Advancing Medical Device Quality Through Supply Chain Process Accreditation. Program Overview & Value Proposition

Transcription

1 1 Advancing Medical Device Quality Through Supply Chain Process Accreditation Program Overview & Value Proposition

2 2 Content Objective Program Risk Analysis Background Confidentiality of Information Chronology Case Studies Benefits Aerospace (Airline Passenger Safety Medical Device Industry Trends) Medical Device Industry OEMs Aerospace (Nadcap Subscriber Critical Medical Device Industry Suppliers Process Escapes) Scope of Project Transportation & Power Generation (OEM) Critical Process Areas of Interest Medical Device (Electronic Circuits Existing PRI Processes and Products Hypothetical) Process Map Financials Timeline High Level Summary Cost Structure 2013 Meetings & Details Template for Cost/Benefit Calculation Program Development Activity (Outside of Roundtable Meetings) Requests to Medical Device Industry Stakeholders

3 3 Objective To demonstrate to the medical device industry the value of creating an industry managed supply chain oversight program (MedAccred) that will reduce risk to patient safety, assure quality products and compliance with requirements as they apply to critical processes

4 4 Background Increased number of recalls attributed to supplier quality issues Overall increased interest in outsourcing and globalization of the supply chain, thereby increasing the challenge of oversight Purchasing controls is one of the top ten cited FDA 483 observations for medical device quality system violations Purchasing controls has been the target of several enforcement actions (warning letters, consent decrees)

5 5 Chronology PRI was approached by several medical device industry OEMs to determine applicability of a Nadcap-like program (Aerospace) for their industry PRI gathered information, presented at industry events, and met individually with multiple OEM supply chain quality executives 5 December 2012 Initial Medical Device Industry Roundtable meeting held in Chicago, Il (5Dec12) Attendees included 19 medical device industry stakeholders representing 15 different OEMs and suppliers Interest expressed in further exploring an industry managed program for the medical device industry Value proposition sub-team established (GE Healthcare, Stryker Corp, Baxter Healthcare Corp and Philips Healthcare)

6 6 Chronology (cont.) 2013 Status eauditnet (web-based audit management software) demonstration conducted (5Feb13) 10 medical device industry stakeholders represented Value Proposition Sub-Team Meeting (13Feb13) Draft Value Proposition document created 5Dec12 Roundtable follow-up meeting/observation of Dallas Nadcap meeting (20-22Feb13) Discussed Value Proposition document Identified how and who should be involved in promoting the value and importance of concept Recap Telecom (13Mar13) Reviewed progress and actions from 5Dec12 and 22Feb13 meetings Discussed Letters of Intent Proposed initial 4 special process areas for proof of concept audits (Electronic Circuits - PCBAs, Electronics Cable & Harnesses, Heat Treat and Welding) April 2013 Proof of Concept audit (welding) conducted Roundtable Meeting (15May13) Discussed: Internal OEM Buy-in, engaging the supply chain, PoC audit results, forming special process task groups, reviewed DRAFT program documents, and next steps June 2013 Program established as MedAccred and Management Council began regular teleconferences 5 Task Groups formed (Electronic Circuits PCBAs, Electronics Cable & Harnesses, Heat Treating, Sterilization, Welding) 3 Management Council Sub-Teams formed (Proof of Concept Audits, Program Documents and External Communications & Strategy) MedAccred Management Council Meeting (28Aug13) Year to date progress reviewed 12 month program development strategy agreed

7 7 Next Steps Ongoing signature of Letters of Intent Continue to develop critical mass of industry stakeholders (OEMs and suppliers) Current active participants in program development to contact less active participants OEMs to identify suppliers and suggest representatives for participating in the program Conduct proof of concept (PoC) audits in four technology areas (Electronic Circuits, Electronics Cable & Harnesses, Welding, Heat Treatment) Task Groups to begin audit checklist development, auditor recruitment, etc. Continue to conduct regular Management Council face to face meetings and biweekly conference calls to provide status updates on sub-team and task group activity and continue program development momentum Introduce MedAccred concept to FDA Signature of Program Development Agreements

