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QSP-02 PROCEDURE FOR DOCUMENTED INFORMATION

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221 views

QSP-02 PROCEDURE FOR DOCUMENTED INFORMATION

documents

Uploaded by

sharif1974
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Ref. No.

QSP-03
QUALITY SYSTEM PROCEDURE Rev. No. 00
Rev. Date 16.11.2023
TITLE: CONTROL OF DOCUMENTED INFORMATION Page No Of 5

1.0 Purpose
To establish and maintain a documented information procedure for control of documented information of internal & external origin and to ensure that pertinent copies are
available with end users.
2.0 Scope
Applicable to all QMS documented information and External origin documented information.
3.0 Responsibilities
3.1 GM for QMS level 1 & 2 documented information
3.2 Process HOD for WI, List, Forms , Formats, SOP, Control Plan, Quality Plan documents
4.0 Process Inputs
Input Description Source Reference (if any)
Extern origin documents / Standards Consultant & Customer QMS/L/03

5.0 Procedure:
5.1 Preparation and approval of Documented Information
5.1.1. The Documented Information and data include
Level I- Quality System Manual
Level II- Quality System Procedure
Level-III – Work Instruction, SOP, In-process drawings, Lists, Inspection/ Quality Plans, & Control plan etc
Level-IV – Forms, formats, registers etc.

5.1.2 The Documented Information and data are reviewed and approved by authority as below –
Preparing Approving
Type of Documented Information
Authority Authority
Quality System Manual, GM MP
GM with Process
Quality System Procedure MP
owner
Work Instruction, SOP, Lists, In-process drawings,
Inspection/ Quality Plans, Process Flow chart, Process Owner MP
Documents, Test Plans etc
Forms , Formats, Register Process Owner GM
Ref. No. QSP-03
QUALITY SYSTEM PROCEDURE Rev. No. 00
Rev. Date 16.11.2023
TITLE: CONTROL OF DOCUMENTED INFORMATION Page No Of 5

5.1.3 Master copy of Documented information is signed (in original) by approving authority. It is identified by original sign by blue pen on the Documented information;
Master copy is maintained by GM Additional copies of Master copy are identified as controlled copy provided they are to be maintained and updated; such controlled
Documented information bear “Controlled Copy” identification seal in Blue color on front side of the Documented information.
5.1.4 GM will maintain the List of documented information QMS/L/02 for level1 to Level 4
5.1.5 GM distributes the controlled copies of relevant documented information of Level- 1 to Level-04 to the respective personnel. Concerned controlled copyholder signs
the distribution Documented Information as a proof of document issued. The user department / function ensure that latest copy is available at place for effective
functioning of the system.
5.1.6 Drawings are controlled by Designer Issue Photo copy of drawing to shop floor
5.1.7 Documented information of drawing issue to suppliers will be maintained in DC and taken back at the time of delivery of material.
5.1.8 Control of Formats:
a. Any user in consultation with Plant I/c can generate format.
b. Whenever a Format is made, a specimen copy will be approved by Plant I/c by affixing his signature on the Format on the rare side (To be followed in case if master
copy not maintained in soft control).
c. The Format No. will be mentioned in the Bottom/Top of Left Hand Corner including Revision Status.
d. Master formats will be maintained in soft control only. Plant I/c shall update list of Documented information.
e. Whenever there is a Revision to the Format, the Revised Format will be routed through GM who shall repeat the action b and d and enters the revision status on
QMS/L/01
f. The earlier format will removed from master folder and stored in the absolete folder separately.
5.2 Documents Distribution/ Issue
5.2.1 GM distributes all the documents and formats and maintains the Master list of documented information QMS/L/02. The Master list of documented information
contains the Title. Of Document, Reference Number, Controlled copyholder (distribution), Revision No. (Rev. Status).
5.2.2 Plant I/c distributes the controlled copies of relevant documents to the respective personnel. Concerned controlled copyholder signs the distribution Documented
Information as a proof of document issued. The user department / function ensure that latest copy is available at place for effective functioning of the system.
5.2.3 Drawings are controlled by Quality I/c Issue Photo copy of Customer drawing to shop floor
5.2.4 Documented information of drawing issue to suppliers will be maintained in DC and taken back at the time of delivery of material.
5.3 Changes and Amendment of the Documented Information
5.3.1 Revision status of Manual, Procedure, Work Instruction, SOP, In-process drawings etc. is identified through Revision Number, Date of. Revision.
5.3.2 For the initial issue of the document the Revision number is identified as “00”. In case of Amendment, the revision number gets incremented.
5.3.3 Whenever any user wants changes in the document, he approaches GM & for changes in drawing approaches Designer. GM review the required Changes along with
the MP and take his Approval. Accordingly changes in the Document are incorporated and revised documents are distributed. Documented Information Amendments
Sheet / Changes are maintained in Document/Engineering change Note
5.3.4 Designer send the controlled copy of the revised document/ drawing to controlled copyholder (user department) and remove the obsolete copies. Last master copy of
obsolete document is retained as obsolete copy stamped as’ OBSOLETE COPY’ to prevent its unintended use. The other copies of obsolete documents are destroyed.
5.4 Control of documents of External Origin
Ref. No. QSP-03
QUALITY SYSTEM PROCEDURE Rev. No. 00
Rev. Date 16.11.2023
TITLE: CONTROL OF DOCUMENTED INFORMATION Page No Of 5

