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ZF Electronics Corp.

Quality Manual

ZF Electronics Corp.

QM01-Quality Manual
Prepared in compliance with ISO/TS 16949:2009
DATE RELEASED : _______________________ RELEASED BY : __________________________ DIRECTOR OF QUALITY:___________________________

Approved by:
Anton Kempf: Managing Director

Date:

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ZF Electronics Corp. Quality Manual

Table of Contents
Page 2 3 4 4 5 6 8 9 11 12 40 Sections Table of Contents and Revison History Scope, Objective, Normative Refrences and Exclusions Quality Policy and Global Quality Guidelines Organization Chart Terms and Definitions Conceptual Model For QMS- QMS Process Interface Diagram Processes relation matrix ZF QMS Documentation System Monthly Objectives to monitor Process Analysis Diagrams ISO/TS 16949:2009 Compliance Summary

Revision History
Revision Date Rev E 8/22/2009 Rev F 02/19/2010 Rev G 08/23/2010 Rev H 05/19/2011 Nature of Change(s) Revised Format and all Content Org Chart updated Quality Policy, Quality Guidelines to ZF GMBH Included Quality Manual Number and modified rev date in all pages.

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ZF Electronics Corp. Quality Manual

1.0

Scope, Objective, Normative Refrences and Exclusions

The Quality Management System described and referenced by this manual applies to:
ZF Electronics Corp. de Mexico, Juarez, Mexico ZF Electronics Corp. Electrical Products, Pleasant Prairie, WI, USA ZF Electronics Corp. El Paso Distribution Center, El Paso 1.1 Scope :

The scope of this quality manual includes the design and manufacture of electrical switches and electronic controls. The scope for ISO 9001:2008 also includes the design and distribution of computer input devices. Quality Management System scope for products manufactured and supplied to automotive customers complies with ISO/TS 16949:2009 requirements, Customer Requirements and applicable Regulatory Requirements. Quality Management System scope for non-automotive customers complies with ISO 9001:2008 Standard. Manufacturing location includes Juarez, Mexico. Supporting locations are in Pleasant Prairie and El Paso and scope includes activities related to Engineering, Procurement, Quality, Receiving, Sales, shipping and warehousing. This Quality Manual includes applicable customer-specific requirements to define the fundamental quality management system. 1.2 Goal : The goal of this quality manual is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. 1.3 Normative References This Quality Manual has been made according to Technical Specification ISO/TS 16949:2009 . ZF Electronics Corp. also follows applicable references and makes sure to keep latest revision active for: ISO 9000 Fundamentals and vocabulary (latest rev). ISO 9004 Guidelines for improving performance (latest rev). Rules for Achieving IATF Recognition (latest rev). Guidance for ISO/TS 16949 (last rev.) 1.4 Exclusions ZF Electronics Corp. has no exclusions to the ISO/TS 16949 requirements (latest rev).
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ZF Electronics Corp. Quality Manual

ZF Electronics Corps Quality Policy


2.0 QUALITY POLICY

ZF Electronics Corporation is committed to the design of innovative products which meet or exceed our customers needs, the delivery of quality product and services, with an aim to increase the Customer satisfaction using efficient processes and through continuous improvement of the Quality System.

3.0 GLOBAL QUALITY GUIDELINES

4.0 ORGANIZATIONAL CHARTS

ZF Electronics Corporation Pleasant Prairie / El Paso Distribution Center / Juarez Org charts are located in the ZF Electronics Corporation Intranet.

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5.0 TERMS AND DEFINITIONS

Business Plan: Controlled document that states strategic planning about quality, productivity, and overall business effectiveness. Concession: Written authorization from customer or similar authority for accepting / releasing a nonconforming product/s. Control Plan: Documented description of the system and processes required for controlling product. Design Responsible Organization: Organization with authority to establish a new, or change an existing, product specification. Error Proofing: Product and Manufacturing process design and development to prevent manufacturing or nonconforming products. Laboratory : Facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical and/or reliability testing. Laboratory Scope: Controlled document containing: Specific tests, evaluations, and calibrations that a laboratory is qualified to perform List of equipment which it uses to perform the above, and. List of methods and standards to which it performs the above Manufacturing: Process of making or fabricating: Production materials Production or Service parts Assemblies Heat treating, welding, painting, plating, or other finishing services. Predictive Maintenance: Activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes Preventive maintenance: Planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design Premium freight: Extra costs or charges incurred additional to contracted delivery. QMS: Quality Management System. Remote location: Location that supports sites and at which non-production processes occur. Site: Location at which value-added manufacturing processes occur Special characteristic: Product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product.

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6.0 CONCEPTUAL MODEL FOR QMS

PROCESSES INTERACTION

Support Processes
Plant, Facility and Equipment.

Human Resources .

Motivation.

Main Processes

PAP.

Customer Requirements.

Marketing,Bids, Quotations ,Orders & Contracts

Research and Development & Product Design.

Design of Mfg Processes.

Planning & Scheduling.

Purchasing.

Receiving, Storage & Inv.

Manufacturing

Shipping and Delivery.

Eng. & Process Changes.

Incoming Product Qualit & Supplier Development.

Equipment Maintenance.

Calibration.

Managerial Processes
Continual Improvement. Monitoring/ Measur. of Mfg Process & Product. Problem Solving. Monitoring/ Measur. of Custom. Satisf.

Internal Audits.

Continuous Improvement

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Customer Satisfaction.

ZF Electronics Corp. Quality Manual

6.1 Quality Management System Product Realization Process Continual Improvement Cycle
Marketing,Bids, Quotations, Orders and Contracts Eng. Research and Development & Product Design Engineering & Process Changes Design of Manufact. Processes Information Resources (Document Control). Requirements CUSTOMERS

Plant, Facility and Equipment. Human Resources Motivation Development

Customer Communication

PPAP Master Scheduling Planning & Scheduling Purchasing Receiving Stor & Inv. MEASUREMENT, ANALYSIS AND IMPROVEMENT Continual Improvement Manufacturing PRODUCT REALIZATION MANAGEMENT RESPONSIBILITY Management Review RESOURCE MANAGEMENT

Incoming Product Qlty & Supplier Development

Equip. Maintenance Calibration Process Monitoring Product Verification

Internal Audits Monitoring/Measurement of Mfg Process & Products Note :Detailed descriptions of Processes shown in this in this diagram are included in the associated process sheets at the end of this section

Problem Solving Shipping and Delivery Monitoring Customer Satisfaction

CUSTOMERS

Feedback Value-Adding Activities Information Flow

BUSINESS PLANNING PROCESSES

MFG & SUPPORT PROCESSES

MANAGERIAL PROCESSES

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6.2 Processes Relation Matrix

Process Relation Matrix


S09 Information Resources (Document Control) M04 Monitoring Customer Satisfaction. M02 Monitoring / Measurement of Mfg. Process and Product. S06-C Plant Facility and Equipment. S07-P & S07-C Human Resources. S03 Incoming Product Quality and Supplier Development

S01 Engineering and Process Changes

M05 Continual Improvement.

S05-P & S05-C Calibration

S04-P & S04-C Equipment Maintenance.

S02 Part Approval Process

M06 Management Review.

S08-P & S08-C Motivation

M03 Problem Solving .

MP01-P Marketing, Bid, Quotations, Orders & Contracts . MP02-P & MP02-C Research & Development and , Product Design . MP03 Design of Manufacturing Processes.


Manuf.

Mrk /Sal Des. Eng

Mfg. Eng.

MP06-P Purchasing .

Purch.

MP04-P Master Sheduling.

Mas. Sch.

MP05-C Planning & Scheduling . MP07-P & MP07-C Receiving, Storage & Inventory Control. MP08-P & MP08-C Manufacturing.

Mat.

Mat.

Prd.

MP09 Shipping & Delivery.

Mat.

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QTY

Des. Eng.

Dsg. Eng.

Mkt. Qty.

Qty.

Qty.

Qty.

Qty.

Qty.

Prd.

Qty

HR

HR

Process Qwner(s)

Maint.

Process Owner(s)

M01 Internal Audit.

