quality manual rev h 05192011

ZF Electronics Corp. Quality Manual

of 45 Revision H date: 05/19/2011

ZF Electronics Corp.

QM01-Quality Manual Prepared in compliance with ISO/TS 16949:2009

DATE RELEASED : _______________________ RELEASED BY : __________________________ DIRECTOR OF QUALITY:___________________________

Approved by: Date: Anton Kempf: Managing Director



Table of Contents

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

Revision History

Revision Date

Nature of Change(s)

Rev E 8/22/2009

• Revised Format and all Content

Rev F 02/19/2010

• Org Chart updated

Rev G 08/23/2010

• Quality Policy, Quality Guidelines to ZF GMBH

Rev H 05/19/2011

• Included Quality Manual Number and modified rev date in all pages.



1.0 Scope, Objective, Normative Refrences and Excl usions 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).



ZF Electronics Corp’s 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.



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.



6.0 CONCEPTUAL MODEL FOR QMS

PROCESSES INTERACTION

Plant, Facility and

Equipment.

Human Resources .

Marketing,Bids, Quotations ,Orders &

Contracts

Planning &

Scheduling.

Research and Development & Product Design.

Eng. & Process

Changes.

Design of Mfg

Processes.Purchasing.

Receiving, Storage & Inv. Manufacturing

Shipping and

Delivery.

PAP.

Equipment Maintenance.

Incoming Product Qualit & Supplier Development. Calibration.

Continuous Improvement

Customer Satisfaction.

Support Processes

Main Processes

Managerial Processes

Customer Requirements.

Motivation.

Continual Improvement. Internal Audits.

Monitoring/ Measur. of Mfg Process &

Product.

ProblemSolving.

Monitoring/ Measur. of

Custom. Satisf.



6.1 Quality Management System – Product Realization Process

Continual Improvement Cycle

Internal Audits

Customer Communication

Feedback

Marketing,Bids, Quotations,

Orders and Contracts

Continual Improvement

PRODUCT REALIZATION

MANAGEMENT RESPONSIBILITY

Management Review

MEASUREMENT, ANALYSIS AND IMPROVEMENT

RESOURCE MANAGEMENT

Plant, Facility and Equipment.

Human Resources Motivation Development

Product Verification

Monitoring/Measurement of Mfg Process & Products

Eng. Research and

Development & Product Design

Engineering & Process

Changes

BUSINESS PLANNING PROCESSES

MFG & SUPPORT PROCESSES

MANAGERIAL PROCESSES

Requirements

CUSTOMERS

CUSTOMERS

Design of Manufact. Processes

PPAP

Master Scheduling

Planning & Scheduling

Purchasing

Receiving Stor & Inv.

Incoming Product Qlty & Supplier Development

Manufacturing

Problem Solving

Monitoring Customer Satisfaction

Information Resources (Document Control).

Equip. Maintenance

Calibration

Shipping and Delivery

Note :Detailed descriptions of Processes shown in this in this diagram are included in the associated process sheets at the end of this section

Process Monitoring

Value-Adding Activities Information Flow



6.2 Processes Relation Matrix

S

07-P

& S

07-C

Hum

an R

esou

rces

.

S08

-P &

S08

-C M

otiv

atio

n

S09

Info

rmat

ion

Res

ourc

es (

Doc

umen

t C

ontr

ol)

S01

Eng

inee

ring

and

Pro

cess

C

hang

es

S02

Par

t App

rova

l Pro

cess

S03

Inco

min

g P

rodu

ct Q

ualit

y an

d S

uppl

ier

Dev

elop

men

t

S04

-P &

S04

-C E

quip

men

t M

aint

enan

ce.

S05

-P &

S05

-C C

alib

ratio

n

S06

-C P

lant

Fac

ility

and

Equ

ipm

ent.

M02

Mon

itorin

g / M

easu

rem

ent o

f Mfg

. P

roce

ss a

nd P

rodu

ct.

M01

Inte

rnal

Aud

it.

M03

Pro

blem

Sol

ving

.

M04

Mon

itorin

g C

usto

mer

Sat

isfa

ctio

n.

M06

Man

agem

ent R

evie

w.

M05

Con

tinua

l Im

prov

emen

t.

Pro

cess

Ow

ner(

s)

√ √ √ √ √ √ √ √ √ √

√ √ √ √ √ √ √ √ √ √ √ √

√ √ √ √ √ √ √ √ √ √ √ √ √ √

√ √ √ √ √ √ √ √ √ √ √

√ √ √ √ √ √ √ √ √ √ √ √ √

√ √ √ √ √ √ √ √ √ √ √

√ √ √ √ √ √ √ √ √ √ √ √ √ √

√ √ √ √ √ √ √ √ √ √ √ √ √ √ √

√ √ √ √ √ √ √ √

Process Qwner(s)

HR

HR

Qty

.

