1.0 OBJECTIVE
1.1 To
lay down the procedure for Document Control of (xyz).
2.0 SCOPE
2.1 This
procedure applies to all Departments of ( xyz).
3.0 RESPONSIBILITIES
3.1 Head
– All Departments for compliance of SOP.
4.0 PROCEDURE
SOP For Management Review Meetings | Management review
meetings
4.1 There is
a document number situated at the bottom left side of each and every document
of Company Name. E.g. QA01/F00-00.
4.2 1st and
2nd character “QA” represents Quality Assurance and it is the
initial identification for each and every document.
4.3 3rd and
4th characters “01” represents QC and like this “02” will
represent QA, “03” will represent Production, “04” will represent Store, “05”
will represent Maintenance, “06” will represent Purchase & “07” will
represent Safety department.
4.4 5th character
will be “/” for separation.
4.5 6th character
“F” represents “Format” which is consent for each department.
4.6 7th &
8th character will represent the formats serial number eg.-00
represent 1st format, 01 represent 2nd format
of the particular department and so on.
4.7 8th character
will be “-”.
4.8 9th &
10th characters will be revision numbers e.g. 00 is the first
revision & 01 is 2nd revision.
4.9 In
the case of SOP there will be an SOP number e.g. SOP/QA/01.
4.10
the first set of letters represents the Standard Operating Procedure.
4.11 2nd character
will be “/”.
4.12 3rd set
of letters represents the departments e.g.
QA/QC/Production/Store/Maintenance etc.
4.13 4th character
will be “/”.
4.14 5th and
6th characters represent the serial number of SOPs e.g. 1st SOP
of the department will be 01 & the 2nd SOP of the
department will be 02.
4.15 The document should include the Effective date, Review date, and sign.
5.0 DOCUMENT CONTROL SYSTEM
5.1 There
is one master document with a red colored stamp of “MASTER DOCUMENT” which
will be only with an authorized person.
5.2 There
is one control copy which is a Xerox copy of the master document and has a blue
colored stamp of “CONTROLLED DOCUMENT DO NOT COPY”.
5.3 If
a document is revised then a new one will be controlled as 4.2.1 & 4.2.2
and an obsolete copy will be stored with the red-colored stamp of
“OBSOLETE”.
5.4 For
all formats same procedure will be followed as 5.1, 5.2, and 5.3.
6.0 DOCUMENT ISSUE SYSTEM
6.1 All
MASTER DOCUMENTS will be held by MR.
6.2 All
CONTROLLED DOCUMENTS will be distributed to the concerned department and
recorded.
6.3 Xerox
of CONTROLLED COPY is highly restricted.
6.4 Any
document required to display should also be stamped with “CONTROLLED DOCUMENT DO
NOT COPY” on a Xerox copy of the MASTER DOCUMENT.
6.5 FORMAT
BOOK will only be issued by QA with a stamp.
7.0 DOCUMENT REVIEW
7.1 Document
will be reviewed every two years but it can be reviewed early depending on
the Necessity.
8.0 DOCUMENT CONTROL
8.1 All the documents and files of QA shall be
maintained as per the “Master List of Documents” format.
9.0 Storage /Disposal of Documents
9.1 All the current versions of the master documents
shall be stored under the control of the QA department.
9.2 Laboratory has different types of documents and
records. All records/document have their current revision number. The old
and previous records have specified times for their retention in the
laboratory.
10.0 ABBREVIATIONS
10.1 SOP: Standard
Operating Procedure
10.2 QA: Quality
Assurance
10.3 No. : Number
11.0 REFERENCE
11.1 Nil
RELATED FORMATS
MASTER LIST OF
DOCUMENTS - QA02/F01-00