Corrective Actions and Risk management for ISO 9001:2015


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The Quality Database is a simple, inexpensive ISO 9001 compliant program that allows small businesses to efficiency manage the Quality System. The database tracks corrective and preventive actions, internal audit tracking, safety improvement, supplier corrective actions, continual improvement projects and risk management. Compile and analyze Customer Survey results. Document QMS review meetings and results. The program is ideal for small businesses striving for ISO 9001 and AS9100 compliance.

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  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • 12/7/2016 9:24 PM
  • Corrective Actions and Risk management for ISO 9001:2015

    1. 1. The Quality Database Features and Benefits Introduction and Tutorial Fueling Small Business Efficiency
    2. 2. Sunday Business 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. 3. Sunday Business 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. 4. Sunday Business User Interface Simple, efficient interface  All modules clearly displayed  Quick Navigation ribbon 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. 5. Sunday Business Analysis Tools Wide variety of detailed reports Charts, graphs, Pareto analysis Quality Performance metrics
    6. 6. Sunday Business 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. 7. Sunday Business Benefits Complies with requirements of  ISO 9001:2015  AS9100  ISO/TS 16949  ISO 13485  API Q1 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. 8. 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 Utilizes a proven method of Corrective Action Organize and track actions from management review meetings
    9. 9. Database Set-up and Configuration Add Employee information Set user passwords and access levels Customize set-up parameters
    10. 10. Sunday Business 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. 11. Sunday Business 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. 12. Sunday Business 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. 13. Sunday Business 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. 14. Sunday Business 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. 15. Sunday Business Set-up Parameters
    16. 16. Sunday Business Set-Up Parameters
    17. 17. Sunday Business Set-Up Parameters
    18. 18. Sunday Business Set-Up Parameters – Document Details Document #s appear on key forms  to trace forms to your document control system
    19. 19. Corrective Action Requests Background: The 8D problem solving process Create a CAR Review reports Measure effectiveness
    20. 20. 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
    21. 21. 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!
    22. 22. 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
    23. 23. Sunday Business 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. 24. 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 – clearly define the problem
    25. 25. Sunday Business CAPA Process Flow / Status 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
    26. 26. Sunday Business 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. 27. Sunday Business 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. 28. 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
    29. 29. Sunday Business Tab #4: Corrective Actions and Validation Establish corrective actions with specific owners Establish Validation criteria and document closure
    30. 30. Sunday Business Corrective Action Life CycleAction Life Cycle Process Action Status Create New Action Item Begin work on closing action item Complete Action item Action no longer needed? Cancel Action Item Validate results of Action Meet or exceed Acceptance Criteria? Action was successfully completed Action was completed but not effective No YES YES NO Open Complete; Validation Needed Complete; Permanent Complete; Invalid Cancelled
    31. 31. Sunday Business 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. 32. 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
    33. 33. Sunday Business Tab #5: Preventive Actions Document any actions to prevent similar occurrences
    34. 34. Sunday Business 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. 35. Sunday Business Professional Reports Print or email the CAR report directly to the Customer
    36. 36. Sunday Business Handy Features Forms may be  Sorted  Filtered  Searched  Export data  Spell check Directory  Lists a summary
    37. 37. Sunday Business CAR Reports A full set of reports, charts, graphs and analysis Apply filters to reports
    38. 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. 39. Sunday Business PARs are handled nearly the same as CARs PAR
    40. 40. Sunday Business PAR Reports
    41. 41. Nonconformance Management Track non-conformances Document product disposition Perform Failure Analysis Analyze defects for continual improvement
    42. 42. Sunday Business Nonconformance Management Enter General Nonconformance details Classify the Nonconformances based on the defect category
    43. 43. Sunday Business Failure Analysis Perform Failure Analysis Assign multiple root causes – later, analyze by root cause Produce professional Failure Analysis reports
    44. 44. 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
    45. 45. Sunday Business Nonconformance Analysis Rich set of configurable reports and charts
    46. 46. Internal Audits Schedule audits Document audit findings Convert findings into a CAR and / or PAR Report and analyze results
    47. 47. Sunday Business Internal Audits Generate audit reports Document general audit details Enter dates; an audit is “open” if there is no completion date
