Control of Documented Information Procedure

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1.0 Purpose
2.0 Theory
3.0 Document Types
4.0 Quality Handbook
5.0 Quality Management System Procedures
6.0 General Work Instructions
7.0 Inspection Instructions
8.0 Forms
9.0 External Documents
10.0 Periodic Re-Evaluation of Documents
11.0 Control of Records
Appendix A: Record Retention Matrix

1.0    PURPOSE
This procedure defines the requirements for the control of documents within the quality management system (QMS). The scope of this procedure is to control documents specifically defined in Section 3.0.

The following documents are not subject to this procedure:

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2.0    THEORY
Documents must be controlled so that only reviewed and approved information is released and used by employees. This ensures...

3.0    DOCUMENT TYPES
The Document Control Center maintains documented information to ensure...

3.1.    Quality Handbook:...

3.2.    QMS Procedures:...

3.3.    General Work Instructions:...

3.4.    Inspection Instructions:...

3.5.    Forms:...

3.6.    Records that are created for temporary retention of miscellaneous information are...

4.0    QUALITY HANDBOOK
4.1.    Creating the Quality Handbook
The Quality Handbook has been established by top management of the Company, which includes...

4.2.    Review and Approval
The Quality Handbook is reviewed and approved by top management before release. Approval is indicated by...

4.3.    Distribution
The Quality Handbook is distributed electronically through the Company's internet server.
The Document Control Center may...

In some cases, a hardcopy of the Quality Handbook may...

Each employee must...

4.4.    Change Control
Any employee may request a change to the Quality Handbook. Requests for changes may be made by...

5.0    QUALITY MANAGEMENT SYSTEM PROCEDURES
5.1.    Creating New QMS Procedures
QMS procedures should be created as soft files (MS Word, etc.). It is recommended that files...

5.2.    Review and Approval
QMS procedures are reviewed and approved by top management. ...

5.3.    Distribution
QMS procedures are distributed electronically through the Company's internet server and/or via the intranet. The Document Control Center may...

In some cases, a hardcopy of the procedure may... Each employee must...

5.4.    Change Control
Changes to QMS procedures are performed in the same manner as the Quality Handbook.

6.0    GENERAL WORK INSTRUCTIONS
6.1.    Creating New Work Instructions
Where necessary, work affecting quality is...

Typically, new work instructions are developed by or under the supervision of... Work instructions should be created as... Work instructions should include, as applicable:...

NOTE REGARDING JOB SPECIFIC WORK INSTRUCTIONS:

Engineering may develop work instructions that are specific to a given job, which...

6.2.    Review and Approval
Work instructions must be reviewed and approved by...

6.3.    Distribution
General work instructions are distributed electronically through the Company's internet server and/or via the intranet. The Document Control Center may retain...

In some cases, a hardcopy of the work instruction may...

... Each employee must...

6.4.    Change Control
Changes to general work instructions are performed in the same manner as the Quality Handbook.

When general work instructions are changed, ...

7.0    INSPECTION INSTRUCTIONS
7.1.    Creating New Inspection Instructions
New inspection instructions are developed by or under the supervision of the Responsible Authority using...

NOTE REGARDING JOB SPECIFIC INSPECTION INSTRUCTIONS:

Engineering may develop inspection instructions that are specific to a given job, which...

7.2.    Review and Approval
Approval is indicated by...

7.3.    Distribution
Inspection instructions are distributed electronically through the Company's internet server and/or intranet.

The Document Control Center may...

In some cases, a hardcopy of the inspection instruction may... Each employee must...

7.4.    Change Control
Any employee may request a change to inspection instructions by...

8.0    FORMS
8.1.    Creating New Forms
Forms undergo a streamlined creation and control process. Any department manager or area supervisor may...

8.2.    Review and Approval
Forms may be reviewed and approved by...

8.3.    Distribution
Forms are made available through the Company's internet server, intranet or Document Control Center. These may...

8.4.    Change Control
Any employee may submit a Request for Change to the appropriate area manager responsible for the form and...

9.0    EXTERNAL DOCUMENTS
9.1.    Some external (third party) standards or specifications may...

9.2.    Third party specifications and engineering drawings, including those of the Customer, are controlled according to the Configuration Management Procedure. Where control of an external document is...

10.0    PERIODIC RE-EVALUATION OF DOCUMENTS
The entire set of quality documentation is subject to...

11.0    CONTROL OF RECORDS
11.1    The controls for each type of record are defined in Appendix A of this procedure.

11.2    The listed "controller" must...

11.3    Records for active contracts are...

11.4    The Document Control Center...

11.5    Records that are discarded after retention shall...

11.6    Hardcopy records are...

11.7    Records are available for review by the Customer and copies...

11.8    Records are...

11.9    The Company does not require vendors to maintain records for the Company; instead...

11.10    Electronic records are...

11.11    Local computer data that is stored on company computers must...

11.12    When making corrections to written record entries, the error is...

11.13    ...

12.0 Appendix A: Record Retention Matrix

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13.0 REVISION HISTORY AND APPROVAL RECORD

Quality System Procedure
CONTROL OF DOCUMENTED INFORMATION PROCEDURE
Rev: Orig (EO #??)

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