Supplier Quality System Assessment (QSA)

Transcription

1 Supplier Quality System Assessment (QSA) Facility Name: Date of Assessment:

2 Chapter 01 General Assessment Guidelines This Assessment is developed to allow MLC to evalute its supplier conformance to ISO9000,ISO/TS16949 and MLC's specific quality sysytem requirement. This guideline is designed to verify, through objectiveevidence, whether or not the supplier's quality manangenent sysytem are indeed carrie out adequately and effectively meet the requirement of MLC. And MLC has established following 5 supplier performance rating based on a percentage of total points available: Commentary Class Final Rating Excellent Supplier 90 to 100% Satisfactory Supplier 70 to 89% Qualified Supplier 60 to 69% Conditional Qualified Supplier 50 to 59% Un-qualified Supplier Less Than 50% Supplier Audit 7-point evaluation scale This rating will be used when evaluating a new supplier that does not have sysytem in place or no need to NE establish for MLC's product. For example ROHS and IMDS etc. Supplier is not familiar with the requirement of element and don't know any any quality system or related 0 document(flow Chart, Control Plan, WI etc.) Supplier is familiar with the requirement of the element but there is no evidence of documentation, planing 1 or implementation Supplier is familiar with the requirements of the element and has preliminary source documentation with 2 incomplete plans for implementation. Source documentation is available and implementation is in progress. Deficiencies have been identified 3 but improvements are not quantifiable. Full implementation of source documentation for the requirement and complete confirmed evidence of 4 implementation effectiveness. The supplier has met minimum requirements. Supplier is able to demonstrate significant innovation in new ways to show relevant results beyond 5 customer requirements. Record the Point (NE, 0-5) for each requirement in the column (B) of Chapter 04 in this assessment. Multiple the Point in (B) with the ing Factor (A) and record the result in the column (AxB). To establish the organizations rating for each element, and for the overall assessment, percentage totals are used. Add the total the number of points scored for the element and record them in the table provided. Then, to determine the percentage, divide the number of points scored by total number of points available and multiply that figure by 100.

3 Chapter 02 Supplier Information Date of Assessment: Supplier Code: Supplier General Information Company Name: Company Phone: Company Fax: Website Address: Company Address: City / Country: Company Structure: Type of Business: Manufacturing Year in Business : Distributor Service Provider Point of Contact: Position / Title: Contact Phone: Contact Fax: Plant General Manager: Contact Phone: Quality Manager: Contact Phone: Engineering Manager: Contact Phone: Sales Manager: Contact Phone: CEO / President: Contact Phone: Ch02-1

4 Bank Reference 1: Bank Reference 2: (Name & Account) (Name & Account) Has a Non Disclosure Agreement (NDA) been signed off? Quality and Environmental Managemen Systems Information Is the company ISO 9000 certified? (Pls attach the cert. copy) Current Registration Date: Is the company ISO/TS certified? (Pls attach the cert. copy) Current Registration Date: General Profile Registrar: Registrar: planning to certified on: planning to certified on: Product (s)/component (s) Manufactured in this location: Product (s) / Component (s) considered by MLC: Total number of manufacturing facilities (Main Site / Site): Facility size Auditing Location Adress: Main Site / Site / Offsite? Total Area : Manufacturin g Area: Maximum Capacity (Units/Time): Location B Address: Cur-Capacity Utilization (%): Employee Turnover (%): Main Site / Site / Offsite? Location C Address: Total Area : Manufacturin g Area: Main Site / Site / Offsite? Marketing Information Total Area : Manufacturin g Area: Customer Name Product Type % of Capacity % of Sales Top 1 % % Ch02-2

5 Top 2 % % Top 3 % % Major Exported Countries: Previous Years Sales: Company Ownership Corporation Partnership Private Description of Production Facility / Testing Equipment / Plant Layout : (Use attachment to describe Equipment List & Plant Layout) Special Communication Facilities: EDI Internets/ Video Conference Satellite Others (Pls specify): Human Resource (Please attach the Company Organization Chart) Do the staff and employess are rotated between shifts? If Yes, How offen will be the shift change? Number of Employees 1st Shift 2nd Shift Administration/Management Design / Project Engineering Manufacturing Engineering Quality Assurance Engineering Production (Direct) Quality Assurance (Direct) Temperatory Employees Others Totals 0 0 3rd Shift 0 0 Totals Any research in new field of activity / product or Foreseen development? If yes, please specify (target & when): Do the staff and employees for all shift are qualified and trained with the same level of standard? Early Customer Awareness Do you have systems to inform MLC and/or other customers in case of below: (Pls check the Box) a. Possible extension of the production deadline or delivery schedules? b. Termination of a manufacturing process or product field? Ch02-3

