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Document Control Requirement

The document outlines the requirements for controlling documents at DII. It states that only documents specifying quality requirements or work instructions must be controlled. It assigns responsibility for document control to the QA Manager and Document Controls Manager. It describes DII's document control system which involves preparing, identifying, reviewing, approving, and distributing controlled documents and maintaining historical/superseded documents. It also covers how controlled documents are made available to personnel and outside organizations.

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adarshkatiyar
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© Attribution Non-Commercial (BY-NC)
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149 views

Document Control Requirement

The document outlines the requirements for controlling documents at DII. It states that only documents specifying quality requirements or work instructions must be controlled. It assigns responsibility for document control to the QA Manager and Document Controls Manager. It describes DII's document control system which involves preparing, identifying, reviewing, approving, and distributing controlled documents and maintaining historical/superseded documents. It also covers how controlled documents are made available to personnel and outside organizations.

Uploaded by

adarshkatiyar
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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4.

4 Document Control Requirement(s)

The documents which shall be controlled are only those which specify quality
requirements or prescribe activities affecting quality such as instructions, procedures
and drawings. Records are a special type of document and shall be controlled
according to the requirements of Section 4.17. Personnel who work directly for or on
behalf of DII are responsible to ensure that the latest revisions of applicable documents
are used.

4.6.1 Responsibility

The QA Manager is responsible for implementing and maintaining a quality assurance


program which includes document review and control as required.

The Document Controls Manager is responsible for maintaining the document control
system.

4.6.2 Document Control System

The DII document control system and implementing procedures provide for the
preparation, issue, and change of documents that specify quality requirements or
prescribe activities affecting quality.

1. Quality manuals, plans and procedures, procurement specifications, instructions,


fabrication and administrative procedures, and drawings are controlled to assure
that the correct documents are being used at the location where the activity is
performed. Such documents, including changes thereto, are reviewed for adequacy
and approved for release by authorized personnel.

2. The document control system utilized by DII is:

 Preparing documents to be in compliance with applicable technical and contract


requirements;

 Identifying documents to be controlled and their specified distribution;

 Identifying the correct document methodology (including revision) to be used


and control of superseded documents;

 Identifying the assignment of responsibility for preparing, reviewing, approving,


and issuing documents;

 Reviewing documents for adequacy, completeness, and correctness prior to


approval and issuance;

 Providing a method for feedback from users to continually improve procedures


and work instructions;

 Ensuring that documents are properly identified (with applicable title and/or
number and revision levels) and that original issues are designated;

 Ensuring that each page has a unique page number, total number of pages,
document identification and revision level;

 Ensuring that the documents are legible and readily identifiable and
 Identifying the controls for documents prepared externally to ensure that the
correct revision and complete document are available for use.

The Document Controls Manager provides a listing of all controlled documents which
identify the current approved revision, so personnel can readily determine the
appropriate document for use.

4.6.3 Review and Approval of Documents

Documents are reviewed for adequacy and approved for release by authorized
personnel. Prior to issuance or use, documents including revisions thereto, are
approved by management of the department owning the document. If the document
concerns a Quality impacting activity the document shall be reviewed by QA
MANAGER prior to release. Changes to documents through the revision process are
reviewed and approved.

4.6.4 Controlled Document Availability

Documents are located in the Records Center and are made available to personnel at
locations where pertinent operations are performed. Managers also have access to a
full set of quality program documents relevant to their departments. The Document
Control Manager maintains an index and distribution list of all controlled documents to
assure updating as needed. Access to controlled documents is maintained by
controlling access to the Records Center and only the Document Control Manager or
designee can issue controlled documents.

4.6.5 Document Distribution

The Document Control Manager maintains a list of all controlled documents. The list
identifies each issued document by:

1. It’s title;

2. Document number (if applicable);

3. Date of issue;

4. The latest revision level; and

5. Distribution.

4.6.6 Historical Documents

DII maintains archives of historical documents such as superseded or previously


utilized drawings, specifications, reports, standards, samples, and so forth. Historical
documents are inactive, and maintained as not current. Historical documents will be
marked “Historical” or “Obsolete.”

4.6.9 Documents Issued to Outside Organizations

Controlled documents that are issued to outside organizations shall be issued using a
Document Transmittal Form (Exhibit 10) either electronically or in a hard copy form
depending on the client requirements per specific document. Revisions to these
documents will be transmitted using a Document Transmittal Form (Exhibit 10).

Documents issued to personnel and outside parties who are not affected by the
document, but need a copy for information only, are marked UNCONTROLLED on the
title page or first page. Such documents are not followed up with revisions.
Uncontrolled copies of documents may not be given to personnel or outside parties
who manage or verify work affecting the quality of product that is directly affected by
the document.

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