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Quality Systems Investigation Technique

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An overview of the Quality Systems Investigation Technique used by the Food and Drug Administration (FDA) for on-site inspections. Presented here as a tool for business and industry to use as a guide …

An overview of the Quality Systems Investigation Technique used by the Food and Drug Administration (FDA) for on-site inspections. Presented here as a tool for business and industry to use as a guide for internal and external audits and inspections.

Published in: Business, Technology

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  • 1. Quality SystemsInvestigation Technique
  • 2. WHAT DOES IT ALL MEAN?
  • 3. Investigation of the Quality System Corrective & Preventive Actions Production &Design Controls Process Controls Management Material Equipment & Controls Facility Controls Records, Documents, & Change Controls
  • 4. Learning ObjectivesUnderstand the Quality Systems InvestigationTechnique progressesUnderstand how QSIT impacts ProjectManagementUnderstand meeting QSIT expectationsComplete a Regulatory Training Requirement
  • 5. Systems-based inspections normallyrequire specific coverage of the QualitySystem, and at least one other system.This may account in part for more QualitySystem deficiencies cited in WarningLetters issued after February 1, 2002
  • 6. Project ManagementQSIT Responsibilities
  • 7. How Will Management be Inspected? QSIT Guide FOOD AND DRUG AD MINISTR ATIO N  Purpose and GUIDE TO INSPECTIONS OF QUALITY SYSTEMS Importance  Objectives  Flow chart  Narratives August 1999 Source: www.fda.gov
  • 8. QSIT Progression1. Management Controls2. Design Controls3. Corrective and Preventive Actions4. Production and Process Controls5. Management Controls
  • 9. What FDA Evaluates Duties Responsibilities Authorities
  • 10. Procedures … FDA Looks At Quality Policy Quality Plan Management Review Quality Audit Quality System Procedures and Instructions
  • 11. Assessment“Top Down” - Defined and Documented 1. Quality Policy Management Review Procedures Quality Audit Procedures Quality Plan QS Procedures and Instructions
  • 12. Assessment“Top Down” - Implemented2. Quality Policy and Objectives3. Organizational Structure4. Management Representative5. Management Reviews6. Quality Audits
  • 13. Assessment“Top Down” (At Inspection Conclusion) 7. Quality System Established and Maintained
  • 14. Quality Policy - 820.3(u) The overall intentions and direction of an organization with respect to quality As established by management with executive responsibility
  • 15. Quality System - 820.3(v) The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management
  • 16. FDA’s Authority to HoldManagement Responsible FD&C Act - Section 704(a)(1) 21 CFR 820.20 Case Law - Dotterweich & Park FDA will determine authority and responsibility to the highest level of the firm as well as the corporation or organization.Source: www.fda.gov
  • 17. Verbal Communications:FDA “Looks At”Management with ExecutiveResponsibility  Commitment to quality  Dialogue during daily “wrap-ups”  Commitment to correction and prevention
  • 18. Verbal Communications:FDA “Looks At”Management Representative  Interviewed prior to review of each subsystem  Provide overview of each subsystem  Demonstrate knowledge and understanding of each subsystem  Dialogue during daily “wrap-ups”
  • 19. Verbal Communications:FDA “Looks At” Employees  Familiar with the Quality Policy  Other dialogue
  • 20. Written Records/ DocumentsFDA Looks At Organizational Structure Appointment of Management Representative
  • 21. Written Records/ DocumentsFDA Looks At Documentation that audits were conducted as scheduled. Documentation that management reviews were conducted as scheduled.
  • 22. FDA Access to Audit andManagement Review Reports FDA’s policy relative to the review of quality audit reports is stated in CPG 7151.02 (CPG Manual subchapter 130.300). This policy restricts FDA access to a firm’s audit reports. more...
  • 23. FDA Access to Audit andManagement Review Reports Under the Quality System Regulation, this restriction extends to reviews of supplier audit reports and management reviews. more...
  • 24. FDA Access to Audit andManagement Review Reports However, the procedures that show conformance with 21 CFR 820.50, Purchasing Controls, and 21 CFR 820.20(3)(c), Management Reviews, and 21 CFR 820.22, Quality Audit, are subject to FDA inspection.
  • 25. FDA Access to Audit andManagement Review Reports FDA may look at those portions of these audit reports and reviews that contain corrective and preventive actions if these are the only places these action decisions are documented.
  • 26. At the Conclusion of theInspection ... “Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained.”
  • 27. Identifying and Assigning Regulatory ResponsibilitiesJob Title/Employee Quality System Subpart 820 Quality System Regulation Assignment(s)__________________ B – QS Requirements ___________________________________________________________________ C – Design Controls ___________________________________________________________________ D – Document Controls ___________________________________________________________________ E – Purchasing Controls ___________________________________________________________________ F – ID and Traceability ___________________________________________________________________ G – PandP Conrols ___________________________________________________________________ H – Acceptance Activities ___________________________________________________________________ I – Nonconforming Product ___________________________________________________________________ J – CandP Action (CAPA) ____________________________________________________________________ K – LandP Control ____________________________________________________________________ L – H,S,D&Installation ____________________________________________________________________ M – Records _____________________________________________________________________ N _ Servicing _____________________________________________________________________ 0 _ Statistical Techniques ___________________________________________________
  • 28. Project Management Regulatory Responsibilities• What are the responsibilities?• Where are the gaps?• What are the risks?• What are the consequences?• What are the potential opportunities?• What are the rewards?
  • 29. Management Production & Design Controls Process Controls Corrective & Preventive ActionsMaterial Equipment &Controls Facility Controls Records, Documents, & Change Controls Controls
  • 30. QUESTIONS