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Corrective and Preventive Actions using the Quality Database
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Corrective and Preventive Actions using the Quality Database


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Managing Corrective and Preventive Actions using the SBS Quality Database

Managing Corrective and Preventive Actions using the SBS Quality Database

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  • 1. Sunday Business Systems The Quality Database Features and Benefits Introduction and Tutorial Fueling Small Business Efficiency
  • 2. Sunday Business Features Nonconformance Tracking Corrective Actions (CA)  Safety Corrective Actions  Supplier Corrective Actions  Internal Audit Corrective Actions Preventive Actions (PA) Internal Audit Management  Record an track audit findings  Manage Audit Schedules Document management review meetings Continuous Improvement Tracking Customer Satisfaction Surveys CAPA = Corrective and Preventive Actions
  • 3. Sunday Business User Interface Simple, efficient interface Menu driven Data entry in simple forms A rich set of configurable reports Email reports with a click
  • 4. Sunday Business Analysis Tools Wide variety of detailed reports Charts, graphs, Pareto analysis Quality Performance metrics
  • 5. Sunday Business Features Control user access levels Link electronic documents, pictures, pdf files, Customer email Supports single and Multi-user network environments Built on Microsoft Access 2003  A free version of Access is included with the full download  No need to purchase Access if you do not have it  Run on Microsoft Access 2007 and 2010 Simple set-up  Enter employee names, passwords, and access levels  Enter Company information  Enter Company locations or sites  Enter CAPA categories (i.e. functional groups within your organization)  Enter Nonconformance defect categories  Enter list of root cause categories
  • 6. Sunday Business Benefits Complies with requirements of  ISO 9001:2008  AS9100  ISO / TS 16949 Provides a concise electronic record of historical events, actions, and improvement  No paper to get lost  No files to shuffle Maintains Quality records of ISO 9001:2008  Management reviews (5.6.1)  Internal audits (8.2.2)  Corrective Action results (8.5.2)  Preventive Action results (8.5.3)  Supplier Corrective Actions (7.4.1)  Customer satisfaction surveys (8.2.1) Improves 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 and how they change over time
  • 7. 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  Little training required  Saves time and improves efficiency Managers get immediate answers  Save time with instant analysis  How many CA/PA Requests are open and why?  How long are CA/PA Requests open? Develop agendas for meetings Utilizes a proven method of Corrective Action Organize and track actions from management review meetings
  • 8. Sunday Business Systems Database Set-up and Configuration Add Employee information Set user passwords and access levels Customize set-up parameters
  • 9. Sunday Business Login Screen The login process limits access to the database features The Demo version includes dummy data and employees  Admin is the default login for demo versions (unregistered)  Admin has full Database privileges  Employee: Admin  Password: admin  All other employees password = pw
  • 10. Sunday Business Setting up the Database Add Employees (owners) Enter Company specific information  Company contact information  Sites  Categories /departments  Root Cause categories  Defect categories  Customer List  Supplier Lists  Parts List  Document names
  • 11. Sunday Business Add / Edit Employees Employees are your CAR, PAR, NC owners Used for automatic emails A password must be entered for a user to log in Defines standard privileges Specific privileges may also be selected
  • 12. Sunday Business Set-Up Parameters Organized into one form with multiple tabs
  • 13. Sunday Business Systems Corrective Action Requests Background: The 8D problem solving process Create a CAR Review reports Measure effectiveness
  • 14. Sunday Business Types of Corrective Action Requests Internal  Originated from within the company External  Originated from outside source like a regulatory body or potential Customer Customer complaint  Defective product shipped to Customer  Late delivery Internal Audit  Internal audit findings Safety  Results of Safety audit  Safety incident investigation  OSHA compliance Supplier  Vendor or supplier failing to perform to specification  Late deliveries, defective parts
  • 15. Sunday Business The 8D Problem Solving Process 1. Assemble the team 2. Define the problem 3. Contain the problem 4. Diagnose the root cause 5. Identify solutions • Verify solutions are effective 1. Validate the solutions • Ensure implementation leads to permanent corrective actions 1. Prevent future, similar occurrences 2. Congratulate the team
