Quality System Overview

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Confidential & Proprietary

2 _{Confidential & Proprietary}

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Agenda

ISO Registration

Flow Down Requirements

Supplier Quality

Inspection

Quality Assurance : Project

CE Marking

Governance

Contract

Performance

Verification

Compliance

Agenda

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ATS Organizational Quality Structure

ATS Global Quality

Senior Vice President

ATS Canada Cambridge ASG

Global Director of Quality

ATS USA Ohio ATS USA Oregon

ATS sortimat USA, Chicago ATS Canada Cambridge ASG

ATS sortimat Germany, Winnenden

ATS sortimat India ATS Canada Cambridge ASG ATS Singapore ATS Malaysia ATS Canada Woodbridge Test ATS Switzerland ATS sortimat Germany, Villingen- Schwenningen ATS Germany, Munich ATS Tianjin ATS USA South Carolina

ATS ATW USA Dayton ATS ATW Germany

ATS ATW USA, Livionia

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Third party quality system

registration with global

appointment (BSI)



On line QMS System accessible

globally

■

Standardized common quality

processes in Canada, US, Asia

& Europe

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Continual Improvement



Common QMS structure



Corporate Quality

Assessments



Global Metrics

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Supplier Development



Global Approval Process



Global Supplier Manual



Global Supplier Assessment Process



Global Key Supplier Scorecards

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Quality Systems



Global Business and Quality Management Systems

• Microsoft Impact award recipient for best business solution



Global metrics with common KPI’s submitted monthly



Global Quality procedures adopted to support one company approach



Global Process Deviation tool



Standard Supplier Corrective Action Management tool



Global Calibration software tool (Procal)



Global ISO Compliance audits (completed by Global Quality Director)

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 ISO 9001 Corporate Registered with BSI

 ISO 13485 (applicable divisions only)

 ISO 14001 (applicable divisions only)

 CSA Z299.2-85 compliant (applicable divisions only)

 Good Manufacturing Practices (GMP) as it applies to validation requirements

 EMC Statement of Certification from accredited body (TUV) - applicable divisions only)

 IEC 61000-6-2: 2001Generic Immunity: Industrial Equipment

 IEC 61000-4-2:1995Electrostatic Discharge Immunity

 IEC 61000-4-3:1995 +A1: 1998Radiated Electromagnetic Field Immunity. Amplitude Modulated.

 IEC 61000-4-4:2004Electrical Fast Transient /Burst Immunity

 IEC 61000-4-5:2005Surge Immunity

 IEC 61000-4-6:2003 + A1:2004Common Mode Conducted RF Immunity

 IEC 61000-4-11:2004 Voltage Dropout & Variations

 EN61000-6-4: 2001Generic emissions: Industrial Equipment

 EN 55011/A2:2002Conducted Emissions

 EN 55011/A2:2002Radiated Emissions

 Certified to CSA Standard W47.1 (Fusion Welding of Steel) - applicable to Cambridge EI only

 Certified Welders to W47.1

 Certified Welding Supervisors (W47.1)

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Flow Down Requirements

Quality Quarantine

Validation of Documentation

•MTR’s •C of C’s •Inspection Reports

Drawing Spec

•Requirements identified on drawing

P.O. Placed

Contractual requirements identified thru: •Purchase Order

•Drawing Spec

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Each supplier is approved thru the Evaluation process.  See procedure for details C7.4.1-2P

 Assessments are done by supplier self evaluation  Documentation reviewed

 Audit performed (onsite or phone)

 Approved and uploaded to Global Supplier Management Site

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Global Supplier Manual

 See procedure for details C7.4-1M  Sections addressing (but not limited to)

• T&C’s

• Documentation requirements. • Supplier performance system • Workmanship

• Corrective action • Traceability • Etc.

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

Supplier Development and Monitoring

 Monthly MRB meetings

 Supplier Quality and Supply chain review the supplier results monthly

 Supplier Performance monitoring:

 OTD

 NCR’s

 Inspection FPY

 Top Worst offenders

 Reduce NCRs on top 50% of Occurrences from FY10

 Top Best suppliers

 LAR

 PPM

 SCAR activity

 Review of Poor Performing Suppliers

 Issue actions and update MRB Action item Plan  Supplier Corrective Actions

 Follow the 8D principle.

 Suppliers are required to respond within 10 days.

 Closure to the SCAR is required within 30 days.

Supplier Quality & Development

100 0.0 25.0 7 7 .8 6 4 .3 8 5 .7 6 6 .7 8 2 .4 9 6 .4 7 5 .0 8 7 .8 7 0 .6 6 0 .0 2 8 .6 4 6 .2 8 8 .9 5 4 .5 5 5 .6 3 1 .6 7 0 .6 6 2 .8 6 3 .3 5 0 .0 6 5 .4 80.0 14.3 35.6 83.3 59.4 70.6 49.1 76.5 79.6 69.2 68.9 68.0 0 10 20 30 40 50 60 70 80 90 100

Rolling Inspection First Pass Yield - Supplier Parts

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Quality Control (applicable divisions only):



Receiving Inspection



CMM measurement capability (examples: Brown & Sharp,

Zeiss)



Key characteristic feature control



Product Audit approach



Internal Calibration Lab Services (traceable to NIST)



Supplier Source Inspection



Non conformance Management (online DB implementation in

process)



Quarantine

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Quality Assurance



QMS ISO 9001, ISO14001, VDA & ISO 13485 Audits



Six Sigma Black Belt (Global Quality division)



RAB Lead Auditor (Qualified to 14001, 18001, 13485, AS9100 &

9001)



Real time root cause & corrective action teams



Statistical capability



Quality Contract Reviews



Project Quality Engineering

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Quality Engineering

Quality Engineering Review

In p u ts O u tp u ts Compliance Verification Controls Design + Regulatory Requirements Customer Requirements Environmental Requirements Reliability Requirements Hardware/Software Interfaces DFMA DFMEA Contract Req/ URS/RFQ. MITP/ATP Requirement Specs BOM Drawings Performance Monitoring VTS Flow down Robust Designed Product Reliable Maintainable Verifiable Standards Compliant

Quality Engineering Overview

Pre FAT/FAT Testing Process Capability Data Non conformance Management QMS /ISO9001

Supplier Quality Flow down

R&R Studies Traceability Matrix Pre-start H&S Review OEE CE Project Compliance

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Quality Control

Quality Control ESD Control (applicable divisions only Sampling Requirements Calibration Control Shelf Life Requirements

Compliant Product Inspection Results Nonconformance

reporting Material Traceability Acceptance and Data Operator

Training

Machine Compliance

Audits Shelf Life _Control

Workmanship Drawing Requirements

Controls Corrective Actions

Deviations /Waivers Post Project Reviews

Lessons Learned Investigations

}

Scorecard, Data Trending

Quality Control Overview

Preventative Maintenance

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Supplier Quality & Development

Supplier & Development Quality

Contracted Service Shelf Life Health and Safety

Packaging

Compliant Material

Supplier History Supplier Rating (SRS)

NCR reports

Feed to Finance / Claims / COPQ Approved Supplier List

Controls Supplier Corrective Actions

Project Specific Requirements VTS Requirements FAI Surveys Six Sigma Engagements Process Capability Data Field

Performance Delivery _History Material Needs

Process

Compliance Source Inspection Receiving Inspection

Audits for Product and System

Vendor Tech Spec

Feed Back into Engineering &

Materials

Shelf Life Control in MFG Supplier Quality & Development Overview

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