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SDLC Control of Quality Records

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SOP 2002: Control of Quality Records

Objective: 
This Standard Operating Procedure details the methods SDLC, Inc. uses to control records relating to the effective operation of the Quality System.  This documentation includes all Quality records that are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.  This includes the Quality Systems Manual, all Standard Operating Procedures (SOP), Work Instructions, Templates and Forms.  The intent is to provide requirements for legibility, identification, storage and retrieval.
Scope: 
This Standard Operating Procedure applies to those documents listed herein.  Documents not listed are controlled by their respective governing documents and procedures.
Owner: 
Manager, Quality Program Management

Sections:

i Definitions
1 Process Flow Diagrams
2 Roles and Responsibilities
3 Metrics
4 Procedure Activities
5 Forms
6 Exceptions
7 Tools/Software/Technology Used
8 Attachments

Related Standard Operating Procedures:

BG SDLC Business gates

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SDLC Standard Operating Procedures:

SDLC Framework:

SDLC Gates:

SDLC Roles and Responsibilities:

SDLC Forms:

SDLC Templates:

 

SOP 2002 - Control of Quality Records Definitions 

    

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

 
Form Description
None  

 

 

6. Exceptions

  • None at this time

 

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

  • None

 

(SDLC INTERNAL USE ONLY)

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Systems Development Life Cycle (SDLC) by Robert E. Stewart, Sr. is licensed under a Creative Commons Attribution 3.0 Unported License.
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