STANDARD OPERATION PROCEDURE - DOCUMENT CONTROL AND RECORD
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STANDARD OPERATION PROCEDURE
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DOCUMENT CONTROL AND RECORD
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Document no : Revision No. :
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Effective date
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Revision date :
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Page :
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I.
Purpose
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Documentation and change control is to prevent the unintended use of
obsolote document , and to apply suitable identification to them if they are
retained for any purpose.
II.
Scope:
This scope of this control is to include type of documentation such as
customer orders; specification; plans / drawing ; quality manual ; standard
operation procedure ; work instruction form and others.
III.
Management
responsibilities.
1.
The factory manager has responsibility for
overall site factory system, to be overseen by the production manager and
Quality assurance Manager.
2.
Have assigned document holder and FE coordinator
which responsible for the administration and maintenance of the site document
control system.
3.
Department supervisor and managers responsible
for actual implementation of all documented process , procedures and forms.
IV.
Document
creation , approval and control .
1.
All new or revised documents must pass through
the document approval process known as the document change request.
2.
After approval of documents presented in
document change request , document control holder and FE coordinator shall
review and after all changes indicated in the document change request
3.
FE coordinator shall be responsible for
notifying supervisor and manager for the revision and issue document distribution form .
4.
Original copies need to withdrawn in work
station and replace with the revised duly signed and approved.
5.
Original copies are to be retained in a master
file by the document holder and shall be used for reference of triple personel.
V.
Work
instruction manual.
1.
Reference manuals relevant ro specific
department will contain corporate specification and department work instruction
.
2.
Document holder and FE coordinator will keep one
copy and one copy to keep in each department’s
work station/area. FE coordinator shall maintain a current manual distribution list.
VI.
Document
issues.
1.
Controlled copies of factory system documents
are issued to department, by referring to master document list ( MSDL ) ensuring that each user has the latest of
the document.
2.
Distribution lists for official controlled
copies of factory system documents shall be determine by the factory and
quality manager.
3.
Distribution of controlled copies shall keep by
the FE coordinator and document control holder.
VII.
Controlled
copies.
1.
Document control holder shall be responsible for
incorporating new or revised documents, and keeping manual update and
accessible both on master file located in main office and a copy in each
departments work station/area.
2.
Document control holder shall ensure that all
obsolote and uncontrolled documents are removed from points of use.
VIII.
Removal
or obsolete documents.
1.
Upon approved of revised documents, old document
shall be removed from point of use . These documents shall be considered
obsolete documents. Any obsolete documents shall be destroyed by using paper
shredder machine with the request for document disposal form duly signed by
authority.
2.
For any obsolote document not destroyed shall be
clearly stamped or marked as “ obosolete document” and shall keep only by the
document control holder in a separate storage cabinet.
IX.
Master
document control list.
1.
This is outline to assist in the control and identification of current system
documents.
X.
Record
retentio procedure.
A record is defined as any information or data that is received or made
by factory staff and management in the course of their duties which is
1.
Recorded in any medium including but not limited
to handwritten or typed forms, e-mails orcomputer disk that may contain any
information about the factory.
2.
All records are property of factory and may not
be destroyed, mutilated, or otherwise damaged of od disposed of , in whole or
in part except as provided by below record retention schedules with completed ‘request for documents disposal form ‘.
3. Record retention schedule
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Type of records
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Length of storage
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All QA and QC inspection report
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5 years
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All process and production report
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5 years
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All preventive and corrective action
plan
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5 years
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All maintenance and machine records
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5 years
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XI.
Back
up of electronically stored documentation.
1.
Documentation electronically stored in main
server or hard disk .
XII.
Use
of forms.
1.
Form use of reference and recording of product
data or process specifications, work practices or of inspections are to be
controlled as part of the document
control system.
2.
The FE coordinator will maintain a form log to
assist in the control of forms requiring document control
3.
The form log shall consist of a form number ,
form title or description, document control number and revision date.
4.
Supervisor is responsible for reviewing forms
when adding , removing or modifying process data . and it should be reviewed
twice a year.
5.
Initiating or revision of forms should follow
document creation , approval ,and control procedure.
XIII.
Document
control and record document
Document
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No.
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File
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Archives
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Time limit
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1.
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2.
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Tracking table of changed
document
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No.
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Content
of change/supplement
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Related
dept
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Effective date
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1.
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2.
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Document index
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No.
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File
no.
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code
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Issued
date
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remark
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1.
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2.
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Revision history
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Date
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Revision
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Description revision
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April 16 2016
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0
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initial
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