The document outlines a quality process for product development consisting of 6 stages (Q0-Q6). Q0 involves business analysis and case confirmation. Q1 is engineering where requirements, design, and testing specifications are developed. Q2 is system testing. Q3 is quality assurance testing. Q4 is project validation. Q5 is beta testing at client sites. Q6 is the final release process where documents are verified and CDs are created and labeled for distribution. Each stage has defined responsibilities, entry and exit criteria, and activities to ensure quality is built into the entire product development life cycle.

1. Quality Team
Product Development Life
Cycle
An Introduction

2. Quality
Policy
“To conform to explicitly stated functional and performance
requirements, explicitly documented development standards,
and implicit characteristics that are expected of a professionally
developed clinical software

3. Quality Team

4. Mecosoft Quality Process
 Product development process
 Maps our PRD process
 Customized to Mecosoft
 Software Company
 Software Oriented
 Innovation & Inspiration – not curtailed
 Cut unnecessary red tape
 Small Teams

5. Product Quality Chart
• Q0- Business Case Confirmed
- Corporate
• Q1- Engineering
- Development
• Q2- System testing
- Development
• Q3- Quality Assurance
- Quality
• Q4- Product / Process Validation
- Product Management
• Q5- Beta Testing
- Product Management
• Q6- Release
- Product Management

6. Q0 – Business Analysis
Responsibility - Corporate

7. Q0 – Business Case Confirmation
• Business case document
• Risk analysis and mitigation plan
• Project proposal
• To be implemented for New Product Development - 2002

8. Q1 - Engineering
Responsibility - Development

9. Q1 – Product Engineering
 Software Requirement Specifications
 Review Requirements
 Prototyping
 Design (SDD)
 Design Review
 Implementation
 Module and System Test Specs
 Integration Test Specs. (TCD)

10. Q1 – Product Engineering
 Entry
- Corporate Approves Product Development Kick off
 Inputs
- User Requirements
- Identified Team & Schedule [Q0/Q1]
 Exit Criteria
- SRS, SDD, Test Case Document, Test Report, Formulae
used, Product, DICOM Conformance, Test Data

11. Q1 – Product Engineering

12. Q2 – System Testing
Responsibility - Development

13. Q2 – System Testing
 Module Testing
 System Testing
 Performance Report
 Bug Tracking
 Code Change
 Quality Handover

14. Q2 – System Testing
 Entry Criteria
- Q1 Exit Criteria
 Exit Criteria
- System Testing Passed
- System Test Report
- Handover Installable to Quality
- Q0, Q1, Q2 Documents verified

15. Q2 – System Testing

16. Q3 – Quality Assurance
Responsibility - Quality

17. Q3 – Quality Assurance
 Functional Testing
 GUI Testing
 Interface with Hardware
 Bug Tracking Updation
 Test Report
 Product Release Document

18. Q3 – Quality Assurance
 Entry Criteria
-Q0, Q1 Milestones
-Q2 Exit Criteria
 Exit Criteria
-No Severity Level 1 & 2
-Bug Tracking & Quality Test Report
-Release Document to PMC
-Product Release to PMC for Q5

19. Q3 – Quality Assurance

20. Q4 – Project Validation
Responsibility - PMC

21. Q4 – Project Validation
• Project / Process validation
-(min no. transactions required)
• Online Help
• User Manual
• Installation Guide
• Spec Sheet for Marketing
• Brochure Design by Marketing

22. Q4 – Project Validation
• Entry Criteria
- Q3 Exit Criteria
- Installable Product
- System Configuration
• Exit Criteria
- Client Validation Approval
- No Severity 1 & 2 level errors

23. Q4 – Project Validation

24. Q5 - Beta Testing
Responsibility - PMC

25. Q5 – Beta Site Testing
 Beta Testing
 Acceptance Testing
 Beta Site Reports
 Bug Tracking Updated
 Approval sign off by User Sites in-charge

26. Q5 – Beta Testing
 Entry Criteria
- Quality Approval & User Validation Approved
 Exit Criteria
- PMC Approval after Beta Testing
- No Severity Level Errors 1 & 2
- Deployable CD Generated

27. Q5 – Beta Testing

28. Q6 – Release Process
Responsibility - PMC

29. Q6 – Product Release and
Distribution
• Release with documents
• Verification of Released Documents
• CD Writing
• Product ID specification and Labeling

30. Q6 – Product Release
• Entry Criteria
- Deployable CD
- Installation Manual, User Manual
- Brochure
- End User Licence Text
• Exit
- Release Document
- Controlled CDs for Pilot Launch

31. Q6 – Product Release and
Distribution

32. Thank You!