|
Item |
Definition |
|
None at this time
|
|
1.
Process
Flow Diagrams
|
Diagram |
Description |
|
None at this time
|
|
2.
Roles and Responsibilities
|
Role |
Responsibility |
|
Director,
Total Quality
|
The
control of Quality Records as required by this procedure is the
responsibility of the Director Total Quality.
|
|
Documentation Manager
|
The
Manager Documentation Services is delegated responsibility for
implementing the requirements of this procedure.
|
|
Project
Manager
|
It
is the responsibility of the project manager to ensure that records of
the various prescribed activities are recorded, stored and available for
retrieval.
|
|
SDLC Staff
|
All SDLC personnel are required to follow the requirements contained in this procedure.
|
3.
Metrics
Metrics
covers from Technical Design through Development.
Defect tracking metrics against Development
efforts is addressed in the Quality Function Procedure..
|
Metric |
Description |
|
Cycle
Time
|
The number of days or hours it takes to complete the review for a SDLC Business Gate and/or milestone.
|
|
Defects
|
Instances
of failure to pass specific tests or quality measures or to meet
specification/acceptance criteria for a gate/milestone. These are
recorded and assessed throughout a project and reported at the end of
the project.
|
|
Change
Agents
|
Individuals
who analyze a process gate or milestone and recommend ways to improve
it. Successful or not in adoption, changes will be reported to
department management. These
individuals will receive recognition for their effort to compress cycle
times and/or improve quality.
|
4.
Procedure
Activities
4.1
Definition of Quality Records
Quality
Records are controlled through the use of planned activities as defined in the
System Design Life Cycle (SDLC). Forms
controlled in accordance with SOP 1001 Document Governance are used as templates
for Quality records
4.2 Storage and
Retrieval of Quality Records
Quality
Records shall be stored as shown in the table below:
|
Type
of Record
|
How
Stored
|
Length
of Time
|
|
Quality
Manual
|
Electronic,
network folder or database application.
|
1
Year
|
|
SOP
|
Electronic,
network folder or database application.
|
1
Year
|
|
Specifications
– Requirements, Design, Code, Test, Work Instructions
|
Electronic,
network folder or database application.
|
7
Years
|
|
Configuration
Records
|
Electronic,
network folder or database application.
|
7
Years
|
|
Test
Records & Defect Reports
|
Electronic,
network folder or database application.
|
3
Years
|
|
Corrective
Action Reports
|
Electronic,
network folder or database application.
|
3
Years
|
|
Quality
Objectives
|
Paper
|
1
Year
|
|
Job
Descriptions
|
Paper,
Human Resources file
|
1
Year
|
|
Management
Reviews, Gate Reviews
|
Paper
or Electronic, TQ Director
|
1
Year
|
|
Purchase
Orders
|
Paper
or Electronic in Purchasing
|
3
Years
|
|
Audit
Records
|
Paper
or Electronic, TQ Director
|
3
Years
|
The
repository for a quality record shall be a location identified by the current
database application or network folder in use at the time the record is created.
Archives and backups shall be made per SOP 1001 Document Governance.
Only the Manager Documentation Services shall have access to master
records once completed, approved and stored.
4.3
Legibility
Quality
Records are in most cases electronic documents.
As such, they are to follow good practice in utilizing font sizes and
types that can easily be read. The
font color for an approved quality record should be limited to black or blue
except where color is used as a graphical depiction or for emphasis.
Fonts smaller than 8 point are not to be used when avoidable.
Font types should be limited likewise to readable font types.
Signatures and other hand made entries are to be made in blue or black
ink wherever practicable. In
addition, signatures are to be underscored with typewritten or printed
identification.
5.
Forms
6.
Exceptions
7.
Tools/Software/Technology
Used
|
Tool |
Description |
|
PerlDesk
|
Program
Management application that controls the identification and storage of
Deliverables for a development program.
Utilizes MySQL as a database.
|
8.
Attachments
(SDLC INTERNAL USE ONLY)
