Remedies for Supply Chain Headaches: Innovating Critical Process - PowerPoint PPT Presentation

Remedies for Supply Chain Headaches: Innovating Critical Process Manufacturing Oversight March 23, 2016

Agenda • Poor Critical Process S upply Chain Management Presents Problems for Medical Device Companies • Role of S upply Chain Management in FDA’ s Case for Quality • How the Aerospace Industry can S erve as a Model for the Medical Device Industry • Effective S trategies for Oversight and Management of Medical Device S upply Chain Based on Aerospace Industry S uccess • Leveraging S uccessful Aerospace S trategies for the Medical Device Industry 2

Poor Critical Process Supply Chain Management Presents Problems for Medical Device Companies 3

Critical Manufacturing Process S upply Chain Oversight Issues Tibial Articular Surface Inserter (Class II) Impact Reason 360 units recalled by FDA Affected product did not undergo heat treatment hardening step leading to lack in material strength that may contribute to the deformation of the tip. 4 Source: www.accessdata.fda.gov

Critical Manufacturing Process S upply Chain Oversight Issues Ventilator (Class II) Impact Reason 46 units recalled by FDA An increased likelihood of failure of the CPU circuit board . This could result in a blank display or loss of mechanical ventilation. 5 Source: www.accessdata.fda.gov

Critical Manufacturing Process S upply Chain Oversight Issues Sterile Adult Multi-Function Electrodes (Class I) Impact Reason 193 cases recalled (6 per case) Disposable single use MFEs by FDA processed through Gamma Radiation to a S terility Assurance Level (S AL) of 10-6 per IS O 11137. Product sterility is not assured 6 Source: www.accessdata.fda.gov

What are the Current Critical Process Problem Areas for Medical Device Industry Leaders? Complete Practical way to elimination of have visibility and Communicating critical process control of expectations at all OEMs/CMs defects which processes at tier levels of supply affect our 2 and 3 suppliers chain is difficult customers is is difficult to problematic achieve Timeliness of Understanding/ Communication/ orders – enough obtaining Resolution of Suppliers time to obtain customer issues at lower requirements and requirements tier suppliers proper processing 7

Results of Poor S upply Chain Management • Problems with Patient S afety • Poor Product Quality • Product Recalls resulting in: • Damaged company reputation and brand • Added costs • Loss of growth opportunities • Loss of productivity • Increased Production Cost • Additional inspection and oversight • S crap and waste 8

General Quality Management S ystem (QMS ) vs. Critical Manufacturing Process Approach to S upply Chain Management Focus on critical “1 mile deep on the critical process, 1 manufacturing inch wide on the Critical Process Focus quality system” processes “1 inch deep on the critical process, 1 mile wide on the quality system” General Quality Focus General Quality Focus 9

S ome Examples of Critical Manufacturing Processes for Medical Device Companies • Assembly • NDT • Bat t eries • Opt ics • Cable & Wire Harness • Packaging • Cast ing / Forging • PCB • Chemical Processing • Plast ics - Ext rusion • Cleaning • Plast ics - Inj ect ion Molding • Coat ings • Plast ics – Blow Molding • Count erfeit Parts • Power S ources • Elect ronic Displays • Print ed Circuit Board Assemblies • Fluidics • Raw Mat erials • Heat Treat ing • Reagents • Machining • S oft ware • Mat erial Test ing Laborat ories • S t erilization • Measurement / Inspect ion • Welding

What are Key Elements of Good Critical Manufacturing Process S upply Chain Management? Understanding impact on final product quality Industry Continuous standards and Improvement best practices QMS Certification and 3rd Party Accreditation SMEs with Contract critical process Review knowledge Validation planning and execution 11

Role of Supply Chain Management in FDA’s Case for Quality 12

FDA CDRH 2016-2017 S trategic Priorities Establish a national Evaluation System for Medical Devices • Goal: Increase access to real-world evidence to support regulatory decision making • Goal: Increase the use of real-world evidence to support regulatory decision making Partner with Patients • Goal: Promote a culture of meaningful patient engagement by facilitating CDRH interaction with patients • Goal: Increase use and transparency of patient input as evidence in our decision making Promote a Culture of Quality and Organizational Excellence • Goal: S trengthen FDA’ s culture of quality within the Center for Devices and Radiological Health • Goal: S trengthen product and manufacturing quality within the medical device ecosystem 13

