1. The Quality Database Features and Benefits Introduction and Tutorial www.SundayBizSys.com Fueling Small Business Efficiency

2. Sunday Business Systems www.SundayBizSys.com Background  Quality management standards require many things, including  Corrective and Preventive Actions  Internal Audits  Management reviews  ISO 9001:2015 “The Organization shall continually improve the effectiveness of the quality management system through the use of…audit results, analysis of data, corrective and preventive actions, and management review.”  The SBS Quality database was created to ease the complexity of compliance to quality management standards  ISO 9001  AS9100  ISO/TS 19649  ISO 13485

3. Sunday Business Systems www.SundayBizSys.com Features  Nonconformance Tracking  Corrective Actions (CA)  Safety Corrective Actions  Supplier Corrective Actions  Internal Audit Corrective Actions  Preventive Actions (PA)  Risk Management (FMEA)  Internal Audit Management  Record and track audit findings  Manage Audit Schedules  Document management review meetings  Manage continuous improvement projects  Customer Satisfaction Surveys CAPA = Corrective and Preventive Actions

4. Sunday Business Systems www.SundayBizSys.com User Interface  Simple, efficient interface  All modules clearly displayed  Ribbon shortcuts  Data entry in simple forms  Easy data analysis  A rich set of configurable reports  Email reports with a single click  Export data to excel, word, or PDF

5. Sunday Business Systems www.SundayBizSys.com Analysis Tools  Wide variety of detailed reports  Charts, graphs, Pareto analysis  Quality Performance metrics

6. Sunday Business Systems www.SundayBizSys.com Features  User login - Controls access to designated modules  Link electronic documents, pictures, pdf files, Customer email  Supports single and Multi-user network environments  Built on Microsoft Access 2007  A free runtime version of Access is available from Microsoft  No need to purchase Access if you do not have it  Compatible with Microsoft Access 2010, 2013 and 2016  Simple set-up  Enter employee names, passwords, and access levels  Enter Company information  Enter Company locations or sites and departments  Enter CAPA categories (i.e. functional groups within your organization)  Enter Nonconformance defect categories  Enter list of root cause categories  Start using the program!!!

7. Sunday Business Systems www.SundayBizSys.com Benefits  Complies with requirements of  ISO 9001:2015  AS9100  ISO/TS 16949  ISO 13485  Provides a concise electronic record of historical events, actions, and improvement  No paper to get lost  No files to shuffle  Efficiently maintains quality records  Management reviews  Internal audits  Corrective Action results  Risk management results  Supplier Corrective Actions  Customer satisfaction surveys  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

8. Sunday Business Systems www.SundayBizSys.com 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  Utilizes a proven method of Corrective Action  Organize and track actions from management review meetings

9. Database Set-up and Configuration Add Employee information Set user passwords and access levels Customize set-up parameters

10. Sunday Business Systems www.SundayBizSys.com Easy Installation  Download the demo database  Save or copy the Quality DB.accde file to a designated folder on your Network File Server  Once purchased, register the demo database (enter the Product Code)  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

11. Sunday Business Systems www.SundayBizSys.com Login Screen  The login process limits access to the database modules  The Demo version includes example data that may be modified  Admin is the default login for demo versions (unregistered)  Admin has full Database privileges  For the demo database, –Employee: Admin –Password: admin –All other employees password = pw

12. Sunday Business Systems www.SundayBizSys.com Setting up the Database  Add Employees (owners)  Company contact information  Build drop-down lists  Sites  Departments  CAR/PAR Categories  Root Cause categories  Defect categories  Customer List  Supplier Lists  Parts List  Document names  FMEA parameters

13. Sunday Business Systems www.SundayBizSys.com Add / Edit Employees and Assign Privileges  Employees are your CAR, PAR, NC owners and action owners  Note: Yellow fields are required Used for automatic emails Enter a password to log in to the database (Must be les than 16 characters long) Access Level defines standard privileges Specific privileges may also be selected

14. Sunday Business Systems www.SundayBizSys.com Set-Up Parameters  Organized into one form with multiple tabs  Many tabs contain information used to build drop-down lists on various forms for example  Parts, Customers, Suppliers, etc.