8 8 Benefits to Medical Device Industry Promotes a philosophy of continuous improvement and a culture of patient safety and quality for all participants Enhances compliance and quality management system effectiveness throughout the industry Promotes best practices to assure patient safety and quality Promotes application of industry and technical standards/practices Provides an opportunity for collaboration between suppliers and OEMs Improves visibility of industry requirements to sub-tier suppliers Similar program in aerospace industry has 20 year history of successful performance and regulatory acceptance

9 Benefits to Medical Device Industry (cont.) 9 Promotes least burdensome approach by reducing redundant process audits by multiple customers Enables reallocation of resources to other areas requiring attention Provides real-time and consistent visibility of supply chain quality Aligns with FDA s Case for Quality strategic initiative

10 Benefits to Medical Device Industry OEMs 10 Establish stringent industry consensus audit criteria based on industry and specific OEM requirements that ensure compliance and quality of devices, reduce the risk to patient safety and will satisfy the requirements of all participants Conduct in-depth special process audits that are compliant and consistent to accepted industry/technical standards and conducted by industry recognized and approved Subject Matter Experts. Covers 3 areas: 1. Assess effectiveness of suppliers QMS at the special process level; 2. Audits based on robust core and OEM-specific checklists; 3. Process-focused Product Audits

11 Benefits to Medical Device Industry OEMs (cont.) 11 Provides greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements (e.g. FDA, ISO 13485, MDD, etc.) Identify and reduce risk of exposure to lower-quality suppliers and reduction of costly recalls Provides early warning notification to OEMs of supply chain quality issues Provides complete visibility of audit results and corrective actions taken in a secure and retrievable format Program reduces cost of non-quality Program reduces cost of compliance

12 Benefits to Medical Device Industry OEMs (cont.) 12 Program frees up OEM resources to focus on supplier development opportunities and/or problem area resolution Improves flow down of OEM requirements to sub-tier suppliers Makes the supplier selection process more efficient Global supply chain visibility through a web based system to support and improve efficiency in industry managed auditing and accreditation system (eauditnet). Supports procurement to identify accredited suppliers (Qualified Supplier List) Supports supplier risk management activity Shared pool of trained, recognized and approved subject matter experts among OEMs

13 Benefits to Medical Device Industry 13 Suppliers Provides consistent/standardized critical process audits accepted by the medical device industry resulting in fewer redundant onsite audits by multiple OEMs Can use accreditation to increase client-base and opportunities across the medical device industry Enhances the supplier s compliance status Medical device industry-accepted and consistent technical requirements leading to process discipline, greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost.

14 Benefits to Medical Device Industry 14 Suppliers (cont.) Helps suppliers develop a structured approach to special process and product Opportunity to participate in development of audit criteria and the accreditation program 85% of suppliers report quality improvements after accreditation, including reducing scrap rates, reworks, escapes and defective products (from aerospace survey data)

15 15 Critical Process Areas of Interest Casting/Forging Chemical Processing Cleaning Coatings Electronics Displays Electronic Circuits - PCBAs**** Power sources/supplies** Cable & Harnesses*** Fluidics (serum samples through instruments via micro pumps) Heat Treatment** Machining Laser Etch Material Testing Laboratories Measurement/Inspection Non-Destructive Testing Optics (sample color changes using spectrophotometers) Packaging Sterile Raw Materials Re-agent (hospital lab consumable products) Resins Composites Injection Molding Sterilization**** Software* Hosted Services Welding* KEY: BOLD - PRI currently has checklists addressing these Critical Process/Product areas * - Number of votes received by 22Mar13 Dallas Roundtable participants for conducting Proof of Concept audits RED - Active Revision Task Groups Date: 30 August as of June