6 c. New technical / technology exists will benefited MLC? d. Key material / changes? e. Key component or material Supplier / Subcontractor Change? f. Process flow or key process control changes? g. Product design changes? h. Plant / Manufactory site relocation? Ch02-4

7 Chapter 03 Assessment Scoring Summary MLC Audit Team Supplier Representatives Name Position / Title Name Position / Title Score Summary Field Factors % per Field Sub-Rating (%) 4.1 Product and process development & realization, Change Control 15.00% 4.2 Materials Management (Incoming, Receiving and Logistic Management) 10.00% 4.3 Supplier Materials Quality Management 10.00% 4.4 Equipment/tooling/jigs/fixtures/ Laboratory Management 10.00% 4.5 Product & Process and Quality Systems Management 35.00% 4.6 Rework/Repairs and Staffs Training 5.00% 4.7 Outgoing Quality, Field Return Management and On-going reliability Testing 10.00% 4.8 Training System, Employee Competent and Quality Culture Total Factor 5.00% % Final Rating Audit Summary Based on survey, the Supplier is recommended to the Class of: ## ## ## Commentary Class Final Rating Excellent Supplier 90 to 100% Satisfactory Supplier 70 to 89% Qualified Supplier 60 to 69% Commentary The Quality System is established with World Class Level The Quality System is established with no any outgoing inspection for MLC The Quality System is ready to supply a specific range of quality parts to MLC ## Conditional Qualified Supplier 50 to 59% Only ready to supply MLC for specific parts under MLC Qualification ## Un-qualified Supplier Less than 50% The Quality System is not ready to supply quality product to MLC Prepared By: Approved By: MLC-SQE MLC Manager Ch03-1

8 Chapter 04 Assessment Checklist and Findings Report 4.1 Product & Process Development & Realization; Change Control Management Elements Factor (A) Availability of customer 5 requirements, design goals and guidelines. (should be concentrated on end product applications; and process stability and effectiveness) Point (B) (AxB) Requested Action / Observation Action Plan fr. Supplier Who When Closure Date Closure Evidence fr. Supplier Documentation system of product 4 and process design reviews / validations for mass production Design 3 plan/reviews/testing/validations with appropriate approvals by suitable authority and/or CFT at each stage, including application reliability FMEAs, control plan, process flow 4 diagram with identification of critical parameters/characteristics form material level to delivery and with capability review prior to mass production and updated as necessary New product introduction / transfer 4 management (Preparation of work instructions, equipment checklist, operator training etc) PPAP/PSW or similar type of 5 Customer Approval Package and Customer Approval Change Control Program for 5 controlling the pre-and-post mass production changes and ensuringcustomer notification and approval Full ed Point 150 Sub-Total % per Field Ch04-1

9 4.2 Materials Management (Incoming, Receiving and Logistic Management) Elements Factor (A) Availability of incoming inspection 4 instructions, training for inspection methods and appropriate inspection equipment Availability of engineering drawing 4 (s) / specifications with identification of inspection items and tolerance of acceptance. Point (B) (AxB) Requested Action / Observation Action Plan fr. Supplier Who When Closure Date Closure Evidence fr. Supplier Non-conforming material control 3 system for suspected and N/C material, WIP and finished goods Material identification and 5 segregation (pass / reject / on-hold / scrap /waiting for inspection / etc.) Incoming inspection traceability (to 4 operator / supplier lot / nonconforming material report / UAI approval / etc) Documented responsibility to pass, 4 reject and waive of the incoming material Dock-to-stock or skip lot inspection 3 with traceable performance records and traceability of the lot Warehouse inventory control 3 (FIFO, Inventory turns monitoring, scrap control, self-life control, identification) Storage condition, packaging, 3 handling and delivery Flammable / Toxic materials and 3 dangerous goods control Maintain a Restricted Substance 4 Survey (IMDS) system to meet Laws / Customer requirements Full ed Point 200 Sub-Total % per Field Ch04-2

10 4.3 Sub-Supplier Materials Quality Management Elements Factor (A) Sub-Supplier / sub-contractor 4 qualification / audit process Approved Sub-Supplier Listing by 3 purchased part/material Point (B) (AxB) Requested Action / Observation Action Plan fr. Supplier Who When Closure Date Closure Evidence fr. Supplier Sub-Supplier Corrective Action, 4 Preventive Action & 8D reporting Systems Sub-Supplier improvement and 3 developing system Sub-Supplier performance tracking 4 and reviews system Supplier's internal engineering 5 change controls on purchased materials/parts Purchased material qualification 5 system (FAI of tooling, components etc) Overall sub-supplier quality 3 management and development program. Full ed Point 155 Sub-Total % per Field Ch04-3

