Published on March 19, 2014
Supplier Management: A Primer for Meeting FDA Requirements Managing Relationships with Your Third-Party Vendors, Suppliers and Auditors By: Martin Browning, President & Co-Founder, EduQuest, Inc. www.EduQuest.net or email Martin@EduQuest.net Washington, DC
EduQuest EDUcation: QUality Engineering, Science and Technology Global team of FDA compliance experts based near Washington, DC, with staff located in U.S. and Europe Founded by former senior officials and expert investigators from FDA’s Office of Regulatory Affairs (ORA) Headquarters Advisors to medical device, pharmaceutical, biologics, tobacco and food companies since 1995 – Fortune 500s and Start-Ups Authorities on audits & training for Quality Systems, Supplier Control, Risk Management, Part 11, Validation, and Inspection Readiness 2© 2014 EduQuest, Inc.
Martin Browning President & Founder, EduQuest 22 years with U.S. FDA as expert investigator and rule-maker Special Assistant to Associate Commissioner of Regulatory Affairs Co-Author of 21 CFR Part 11 for Electronic Records & Electronic Signatures Former chair of U.S. ISO 9000 committee; served as FDA liaison to the Global Harmonisation Task Force (GHTF) Helped to develop the Quality System Regulation (QSR) for Medical Devices Chair of EduQuest’s classroom training courses (www.EduQuest.net) , & Technology
Managing Relationships with Third-Party Vendors, Suppliers and Auditors Overview • What’s Behind the Drive to Outsource – A growing problem • FDA Requirements and Expectations – Who’s responsible for what? – Selecting partners – Notifying FDA • What NOT to Outsource • Common Pitfalls & Advice for Avoiding Them • Looking Ahead at the Trends © 2014 EduQuest, Inc. 4
© 2014 EduQuest, Inc. 5 What’s Behind the Drive to Outsource “What can be outsourced? Everything, except responsibility.”
© 2014 EduQuest, Inc. 6 What’s Behind the Drive to Outsource Why outsource? • Cost reduction • Better focus on “core” business • Reduce or control personnel “overhead” • Improve organizational performance
© 2014 EduQuest, Inc. 7 What’s Behind the Drive to Outsource Outsourcing IT, for example • Reduce the cost of supporting an IT infrastructure • Improve the organization’s efficiency and performance • Comply with the company’s strategic direction
© 2014 EduQuest, Inc. 8 What’s Behind the Drive to Outsource Outsourcing Manufacturing, for example • Reduce the cost of supporting a manufacturing facility (or unique line, or special product) • Improve the organization’s efficiency and performance • Comply with the company’s strategic direction and core expertise (development, marketing, etc.)
© 2014 EduQuest, Inc. 9 FDA Requirements and Expectations • You, the regulated entity, are responsible for compliance with all of the applicable regulatory requirements. • If you outsource, you are responsible for the performance of your outsourcing partners.
© 2014 EduQuest, Inc. 10 FDA Requirements and Expectations • If you outsource IT, you are still responsible for assuring that all required activities are performed and documented. • Monitoring is critical, so typically a more robust quality organization is needed for audit, oversight, etc. (note that this also can be outsourced)
© 2014 EduQuest, Inc. 11 FDA Requirements and Expectations • If you outsource manufacturing, you are still responsible for assuring that all specifications are met, required activities are performed, data is maintained, and regulatory requirements are met. • Monitoring is critical, so typically a more robust quality organization is needed for audit, oversight, etc. (note that this also can be outsourced)
© 2014 EduQuest, Inc. 12 Select Partners Compatible with Your Standards and Integrity • Those who outsource must have established: – Company moral and integrity standards clearly stated in policy documents – Mission statement – Quality policy – Management responsibilities – Quality responsibilities
© 2014 EduQuest, Inc. 13 Select Partners Compatible with Your Standards and Integrity • Management (not Quality) must have processes for evaluating potential partners (suppliers, sub- contractors, etc.) – Survey, audit, selection process – CAPA processes – Clearly defined risk analysis – Clearly defined regulatory compliance processes
© 2014 EduQuest, Inc. 14 Select Partners Compatible with Your Standards and Integrity • Potential partners should have already defined their own moral standards and integrity and these must be a good “fit” • Potential partners must understand and be willing to fully comply with regulatory requirements • Potential partners must understand and be willing to accept regulatory risks
© 2014 EduQuest, Inc. 15 Notify FDA About Your Partners • Disclosure (in advance) is required for some submissions • Disclosure is made during inspections, discussions, meetings, formally and informally • Some outsourcing partners are required to register with the FDA
© 2014 EduQuest, Inc. 16 Notify FDA About Your Partners • FDA has authority to inspect most (if not all) outsourcing partners • A corporation can outsource to itself but… • Changes of suppliers may require Agency notification • Document everything!