ZF Electronics Corp. Quality Manual

7.0 ZF Electronics QMS documentation includes:

Quality Manual

Process Procedures Documents

Procedures and Work Instructions

Formats

a) Quality Manual (QM-01) according to ISO/TS 16949:2009 and ISO9000:2000. b) Documented Procedures required for ISO/TS 16949:2002 and ISO9000:2000 are included in processes description as follows:

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Main Processes - Marketing, Bids, Quotations, Orders and Contracts (MP01-P) - Research and Development & Product Design (MP02) - Design Process (MP02-C) - Design of Manufacturing Processes (MP03) - Master Scheduling (MP04-P) - Planning & Scheduling (MP05-C) - Purchasing (MP06) - Receiving, Storage & Inventory (MP07-P) - Receiving, Warehousing and Inventory Control Process (MP07-C) - Manufacturing (MP08-P) - Manufacturing (MP08-C) - Shipping and Delivery (MP09) Supporting Processes Engineering & Process Changes (S01) Part Approval Process (PAP) (S02) Incoming Product Quality & Supplier Development (S03) Equipment Maintenance Process (S04-P) Equipment Maintenance Process (S04-C) Calibration (S05-C) PP Engineering Calibration Process (S05-P) Plant, Facility, and Equipment (S06-C) Training Process (S07-C) Human Resource Competence Development (S07-P) Motivation (S08-C) Human Resource Motivation Development (S08-P) Information Resources (Document Control) (S09)

Managerial Processes Internal Audits (M01) Monitoring/Measurement of Mfg. Process & Products (M02) Problem Solving (M03) Monitoring Customer Satisfaction (M04) Continual Improvement (M05) Management Review Process (M06)

c) Work Instructions. d) Control Plans. e) FMEAs. f) Visual Aids. Also QMS documentation defines responsibility and authority for complying with customer requirements and assures process effectiveness. Process descriptions and flow charts include criteria and methods as well as main conditions to be controlled in order to assure process effectiveness.
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7.1 MONTHLY OBJECTIVES TO MONITOR The objectives are broken in to three areas: OBJECTIVES ITEM Quality Supplier PPM SCAR response time ZFdM Mfg. PPM Down Time Overall efficiency Process conformance-Layered Audits Customer Corrective Action Response time ICAR response time Costs Scrap Cost of Poor Quality Premium Freight Sales variance against forecast Service On time Delivery Performance Customer Satisfaction-Survey Customer Scorecards Employee Satisfaction On Time PPAP Submission Receivables % current and dollars past due. Past Due to Customer ($)

Dept. Responsible Quality Quality Operations Operations Operations Operations Quality Quality Operations Quality Materials/Quality Sales and Marketing Sales and Marketing Sales and Marketing Quality Human Resources Quality Finance Purchasing

Frequency Monthly Monthly Monthly Monthly Monthly Monthly Monthly Monthly Monthly Monthly Monthly Monthly Monthly Once per year Monthly Monthly Monthly Monthly Monthly

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Process Analysis Diagram: Business Planning Process MP-01 Marketing, Bids, Quotations, Orders & Contracts

Objectives: Review/Modify/Analyze customer & market requirements (including contracts) to provide products and services that meet or exceed customers requirements/expectations while following ZF Electronics Corporations guidelines and Global Vision and Values established by top management.

Input:
Information: -Customer requirements Mapics -Customer Master X-reference files -Price Inquiry Matrix -Quotations -Commission Report -EDI & Web based EDI -Purchase Order -Price Lists -Contracts / NDAs -CSR -Market Research (including trends) -Empowering Systems

Conditions:
Machinery / Tooling: Computer w/ standard OS Matrix Mapics Future 3 Demand Solutions Microsoft Office Suite Internet Access File Cabinets - Standard Office Equipment - Prep Stamp Methods: -Work Instructions as listed in related documents -Contract review based on Sales Guidelines -ROI Financial Models

Output:
Product characteristics: Compliance to customer requirements per contract (PO)

Materials:

Information: Order Acknowledgment, Pick List and/or Invoice COM / Future 3 Order Forecast (future demand) RSS log _Premium Freight Signed/Approved Contract ROI calculation

Environment: Office environment w/ Proper lighting, order & cleanliness People: Qualified Personnel based on job descriptions on file. Sales Specialist; Program Mgmt. Reps, Account Managers, Regional Sales Mgrs, Product Marketing Managers, Demand Manager, Customer Service Manager, Marketing Manager, Director of Sales, VP of Sales, Managing Director

Materials:

Effectiveness / Efficiency Indicators: (Measure) -On Time Delivery Performance -Customer Satisfaction Surveys - Quote Performance ((Monitor) -Customer Scorecards -Premium Freight Expenses -Customer Backlog Reports -Sales Performance

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Business Planning Process MP-02 Engineering Research and Development & Product Design
Objective: Product designs that meet or exceed customer expectations e.g. product quality, cost, reliability, etc.

Design Inputs:
Requirements: Authorizations; Customer, Product specs; Statutory, Legal, Regulatory, EMS requirements; Mfg. targets, costing; Lessons learned, TGR/TGW; Service concerns; Math data, drawings; Financials, Strategic initiatives Mfg. requirements

Conditions:
Machinery / Tooling: Specs, equipment settings; Capital, Tooling; PM; Set-up, maintenance; Calibration equipment; Measurement (GR&R) devices; Test fixtures Fail-safe equipment; PC workstations, PLC controllers Manufacturers installation, configuration set-up Methods: CDSN1006 procedure; ECR/ECOs; Establish testing acceptance criteria; Key characteristics, SPCs; Cross-functional PDT, meetings; PM checklists, MS Project plan; Action items; Design reviews; FEAs

Outputs:
Product Specs; Design input, review records; DFMEAs; DVP&Rs; Test acceptance criteria; Verification, Validation plans and results; Math data, drawings; Marked up BOMs, drawings; Drawing objects; Data st measurement, 1 piece; Capability, yield studies; Gantts; PM documents and deliverables; Management approvals

Materials: Customer Samples; mating component parts; Competitor products

Environment: Mfg. Line Layout safety; EMS/Compliance inspection; Workflows promoting order, contamination prevention; Utilities, HVAC monitors, controls; IT/Network; MS Office Suite; Internet access; CAD/CAM Design, modeling software; Quality alerts;

Materials: Pkg., Labels; SLA, prototype sample, assemblies; Product identification, trace ability; RGM, rework supplies;

People: Multi-functional teams comprised of skilled and qualified personnel based on experience, education, etc. for Modeling (Pro/E, I-deas), DFM, DFA, DOE, GD&T, VE

Effectiveness/Efficiency Indicators: Monitor: st -PPAP Submission 1 time approvals -Customer Satisfaction -Project Status;

Analysis and Improvement Process


Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Business Planning Process MP-02C Engineering Research and Development & Product Design o Design (prototype and product validation department)
Objective: The main objective of the PVD department is to provide accurate and precise information to guarantee a reliable and robust process. INPUTS: CONDITIONS:
Method: - Test according to standards and specifications. - Test according to diagrams and schematics. - General procedure of PVD -OPC-76-03 and others department procedure and instructions.

OUTPUTS:
Product characteristics: - Engineering samples. - SLA samples.

Information: - Test requirements/SLA. - Draws and schematics. - Standards or test specifications.

Machinery / Equipment: - Measurement Equipment. - Tools. - Durability test area. - Climates test area. - Test fixtures. - Table work. - SLA construction area. - Vision test area. - Corrosion test area.

Information: - Investigation result report. - Precise, trusty, clear and understandable inform.

Materials: - Fixtures and test accessories. - Samples for investigation. - Material and assemble accessories.

Materials: - Material and general use accessories - Chemicals (according to specification).

Environment: - Controlled illumination (if required) - Room temperature. - Controlled humidity (if required).

Staff: - Qualified technical staff to dimensional area, SLA and UL. - Qualified engineering staff in different test systems. - External supplier (if necessary).

Process of Analysis and Improvement: Analysis of data, identification of improvement opportunities, corrective and preventive action, projects of improvement, audits, objectives, feedback of the client, plan of action, improvements to the conditions of the process and/or entrance to the process. Document standardization and update.

Effectiveness/ Efficiency Indicators: Measurement: - Monthly development metric. Follow to: - Enquiry to customer satisfaction evaluation. - Weekly meeting with lab people. - Weekly meeting with engineering staff (through logs and action plans). - Follow to date compliment. - Follow to database. - Feedback (speed, precise, trusty, true, clear and understandable).

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Process Analysis Diagram: Business Planning Process S01 Engineering & Process Changes
Objectives: Ensure that Engineering changes are properly implemented and comply with Customer requirements, including timing

Input:
Information: Excel worksheet; Drawings and BOM(s) marked up; Math Data, drawing objects new, revised, or obsolete; List Approvers; Engineering Analysis, as required

Conditions:
Machinery / Tooling: IT/Network, PC workstations, MS Office Suite, MATRIX application, Internet access Methods: Matrix ECR/ECO Work Flow; Defined component structure; Connect released new, revised, and obsolete drawings; Update, check-in, promote, and validate (MultiDisciplinary); IT737.001 Work Instructions To Handle Engineering Changes

Output:
Product characteristics: Electronically controlled, approved ECR/ECO; New released drawings; Obsolete drawing objects; MAPICS updates; Updated QMS documentation (FMEAs, etc.)

Environment: N/A

Materials: Component definitions reviewed by planners, verifiers, Designers, PC workstations

Information: ECR/ECO records and reporting mechanisms

Materials: Component definitions to be reviewed by Planners and Verifiers; PC workstations

People: Skilled and trained Initiators, Planners, Verifiers, Designers, Reviewers, and Validators based on work experience, education, and demonstrated abilities

Effectiveness / Efficiency Measure -On-Time ECR, ECO releases, -On-Time implementation -Data Entry Accuracy Monitor: -Departments affected -Weekly staff meetings -Customer satisfaction.

