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ASQ Presentation Lean Mgt Reviews

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Presented Lean and Compliant Quality Management Reviews, Dec 2, 2009

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ASQ Presentation Lean Mgt Reviews

  1. 1. Lean & Compliant Quality Management Reviews Rich Laguna, Quality Assurance Consultant A process approach to lean & compliant lagunar@sbcglobal.net Quality Management Reviews
  2. 2. Topics of discussion • Lean, compliant, process approach – understanding of terms • A Quality Management Review process model • Identify lean opportunities • Evolution of a Quality Management System • Compliance – FDA 483s/warning letters Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 2
  3. 3. Initial Thoughts… Compliant Quality Management Reviews ~ Quality System Regulation - 21CFR 820.20(c) Management Review ~ ISO 13485:2003 - 5.6 Management review ~ Determine suitability, adequacy & effectiveness of the QMS Lean Quality Management Reviews ~ How can lean principles be applied? ~ Understanding of lean processes. Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 3
  4. 4. Quality Management Review Process Approach Defined Lean Quality Management Reviews ~ How can lean principles be applied? ~ Understanding of lean processes. Definition: “Any activity that receives inputs and converts them to outputs can be considered as a process.” “The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach.” Quoted: ISO 13485:2003 (0.2) Process approach Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 4
  5. 5. Quality Management Review Process Control System Model Voice of the process • Attendance record • Agenda • Presentation • Meeting Minutes People Blending of resources / Customers QMS QMR Meeting QMR Development (internal/external) Stds & Regs Identify changing Needs & expectations Inputs Process / System Outputs Voice of the customer Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 5
  6. 6. Identify LEAN Opportunities Voice of the process • Attendance record • Agenda IES • Presentation • Meeting Minutes Blending of resourcesNIT People TU QMR Meeting / Customers OR QMS QMR Development (internal/external) PP Stds & Regs NO LEA Identify changing Needs & expectations Inputs Process / System Outputs Voice of the customer Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 6
  7. 7. Lean Quality Management System Concept Eliminate / Reduce Non-Value Added Activities (NVA) FOCUS: Efficiency & Compliance Identify waste • Excessive layers of procedures and forms (policy Vs process) – Consolidate were appropriate. • Top down approach to signature approvals – Realign approval signatures to individuals with direct responsibility. • Conflicting requirements within the QMS – Align requirements and only state a requirement once. • Stagnant MS Word forms – poor data collection methods – Appropriate database solutions (Enterprise Quality Management System or Hybrid System). Capture data once, query the data, generate predefined metrics, report into Management Reviews. Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 7
  8. 8. Evolution of the Quality Management System finding a balance • Information (metrics) presented and frequency of Management Reviews are influenced by the Company Life Cycle and the evolution of the QMS. Annually Bi-Annually Quarterly Voice of Customer & QMS Evolution Process of QMS (Risk) EQMS Hybrid ed p th ed n re it Se -u sh sio tu Ex rt ow i an a St a Gr bl M ta xp Es E Company Life Cycle Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 8
  9. 9. Compliant Quality Management Reviews Compliant Quality Management Reviews ~ Quality System Regulation - 21CFR 820.20(c) Management Review ~ ISO 13485:2003 - 5.6 Management review ~ Determine suitability, adequacy & effectiveness of the QMS FDA 483s / Warning Letters: 1. Failure of management with executive responsibility to effectively establish and maintain quality system requirements, as required by 21 CFR 820.20(b)(3)(i). For example: “Management review failed to identify inadequate or missing aspects of the quality system requirements, such as inadequate SOPS, inadequate training of employees, inadequate record keeping, inadequate quality audits, lack of design controls and failure to adequately validate processes and equipment.” Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 9
  10. 10. Compliant Quality Management Reviews Compliant Quality Management Reviews ~ Quality System Regulation - 21CFR 820.20(c) Management Review ~ ISO 13485:2003 - 5.6 Management review ~ Determine suitability, adequacy & effectiveness of the QMS FDA 483s / Warning Letters cont. 2. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, as required by 21 CFR 820.20(c). FDA Inspections In recent FDA inspections, the agency has asked to see the Management Review presentation deck. Does your company have a plan to handle this request? Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 10
  11. 11. Compliant Quality Management Reviews Agenda Quality Assurance Review oComplaints Purpose oInternal Audits Quality Policy Review oCAPA Quality Plan & Objectives oNon-Conforming Material oSupplier Management Human/IT/Facility Resources oDocument Change Mgmt Manufacturing Review Quality System Changes Engineering & Field Service QMS Management Review output Clinical & Regulatory Affairs o New/revised regulatory QMS Compliance Statement requirements Action Items Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 11
  12. 12. Compliant Legend Quality Management Reviews On track Careful watch Action required System System Quality System Corrective/Preventive Action Documentation Effectiveness 1. Quality management system General requirements Yellow – State monitoring plan plan Yellow – State monitoring Documentation requirements G Y Red – CAPA plan Red – CAPA Plan 2. Management Responsibility Management commitment Customer focus G R Planning Responsibility, authority, com Management review 3. Resource Management Provision of resources Human resources G Y Infrastructure Work environment 4. Product Realization… G G 5. Measurement, analysis, and improvement… G G Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 12
  13. 13. Compliant Quality Management Reviews Compliance Statements Fully Implemented QMS • The [company name] Quality Management System continues to be suitable and effective with the identified Quality Plan, goals, and resource needs. Start-Up QMS (pre-commercialization) • The [company name] Quality Management System (QMS) continues to evolve into a fully implemented system. The Management Review has identified sub-processes status, implementation, and monitoring plans. Therefore, the QMS is found to be suitable and effective with the Quality Plan, goals, and resource needs. Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 13
  14. 14. Summary Lean & Compliant Quality Management Reviews LEAN: • Consider the entire Quality Management Review process for lean opportunities. – Reduce the time it takes to produce the Management Review meetings. Implement efficient data collection and reporting methods. – Align the frequency with the Company Life Cycle. – Be aware of “analysis paralysis”. Present information only necessary to make decisions. COMPLIANT: • Present the “tough” information to make CAPA decisions. • Information presented is sufficient to determine the suitability, adequacy, and effectiveness of the entire QMS. • Align to the QSR & ISO 13485:2003 (5.6) Review Input, Review Output. – Say what you do (procedures), Do what you say (execution) • Close loop process. – i.e., Management Review documentation should be reviewed to determine if the process failed to identify field action decisions. Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 14
  15. 15. Summary cont. Lean & Compliant Quality Management Reviews LEAN & COMPLIANT QUALITY MANAGEMENT REVIEW PROCESS Thank you! Rich Laguna, Quality Assurance Consultant lagunar@sbcglobal.net Rich Laguna, Quality Assurance Consultant (lagunar@sbcglobal.net) 15

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