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
2
3
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
Tibial Articular Surface Inserter (Class II)
Source: www.accessdata.fda.gov
Impact Reason
46 units recalled by FDA An increased likelihood of failure of the CPU circuit
blank display or loss of mechanical ventilation.
5
Ventilator (Class II)
Source: www.accessdata.fda.gov
Impact Reason
193 cases recalled (6 per case) by FDA Disposable single use MFEs 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
Sterile Adult Multi-Function Electrodes (Class I)
Source: www.accessdata.fda.gov
7
8
9
General Quality Focus General Quality Focus
“1 mile deep on the critical process, 1 inch wide on the quality system” “1 inch deep on the critical process, 1 mile wide on the quality system”
Critical Process Focus
t erilization
QMS Certification and 3rd Party Accreditation Understanding impact on final product quality Industry standards and best practices Contract Review Validation planning and execution SMEs with critical process knowledge Continuous Improvement
11
12
13
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.
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.
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 Industry-Managed Accreditation FOCUS: Ensure compliance to critical manufacturing process requirements
Critical to Quality FOCUS: Derived from DFMEA/ PFMEA FDA Case for Quality FOCUS: Improve quality with a CtQ focus Support Support Support
16
Case for Quality Medical Device Industry-led Initiative
Enhanced focus on quality while maintaining compliance
Supplier preparation and rigorous audit conducted by a technical expert will ensure product quality and compliance Promotion of a root cause approach to quality challenges
In-depth root cause corrective action responses and sustainable implementation required for closure of all non-conformances CAPA training provided to support suppliers Enhanced transparency
Instant web-based access to real time supplier audit data and CAPA Early warning system enables OEM/CM to take prompt preventative action Stakeholder engagement
OEM, CM, and supplier collaboration improves communication and identifies best practices to address quality issues Regulatory focus on preventative quality practices
Integrating audit criteria into day to day operations supports a proactive culture
Critical to Quality methodology
Ensuring compliance to critical manufacturing process requirements
17
18
19
20 Boeing 737 400,000 parts Boeing 787 2.3 million parts Boeing 777 3 million parts Boeing 747 6 million parts
Source: Boeing - http://787updates.newairplane.com/787- Suppliers/World-Class-Supplier-Quality
21
22
> 85% of the top global aerospace companies participate in Nadcap 5,500 audits per year 17 critical processes
23
24
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9
Nadcap OEM Subscriber CtQ Results
Suppliers Internal OEM
25
Nadcap Supplier Audits (2015)
2883 1639 944
Americas Europe Asia
26
28 Audit Criteria Developed Process Evaluation/ Improvement Corrective Actions Completed Audit Reviewed Auditors Selected
Medical Device Industry leaders manage all key steps
Accreditation Decision Audit Conducted
29 Audit Criteria Developed Process Evaluation/ Improvement Corrective Actions Completed Audit Reviewed Auditors Selected
Medical Device Industry leaders manage all key steps
Accreditation Decision Audit Conducted
30
OEMs/CMs Suppliers PRI Staff
Establish Audit Criteria Audit Criteria: Document containing audit questions to determine compliance to established industry standards and OEM requirements.
31 Audit Criteria Developed Process Evaluation/ Improvement Corrective Actions Completed Audit Reviewed Auditors Selected
Medical Device Industry leaders manage all key steps
Accreditation Decision Audit Conducted
32
33 Audit Criteria Developed Process Evaluation/ Improvement Corrective Actions Completed Audit Reviewed Auditors Selected
Medical Device Industry leaders manage all key steps
Accreditation Decision Audit Conducted
34
General Quality Focus
Critical Process Focus
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 mile deep on the critical process, 1 inch wide on the quality system” “1 inch deep on the critical process, 1 mile wide on the quality system”
Example of MedAccred Audit Criteria
36 Audit Criteria Developed Process Evaluation/ Improvement Corrective Actions Completed Audit Reviewed Auditors Selected
Medical Device Industry leaders manage all key steps
Accreditation Decision Audit Conducted
37
38 Audit Criteria Developed Process Evaluation/ Improvement Corrective Actions Completed Audit Reviewed Auditors Selected
Medical Device Industry leaders manage all key steps
Accreditation Decision Audit Conducted
39
Supplier
PRI
Task Group
PRI
40 Audit Criteria Developed
Process Evaluation / Improvement
Corrective Actions Completed Audit Reviewed Auditors Selected
Medical Device Industry leaders manage all key steps
Accreditation Decision Audit Conducted
41
Process Active Industry Management at all Steps
Audit Criteria Developed
Industry participants create and approve all audit checklists that are used in the program. Auditors Selected
Industry participants set the qualification criteria that is used to select auditors, participate in the interview process and provide on-going annual training Audit Conducted
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. Audit Reviewed
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. Corrective Actions Completed
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 Accreditation Decision
Supplier Accreditation is not granted until approval is provided by OEM Subscribers.
Process Evaluation/ Improvement
Management Council is required to perform an annual audit of entire program to identify areas for improvement.
42
Administ ered by t he Perf ormance Review Inst it ut e (PRI), a not -f or-prof it t rade associat ion,
43
Reduces Risk Improves Patient Safety Assures Quality Products
44
45
Tiers 1 & 2 Tiers 1 & 2 Tier 3 Tier 4 Tier 5
46
47
Molding
Assemblies
Laboratories
48
49
MedAccred Management Council
Task Groups
Cable & Wire Harness Heat Treating PCBA Plastics Sterilization Welding Supported by quality and technical training
50 THE CONNECTION TO OUR PATIENTS
Connie Conboy Director, Business Development & Strategy cconboy@p-r-i.org +1 724 772 7153 Joe Pinto Executive Vice President & Chief Operating Officer jpinto@p-r-i.org +1 724 772 7175 Hannah Godfrey
Business Development hgodfrey@p-r-i.org +44 207 034 1247 Liu Le Manager, PRI Asia Pacific lle@p-r-i.org +86 10 6461 9807 Americas / International Europe Asia Justin McCabe
Business Development jmccabe@p-r-i.org +1 724 772 8693