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

Transcription

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

2 Agenda Poor Critical Process Supply Chain Management Presents Problems for Medical Device Companies Role of Supply Chain Management in FDA s Case for Quality How the Aerospace Industry can Serve as a Model for the Medical Device Industry Effective Strategies for Oversight and Management of Medical Device Supply Chain Based on Aerospace Industry Success Leveraging Successful Aerospace Strategies for the Medical Device Industry 2

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

4 Critical Manufacturing Process Supply 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:

5 Critical Manufacturing Process Supply 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:

6 Critical Manufacturing Process Supply Chain Oversight Issues Sterile Adult Multi-Function Electrodes (Class I) Impact 193 cases recalled (6 per case) by FDA Reason Disposable single use MFEs processed through Gamma Radiation to a Sterility Assurance Level (SAL) of 10-6 per ISO Product sterility is not assured 6 Source:

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

8 Results of Poor Supply Chain Management Problems with Patient Safety 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 Scrap and waste 8

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

10 Some Examples of Critical Manufacturing Processes for Medical Device Companies Assembly Batteries Cable & Wire Harness Casting / Forging Chemical Processing Cleaning Coatings Counterfeit Parts Electronic Displays Fluidics Heat Treating Machining Material Testing Laboratories Measurement / Inspection NDT Optics Packaging PCB Plastics - Extrusion Plastics - Injection Molding Plastics Blow Molding Power Sources Printed Circuit Board Assemblies Raw Materials Reagents Software Sterilization Welding

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

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

13 FDA CDRH Strategic 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: Strengthen FDA s culture of quality within the Center for Devices and Radiological Health Goal: Strengthen product and manufacturing quality within the medical device ecosystem 13

14 FDA CDRH Strategic Priorities Goal: Strengthen 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

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

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

17 17 AdvaMed Case for Quality Best Practices

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

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

20 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 ,000 parts 2.3 million parts 3 million parts 6 million parts Boeing procures 783 million parts in one year 20 Source: Boeing - Suppliers/World-Class-Supplier-Quality

21 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 Savings Risk Reduction 21

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

23 23 Nadcap OEM Subscribing Members

24 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

25 Global Supply Chain Focus Nadcap Supplier Audits (2015) Americas Europe Asia 5,466 PRI Audits in 2015 Over 5,500 audits projected in

26 26 Effective Strategies for Oversight and Management of Medical Device Supply Chain Based on Aerospace Industry Success

27 Effective Strategies for Oversight and Management of Medical Device Supply Chain Based on Aerospace Industry Success Identify each critical manufacturing process technology where a process failure could result in defects affecting patient safety Prioritize the key critical manufacturing process technologies Address each critical manufacturing process separately in order to develop process requirements based on industry standards and best practices Follow the Nadcap methodology to validate the critical manufacturing process supply chain capability at all tiers

28 Process to Manage Medical Device Supply Chain Modeled after Aerospace Industry for each Critical Manufacturing Process Audit Criteria Developed Process Evaluation/ Improvement Accreditation Decision Medical Device Industry leaders manage all key steps Auditors Selected Audit Conducted Corrective Actions Completed Audit Reviewed 28

29 Process to Manage Medical Device Supply Chain Modeled after Aerospace Industry Audit Criteria Developed Process Evaluation/ Improvement Accreditation Decision Medical Device Industry leaders manage all key steps Auditors Selected Audit Conducted Corrective Actions Completed Audit Reviewed 29

30 Audit Criteria Development Establish OEMs/CMs PRI Staff Suppliers Audit Criteria Audit Criteria: Document containing audit questions to determine compliance to established industry standards and OEM requirements. 30

31 Process to Manage Medical Device Supply Chain Modeled after Aerospace Industry Audit Criteria Developed Process Evaluation/ Improvement Accreditation Decision Medical Device Industry leaders manage all key steps Auditors Selected Audit Conducted Corrective Actions Completed Audit Reviewed 31

32 Auditors are Subject Matter Experts Audits are conducted by Subject Matter Experts (SMEs) for each critical process area SME Auditors are selected and approved by industry technical experts participating in the critical process Task Groups Auditors have considerable experience in each critical process they audit and receive initial and continued training from PRI and industry critical process Task Groups 32

33 Process to Manage Medical Device Supply Chain Modeled after Aerospace Industry Audit Criteria Developed Process Evaluation/ Improvement Accreditation Decision Medical Device Industry leaders manage all key steps Auditors Selected Audit Conducted Corrective Actions Completed Audit Reviewed 33

34 General Quality Management System (QMS) vs. Critical Manufacturing Process Approach to Supply Chain Management Critical Process Focus 1 mile deep on the critical process, 1 inch wide on the quality system Critical Process Audits verify the Supplier has process capability, necessary equipment, controls, qualified personnel, sub-tier controls, and the ability to follow the process requirements as defined by the OEM requirements and/or industry specifications, and validates actual compliance. 1 inch deep on the critical process, 1 mile wide on the quality system General Quality Focus 34

35 Critical Process Audits consist of: Verification of General Quality Systems (QMS) effectiveness for the critical process area being audited Critical Process specifications (audit criteria) and OEM requirements Critical processfocused job audits Example of MedAccred Audit Criteria

36 Process to Manage Medical Device Supply Chain Modeled after Aerospace Industry Audit Criteria Developed Process Evaluation/ Improvement Accreditation Decision Medical Device Industry leaders manage all key steps Auditors Selected Audit Conducted Corrective Actions Completed Audit Reviewed 36