    48. 48. Sunday Business Internal Audits Generate audit reports Document general audit details Enter dates; an audit is “open” if there is no completion date
    49. 49. Sunday Business Internal Audits - Findings Document detailed audit findings Create a CAR or PAR Linked to the Audit with a click of a button
    50. 50. Sunday Business 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. 51. Sunday Business 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. 52. Sunday Business Audit Reports and Analysis
    53. 53. Risk Management FMEA SWOT Analysis
    54. 54. Sunday Business Risk Management Overview The Quality Database incorporates 2 risk management techniques  SWOT analysis (Strengths Weaknesses Opportunities and Threats)  FMEA (Failure Modes and Effects Analysis) For compliance, we recommend  Using SWOT analysis for upper level business risk analysis  Competitive advantages  Threats to overall business  Market analysis  Using FMEA analysis for detailed product and process risk management  Product Design FMEA  Manufacturing operations (process) FMEA These two risk management techniques can be optimally applied to different levels of organizational risk management
    55. 55. Sunday Business Overall Risk Management Strategy SWOT Analysis FMEA Sales / Marketing Strategy Project Planning Product Design Manufacturing Process Manufacturing Process Design Corporate Vision Competitive Analysis
    56. 56. FMEA FMEA Background Features and Benefits Set-up and Use
    57. 57. Sunday Business 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
    58. 58. Sunday Business 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
    59. 59. Sunday Business 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
    60. 60. Sunday Business 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
    61. 61. Sunday Business 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
    62. 62. Sunday Business 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
    63. 63. Sunday Business 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
    64. 64. Sunday Business 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
    65. 65. Sunday Business USING THE FMEA MODULE Using the SBS FMEA Module in the SBS Quality Database
    66. 66. Sunday Business 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
    67. 67. Sunday Business FMEA form - Details Data Organized into 3 tabs FMEA details determine the type and scope Define the Team Approvals and edits
    68. 68. Sunday Business FMEA form - Details Data Organized into 3 tabs FMEA details determine the type and scope Define the Team Electronic signatures to document approval and closure
    69. 69. Sunday Business 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
    70. 70. Sunday Business FMEA Form – Comments and Attachments Supporting documentation may be linked to the FMEA
    71. 71. Sunday Business FMEA Form - Reports
    72. 72. Sunday Business FMEA Form – Reports (FMEA Actions)
    73. 73. Sunday Business Reports and Analysis Report filters Reports and analysis
    74. 74. Sunday Business FMEA SET-UP FMEA Set-up and Configuration
    75. 75. Sunday Business FMEA Set-up Edit FMEA Types and RPN Ratings  FMEA Types  Classification  Severity  Occurrence  Detection Customize your RPN rating to meet your requirements
    76. 76. Sunday Business Set-up Parameters Set-up parameters are organized into multiple tabs
    77. 77. Sunday Business Set-up Parameters – FMEA Types Used in FMEA Type list
    78. 78. Sunday Business Set-up Parameters – Classification
    79. 79. Sunday Business Set-up Parameters – Severity Rating Customizable  For example: change scale from 1-10 to 1-3 Short description shows in Severity List
    80. 80. Sunday Business Set-up Parameters – Occurrence Rating
    81. 81. Sunday Business Set-up Parameters – Detection Rating
    82. 82. Sunday Business USING THE SWOT MODULE Using the SWOT Module in the SBS Quality Database
    83. 83. Sunday Business SWOT Form Form organized into 3 tabs
    84. 84. Sunday Business SWOT Matrix
    85. 85. Sunday Business SWOT Actions Manage Actions to reduce risk
    86. 86. Sunday Business SWOT Report
    87. 87. Meeting Manager Document meeting minutes Track and manage meeting actions Drive Continual Improvement at the management level Use for mission critical meetings
    88. 88. Sunday Business 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
    89. 89. Sunday Business Meeting Manager – Meeting Details
    90. 90. Sunday Business Meeting Manager – Data Review
    91. 91. Sunday Business Meeting Manager - Actions and Validation
    92. 92. Sunday Business Meeting Manager – Comments and Attachments
    93. 93. Sunday Business Meeting Manager - Reports
    94. 94. Simple Surveys Create Customer Satisfaction surveys Create Vendor Qualification surveys Manage & analyze survey results
    95. 95. 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
    96. 96. 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
    97. 97. 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
    98. 98. 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.
    99. 99. Sunday Business Produce Professional Looking Surveys
    100. 100. Sunday Business Survey Analysis Tools Variety of customizable reports Charts, graphs
    101. 101. SBS Quality Database Best in class software solution
    102. 102. Sunday Business 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
    103. 103. 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 ISO9001:2015 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
    104. 104. © 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 for: •Additional information •Free product demos •Pricing •Links to purchase software