QSP 73

TITLE : DOCUMENTED INFORMATION CONTROL

PURPOSE : All documented records of external and internal origin are controlled to ensure that relevant
version of applicable documents are available at points of use to effectively support
operations
of the organization's processes and Quality records provides for identification, storage,
protection, retrieval. Retention time and disposition of records.

SCOPE: Documented records are generated in the organization to provide evidence of conformity to
Quality Management System requirements and its effectiveness.

METHODS: Each document related records is identified by unique identification as follows-

XX- Type of document

{Statement of Quality Policy &
{ Quality Objectives
{Quality Management Systems Manual - QSM
Quality Management Systems Procedure - QSP
Master File - MF
Work Instruction - WI
Flow Chart/Operational Sheet - OS

YY- Department/Activity
Purchase - PUR
Quality Assurance - QA
Marketing - MKT
Production - PR
Finished Goods Warehouse - FG WH
R.M./P.M. Warehouse - RM/PM WH
Research & Development -R&D

ZZ- Serial No. in running order from 01-99

AA- Revision Status 00-99

Sl.No. Activity Responsibility

----- -------- --------------
1.0 All documents are reviewed for adequacy, approved and controlled prior to issue, as per the table
below.

Document Reviewing Approving Controlling

Authority Authority Authority
Quality Manual Chief Executive Director Chief Executive
( OPN). ( OPN).

Quality Procedures Chief Executive Director Chief Executive

( OPN). ( OPN).

Contracts from the Customers Marketing Director Chief Executive

(Marketing) Coordinator (Finance & Admin)
National / International Q.A.Manager Director Chief Executive
and Industry Sector Standards ( Pro & Plan)

Statutory & Regulatory Purchase Director Chief Executive

Requirements Coordinator ( OPN)

Decisions of the Organization Chief Executive Director Chief Executive

(Finance & Admin) ( Pro & Plan)

Master Files Q.A. Manager Chief Executive Chief Executive

( Pro & Plan) ( OPN)
Work Instructions Q.A. Manager Chief Executive Chief Executive
( OPN) ( OPN)
Batch Sheets Q.A.Manager R&D Manager Chief Executive
( OPN)
Formats Q.A.Manager Chief Executive Chief Executive
( Pro & Plan) ( OPN)

Mark the controlled copies as controlled in Violet ink Chief Executive (Pro & Plan) / (OPN)

2.0 Change in documents can be suggested by anyone in the organization . Chief Executive
Each and every identification change is reviewed and approved by the approving ( Pro & Plan)
authority and the distribution of amended documents is controlled by (OPN)
Chief Executive ( Pro & Plan)

3.0 Amended documents/latest versions are issued Chief Executive(OPN) to the Chief Executive
concerned users through revisions to the existing documents. All the documents (OPN)
are identified uniquely including their revision status. The index/contents page
of different types of documents identifies the current revision status. The index/
contents page is revised along with the revision status of documents.

4.0 Chief Executive(OPN) ensures that the relevant versions of the applicable Chief Executive
documents are available at points of use and record of distribution is maintained in a file. (OPN)
Disposition of Quality records where retention period is over
is carried out by the Chief Executive (OPN) adopting any appropriate
method, in consultation with the concerned Departmental Head. Concerned
Departmental HD
Obsolete documents are removed from all work places and destroyed by Chief Executive
(OPN) to prevent the unintended use of "obsolete" documents. However one copy of
obsolete documents can be retained by Chief Executive (OPN) clearly marked as "obsolete
document" with red ink, if they are required to be retained for any purpose.

5.0 All documents of external origin like customer specifications, relevant Chief Executive
National/international, Standards, Industry sector codes are identified and (OPN)
their distribution is controlled by Chief Executive(OPN).
6.0 Revision status of national/ international standards are verified by Chief Executive Chief Executive
National/international, Standards, Industry sector codes are identified and (OPN)
(OPN) with concerned national/international standards bodies (viz. B.I.S.) as and Chief Executive
when communication is received from customer. (OPN)

8.0 One Master copy of all controlled latest versions documents having suitable Identification Chief
"Controlled copy" marked with violet ink is maintained by Chief Executive (Pro & Plan) / Executive
and kept in Master File (OPN)
9. Records of unique iden- 7.5.3 Q.A. Q.A. 2 years
tification of products Mgr . Mgr.

10.Records of customer process

property R.M./P.M. when it is-

a) Lost, damaged, or 7.5.4 Q.A. Q.A. 2

years
otherwise found Mgr. Mgr.
unsuitable for use

b) Intellectual property Chief Executive Chief Executive 2

years
of customer (OPN) (OPN)

11. Records of results 7.6 Q.A. Q.A. 2 years

of calibration of Mgr. Mgr.
measuring equipment

12. Audit results records 8.2.2 Chief Executive Chief Executive 2 years
(OPN) (OPN)

13. Records of the result 8.2.4 Q.A. Q.A. 2 years

of monitoring and Mgr. Mgr.
measurement of product
(including production
batch sheets and test
reports after completion
of production).

14. Records of 8.3 Production Production 2 years

nonconforming product sr. Mgr. Sr. Mgr.

15. Records of corrective 8.5.2 Production Production 2 years

action Sr Mgr. Sr. Mgr.

16. Records of preventive 8.5.3 Asst..Mgr. Asst.Mgr. 2 years

action R&D R&D