© 2014 EduQuest, Inc. 17 Common Pitfalls of Outsourcing • A partner changes processes, personnel, locations, ownership, etc. without notifying you • If it’s not in the contract… • The service, system, software, product, etc. doesn’t really exist…yet • A partner has your data…now what?
© 2014 EduQuest, Inc. 18 How to Avoid the Pitfalls • Diligent audits • More diligent monitoring • Review the data • Make sure everything is in writing • Train them on your requirements, regulatory requirements -- and retrain as necessary • Constantly measure compliance
© 2014 EduQuest, Inc. 19 What Should NOT be Outsourced • Activities where a company holds the technical expertise and does not want to give away control • Activities that cannot be monitored • Activities involving specific commitments to FDA or other government Agencies
© 2014 EduQuest, Inc. 20 How to Protect Your Company • Contracts and Service Level Agreements (SLAs) – Responsibility and processes must be established for handling non-conformances – Responsibility for initial investigation, root cause analysis, follow-up, correction, corrective action, etc. must be established – Issue closure must be clearly defined and assured
© 2014 EduQuest, Inc. 21 Keys to Supplier Oversight and Monitoring • Monitor and Trend – Monitor based upon defined processes and defined risk – Collect key process data on performance (control points) – Trend past, current, and future performance relative to expectations and quality goals
© 2014 EduQuest, Inc. 22 Keys to Supplier Oversight and Monitoring • Continuous Improvement – Actions based upon defined risks • Reevaluate risks • Reevaluate processes – Predefined mitigations • Measure effectiveness • Refine mitigations
© 2014 EduQuest, Inc. 23 Looking Ahead at Trends • FDA currently inspects outsourced activities based upon submissions (GLP, GCP), upon risk (contract sterilizers, etc.), or upon complaint – Inefficient – Costly – Too late – Embarrassing
© 2014 EduQuest, Inc. 24 Looking Ahead at Trends • FDA’s movement toward Quality Systems and risk-based approaches for Agency activity logically leads toward a QS approach in the GLP and GCP areas (periodic quality systems inspections rather than submission specific inspections) • Preventive rather than reactive oversight is far more efficient
© 2014 EduQuest, Inc. 25 Looking Ahead at Trends • Increased use of standards and international harmonization efforts • More regulation of research and development (standards, regulation, guidance) • Continued growth of outsourcing • New data risks • More regulatory oversight
© 2014 EduQuest, Inc. 26 Need Help with Your Supplier Management? Contact: EduQuest, Inc. 1896 Urbana Pike, Suite 14 Hyattstown, MD 20871 USA (near Washington, DC) +1 (301) 874-6031 info@EduQuest.net www.EduQuest.net To subscribe to free monthly EduQuest-ions & Answers e- newsletter: http://bit.ly/EduQuestQAsignup
© 2014 EduQuest, Inc. 27 For continued news & updates: Subscribe to free monthly EduQuest-ions & Answers e-newsletter: http://bit.ly/EduQuestQAsignup
EduQuest EDUcation: QUality Engineering, Science and Technology FDA Compliance Training Classes available from EduQuest: Managing and Auditing Supplier Quality (Learn to measure and monitor supplier quality systems, processes and documentation) FDA Auditing of Computerized Systems and Part 11/Annex 11 (FDA’s expectations for data integrity. Includes 3 mock FDA audits of real-world computer systems.) Quality Risk Management for FDA/ICH Q9 Compliance (How to identify, assess, and mitigate GxP risks while meeting FDA rules and international guidance) The CAPA Clinic: Effective CAPA Systems, Failure Investigations and Complaint Management (Improving your CAPA system through better data collection, management reporting, trending, and root cause analysis) QSR Compliance Basics: Complying with FDA’s 21 CFR 820 Quality System Regulation (Fully understand your company’s obligations for Quality Systems under 21 CFR 820) Design Control for Medical Devices (How FDA expects you to develop, implement, and manage design controls) All offered publicly or as on-site, on-demand classes -- when and where you need them. Details at www.EduQuest.net , or Email: Info@EduQuest.net
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