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CAPA for FDA regulated industries


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Utilizing the Q-Med Database for low cost and effective Corrective and Preventive Action management

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CAPA for FDA regulated industries

  1. 1. Sunday Business Systems The SBS Q-Med Database Introduction Features and Benefits Fueling Small Business Efficiency Corrective and Preventive Action software for FDA regulated industries
  2. 2. Sunday Business Background Medical Device / FDA Quality standards require many things including:  Corrective Actions  Preventive Actions  Nonconformance dispositions  Internal Audits  Management reviews  Continual Improvement  Customer satisfaction assessments The SBS Q-Med database was created to ease the complexity of compliance to quality management system standards:  ISO 13485: Medical devices-Quality management systems-Requirements for regulatory purposes  Quality System Regulation 21 CFR 820
  3. 3. Sunday Business Q-Med Database Key Features Nonconformance Tracking  Escalate a Nonconformance to a Corrective Action Corrective Actions (CA)  Safety, Supplier, Internal Audit CARs  With Validation and Verification  Approvals require electronic signatures Preventive Actions (PA) Audit management  Record audit findings  Manage Audit Schedules  Escalate to a Corrective Action or Preventive Action Meeting management Project management Customer satisfaction surveys
  4. 4. Sunday Business Q-Med Modules Non-Conformance (NCR) Corrective Actions (CAR) Preventive Actions (PAR) Customer Complaint Audits Surveys Quality Control / Inspection Meeting Manager Improvement Projects
  5. 5. Sunday Business User Interface Username and Password protected Efficient menu listing / “Switchboard” Data entry in simple forms A rich set of configurable reports Email reports with a single click Easily export data to Excel or Word
  6. 6. Sunday Business Analysis Tools Wide variety of detailed reports Charts, graphs, Pareto analysis Quality performance metrics
  7. 7. Sunday Business General Features Utilizes the 8D Corrective Action Process Security with password access and control of privileges CFR21 part 11 compliant security, Electronic signatures, audit trails Link electronic documents for a paperless system Supports single and Multi-user network environments Built on Microsoft Access 2007  Compatible with Microsoft Access 2010 and 2013  No need to purchase Access if you do not have it  A free run-time version of Access is available from the Microsoft website
  8. 8. Sunday Business Benefits Complies with requirements of  21 CFR 820  ISO 13485  ISO 9001:2008  CFR 21 part 11 Provides a concise, electronic record of historical events, actions, and improvement  No paper to get lost Efficiently maintains quality records for  Internal audits  Corrective Action results  Preventive Action results  Management review or MRB meetings  Nonconformances  Customer satisfaction surveys Improve product reliability and process performance Improve Customer Satisfaction  Rapidly report results to Customers  Email report directly from the database  Stay on top of key Customer issues  Rebuild customer confidence when things go wrong  Analyze Customer perceptions over time
  9. 9. Sunday Business Benefits Efficient and cost effective  Simple, low cost solution  No additional software to purchase  No annual maintenance fees  Concurrent user licensing – not CPU based  Minimal training is required  Saves time and improves efficiency Reports and analysis  Managers get immediate answers  How many CA/PA Requests are open and why?  How long are CA/PA Requests open?  Email reminders for open actions Develop agendas for meetings Easy to identify and manage open action items Reduce cycle time to implement corrective actions
  10. 10. Sunday Business Login Screen The login process limits access to the database features The Demo version includes dummy data and employees  administrator has full Database privileges  For the demo database, – Username: administrator – Password: Aa777777 – Note: username and password are case sensitive
  11. 11. Sunday Business Systems Corrective Action Requests Background: The 8D problem solving process CAR Form Reports and analysis Measure effectiveness
  12. 12. Sunday Business The 8D Problem Solving Process D0 • Plan D1 • Build a team D2 • Define the problem D3 • Contain the problem D4 • Define and verify the root cause(s) D5 • Determine and verify the permanent corrective actions D6 • Implement and verify the permanent solution D7 • Prevent recurrence D8 • Congratulate the team!