15. Sunday Business Systems www.SundayBizSys.com Set-up Parameters

16. Sunday Business Systems www.SundayBizSys.com Set-Up Parameters

17. Sunday Business Systems www.SundayBizSys.com Set-Up Parameters

18. Sunday Business Systems www.SundayBizSys.com Set-Up Parameters – Document Details  Document #s appear on key forms  to trace forms to your document control system

19. Corrective Action Requests Background: The 8D problem solving process Create a CAR Review reports Measure effectiveness

20. Sunday Business Systems www.SundayBizSys.com 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

21. Sunday Business Systems www.SundayBizSys.com 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!

22. Sunday Business Systems www.SundayBizSys.com

23. Sunday Business Systems www.SundayBizSys.com Corrective Actions – organized into 5 tabs Use filters to display a limited set of data Yellow fields are required Double click blue to jump to part list

24. Sunday Business Systems www.SundayBizSys.com 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 – clearly define the problem

25. Sunday Business Systems www.SundayBizSys.com CAPA Process Flow / Status Process CAR / PAR Status Exceptions Status

26. Sunday Business Systems www.SundayBizSys.com Tab #2: Containment  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  Definition: ECD = Estimated Completion Date or due date Establish containment actions with specific owners

27. Sunday Business Systems www.SundayBizSys.com Tab #3: Root Cause Analysis  Determine the Root Cause (s)  Document the 5 Why’s  The problem may have multiple root causes  Primary root cause  Escape Root cause  Contributing root cause  Corrective actions must be aligned to each root cause Document multiple root causes for a single CAR including Primary, Escape, and contributing root causes Ask why?, why?, why?, why?, why? to determine effective corrective actions

28. Sunday Business Systems www.SundayBizSys.com 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

29. Sunday Business Systems www.SundayBizSys.com Tab #4: Corrective Actions and Validation Establish corrective actions with specific owners Establish Validation criteria and document closure

30. Sunday Business Systems www.SundayBizSys.com Corrective Action Life Cycle

31. Sunday Business Systems www.SundayBizSys.com Verification and Validation  Verification  Documented by approving the corrective action plan  Should require management review and approval  Upon completion, 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 and reviewed  Actual Value  the observed or actual value  Record who validated the action, when, and definitively state that the action was effective (or not)

32. Sunday Business Systems www.SundayBizSys.com Examples of Actions with Validation

33. Sunday Business Systems www.SundayBizSys.com Tab #5: Preventive Actions  Document any actions to prevent similar occurrences

34. Sunday Business Systems www.SundayBizSys.com Tab #6: Comments and Files Add comments including customer feedback Link any number of electronic files such as pictures, customer emails, etc. Email the electronic CAR report directly to Management or Customers

35. Sunday Business Systems www.SundayBizSys.com Professional Reports  Print or email the CAR report directly to the Customer

36. Sunday Business Systems www.SundayBizSys.com Handy Features  Forms may be  Sorted  Filtered  Searched  Export data  Spell check  Directory  Lists a summary

37. Sunday Business Systems www.SundayBizSys.com CAR Reports  A full set of reports, charts, graphs and analysis Apply filters to reports

38. 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!

39. Sunday Business Systems www.SundayBizSys.com  PARs are handled nearly the same as CARs PAR

40. Sunday Business Systems www.SundayBizSys.com PAR Reports

41. Nonconformance Management Track non-conformances Document product disposition Perform Failure Analysis Analyze defects for continual improvement

42. Sunday Business Systems www.SundayBizSys.com Nonconformance Management Enter General Nonconformance details Classify the Nonconformances based on the defect category

43. Sunday Business Systems www.SundayBizSys.com Failure Analysis Perform Failure Analysis Assign multiple root causes – later, analyze by root cause Produce professional Failure Analysis reports

44. Sunday Business Systems www.SundayBizSys.com 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

45. Sunday Business Systems www.SundayBizSys.com Nonconformance Analysis  Rich set of configurable reports and charts

46. Internal Audits Schedule audits Document audit findings Convert findings into a CAR and / or PAR Report and analyze results

47. Sunday Business Systems www.SundayBizSys.com Internal Audits Generate audit reports Document general audit details Enter dates; an audit is “open” if there is no completion date

48. Sunday Business Systems www.SundayBizSys.com Internal Audits Generate audit reports Document general audit details Enter dates; an audit is “open” if there is no completion date

49. Sunday Business Systems www.SundayBizSys.com Internal Audits - Findings Document detailed audit findings Create a CAR or PAR Linked to the Audit with a click of a button

50. Sunday Business Systems www.SundayBizSys.com Manage Audit Schedule To schedule an audit in the future: 1) enter the audit details 2) Click button to schedule audit Review the entire audit schedule

51. Sunday Business Systems www.SundayBizSys.com Internal Audit CARs  Once Audit Findings have been escalated to a Corrective Action Request, they may be managed in the CAR Module Click to view the IA CAR