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Business Planning Processes MP 03 Design of Manufacturing


Objective: Design an effective and efficient manufacture process that will allow us to comply with the product specifications, as well as achieving cost expectations and ZF Electronics reliability. INPUT:
Information: - Product specification (Drawings). - Approved prototypes. - Prod. amount (yearly demand). - Productivity goals, capacity and cost. - Special characteristics - Experience, previous developments. - Lessons Learned - DFMEA - Technology - Tooling Drawing - Specific customer requirements -Original quote -Project Timeline -Capital -Appropriations -MSDS Sheets

OUTPUT: CONDITIONS:
Machinery/Equipment: - Computer Equipment - Software. - Machinery for usage (install). - Work tables. - Spare parts. - Electric and pneumatic installations. Methods: - Time study and movements - Proc. SOPC-71-03 of new product Transfers and F710.001 format. - Laboratory (validations) - Product Development Meetings (PDT) - Project Schedule (Gant Chart) Product Characteristics: -Production tooling -Flow Chart -PFMEA, Plan Ctrl, OMS -Routing line balancing. -Equipment specifications -Tool Drawings & software -Pokka yokes -Run-Rate -Lay-out -Packaging standards -Prevent/predictive Maintenance -Feedback methods -Equipment Manuals -Transfer checklist -Quotes: labor and capital assembly equipment; lead-time Information: - Laboratory Results - Information for maintenance - Information for measurement - Updated tooling drawings

Materials: - Material for installation Environment: - Adequate lighting. - Cleanliness and organization (5s program) People: - Job description. - Trained personnel - Drawing interpretation - Control Plan, PFMEA, AutoCAD - APQP, MSA - Multidisciplinary Focus

Materials: - Approved production parts.

Analysis and improvement process: Data analysis, identification of improvement opportunities, corrective actions, prevention, improvement projects, audits, objectives, feedback from customer, action plan, improvement to process conditions and/or process input, Standardization and document actualization.

Effectiveness Indicators and/or Efficiency: Measurement: -Equipment completed on time & budget -Run @ Rate Monitor: - Product Meets Lab Requirements - Cpk follow-up - Product development meetings (PDT) for timing. -Customer Corrective Action Requests (CCAR)

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Process Analysis Diagram: Manufacturing Support Processes S02 PPAP (Production Part Approval Process)
OBJECTIVE: To determine if all engineering requirements are accomplished and that the manufacturing process is capable to meet these requirements, through accurate and complete PAP submissions, documentation sent on time, reflecting changes to specifications.

INPUTS:
Information: - PAP level. - Additional Customers requirements. - ECO EWO. - Material certification. - Draws. - FMEA. - Gage R&R. - Chart flow. - Control Plan. - Validations. - Production samples.

CONDITIONS:
Machinery / Equipment: - Personal Computer / Microsoft Office applications. - Access to customers database. - Matrix - Mapics and Future 3 Environment: - Based in 9s program. Materials: - Conformant material approved for quality to product samples. - Office materials. Method: - SOPC-73-01 PAP Procedure. - AIAG MSA Manual - PAP customers Manual. - G111 Procedure for PPAP

OUTPUTS:
Product characteristics: - Completes PAP packet, at time with customers characteristics required.

Information: - PSW approved. - AAR approved (if applicable).

Materials: - AAR, (If applicable). - Conforming Material approved for samples.

Staff: - Qualified and trained in PAP, MSA, Control Plan and PFMEA.

Analysis and Improvement. Data Analysis, Identification of improvement opportunities, Corrective action, preventive, improvement projects, audits, objectives, customer feedback, action plan, process condition improvement and/or input to process. Standardization and as applicable data or documents update.

Effectiveness/ Efficiency Indicators: Measurement: Customer PAP -First time approval. -On time submission. Supplier PAP -Received on time -First time approval Monitoring Customer PPAP:Customer satisfaction.

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Process Analysis Diagram: Manufacturing Support Processes MP 04 Master Scheduling


Objective: To ensure product is ready to ship per Customers request

Input:
Information: - Firming potential schedules in MRP & MPSP to drive Procurement to order material within leadtime. - Enter schedules for production. -Material or component shortage report.

Conditions:
Machinery / Tooling: MRP MPSP Demand Solutions for forecast Adding machine Methods: - Releasing schedules into system for production. - Checking for shortages; expediting with Procurement. - Rescheduling per shortages and expedites from Sales. - Weekly review of planning data and customer orders. - Prioritizing schedules for prod.

Output:
Product characteristics: - Fulfilled schedules which utilize production capacity, resulting in finished goods available to ship to meet customer request dates or finished goods levels supporting forecast.

Information: N/A Environment: - Available storage for files. - Access to Mapics, Matrix, E-mail and the Internet. People: - Competent in accordance with job description. - Understanding various Mapics screens. - Understanding flow of material between vendors and various ZF facilities. - Understanding capacity & capabilities of production centers.

Materials: N/A

Materials: N/A

Effectiveness / Efficiency Indicators: Monitor: - Customer order backlog report. - Schedule Fulfillment - On-time shipment report. -Mexico Shortage Report -DMR, RGM -FG Inventory Levels Measurement: -Schedule Variance by line and week

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Manufacturing Support Processes MP 05C Planning and Scheduling
Objective: Provide information to manufacturing in order to guarantee on time production to satisfy customer orders.

INPUT: Information: - Weekly production schedules report. - Monthly planned demand and production lines capacity. - Direct staff assignation. - Shortages report. - Quick requests.

CONDITIONS:
Machinery / Equipment: - Personal computer - Software ( MAPICS, AMIS, MS-Office etc.). - Quick request file data base. Method: - General procedures and work instructions for inventory and production control. MP04, SOPC-7511 & IT755.021 thru 755.024 - Analysis of personnel requirements. - Daily monitoring to production schedules and inventories. - Material releases to production lines on time to meet schedules. - Communication and expedite of shortages to corporate. Materials: - Office equipment; communications. - Production schedules available.

OUTPUT: Product characteristics: - Production schedules released to production without shortages, according to lines capacity and less possible set-ups. Information: - Information in Mapics updated of open and closed production schedules.

Materials: - Raw Material and MROs inventories.

Environment: - Order, organization and cleanliness

Staff: - Competent and trained personnel.

Analysis and Improvement Process: Data analysis, identification of improvement opportunities, corrective and preventive actions, improvement projects, audits to procedures and objectives, customers feedback, action plans, improvements to process conditions and process inputs, Standardization and updating of documentation..

Effectiveness / Efficiency Indicators: Measurement: -Attainment to Schedule Charts. Monitoring: -Shortages Report. -Production Schedules progress thru periodic meetings.

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Process Analysis Diagram: Manufacturing Support Processes MP 06 Purchasing


Objective: Quality Products, on time delivery, within cost, and Optimum

Input:
Information: MRP Orders Sup. Performance Eng. Drawings Requirements Specs Forecasts Updated BOM ECO/ECR Quotes Supplier PPAP Customer Specifications .

Conditions:
Machinery / Tooling: Mapics Methods: Procedure Supplier Approval Criteria Second Party Assessment Long Term Planning Forecasts Commitments Optimize Logistics PPAP

Output:
Product characteristics: Purchase Order Approved Sup. PPAP Sup Sel. & Dev. Blanket P.O. Updated Mapics Logistics Decision Customs Impact

Environment: Organization Clean Ethical Trust sup/client Relations Accountability

Materials: N/A

Information: N/A

Materials: Samples Prototypes

People: Negotiations Communications Organization

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

Effectiveness / Efficiency Indicators: Measurement: Sup. Performance, OTD, PPM Cost Variation - PPV Freight Costs % of sales Monitor Supplier report cards SCAR Quarantine Inventory Manufacturing PPM

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Process Analysis Diagram: Manufacturing Support Processes MP 07 Receiving, Warehousing and Inventory Control
Objective: Preventing damage ensuring the adequate identification of materials from receiving, until delivery to Production and maintaining reliable inventories.
INPUTS: CONDITIONS: Machinery / Equipment: Information - Packing list - Cyclical count Program - Forklifts - Computer Equipment -Software (AMIS, MAPICS, Office etc.) - Weight Scales - Scanners - Racks - Printers Methods : - Procedures SOPC-74-03, SOPC75-06, SOPC-75-07, SOPC-75-04 - Instructions IT743.006, IT743.007, IT743.008 - Manuals (MAPICS, AMIS) - First In First Out - Cyclical count Programs - Audit of conservation and preservation of inventories

OUTPUTS :
Characteristics of the Product: - Material correctly identified and in good condition - Reliability and accuracy of inventory. - Inventory updating Information : -Information of inventories (Historic , transferences) through MAPICS - Report of receiving discrepancies.

Materials: - Raw materials correctly identified MATERIALS : - Manuals (MAPICS, AMIS) - Safety equipment - Supplies (Labels, strapping, pallet, ribbons, etc) PEOPLE : - Knowledge in handling warehouse equipment in general. - Certified in forklift operation. - Training and skill in 9 S - Basic math

ENVIRONMENT : - Space for receiving and classifying materials. - Layout. - Order and cleanliness, 9 S

ANALYSIS AND IMPROVEMENT PROCESS Data analysis, identification of improvement opportunities, preventive and corrective actions, improvement projects, audits, objectives, customer feedback, action plan, improvement to conditions of the process and of inputs to the process; standardization and updating of documentation.