  13. 13. Sunday Business
  14. 14. Sunday Business Corrective Action Form Form is organized into 6 tabs Yellow fields are required fields Purple fields indicate Electronic Signatures
  15. 15. Sunday Business CAPA Status (Process flow) NEW CAR / PAR Containment Actions Approved Proposed Corrective Actions Approved CA have been completed and validated Waiting Containment Containment Approved Corrective Action Approved CLOSED CAR / PAR is on HOLD CAR / PAR has been CANCELLED HOLD CANCELLED Process CAR / PAR Status Exceptions Status
  16. 16. Sunday Business Corrective Action Form - Containment Establish containment actions with specific owners Electronic signature required to approve containment
  17. 17. Sunday Business Corrective Action Form – Root Cause Analysis Document multiple root causes for a single CAR including Primary, Escape, and Contributing root causes Ask why? Enough times to determine effective root causes
  18. 18. Sunday Business Corrective Action Form – Corrective Actions Electronic signature required to approve Root Cause/Corrective Action Plan Electronic signature required to approve validation Establish clear, quantifiable acceptance criteria
  19. 19. Sunday Business Corrective Action Life Cycle
  20. 20. Sunday Business Corrective Action Form – Preventive Actions Electronic signature required to approve Preventive Action plan
  21. 21. Sunday Business Corrective Action Form – Comments and Attachments
  22. 22. Sunday Business Corrective Action Report Print or email the CAR report directly to the Customer
  23. 23. Sunday Business Reports and Analysis Rich set of reports including Pareto graphs and trend charts
  24. 24. Sunday Business Systems Preventive Actions PAR Form Reports and analysis Measure effectiveness For want of a nail, the shoe was lost, For want of the shoe, the horse was lost, For want of the horse, the rider was lost, For want of the rider, the battle was lost, For want of the battle, the kingdom was lost, And all for the want of a horseshoe nail!
  25. 25. Sunday Business PARs are handled nearly the same as CARs Preventive Actions
  26. 26. Sunday Business PAR Reports
  27. 27. Sunday Business Systems Nonconformance Tracking Track non-conformances Failure Analysis Analyze defects for continual improvement Escalate a Nonconformance to a CAR
  28. 28. Sunday Business Nonconformance Tracking Enter General Nonconformance details Classify the Nonconformances based on the defect
  29. 29. Sunday Business Failure Analysis Produce professional Failure Analysis reports Assign multiple root causes – later, analyze by root cause Describe the failure analysis technique and results
  30. 30. Sunday Business Disposition Document what is to be done with the material: Release, Rework, Downgrade, or Scrap Produce a concise nonconformance report Escalate any Non- conformance to a CAR with a click of a button Electronic Signature required to approve Material Disposition
  31. 31. Sunday Business Actions associated with the NC
  32. 32. Sunday Business Nonconformance Analysis Rich set of configurable reports and charts
  33. 33. Sunday Business Systems Audit Management Maintain audit schedules Document audit findings Convert findings into a CAR and / or PAR Report and analyze results
  34. 34. Sunday Business Audit Details Electronic Signature required to approve and close Audit
  35. 35. Sunday Business Audits Findings Document detailed audit findings Create a CAR or PAR Linked to the Audit with a click of a button
  36. 36. Sunday Business Audit Conclusions Summarize Strengths, Weaknesses, and overall Conclusions
  37. 37. Sunday Business Audit documentation Add all supporting documentation (electronic files)
  38. 38. Sunday Business Audit Report
  39. 39. Sunday Business Manage Audit Schedule
  40. 40. Sunday Business Audit Reports and Analysis
  41. 41. Sunday Business Systems Meeting Manager Document meeting minutes Track and manage actions Drive Continual Improvement at the management level
  42. 42. Sunday Business Background Great for MRB and Quality Management System Review meetings Document a meeting  Who attended  What was the agenda?  What was discussed?  What were the resulting actions to be taken?  Are the actions complete?  Were the actions effective?
