Windows Small Business Server 4/11/2017 5:16 PM The Quality Database Features and Benefits Introduction and Tutorial www.SundayBizSys.com Fueling Small Business Efficiency © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

Background Quality management standards require many things, including Corrective and Preventive Actions Internal Audits Management reviews ISO 9001:2008 “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

Features Nonconformance Tracking Corrective Actions (CA) Safety Corrective Actions Supplier Corrective Actions Internal Audit Corrective Actions Preventive Actions (PA) 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

Windows Small Business Server 4/11/2017 5:16 PM User Interface Simple, efficient interface Menu driven 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 © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

Windows Small Business Server 4/11/2017 5:16 PM Analysis Tools Wide variety of detailed reports Charts, graphs, Pareto analysis Quality Performance metrics © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

Windows Small Business Server 4/11/2017 5:16 PM Features Control user access levels Link electronic documents, pictures, pdf files, Customer email Supports single and Multi-user network environments Built on Microsoft Access 2007 A free version of Access is included with the full download No need to purchase Access if you do not have it Compatible with Microsoft Access 2010 and 2013 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!!! © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

Windows Small Business Server 4/11/2017 5:16 PM Benefits Complies with requirements of ISO 9001:2008 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 (ISO 9001:2008 5.6.1) Internal audits (ISO 9001:2008 8.2.2) Corrective Action results (ISO 9001:2008 8.5.2) Preventive Action results (ISO 9001:2008 8.5.3) Supplier Corrective Actions (ISO 9001:2008 7.4.1) Customer satisfaction surveys (ISO 9001:2008 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 © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

Benefits Efficient and cost effective Reports and analysis 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

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

Easy Installation Download the demo database Save or copy the Quality DB.mde or 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

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 For the demo database, Employee: Admin Password: admin All other employees password = pw

Setting up the Database Add Employees (owners) Enter Company specific information Company contact information Sites Departments CAR/PAR Categories Root Cause categories Defect categories Customer List Supplier Lists Parts List Document names

Add / Edit Employees and Assign Privileges Used for automatic emails Employees are your CAR, PAR, NC owners and action owners Enter a password to log in to the database Access Level defines standard privileges Specific privileges may also be selected

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.

Set-up Parameters

Set-Up Parameters

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

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

The 8D Problem Solving Process 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!

Start a CAR – organized into 5 tabs

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

CAPA Process Flow / Status Windows Small Business Server 4/11/2017 5:16 PM CAPA Process Flow / Status Process CAR / PAR Status Exceptions Status © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

Establish containment actions with specific owners 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

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 Ask why?, why?, why?, why?, why? to determine effective corrective actions Document multiple root causes for a single CAR including Primary, Escape, and contributing root causes

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” when a date is entered in the “CA Plan Approved” field

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

Corrective Action Life Cycle Windows Small Business Server 4/11/2017 5:16 PM © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

Verification and Validation 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)

Examples of Actions with Validation

Tab #5: Preventive Actions Document any preventive actions to prevent similar occurrences

Tab #6: Comments and Files Add comments including customer feedback Tab #6: Comments and Files Email the electronic CAR report directly to Management or Customers Link electronic files such as pictures, customer emails, etc.

Professional Reports Print or email the CAR report directly to the Customer

Handy Features Forms may be Directory Sorted Filtered Searched Export data Spell check Directory Lists a summary

Apply filters to reports CAR Reports A full set of reports, charts, graphs and analysis Apply filters to reports

PARs use the same process and similar forms as CARs Preventive Actions 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! PARs use the same process and similar forms as CARs

PAR PARs are handled nearly the same as CARs

PAR Reports

Nonconformance Tracking Track non-conformances Failure Analysis Analyze defects for continual improvement

Nonconformance Tracking Enter General Nonconformance details Nonconformance Tracking Classify the Nonconformances based on the defect category

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

Document what is to be done with the material: Release, Return, or scrap Disposition Produce a concise nonconformance report Escalate any Non-conformance to a CAR with a click of a button

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

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

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

Manage Audit Schedule

Internal Audit CARs

Audit Reports and Analysis

Management Reviews Quality Management System Reviews Document meeting minutes Track and manage actions Drive Continual Improvement at the management level

Quality Management System (QMS) Reviews Document a QMS Meeting Who attended What was the agenda? What was discussed? ISO9001:2008 establishes the basic agenda What were the resulting actions taken? Are the actions complete? QMS review organized in 4 tabs QMS Details Data Review Actions and Validation Comments and files

QMS Details

QMS - Data review

QMS - Actions and Validation

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

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

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

Windows Small Business Server Enter General Information Windows Small Business Server 4/11/2017 5:16 PM User Interface Simple, efficient interface Menu Driven Data entry in simple forms Organize the survey into topics List all Survey questions & define types © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

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.

Produce Professional Looking Surveys

Windows Small Business Server 4/11/2017 5:16 PM Survey Analysis Tools Variety of customizable reports Charts, graphs © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.

Best in class software solution SBS Quality Database Best in class software solution

Summary The SBS Quality Database is a cost effective tool to Ensure effective training compliance with Quality standards ISO 9001:2008 AS 9100 TS 16949 ISO 13485 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

About SBS Sunday Business Systems 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 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

Windows Small Business Server 4/11/2017 5:16 PM Sunday Business Systems Fueling Small Business Efficiency Visit www.SundayBizSys.com for: Additional information Free product demos Pricing Links to purchase software © 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. © 2006 Microsoft Corporation. All rights reserved. This presentation is for informational purposes only. Microsoft makes no warranties, express or implied, in this summary.