16 Existing Nadcap Processes and Products 16 Special Processes Systems & Products Non-Destructive Testing Coatings Aerospace Quality Systems Electronics Welding Non-Conventional Machining Composites Fluid Distribution Systems Chemical Processing Conventional Machining as a Special Process Elastomer Seals Sealants Heat Treating Surface Enhancement Future Processes Materials Testing Laboratories Non Metallic Materials Testing Raw Materials Castings & Forgings Measurement & Inspection Non Metallic Materials Manufacturing The Medical Device Industry has expressed interest in these Critical Processes Revision and Products Date: 30 August 2013

17 MMC Meeting (Pittsburgh, PA) 8/28/13 Proposed MedAccred Development Plan (28Aug13 29Aug14) MMC Meeting (Minneapolis, MN) 10/31/13 MMC Meeting (Pittsburgh, PA) 12/5/13 MMC Meeting (Location TBD) 3/19/14 MMC Meeting (Location TBD) 6/18/14 17 Start 8/28/13 September November January March May July Internal OEM Buy-in 8/28/13-1/3/14 (ASK) OEMs issue supplier mandates as applicable 4/1/14-8/29/14 (ASK) Identify # of Suppliers in Supply Base 8/28/13-10/31/13 (ASK) OEMs sign Program Development/Subscriber Agreements 10/1/13 3/28/14 Draft Program Documents 8/28/13-12/5/13 Conduct PoC Audits 8/28/13-3/28/14 Review PoC Audit Results for Value 8/28/13-3/28/14 Approach and gain buy-in from Regulatory Agencies 9/30/13-6/27/14 Define Auditor Requirements/Hiring 11/4/13-6/27/14 Validate Software 8/28/13-6/27/14 Configure eauditnet to support MedAccred Wed 8/28/13 - Fri 6/27/14 Approach Industry Associations 11/4/13-8/29/14 Rally external stakeholders for Program buy-in 4/1/14-8/29/14 European and Asian OEM engagement 4/1/14-8/29/14 Approach broader Supply base 1/6/14-8/29/14 Finish Fri 8/29/14 Key FDA Meetings (CDRH and OGROP) 10/1/13-10/29/13 Release MedAccred Program Document (PD1300) 12/5/13 (PRI) Present strategy for supplier engagement 12/5/13 Launch Supplier Support Committee 4/1/14 Seek FDA follow-up meeting/progress report 4/1/14 - Thu 5/1/14 OEM Responsibility PRI Responsibility Joint Responsibility

18 Task Group Development Timeline (28 August 2013 Q4 2014) 18 MMC Meeting (Pittsburgh, PA) 8/28/13 MMC Meeting (Minneapolis, MN) 10/31/13 MMC Meeting (Pittsburgh, PA) 12/5/13 MMC Meeting (Location TBD) 3/19/14 MMC Meeting (Location TBD) 6/18/14 MMC Meeting (Location TBD) 9/17/14 MMC Meeting (Location TBD) 12/3/14 Start 8/21/13 Today 4th Quarter 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter (STL) Checklist development 8/21/13 - Fri 3/28/14 (STL) Checklist refinement 5/2/14 - Tue 9/30/14 (WLD) Ongoing checklist review 8/21/13-1/31/14 (WLD) Define auditor requirements/hiring 8/21/13-1/31/14 PoC 9/9/13-9/27/1 3 PoC 9/30/ 13-10/18 /13 (EC) Checklist review 9/30/13-2/14/14 (EC) Define auditor requirements/hiring Mon (HT) 9/30/13 Ongoing - Fri 2/14/14 checklist review 10/21/13-3/4/14 (HT) Define auditor requirements/hiring PoC 12/2/ 13-12/20 /13 (WLD) Pilot audit of revised checklists 2/3/14-6/20/14 (EC) Pilot audit of revised checklists 2/17/14-7/7/14 (CH) Ongoing checklist review 12/23/13 - Wed 4/30/14 (CH) Define auditor PoC 4/1/14-5/1/14 (HT) Pilot audit of revised checklists 3/5/14 - Mon 8/4/14 requirements/hiring Develop Task Group Operating Procedures as applicable 10/1/13-9/15/14 (STL) Define auditor requirements/hiring 5/2/14-9/30/14 (WLD) Release checklists for supplier preparation 6/23/14-11/7/14 (CH) Pilot audit of revised checklists 5/1/14-9/17/14 (STL) Pilot audit of revised checklists 10/1/14-12/19/14 (EC) Release checklists for supplier preparation 7/8/14-11/24/14 (HT) Release checklists for supplier preparation 8/6/14-12/19/14 (CH) Release checklists for supplier preparation 9/18/14-12/19/14 Finish Fri 12/19/14 Key Electronic Circuits - PCBA (ASK) OEMs sign Prog. Dev. Agreements 10/1/13 FDA Meetings (CDRH and OGROP) 10/1/13-10/29/13 (ASK) OEMs sign Subscriber Agreements 1/6/14 (ASK) OEMs issue supplier mandates as applicable 4/1/14 Launch Supplier Support Committee 4/1/14 Electronics C & H Heat Treating (ASK) Identify # of Suppliers in Supply Base 8/28/13-10/31/13 Release MedAccred Program Document (PD1300) 12/5/13 Sterilization Welding