EFFECTIVENESS/ EFFICIENCY INDICATORS: Measurement -Inventory accuracy Indicator. Monitoring. - Monitoring of discrepancy reports and preservation audits. - Follow-up to customer satisfaction through production meetings.

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Process Analysis Diagram: Manufacturing Support Processes S03 Incoming Inspection Quality and Supplier Development

Objective: Monitoring quality of the received product of suppliers, performance communication to suppliers and follow up to non-conformances and processes
improvement opportunities.

INPUTS: Information: - Matrix System - Quality Alerts. - Suppliers Performance. - PIRS. - Breakdown Report.

CONDITIONS: Machinery / Equipment: - MAPICS, MATRIX Softwares - Scanner - Measurement equipment (vernier, microscope, optic comparator, micro view, metric rule, height indicator, pins gauge). Method: - SOPC-74-01 Inspection & Test Procedure. - SOPC-83-01 No conformant Product Procedure. -- IT 743.001 Instruction for Follow to work. - Formats. - Quality Alerts. - IT 830.004 DMR s Procedure.

OUTPUTS: Product characteristics: - Correctly identified material. - Delivered in time. - Material according specifications. - Supplier performance with greatest tendencies.

Environment: - Adequate illumination. - Order and cleaning. Materials: - Raw Material. (Quality, quantity, delivery time)

Materials: - Personal seals. - Special tools. - Work equipment.

Personnel: - Qualified Technician. - Measurement Equipments Knowledge. - Product evaluation skills. - Education and training in interpretation and planes reading. - Multifunctional equipment.

Information: - DMRs - MAPICS (AMIS) systems. - Debit memos (Nonconforming material). - Suppliers feedback. - Corrective actions report. - Suppliers evaluation report.

Analysis and Improvement Process Corrective and preventive action, improvement projects, layered & process audits, product & process monitoring, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

Effectiveness/ Efficiency Indicators: Measurements: -SCAR Quality response Time -Supplier PPMs -RGM/Hold Location Reduction. Monitor: -Customer Satisfaction -Supplier Audit Results -Supplier Performance Report -Score Cards

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Process Analysis Diagram: Manufacturing Support Processes MP 08 Manufacturing


Objective: Provide product to the customer that meets their quality and delivery expectations.

Input:
Information: Equipment Tooling People Facilities Schedules OMSs Quality Alerts Corrective actions Schedule packet Production Priorities Material: Identified Conforming Traceable Non Damaged

Conditions:
Machinery / Tooling: Measurement tools calibrated and in working conditions. Preventive maintenance Engineering approved tooling Fixtures Working within parameters Properly set-up equipment Identified tools Environment: Cleaned and organized Temperature and humidity controlled. Proper lighting People: Competent (training, skills, experience& education) Empowered On the job training Quality awareness Motivated Knowledge of statistical tools Methods: OMSs QAs Visual Aids Cosmetic Standards Setup verifications Validation Procedure GP70007,GP70013, & GP70036 Layered Audit Statistical Tools

Output:
Product characteristics: Functionally acceptable per customer requirement Compliance with dimensions according to print. Acceptable appearance per customer criteria. Correct quantities to schedule Information: PPM SPC charts Updated TCM and training records Layered audit

Materials: Non-damaged Properly identified Compliant part Labels

Analysis and Improvement Process Corrective and preventive action, improvement projects, layered & process audits, product & process monitoring, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

Effectiveness / Efficiency Measurement: -PPM -Efficiency -Production Program Compliance. -Scrap Monitoring: -Program by production meetings. -Customer Satisfaction.

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Process Analysis Diagram: Manufacturing Support Processes S04 Equipment Maintenance


Objective: Guaranteeing the continuous functioning of equipment that supports Manufacturing to comply its objectives of quality, productivity, efficiency and capability.

INPUTS:
Information : - -Equipment Manuals - Manuals for equipment and spare parts. -Information about design of the manufacturing process (drawings, tools). -Maintenance requests. -Maintenance Calendar. -Equipment and tool listings.

CONDITIONS :
Machinery / Equipment : - Equipment and tools available for maintenance. - Tooling. - Calibrated Measuring Devices. - Safety devices and equipment.

OUTPUT:
Methods : - Maintenance Programs IT 751.067. - Preventive Maintenance Procedure SOPC-75-09 and Tool Management SOPC-75-10. - Effective verification of activities done. - Predictive Methods. - Replacement-Parts control for tools and equipment (Max./ Min.) Materials : - Chemical solvents. - Spare parts (max-min) - Towels or rags. - Machine-tooling shops. Persons: Technician with skills: -Pneumatic, Safety, Electricity, Electro mechanic Engineering Specialist: -Industrial, Electronic, Electro mechanic. - Prior experience
Product Characteristics: - Machinery, equipment and tools with preventive and predictive maintenance. - Tooling Control. - Spare-Parts Control.

Environment : - Order and cleanliness. - Ventilation . - Lighting. - Climate . - Space.

Information : - Maintenance Calendar complied with. - Maintenance Reports - Updated equipment list. - Fill work order with results obtained. - Spare Parts request.

Materials : - Machinery or equipment and tooling without maintenance.

Effectiveness and efficiency Indicators : - Down time Report (man hours per equipment down. - % Compliance to Maintenance Program. - Follow-up to customer satisfaction through daily production meetings. - Follow-up to compliance of the preventive maintenance plan.

Analysis and Improvement Analysis: Data Analysis, identifying opportunities for improvement, corrective and preventive action, improvement projects, audits, objectives, feedback from the customer, action plan, improvements to process conditions and/or its inputs. Standardization and updating of documents.

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Process Analysis Diagram: Manufacturing Support Processes S05 Calibration


Objective: Providing inspection, measuring, and testing equipment.

INPUTS: Information: - Calibration Program. - Requirements for measuring and monitoring by the manufacturing design process (engineering). - Quality Alerts. - Plan de control - Manufacturing specifications. - Technical Recommendation - Acceptance criteria from customer MSA - External calibration certification. Materials: - Calibration standards. - Budget for external calibrations. - Equipment to be calibrated available.

CONDITIONS:
Machinery / Equipment: - Spare parts. - Test equipment. - Technical recommendations. - Computer with calibration program to control equipment. Methods: - General calibration Procedure. SOPC-76-01 - Instructions for Calibration. - External calibration orders. - MSA (Gage R & R). - Calibration formats. - Equipment protection. Materials: - Calibrated calibration standards. - Special tools. - Cleaning materials. - Filing cabinets for storage of certificates and equipment. Persons: - Engineer of Lab and technician trained in calibration, MSA. - Proven skills in calibration and use of computer programs. - External calibration labs certified.

OUTPUTS:

Product Characteristics: - Equipment calibrated and labeled with calibration certificate.

Environment: - Monitoring temperature and control of area of Calibration with defined tolerances. - Order and cleanliness.

Information: - Updated calibration program. - Calibration certificates. - MSA studies. - Calibration scope.

Effectiveness and/or Efficiency Indicators: - Chart of monthly calibration delays. - Monitor equipment found out of calibration. - R&R studies. - Monitor customer satisfaction.

Process of Analysis and Improvement: Data analysis, identification of opportunities for improvement, corrective and preventive action, improvement projects, audits, objectives, feedback of the customer, plan of action, improvements to the conditions of the process and/or of entry to the process. Standardization and updating documents.

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Process Analysis Diagram: Manufacturing Support Processes S05 PP Calibration o PP Engineering Calibration
Objective: Have measuring equipment capable of providing reliable measurements

Input:
Information: GAGEtrak equipment schedule listing calibration requirements; Operations requirements; Quality alerts CARs

Conditions:
Machinery / Tooling: Master measurement standards to be calibrated; Production, Test equipment; Periodic, run-time frequency; Manufacturers specs; Technician recommendations based on out of spec results; Equipment breakdown or unusual damage; GAGEtrak software Methods: Equipment inspection and testing work instructions; G411 Standard Calibration procedure; Outside contractor services i.e. service contracts; External standards such as ASTM, SAE, UL,

Output:
Product characteristics: Accurately calibrated and identified/labeled Gage, Equipment under test (EUT);

Materials: Equipment requiring calibration; Special tools; PC workstation Environment: Monitor, control calibration area temperature, humidity within defined tolerances; MS Office Suite, IT/Network; Proper identification and calibration status

Information: GAGEtrak software reporting mechanisms; Special work requests

Materials: Equipment requiring calibration; Special tools; PC workstation

People: Skilled, trained, certified calibration staff based on work experience, education, and demonstrated abilities

Effectiveness / Efficiency Indicators: Measure calibration schedule compliance and out of spec occurrences. Monitor gage variation analysis.

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Manufacturing Support Processes MP 09 Shipping and Delivery


Objective: To guarantee that Customer Orders are completed in quantity, quality and on time.

CONDITIONS: INPUTS:
Information: - Shipping Requirements. - Packing List (shipping order) - Shipping special requirements. Machinery / Equipment: - Forklift. - Scanner. - Scales. - Computer equipment. - Software. Method: - SOPC-75-08 customers shipping. - IT755.031 Special labeling requirements for F.G. - IT755.017 Instruction for Automotive Product Re-labeling. - Amis and Mapics manual. - Shipping product. Materials: - Office tools. - Tags. - Pallets.

