Guide to FDA QSR Compliance

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In order to register your medical device for sale in the US, you must implement a quality management system compliant with FDA Quality System Regulations.

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Guide to FDA QSR Compliance

  1. 1. Implementing FDA QSR Implementing FDA QSR Implementing FDA Quality System RegulationsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  2. 2. Implementing FDA QSR Implementing FDA QSR Presentation Objectives • Initiating the steps of a Quality System implementation project • Establishing the QMS requirements • Determining training requirements • Defining the compliance activities • Implementing your quality system • Generating records • Preparing for an FDA inspectionASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  3. 3. Implementing FDA QSR Implementing FDA QSR Senior Management Commitment • Educate senior management in regulatory requirements • Senior management must support and “buy-in” to the quality system requirements • Needs for new or updating existing system • Create a vision and roadmap for successASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  4. 4. Implementing FDA QSR Implementing FDA QSR Senior Management Commitment, cont’d. Identify the goals for the organization: •Regulatory requirements for meeting the law •Customer and business requirements •Maintaining the regulatory requirements •Assign resources to meet requirements •Prepare for an FDA inspectionASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  5. 5. Implementing FDA QSR Implementing FDA QSR Defining Your QMS Criteria for Compliance • An FDA quality management system is designed specifically for medical device manufacturers • Used for regulatory compliance – Title 21 Code of Federal Regulations – FD&C Act is a federal law – Subject to periodic FDA inspection • Part 820 identifies the regulations for device manufacturers to meet current Good Manufacturing Practices (cGMP) • GMP = keep current with guidelines and technologyASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  6. 6. Implementing FDA QSR Implementing FDA QSR Defining Your Business Processes Conduct gap analysis •What does your current quality system look like? •How are your key business systems handled? •How much documentation do you have in place? •Has an FDA inspection been performed?ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  7. 7. Implementing FDA QSR Implementing FDA QSR Defining Business Processes, cont’d. • Create quality plan for implementing the quality system • Conduct a gap assessment = where you are and where you want to be for the quality system • Set goals based on your gap analysis findings • Utilize inputs from your implementation planASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  8. 8. Implementing FDA QSR Implementing FDA QSR Develop an Implementation Plan • Review against the sections of the QSR for completing the established plan • Define timing and resources • Document in a formalized plan • Gain senior management approvalASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  9. 9. Implementing FDA QSR Implementing FDA QSR Typical Implementation Timelines Timelines depend on company type, size and resources. Number of Employees Time • Under 100 • Five to Nine Months • 100 – 250 • Eight to 12 Months • 250 or More • 12+ MonthsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  10. 10. Implementing FDA QSR Implementing FDA QSR Typical Implementation PlanASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  11. 11. Implementing FDA QSR Implementing FDA QSR Quality Policy/Company Vision • Quality policy reflects essence of company • Generated and supported by senior management team • Apply to the needs of the companyASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  12. 12. Implementing FDA QSR Implementing FDA QSR Example Quality Policy •Shows Commitment to quality •Able to generate Quality Objectives •Developed by Senior ManagementASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  13. 13. Implementing FDA QSR Implementing FDA QSR Establish Quality Objectives • Related to the Quality Policy • Established by senior management • Realistic and measurable goals • Make them visible to the entire company • Define periods for review of objectives • Make improvements each year; not staticASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  14. 14. Implementing FDA QSR Implementing FDA QSR Example Quality Objectives, cont’d. Quality objective for January 1, 2013 to December 31, 2013: •Complete a 96% on-time delivery of finished goods to customers •Attain compliance rate of less than 1% versus finished goods sold per month •In-process rejection rates must be less than 1% throughout the manufacturing process •Meet FDA QSR compliance by September 2013 •Launch next-generation product line according to released development plan by August 2013ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  15. 15. Implementing FDA QSR Implementing FDA QSR Understand Product Requirements • A good, established QMS indicates good quality products • Regulators link QMS to product approval • A Quality System provides consistent processes • FDA inspection focuses on the productsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  16. 16. Implementing FDA QSR Implementing FDA QSR Product Relations, cont’d. Maintain an effective quality system – Addresses quality concerns – Identifies issues and concerns with product quality – Assures consistent methods and processes – Apply the proper resources for maintaining the quality systemASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  17. 