37 Audit Results eauditnet All audits are electronically recorded in a in-house web based system called eauditnet Auditor The Auditor will submit into eauditnet completed checklist, required attachments and write-up and grading of nonconformances eauditnet Upon Audit report submission, all automatic notifications are sent to designated OEM, Suppliers, PRI Staff and Auditors and time control metrics are automatically initiated and sent to OEMs 37

38 Process to Manage Medical Device Supply Chain Modeled after Aerospace Industry Audit Criteria Developed Process Evaluation/ Improvement Accreditation Decision Medical Device Industry leaders manage all key steps Auditors Selected Audit Conducted Corrective Actions Completed Audit Reviewed 38

39 CAPA Process Supplier Supplier submits root cause analysis and objective evidence of corrective actions for each non-conformance PRI PRI Staff Engineer (SME) reviews the audit report, works with the Supplier to close and approve corrective actions Task Group Reviews each non-conformance, approves or rejects the Supplier s response All issues must be resolved prior to closure of the audit by Task Group Votes to accredit the Supplier if all corrective actions are acceptable If the audit fails, Supplier must start the audit process again (initial audit) PRI Issues certificate of accreditation (period of validity dependent on merit status) Schedules next audit (reaccreditation audit) 39

40 Process to Manage Medical Device Supply Chain Modeled after Aerospace Industry Audit Criteria Developed Process Evaluation / Improvement Accreditation Decision Medical Device Industry leaders manage all key steps Auditors Selected Audit Conducted Corrective Actions Completed Audit Reviewed 40

41 Industry Managed Supply Chain Points of Oversight Process Audit Criteria Developed Auditors Selected Audit Conducted Audit Reviewed Corrective Actions Completed Accreditation Decision Process Evaluation/ Improvement Active Industry Management at all Steps Industry participants create and approve all audit checklists that are used in the program. Industry participants set the qualification criteria that is used to select auditors, participate in the interview process and provide on-going annual training OEM Subscribers can participate in an Observation Audit. This process allows the OEM Subscriber to attend an audit with the purpose of evaluating auditor performance and adequacy of audit criteria. Feedback is shared with Task Group and Management Council. OEM Subscribers have access to all audits results including any historical audit data. Access is provided the moment the Auditor submits the results of audit into eauditnet. OEM Subscribers evaluate corrective actions that are put in place by Supplier to ensure they are adequate and effective. This oversight is documented by requiring a vote to Approve or Disapprove results of each audit Supplier Accreditation is not granted until approval is provided by OEM Subscribers. Management Council is required to perform an annual audit of entire program to identify areas for improvement. 41

42 42 Leveraging Successful Aerospace Strategies for the Medical Device Industry

43 Learning from the Aerospace industry, the Medical Device industry founded MedAccred An industry-managed critical process supply chain quality program Reduces Risk Assures Quality Products Improves Patient Safety Administered by the Performance Review Institute (PRI), a not-for-profit trade association, on behalf of leaders in the Medical Device Industry. 43

44 Through MedAccred, the industry is streamlining requirements through technical Task Groups, Multiple Customer Requirements Medical device industry-agreed approach to Process Validation included in audit criteria. 44

45 Through MedAccred, the industry is reaching further down the supply chain, Tiers 1 & 2 My Direct Suppliers Tiers 1 & 2 My Supply Chain Tier 3 Tier 4 Tier 5 45

46 Through MedAccred, the industry is conducting fewer but more rigorous critical process audits with experienced technical experts, Individual Customer Audits 46

47 MedAccred Critical Manufacturing Process Task Groups Active Future (potential development) Cable & Wire Harness Heat Treating Plastics - Injection Molding Printed Circuit Board Assemblies Sterilization Welding Assembly Batteries Casting / Forging Chemical Processing Cleaning Coatings Counterfeit Parts Electronic Displays Plastics - Extrusion Fluidics Machining Material Testing Laboratories Measurement / Inspection NDT Optics Packaging PCB Power Sources Raw Materials Reagents Software 47

48 Why are Industry Leaders Utilizing Industry-led Initiatives to Address Critical Process Supply Chain Issues? OEMs/CMs Will bring consensus industry standards, best practices and OEM processing requirements to all levels of the supply chain Participation will differentiate suppliers who are committed to improvement Visibility of critical manufacturing process capability will reach all levels of supply chain Suppliers Improved flowdown of requirements to all tiers in the supply chain. Reduced OEM audit frequency. Audits by SMEs and a rigorous CAPA process will lead to improved process quality Process discipline will lead to reduce scrap, rework, and improved quality 48

49 Through MedAccred, the industry is encouraging industry-wide involvement. MedAccred Management Council YOU Task Groups Cable & Wire Harness Heat Treating PCBA Plastics Sterilization Welding Supported by quality and technical training 49

50 Concluding Thoughts To get your company involved in MedAccred or for more information please visit: THE CONNECTION TO OUR PATIENTS Americas / International Europe Asia Joe Pinto Executive Vice President & Chief Operating Officer jpinto@p-r-i.org Connie Conboy Director, Business Development & Strategy cconboy@p-r-i.org Justin McCabe Sr. Specialist, Business Development jmccabe@p-r-i.org Hannah Godfrey Sr. Specialist, Business Development hgodfrey@p-r-i.org Liu Le Manager, PRI Asia Pacific lle@p-r-i.org