2.1.6.3 Quality Plan

In conformity with the Rational Unified Process best practices, and in preparation for the rigorous standards of the FDA Premarket Approval required of Class III medical devices, Tree Star is implementing a new, more complete, and more explicit testing/validation regime. This program specifies rules for testing, including:

2.1.6.3.1 FlowDx Quality Assurance Plan
General overview of purpose, scope, roles & responsibilities of project (2.6 Workflow Doc)
Describes purpose of documentation, lists supporting documents
General info on tests & corrective actions

2.1.6.3.2 Database Assurance plan
How do we know the database is solid?
How do we know the info is good? Quantity and quality
Policies for data collection

2.1.6.3.3 Database Management Plan
Who is the owner of the database? What are the responsibilities of the owner?
What other roles are there that will manage the DB?
Where is DB stored?How is it interacted with?
Training materials/work instructions for interacting with DB

2.1.6.3.4 Database Requirements Spec
Who is responsible for info and troubleshooting?
System info, name, code, ...
Operational status
System environment
Data owners for data quality and accuracy
Systems using DB
Relationships to other DBs?
Schema
Data dictionary
Special instructions for entering data
Hardware, software, utilities
Storage requirements
Recovery
Partition/file info
Database interfaces
Error handling

2.1.6.3.5 Database Maintenance Plan
Who is responsible for DB updates? code changes?
Operation and maintenance activities
Virus protection
DB software update frequencies (i.e., updates of Tomcat or other underling software)
Test machine plan (use a single machine to test updates first)
Preventative maintenance
Reactive maintenance
Training
Back ups
Expect life of DB
Facilities & resources
Operation activities; automated processes, human involvement, back-up facilities & procedures
Coordination needed to interact with other systems
Security - hardware & software policies, firewalls, remote access, fire, ...
Health reporting of DB

2.1.6.3.6 Disaster Recovery Plan
Do we need a safety plan? Is the DB safety-critical?
Who is responsible for safety functions?
Evaluate DB for safety hazards

2.1.6.3.7 Test Plans for Verification and Validation
Parts of DB and how we test them
Clearly defined test scope and parameters
Detailed outcome record
Retest specification
Tests of functionality
Tests of usability
Tests of reliability
Tests of performance
Tests of supportability
List of tests
Testing methods
Testing sequence
Testing process
Test approval criteria
Problem reporting
Validation of DB data to use cases
Verification of data that already exists and new data in the future

2.1.6.3.8 Risk Management Plan
Process (methods and tools) for handling risk
Identify, analysis, planning, tracking & controlling, communication of risks
Who is responsible and what are their responsibilities

2.1.6.3.9 Test Reports and Artifacts
Reports from processes, DB assessments
Reports from tests, verification and validation
Draft and released versions of documents