SDLC SOP 2002 - Control of Quality Records

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Contents

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 (J. Soybel)


Definitions

Item Definition

None at this time


Process Flow Diagrams

Diagram Description

None at this time


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.



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.



Procedure Activities

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


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.


Forms

Form Description

None



Exceptions

  • None at this time


Tools/Software/Technology Used

Tool Description

ProductFactory

Program Management application that controls the identification and storage of Deliverables for a development program.Utilizes MSSQL as a database.



Attachments

  • None


Related Standard Operating Procedures:


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