52. Sunday Business Systems www.SundayBizSys.com Audit Reports and Analysis

53. Risk Management Failure Modes and Effects Analysis

54. Sunday Business Systems www.SundayBizSys.com Set-up Parameters – Detection Rating

55. Risk Management FMEA Background Features and Benefits Set-up and Use

56. Sunday Business Systems www.SundayBizSys.com History  FMEA: Failure Mode and Effects Analysis  Was one of the first systematic techniques for failure analysis  Developed by reliability engineers in the 1950s to study problems that may arise from military system malfunctions  Further developed and adopted by the aerospace and automotive industries  Today, it is a standard technique for risk analysis and continual improvement

57. Sunday Business Systems www.SundayBizSys.com FMEA  An FMEA is often the first step of a system reliability study.  It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects.  FMEA begins during the earliest stages of design and continues throughout the life of the product or service.  You can use the FMEA Tool in two separate, but related ways:  Analyze the current process and evaluate the potential impact of changes under consideration  Track improvement over time

58. Sunday Business Systems www.SundayBizSys.com Reduce Risk and Improve Performance  The FMEA is a simple business process:  Anticipate: what can go wrong?  Prioritize actions to  Reduce the severity or impact of an adverse event  Decrease the frequency of an adverse event  Increase the delectability of an adverse event  Complete the actions in a timely fashion  Re-evaluate the process / product / service in light of  New data  Improved processes  New processes

59. Sunday Business Systems www.SundayBizSys.com FMEA Process Flow Complete Actions and Re-compute RPN Determine actions to Reduce each RPN Analyze the current controls and determine Detection Rating Identify the Cause and Occurrence Rating Determine the Effects and Severity Rating Identify the failure modes Map the process Assemble the Team Management review and approval Customer Feedback Field Failure Data Yield / Rework Data Process Experience Inspection Results Gauge R&R Inputs

60. Sunday Business Systems www.SundayBizSys.com The FMEA Process 1. Assemble a cross-functional team of people with diverse knowledge about the process, product or service and customer needs. 2. Identify the scope of the FMEA.  for Safety, concept, system, design, process, or service? 3. Identify the items: process steps, components, subsystems, parts, assemblies 4. For each item, identify the possible failure modes  What could go wrong? 5. Identify all the consequences or effects of each failure mode 6. Determine the Severity of each failure mode  rate it on a scale of 1-10 where 1 is not severe and 10 is extremely severe 7. Determine all the potential root causes

61. Sunday Business Systems www.SundayBizSys.com The FMEA Process 8. For each cause, determine the Occurrence rating  occurrence estimates the probability of the failure occurring  rate it on a scale of 1-10 where 1 is infrequent and 10 is commonplace 9. Identify current process controls for each cause 10. Determine the Detection rating based on the effectiveness of the current process controls  rate it on a scale of 1-10 where 1 is highly detectable and 10 is not detectable 11. Calculate the risk priority number, or RPN  RPN = [Severity] × [Occurrence] × [Detection]  Rank Failure modes according to the estimated risk factor (RPN) 12. Identify actions to lower the severity and occurrence, and / or add controls to improve detection. 13. Actions are assigned to owners, completed, validated and closed 14. Risk factors (Severity, Occurrence, and Detection) are then re-evaluated after remedial action has been completed

62. Sunday Business Systems www.SundayBizSys.com Traditional Methods  Paper forms  Excel Spreadsheets  Problems  Difficult to work collaboratively  Difficult to audit  No user based restrictions to protect data integrity  Difficult to manage  No concise reports for actions due  Poor visibility to FMEA effectiveness

63. Sunday Business Systems www.SundayBizSys.com SBS FMEA Database Advantages  Easy to use  Collaborative platform  Simple, menu driven user interface  Easy to train users  Convenient, intuitive forms  Can restrict users to control data integrity  Rich set of reports  Easy to identify delinquencies, stalled actions  Reports may be emailed with a single click  Export data to Excel for further analysis  Built using Microsoft Access  Common, convenient software platform  Runtime version of Access is available as a free download

64. Sunday Business Systems www.SundayBizSys.com USING THE FMEA MODULE Using the SBS FMEA Module in the SBS Quality Database

65. Sunday Business Systems www.SundayBizSys.com Key Features  List items, process steps, or functions  Identify Failure Modes for each  Identify effects and severity  Identify causes and frequency  Identify current controls and detection level  Develop multiple actions associated with this failure mode  Assign owners and due dates  Establish verification and validation criteria  Electronic signature for management approval  Rich set of reports  Track open actions and delinquent due dates