17. Implementing FDA QSR Implementing FDA QSR Review Process Interactions • Output from gap analysis and implementation plan • Lay out your different key processes • Understand interactions and workflow • Helps to organize implementation • Key component of the quality system – Becomes part of an SOP or Quality Manual – Document process interactionsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  18. 18. Implementing FDA QSR Implementing FDA QSR Educate All Employees • Train all employees on what meeting the FDA requirements means to the company – it is the law • Train employees on what meeting the requirements means to them • Need compliance awareness from everyone • Also serves as communication of complying with the FDA regulations – what is needed • Train individuals on processesASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  19. 19. Implementing FDA QSR Implementing FDA QSR Communicate Key Principles • Establish the following for staff training – Quality policy – Quality objectives – Process interactions – Compliance requirements • Explain compliance is mandatory • Communicate regulatory requirements • Make these visible and understoodASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  20. 20. Implementing FDA QSR Implementing FDA QSR Develop Documentation Tier 1 Quality Manual Written policies, goals, and measurable Tier 2 objectives of a company. Work Instructions Tier 3 Details job specific instructions for a particular process. Tier 4 Forms A documented output that helps record, measure, and describe a certain procedure.ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  21. 21. Implementing FDA QSR Implementing FDA QSR Draft Operating Procedures •Update or generate the Level 2 standard operating procedures (SOP) •Update or generate Work Instructions (WIs) Level 3 as needed •Create the associated forms (ref in procedures) as needed for Level 4 •Forms become the Quality Records (objective evidence or proof)ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  22. 22. Implementing FDA QSR Implementing FDA QSR Implementation Process • Follow the FDA Chapters for implementation – Document Controls -> Management Controls -> Design Controls -> Production Controls -> Corrective Action – Prioritize development as needed – Utilize a checklist to gauge process • Roll out in phases, implement, then train • Start generating quality records ASAP • Need to show evidence of utilization • Have periodic (weekly) review meetingsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  23. 23. Implementing FDA QSR Implementing FDA QSR 21 CFR Part 820 Quality System Regulation QUALITY SYSTEM REGULATION (cGMPs) Subpart Description A GENERAL PROVISIONS B QUALITY SYSTEM REQUIREMENTS C DESIGN CONTROLS D DOCUMENT AND RECORD CONTROL E PURCHASING CONTROLS F IDENTIFICATION AND TRACEABILITY G PRODUCTION AND PROCESS CONTROLS H ACCEPTANCE ACTIVITIES I NONCONFORMING COMPONENTS AND DEVICES J CORRECTIVE AND PREVENTIVE ACTION K LABELING AND PACKAGING CONTROL L HANDLING, STORAGE, DISTRIBUTION, AND INSTALLATION M RECORDS N SERVICING O STATISTICAL TECHNIQUESASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  24. 24. Implementing FDA QSR Implementing FDA QSR Subparts D & M: Document Controls and Quality Records • Develop SOP/WI/Forms template • Document Controls • Managing Changes or Change Control • Control of Quality Records • Record RetentionASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  25. 25. Implementing FDA QSR Implementing FDA QSR Subpart B: Management Controls • Quality Policy • Quality Objectives • Quality Planning • Start the Quality Manual (more later) • Responsibility definitions (org chart) • Management Representative (and designate) • Management Review meetingsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  26. 26. Implementing FDA QSR Implementing FDA QSR Subparts B & G: Training and Production • Training Program • Job descriptions (org chart) • Infrastructure – Equipment and facilities – Preventive maintenance • Work environment – Controlled environments – clean rooms – Cleaning and cleanlinessASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  27. 27. Implementing FDA QSR Implementing FDA QSR Subpart C: Design Controls • Development plan • Design inputs • Design outputs • Design reviews • Design verification • Design validation • Design transferASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  28. 28. Implementing FDA QSR Implementing FDA QSR Subparts E through H: Production Controls • Customer ordering • Supplier Qualification and Purchasing • Manufacturing controls • Identification and Traceability • Distribution and handling • Servicing and Installation • Calibration of Measuring EquipmentASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  29. 29. Implementing FDA QSR Implementing FDA QSR Subparts K & L: Labeling, Handling, Storage and Distribution • Product labeling controls • Prevent mix-ups of product and labels • Proper identification of materials • Review deteriorate aspects – expiration dates or shelf life • Distribution records of shipmentsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  30. 30. Implementing FDA QSR Implementing FDA QSR Subparts II & J: Nonconformity and Corrective Actions • Customer Feedback • Customer complaint handling (returns) • Internal Audits • Control of Non-Conforming product • Corrective and Preventive ActionsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  31. 31. Implementing FDA QSR Implementing FDA QSR Other Procedures Needed • Medical Device Reporting • Recalls and field corrections • Regulatory notification of changes • Maintenance of regulatory files • Establishment registration • Medical device listingASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  32. 