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1. (QSP-01) Process for Control of Documents & Record

The document outlines the procedure for controlling documents and records within a quality management system, detailing responsibilities, document generation, approval processes, and retention periods. It specifies the roles of the Management Representative and various departments in managing different types of documents, including quality manuals, work instructions, and engineering specifications. Additionally, it includes guidelines for document changes, obsolescence, and storage requirements to ensure effective quality system functioning.

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0% found this document useful (0 votes)
29 views6 pages

1. (QSP-01) Process for Control of Documents & Record

The document outlines the procedure for controlling documents and records within a quality management system, detailing responsibilities, document generation, approval processes, and retention periods. It specifies the roles of the Management Representative and various departments in managing different types of documents, including quality manuals, work instructions, and engineering specifications. Additionally, it includes guidelines for document changes, obsolescence, and storage requirements to ensure effective quality system functioning.

Uploaded by

anil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 6

QUALITY SYSTEM PROCESS DOC. No.

: QSP/01
REV. No. : 01
REV.DATE :
TITLE: PROCESS FOR CONTROL OF DOCUMENTS & RECORDS
08/03/2022

1. PURPOSE:The purpose of this procedure is to establish and maintain a documented system


for control of all the documents required by the quality management system.

2. SCOPE: This procedure is applicable to the following categories.


 Quality Manual
 Quality System Procedures
 Work Instructions
 Forms & Formats
 Drawings : (A) Customer's and (B) Anand Engineering Works
 Engineering Specifications
 Reference Standards
 Process Flow Chart
 Control Plan
 Process Control Sheet
 Inspection Standards
This procedure concerns the Management Representative and, all departments.

3. RESPONSIBILITIES: The Management Representative is responsible for effective


implementation of this procedure.

4. PROCESS DESCRIPTION :

Sr. Responsibilit
Activity Ref. Doc.
No. y
Document Generation :
Every document relevant to the quality system is
originated by a specific department /individual designated
Master list of
as its originator ; The MR is responsible for initiation,
documents &
generation and updating of the document.
5.1 QMS Head Records
The originator for various types of document have been

identified and are listed in the matrix table given in
F/MR/01
Annexure - I of this procedure. All documents are
identified by their title, document no., date of issue,
revision level and an authorized approval signature.
Document Control Authority :
The Management representative is designated as the
"Document Control Authority" for the Quality manual and Master list of
Quality system procedure. The document authority for all documents &
5.2 QMS Head
theother controlled document is indicated on the last Records
page. Each document control authority is responsible for - F/MR/01
distribution and control of respective document related to
him.
Document Approving Authority :
The document shall be reviewed and approved for
Master list of
adequate by authorized person prior to issue. Details of
documents &
5.3 approving authority of different types of controlled QMS Head
Records
documents are indicated in the matrix given.
- F/MR/01
The data controlling authority for different types of quality
data have been indicated in Annexure – I

Page 1 of 6
QUALITY SYSTEM PROCESS DOC. No. : QSP/01
REV. No. : 01
REV.DATE :
TITLE: PROCESS FOR CONTROL OF DOCUMENTS & RECORDS
08/03/2022

5.4 Document Initial issue, release and control :


Master list of
For document other than quality system procedure, the
documents &
5.4.1 originator is responsible for preparing and taking approval QMS Head
Records
from designated authority.
F/MR/01
Originator shall forward the master copy to DCN Authority,
the DCN has to check the sign of designated approving Master list of
authority prior to issue. He shall thereafter issue the documents &
5.4.2 QMS Head
documents to all the concerned deptt. / sec. Through a Records
document distribution list and under clear F/MR/01
acknowledgement of its receipt from receipting.
with regard quality system procedure originator shall
5.4.3 submit the finalized draft to Plant Head Who shall check QMS Head ----
and approve the same.
Each page of the Master copy shall be stamped "MASTER
COPY" in Greencolour at back side In addition every
5.4.4 QMS Head ----
Master copy should bear document control and revision
status.
Each page of the controlled copy shall be stamped
CONTROLLED COPY" in Bluecolour at front In addition
5.4.5 QMS Head ----
every controlled copy should bear document control and
revision status.
Master copy of the initial issue and revisions of the initial
5.4.6 QMS Head ----
issue and revision of each document shall be maintained
Each DCN shall maintain an update master list of all
5.4.7 documents released by him along with the current revision QMS Head ----
level and issue date.
5.5 Document change and withdrawal :

