SBS FMEA Database FMEA Background SBS Database Features
SBS FMEA Database FMEA Background SBS Database Features and Benefits SBS Database Set-up and Use
History 4 FMEA: Failure Mode and Effects Analysis 4 Was one of the first systematic techniques for failure analysis 4 Developed by reliability engineers in the 1950 s to study problems that may arise from military system malfunctions 4 Further developed and adopted by the aerospace and automotive industries 4 Today, it is a standard technique for risk analysis and continual improvement www. Sunday. Biz. Sys. com Sunday Business Systems
FMEA 4 An FMEA is often the first step of a system reliability study. 4 It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. 4 FMEA begins during the earliest stages of design and continues throughout the life of the product or service. 4 You can use the FMEA Tool in two separate, but related ways: 8 Analyze the current process and evaluate the potential impact of changes under consideration 8 Track improvement over time www. Sunday. Biz. Sys. com Sunday Business Systems
Reduce Risk and Improve Performance 4 The FMEA is a simple business process: 8 Anticipate: what can go wrong? 8 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 8 Complete the actions in a timely fashion 8 Re-evaluate the process / product / service in light of = = = New data Improved processes New processes www. Sunday. Biz. Sys. com Sunday Business Systems
FMEA Process Flow Assemble the Team Inputs Process Experience Map the process Customer Feedback Field Failure Data Identify the failure modes Yield / Rework Data Inspection Results Determine the Effects and Severity Rating Gauge R&R Complete Actions and Re-compute RPN Identify the Cause and Occurrence Rating Management review and approval Analyze the current controls and determine Detection Rating Determine actions to Reduce each RPN www. Sunday. Biz. Sys. com Sunday Business Systems
The FMEA Process 1. 2. Assemble a cross-functional team of people with diverse knowledge about the process, product or service and customer needs. Identify the scope of the FMEA. 8 for Safety, concept, system, design, process, or service? 3. 4. Identify the items: process steps, components, subsystems, parts, assemblies For each item, identify the possible failure modes 8 5. 6. What could go wrong? Identify all the consequences or effects of each failure mode Determine the Severity of each failure mode 8 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 www. Sunday. Biz. Sys. com Sunday Business Systems
The FMEA Process 8. For each cause, determine the Occurrence rating 8 occurrence estimates the probability of the failure occurring 8 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 8 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 8 8 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 www. Sunday. Biz. Sys. com Sunday Business Systems
Traditional Methods 4 Paper forms 4 Excel Spreadsheets 4 Problems 8 Difficult to work collaboratively 8 Difficult to audit 8 No user based restrictions to protect data integrity 8 Difficult to manage = = No concise reports for actions due Poor visibility to FMEA effectiveness www. Sunday. Biz. Sys. com Sunday Business Systems
SBS FMEA Database Advantages 4 Easy to use 8 Collaborative platform 8 Simple, menu driven user interface 8 Easy to train users 4 Convenient, intuitive forms 8 Can restrict users to control data integrity 4 Rich set of reports 8 Easy to identify delinquencies, stalled actions 8 Reports may be emailed with a single click 8 Export data to Excel for further analysis 4 Built using Microsoft Access 8 Common, convenient software platform 8 Runtime version of Access is available as a free download www. Sunday. Biz. Sys. com Sunday Business Systems
SBS FMEA Database Using the SBS FMEA Database
Key Features 4 List items, process steps, or functions 8 Identify Failure Modes for each = = = Identify effects and severity Identify causes and frequency Identify current controls and detection level 8 Develop multiple actions associated with this failure mode = = Assign owners and due dates Establish verification and validation criteria 4 Electronic signature for management approval 4 Rich set of reports 8 Track open actions and delinquent due dates www. Sunday. Biz. Sys. com Sunday Business Systems
Login Screen 4 The login process limits access to the database features 8 Password is required 8 Privileges may be restricted to protect data 4 The Demo version includes dummy data and employees 8 Admin is the default login for demo versions 8 Admin has full Database privileges = = = Employee: Admin Password: admin All other employees: password = pw www. Sunday. Biz. Sys. com Sunday Business Systems
