Document Control Procedure

DC-PD
Version: 1.1

Issue Status: Draft

Issues Date: 12-12-2006
Owner: QA Team
Author: ntminh
Location: CMMI-L3 Repository
Confidential Class: IVC Confidential

Date:

Approved by: Takeda Yoichi

Signature:

Review Information
Reviewer Name Role Required / Suggested Comment

Confidential TL-CO-PO 0.3

Dung Do Required
QA Leader
Sang Tan PM Suggested

Approval Information
Date
Approver Name Role (mm-dd-yyyy) Revision Comment

Takeda Yoichi Managing Director 12-12-2006 1.0 First approval

Revision History
Date
Revision (mm-dd-yyyy) Description Revised by Reviewer Date

0.1 12-04-2006 First Version Lan Pham Dung Do 12-06-2006

0.2 12-07-2006 - Refine statements for better, Lan Pham Dung Do 12-10-2006
- Add input/output into
flowchart,
- Add Table of Figures and
section Appendix.
1.0 12-12-2006 First approval Lan Pham Takeda Yoichi 12-12-2006
1.1 06-12-2009 - Add Manage Document Model Minh Nguyen
information
- Add Data Folder Structure
information

Confidential TL-CO-PO 0.3

 TABLE OF CONTENT
1 Introduction................................................................................................................................. ...........4
1.1 Purpose.............................................................................................................................. ..........4
1.2 Scope............................................................................................................................ ...............4
1.3 Acronyms & Abbreviation.................................................................................. ...........................4
1.4 Definitions........................................................................................................ ............................4
1.5 References........................................................................................................................ ...........4
1.6 Templates / Forms.............................................................................................................. ..........5
2 Participants...................................................................................................................... ......................5
3 Process Overview...................................................................................................................... ............6
4 Manage Documents Model............................................................................................................... .....7
5 Data Folder Structure........................................................................................................ ....................9
6 Document Control Procedures ................................................................................................ ............9
6.1 Workflow: Control of Internal Documents................................................................... ..................9
6.1.1 Participant.................................................................................................................. .......9
6.1.2 Entry Criteria........................................................................................................... ........10
6.1.3 Inputs................................................................................................................... ...........10
6.1.4 Outputs......................................................................................................... ..................10
6.1.5 Exit Criteria.................................................................................................. ...................10
6.1.6 Flow of Activities........................................................................................ .....................10
6.1.7 Activities Description..................................................................................... ..................11
6.2 Workflow: Manage External Documents.................................................................................... .12
6.2.1 Participants........................................................................................................ .............12
6.2.2 Entry Criteria........................................................................................................... ........12
6.2.3 Inputs................................................................................................................... ...........12
6.2.4 Outputs......................................................................................................... ..................12
6.2.5 Exit Criteria.................................................................................................. ...................12
6.2.6 Flow of Activities........................................................................................ .....................12
6.2.7 Activities Description............................................................................................ ...........12
6.3 Workflow: Manage Obsolete Documents........................................................... ........................13
6.3.1 Participants........................................................................................................ .............13
6.3.2 Entry Criteria........................................................................................................... ........13
6.3.3 Inputs................................................................................................................... ...........13
6.3.4 Outputs......................................................................................................... ..................13
6.3.5 Exit Criteria.................................................................................................. ...................13
6.3.6 Flow of Activities........................................................................................ .....................13
6.3.7 Activities Description............................................................................................ ...........13

TABLE OF FIGURES
Figure 1. Document Control Workflow Overview........................................................................... ........6
Figure 2. Generic Control Model............................................................................................................. .7
Figure 3. Manage Internal Documents............................................................................. ....................10
Figure 4. Manage External Documents................................................................................. ...............12
Figure 5. Manage Obsolete Documents....................................................................................... .........13

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1 Introduction

1.1Purpose
This procedure is used to establish a uniform and consistent method for preparing and handling
documentation with these following purposes:
• To approve documents for adequacy prior to issue,
• To review and update as necessary and re-approve amended documents,
• To ensure that changes and the current revision status of documents are identified,
• To ensure that relevant versions of applicable documents are available at points of use,
• To ensure that documents of external origin are identified and their distribution controlled,
• To prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose.
• To define the method of identification, storage, protection, retrieval, retention period and
disposition of records.