Dsg

. E

ng.

Qty

.

Qty

.

Mai

nt.

Des

. E

ng.

Man

uf.

Prd

.

Qty

.

Qty

.

Mkt

. Q

ty.

Qty

QT

Y

Mat.

Mrk/Sal

Des. Eng

Mfg. Eng.

Purch.

Mas. Sch.

Mat.

Mat.

Prd.MP08-P & MP08-C Manufacturing.

MP09 Shipping & Delivery.

MP06-P Purchasing .

MP04-P Master Sheduling.

MP05-C Planning & Scheduling .

MP07-P & MP07-C Receiving, Storage & Inventory Control.

Process Relation Matrix

MP01-P Marketing, Bid, Quotations, Orders & Contracts .

MP02-P & MP02-C Research & Development and , Product Design .

MP03 Design of Manufacturing Processes.



7.0 ZF Electronics QMS documentation includes:

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:

Quality Manual

Process Procedures

Documents

Process Procedures

Documents

Procedures and

Work Instructions

Formats



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) FMEA’s.

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.



7.1 MONTHLY OBJECTIVES TO MONITOR The objectives are broken in to three areas: OBJECTIVES ITEM Dept. Responsible Frequency Quality Supplier PPM Quality Monthly SCAR response time Quality Monthly ZFdM Mfg. PPM Operations Monthly Down Time Operations Monthly Overall efficiency Operations Monthly Process conformance-Layered Audits Operations Monthly Customer Corrective Action Response

time Quality Monthly

ICAR response time Quality Monthly Costs Scrap Operations Monthly Cost of Poor Quality Quality Monthly Premium Freight Materials/Quality Monthly Sales variance against forecast Sales and Marketing Monthly Service On time Delivery Performance Sales and Marketing Monthly Customer Satisfaction-Survey Sales and Marketing Once per

year Customer Scorecards Quality Monthly Employee Satisfaction Human Resources Monthly On Time PPAP Submission Quality Monthly Receivables % current and dollars past

due. Finance Monthly

Past Due to Customer ($) Purchasing Monthly



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

Conditions:

Input:

Output:

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.

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

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

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

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

Materials:

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

Materials:

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

Environment: Office environment w/ Proper lighting, order & cleanliness



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.

Conditions:

Design Inputs:

Outputs:

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


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

Materials: Customer Samples; mating component parts; Competitor products

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 Manufacturer’s installation, configuration set-up

Methods: CDSN1006 procedure; ECR/ECO’s; Establish testing acceptance criteria; Key characteristics, SPC’s; Cross-functional PDT, meetings; PM checklists, MS Project plan; Action items; Design reviews; FEA’s

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

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;

Product Specs; Design input, review records; DFMEA’s; DVP&R’s; Test acceptance criteria; Verification, Validation plans and results; Math data, drawings; Marked up BOM’s, drawings; Drawing objects; Data measurement, 1st piece; Capability, yield studies; Gantts; PM documents and deliverables; Management approvals

ZF Electronics Corp. Quality Policy Manual


Process Analysis Diagram: Business Planning Process – MP-02C Engineering Research and Development & Product Design

o Design (prototype and product validation department)

INPUTS:

CONDITIONS:

OUTPUTS:

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.

Product characteristics: - Engineering samples. - SLA samples.

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.

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.

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

Staff: - Qualified technical staff to

dimensional area, SLA and UL. - Qualified engineering staff in different

test systems. - External supplier (if necessary).

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

Information: - Investigation result report.

- Precise, trusty, clear and understandable inform.

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).

Materials: - Fixtures and test accessories.

- Samples for investigation.

- Material and assemble accessories.

Objective: The main objective of the PVD department is to provide accurate and precise information to guarantee a reliable and robust process.



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


Conditions:

Input:

Output:

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

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

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

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 (Multi-Disciplinary); IT737.001 Work Instructions To Handle Engineering Changes

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

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

Environment: N/A

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

Information: ECR/ECO records and reporting mechanisms

ZF Electronics Quality Policy Manual


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

CONDITIONS:

INPUT:

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.

OUTPUT:

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

Machinery/Equipment: - Computer Equipment - Software. - Machinery for usage (install). - Work tables. - Spare parts. - Electric and pneumatic installations.