FDA CDRH 2016-2017 S trategic Priorities Goal: S trengthen product and manufacturing quality within the medical device ecosystem • As part of the Case for Quality, collaborate with members of the medical device ecosystem to identify, develop, and pilot metrics, successful practices, standards, and evaluation tools that will be specific to the medical device industry and focus on assuring product and manufacturing quality. • Identify external partnerships and mechanisms to support a sustainable, voluntary third party program that will utilize quality metrics, practices, standards, and evaluation tools to assess and promote medical device product and manufacturing quality within industry beyond compliance with regulatory requirements. • Identify FDA policies and practices that will encourage adoption of metrics, practices, standards and evaluation tools that promote medical device product and manufacturing quality, and recognize efforts to exceed baseline expectations of compliance with regulatory requirements. 14

Aligning with Critical to Quality (CtQ) Supplier Quality Support Support Support Industry-Managed FDA Case for Critical to Quality Accreditation Quality FOCUS: Derived from FOCUS: Ensure FOCUS: Improve DFMEA/ PFMEA compliance to critical quality with a CtQ manufacturing process focus requirements 15

What is the Medical Device Industry Doing to Align with FDA’ s Case for Quality Initiative Case for Quality Medical Device Industry-led Initiative Enhanced focus on quality while  Supplier preparation and rigorous audit conducted by a technical expert will maintaining compliance ensure product quality and compliance  In-depth root cause corrective action responses and sustainable Promotion of a root cause implementation required for closure of all non-conformances approach to quality challenges  CAPA training provided to support suppliers  Instant web-based access to real time supplier audit data and CAPA Enhanced transparency  Early warning system enables OEM/CM to take prompt preventative action  OEM, CM, and supplier collaboration improves communication and identifies Stakeholder engagement best practices to address quality issues Regulatory focus on preventative Integrating audit criteria into day to day operations supports a proactive culture  quality practices of preventative quality and standardized operating practices  Critical to Quality methodology Ensuring compliance to critical manufacturing process requirements 16

AdvaMed Case for Quality Best Practices 17

How the Aerospace Industry can Serve as a Model for the Medical Device Industry 18

Medical Device & Aerospace Industry S imilarities • Importance of quality and safety • Life-critical products/ parts/ components • Critical manufacturing processes • Critical Process S upply Chain • Complex multi-tiered Global S upply Chain • S trict regulatory oversight • High cost of product failure 19

Importance of Auditing the Process Adopting a process based approach to auditing enables oversight of supply chains on an enormous scale: Boeing 737 Boeing 787 Boeing 777 Boeing 747 400,000 parts 2.3 million parts 3 million parts 6 million parts Boeing procures 783 million parts in one year 20 Source: Boeing - http://787updates.newairplane.com/787- Suppliers/World-Class-Supplier-Quality

Nadcap: Process to Manage the Aerospace Critical Manufacturing Process Supply Chain Nadcap is an industry managed accreditation program for the Global Aerospace Industry. Nadcap verifies that an audited company has the process capability, necessary equipment, controls, qualified personnel, sub-tier controls etc. to follow process requirements as defined by industry standards and/ or OEM requirements and validates actual compliance. Compliance – Control – Cost S avings – Risk Reduction 21

25 Years of Aerospace S uccess 5,500 audits per year Over 7,500 global accreditations > 85% of the top global 86% of S uppliers credit Nadcap with aerospace companies participate in Nadcap improving quality in the aerospace industry. 17 critical processes 22

Nadcap OEM S ubscribing Members 23

Delivering Results Nadcap OEM Subscriber CtQ Results Suppliers Internal OEM Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 24

Global S upply Chain Focus Nadcap Supplier Audits (2015) 944 2883 1639 Americas Europe Asia  5,466 PRI Audits in 2015  Over 5,500 audits projected in 2016 25