19 19 Program Risk Analysis Risks of developing a program/not doing it right Not timely No critical mass Proof of Concept audits not showing much Cost could go up without critical mass Risks to implementing a program Will find suppliers that aren t capable increased exposure Could mean more work for OEM short term stretch on resources Finding enough/the right SMEs to conduct audits Agency acknowledgement OEM may still have to conduct special process audits

20 Confidentiality of Information Addressed in Nadcap Operating Procedures (NOP): 20 NOP-001 describes the Nadcap program These Operating Procedures shall govern the operations of the Nadcap Program. This document establishes the policies for how Nadcap shall meet the requirements defined in SAE AS7003. Nadcap Management Council (NMC) and all Nadcap Task Groups and committees shall operate in accordance with these procedures and all referenced documents. NOP-002 describes the roles and functions around Task Groups.

21 Confidentiality of Information (cont.) 21 eauditnet security features: eauditnet implements operating procedures: Each Company has one (or more) administrator(s) who are verified by PRI before any other users can be associated with that Company Each user has unique credentials, and is only associated with a Company by that Company's administrator(s) Each user can only access audits/functions relevant to their company and roles eauditnet uses standard IT security best practices: All eauditnet/program data is delivered over Secure Socket Layer ( https ) All system activity is logged Audit data is stored behind multiple firewalls, and physical safeguards are in place PRI and SAE have regular information security audits: PCI compliance External penetration testing, etc

22 22 Case Studies Aerospace (Airline Passenger Safety Trends) Aerospace (Nadcap OEM Critical Process Escapes) Transportation & Power Generation (OEM) Medical Device (Electronic Circuits Hypothetical)

23 Aerospace (Airline Passenger Safety Trends) Accidents/Year Casualties/year 4500 PRI - Products Removed, Suspended, Recalled or Stopped Number of Nadcap Audits/year *Data from Aviation Safety Network and NTSB

24 Major accidents/million hrs flown Serious accidents/million hrs flown Injury accidents/million hrs flown Damage accidents/million hrs flown Aircraft hours shown in Millions Number of Nadcap Audits (cumulative) PRI - Products Removed, Suspended, Recalled or Stopped *Data from Aviation Safety Network and NTSB Since March 20, 1997, aircraft -10 or more seats 24 scheduled passenger service have been operated under 14 CFR 121. Definitions of NTSB Classifications: Major - an accident in which any of three conditions is met: 1. a Part 121 aircraft was destroyed, or 2. there were multiple fatalities, or 3. there was one fatality and a Part 121 aircraft was substantially damaged. Serious - an accident in which at least one of two conditions is met: 1. there was one fatality without substantial damage to a Part 121 aircraft, or 2. there was at least one serious injury and a Part 121 aircraft was substantially damaged. Injury - a nonfatal accident with at least one serious injury and without substantial damage to a Part 121 aircraft. Damage - an accident in which no person was killed or seriously injured, but in which any aircraft was substantially damaged.