32. Implementing FDA QSR Implementing FDA QSR Develop Quality Manual •Fill in during implementation or complete at the end (review all of the company processes) •FDA reviews a company’s Quality Manual •These are “cliff notes” to the QMS •Summary of your QMS and company •Defines the scope and exclusions; those processes not applicable to the organization •Make reference to the SOPs/Level 2 docsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  33. 33. Implementing FDA QSR Implementing FDA QSR Create One Quality System • Depending on the system scope – FDA QS Regulations versus ISO 9001 – FDA QS Regulations versus ISO 13485 – FDA QS Regulations versus country GMPs like Brazil or China • Address other regulatory & quality system components in different procedures • Include the scope in management review • Define the scope in the Quality ManualASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  34. 34. Implementing FDA QSR Implementing FDA QSR Make It Personal with Employees •Discuss one-on-one with employees on requirements •Make sure the compliance requirements are understood •Evaluate effect on existing processes •Establish a due date for the implementing procedure(s) •Review implementation against planASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  35. 35. Implementing FDA QSR Implementing FDA QSR Review Your Implementation Plan • Utilize different metrics for review – Number of procedures required and done – Target times being met to plan – Training effectiveness and completion • Update through frequent meetings • Management Representative reports frequently to management team • Periodic updates to managementASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  36. 36. Implementing FDA QSR Implementing FDA QSR Implement Your Quality System • Complete and generate quality records • Hold at least one or two Management Review meetings – This helps review the implementation process • Complete a full cycle of Internal Audits • Educate employees throughout • Update and change documents as needed • Prepare for FDA “readiness”ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  37. 37. Implementing FDA QSR Implementing FDA QSR Conduct “Readiness” Review • Preferably done by external party • Should simulate by doing FDA mock inspection • Ensure you’re on the right track • May be surprised: “Cannot see the forest for the trees” by being too close • May be painful; don’t make it personalASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  38. 38. Implementing FDA QSR Implementing FDA QSR Utilize System to Respond to Findings • Generate Corrective Actions (CAs) from internal audit findings or internal reviews • Generate CAs from the readiness review • Again … don’t make it personal • Apply the requirements to business processes • Select important issues to correctASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  39. 39. Implementing FDA QSR Implementing FDA QSR Discussion about QSIT Program • QSIT = Quality System Inspection Technique • The Method used by FDA Inspectors • “Top-Down” approach like ISO Auditors • Still the most important process = Corrective and Preventive Action – how are you doing it?!? • Generally still focuses on Customer Complaints • Inspectors use in Conjunction with Compliance Program Guidelines (CPGs)ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  40. 40. Implementing FDA QSR Implementing FDA QSR Preparing for an FDA Inspection • Implement and maintain your quality management system • Continuous diligence of the quality system – be Audit-Ready • Complete internal audits on schedule • Complete management reviews • Run mock FDA inspection by experienced staff member or external party • Review previous inspectionsASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  41. 41. Implementing FDA QSR Implementing FDA QSR Understand Industry Trends • Review FDA published Warning Letters • Current “Hot Topics” – Corrective and Preventive Action – Supplier Management/Outsourcing – Design Controls – Customer Complaints – Risk Management • Principles of “Good Manufacturing Practices” • Be aware of Flags for your companyASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  42. 42. Implementing FDA QSR Implementing FDA QSR Tips for Successful Implementation • Keep procedure simples – K.I.S.S. • Allow flexibility and course correction • Implement using practical sense • Identify good business practices • Monitor procedures and processes for compliance and meeting objectives • Periodic review meetings with team • Understand underlying reason: complianceASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  43. 43. Implementing FDA QSR Implementing FDA QSR Conclusion • Management must support actions • Develop an Implementation Plan • Educate the employees • Develop the procedures • Review the process frequently • End objective is complianceASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com
  44. 44. Implementing FDA QSR Implementing FDA QSR Additional Resources US Quality System Regulations: http://www.emergogroup.com/resources/regulations-united-states/21-cfr-820 Pre-recorded webinar on the FDA 510(k) process: http://www2.emergogroup.com/videos-fda-510k FDA QSR consulting services: http://www.emergogroup.com/services/us/fda-gmp-consulting Presented by: Richard Vincins EMERGO GROUP | VP of Quality Assurance US office: +1.512.327.9997ASIA | EUROPE | MIDDLE EAST | NORTH AMERICA | SOUTH AMERICA EmergoGroup.com

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