• 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

  • 0.2.1 - Rate of Warranty (%)

  • 0.2.2 - Rate of Customer Complaints (ppm

  • 0.2.3 - Rate of process defect (Scrap rate+Rework rate) (ppm)

1. Quality Policy & Quality Assurance

  • (1) QA System

  • 1.1.1 - State of Certification

  • 1.1.2 - Status of internal audit implementation

  • 1.1.3 - Policy, Target & actual status

  • (2) Quality Organization and QA Meetings

  • 1.2.1 - Quality organization to clarified responsibility and task allocation and QA meetings

  • (3) Quality Objectives

  • 1.3.1 - Status of Target Value (Warr.,PPM, & Internal PPM)

  • 1.3.2 - Target attainability (Warr.,PPM, & Internal PPM)

2. Analysis on the quality concerns for current products

  • (1) Activity for target achievement

  • 2.1.1 - Existence of Pareto of claim phenomena (monthly / weekly)

  • 2.1.2 - Consistency between results of defect reduction activity and target values

  • 2.1.3 - Progress management for defect reduction activity

  • (2) Information analysis for warranty claims

  • 2.2.1 - Obtaining claim information

  • 2.2.2 - Analysis of information

    • Warranty

  • 2.2.3 - For the case of product with a few incident on claim

    • Warranty (Claim control in consolidated list / claim tracker to control to reduce)

  • (3) Cause analysis of non-conforming parts

  • 2.3.1 - Standard of Quality non-conformity to analyse

  • 2.3.2 - Cause analysis of non-conforming parts (warranty, customer complaints, internal process defect)

    • Method, contents and relevance of root cause analysis
    • 8D reports for internal quality issues
    • To visit the OEM to analyze the Root cause and take a preventive action

  • 2.3.3 - Activity for NDF reduction (This line applies for parts subject to warranty issues)

  • (4) Prevention of recurrence / deployment

  • 2.4.1
    ・Warranty
    ・Customer complaints
    ・Process defect

  • 2.4.2 - Database for past troubles

    ・Warranty
    ・Customer complaints
    ・Process defect

    • Management of recurrence asa low effectiveness analysis
    • Existence of past troubledatabase, confirmation of itsorganization

    Richness in contents of past troubles
    ・Warranty
    ・Customer complaints
    ・Process defect

  • 2.4.3 - Feedback status of past troubles

    ・Process FMEA
    ・Process assurance level evaluation
    ・Control plan
    ・Technical standard

  • (5)

  • 2.5.1 - Methods of progress control for investigation and defect analysis

3. Project Management

  • (1) Organization

  • 3.1.1 - New Model Launch; Standard and Implementation of organization and role / Project team organization; For manufacturing plant only. Project Team organization

  • 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.

  • 3.2.1 - For Full evaluation > Feasibility Study

  • (3) Supplier Master Schedule and progress meetings

  • 3.3.1 - Set up of action Items; Set development rank; Milestone management; Progress management

  • (4) Phase review and Design reviews

  • (2) Feasibility study for full evaluation

  • 3.4.1 - Milestone management meetings

  • 3.4.2 - Prevention of problems related to new mechanism and new material. DR member; Follow up on DR results

  • 3.4.3 - Reccurrence prevention based on past trouble

  • 3.4.4 - Implementation of countermeasures for past troubles

  • 3.4.5 - CSCC implementation

  • 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

  • (1) FMEA

  • 4.1.1 - Implementation of countermeasure on design based on evaluation standard.

  • 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

  • (2) Control Plan

  • 4.2.1 - Rule, Standard to prepare Control plan and how quality characteristics are incorporated in it.

