Heat Treating

Critical manufacturing processes for the Medical Device Industry Bruce Dall, Stryker

MedAccred Heat Treatment Task Group Chairman Senior Metallurgist - Stryker Global Supply, Kalamazoo Campus 13 Years in Medical Device and Aerospace Special Process Management Stryker, Northrop Grumman Heat Treatment, Welding, Forging, Casting, PCBs Supplier Process Assessment/Development Experienced Material Failure Analyst Certified Lead Quality Systems Auditor ISO13485, AS9100, ISO17025 University of Michigan, Ann Arbor Bachelors of Materials Science and Engineering

1 Edward Engelhard, Solar Atmospheres

Vice President of Corporate Quality - Jan 2015 to present Corporate Quality Manager – March 2012 to Jan 2015 Owner/operator of commercial heat treat company – 1991 to Feb 2012 Process Metallurgist and General Manager at commercial heat treat company – 1978 to 1991 B.S., Metallurgy and Materials Science - Lehigh University 40 years - heat treat process metallurgy in aerospace, medical, transportation, energy production, and commercial manufacturing 15 years – establishment, maintenance and operations within ISO9001/AS9100 QMS environment 20 years – establishment, maintenance and operations within Nadcap accredited environment 2 years – establishment, maintenance and operations within MedAccred accredited environment

2 Marcel Cuperman, PRI

Performance Review Institute (PRI), Staff Engineer 32 years of experience in the Heat Treating industry Extensive experience with Special Processes projects Pyrometry Instructor Goodrich Corporation, Chief Metallurgist Polytechnic Institute College of Romania, Master in Metallurgy Heat Treating Extractive Technologies ISO-9000 Internal Auditor Heat Treating and Surface Enhancement Lead Auditor

3 Agenda

Recall Examples Critical Process Parameters and Execution Product NCRs Due to Heat Treating Technical Standards Compliance Top Audit NCRs Typical Initial Root Cause Responses What is the Medical Device industry doing to improve HT Quality and Supply Chain Oversight?

4 Critical Manufacturing Process

Best process controls for ensuring Quality Consistency Safety Reliability

5 Examples of FDA Product Failure Recalls - HT

Product Class Reason Impact Medline Guidewire with I The potential for the coating to flake off of the wire. Improper coating and post- Flaking Coating coating heat treating. Medline Guidewire is meant to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. Steel Rust in a Hospira I Particles of oxidized stainless steel found in a Improper heat treating and Injection container of a cardiac drug. post-heat treating protection.

6 Heat Treating – Critical Process Parameters

Temperature Time Atmosphere Pressure Cooling

7 Heat Treating - Critical Process Execution

Training Operator Qualification Validation Pyrometry Cleanliness Loading Recording (Process Records) Testing

8 Product Non-conformances Due to HT

Failed mechanical properties Grain size, grain growth Intergranular corrosion Brazing voids Cracks Micro structure elements/content Photo: Intergranular Attack

9 Technical Standards Compliance is Critical

Heat Treating Customer standards Industry standards Pyrometry AMS2750 – Compliance tests Thermocouples calibration Instruments calibration SAT (System Accuracy Test) TUS (Temperature Uniformity Test) Testing Hardness (ASTM E10, ASTM E18, ASTM E92, ASTM E384) Tensile (ASTM E8)

10 Technical Standards Compliance ensures:

Process and Product Quality Final mechanical properties of metallic components Process consistency Consistency Process Validation Time/Temperature Profiles Recipes Detailed Work Instructions

11 Top Non-conformances

Instruments calibration Pyrometry internal procedures Nonsustaining corrective actions SAT (System Accuracy Test) on all systems Cleanliness prior Heat Treating TUS (Temperature Uniformity Survey) reports Process temperature violations Process time violations Customers’ requirements flow down

12 Typical Initial Root Cause Responses

Parts heat treated outside qualified working zone. Operator wasn’t aware of the requirement. AMS2750 Rev. E section 2.2.41 specifies “Qualified Working Zone = The defined portion of a furnace volume where temperature variation conforms to the required uniformity tolerance” Engineer did not flow down the requirement to operator

Consequences: Parts are not heated uniformly Parts fail mechanical properties Process/product escapes

13 What is the Medical Device industry doing to improve HT Quality and Supply Chain Oversight?

Heat Treating Task Group Stryker, J&J, GE Healthcare, Medtronic, Solar Atmospheres, Bodycote, Hansen-Balk, Midwest Thermal-Vac, Paulo Products, Applied Thermal Technologies, Lake City Heat Treating Open to subject matter experts from OEMs, CMs and Suppliers Develop Audit Criteria Approve auditors Grant Supplier accreditations MedAccred Accreditation is used by OEMs/CMs as a criteria to award new business and oversee their critical process supply chain quality. Suppliers use MedAccred Accreditation to ensure final product quality and improved manufacturing operations.

14 Questions?

Marcel Cuperman Justin McCabe MedAccred MedAccred Staff Engineer Sr. Specialist, Business Development [email protected] [email protected] 412-367-2547 724-772-8639

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