OUTPUTS:
Product characteristics: - Shipping according to customers requirements.

Materials: - Finish Product accepted by QC - Raw material

Information: - Loc TOSHIP and actual FIFO. - Complete historic pick List of SAs in MAPICS.

Environment: - Shipping area. - Orderly and clean.

Personnel: - Qualified materialist in Forklift mount, Software (Mapics & Amis) and Scanner. - Qualified in materials management. - Trained in necessary instructions.

Analysis and Improvement Process Corrective and preventive action, improvement projects, layered & process audits, product & process monitoring, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

Effectiveness/ Efficiency Indicators: Monitor: - Customer Satisfaction - Open Pick Lists - Production Schedules - Attainment to Schedule (Juarez) - OTD Chart (Corporative). Measurement: - Cycle Count - Pick List Accomplishment (Juarez)

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Process Analysis Diagram: Manufacturing Support Processes S06 Plant, installations and Equipment
Objective: Ensuring installations, services, and equipment at the building adequate for the plants activities.

INPUTS :
Information : - Manufacturing process requirements (Layout). - Maintenance requirements for plant equipment. - Work Requirements for Health and Environment. - Requirements for Support Services. - Inadequate conditions

CONDITIONS : Machinery / Equipment: - Available Equipment. - Tools. - Measuring Devices. - Safety Devices and equipment. Methods : - Procedure (SOPC-75-09). - Work Instructions (IT751.067). - Manufacturers Manuals - Work Orders. - Verification of activities conducted. - Audits to the plant, building, services, and equipment. - Method for evaluating effectiveness for optimizing materials circulation.

OUTPUTS:
Product Characteristics: - Planning for building, services, and equipment. - Maintenance Plan. - Contingency Plans. - Spare parts Control. - Adequate conditions. - Services Conducted

Environment : - Order and cleanliness. - Ventilation . - Lighting. - Artificial Climate. - Space. Materials : - Budget for Spare Parts. - Budget for Tools. - Supplier list (FAQ #2). - Data base (max. and min.) Spare Parts for plant equipment.

Materials: - Equipment, services and plant without planning (Inadequate Conditions).

Persons : Skilled Technician: - Pneumatic , Safety, Electrical, Electro mechanic, Sense of Urgency. Specialized Engineer: -Industrial, Electronic, Electro mechanic. - Cross-functional team

Information : - Calendars. - Maintenance Reports - Equipment listing.

Effectiveness and Efficiency Indicators: - Event follow-up. - Follow-up to customer satisfaction by means of daily production meetings - Audits to Plant, Facility, and Equipment (follow-up)

Analysis and Improvement Process : Analysis of data, improvement opportunity identification, corrective and preventive action, improvement actions, audits, objectives, customer feedback, action plan, improvements to process conditions and/or inputs to the process. Standardization and document updating.

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Process Analysis Diagram: Manufacturing Support Processes S08 P Human Resources Motivation Development
Objective: employees to achieve quality objectives, to make continual improvements and to create an environment to promote innovation

Input:
Information: -performance in the market. -New developments. -New products coming up. -Objectives and targets that are set up and followed. Quality system and Changes to the system.

Conditions:
Machinery / Tooling: N/A Methods: Procedure Employee Review Focus Group Improved Benefits Company Events Employee Supplier Discounts Recognition Awards

Output:
Product characteristics: Personnel are awareness of their contribution to the achievement of planned objectives

Environment: Well lit Clean Environment Facility is well maintained Organized Innovative

Information: Feedback and data from Random surveys Materials: N/A Materials: N/A People: Personnel of all levels of organization Effectiveness / Efficiency Indicators: Awareness surveys results. Employee satisfaction Index.

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Manufacturing Support Processes S08 C Human Resources Motivation Development o Motivation
Objective: Increasing motivation of employees, with the intention that they reach their objectives and that they continuously improve their performance

Input:
Information: - Supervisor feedback - Information from additional Sources (Spontaneous feedback).

Conditions:
Machinery / Tools: - Computer - Software - Area adequate to apply surveys - Areas adequate for scheduled events

Methods : - Work Instructions Motivation IT 622.004 - Bi-annual survey - Exit survey - Recognition process. - Participation encouragement: Kaizen IT622.003, 9 S IT 642.001. - Teamwork

Output:
Product Characteristics: - Employees with greater motivation.

Materials: N/A

Environment: - Good lighting - Clean environment - Good building maintenance. - Adequate services: Sound, Medical, Food, Transport, etc. - Artificial Climate - Innovation Materials: - Recognition, prices, and/or individual and group gifts - Survey forms

Information: - Survey results. - Turnover report and absenteeism (benchmarking).

People : - Personnel trained in management of human relations and problem analysis and solution. - Creative personnel - Skill in Internal Communication systems.

Process of Analysis and Improvement Data analysis, identification of improvement opportunities, corrective and preventive action, improvements projects, audits, objectives, feedback of the customer, plan of action, improvements to the conditions of the process and/or of input to the process. Standardization and updating of the documents.

Effectiveness / Efficiency Indicators: Measurements: - Indicator of Absenteeism and Turnover: JIS/AMAC - Trend of Survey of Employee Satisfaction Monitor: -Exit surveys -Training and/or similar activates -Training and competency development plan -Performance Evaluation -Customer Satisfaction

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Process Analysis Diagram: Manufacturing Support Processes S07 P- Human Resources o Human Recourse Competence Development
Objective: Providing personnel aware of the importance of their activities with the necessary skills to do their work according to the quality objectives.

Input:
Information: Employee not aware of Quality Objective Job Description Performance Appraisal Employees Experience & Education Training Needs Analysis Training Effectiveness Evaluation

Conditions:
Machinery / Tooling: Projector Computer HR Perspective (software) Methods: Procedure G418, Training Quality Objectives Deployment Quality Awareness

Output:
Product characteristics: Competent Workforce Aware of Quality Objectives

Environment: Organized Conducive for Training (lighting, temperature)

Materials: Learning History Sheet Related to Training Subject

Information: Training Records

Materials:

People: Qualified Trainer of Subject Effective Communicator

Effectiveness / Efficiency Indicators: Measure Training Evaluation Feedback Monitor Performance Appraisal Scores

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Manufacturing Support Processes S07 C Human Resources o Training
Objective: Providing personnel aware of the importance of their activities with the necessary skills to do their work according to the quality objectives. INPUTS:
Information: - Job descriptions. - D.N.C. - Training Matrix. - Performance Evaluations. - Customer requirements (Internal/External) - External Market Needs - Design Manufacturing Information

CONDITIONS:
Machinery / Equipment: Training room. Projector. Computer Equipment Dry-erase board. Furniture (chairs, tables, etc.). Training Software. Methods: - Training Procedures (SOPC 62-01) y DNC (SOPC-62-02) - Work Instructions IT 622.001 Induction and IT 622.002 Training. - O.M.S. - Training Program / Syllabus. - Need assessment

OUTPUTS:
Product Characteristics: - Personnel skilled in their area made aware of the importance of their activities in achieving product quality.

Environment: - Factors that can be controlled (order, cleanliness, artificial climate, etc).

Materials: - Stationery (paper, pencils, exams, etc). - Course manual. - Teaching Materials.

Information : - Training Records - Operation certifications. - Training Plan. - Training History. - Skills certificates. - Performance evaluations.

Materials: - Unskilled persons and raising awareness of the importance of their activities.

Person: - Vendors / instructors. - Certified in mastery of the topic or area. - Having the skill to convey knowledge. - Group management skills. - Effective communication.

Effectiveness Indicators and/or efficiency: - Follow-up of the effectiveness of the training and/or similar activities (feedback, meetings, etc.) - Follow-up to the Training Plan and Skill Development. - Follow-up of performance evaluations. - Follow-up to customer satisfaction.

Process of Analysis and Improvement:


Data analysis, identification of opportunities for improvement, corrective, preventive actions, improvement projects , audits, customer feedback improvement to process and/or input conditions. Standardization and updating documents.

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Process Analysis Diagram: Manufacturing Support Processes S09 Information Resources (Document Control)

OBJECTIVE: To guarantee the usage of updated documents to prevent from shipping an obsolete product to Customer.

INPUTS: Information: - Customer Requirements and specifications. - Requirements of the Doc. Ctrl. System. - Customer requirements on records retention. - Changes request

CONDITIONS: ; Equipment: - Computers - Software

Environment: - Cleanliness of area, and good illumination. - Dead file area. - Prevention of damages to documents and records

Methods: ZEDM - Procedures Doc. Ctrl. SOPC-42-01 Doc. Elaboration. SOPC-42-03 y Records Retention SOPC-42-02 ZF PP -Document and Data Control G45. -Quality Records G416 -Preparation, Approval, Obsolete and Training of Documents, GP70016 - EtQ Doc. Cont. dB User Guide IT1300 - Database - Restrictions to drive on the net. Access to internet to review updated documents - Audit to Documents

OUTPUTS: Product Characteristics: - Updated Documents. - Reviewed Documents - Approved Documents. - Distributed Documents where needed. - Records retained

Information: -Updated document master List.