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

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)

Materials: - Material for installation

People: - Job description. - Trained personnel - Drawing interpretation - Control Plan, PFMEA, AutoCAD - APQP, MSA - Multidisciplinary Focus

Environment: - Adequate lighting. - Cleanliness and organization (5’s program)

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)

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.

Information: - Laboratory Results - Information for maintenance - Information for measurement - Updated tooling drawings



Process Analysis Diagram: Manufacturing Support Processes – S02 PPAP (Production Part Approval Process)

INPUTS:

CONDITIONS: Information:

- PAP level. - Additional Customer’s requirements.

- ECO EWO. - Material certification.

- Draws. - FMEA. - Gage R&R. - Chart flow. - Control Plan. - Validations. - Production samples.

Machinery / Equipment: - Personal Computer / Microsoft Office applications. - Access to customer’s database. - Matrix - Mapics and Future 3

-

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

Method: - SOPC-73-01 PAP Procedure. - AIAG MSA Manual - PAP customer’s Manual. - G111 Procedure for PPAP

Materials: - Conformant material approved for quality to product samples.

- Office materials.

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

Environment: - Based in 9’s program.

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

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.

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

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.

OUTPUTS:

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.



Process Analysis Diagram: Manufacturing Support Processes – MP 04 Master Scheduling

Objective: To ensure product is ready to ship per Customer’s request

Conditions:

Input:

Output:

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.

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

Materials: N/A

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.

Materials: N/A

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.

Environment: - Available storage for files. - Access to Mapics, Matrix, E-mail and the Internet.

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



Process Analysis Diagram: Manufacturing Support Processes – MP 05C Planning and Scheduling

INPUT:

CONDITIONS:

OUTPUT:

Information: - Weekly production

schedules report. - Monthly planned

demand and production lines capacity.

- Direct staff assignation.

- Shortages report. - Quick requests.

Machinery / Equipment: - Personal computer - Software ( MAPICS, AMIS,

MS-Office etc.). - Quick request file data base.

Product characteristics: - Production schedules released to production without shortages, according to lines capacity and less possible set-ups.

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

Method: - General procedures and work

instructions for inventory and production control. MP04, SOPC-75-11 & 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.

Staff: - Competent and trained personnel.

Environment: - Order, organization and

cleanliness

Information: - Information in Mapics

updated of open and closed production schedules.

Materials: - Raw Material and MRO’s inventories.

Objective: Provide information to manufacturing in order to guarantee on time production to satisfy customer orders.

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



Process Analysis Diagram: Manufacturing Support Processes – MP 06 Purchasing Objective: Quality Products, on time delivery, within cost, and Optimum

Conditions:

Input:

Output:

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


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

Materials: Samples Prototypes

Machinery / Tooling: Mapics

Methods: Procedure Supplier Approval Criteria Second Party Assessment Long Term Planning Forecasts Commitments Optimize Logistics PPAP

Materials: N/A

People: Negotiations Communications Organization

Environment: Organization Clean Ethical Trust sup/client Relations Accountability

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

Information: N/A



Process Analysis Diagram: Manufacturing Support Processes – MP 07 Receiving, Warehousing and Inventory Control

INPUTS:

CONDITIONS:

OUTPUTS :

Information

- Packing list - Cyclical count Program

Machinery / Equipment: - Forklifts - Computer Equipment -Software (AMIS, MAPICS, Office etc.) - Weight Scales - Scanners - Racks - Printers

Characteristics of the Product: - Material correctly identified and in good condition

- Reliability and accuracy of inventory.

- Inventory updating

Methods : - Procedures SOPC-74-03, SOPC-75-06, 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

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

Information : -Information of inventories (Historic , transferences) through MAPICS - Report of receiving discrepancies.

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

Materials: - Raw materials correctly identified

Objective: Preventing damage ensuring the adequate identification of materials from receiving, until delivery to Production and maintaining reliable inventories.

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.



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

OUTPUTS: CONDITIONS:

INPUTS:

Information: - Matrix System - Quality Alerts. - Supplier’s Performance.

- PIR’S. - Breakdown Report.

Machinery / Equipment: - “ MAPICS, MATRIX” Software’s - Scanner - Measurement equipment (vernier, microscope, optic comparator, micro view, metric rule, height indicator, pin’s gauge).

Product characteristics: - Correctly identified material. - Delivered in time. - Material according specifications.

- Supplier performance with greatest tendencies.

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.

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

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

Environment: - Adequate illumination. - Order and cleaning.

