Operating in a State of Control; A Risk-Based Approach to Quality

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1 Operating in a State of Control; A Risk-Based Approach to Quality Denise D. Dion Vice President Regulatory and Quality Services EduQuest EDUcation: QUality Engineering, Science, & Technology

2 Management Design Controls Production and Process Controls Material Controls Corrective and Preventive Actions Records, Documents, and Change Controls Controls Equipment and Facility Controls 2

3 FDA Focus Management oversight Product life-cycle concept (cradle-to-grave) Conformance evidence documentation Change Management Audits overall quality system/design controls Corrective and Preventive Action system 3

4 4

5 5

6 FDA Product Lifecycle P1, early P2 Draft Requirements Prelim. Risk Assessment Approved Requirements 510(k), PMA, PMA supplement, IDE, HDE, IRB 6

7 Pre-Market: Design Concept and Feasibility This is the time to determine the requirements of the device Design starts once your initial requirements are approvable Preliminary risk analysis (top-down) should be done concurrent with determining your requirements 7

8 The Yin/Yang of Design/CAPA Design is the beginning Risk Analysis (product and process) begins with Design Production and Post-Production Planning feeds the CAPA system 8

9 Cradle-to-Grave Concept Design Controls CAPA Risk Management Product Monitoring Complaints Service Reports Audits 9

10 The Yin/Yang of Design/CAPA Production and Post-Production data is used to Assure our original risk assessments were correct Assist us in proper evaluation and investigation of nonconformances (product, process, system) Identify needed actions to improve our product design, processes and systems 10

11 The Yin/Yang of Design/CAPA In deciding on requirements for design changes or new designs Marketing data Voice of the Customer Human Factors Regulatory/Standards Production/Post-production data from similar designs 11

12 Use of Trace Matrices Use trace matrices To help identify affected parts of design when changes are made To Identify tests to be repeated on changed design To understand where you may be introducing new risks or failure modes or affecting existing mitigations 12

13 Design Input Requirements Initial Design Input Requirements include: User needs Intended uses Safety attributes Performance features or usability (Human Factors) Technical compatibility, Standards 13

14 Design Inputs Sources Human Factors Regulations Standards Guidance Preliminary Risk Assessment activities Failure Investigations of Complaints, MDRs, CAPAs, Recalls (Yours and Others) Marketing and Clinical studies and surveys 14

15 Design Input and Outputs Initial Design Input Requirements What we design to Final Design Output Specifications the Device Master Record What we build to 15

16 Design and Usability Goals Design for the most common users and tasks 80% of users and tasks Users, not engineers Make information easily obtainable (intuitive) Memory is fallible 19

17 Design and Usability Goals Provide obvious error control Prevent errors Make errors recognizable Enable immediate error recovery 20

18 Consequences of Poor Usability Use Error complaints, recalls Increased technical support costs Increased training requirements Revision of User Manual (possible FDA submission) 21

19 Why Design Input is Important Garbage In Garbage Out (GIGO) 2012 EduQuest, Inc. 22

20 Consequences of Inadequate Design Input Device not fit for its intended use Not effective Not safe Complaints, MDRs, Recalls Changes design, manufacturing process FDA Regulatory Action 23

21 Design and Risk Management Perform initial (top-down) risk assessment during the creation of the initial design input requirements. Perform final risk assessment (bottom-up) to help finalize your design output specifications contained in the device master record. For pre-market knowing frequency of occurrence of harm may be enough; For post-market you will also need frequency of occurrence of the event or failure mode. 24

22 Post-Market: CAPA An effective CAPA system uses mechanisms to monitor the quality of people, processes, product, and quality system This includes complaint handling, nonconforming product mechanisms, adverse event reporting, corrections, removals, and recalls Need to understand product and process risk to make appropriate decisions 22

23 Purpose of a CAPA System To collect and analyze quality information - feedback Identify and investigate product and quality problems Take appropriate and effective corrective and preventive actions to prevent their occurrence or recurrence 23

24 CAPA Data Sources Quality Data Customer complaints Incoming components /Materials Inspection/test data final Inspection/test data in process Calibration Record/document issues Nonconforming material or product Supplier audits Management review 3 rd party audits Internal audits 24

