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QP#1 Documented Information Control-rev.1

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QP-1
Documented Information Control
Procedures
Rev.1
Issue Date: 07/01/19
1. Purpose
This procedure describes how MISCo. controls its QMS documented information.
2. Scope
This procedure applies to all MISCo.'s QMS documented information either maintained or retained by
MISCo. including documents of external origin.
3. Definitions
None
4. Responsibility
Management Representative (M.R.)
QA Engineer
Department Heads
5. Procedures
#
Responsibility
Procedure
Document
5.1 Documents Coding System
5.1.1
MISCo.’s QMS documents consists of:
 Manuals
 Procedures and related Flowcharts
 Forms
 Work Instruction
5.1.2
All documents shall be assigned a unique identifier. The document
coding shall be as follows:
XX-YY, where,
XX: Stands for the document type
Manuals:
QM
Procedures:
QP
Forms:
QF
Work Instructions: WI
Flowcharts
FC
YY: A serial number of the document.
For Flowcharts, Forms and Work Instructions an additional serial
number is added following the YY related procedures number.
5.2 Creation, Reviewing and Approving the QMS Documents
5.2.1
M.R.
Prepare all QMS documents with the help of concerned
departments' heads.
5.2.2
M.R.
Review and approve all QMS documentation before issuing, then
sign it to show acceptance (Forms needs no signing).
5.2.3
M.R.
Ensure that each page of the QMS documents contain the
following information:

MISCo. Logo,

Document title and Code, and

Revision and Issue date.
5.3 Distribution of Controlled Documents
5.3.1
M.R. /
Prepare a Master File, containing the current revisions of all
QA Eng.
MISCo.'s QMS as a softcopy and place it in MISCo.’s server.
5.3.2
M.R.
If a hard copy Master file is printed, stamp its documents from the
QA Eng.
back in red as "Controlled Document" and keep it in QA Dept.
5.3.3
M.R.
List all of the QMS documents in the Documents Master List (QF-1/1)
QA Eng.
(QF-1/1) and place it in the server for all MISCo. staff to access.
Printed copies are uncontrolled unless stamped in red as controlled
Page: 1/3
QP-1
Documented Information Control
Procedures
#
Responsibility
5.3.4
5.3.5
M.R. /
QA Eng.
5.3.6
M.R.
QA Eng.
Rev.1
Issue Date: 07/01/19
Procedure
Document
Documents should be saved in a way that prevents contents
alteration and shall be considered uncontrolled when printed.
When a hard copy of a document is to be controlled, stamp all its
pages from the front with “Controlled Document” in red, then list
it in the Controlled Document Distribution List (QF-1/2) and let
the document holder sign the list.
Ensure that only valid documents are used by MISCo.’s personnel (QF-1/2)
and only authorized persons have access to pertaining documents.
5.4 Changing of Document
5.4.1
Requestor
Propose any changes to the QMS by informing the M.R.
5.4.2
M.R.
Consult concerned department heads and study the effect of the
change on other departments work and on other documents.
5.4.3
M.R.
If the change is accepted, fill a Document Change Request (QFQA Eng.
1/3). Amend the document and update its Revision No. and Issue
Date. Update the Documents Master List (QF-1/1) and master
file. Check the Controlled Document Distribution List (QF-1/2)
to make sure all holders have current copies.
5.4.4
M.R.
List all document change requests in the Document Change
QA Eng.
Requests Log (QF-1/4) to keep track of who has proposed what,
when and the change progress.
5.4.5
M.R.
Ensure that old versions of the replaced documents are withdrawn
QA Eng.
from their point of use (Soft/Hard copies). Destroy obsolete
hardcopy documents. If these documents need to be kept for any
reason, stamp them from the front "OBSOLETE DOCUMENT".
Softcopy obsolete documents are kept in QA files
5.4.6
M.R.
Update all concerned personnel of the change and make sure they
QA Eng.
are using the new document revision.
5.4.7
Adding comments or correcting typographical errors are not
considered as changes but annotations, thus the document revision
does not need to be changed. Changes are alterations that modify
instructions and work order.
(QF-1/1)
(QF-1/2)
(QF-1/3)
(QF-1/4)
5.5 Control of Documents of External Origin
5.5.1
Departments
Identify the documents of external origin which are necessary for
Heads
the operation of your Department work. Such documents include:
 Manuals, codes, and standards, and
 Technical documents from clients
5.5.2
M.R.
List all these documents in the Documents of External Origin (QF-1/5)
QA Eng.
List (QF-1/4). Review the list annually and contact departments
heads to ensure that latest revisions are obtained, as necessary.
5.5.3
4.5.4
Department
Heads
Ensure that each department documents of external origin are
stored and protected in an easily retrievable way and are kept
available to concerned personnel.
External documents for non-critical use, such as user manuals,
reference books, marketing materials, etc. are not controlled.
Printed copies are uncontrolled unless stamped in red as controlled
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QP-1
Documented Information Control
Procedures
#
Responsibility
5.6 Records Control
5.6.1
Department
Heads
5.6.2
M.R.
5.6.3
Rev.1
Issue Date: 07/01/19
Procedure
Document
Ensure that all your department generated records have a
distinctive serial index and are filed in an orderly manner so that
they are easily retrieved and detected if any is missing.
In general, MISCo. records are indexed as per the following:
Record Initials-YY-XXX
Where, YY - stands for the year
XXX - stands for a serial number starting that year
Once a record is complete it should not be changed. If it is
subsequently found to be inaccurate, a new record should be
created. If modifications are unavoidable, they should be struck
through so that the original wording can still be read, and the new
data added in ink and signed by the original data initiator.
5.7 Records Storage, Retention and disposition
5.7.1
Dept. Heads
Ensure that your department records are stored in orderly files to
prevent damage or deterioration and to prevent any loss or
unauthorized access.
5.7.2
Electronic records are subject to periodic backups, with the backup
stored on a separate server.
5.7.3
Dept. Heads
At the end of each job, ensure archiving its related data in an
appropriate manner to easily find it when needed and to prevent
unintended deletion.
5.7.4
Unless otherwise specified, records shall be maintained for a
minimum of 5 years and then should be destroyed. If a greater
retention period is required, then it shall be indicated clearly on the
specified records to prevent disposal before the required time.
5.7.5
Dept. Heads
At the beginning of each year, review the stored records and check
which records must be disposed. Ensure that records are not
destroyed without prior instruction from G.M.
6. Flow Charts
None
7. References
7.1 International Standard ISO 9001-2015
7.2 Documents Master List
7.3 Controlled Documents Distribution List
7.4 Document Change Request
7.5 Document Change Requests Log
7.6 Documents of External Origin List
clause 7.5
(QF-1/1)
(QF-1/2)
(QF-1/3)
(QF-1/4)
(QF-1/5)
Approved by:
Prepared by:
R. Abdulhadi, M. R.
Printed copies are uncontrolled unless stamped in red as controlled
N. Al-Minawy, Operations Manager
Page: 3/3
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