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- Words: 2,944
- Pages: 14
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 Confidential
Comment TL-CO-PO 0.3
Dung Do
Required
QA Leader
Sang Tan
PM
Suggested
Approval Information Approver Name Takeda Yoichi
Date (mm-dd-yyyy)
Role Managing Director
12-12-2006
Revision 1.0
Comment First approval
Revision History Revision
Date (mm-dd-yyyy)
0.1
12-04-2006
0.2
12-07-2006
Revised by
Reviewer
Date
First Version
Lan Pham
Dung Do
12-06-2006
- Refine statements for better,
Lan Pham
Dung Do
12-10-2006
Lan Pham
Takeda Yoichi
12-12-2006
Description
- Add input/output into flowchart, - Add Table of Figures and section Appendix. 1.0
12-12-2006
First approval
1.1
06-12-2009
- Add Manage Document Model information
Minh Nguyen
- 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 No.
Artifact Name
Description
Charge
1
Documents Master List
Used to manage all the documents have in IVC
CC
Required (Y/N) Y
Template TL-DC-Document Master List Template 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 Controller)
Te person who plays the role as a librarian to do the following:
Copyright © ISB Vietnam Corporation. (IVC)
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 List Template
CM Prime
Document Master List
CM Prime
Control Internal Documents
Document Master List
CM Prime
Control External Documents
Control Obsolete Documents Updated Document Master List
Document Master List
Updated Document Master List
End
Figure 1. Document Control Workflow Overview
Procedures
Description
Role Owner
Control Internal Documents
Control internal documents creating until disposing them.
from
CC
Control External Documents
Control external documents as from receiving, also issuing and then disposing them.
CC
Control Obsolete Documents
Control how to revoke/dispose obsolete documents.
CC
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as
the
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4 Manage Documents Model Start
Requirements
Corrective Action
Plan
Do
Check
CONFORM ?
Remedial Action
N
Y
CM Prime
Document Master List
Products
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
Manager
Decide to create /revise document
Author/ Editor
Create/Revise document
Reviewer
Review document Yes
Need revising ? N No
Approver
Approve document
Approve ? Document Master List Template
Y
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. 1
Steps
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. 1
Steps
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.
Prepare for issuing
3
Refer to Products step of Manage Document Model
Issue document
4
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
Identify obsolete documents
Manager
CC
Document Master List
Revoke/dispose the obsolete documents
Updated Document Master List
End Figure 5. Manage Obsolete Documents
6.3.7Activities Description No. 1
Steps
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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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 Confidential
Comment TL-CO-PO 0.3
Dung Do
Required
QA Leader
Sang Tan
PM
Suggested
Approval Information Approver Name Takeda Yoichi
Date (mm-dd-yyyy)
Role Managing Director
12-12-2006
Revision 1.0
Comment First approval
Revision History Revision
Date (mm-dd-yyyy)
0.1
12-04-2006
0.2
12-07-2006
Revised by
Reviewer
Date
First Version
Lan Pham
Dung Do
12-06-2006
- Refine statements for better,
Lan Pham
Dung Do
12-10-2006
Lan Pham
Takeda Yoichi
12-12-2006
Description
- Add input/output into flowchart, - Add Table of Figures and section Appendix. 1.0
12-12-2006
First approval
1.1
06-12-2009
- Add Manage Document Model information
Minh Nguyen
- 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 No.
Artifact Name
Description
Charge
1
Documents Master List
Used to manage all the documents have in IVC
CC
Required (Y/N) Y
Template TL-DC-Document Master List Template 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 Controller)
Te person who plays the role as a librarian to do the following:
Copyright © ISB Vietnam Corporation. (IVC)
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 List Template
CM Prime
Document Master List
CM Prime
Control Internal Documents
Document Master List
CM Prime
Control External Documents
Control Obsolete Documents Updated Document Master List
Document Master List
Updated Document Master List
End
Figure 1. Document Control Workflow Overview
Procedures
Description
Role Owner
Control Internal Documents
Control internal documents creating until disposing them.
from
CC
Control External Documents
Control external documents as from receiving, also issuing and then disposing them.
CC
Control Obsolete Documents
Control how to revoke/dispose obsolete documents.
CC
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the
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4 Manage Documents Model Start
Requirements
Corrective Action
Plan
Do
Check
CONFORM ?
Remedial Action
N
Y
CM Prime
Document Master List
Products
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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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
Manager
Decide to create /revise document
Author/ Editor
Create/Revise document
Reviewer
Review document Yes
Need revising ? N No
Approver
Approve document
Approve ? Document Master List Template
Y
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. 1
Steps
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. 1
Steps
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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Steps the appropriate documentation repository for arranging the received document.
Prepare for issuing
3
Refer to Products step of Manage Document Model
Issue document
4
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
Identify obsolete documents
Manager
CC
Document Master List
Revoke/dispose the obsolete documents
Updated Document Master List
End Figure 5. Manage Obsolete Documents
6.3.7Activities Description No. 1
Steps
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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