplier performance management
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9.3.1 - Standard for quality management
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9.3.2 - Making action plans
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9.3.3 - Special activities
Evaluation Completion
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Auditor's Name and Signature