25 CAPA Data Sources Quality Data Process control data FDA observations Process Validation issues Facility control Training records Design Verification /Validation Device history records Field actions (corrections and removals) Equipment maintenance Change control records Scrap/rework/yield data Environmental monitoring/control 25

26 CAPA Data Sources Quality Data Returned goods Medwatch/MDR/ Vigilance reports Handling/storage of product data Field service reports Clinical data Employee complaints Product warranty Clinical literature and journal articles Legal claims 26

27 CAPA Procedures Procedures that discuss how any nonconformance or complaint is initially evaluated for validity, extent and impact Procedures that state when a root cause investigation is required for all data sources as well as for trends criteria for escalation Procedures to describe how root cause investigations are to be conducted and documented 27

28 General Flow for a CAPA System Nonconformance Product Process or System Complaint Noncomplaint Potential or Actual Potential Actual Level 1 FI NCMR Potential NC Report Process or Quality NC Report Level 2 FI? Level 1 FI No Yes Close Yes Level 2 FI? Level 2 FI No Document and Trend Level 2 FI Document Corrections for all existing and trend all No CAPA? Yes Trend Analysis Indicates Actual or Potential Nonconformance Enter Into CAPA Database Trend Analysis Indicates Actual or Potential Nonconformance Document and Track through Implementation and Effectiveness 28

29 CAPA System Advice Not every situation can be a code red Use risk management to prioritize Non-conformance and CAPA work 29

30 Key Phases of Investigations Three key phases (some companies break these out into more than three) Investigation (to assess whether the observed result is valid, extent and impact) Expanded investigation (to assess cause) Corrective action (to identify action(s) to correct the cause of the problem and ensure the nonconformity cannot recur) 30

31 Key Objectives of Initial Evaluation To determine if the observed result is valid To determine its impact or significance To determine the extent of the problem Other lots or serial numbers of that product Related products and processes 31

32 FDA Guidance To be meaningful, the investigation should be thorough, timely, unbiased, well-documented, and scientifically defensible. Note this is an excellent starting checklist for reviewing and challenging draft investigation reports 32

33 SOAP S Subjective data at input, initial evaluation O Objective data initial evaluation and root cause investigation A Assessment probable or actual cause Rule Out what it definitely, maybe is not P Plan corrections, containment, corrective or preventive actions, additional actions 33

34 Corrective and Preventive Action Need to both Treat the symptoms Design and implement corrective actions for each cause Cure the related diseases Thorough and exhaustive root cause analysis Design and implement additional corrective or preventive actions to ensure that the problem cannot recur or occur 34

35 Cradle-to-Grave Concept Design Controls CAPA Risk Management Product Monitoring Complaints Service Reports Audits 35

36 EduQuest EDUcation: QUality Engineering, Science and Technology Global team of FDA compliance experts based near Washington, DC Founded by former senior officials & investigators from FDA s Office of Regulatory Affairs (ORA) Headquarters Advising medical device and bio-pharmaceutical companies worldwide since 1995 Focus on Audits and Training for Quality Systems, Risk Management, Part 11, Validation, Inspection Readiness 39

37 Denise Dion Vice President, Regulatory & Quality Services EduQuest 18 years of experience with the U.S. FDA Office of Regulatory Affairs (ORA) Former FDA Medical Device Expert Investigator Developed many of FDA s inspection guidance and training materials Primary editor of the FDA Investigations Operations Manual (IOM) the bible for FDA inspectors Lead instructor for EduQuest CAPA, QSR Basics, and Design Control classroom training courses ( 40

38 EduQuest EDUcation: QUality Engineering, Science and Technology The CAPA Confidence Clinic: Additional Opportunity for Staff Training from EduQuest: Effective CAPA Systems, Failure Investigations & Complaint Management September 27-28, 2012 Frederick, MD (near Baltimore and Washington, DC) QSR Compliance Basics: Complying with FDA s Medical Device 21 CFR 820 Quality System Regulation October 16-17, 2012 Frederick, MD (near Baltimore and Washington, DC) Design Control for Medical Devices: Meeting FDA s 21 CFR Rules for Quality Design and Manufacturing October 17-20, 2012 Frederick, MD (near Baltimore and Washington, DC) Details at Or EduQuest, Inc. 41

39 Questions or Comments? Contact: EduQuest, Inc Urbana Pike, Suite 14 Hyattstown, MD (301)

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