11 4.4 Equipment / Tooling / Jigs / Fixtures / Laboratory Management Elements Factor (A) Automation and utilization of jig 2 and fixtures with mistake proofing approach Tool life management. 3 Point (B) (AxB) Requested Action / Observation Action Plan fr. Supplier Who When Closure Date Closure Evidence fr. Supplier Machine / equipment set up 4 verification and approval Preventive Maintenance program Back up capabilities and spare 4 parts control Equipment/ Tooling/ Measuring 3 Equipment, etc. control and protection Facilities and housekeeping 2 management Testers / measurement equipment 3 verification and correlation Temperature and humidity 2 controls, working environment, 6S MSA (e.g. GR&R, Liniability, 3 Stability, Bias) per control plan measurement systems Laboratory testing control with 3 appropriate equipment, testing personnel and testing method. Full ed Point 165 Sub-Total % per Field Ch04-4

12 4.5 Process / Product Quality and Quality Systems Management Elements Factor (A) Use of Statistical tools (SPC, Cpk 5 analysis, DOE, etc) especically on key product and process characteristics Process data collection and 5 analysis with improvement actions Point (B) (AxB) Requested Action / Observation Action Plan fr. Supplier Who When Closure Date Closure Evidence fr. Supplier Continuous Improvement plans 3 (CIP) and follow-up Internal process corrective actions. 5 (Feedback Loop Control) Process work instructions. (All 5 working area) Document Control (ECN, WI, 4 Specs., etc) Process / test traceability (to 4 operator/equipment) In process quality audits. (QA 4 Patrol Report / Line Alert System) In process inspection / testing ESD / Safety / Se-up control 3 (storage, handling, equipment / line setup, operator training, etc) Material / WIP identification and 4 control Material / WIP flow, staging, 3 handling and delivery Material usage traceability to 5 finished products Plan-Do-Check-Act systems to 5 review the overall performance continuously with feedback and quality policy and objectives deployment and promotion. Full ed Point 290 Sub-Total % per Field Ch04-5

13 4.6 Rework Control and Staff Training Elements Factor (A) Good / bad / suspected parts 4 identification / segregation Reworking process and support 3 (method, equipment, operators, etc.) Rework product traceability Reworking Approval Process and if 5 required with notification to customers Re-inspection control on the 5 reworked part/products Rework data collection, analysis 4 and utilization for corrective actions Point (B) (AxB) Requested Action / Observation Action Plan fr. Supplier Who When Closure Date Closure Evidence fr. Supplier Full ed Point 130 Sub-Total % per Field Ch04-6

14 4.7 Outgoing Quality, Field Return Management, Customer Relation Management and On-Going Reliability Testing Elements Factor (A) Inspection and Production Testing 5 plan Qualification of equipment and 4 tools used for inspection Pre-shipment inspection system Out-going inspection system Lot status and traceability Outgoing quality failure analysis 5 and corrective actions like, 8D, QCC Tools used, including initial responding time and containment action identification Point (B) (AxB) Requested Action / Observation Action Plan fr. Supplier Who When Closure Date Closure Evidence fr. Supplier Finished goods packaging, storage 5 conditions / handling Finished goods inventory control 4 (FIFO / Obsolesces) Field performance tracking Field return failure analysis and 4 corrective actions On-going reliability testing process Humidity and temperature control 5 for shipment units External corrective action & 5 improvement 8D reporting system to customer Field Return Rating or Customer 3 Primary information was collected by Relationship Management system sales department. to improve customer satisfication. Full ed Point 290 Sub-Total % per Field Ch04-7

15 4.8 Training Systems, Employee Competent and Quality Culture Elements Factor (A) Training needs identifications and 4 Training Systems Jobs and Tasks Assignment 5 Systems (Job Competent System) Point (B) (AxB) Requested Action / Observation Action Plan fr. Supplier Who When Closure Date Closure Evidence fr. Supplier Quality Culture (e.g. organizational 3 structure, responsibility and authority, reporting channel, communication channel and method, etc.) Full ed Point 60 Sub-Total % per Field Ch04-8

16 Chapter 05 Auditor Note (Supplier's Strength & Weakness) Ch05-1