  • 4.2.2 - Manufacturing actual conditions for quality characteristics

  • 4.2.3 - Receiving and shipping

  • (3) POKA - YOKE

  • 4.3.1 - Installation Status; Standard to install Poka-yoke

  • (4) Equipment & tools commissioning

  • 4.4.1 - Maintenance procedures and frequency

  • (5) Process capability

  • 4.5.1 - Selection of management items of frequency

  • (6) Production trials

  • 4.6.1 - Trial schedule Control items and targets

  • 4.6.2 - Trial schedule Control items and targets; Process audit; Production trial results Actions

5. Ramp up activity

  • 5.1.1 - Setting of action plans; Contents to control

  • 5.1.2 - To set the target

  • 5.1.3 - To clarify the condition; the Evidence to set the condition

6. Training

  • (1) Operator Training

  • 6.1.1 - Training plan and result

  • 6.1.2 - Traning effectiveness evaluation

  • 6.1.3 - Qualification / Skill authorization

  • 6.1.4 - Training tool; Training contents

  • (2) Operator Skill Evaluation

  • 6.2.1 - The confirmation of the operation monitoring

7. Shop Floor

  • (1) Raw materials and components receiving

  • 7.1.1 - Receiving Inspection procedure: Does the receiving process contain all confirmation items based on the control plan? Are the results recorded?

  • 7.1.2 - Is inspected packaging identified with an indication level?

  • 7.1.3 - If a problem is detected after inspection, is it feedback to sub-supplier?

  • 7.1.4 - If a problem is detected after inspection, is there a system to prevent the use of non-conformity?

  • (2) Check at line start-up

  • 7.2.1 - Regular quality confirmation

    • Quality check sheet

  • 7.2.2 - Record of quantitative control item

  • 7.2.3 - Placement of Poka-Yoke

  • 7.2.4 - Handling rule for abnormality on Poka-Yoke

  • 7.2.5 - Poka-Yoke prior to use check sheets

  • 7.2.6 - Running condition of Poka-Yoke

  • 7.2.7 - Control on master to check Poka-Yoke (Master which is a basis for Poka-Yoke setting: Leak master, etc)

  • (3) Control of Equipment conditions

  • 7.3.1 - Manufacturing conditions

  • 7.3.2 - Control of condition setting

    Condition record sheet
    • Equipment condition check sheet
    • Prior to use check sheet

    Record the reaction in case of finding non-conformity

  • 7.3.3 - Condition change management within the tolerance ranges

  • 7.3.4 - Change over and set up operation

  • (4) Process Instructions

  • 7.4.1 - Update on standards & control documents

    • Confirmation of consistency on standards & Control documents

  • 7.4.2 - Preparing and storing conditions of standard operation sheets

  • 7.4.3 - Ideas to help operators' understanding

  • 7.4.4 Contents of standard operation sheets

  • 7.4.5 - 3Z assurance sheet prepared,

    • Ideas to help operators' understanding

  • (5) 5S

  • 7.5.1 - 3S condition of Equipments and tools

  • 7.5.2 - Storing condition of Equipments and tools

  • 7.5.3 - Controlling dropped goods

  • 7.5.4 - Control of bringing in personal belongings

  • 7.5.5 - Control of clothing

  • 7.5.6 - 5S improvement activity

  • 7.5.7 - Noise, bad smell, Dust-proof

  • 7.5.8 - Measures for static electricity

  • (6) Part cleanliness and preservation

  • 7.6.1 - Maintenance of parts, materials and finished products; Deterioration prevention of parts, materials and finished products

  • 7.6.2 - Container control

  • 7.6.3 - Control of contamination

  • 7.6.4 - Control of cleaning agent.

  • (7) Inspection of work in process/finished parts

  • 7.7.1 - Inspection of internal process (Includes functional inspections (Exam), 100% voluntary check in Process)

  • 7.7.2 - Boundary limit samples

  • 7.7.3 - Illumination for operation

  • (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.)

  • 7.8.2 - Action when control chart shows abnormality

  • 7.8.3 - Management of process defect performance

  • (9) Special characteristics

  • 7.9.1 - Identification of critical safety parts and Critical characteristics

  • 7.9.2 - Management of critical safety parts and critical characteristics

  • 7.9.3 - Special Process Management

  • (10) Management of non-conforming parts

  • 7.10.1 - Handling of Nonconforming parts and record.