Changes to documents are reviewed and approved by the


5.5.1 same function or deptt. That approved the initial QMS Head ----
document, unless specifically designated otherwise.
Where practical nature of modification or change should
5.5.2 QMS Head ----
be noted in the document or appropriate attachment.
A change request shall be submitted by the deptt. /
individual to the concerned DCN who shall coordinate and
set up a meeting of all the concerned and if the change is
5.5.3 agreed by the same authority who has approved original QMS Head ----
issue.
The DCN should ensure that the changed documents are
issued in the same manner as the original issue
The receipting shall ensure that the document rendered
5.5.4 obsolete or removed from the point of use and destroyed QMS Head ----
on receipt of the revised documents.
The DCN shall retain the master copy of the obsolete
5.5.5 document for record and possible future but shall obsolete QMS Head ----
stamp on each paper.
5.6 OBSOLETE Copies : QMS Head ----
We will take concern documents from concern department
Page 2 of 6
QUALITY SYSTEM PROCESS DOC. No. : QSP/01
REV. No. : 01
REV.DATE :
TITLE: PROCESS FOR CONTROL OF DOCUMENTS & RECORDS
08/03/2022

put obsolete stamp on it. Keep them in the obsolete file


issue them the new document with signature on the
documents issue records with latest revision number and
revision date .
Review of Document :
PFD, Control plan, FMEA & Operation Std., Inspection STD
of each part shall be reviewed as per Customer Drawing at
5.7 every Year or customer complaint or In-house rejection or QMS Head ----
customer return or ECN.
After review or up-dation of all document fill in the detail
in Doc. Consistency review record.
Records, Storage location and Retention Periods :
Quality records and documents, which furnish evidence
regarding, verification activities andmaintenance of the
effective functioning of the quality system. Each
department shallmaintain a list of the quality records
requiring retention and indicate applicable
retentionperiods. Such records shall be identified in the
respective operational procedure and shallbe disposed off
only after approval of concerned department head, on
expiry of minimumretention period.
Production Part Approval, Tooling records, Purchase Order Master list of
and amendments shall be maintained for the length of documents &
5.8 QMS Head
time till the part is active for production plus three Records
calendar year unless otherwise specified by the customer. F/MR/01
(All customer Purchase Order / amendments and customer
specified records are included in this requirement).
Quality performance records (e. g. control charts,
inspection and test results) shall be retained for three
calendar year after the year in which they were created.
Records of Internal Quality System Audits and
Management reviews shall be retained for three years.
This requirement does not supersede any governmental
requirements. All specified retention periods indicated
above shall be considered minimum.
Identification :
Master list of
Records shall be identified to the product, person or event
documents &
5.9 to which they pertain. Recordsshall be dated and shall QMS Head
Records
identify by the person who establish the records. Records
F/MR/01
shall beindexed or grouped to facilitate retrievable.
Storage :
Records shall be stored by the same department that
initially establishes the records.
Master list of
Records shall be stored in the dry and clean environment.
documents &
5.10 Cabinets / racks contain recordsshall be clearly labeled to QMS Head
Records
display their contents. Records and other quality
F/MR/01
documents mustnot be stored in private desks or other
obscure locations that are generally not known.