Information: - DMR’s - MAPICS (AMIS) systems. - Debit memos (Non- conforming material). - Supplier’s feedback. - Corrective actions report. - Supplier’s evaluation report.

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

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

Materials: - Raw Material. (Quality, quantity, delivery time)

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.



Process Analysis Diagram: Manufacturing Support Processes – MP 08 Manufacturing

Conditions:

Input:

Output:

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


Information: Equipment Tooling People Facilities Schedules OMS’s Quality Alerts Corrective actions Schedule packet Production Priorities

Material: Identified Conforming Traceable Non Damaged

Machinery / Tooling: Measurement tools calibrated and in working conditions. Preventive maintenance Engineering approved tooling Fixtures Working within parameters Properly set-up equipment Identified tools

Methods: OMS’s QA’s Visual Aids Cosmetic Standards Setup verifications Validation Procedure GP70007,GP70013, & GP70036 Layered Audit Statistical Tools

Materials: Non-damaged Properly identified Compliant part Labels

People: Competent (training, skills, experience& education) Empowered On the job training Quality awareness Motivated Knowledge of statistical tools

Environment: Cleaned and organized Temperature and humidity controlled. Proper lighting

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

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



Process Analysis Diagram: Manufacturing Support Processes – S04 Equipment Maintenance

OUTPUT: INPUTS:

CONDITIONS :

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.

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

Product Characteristics: - Machinery, equipment and tools with preventive and predictive maintenance. - Tooling Control.

- Spare-Parts Control.

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.

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

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.

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.

Materials : - Machinery or equipment and tooling without maintenance.

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



Process Analysis Diagram: Manufacturing Support Processes – S05 Calibration

INPUTS:

CONDITIONS:

OUTPUTS:

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.

Machinery / Equipment: - Spare parts. - Test equipment. - Technical recommendations.

- Computer with calibration program to control equipment.

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

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.

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.

Materials: - Calibration standards. - Budget for external

calibrations. - Equipment to be

calibrated available.

Objective: Providing inspection, measuring, and testing equipment.

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.



Process Analysis Diagram: Manufacturing Support Processes – S05 PP Calibration o PP Engineering Calibration

Objective: Have measuring equipment capable of providing reliable measurements

Conditions:

Input:

Output:

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


Information: GAGEtrak equipment schedule listing calibration requirements; Operations requirements; Quality alerts CAR’s

Materials: Equipment requiring calibration; Special tools; PC workstation

Machinery / Tooling: Master measurement standards to be calibrated; Production, Test equipment; Periodic, run-time frequency; Manufacturer’s 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,

Materials: Equipment requiring calibration; Special tools; PC workstation

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

Environment: Monitor, control calibration area temperature, humidity within defined tolerances; MS Office Suite, IT/Network; Proper identification and calibration status

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

Information: GAGEtrak software reporting mechanisms; Special work requests



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

INPUTS:

CONDITIONS:

OUTPUTS:

Information: - Shipping Requirements.

- Packing List (shipping order)

- Shipping special requirements.

Machinery / Equipment: - Forklift. - Scanner. - Scales. - Computer equipment. - Software.

Product characteristics: - Shipping according to customer’s requirements.


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.

Personnel: - Qualified materialist in Forklift mount, Software (Mapics & Amis) and Scanner.

- Qualified in materials management.

- Trained in necessary instructions.

Environment: - Shipping area. - Orderly and clean.

Information: - Loc TOSHIP and actual FIFO.

- Complete historic pick List of SA’s in MAPICS.

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)

Materials: - Finish Product accepted by QC

- Raw material

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



Process Analysis Diagram: Manufacturing Support Processes – S06 Plant, installations and Equipment

INPUTS :

CONDITIONS :

OUTPUTS:

Information : - Manufacturing process requirements (Layout).

- Maintenance requirements for plant equipment.

- Work Requirements for Health and Environment.

- Requirements for Support Services.

- Inadequate conditions

Machinery / Equipment: - Available Equipment. - Tools. - Measuring Devices.

- Safety Devices and equipment.

Product Characteristics: - Planning for building, services, and equipment.

- Maintenance Plan. - Contingency Plans. - Spare parts Control. - Adequate conditions. - Services Conducted

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.

Methods : - Procedure (SOPC-75-09). - Work Instructions (IT751.067). - Manufacturer’s Manuals - Work Orders.

- Verification of activities conducted. - Audits to the plant, building, services, and equipment. - Method for evaluating effectiveness for optimizing materials circulation.

Materials : - Budget for Spare Parts. - Budget for Tools. - Supplier list (FAQ #2). - Data base (max. and min.) Spare Parts for plant equipment.

