Quality System Overview

Transcription

1 Quality System Overview

2 Agenda Agenda ISO Registration Flow Down Requirements Governance Contract Supplier Quality Performance Inspection Quality Assurance : Project Verification Compliance CE Marking Compliance 2

3 ATS Organizational Quality Structure Senior Vice President Global Director of Quality ATS Global Quality Products Life Sciences Energy & Industry Transportation ATS Canada Cambridge ASG ATS Canada Cambridge ASG ATS Canada Cambridge ASG ATS Canada Woodbridge Test ATS ATW USA Dayton ATS Malaysia ATS Singapore ATS USA Ohio ATS Germany, Munich ATS ATW Germany ATS Switzerland ATS sortimat Germany, Winnenden ATS USA Oregon ATS Tianjin ATS ATW USA, Livionia ATS sortimat Germany, Villingen- Schwenningen ATS sortimat India ATS sortimat USA, Chicago ATS USA South Carolina 3

4 Quality Systems at ATS Third party quality system registration with global appointment (BSI) On line QMS System accessible globally Standardized common quality processes in Canada, US, Asia & Europe Continual Improvement Common QMS structure Corporate Quality Assessments Global Metrics 4

5 Quality Systems at ATS Supplier Development Global Approval Process Global Supplier Manual Global Supplier Assessment Process Global Key Supplier Scorecards 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) 5

6 Standards and Specifications ISO 9001 Corporate Registered with BSI ISO (applicable divisions only) ISO (applicable divisions only) CSA Z 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 : 2001Generic Immunity: Industrial Equipment IEC :1995Electrostatic Discharge Immunity IEC :1995 +A1: 1998Radiated Electromagnetic Field Immunity. Amplitude Modulated. IEC :2004Electrical Fast Transient /Burst Immunity IEC :2005Surge Immunity IEC : A1:2004Common Mode Conducted RF Immunity IEC :2004 Voltage Dropout & Variations EN : 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) 6

7 Flow Down Requirements Drawing Spec Requirements identified on drawing P.O. Placed Contractual requirements identified thru: Purchase Order Drawing Spec Supplier Quality Manual Quality Quarantine Validation of Documentation MTR s C of C s Inspection Reports 7

8 Supplier Quality & Development Each supplier is approved thru the Evaluation process. See procedure for details C P Assessments are done by supplier self evaluation Documentation reviewed Audit performed (onsite or phone) Approved and uploaded to Global Supplier Management Site 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. 8

9 Supplier Quality & Development 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 FY 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. Rolling Inspection First Pass Yield - Supplier Parts Manual FPY CMM/Both FPY AVG FPY

10 Quality Inspection 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 10

11 Quality Assurance Quality Assurance QMS ISO 9001, ISO14001, VDA & ISO 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 11

12 Quality Engineering Quality Engineering Overview Controls QMS /ISO9001 Contract Req/ URS/RFQ. MITP/ATP Requirement Specs Project Compliance Non conformance Management Inputs Design + Regulatory Requirements Customer Requirements Environmental Requirements Reliability Requirements Hardware/Software Interfaces DFMA DFMEA Quality Engineering Review BOM Drawings Performance Monitoring VTS Flow down Supplier Quality Flow down Robust Designed Product Outputs Maintainable Pre FAT/FAT Testing CE Process R&R Traceability Pre-start H&S Capability Data OEE Studies Matrix Review Compliance Verification Verifiable Standards Compliant Reliable 12

13 Quality Control Quality Control Overview Deviations /Waivers Post Project Reviews Lessons Learned Controls Corrective Actions Investigations Operator Training Audits Preventative Maintenance Shelf Life Control Machine Compliance Drawing Requirements Workmanship Compliant Product Shelf Life Requirements Calibration Control Quality Control Inspection Results Nonconformance reporting } Scorecard, Data Trending Sampling Requirements Material Traceability ESD Control (applicable divisions only Acceptance and Data 13

14 Supplier Quality & Development Supplier Quality & Development Overview Controls Supplier Corrective Actions Process Compliance Source Inspection Receiving Inspection Surveys Audits for Product and System Six Sigma Engagements Process Capability Data Vendor Tech Spec Material Needs FAI VTS Requirements Project Specific Requirements Packaging Health and Safety Shelf Life Contracted Service Supplier & Development Quality Compliant Material Supplier Rating (SRS) Supplier History NCR reports Feed to Finance / Claims / COPQ Approved Supplier List } Shelf Life Control in MFG Feed Back into Engineering & Materials Field Performance Delivery History 14

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