Materials: - Internal and external Documents

Materials: - Control stamp on controlled documents

Personnel: - Competent, skilled and trained Personnel - Microsoft Office, database - Organized

Effectiveness / Efficiency Indicators: Monitor: - Monitored through process audits, layered audits and internal audits. Customer satisfaction Discrepancy on latest revision documents.

Analysis and Improvement Process Corrective and preventive action, improvement projects, layered & process audits, product & process monitoring, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Managerial Processes M01 Internal Audits


OBJETIVE: To monitor processes to ensure that the Quality Management System is effectively implemented and maintained through Internal Audits

INPUTS:
Information: - Internal Audit Plan (QMS). - Audit check list (QMS). - Past audits results. - Customer complaints and feedback. - Customer satisfaction data. - Management review results. - Corrective actions status.

CONDITIONS:
Equipment and Tooling: - Computers - Software - Meeting room Methods: - ZFEdM - Internal Audit Procedure SOPC-82-01. - G414 Corrective Action and Preventive Action - Corrective action database. - Corrective action procedure. - Layered audits - Process audits Internal Auditors competence follow up

SALIDAS: Product Characteristics:


- Conclusions about the adequacy, conformity, effectiveness and efficiency of the Quality System. - Areas that require attention identified.

Materials: - ISO/TS16949 Standard. - Audit checklist.

Materials: - QMS requirements (ISO/TS 16949 standard). - Customer requirements manuals.

Environment: - Clean areas. - Comfortable environment when auditing.

Personnel: - Trained and capable Internal Auditors. - Auditors skilled to perform audits trained in: - Process approach. - ISO/TS16949 - Core Tools. - Customer specific requirements.

Information: - Audit Report that identifies area that requires attention. - Non-Conformities and opportunities of improvements reports. - External Audit and Customer Audit results. - Auditors Training detection needs.

Efficiency and effective Indicators: - Performance indicator of quantity of non-conformances by process. - Performance Indicator of ICARs response time - Monitor of findings and corrective actions. - Monitor of Internal Auditors performance - Monitor Audit schedule compliance

Analysis and Improvement Process Corrective and preventive action, improvement projects, layered & process audits, product & process monitoring, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Managerial Processes M02 Monitoring and Measuring of Process and Product in Manufacturing
Objective: Assuring the manufacturing processes capability and providing information for the control, improvement, and strength of the processes guaranteeing the Process Control.

Input:
Information: - Drawing and/or print specifications - OMS - Quality Alerts - Visual aids - Cosmetic Standards - Control plans - Sampling plans - Flow charts - PFMEA - PPAP - Specific Requirements of the Automotive industry. - Regulatory requirements. - Internal Requirements

CONDITIONS:
Machinery / Tooling: - Production testers - Measurement tools calibrated and in working conditions. - Analysis tools and equipment - Minitab - Personal computer - Calculator Environment: - Clean and organized - Proper lighting - Safe People: - Competent (training, skills, experience& education) - Empowered - On the job training - Quality awareness - Motivated Knowledge of statistical tools - Responsibility & authority

Output:
Methods: - OMSs -Procedures - IT1969 Quality alerts. - 70012 Visual Inspection Criteria and Visual Standard Boards, - Customer Specific Requirements. - Cosmetic standars. - Visual aids. -SOPC -81-01 Statistical Process Control, -Inspection Equipment control SOPC-76-01 - Statistical techniques SOPC81-01 - Inspection Equipment Control SOPC-76-01 - Audits to manufacturing processes IT822.001-003-004 - Verification of process adjustments - Acceptance criteria - Reaction and control plans for nonconforming product SOPC-83-01 - Run & rate, when customer requests it.

Product characteristics: - Actions recommended for the control of processes. - Documentation of process studies F811.001 X-R Control Chart. - Results o Run & rate Information: - Quality data and trends - Quality reports

Materials: - Production parts

Materials:

- Sampling of in-process production.


- Finished product

Effectiveness / Efficiency Indicators: Measurements -Layered audits --PPM -Scrap Monitor: -Corrective Actions Continuous Improvement projects

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Managerial Processes M03 Problem Solving


Objective: Problem solved so that it does not reoccur

Input: Information: * Clear Problem Definition *Internal/External Audits. * Experience from Previous Issues * History Data * Production Records *Application Information

Conditions: Methods: * Procedure: G414 Corrective and Preventive Action, GP70033, customer complaint and return analysis procedure, GP70053, eight-discipline team oriented problem solving; GP70013 Reaction Plan Procedure for Non-conforming Situations * OMS or other Visual Aids * Criteria Customer Requirements * Problem solving tools like PDCA, 8D, 5 whys *Preventive and Corrective Actions P *Procedure SOPC-85-02. *Root cause analysis like 5 why

Output: Product characteristics: *Compliance with Component Print or Specification -*Implemented actions on time and effective - Error proofing devices (PokeYoke) * Improved processes Information: * CAR requests * Problem analysis reports. * Updated documents.

Machinery / Tooling: * ETQ Database * X-ray Equipment * Various Labs or other Diagnostic Equipment *SPC software like Minitab *Database

Environment: * Organized and Clean Environment *Proper Lighting * Innovative environment Materials: * Defective Parts (not Damaged in Transit) * Properly IDd

Materials: * Defective Parts (not Damaged in Transit) * Properly IDd

People: *Competent (trained, skilled, experienced and educated) in Problem Solving Techniques solving, (etc. PDCA, 8D, 5 Whys) *Multifunctional team

Effectiveness / Efficiency Indicators: * Measure: - Number of customers complaints - Response time to customers complaints - Customer Scorecards - Production PPM - SCAR *Monitor: - Corrective actions to internal problems and customers complaints.

Analysis and Improvement Process Corrective and preventive action, improvement projects, layered & process audits, product & process monitoring, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Managerial Processes M04 Monitoring Customer Satisfaction


Objective: Obtain the customer perception relating to quality, delivery and service to continually improve the organization.

OBJETIVE: Obtain the customer perception relating to quality, delivery and service to continually improve the organization. INPUTS: Information - Customer survey results - Customer score cards results - On time delivery results - Internal Quality, Maintenance, Engineering and production results CONDITIONS: ; Machinery / Equipment: - Communication media - Office software Methods: - Complaint responses - Lessons learn communication - Training in problem solving tools - Top management involvement - Supplier development - Continual Improvement OUTPUTS: Product characteristics: - Improved quality performance - Improved delivery performance - Improved internal perform - Good customer grades

Environment: - Open Communication between departments (Sales, Quality, Engineering, Design, Production, materials) Materials - Notification and follow up software for customer complaints (ETQ) - Notification and follow up software for customer complaints (Covisint, GQTS) - Conferences with customers and suppliers

Information: - Internal and external Quality charts - Internal and external Delivery charts

Materials: - Score cards - Surveys - Internal performance charts People: - Trained personnel in ETQ, COVISINT, MAPICS, problem solving tools.

Indicators of efficiency: Measure: - Customer Satisf Survey - Customer PPM - Cost of poor Quality - Delivery Performance Follow up: - Complaint Status - Internal indicators - Warranty - Customer Scorecards - Internal Customer Satisfaction

Analysis and improvement: Comparison between customer indicators throughout the time for improvement evaluation.

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Process Analysis Diagram: Managerial Processes M06 Management Review

Objective:: Review the Plants main indicators that are related to the business objectives, to observe tendencies and improvements. Create an action plan for those that have no positive tendencies plus reviewing improvements to the quality system, and the potential changes that could affect it.

INPUT:

CONDITIONS: MACHINERY AND EQUIPMENT: - Computer and Software. - Conference Rooms, projector. METHODS: - Management Responsibility procedure SOPC-51-01 & G41

OUTPUT: Product Characteristics: -Actions to improve the performance of the quality system. -Actions to improve products. -Identification and assignation of Resources.

INFORMATION: - Actions from previous reviews. - Results form internal and external audits. - Complaints and feedback from customers. - Bad quality cost. - Process performance and product conformance. - Field failure reports. - Preventive and corrective action status. - Changes that could affect the quality system. - Client Satisfaction. - Training Programs. - Policy and quality objectives - Quality system tendencies.

MATERIALS: - All the performance indicators. ENVIRONMENT: - Order and cleanliness. PEOPLE: - Management involvement. - Multidisciplinary focus.

INFORMATION: - Revised Quality policy (if there was a change) - New quality objectives. - Indicators action plan.

EFFECTIVENESS/EFFICIENCY INDICATORS: - Process PPMs - Efficiency. - Deliveries. - Customer Complaints. - SCAR Response - Performance of all indicators in general.