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

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

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)

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

Objective: Ensuring installations, services, and equipment at the building adequate for the plant’s activities.



Process Analysis Diagram: Manufacturing Support Processes – S08 P Human Resources Motivation Development

Conditions:

Input:

Output:

Effectiveness / Efficiency Indicators: • Awareness surveys results. • Employee satisfaction Index.


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.

Materials: N/A

Machinery / Tooling: • N/A

Methods: • Procedure • Employee Review • Focus Group • Improved Benefits • Company Events • Employee Supplier Discounts • Recognition Awards

Materials: N/A People:

• Personnel of all levels of organization

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

Product characteristics: • Personnel are awareness of

their contribution to the achievement of planned objectives

Information: Feedback and data from Random surveys

Objective: employees to achieve quality objectives, to make continual improvements and to create an environment to promote innovation



Process Analysis Diagram: Manufacturing Support Processes – S08 C Human Resources Motivation Development

o Motivation

Conditions:

Input:

Output:

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

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

Materials: N/A

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

Materials: - Recognition, prices, and/or individual and group gifts - Survey forms

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

Environment: - Good lighting - Clean environment - Good building maintenance. - Adequate services: Sound, Medical, Food, Transport, etc. - Artificial Climate - Innovation

Product Characteristics: - Employees with greater motivation.

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

Objective: Increasing motivation of employees, with the intention that they reach their objectives and that they continuously improve their performance

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.



Process Analysis Diagram: Manufacturing Support Processes – S07 P- Human Resources o Human Recourse Competence Development

Conditions:

Input:

Output:

Effectiveness / Efficiency Indicators:

Measure • Training Evaluation – Feedback Monitor • Performance Appraisal Scores


Information: • Employee not

aware of Quality Objective

• Job Description • Performance

Appraisal • Employee’s

Experience & Education

• Training Needs Analysis

• Training Effectiveness Evaluation

Materials:

Machinery / Tooling: • Projector • Computer • HR Perspective (software)

Methods: • Procedure G418, Training • Quality Objectives Deployment • Quality Awareness

Materials: • Learning History Sheet • Related to Training Subject

People: • Qualified Trainer of Subject • Effective Communicator

Environment: • Organized • Conducive for Training (lighting,

temperature)

Product characteristics: • Competent Workforce • Aware of Quality Objectives

Information: • Training Records

Objective: Providing personnel aware of the importance of their activities with the necessary skills to do their work according to the quality objectives.



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

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

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.

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

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

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

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

OUTPUTS:

Product Characteristics: - Personnel skilled in their area made

aware of the importance of their activities in achieving product quality.

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

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

INPUTS:

CONDITIONS: ‘;

OUTPUTS:

Information:

- Customer Requirements and specifications.

- Requirements of the Doc. Ctrl. System.

- Customer requirements on records retention. - Changes request

Equipment: - Computers - Software

Product Characteristics: - Updated Documents. - Reviewed Documents - Approved Documents. - Distributed Documents where

needed. - Records retained

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

Materials: - Control stamp on controlled documents

Personnel: - Competent, skilled and trained Personnel

- Microsoft Office, database - Organized

Environment: - Cleanliness of area, and good illumination.

- Dead file area. - Prevention of damages to documents and records

Information: -Updated document master List.

Materials: - Internal and external Documents

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

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




Process Analysis Diagram: Managerial Processes – M01 Internal Audits

INPUTS:

CONDITIONS:

SALIDAS: 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.

Equipment and Tooling: - Computers - Software - Meeting room

Product Characteristics: - Conclusions about the adequacy, conformity, effectiveness and efficiency of the Quality System.

- Areas that require attention identified.

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

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

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

Environment: - Clean areas. - Comfortable environment

when auditing.

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

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

- Customer requirements manuals.

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




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.

CONDITIONS:

Input:

Output:

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

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

Materials: - Production parts

Machinery / Tooling: - Production testers - Measurement tools calibrated and in working conditions.

- Analysis tools and equipment - Minitab - Personal computer - Calculator

Methods: - OMS’s -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 non-conforming product SOPC-83-01

- Run & rate, when customer requests it.

Materials:

- Sampling of in-process production. - Finished product

People: - Competent (training, skills, experience& education)

- Empowered - On the job training - Quality awareness - Motivated Knowledge of statistical tools - Responsibility & authority

Environment: - Clean and organized - Proper lighting - Safe

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




Process Analysis Diagram: Managerial Processes – M03 Problem Solving

Conditions:

Input:

Output:

Effectiveness / Efficiency Indicators: * Measure: - Number of customer’s complaints - Response time to customer‘s complaints

- Customer Scorecards - Production PPM - SCAR *Monitor: - Corrective actions to internal problems and customer’s complaints.