  • 16. Sunday Business Corrective Action Process Flow Employee / Manager CAR Team Management ReviewCustomer Internal problem escalated to a CAR Review Problem Definition / Containment Reports a Non- Conformance 1) Form Team 2) Define The Problem 3)Establish Containment Containment approved? Open a CAR in Quality DB 4) Diagnose Root Cause 5) Identify Solutions Review Root Cause / proposed CAs 8D approved? 6) Validate Solutions 7) Define Preventive Actions Review effectiveness of Corrective / Preventive Actions Can the problem re- occur? Present CAR to Customer Close the CAR Is CAR response accepted? NO YES NO YES NO NO Re-Open the CAR and address the Customer's concern Corrective Action Complete! YES Waiting for Containment Containment Approved 8D Approved ClosedCongratulate the TEAM! YES Safety Issue Escalated to a CAR Supplier Non- conformance escalated to a CAR
  • 17. Sunday Business Start a CAR – organized into 5 tabs Yellow fields indicate required parameters
  • 18. Sunday Business Tab #1: CAR Details - (8D steps 1 & 2) CAR Type  Internal  External  Customer Complaints  Safety – for OSHA compliance  Internal Audit  Supplier CAR – issued to supplier Category  User defined functional areas or departments Status  Automatically set based on the dates entered Dates  Determine the status of the CAR Details  (Part #, PO, etc.) Define the CAR team Detailed Problem description
  • 19. Sunday Business CAPA Process Flow / Status CAR / PAR is on HOLD CAR / PAR has been CANCELLED HOLD CANCELLED ProcessProcess CAR / PAR StatusCAR / PAR Status ExceptionsExceptions StatusStatus
  • 20. Sunday Business Establish containment actions with specific owners Tab #2: Containment and Root Cause - (8D steps 3 & 4) Document multiple root causes for a single CAR
  • 21. Sunday Business Containment and Root Cause Contain the problem  Take immediate and possibly temporary actions to prevent the problem from happening today  For example, Stop shipping and 100% inspect for the defect Determine the Root Cause (s)  May have multiple root causes  Primary root cause  Escape Root cause  Contributing root cause Corrective actions must be aligned to each root cause
  • 22. Sunday Business Tab #3: Corrective Actions and Validation – (8d steps 5-7) Establish corrective actions with specific owners Establish Validation criteria and document closure
  • 23. Sunday Business Corrective Actions Record multiple Corrective Actions for each CAR Management or designate may verify each action to ensure they  Effectively address each root cause  Ensure the problem will not re-occur Each Action has an  Owner  ECD – Estimated Completion date  First ECD – original ECD (does not change)  Current ECD – may be changed  Status – see corrective Action Life Cycle  Date complete Comment – used to explain current status  Validation or acceptance criteria  Validation name and date Once reviewed and approved, the Corrective Action plan is considered “Approved”
  • 24. Sunday Business Corrective Action Life Cycle
  • 25. Sunday Business Verification and Validation Verification Documented by approving the corrective action plan Should require management review and approval Each action must be validated Validation / Acceptance Criteria  Defines pass / fail criteria  For example: – 99% of all parts measure < 15mm – Document XX version 02 released on 4-May-2006 – Training records updated Actual Value  Document the actual value observed  Pass / Fail is recorded by changing the Action Status
  • 26. Sunday Business Examples of Actions with Validation Action Validation / Acceptance Criteria Acutal Value P / F Change Specification Rev 01 replaced by Rev 02 Rev 02 released and distributed Pass Train employees to rev 02 all production employees re-trained Training records audited and complete Pass Purchase new tool visually observe new tool in use new tool in use Pass Monitor gap measurement 98% < 15mm 100% < 15mm Pass Monitor defect for 3 months Zero Re-occurances 1 defect observed Fail
  • 27. Sunday Business Tab #4: Preventive Actions Document any preventive actions to prevent similar occurances
  • 28. Sunday Business Tab #5: Comments and Files Add comments including customer feedback Link electronic files such as pictures, customer emails, etc. Email the electronic CAR report directly to Management or Customers
  • 29. Sunday Business Professional Reports Print or email the CAR report directly to the Customer
  • 30. Sunday Business Handy Features Tool Bars  Sort  Filter forms  Search for data  Export data  Spell check Directory
  • 31. Sunday Business Systems Preventive Actions PARs use the same process and similar forms as CARs 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!