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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Process Analysis Diagram: Managerial Processes M05 Continual Improvement


Objective: Continually improve the effectiveness of the Quality Management System

Input: Information: Quality policy Quality objectives Audit results Corrective actions Preventive actions Management review, employee suggestion program

Conditions: Machinery / Tooling: Computer Excel, Word, Access Employee suggestion database Methods: Continual improvement procedure / flow chart Continuous Improvement Web Process Instructions, Continuous Improvement Idea Form (#X2142)

Output: Product characteristics: Continual improvement in key effectiveness indicators. Improved quality, costs, and delivery, implemented idea

Environment: Organized and clean Materials: Accurate data Clearly defined Detailed

Materials: Accurate data Clearly defined Detailed

Information: Continual improvement reports

Effectiveness / Efficiency Indicators: People: Competent in problem solving techniques. Objective trends

Analysis and Improvement Process Corrective and preventive action, improvement projects, audits, objectives, monitoring & measuring, customer feedback, action plan, improving input and/or conditions and standardization after effectiveness.

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ISO/TS 16949:2009 Compliance Summary


ISO/TS 16949 4 4.1 4.1 4.2 Section Title QUALITY MANAGEMENT SYSTEM General Requirements General Requirements Documentation Requirements Quality Policy is documented in the Quality Manual; quality objectives are documented in the Annual Business Plan [see 5.4.1]; the Quality Manual includes all required content; all required procedures have been documented and implemented; all additional documentation deemed necessary by management has been prepared and implemented; all required records are maintained. This document. See Document Control Procedure Customer specifications and changes are reviewed timely, and always within 2 weeks of receipt. Implementation dates of changes in production are recorded on ECO Data base See Record Control Procedure Record control practices satisfy all applicable regulatory and customer requirements. The processes of the business and their sequence and interaction are defined in the Quality Manual. Comments

4.2.1

General

4.2.2 4.2.3 4.2.3.1 4.2.4 4.2.4.1 5 5.1 5.1 5.1.1 5.2 5.2 5.3 5.3 5.4 5.4.1 5.4.1.1

Quality Manual Control of Documents Engineering specifications Control of Records Record retention MANAGEMENT RESPONSIBILITY Management Commitment Management Commitment Process efficiency Customer Focus Customer Focus Quality Policy Quality Policy Planning Quality Objectives Quality objectives Quality Management System Planning Responsibility, authority and communication Responsibility and Authority

Commitment is demonstrated through fulfillment of all other requirements in Section 5. Management reviews various metrics monthly, quarterly and annually to assure the ongoing effectiveness and efficiency of all processes. See 7.2 and 8.2.1; the combination of effective methods to determine customer requirements + good information related to customer satisfaction = customer focus. As stated in an earlier section of this document. Objectives include business level measures related to SBU. More specific supporting measures are established at a functional / process level. The objectives are included in and driven from the business plan. Management has ensured that all requirements in 4.1 have been accomplished. Their primary method for ensuring this is through the internal audit results presented in Management Review [5.6]. Management also ensures that changes do not adversely impact the QMS by identifying and addressing pertinent events in Business Planning [7.2] and Management Review [5.6]

5.4.2

5.5

5.5.1

5.5.1.1

Responsibility for quality

5.5.2

Management Representative

Defined and communicated through the organization chart and process owner descriptions in business process summaries [both included in Quality Manual]; also clearly defined in procedures for any given activity and in Skill Control Item Sheets for each department. Supervisors and manufacturing management review Production Reports daily, which provides them with prompt information regarding products or manufacturing processes which do not conform to requirements. Operators on all shifts are delegated responsibility for ensuring product quality, and have the authority to stop production to correct quality problems. The Director of Quality is appointed as managements representative for ensuring that the quality management system is implemented and maintained, and for the other responsibilities associated with this assignment.

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ISO/TS 16949:2009 Compliance Summary


ISO/TS 16949 5.5.2.1 Section Title Customer representative Internal Communication 5.5.3 5.6 5.6.1 Management Review General The Quality Director reviews the QMS once per year. A formal agenda defines all intended inputs and outputs for each review event. The annual review is supplemented by numerous routine reports and meetings throughout the year that also address topics pertinent to the performance of the QMS. These reviews include all requirements of the QMS, as well as trends related to its performance. This includes a review of quality objectives and an evaluation of quality costs. Records are maintained. See Annual Management Review Agenda Actual and potential field failures are discussed in the review, primarily from the perspective of customer feedback and impact on PFMEA. See Management Review Agenda Comments Management has designated personnel with responsibility and authority for ensuring that customer requirements are met. There are a variety of routine meetings involving personnel from different functions and representing different levels that are used for planning, status tracking, improvements and adjustment to changes. Specific information such as schedules, daily output, and quality results are posted in work areas.

5.6.1.1 5.6.2 5.6.2.1 5.6.3 6 6.1 6.1 6.2 6.2.1 6.2.2 6.2.2.1 6.2.2.2 6.2.2.3

Quality management system performance Review Input Review input - supplemental Review Output RESOURCE MANAGEMENT Provision of Resources Provision of Resources Human Resources General Competence, Awareness and Training Product design skills Training Training on the job

Senior management determines and ensures the provision of resources necessary to support the quality management system through the annual planning process. This includes personnel, facilities/equipment and other factors necessary to achieve commitments in the plan. See Employee Training & Competence Procedure, plus related Skill Control Item Sheets [specific for production, and general for administration]. Procedures are defined to determine competence, awareness and training needs and evaluation of the effectiveness. Design skills are defined in Job Descriptions and Design matrix files See Employee Training & Competence Procedure On-the-job training is provided for all employees in any new or modified job where quality is affected, including for personnel brought in on a temporary basis. Personnel are aware of consequences to customers if product is not produced to specification. Related processes include monthly all-employee meetings, periodic all-employee business overviews, Nonconforming Material Finding Reports, metrics at each work station and general availability of technical publications and business plans/results. These collectively promote quality and technological awareness, as well as improvement. The extent to which employees are aware of the relevance and importance of their activities relative to achievement of objectives is assessed / measured during internal audits and the results are specifically addressed during Management Review(s). Facilities, equipment, software and their related maintenance are adequate. Plant expansions for the next several years are laid out with all planned equipment and storage locations. Also, there is a machine installation schedule covering the expansion period. Procedures for Plant Equipment are in place. Contingency Plans Procedures are in place to satify customer requirements in the vent of an emergency. Work environment is appropriate for the work performed in each process. Related issues are considered during both Quality Planning and Process Design activities and incorporated into related documentation, equipment and practices.

6.2.2.4

Employee motivation and empowerment

6.3 6.3 6.3.1 6.3.2 6.4 6.4 6.4.1

Infrastructure Infrastructure Plant, facility and equipment planning Contingency plans Work Environment Work Environment Personnel safety to achieve product quality

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ISO/TS 16949:2009 Compliance Summary


ISO/TS 16949 6.4.2 7 7.1 7.1 7.1.1 7.1.2 7.1.3 7.1.4 7.2 7.2.1 Section Title Cleanliness of premises PRODUCT REALIZATION Planning of Product Realization Planning of Product Realization Planning of Product Realization - Supplemental Acceptance Criteria Confidentiality Change control Customer Related Processes Determination of Requirements Related to the Product Customer-designated special characteristics Review of Requirements Related to the Product Review of Requirements Related to the ProductSupplemental Organization Manufacturing feasibility Customer Communication Customer CommunicationSupplemental Design and/or Development Design and Development Planning Multidisciplinary approach Design and Development Inputs Product Design input Manufacturing PD input Special characteristics D and D Outputs Product Design outputs-Supp Manufact PD output D and D Review Monitoring D and D Verification D and D Validation D and D Valid- Suppl Prototype programme Product Approval process Customer capacity/quantity requirements are determined at a macro level through the Business Planning Process. Customer daily production requirements are determined in the Materials Management Process through customer release schedules and open order reports. Process to define special characteristics in in place, there are included in Prints, DFMEA, PFMEA, CP and Work Instructions All activities noted above include reviews and approvals. Comments The facility is maintained in a manner consistent with product and process needs.

Process for plan and develop the process for productrealization is implemented. APQP process is being followed. Quality prepares control plans and Target Sheets for production and inspection. Engineering determines equipment / tooling requirements. Quality plans are developed with consideration given to applicable customer requirements and technical specifications; see Quality Planning Checklist Acceptance criteria for all product characteristics [including visuals] is defined on control plans and/or part specific instructions reference in control plans. Confidentiality of customer information is protected. Any change that would affect product realization results in a new PPAP [although possibly abbreviated] that would result in a thorough assessment of the impact of the change and would include verification, validation and customer approval prior to implementation.

7.2.1.1 7.2.2 7.2.2.1 7.2.2.2 7.2.3 7.2.3.1 7.3 7.3.1 7.3.1.1 7.3.2 7.3.2.1 7.3.2.2 7.3.2.3 7.3.3 7.3.3.1 7.3.3.2 7.3.4 7.3.4.1 7.3.5 7.3.6 7.3.6.1 7.3.6.2 7.3.6.3

Procedures states that when waiving requirements require customer approval Feasibility review is included in the process There is communication to all customers in various formats. Communication tends to be functional in nature [i.e. customer quality and internal quality, customer scheduling and internal scheduling, etc.]. Communication is eing done according to Customer needs, language and formats. A design and development process has been documented that incorporates a checklist to identify stages, reviews, verification and validation. It also identifies the multidisciplinary responsibilities and authorities for design and development or product and process.