1.2Scope
This procedure is used to apply to all kind of documents that are generated by IVC staff and all
documents that have come from the external customer for businesses.

1.3Acronyms & Abbreviation

No. Acronyms Description
1 PM Project Manager
2 PL Project Leader
3 TL Team Leader
4 TM Technical Manager
5 CC Configuration Controller
6 NC Non-compliance

1.4Definitions
Document: is information in written or printed form needed by IVC to carry out the business. It may
be in any form of soft copies and hard copies.
Control of documents: means regulating the development, approval, issue, change,
distribution, maintenance, use, storage, security, obsolescence or disposal of documents.
Internal documents: the documents which are produced by IVC staff.
External documents: the documents which are produced by other companies or individuals outside
of IVC.
Obsolete documents: the documents which have been expired date and media with old version, etc.

1.5References
ISO 9001:2000 Quality Management Systems
IVC Conventions
Common Templates
Guideline for using Common Template

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 1.6Templates / Forms
Required
No. Artifact Name Description Charge (Y/N) Template
1 Documents Master Used to manage CC Y TL-DC-Document
List all the documents Master List Template
have in IVC 1.0-EN.xlt

2 Participants
Roles Responsibilities
Author / Editor Te person who creates the document or revises it.
Reviewer(s) The person or group of person who review the document.
Approver Te person who has rights or has been delegated to approve the
document.
Manager Te higher level management of the author/editor. Manager will
assign the author/editor of document, also the CC and
responsible for deciding to create/revise document, identify
obsolete documents and receive external documents.
CC (Configuration Te person who plays the role as a librarian to do the following:
Controller)
 Manage all documents in a project/department’s library,
 Announce new issue of a document make sure its availability
the to point of use,
 Ensure of appropriate access to point of use,
 Revoke/dispose the obsolete documents from point of use.

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3 Process Overview
Start

Document Master Document Master Document Master

List Template List List

CM Prime CM Prime CM Prime

Control Internal Control External Control Obsolete

Documents Documents Documents

Updated Updated
Document Master Document Master Document Master
List List List

End

Figure 1. Document Control Workflow Overview

Procedures Description Role Owner

Control Internal Documents Control internal documents as from CC
creating until disposing them.
Control External Documents Control external documents as from CC
receiving, also issuing and then disposing
them.
Control Obsolete Documents Control how to revoke/dispose the CC
obsolete documents.

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4 Manage Documents Model
Start

Requirements

Corrective
Plan
Action

Do

Check

Remedial
CONFORM ? N
Action

Document Master
CM Prime Products List

End
Figure 2. Generic Control Model

Generic Control Model could be applied at four levels:

1. At the organization level: to reveal the organization requirements, organization measurements
and organization changes and thus identify business requirements, business plans, business
performance reviews and changes in the business strategy and structure. The organization level
is at the level of the whole organization. For example: IVC process improvement program…
2. At the business level: to reveal the process requirements, process measurements and process
changes and thus identify customer requirements, quality plans, compliance checks, and
customer feedback. The process level is at the level of the functions that make up the business
that may be discharged through one or more departments.
3. At the process level: to reveal the process requirements, process measurements and process
changes thus identify the product requirements, product plans, inspections, test, reviews and
modification actions. The process level is at the level of a group or department that may assign
people to perform the various activities that make up the process.
4. At the activity level: to reveal the activity requirements, activity measurements and activity
changes and thus identify work instructions, work plans, checks and rework actions. The activity
level is at the level of the individual. For example: observation results, improvement ideas…

No. Steps
1 Requirements: Based on the Standard requires documents required by the Quality

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 No. Steps
Management System to be controlled. Controlling documents to ensures that:
1. Documents fulfill a useful purpose in the IVC organization;
2. Resources are not wasted in the distribution of non-essential information ;
3. Only valid information is used in the organization’s processes;
4. IVC staffs have access to appropriate information for them to perform their work;
5. Information is kept up-to-date and in a form that can be used by all relevant people;
6. Classified information is restricted to only those with a need to know;
7. Information important to the investigation of problems, improvement
8. Opportunities or potential litigation is retained
2 Plan:
By the way, document review action at quarterly or on demand could help Manager make
decide to prepare planning for developing internal/ external documents or disposing
obsolete documents for controlling:
1. Develop new documents: Manager will assign the author/ editor to prepare
documents for developing as required
2. Revision of issued documents: Manager will assign author/ editor to prepare
documents for maintenance as required.
3. Document retention and obsolescence: Manager identifies the obsolete
documents to prevent the unintended use of obsolete documents and to apply
suitable identification to them if they are retained for any purpose.

