Heat Treating Critical manufacturing processes for the Medical - - PowerPoint PPT Presentation

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

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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

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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

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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?

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Critical Manufacturing Process

Best process controls for ensuring Quality Consistency Safety Reliability

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Examples of FDA Product Failure Recalls - HT

Product Class Reason Impact

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

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Heat Treating – Critical Process Parameters

Temperature Time Atmosphere Pressure Cooling

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Heat Treating - Critical Process Execution

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

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Product Non-conformances Due to HT

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

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Photo: Intergranular Attack

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)

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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

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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

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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

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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.

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Questions?

15 Marcel Cuperman MedAccred Staff Engineer mcuperman@p-r-i.org 412-367-2547 Justin McCabe MedAccred

• Sr. Specialist, Business Development

jmccabe@p-r-i.org 724-772-8639