5.4.1 List of standards is maintained QMS/L/03 to verify the revision status of standards. The verification of latest copy of such documents is verified against information
obtained from Customer Representative / Consultant / Authentic source of information like Certification body/ consultants. The latest copies are obtained and
distributed to the user department.
5.4.2 Customer drawing & intellectual property latest revisions are controlled by Designer by referring the revision No. on the customer purchase order.
5.5 CONTROL OF ELECTRONIC DOCUMENTS:
5.5.1 Documents, which are stored in computer, shall be made accessible to the persons who are authorized to use such documents. In order to avoid un-authorized usage of
documents stores in computer, necessary password shall be given and shall be known only to the authorized person. Every day all documents back-up shall be taken.
5.5.2 All the controlled copyholders will ensure that the document available with them is legible.
5.6 Documented Information Codification/ Identification
5.6.1 Document codification for all four levels is as follows
Manual
QM/ 01
Running Serial Number
Quality Manual
The Procedures, Work Instructions, Forms, Formats, SOP, Quality Plan,
Process Sheet, Test Plan, Registers are numbered as follows;

XX – ZZ - 01
Running Serial. Number
Type of Documented Information like Procedure, Work
Instruction, forms, List, SOP etc.
Department / Activities Code

5.7 Storage:
Documented Information’s may be Hard Copy (such as Paper) or in Electronic Media. Storage of forms/ reports will be cub-board or table drawer.
5.8 Protection
Documented Information’s, which are generated on paper, are protected by maintaining them in various files of Corrugated Paper or Plastic folder. Documented
Information’s, which are generated in Electronic Media, have Access control through login passwords at department level (process level). Regular backup (i.e., once in 3
months) of the data from server is taken on external hard disk
5.9 Retrieval
Documented Information’s, which are generated on paper, are retrieved by referring the identification number of the Documented Information.
Documented Information, which are generated in Electronic Media, are retrieved by opening the respective folder/file.
Access to Documented Information is controlled on a “need to know” basis.
Access by appropriate personnel is maintained, so that Documented Information are readily available.
Ref. No. QSP-03
QUALITY SYSTEM PROCEDURE Rev. No. 00
Rev. Date 16.11.2023
TITLE: CONTROL OF DOCUMENTED INFORMATION Page No Of 5

5.10 Retention Period


Retention Periods of all the Documented Information are determined by the concerned personnel/s nominated for collection and maintenance of Documented
Information. In doing this, attention is given to legislative requirements and need to protect the company against future litigation. Retention period of all the
Documented Information is mentioned in “List of Documented information”.
5.11 Disposition
Upon expiry of the retention period, Documented Information are destroyed by any appropriate means, preferably by shredding.

6.0 Documented Information Reference:


List of Documented information QMS/L/01
List of External origin Standards QMS/L/03
Documented Information Amendment Sheet QMS/F/06

Approved By:
Prepared By:

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