3 Do:
The aspects you should cover in your document control procedures, are as follows
4. Preparation of documents.
5. Standards and Convention for the format and content of document templates,
forms and diagrams, issue notation, draft issues, post approval issues, dating
conventions, date of issue, date of approval or date of distribution.( Refer to IVC
Conventions and Common templates )
6. Document review: Reviewer shall review them and what evidence is retained.
(Refer to Peer Review Procedure)
7. Document approval: means that approver has authorities have agreed the
document before being made available for use.
8. Distribution of documents include printing and publication, who decides, who
does it, who checks it.
9. Document protection: unauthorized changes, copying, disposal, computer viruses,
fire and theft. (Refer to ISMS Policy)
10. Document identifying: use of documents, limitations, unauthorized copying and
marking. (Refer to ISMS Policy)
11. Document storage: We defined the DPAL structure will be stored all documents
which can be used in IVC and CCs who shall control location and loan
arrangements them following DPAL Guideline (Refer to Data folder structure)
12. Document maintenance: keeping them current, periodic review.
13. Denoting changes, revision marks, reissues, sidelining, and underlining.
14. Amending copies of issued documents, amendment instructions, and amendment
status.
15. Indexing documents: listing documents by issue status (Refer to Document

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 No. Steps
Master List)
4 Check:
The standard requires that documents be reviewed
1. Remedial action (correcting error) (Refer to Peer Review Procedure)
2. Corrective action (preventing error recurring) & Preventive action (preventing the
occurrence of an error)
3. Maintenance action (keeping information current) & Improvement action (making
beneficial change to the information)
Reviews may be random or periodic. Random reviews are reactive and arise from an error
or a change that is either planned or unplanned. Periodic reviews are proactive and could be
scheduled to review the policies, processes, products, procedures, specification etc. for
continued suitability.
6 Products:
A – Prepare for issuing:
CC of each department will take his/ her responsible to prepare for issuing
1. CC updates Documents Master List to keep track the existence of the document.
2. CC checks the documentation repository for the previous versions of document.
These are now the obsolete versions and will be revoked. (Refer to the workflow
detail of Manage Obsolete Documents.)
3. CC checks-in the approved document:
- For electronic documents:
 All documents will be published in the DPAL folder structure.
 CC must ensure the users privileges to access to the document.
 The old versions of the document must be kept in the obsolete folder to
avoid from unintended access.
- For hard copy documents: All hardcopies of the document that is to be distributed
shall be marked with “CONTROLLED COPY” on the cover/first page the CC. With
obsolete documents are either disposed at once or marked in case of keeping for
legal purpose or reference. (Refer to ISMS Policy)
B - Issue document
1. CC sends an e-mail to all relevant users to inform about the issue of document.
The announcing email should contain: the references to the documentation repository where
the document is made available, the obsoleteness of the old version that have been in use
(if any), applicable scope and the time to apply

5 Data Folder Structure

6 Document Control Procedures

6.1Workflow: Control of Internal Documents

This workflow detail is used to describe on how to manage an internal document during its life as
from creating until disposing it.

6.1.1Participant

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 • Manager
• CC
• Author/Editor
• Reviewer
• Approver

6.1.2Entry Criteria
• Requirement of creating/revising a document.

6.1.3Inputs
• Document Master List Template.

6.1.4Outputs
• Document Master List.

6.1.5Exit Criteria
• Finish issuing document.

6.1.6Flow of Activities
Start

Decide to create /revise

Manager document

Author/
Editor Create/Revise document

Reviewer Review document

Yes

Need revising ?
N

No

Approver Approve document

Approve ?

