The Quality Database Features and Benefits Introduction and Tutorial Fueling Small Business Efficiency

Sunday Business Systems 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  ISO 13485

Sunday Business Systems 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

Sunday Business Systems 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  reports with a single click  Export data to excel, word, or PDF

Sunday Business Systems Analysis Tools  Wide variety of detailed reports  Charts, graphs, Pareto analysis  Quality Performance metrics

Sunday Business Systems Features  User login - Controls access to designated modules  Link electronic documents, pictures, pdf files, Customer  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!!!

Sunday Business Systems Benefits  Complies with requirements of  ISO 9001:2015  AS9100  ISO/TS  ISO  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  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

Sunday Business Systems 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?  reminders for open actions  Develop agendas for meetings  Utilizes a proven method of Corrective Action  Organize and track actions from management review meetings

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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems Add / Edit Employees and Assign Privileges  Employees are your CAR, PAR, NC owners and action owners  Note: Yellow fields are required Used for automatic s 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

Sunday Business Systems 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.

Sunday Business Systems Set-up Parameters

Sunday Business Systems Set-Up Parameters

Sunday Business Systems Set-Up Parameters

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

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

Sunday Business Systems 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

Sunday Business Systems 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!

Sunday Business Systems

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems CAPA Process Flow / Status Process CAR / PAR Status Exceptions Status

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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

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

Sunday Business Systems Corrective Action Life Cycle

Sunday Business Systems 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)

Sunday Business Systems Examples of Actions with Validation

Sunday Business Systems Tab #5: Preventive Actions  Document any actions to prevent similar occurrences

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

Sunday Business Systems Professional Reports  Print or the CAR report directly to the Customer

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

Sunday Business Systems CAR Reports  A full set of reports, charts, graphs and analysis Apply filters to reports

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!

Sunday Business Systems  PARs are handled nearly the same as CARs PAR

Sunday Business Systems PAR Reports

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

Sunday Business Systems Nonconformance Management Enter General Nonconformance details Classify the Nonconformances based on the defect category

Sunday Business Systems Failure Analysis Perform Failure Analysis Assign multiple root causes – later, analyze by root cause Produce professional Failure Analysis reports

Sunday Business Systems 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

Sunday Business Systems Nonconformance Analysis  Rich set of configurable reports and charts

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

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

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

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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems Audit Reports and Analysis

Risk Management Failure Modes and Effects Analysis

Sunday Business Systems Set-up Parameters – Detection Rating

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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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 ed 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

Sunday Business Systems USING THE FMEA MODULE Using the SBS FMEA Module in the SBS Quality Database

Sunday Business Systems 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

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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems FMEA Form – Comments and Attachments Supporting documentation may be linked to the FMEA

Sunday Business Systems FMEA Form - Reports

Sunday Business Systems FMEA Form – Reports (FMEA Actions)

Sunday Business Systems Reports and Analysis Report filters Reports and analysis

Sunday Business Systems FMEA SET-UP FMEA Set-up and Configuration

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

Sunday Business Systems Set-up Parameters Set-up parameters are organized into multiple tabs

Sunday Business Systems Set-up Parameters – FMEA Types Used in FMEA Type list

Sunday Business Systems Set-up Parameters – Classification

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

Sunday Business Systems Set-up Parameters – Occurrence Rating

Sunday Business Systems Set-up Parameters – Detection Rating

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

Sunday Business Systems 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

Sunday Business Systems Meeting Manager – Meeting Details

Sunday Business Systems Meeting Manager – Data Review

Sunday Business Systems Meeting Manager - Actions and Validation

Sunday Business Systems Meeting Manager – Comments and Attachments

Sunday Business Systems Meeting Manager - Reports

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

Sunday Business Systems Simple Survey Features  Easily create custom surveys  Simple, intuitive interface  Print out or 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

Sunday Business Systems 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

Sunday Business Systems 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

Sunday Business Systems 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.

Sunday Business Systems Produce Professional Looking Surveys

Sunday Business Systems Survey Analysis Tools  Variety of customizable reports  Charts, graphs

SBS Quality Database Best in class software solution

Sunday Business Systems Summary  The SBS Quality Database is a cost effective tool to  Ensure effective training compliance with Quality standards  ISO 9001:2015  AS 9100  TS  ISO  ISO  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

Sunday Business Systems 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

© 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