25 Aerospace OEM - Critical Process Escapes 25 Internal Data Provided by Nadcap Subscriber Supplier SP Process Internal SP Process No. of Escapes 78% decrease as of (6/09)

26 Transportation & Power Generation 26 (TPG) Program Fastener Example Event: OEM experienced a product escape due to a faulty fastener and were forced to make an expensive repair Included in OEM Recourse: Requested a PRI NDT audit for their fastener supplier TPG Audit Results: NDT audit uncovered cracks not found during initial inspection and process control violations that would have prevented the cracks Pre-TPG Program: Focus was on certifying the component (product-centric)

27 Medical Device Quality Related Product Recall (Hypothetical) 2010: FDA issues a Class II recall on an Automated External Defibrillator ¹. Root cause: Printed Circuit Board Assembly (Electronic Circuits) 27 Specific rootcauses Supplier has incorrectly applied solder flux Ineffective cleaning Product failure/recall 20,525 devices were recalled Contamination could have lead to inoperability Threat to life & profits Although individual supplier could resolve issue, the industry remains exposed Customers remain exposed to potential consequences Highly likely industry will face similar issues from other suppliers (1) Trautman, K. (2010). Purchasing Controls Background & Examples. Retrieved November 02, 2012, from FDANews.com

28 Medical Device Quality Related Product Recall (Hypothetical) (cont.) How would Nadcap address this issue? Root cause: Printed Circuit Board Assembly (Electronic Circuits) 28 Supplier has incorrectly applied solder flux Ineffective cleaning Nadcap process compliance is used as a preventative measure: AC7120 Revision B audit criteria for circuit card assembly 17.1 Reflow Soldering C Are soldering defects including solder joint touchup identified, recorded and addressed in a continuous improvement plan? C Is the cleaning method being used as per the procedure and is the maximum time permitted between reflow and cleaning being observed? Audit Note: Maximum allowed time of 8 hours unless otherwise specified by customer or manufacturer s recommendation. 20 Coatings and Encapsulation 20.1.C Is there objective evidence of cleanliness verification?

29 29 Cost Structure Program Development and Setup fee (one-time per-subscriber fee): 1-14 Large OEMs: USD > 15 Large OEMs: USD (at initial program launch) Small OEMs A lower fee to be determined Program Operations fee (annual per-subscriber fee): USD Small OEMs USD 5000 Shared Program Administration fee (annual per-subscriber fee): USD for all new Subscribers. Fees in subsequent years based on total number of Subscribers Small OEMs: USD Smaller OEMs will not be able to participate in Management Council activities and will only be given access to their own suppliers data Number of Subscribers New >11 Administration Fee $30,000 $30,000 $25,000 $20,000 Supplier Audit Pricing (per-audit fee including travel costs) Based on current auditor daily fee of $420 per day. Will be increased as Auditor fees and travel costs increase in subsequent years. Stand Alone Audits (includes travel costs) Americas & Asia UK (Pound) Europe (Euro) 1 Day $4, Day $5, Day $6, Day $8, Day $9, Application Fee included Follow-up Audits For Verification Of Corrective Action 1 Day $4, Each Added Auditor Day $1, * Revision A travel Date: surcharge 30 August will 2013 be added (expected to be between USD 1000 and 2000) for Asia-Pacific and South American audits, and for ITAR/EAR audits outside of North America

30 30 OEM Cost/Benefit Template What number of Critical Process Audits currently performing? How many can be eliminated? What is the cost to conduct these audits? Travel/Time savings? Can the QMS audits currently being conducted by OEMs be reduced? cgmp compliance Intangibles Draw from entire med-tech industry expertise OEM experts could observe audits conducted by Subject Matter Experts

31 31 Upcoming MMC Meetings Next Teleconference 11 September, 11:00 EST Face to Face 31 October, Minnesota MN To follow the MD&M conference 17 December, Pittsburgh PA