  • 7.10.2 - Identification of Nonconforming products; At Products Line side, Sub line side, Part return site ex.) Return part Cage

  • 7.10.3 - Abnormality control of supplied parts from customer control

  • 7.10.4 - Claim Treatment

  • 7.10.5 - 8D list

  • (11) Treatment of non-conforming parts (by rework, disassembly, repair, replacement, re-assembly, re-useetc.)

  • 7.11.1 - Handling rules for rework

  • 7.11.2 - Rework operator

  • 7.11.3 - Rework record

  • (12) "Unusual "product and equipment situations

  • 7.12.1 - Handling abnormality; Information of abnormality analysis; Communication; Verifications for recurrence prevention of abnormality; Definintion of abnormality; Definintion of abnormality

  • (13) Internal Auditing, Improvement activity , and Sub-supplier 8D management

  • 7.13.1 - Process Quality current state understanding

  • 7.13.2 - Process defect reduction activity

  • 7.13.3 - Continuous check on countermeasure

  • 7.13.4 - Lateral deployment of countermeasures

  • 7.13.5 - Daily improvement activity QRQC

  • 7.13.6 - Small group improvement activity; Action plan QCC

  • (14) Control of delivery process

  • 7.14.1 - Production change over; Similar products control for finished products, reworks, and at delivery area

  • 7.14.2 - Odd part control

  • 7.14.3 - First-in first-out control of components and finished goods

  • 7.14.4 - The management of packing specification

  • (15) Storage of work in process/ finished parts

  • 7.15.1 - Container labeling; Applies to production order labels, work in process labels, Finished Goods labels and Warehouse or Shipping labels

  • 7.15.2 - Location control; Applies to: Parts Depository, Line side storage, Shelves for components, WIP locations, Finished goods locations.

  • (16)Traceability

  • 7.16.1 - Traceability of critical/Special parts

  • 7.16.2 - Lot Management; Traceability for general parts

  • (17) Maintenance of equipment and Dies

  • 7.17.1 - Periodical inspection

  • 7.17.2 - Management of consumables; TOOLING - consuming tools conditions and follow-upApplies to blades, drills, copper tips, die cast tooling

  • 7.17.3 - Chokotei control ("Chokotei" means short time stop. Interruption time is not over 10 minutes, not over 3 times/month)

  • (18) Calibration of gauges/measurement instruments Gauges/measuring instruments

  • 7.18.1 - Storing of measuring equipments; The usual check of measuring equipment ; Protection on calibrated equipments

  • 7.18.2 - Measurement; calibration environment control

  • 7.18.3 - Management of calibration on measuring equipment

  • 7.18.4 - Expiration date identification

8. Change Management

  • (1) Process / plant / sub-supplier change management

  • 8.1.8 - Confirmation of processes sufficient. Please show the file of process change sheets of the previous year.

  • 8.1.2 - Risk evaluation - for planned and sudden change.

  • 8.1.3 - Updating of documents for a change

  • 8.1.4 - Comparison before and after the change

  • 8.1.5 - Status of each change

  • 8.1.6 - Control of change in operator (new operator)

  • 8.1.7 - Control of infrequent production

  • 8.1.8 - 4M Change training

  • (2) Design (Product) change management

  • 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.

  • 8.2.2 - Design notes managemant

  • 8.2.3 - Design change risk identificaition

  • 8.2.4 - Are FMEA, control plan and process instructions up-dated?

  • (3) Control of change at sub-suppliers

  • 8.3.1 - Change / Modificationin formation Tier 2':- Process / plant change request- Design (product) change request

  • 8.3.2 - Definition of change; Management of process changes; Record of process change

9. Sub-Supplier Management

  • (1) Sub-supplier sourcing and quality assurance contracts

  • 9.1.1 - Procedure and Method to select the supplier

  • 9.1.2 - Quality control Manual for supplier

  • (2) Sub-supplier project management

  • 9.2.1 - Procedure to manage suppliers

  • 9.2.2 - Risk Evaluation for supplier

  • 9.2.3 - Project control of Supplier activity

  • (3) Sub-supplier performance management

  • 9.3.1 - Standard for quality management

  • 9.3.2 - Making action plans

  • 9.3.3 - Special activities

Evaluation Completion

  • Auditor's Name and Signature

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