66. Sunday Business Systems www.SundayBizSys.com FMEA form - Details Data Organized into 3 tabs FMEA details determine the type and scope Define the Team Approvals and edits

67. Sunday Business Systems www.SundayBizSys.com FMEA form - Details Data Organized into 3 tabs FMEA details determine the type and scope Define the Team Approvals and edits Electronic signatures to document approval and closure

68. Sunday Business Systems www.SundayBizSys.com FMEA Form – Failure Modes and Actions For each Failure mode, you may create any number of actions to reduce the RPN Actions include acceptance criteria and validation

69. Sunday Business Systems www.SundayBizSys.com FMEA Form – Comments and Attachments Supporting documentation may be linked to the FMEA

70. Sunday Business Systems www.SundayBizSys.com FMEA Form - Reports

71. Sunday Business Systems www.SundayBizSys.com FMEA Form – Reports (FMEA Actions)

72. Sunday Business Systems www.SundayBizSys.com Reports and Analysis Report filters Reports and analysis

73. Sunday Business Systems www.SundayBizSys.com FMEA SET-UP FMEA Set-up and Configuration

74. Sunday Business Systems www.SundayBizSys.com FMEA Set-up  Edit FMEA Types and RPN Ratings  FMEA Types  Classification  Severity  Occurrence  Detection  Customize your RPN rating to meet your requirements

75. Sunday Business Systems www.SundayBizSys.com Set-up Parameters Set-up parameters are organized into multiple tabs

76. Sunday Business Systems www.SundayBizSys.com Set-up Parameters – FMEA Types Used in FMEA Type list

77. Sunday Business Systems www.SundayBizSys.com Set-up Parameters – Classification

78. Sunday Business Systems www.SundayBizSys.com Set-up Parameters – Severity Rating  Customizable  For example: change scale from 1-10 to 1-3  Short description shows in Severity List

79. Sunday Business Systems www.SundayBizSys.com Set-up Parameters – Occurrence Rating

80. Sunday Business Systems www.SundayBizSys.com Set-up Parameters – Detection Rating

81. Meeting Manager Document meeting minutes Track and manage meeting actions Drive Continual Improvement at the management level Use for mission critical meetings

82. Sunday Business Systems www.SundayBizSys.com Meeting Manager  Track Mission Critical meetings:  Quality Management System Reviews  Safety Meetings  MRB meetings  Design reviews  Daily operations meetings  Document meeting decisions and actions  Maintain an auditable record of compliance  Demonstrate evidence of risk based thinking  Meeting Manager is organized in 4 tabs  QMS Details  Data Review  Actions and Validation  Comments and files

83. Sunday Business Systems www.SundayBizSys.com Meeting Manager – Meeting Details

84. Sunday Business Systems www.SundayBizSys.com Meeting Manager – Data Review

85. Sunday Business Systems www.SundayBizSys.com Meeting Manager - Actions and Validation

86. Sunday Business Systems www.SundayBizSys.com Meeting Manager – Comments and Attachments

87. Sunday Business Systems www.SundayBizSys.com Meeting Manager - Reports

88. Simple Surveys Create Customer Satisfaction surveys Create Vendor Qualification surveys Manage & analyze survey results

89. Sunday Business Systems www.SundayBizSys.com 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

90. Sunday Business Systems www.SundayBizSys.com 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

91. Sunday Business Systems www.SundayBizSys.com 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

92. Sunday Business Systems www.SundayBizSys.com 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.

93. Sunday Business Systems www.SundayBizSys.com Produce Professional Looking Surveys

94. Sunday Business Systems www.SundayBizSys.com Survey Analysis Tools  Variety of customizable reports  Charts, graphs

95. SBS Quality Database Best in class software solution

96. Sunday Business Systems www.SundayBizSys.com Summary  The SBS Quality Database is a cost effective tool to  Ensure effective training compliance with Quality standards  ISO 9001:2015  AS 9100  TS 16949  ISO 13485  ISO 14001  Manage Corrective and Preventive Actions  Document Risk management  Manage meetings  Monitor Customer perceptions  Maintain paperless quality records  Analyze performance and develop improvement strategies  Save time and effort

97. Sunday Business Systems www.SundayBizSys.com 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 ISO9001:2015 compliant systems  Document Control  Corrective and Preventive Actions  Audit Management  Employee Training  Control of calibrated equipment  Vendor Management  SPC  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 Sunday Business Systems

98. © 2013 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 www.SundayBizSys.com for:www.SundayBizSys.com Additional information Free product demos Pricing Links to purchase software