  43. 43. Sunday Business Meeting Details
  44. 44. Sunday Business Meeting Minutes
  45. 45. Sunday Business Actions and Validation
  46. 46. Sunday Business Supporting documents
  47. 47. Sunday Business Systems Surveys Create Customer Satisfaction surveys Create Vendor Qualification surveys Manage & analyze survey results
  48. 48. Sunday Business Simple Survey Features Easily create custom surveys Simple, intuitive interface Print out or e-mail a professional looking survey directly from the program Ask different types of questions  True or False / Yes or No  Rating (on a scale of one to ten)  Text response (let the customer provide feedback in his own words) Create an efficient quality record
  49. 49. Sunday Business Simple Survey Features Customer Satisfaction  Directly quantify customer satisfaction  Monitor Customer perceptions  Analyze trends with grafts and reports Vendor qualification surveys  Measure vendor suitability  Monitor vendor improvement Employee opinion polls  Measure job satisfaction  Solicit continual improvement ideas  Measure and track long term results print
  50. 50. Sunday Business Create a Survey Simple, efficient interface Data entry in simple forms Enter General Information Organize the survey into topics List all Survey questions & define types
  51. 51. Sunday Business Creating Surveys Enter general survey information Create a survey Category (i.e. Customer Service, General, Engineering Support, etc.) Create a question and establish the order in which it will appear on the survey Select the question type.  Yes/no and true/false questions are rated as either 0 or 10  Text response questions have no score  Rating types receive a number rating from 1 to 10 with 1 being the lowest or worst level. If the question was yes/no or true/false, you must determine if a positive answer (yes or true ) carries the maximum score.  Check the check box labeled "PositiveIsTen" if a positive answer receives the maximum score.  Leave the "PositiveIsTen" check box unchecked if a positive answer should receive the minimum score. Each question may be weighted differently (not all questions were created equal).  The "Weight" field is used to score each question where Score = Rating * weight.  The user must determine appropriate waiting factors.
  52. 52. Sunday Business Produce Professional Looking Surveys
  53. 53. Sunday Business Survey Analysis Tools Variety of customizable reports Charts, graphs
  54. 54. Sunday Business Systems SBS Q-Med Database Configuration and Installation
  55. 55. Sunday Business Demo Database Installation The demo database is a stand-alone access database with all the features of the standard product. To install the program:  Download the demo database from  Save or copy the Q-Med Database.accde file to a designated folder on your Network File Server  Ensure all Workstations have  Microsoft Access or the free Runtime version of Microsoft Access  Read and write privileges to the designated folder on the Network File Server Note: The above graphic is for stand alone Access databases - SQL configurations are different
  56. 56. Sunday Business Purchased Product Installation The purchased product has 2 parts:  Microsoft SQL back end  Microsoft Access front end The Microsoft Access front end connects to the SQL back end through standard ODBC links from each user computer. The Customer must provide the SQL server and the database administration. SBS will provide the SQL files for installation and the Q-Med front end.
  57. 57. Sunday Business Systems SBS Q-Med Database Best in class software solution
  58. 58. Sunday Business Summary The SBS Q-Med Database is a cost effective tool to Ensure effective compliance with Quality standards  ISO 13485  21 CFR 820 - Quality System Regulation  21 CFR Part 11  ISO 9001:2008 Manage meetings Monitor Customer perceptions Maintain paperless quality records Analyze performance and develop improvement strategies Save time and effort
  59. 59. Sunday Business About SBS Sunday Business Systems is engaged in software sales and consulting services. Sells affordable and efficient software solutions to implement Quality management systems:  Document Control  Corrective and Preventive Actions  Audit Management  Employee Training  Control of calibrated equipment  Vendor Management  SPC  Continual improvement Provides Training and instruction Provides custom software solutions  Modify and existing program  Build a complete custom solution for your specific business processes Sunday Business Systems
  60. 60. Sunday Business Systems © 2014 Sunday Business Systems. All rights reserved. This presentation is for informational purposes only. Sunday Business Systems MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN THIS SUMMARY. Microsoft is a registered trademark of Microsoft Corporation in the United States and/or other countries. Fueling Small Business Efficiency Visit for: •Additional information •Free product demos •Pricing •Links to purchase software