  • 32. Sunday Business PARs are handled nearly the same as CARs PAR
  • 33. Sunday Business PAR Reports Measure PAR effectiveness  Rich set of PAR reports
  • 34. Sunday Business Systems Nonconformance Tracking Track non-conformances Produce Failure Analysis reports Analyze defects for continual improvement
  • 35. Sunday Business Nonconformance Tracking Enter General Nonconformance details Analyze Nonconformances based on the defect category
  • 36. Sunday Business Failure Analysis Perform Failure Analysis Assign multiple root causes – later, analyze by root cause Produce professional Failure Analysis reports
  • 37. Sunday Business Disposition Document what is to be done with the material: Release, Return, or scrap Produce a concise nonconformance report Escalate any Non- conformance to a CAR with a click of a button
  • 38. Sunday Business Nonconformance Analysis Rich set of configurable reports and charts
  • 39. Sunday Business Systems Internal Audit Management Schedule Audits Document audit findings Convert findings into a CAR and / or PAR
  • 40. Sunday Business Internal Audits Document general audit details Enter dates; an audit is open if there is no completion date Generate audit reports
  • 41. Sunday Business Internal Audits Document detailed audit findings Create a CAR or PAR from the Audit with a click of a button
  • 42. Sunday Business Manage Audit Schedule
  • 43. Sunday Business Internal Audit CARs
  • 44. Sunday Business Systems Analysis and Reporting Simple and effective reporting Measures the health of your CAPA system Helps identify opportunities for improvement
  • 45. Sunday Business Reports and Analysis Graphs and charts Extensive Reports Email reports with a click of a button  Automatically email all CAR owners Export data to Excel or Word
  • 46. Sunday Business Systems Management Reviews Quality Management System Reviews Document meeting minutes Track and manage actions Drive Continual Improvement at the management level
  • 47. Sunday Business QMS Review Document a QMS Meeting  Who attended?  What was discussed?  ISO9001:2008 establishes the basic agenda  What were the resulting actions taken? Organized in 4 tabs  QMS Details  Data Review  Actions and Validation  Comments and files
  • 48. Sunday Business QMS Details
  • 49. Sunday Business QMS - Data review
  • 50. Sunday Business QMS - Actions and Validation
  • 51. Sunday Business Systems Simple Surveys Create Customer Satisfaction surveys Create Vendor Qualification surveys Manage & analyze survey results
  • 52. 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
  • 53. 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
  • 54. Sunday Business User Interface Simple, efficient interface Menu Driven Data entry in simple forms Enter General Information Organize the survey into topics List all Survey questions & define types
  • 55. 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.
  • 56. Sunday Business Produce Professional Looking Surveys
  • 57. Sunday Business Survey Analysis Tools Variety of customizable reports Charts, graphs
  • 58. Sunday Business Summary The SBS Quality Database is a cost effective tool to Ensure effective training compliance with  ISO 9001:2008  AS 9100  TS 16949  OHSAS 18001  ISO 14001 Manage Corrective and Preventive Actions Manage Management Review meetings Monitor Customer perceptions Maintain paperless quality records Analyze performance and develop improvement strategies Save time and effort
  • 59. Sunday Business About SBS Sunday Business Systems is engaged in software sales and consulting services. Applies Lean Manufacturing principles to Quality Management Systems Sells affordable and efficient software solutions to help implement ISO9001:2008 compliant systems  Corrective and Preventive Actions  Employee Training  Control of calibrated equipment  Communication / Continual improvement Provides Training and instruction Will customize the software for specific Customer needs  We build a custom solution for your specific business processes
  • 60. Sunday Business Systems © 2007 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 EfficiencyFueling Small Business Efficiency Visit for: •Additional information •Free product demos •Pricing •Links to purchase software