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

Materials: * Defective Parts (not Damaged in Transit) * Properly ID’d

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

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

Materials: * Defective Parts (not Damaged in Transit) * Properly ID’d

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

Environment: * Organized and Clean Environment *Proper Lighting * Innovative environment

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

Objective: Problem solved so that it does not reoccur



Process Analysis Diagram: Managerial Processes – M04 Monitoring Customer Satisfaction

INPUTS:

CONDITIONS: ‘;

OUTPUTS:

Information

- Customer survey results - Customer score cards results - On time delivery results - Internal Quality, Maintenance, Engineering and production results

Machinery / Equipment: - Communication media - Office software

Product characteristics: - Improved quality performance - Improved delivery performance - Improved internal perform - Good customer grades

Methods: - Complaint responses - Lessons learn communication - Training in problem solving tools - Top management involvement - Supplier development - Continual Improvement

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

People: - Trained personnel in ETQ, COVISINT, MAPICS, problem solving tools.

Environment: - Open Communication between departments (Sales, Quality, Engineering, Design, Production, materials)

Information: - Internal and external Quality

charts - Internal and external Delivery

charts

Materials: - Score cards - Surveys - Internal performance charts

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

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.

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



Process Analysis Diagram: Managerial Processes – M06 Management Review

INPUT:

OUTPUT:

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.

MACHINERY AND EQUIPMENT: - Computer and Software. - Conference Rooms, projector.

Product Characteristics: -Actions to improve the performance of the quality system.

-Actions to improve products. -Identification and assignation of Resources.

METHODS: - Management Responsibility procedure SOPC-51-01 & G41

MATERIALS: - All the performance indicators.

PEOPLE: - Management involvement. - Multidisciplinary focus.

ENVIRONMENT: - Order and cleanliness.

INFORMATION: - Revised Quality policy (if there was a change)

- New quality objectives. - Indicator’s action plan.

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

Objective:: Review the Plant’s 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.

CONDITIONS:




Process Analysis Diagram: Managerial Processes – M05 Continual Improvement

Objective: Continually improve the effectiveness of the Quality Management System

Output:

Effectiveness / Efficiency Indicators: Objective trends

Conditions:

Input:


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

Materials: Accurate data Clearly defined Detailed

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)

Materials: Accurate data Clearly defined Detailed

People: Competent in problem solving techniques.

Environment: Organized and clean

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

Information: Continual improvement reports



ISO/TS 16949:2009 Compliance Summary

ISO/TS 16949

Section Title Comments

4 QUALITY

MANAGEMENT SYSTEM

4.1 General Requirements

4.1 General Requirements The processes of the business and their sequence and interaction are defined in the Quality Manual.

4.2 Documentation Requirements

4.2.1 General

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.

4.2.2 Quality Manual This document. 4.2.3 Control of Documents See Document Control Procedure

4.2.3.1 Engineering specifications 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

4.2.4 Control of Records See Record Control Procedure 4.2.4.1 Record retention Record control practices satisfy all applicable regulatory and customer requirements.

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment 5.1 Management Commitment Commitment is demonstrated through fulfillment of all other requirements in Section 5.

5.1.1 Process efficiency Management reviews various metrics monthly, quarterly and annually to assure the ongoing effectiveness and efficiency of all processes.

5.2 Customer Focus

5.2 Customer Focus See 7.2 and 8.2.1; the combination of effective methods to determine customer requirements + good information related to customer satisfaction = customer focus.

5.3 Quality Policy 5.3 Quality Policy As stated in an earlier section of this document. 5.4 Planning

5.4.1 Quality Objectives Objectives include business level measures related to SBU. More specific supporting measures are established at a functional / process level.

5.4.1.1 Quality objectives The objectives are included in and driven from the business plan.

5.4.2 Quality Management System

Planning

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]

5.5 Responsibility, authority and

communication

5.5.1 Responsibility and Authority

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.

5.5.1.1 Responsibility for quality

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.

5.5.2 Management Representative

The Director of Quality is appointed as management’s representative for ensuring that the quality management system is implemented and maintained, and for the other responsibilities associated with this assignment.




ISO/TS 16949


5.5.2.1 Customer representative Management has designated personnel with responsibility and authority for ensuring that customer requirements are met.

5.5.3 Internal Communication

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 Management Review

5.6.1 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.