Document Master
Y List Template

CM Prime Prepare for issuing

Document Master
List

CM Prime Issue document

End
Figure 3. Manage Internal Documents

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 6.1.7Activities Description
No. Steps
1 Making decision:
1. All the documentation requirements shall be reviewed and approved by manager.
2. The manager makes a decision to develop or control the document based on four
mandatory documentation requirements level then shall assigns the author/ editor to
implement documents as required.
3. The author/ editor will make plan to implement document as required.
4. The manager shall review and approve plan

Develop document:
1. If there is a template required, the author must apply it strictly or uses the common
template to develop specific template before creating document based on this
specific template. Refer to Guideline for Using Common Templates.
2. In case of revising document, the editor also has to revise the identification of
document (version, issue date, issue status, revision, review, approve information)
that must conform to Common Template or IVC Convention, and do update
document whose changes are controlled via Track Changes function of Ms. Word
and comment of Ms. Excel.
After finish editing/revising document, the author/editor sends document to the reviewer(s)
for review/re-consideration in case the document has passed through the review document
and need to revise again.
2 Review documents:
1. The reviewer receives the document that was sent by the author/editor to review it
as required using Peer Review Procedure.
2. If there is any mistakes or detected errors occur, the reviewer will do:
Send the Inspection Logs for Formal Inspection method and Comments in attached file
for Walkthrough or Pass-around method. Refer to Peer Review Procedure for further
information.
Send an e-mail to inform the author/editor with attached comment file and/or inspection
log to revise the document then document has to pass through review phase again until
all consideration has been passed.
3. If there is no mistake and all comments are fixed, the reviewer will send an e-mail to
inform the author as confirmation.
4. The author/editor will submit document to the approver for approval via e-mail with
inspection log if any and review confirmation email.
3 Approve documents:
1. The approver receives the document that is submitted by the author/editor to review
for ensuring the document is adequate and suitable for using purposes.
2. If there is no more comment, the approver sends an e-mail to the
author/editor/CC/Reviewer to inform that the document has been approved.
3. Otherwise, the approver will send an e-mail to the author/editor to request a
fixing/updating to document with specifying the reason why it is rejected to approve,
and what it should be done for approval.
4 Prepare for issuing
Refer to Products step of Manage Document Model
5 Issue document
Refer to Products step of Manage Document Model

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 6.2Workflow: Manage External Documents
This workflow detail is used to describe on how an external document is managed and issued.

6.2.1Participants
• Manager
• CC

6.2.2Entry Criteria
• Receiving document from outside of IVC.

6.2.3Inputs
• Document Master List.

6.2.4Outputs
• Updated Document Master List.

6.2.5Exit Criteria
• Finish issuing external document.

6.2.6Flow of Activities

Start

Manager Receive external document

CC Manage external document

Document Master
List

CC Prepare for issuing

Updated
Document Master
List
CC Issue document

End
Figure 4. Manage External Documents

6.2.7Activities Description
No. Steps
1 Receive external document
1. The manager receives documents from the others company or individuals outside of
IVC. In case anyone else receives these documents, they must forward them to the
manager for the gathering documents management.
2. The manager sends the received documents to CC.
2
2. In case of hardcopy documents, if the document ID is not already shown on the
document itself, CC needs to mark it on the first page.
3. If the received document is an updated issue for a previous one, CC should update

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 No. Steps
the appropriate documentation repository for arranging the received document.
3 Prepare for issuing
Refer to Products step of Manage Document Model
4 Issue document
Refer to Products step of Manage Document Model

6.3Workflow: Manage Obsolete Documents

This workflow detail is used to describe how to revoke/dispose the obsolete documents.

6.3.1Participants
• Manager
• CC

6.3.2Entry Criteria
• At quarterly or on demands from manager.

6.3.3Inputs
• Document Master List

6.3.4Outputs
• Updated Document Master List

6.3.5Exit Criteria
• Finish revoking/disposing the obsolete documents.

6.3.6Flow of Activities

Start
Document Master
List

Identify obsolete
Manager
documents
Updated
Document Master
List
Revoke/dispose the
CC
obsolete documents

End
Figure 5. Manage Obsolete Documents

6.3.7Activities Description
No. Steps
1 Identify obsolete documents
1. At quarterly or on demand of Manager, the manager identifies the obsolete
documents.
2. Manager sends an e-mail to CC to ask for revoking/disposing the obsolete
documents.
2 Revoke/Dispose the obsolete documents

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 1. For documents that are being distributed, CC will dispose them from all points of
use. This shall be done for either of these following:
• For electronic documents, CC shall remove them out of the documentation
repository, and send e-mail to all relevant target users.
• For hard copies, CC shall dispose all previous distributions by using the Paper
Shredder.
2. CC sends an e-mail to all relevant users to inform about the obsolete documents.

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