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Welcome Empire SMTA Chapter High Reliability in an EMS World 4/23/13

Mark Talmadge & Mark Northrup

Customized for markets

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Agenda: 1. What is High Reliability?

2. Avenues to achieve High Reliability?

3. High Reliability as it relates to End Markets

• Medical, • Military, Aerospace, Defense & Space, • Industrial

Our Strategy – “High Reliability”

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IEC Operating Units Overview

Customer

Albuquerque, NM Rochester, NY Bell Gardens, CA

Customer

Newark, NY

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What is High Reliability?

Definition – – The quality or state of being reliable – The extent to which an experiment, test, or measuring

procedure yields the same results on repeated trials – Reliance on and confidence in the truth, worth, reliability,

of a person or thing – The assurance that a product will perform as designed for

an extended period of time with out failure

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Avenues to achieve High Reliability?

Best in class people, processes, and procedures – Effective Quality System – Education, and training of personnel involved / Focused Factories – Process capability – Building quality in versus reworking to the class 3 standard – Material supply chain – DFx

• DFP - BOM analysis • DFM (Valor) • DFT

– Extensive testing • FPT / ICT • Functional • ESS / Thermal cycling • Vibration

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Medical

Surgical Navigation Device Wearable Defibrillator

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Medical

Industry Specifications , Standards , and Certifications – IPC-600, 610, 620, 7711/22 – ISO13485 – FDA registration ( Actual Assembler of Medical Device )

Discipline requirement challenges

– No MRB authority – IQ/OQ/PQ medical process validation and protocol critical – Process locked (e.g., customer approval & validate submission ) – Foreign Object Debris (FOD) mitigation

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Medical

Pros

– Attention Details – Discipline Approach – BOM, DWG, Test Specification , SW/HW, etc. information packages are electronic very

detailed – Component traceability , Obsolescence, and Counterfeit

Cons

– Change is difficult (Product and Process) – Continuous improvement difficult – BOM, DWG, Test Specification , SW/HW, etc. information packages are cumbersome – Traceability adds to the overhead

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Military Aerospace

PCBA and Box build

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Military, Aerospace, Defense, and Space

Industry Specifications , Standards , and Certifications – IPC-600, 610, 620, 7711/22, J-STD-001ES – AS9100, NADCAP (National Aerospace and Defense Contractors

Accreditation Program) Discipline requirement challenges

– No MRB authority – Component obsolescence rampant

• Counterfeit mitigation important – Environmental Testing Requirements

• ESS -45 to +85C @ 30C/min., Vibration 3-axis, etc. – Conformal Coatings – Foreign Object Debris (FOD) mitigation

IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission

Pros

– Attention Details – Discipline Approach – BOM, DWG, Test Specification , SW/HW, etc. information packages are very

detailed – Change is not as difficult – Continuous improvement less of a problem

Cons

– BOM, DWG, Test Specification , SW/HW, etc. information packages are cumbersome

– Obsolescence, and Counterfeit

Military, Aerospace, Defense, and Space

IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission

Industrial

PCBA Box build

Wire and Harness

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Industrial

Industry Specifications , Standards , and Certifications – IPC-600, 610, 620, 7711/22, J-STD-001 – ISO9001

Discipline requirement challenges

– Component obsolescence minimal • Counterfeit mitigation minimal

– Environmental Testing Requirements • ESS -45 to +85C @ 30C/min., Vibration 3-axis, etc.

– Conformal Coatings – Process is not locked (e.g., customer approval & validate submission ) – Foreign Object Debris (FOD) minimal

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Pros

– MRB authority granted – Less Attention Details – Discipline Approach Reduced – Continuous improvement less of a problem – Change is not as difficult – Obsolescence, and Counterfeit is better

Cons

– BOM, DWG, Test Specification , SW/HW, etc. information packages can be incomplete

– Less testing can lead to escapes – Inaccurate Doc packages can lead to mistakes – Product changes are less formal

Industrial

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DRTL Overview Dynamic Research and Testing Laboratories (DRTL)

Component Risk Mitigation Destructive Physical Analysis Failure Analysis Product Qualifications Material Qualifications Consulting Services

ISO 17025

Our staff offers highly respected technical expertise, personable service, and quick response.

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50% 55% 60% 65% 70% 75% 80% 85% 90% 95%

100%

Level 1 Level 2 Level 3 Level 4 Level 5

Probability of catching a sub-standard or counterfeit part should one exist

Economics surrounding this level of avoidance may not

be warranted

What are the chances of catching an escape?

Low

Medium

High

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People are key

DFx

Process Improvement – Focus – Continually monitor and improve your process – Reliability can not be “reworked in”

Test

– ICT, Vibration, ESS, Functional

Discipline requirements – Allow MRB authority – Common sense IQ/OQ/PQ medical validation process and protocol – Component obsolescence & Counterfeit mitigation – Environmental Testing Requirements – Process is not locked / Allow continuous improvement

Optimized Case Recommendations ?

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Thank you!

Q&A ?

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Thank you!

Mark T. Talmadge Director of Engineering Solutions IEC Electronics Corp. 105 Norton St. Newark, NY, 14513-0271 Phone: (315) 332-4460 Cell:(315)-374-3888 mtalmadg@iec-electronics.com

Mark R. Northrup VP of Advanced Technical Operations and Strategy IEC Electronics Corp. 105 Norton St. Newark, NY, 14513-0271 Phone: (315) 332-4283 Cell:(315)-573-2837 Mnorthru@IEC-Electronics.com