5.6.1.1 Quality management system

performance

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.

5.6.2 Review Input See Annual Management Review Agenda

5.6.2.1 Review input - supplemental Actual and potential field failures are discussed in the review, primarily from the perspective of customer feedback and impact on PFMEA.

5.6.3 Review Output See Management Review Agenda

6 RESOURCE MANAGEMENT

6.1 Provision of Resources

6.1 Provision of Resources

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.

6.2 Human Resources

6.2.1 General See Employee Training & Competence Procedure, plus related Skill Control Item Sheets [specific for production, and general for administration].

6.2.2 Competence, Awareness and

Training Procedures are defined to determine competence, awareness and training needs and evaluation of the effectiveness.

6.2.2.1 Product design skills Design skills are defined in Job Descriptions and Design matrix files 6.2.2.2 Training See Employee Training & Competence Procedure

6.2.2.3 Training on the job 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.

6.2.2.4 Employee motivation and

empowerment

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).

6.3 Infrastructure 6.3 Infrastructure Facilities, equipment, software and their related maintenance are adequate.

6.3.1 Plant, facility and equipment

planning

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.

6.3.2 Contingency plans Contingency Plans Procedures are in place to satify customer requirements in the vent of an emergency.

6.4 Work Environment 6.4 Work Environment Work environment is appropriate for the work performed in each process.

6.4.1 Personnel safety to achieve

product quality Related issues are considered during both Quality Planning and Process Design activities and incorporated into related documentation, equipment and practices.




ISO/TS 16949


6.4.2 Cleanliness of premises The facility is maintained in a manner consistent with product and process needs.

7 PRODUCT REALIZATION

7.1 Planning of Product

Realization

7.1 Planning of Product

Realization

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.

7.1.1 Planning of Product

Realization - Supplemental Quality plans are developed with consideration given to applicable customer requirements and technical specifications; see Quality Planning Checklist

7.1.2 Acceptance Criteria Acceptance criteria for all product characteristics [including visuals] is defined on control plans and/or part specific instructions reference in control plans.

7.1.3 Confidentiality Confidentiality of customer information is protected.

7.1.4 Change control

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 Customer Related Processes

7.2.1 Determination of

Requirements Related to the Product

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.

7.2.1.1 Customer-designated special

characteristics Process to define special characteristics in in place, there are included in Prints, DFMEA, PFMEA, CP and Work Instructions

7.2.2 Review of Requirements Related to the Product

All activities noted above include reviews and approvals.

7.2.2.1 Review of Requirements Related to the Product-

Supplemental Procedures states that when waiving requirements require customer approval

7.2.2.2 Organization Manufacturing

feasibility Feasibility review is included in the process

7.2.3 Customer Communication 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.].

7.2.3.1 Customer Communication-

Supplemental Communication is eing done according to Customer needs, language and formats.

7.3 Design and/or Development

7.3.1 Design and Development

Planning 7.3.1.1 Multidisciplinary approach

7.3.2 Design and Development

Inputs 7.3.2.1 Product Design input 7.3.2.2 Manufacturing PD input 7.3.2.3 Special characteristics 7.3.3 D and D Outputs

7.3.3.1 Product Design outputs-Supp 7.3.3.2 Manufact PD output 7.3.4 D and D Review

7.3.4.1 Monitoring 7.3.5 D and D Verification 7.3.6 D and D Validation

7.3.6.1 D and D Valid- Suppl 7.3.6.2 Prototype programme 7.3.6.3 Product Approval process

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.




ISO/TS 16949


7.3.7 Control of D and D Changes 7.4 Purchasing

7.4.1 Purchasing Process See Purchasing Process Procedure

7.4.1.1 Regulatory conformity All product/materials used in product conform to applicable regulatory requirements.

7.4.1.2 Supplier quality management

system development See Supplier Selection and Development Process Procedure

7.4.1.3 Customer-approved sources ZF Electronics does not deviate from the customer approved sources. 7.4.2 Purchasing Information See 7.4.1

7.4.3 Verification of Purchased

Product See 7.4.3.1

7.4.3.1

Incoming product quality

Method of Verification of purchased materials is through, incoming sampling plans, third party certification of suppliers’ quality management systems, plus evidence of satisfactory performance.

7.4.3.2

Supplier monitoring Delivered product quality and shipping accuracy performance is monitored for feedback purposes

7.5 Production and Service

Provision

7.5.1 Control of 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.

7.5.1.1 Control plan Control plans are developed during the APQP process; see related Quality Planning Checklist.

7.5.1.2 Work instructions Work instructions are available in each work center. Part specific instructions are developed during the APQP process and placed in the appropriate work centers.