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ISO/TS 16949 7.3.7 7.4 7.4.1 7.4.1.1 7.4.1.2 7.4.1.3 7.4.2 7.4.3 7.4.3.1 Section Title Control of D and D Changes Purchasing Purchasing Process Regulatory conformity Supplier quality management system development Customer-approved sources Purchasing Information Verification of Purchased Product Incoming product quality Supplier monitoring Production and Service Provision A variety of instructions/forms are provided to production personnel to clearly define processing and process monitoring requirements for product characteristics. Monitoring and measurement devices are made available to production and QA personnel who perform required inspections. Product monitoring/measurement is carried out in accordance with the related checklists at the work centers. Control plans are developed during the APQP process; see related Quality Planning Checklist. Work instructions are available in each work center. Part specific instructions are developed during the APQP process and placed in the appropriate work centers. Set-ups are verified by Technicians and/or quality inspectors per the documented requirements Preventive maintenance plans are developed for key processing equipment. Most critical facility maintenance [e.g. cooling systems and compressors] is done on contract basis with activities and intervals included in the contract. Spare parts requirements and ensure their availability. Maintenance objectives: reduce unplanned downtime; implement software-based maintenance system. Fabrication of tools and gauges [masters] is outsourced. Engineers manage production tooling. Tooling is verified through 1st piece part verification. Gauges are verified through internal calibration. Perishable tooling is adequately stored and is clearly identified relative to type/size. Set-up instructions specify tools/gauges to use on machine and part specific basis. Perishable tool change intervals are programmed into the machines. The machines signal operators at the designated interval. Suppliers are responsible for design of production tools and related modifications. Revision control is accomplished through new part numbers with any modification. Various methods used to identify tool status, including: designated containers for used tools, tags, marking/notes on tool containers or racks. Outsourced tool fabrication and repair is initiated and monitored by the engineer for the related process. Production is scheduled directly from customer releases covering a four week period, but updated weekly. Service concerns would initially be evaluated by the customer and only communicated to ZF Electronics Products if it was determined that it resulted from an internal manufacturing defect. The corrective action process would be initiated, and all appropriate members of management would be involved in analyzing and resolving the Comments

See Purchasing Process Procedure All product/materials used in product conform to applicable regulatory requirements. See Supplier Selection and Development Process Procedure ZF Electronics does not deviate from the customer approved sources. See 7.4.1 See 7.4.3.1 Method of Verification of purchased materials is through, incoming sampling plans, third party certification of suppliers quality management systems, plus evidence of satisfactory performance. Delivered product quality and shipping accuracy performance is monitored for feedback purposes

7.4.3.2 7.5

7.5.1

Control of Production and Service Provision

7.5.1.1 7.5.1.2

Control plan Work instructions

7.5.1.3

Verification of job set-ups

7.5.1.4

Preventive and predictive maintenance

7.5.1.5

Management of production tooling

7.5.1.6

Production scheduling

7.5.1.7

Feedback from service

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problem. There are no service agreements with customers. Capability studies are performed upon the installation of new tooling and equipment to prove the suitability. Production quality and efficiency data are routinely reviewed to identify and deterioration in capability for any production process/machine. Above validation activities cover all processes/equipment. Product brought into production with the supplier provided identification that was verified upon receipt. Accepted processed product gets identified with a serial number and or a date code. Identification methods are applied to all products throughout product realization activities. All customers owned property is managed as identified in the customer specific requirements and where the property is lost, damaged or unsuitable for use is reported to the customer and records retained. All customers owned production tooling is identified as required. Product is identified, handled, packaged, stored and protected in a manner that prevents damage. All finished goods are shipped in product specific containers. Condition of product in stock is assessed at appropriate planned intervals. FIFO system is used to optimize inventory turns over time and assure stock rotation. Obsolete products are controlled. Appropriate devices for product measurements are determined during quality planning activities and identified in control plans. The Quality Department determines calibration requirements for each device or device type, documents the requirements in a dedicated database, performs or subcontracts the required calibrations, and maintains related records [also in the database]. Studies have been conducted on all instrument families. Internal and external calibration records include all required information.

7.5.1.8

Service agreement with customer Validation of Processes for Production and Service Provision Validation - supplemental Identification and Traceability Identification - supplemental Customer Property Customer-owned production tooling Preservation of Product Storage and inventory

7.5.2 7.5.2.1 7.5.3 7.5.3.1 7.5.4 7.5.4.1 7.5.5 7.5.5.1

7.6

Control of Monitoring and Measurement Devices Measurement system analysis Calibration/verification records Laboratory requirements

7.6.1 7.6.2 7.6.3

7.6.3.1

Internal laboratory

7.6.3.2 8 8.1 8.1.1 8.1.2 8.2 8.2.1 8.2.1.1 8.2.2 8.2.2.1

External laboratory MEASUREMENT, ANALYSIS AND IMPROVEMENT General Identification of statistical tools Knowledge of basic statistical concepts Monitoring and Measurement Customer Satisfaction Customer satisfaction supplemental Internal Audit Quality management system

The laboratory scope are included in the procedures in general includes calibration activities and layout inspections. Instrument or part specific instructions collectively provide all scope detail for each of these categories of activity. The QA Manager assures the adequacy of instructions specifying methods of calibration and inspection. Laboratory personnel achieve competence in performing and recording results of calibrations and inspections as defined in section 6.2 of this document. Any calibration performed externally is within the ISO 17025 accredited scope of the service provider.

See the Monitoring and Analysis Summary See Planning & Initiation phase of the Quality Planning C/L Technical personnel whose responsibilities might require this knowledge are appropriately qualified.

See the Monitoring and Analysis Summary See the Monitoring and Analysis Summary See the QMS Internal Audit Procedure Audits are based on and address TS 16949 requirements.

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audit 8.2.2.2 8.2.2.3 8.2.2.4 8.2.2.5 8.2.3 Manufacturing process audit Product audit Internal audit plans Internal auditor qualification Monitoring and Measurement of Processes Monitoring and measurement of manufacturing processes Monitoring and Measurement of Product Layout inspection and functional testing Appearance items Control of Nonconforming Product Control of nonconforming product supplemental Control of reworked product Customer information Manufacturing process audits are being performed daily and monthly in each line according to the Layered Process Audits. Product audits are performed by Quality Inspectors in a daily basis to release product. The Quality System Manager maintain an annual audit plan that covers all processes and related activities on all shifts. [see QMS Internal Audit Procedure] See QMS Internal Audit Procedure See the Monitoring and Analysis Summary See 7.5.2 Significant process events are recorded on Daily Production Sheets. The reaction plan to not capable or unstable process conditions includes containment, 100% inspection and corrective action. These plans are approved by customers when appropriate. Product is inspected in accordance with the related check sheet for the product at the operation. The check sheet indicates who performed the inspections. Check sheets are based on requirements initially established in Control Plans. Layout inspection is performed for PPAPs and according to Customer Specific Requirements The Quality and Production Planning Process would address required. See the Control of Nonconforming Product Procedure The procedure specifically states that it applies to unidentified or suspect product. Rework instructions are noted on the related OMS Operational Method sheets. Frequently this involves re-processing product per standard instructions for the part #. Post-repair repair inspection results [whether performed in-line or off-line] are recorded. Quality Manager or Engineer is responsible to promptly notify customers if it is discovered after-the-fact that nonconforming product was inadvertently shipped. Nonconforming product is not further processed or shipped without a customer waiver. This is typically only the case for product that has already been produced. In situations where a waiver applies to future production, expiration dates or quantities are controlled through temporary processing/inspection documentation reflecting a modified part #, which in turn is reflected in the schedule. Waiver requests from ZF Electronics suppliers are fully considered and only passed along to the customer when ZF Electronics Products views the request as acceptable. See the Monitoring and Analysis Summary See the Monitoring and Analysis Summary Continual improvement can be demonstrated through progress in achieving quality objectives and the effective/permanent resolution of actual or potential problems through corrective and preventive action. Several processes drive continual improvement: Innovative Mfg. Nonconforming Material Findings Report, suggestion system, audits, corrective and preventive action, use of working level metrics within specific SBU processes. Manufacturing process improvements focuses upon control and reduction of variation in product characteristics and manufacturing process parameters. See the Corrective and Preventive Action Procedure The CAR form provides a disciplined approach to problem solving See the Permanent Corrective Action Taken section of the CAR form See the Permanent Corrective Action Taken section of the CAR form Evidence of prompt analysis and corrective action is through a combination of the customer satisfaction reports and or CARs, plus internal Claim Reports and CARs. See the Corrective and Preventive Action Procedure

8.2.3.1

8.2.4 8.2.4.1 8.2.4.2 8.3 8.3.1 8.3.2 8.3.3

8.3.4

Customer waiver

8.4 8.4.1 8.5 8.5.1

Analysis of Data Analysis and use of data Improvement Continual Improvement Continual improvement of the organization Manufacturing process improvement Corrective Action Problem solving Error-proofing Corrective action impact Returned product test/analysis Preventive Action

8.5.1.1 8.5..1.2 8.5.2 8.5.2.1 8.5.2.2 8.5.2.3 8.5.2.4 8.5.3

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