FMEA form - Details Data Organized into 3 tabs FMEA details determine the type and scope Define the Team Approvals and edits www. Sunday. Biz. Sys. com Sunday Business Systems
FMEA Form – Failure Modes and Actions include acceptance criteria and validation For each Failure mode, you may create any number of actions to reduce the RPN www. Sunday. Biz. Sys. com Sunday Business Systems
FMEA Form – Comments and Attachments Supporting documentation may be linked to the FMEA www. Sunday. Biz. Sys. com Sunday Business Systems
FMEA Form - Reports www. Sunday. Biz. Sys. com Sunday Business Systems
FMEA Form – Reports (FMEA Actions) www. Sunday. Biz. Sys. com Sunday Business Systems
Reports and Analysis Report filters www. Sunday. Biz. Sys. com Reports and analysis Sunday Business Systems
Set-up and Configuration FMEA Database Set-up and Configuration
Easy Installation 4 Download the demo database 4 Save or copy the FMEA. accde file to a designated folder on your Network File Server 4 Once purchased, register the demo database (enter the Product Key) 4 Ensure all Workstations have 8 Microsoft Access or the free Runtime version of Microsoft Access 8 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 www. Sunday. Biz. Sys. com Sunday Business Systems
Database Set-up 4 Enter Employees 8 Enter password if employee login is required 8 Detail employee login privileges 4 Enter Company information 8 Company name, address, etc. 8 Sites 8 Departments 8 Customers 8 Parts 4 Edit FMEA Types and RPN Ratings 8 FMEA Types 8 Severity 8 Occurrence 8 Detection www. Sunday. Biz. Sys. com Sunday Business Systems
Set-up Parameters www. Sunday. Biz. Sys. com Set-up parameters are organized into multiple tabs Sunday Business Systems
Set-up Parameters - Sites Used in Site list www. Sunday. Biz. Sys. com Sunday Business Systems
Set-up Parameters - Departments Used in Department list www. Sunday. Biz. Sys. com Sunday Business Systems
Set-up Parameters - Customers Used in Customer list www. Sunday. Biz. Sys. com Sunday Business Systems
Set-up Parameters - Parts Used in Parts list www. Sunday. Biz. Sys. com Sunday Business Systems
Set-up Parameters – FMEA Types Used in FMEA Type list www. Sunday. Biz. Sys. com Sunday Business Systems
Set-up Parameters – Severity Rating 4 Customizable 8 For example: change scale from 1 -10 to 1 -3 4 Short description shows in Severity List www. Sunday. Biz. Sys. com Sunday Business Systems
Set-up Parameters – Occurrence Rating www. Sunday. Biz. Sys. com Sunday Business Systems
Set-up Parameters – Detection Rating www. Sunday. Biz. Sys. com Sunday Business Systems
Overall Risk Management Strategy SWOT Analysis FMEA Corporate Vision Sales / Marketing Strategy Competitive Analysis www. Sunday. Biz. Sys. com Product Design Project Planning Manufacturing Process Design Manufacturing Process Sunday Business Systems
Summary 4 The SBS FMEA Database is a cost effective tool to 8 Ensure effective compliance with OSHA and Quality Standards = ISO 9001: 2008 = AS 9100 = TS 16949 = ISO 14001 = ISO 13485 8 Develop and execute Risk Reduction plans 8 Maintain paperless quality records 8 Analyze performance and develop improvement strategies 8 Save time and effort 4 Customization is available 8 Talk to us about customizing the software to meet your needs! www. Sunday. Biz. Sys. com Sunday Business Systems
Additional Services 4 Data Import Service 8 Import legacy data from excel spreadsheets into your Database 4 Training Services 8 SBS offers instructor led, Webex based, interactive training sessions 8 We cover the following subjects: = = = Vendor Management Database features and benefits General set-up and configuration Creating Qual plans / requirements Creating Qualifying Vendors Using reports to manage the qualification process Microsoft Access tips and tricks 4 Customization 8 Talk to us about customizing the software to meet your needs! 4 Contact Sales@sundaybizsys. com for more information www. Sunday. Biz. Sys. com Sunday Business Systems
About SBS 4 Sunday Business Systems provides cost effective software for your Quality Management System 8 Corrective and Preventive Actions (CAPA) 8 Audit management 8 Employee Training 8 Document Control 8 Control of calibrated equipment 8 Vendor management 8 Customer Satisfaction Surveys 8 Communication / Continual improvement 8 Shop Floor Control 4 SBS will customize the software for your particular needs 4 Offers instructor led training services www. Sunday. Biz. Sys. com Sunday Business Systems
Fueling Small Business Efficiency Visit www. Sunday. Biz. Sys. com for: • Free product demos • Additional information • Pricing • Links to purchase software © 2014 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.
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