Page 3 of 6
QUALITY SYSTEM PROCESS DOC. No. : QSP/01
REV. No. : 01
REV.DATE :
TITLE: PROCESS FOR CONTROL OF DOCUMENTS & RECORDS
08/03/2022

5.11 Sr. Inputs Source Frequency/ Review Criteria Reference


No. When
1. Request for Respective As & When Dept. In charge --
New Dept. received Approval
Document
along with
Draft
Document
2. Request for Respective As & When Justification for --
Document Dept. received Modification
Change / Required and Dept.
Revision
In charge Approval
3. Customer Customer As & When Customer Approved Customer
Drawing Drawing
4. PFD Production As & When Operation Relevant
New Product
(Process Sequence Process
Developed,
Flow Revised, customer Flow Diagram
Diagram) complaint , Major in
house rejection, yearly
review
5. FMEA Concerned As & When Characteristic Class Relevant FMEA
New Product
(Failure Dept. CFT and RPN Including
Developed,
Mode & Revised, customer Action Plans for
Effect complaint , Major in
reducing RPN
Analysis) house rejection, yearly
review

6. Control Plan Concerned As & When Product / Process Relevant


New Product
Dept. CFT Controls & Control
Developed,
Revised, customer Characteristic Plan
complaint , Major in
Class including
house rejection, yearly
review Checking Aids
7. W.I (Work Respective As & When Product / Process Relevant W.I
New Product
instruction) Dept. Developed, Controls &
Revised, customer Characteristic
complaint , Major in
Class including
house rejection, yearly
review Checking Aids
8. AOI Concerned As & When Product / Process Relevant A.O.I
New Product
(Agreement Dept. CFT Developed, Controls &
of Revised, customer Characteristic
complaint , Major in
inspection ) Class including
house rejection, yearly
review Checking Aids

Page 4 of 6
QUALITY SYSTEM PROCESS DOC. No. : QSP/01
REV. No. : 01
REV.DATE :
TITLE: PROCESS FOR CONTROL OF DOCUMENTS & RECORDS
08/03/2022

9. Engineering Customer As & When Modification Customer Note


New Product
Change via Developed, Required and
Note Production Revised, customer Customer Approval
complaint , Major in
house rejection, yearly
review
10. Obsolete Respective As & When Revision No. Obsolete
New Product
Documents Dept. Document
Developed,
Revised, customer File
complaint, Major in
house rejection, yearly
review

Annexure – I
Sr. Document originating In Controlling In Approved In Doc.
No. name charge charge charge Retention
Authority Authorized Authorized Period
1 Quality manual MR MR Plant Head Till Next
Revision
2 Quality System MR MR Plant Head/HOD Till Next
Procedure Revision
3 Master list of MR MR Plant Head/ MR 3 Years
documents
4 Work Concerned Dep’t. Concerned Dep’t. Concerned Dep’t. Function
Instruction Head Head Head Document
5 Forms & Concerned Dep’t. Concerned Dep’t. Concerned Dep’t. 3 Years
Formats Head Head Head
6 Customer N. A. NPD Head Plant Head As per CSR
Drawing
7 Engineering NPD Head NPD Head Q.A / Plant Head Product Life
Specification +Three
More year
8 Process Flow NPD Head NPD Head Production / Plant Product Life
Charts Head +Three
year
9 Control Plan NPD Head NPD Head Q.A/Plant Head Product Life
+Three
year
10 Reference N.A. Q.A Head N.A. AS Per CSR
Standards
11 Operation NPD Head NPD Head Q.A Head Product Life
Control +Three
Standards year

Page 5 of 6
QUALITY SYSTEM PROCESS DOC. No. : QSP/01
REV. No. : 01
REV.DATE :
TITLE: PROCESS FOR CONTROL OF DOCUMENTS & RECORDS
08/03/2022

# Time to submit Customer :- As per NPD procedure /CSR Making Period

KEY PERFORMANCE INDICATORS:-

 No. of cases old version document available on station. REFERENCE


DOCUMENTS & RECORDS:-

Sr. No. Description Format/ Doc. No. Responsibility


(if any)

01 Master list of documents &


F/MR/01 QMS HEAD
Record

Page 6 of 6

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