7.5.1.3 Verification of job set-ups Set-ups are verified by Technicians and/or quality inspectors per the documented requirements

7.5.1.4 Preventive and predictive

maintenance

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.

7.5.1.5 Management of production

tooling

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.

7.5.1.6 Production scheduling Production is scheduled directly from customer releases covering a four week period, but updated weekly.

7.5.1.7 Feedback from service

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



problem.

7.5.1.8 Service agreement with

customer There are no service agreements with customers.

7.5.2 Validation of Processes for

Production and Service Provision

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.

7.5.2.1 Validation - supplemental Above validation activities cover all processes/equipment.

7.5.3 Identification and

Traceability

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.

7.5.3.1 Identification - supplemental Identification methods are applied to all products throughout product realization activities.

7.5.4 Customer Property 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.

7.5.4.1 Customer-owned production

tooling All customers owned production tooling is identified as required.

7.5.5 Preservation of Product Product is identified, handled, packaged, stored and protected in a manner that prevents damage. All finished goods are shipped in product specific containers.

7.5.5.1 Storage and inventory 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.

7.6 Control of Monitoring and

Measurement Devices

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].

7.6.1 Measurement system

analysis Studies have been conducted on all instrument families.

7.6.2 Calibration/verification

records Internal and external calibration records include all required information.

7.6.3 Laboratory requirements

7.6.3.1 Internal laboratory

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.

7.6.3.2 External laboratory Any calibration performed externally is within the ISO 17025 accredited scope of the service provider.

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General See the Monitoring and Analysis Summary

8.1.1 Identification of statistical

tools See Planning & Initiation phase of the Quality Planning C/L

8.1.2 Knowledge of basic statistical concepts

Technical personnel whose responsibilities might require this knowledge are appropriately qualified.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction See the Monitoring and Analysis Summary

8.2.1.1 Customer satisfaction –

supplemental See the Monitoring and Analysis Summary

8.2.2 Internal Audit See the QMS Internal Audit Procedure 8.2.2.1 Quality management system Audits are based on and address TS 16949 requirements.



audit

8.2.2.2 Manufacturing process audit Manufacturing process audits are being performed daily and monthly in each line according to the Layered Process Audits.

8.2.2.3 Product audit Product audits are performed by Quality Inspectors in a daily basis to release product.

8.2.2.4 Internal audit plans The Quality System Manager maintain an annual audit plan that covers all processes and related activities on all shifts. [see QMS Internal Audit Procedure]

8.2.2.5 Internal auditor qualification See QMS Internal Audit Procedure

8.2.3 Monitoring and

Measurement of Processes See the Monitoring and Analysis Summary

8.2.3.1 Monitoring and measurement of

manufacturing processes

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.

8.2.4 Monitoring and

Measurement of Product

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.

8.2.4.1 Layout inspection and

functional testing Layout inspection is performed for PPAP’s and according to Customer Specific Requirements

8.2.4.2 Appearance items The Quality and Production Planning Process would address required.

8.3 Control of Nonconforming

Product See the Control of Nonconforming Product Procedure

8.3.1 Control of nonconforming

product – supplemental The procedure specifically states that it applies to unidentified or suspect product.

8.3.2 Control of reworked 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.

8.3.3 Customer information Quality Manager or Engineer is responsible to promptly notify customers if it is discovered after-the-fact that nonconforming product was inadvertently shipped.

8.3.4 Customer waiver

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.

8.4 Analysis of Data See the Monitoring and Analysis Summary 8.4.1 Analysis and use of data See the Monitoring and Analysis Summary 8.5 Improvement

8.5.1 Continual Improvement 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.

8.5.1.1 Continual improvement of

the organization

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.

8.5..1.2 Manufacturing process

improvement Manufacturing process improvements focuses upon control and reduction of variation in product characteristics and manufacturing process parameters.

8.5.2 Corrective Action See the Corrective and Preventive Action Procedure 8.5.2.1 Problem solving The CAR form provides a disciplined approach to problem solving 8.5.2.2 Error-proofing See the “Permanent Corrective Action Taken” section of the CAR form 8.5.2.3 Corrective action impact See the “Permanent Corrective Action Taken” section of the CAR form

8.5.2.4 Returned product

test/analysis Evidence of prompt analysis and corrective action is through a combination of the customer satisfaction reports and or CAR’s, plus internal Claim Reports and CAR’s.

8.5.3 Preventive Action See the Corrective and Preventive Action Procedure