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Pro Sys 04

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0% found this document useful (0 votes)
9 views3 pages

Pro Sys 04

Uploaded by

Asif
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as RTF, PDF, TXT or read online on Scribd
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PRO_SYS_04

Doc.Ref.No:
Procedure for Rev.No/ Issue Date 0 / 01-05-2023

Control of
Records
1.0 Purpose
The purpose of this procedure is to describe details of identification, indexing, collection, access,
filing, storage, maintenance and disposition of records.
2.0 Scope
This procedure covers all records including “Test and Calibration Certificate” received from
subcontractor / test laboratories, which are included in the product safety management system.
It also includes all the records maintained as a part of contractual requirements.
3.0 Responsibility
3.1 Management Representative is responsible for codifying the identification number and
establishing control for recording system, which applies to quality records throughout the
organization.
3.2 Functional Heads are responsible for ensuring that records in their departments are correctly
collected, numbered, filed, stored, legible and easily retrievable with the help of proper indexing
method by the persons made responsible.
3.3 Top Management / Marketing Authorized Person are responsible to convey the message to
respective Functional Heads, if there is any specific requirement in the contract regarding
maintaining and retention of records differing from the present system.
4.0 Description of Activity
4.1 Identification of Records
4.1.1 All the loose formats used to maintain records have a unique number put on them according to
the type of activity as per numbering system described in the E/SYS/01. The handmade / printed
formats used in registers may not be given a unique number. Master copies of such formats are
kept with approval of authorized person. The user / functional heads are authorized to change
the format(s) to suit their requirement. The identification number for any format used is written on
the cover page of files / books and need not be written on each page. The separate records for
sub-groups (like area wise, product wise, customer wise, etc.) are made for simplicity, but record
number for sub-group remains same or further alphabet is given as suffix to the record number,
if required, with sub-group title on the cover page to locate it easily.
4.1.2 The records kept in electronic medium like computer are identified by the file name and indexed
properly by users.
4.2 Collection of Record
The data is recorded by the personnel in standard formats / memo book / registers. Wherever
standard formats are used, Management Representative / Functional Heads are responsible for
approving such formats. The issue number of such format may also be written on the forms. The
frequency of collection is decided, and documented in the master list of records.
4.3 Filing of Records

Prepared And Approved By Signature Page


Management Representative 1 OF 3
PRO_SYS_04
Doc.Ref.No:
Procedure for Rev.No/ Issue Date 0 / 01-05-2023

Control of
Records
The filled formats are legible and filed in the respective files or simply registered in registers /
books. The records are maintained in box file, flat file, computer, register books, etc.
4.4 Access to Records
Access to the quality records is restricted to Management Representative / Functional Heads or
those who need to have access because of their day-to-day activities in a routine practice. If it is
required to be referred by other person / department then provision for easy availability to others
is arranged.
For computer records, it is restricted to limited users; password facility is arranged as well as
secret records are safeguarded from access to other staff members. If required, records are
made available to customer or his representative for evaluation for an agreed period as a part of
contract.
4.5 Method of Indexing
The records are filed in such a way that the latest record could remain at the top in the files or on
continued last page of books / registers. The records are indexed date wise and if further
classification is required for product wise, customer wise, and department wise then the same is
done and written in department wise master list of records.
4.6 Storage and Maintenance of Records
4.6.1 The records in the form of files or box files or registers are stored in filing cabinets / cupboards or
at any suitable place to protect them from damage or loss. This would be in a suitable environ-
ment under the responsibility of the personnel and at location mentioned in the master list of
records. The records also include inspection and test records of sub-contractors, test laboratory
calibration records and all the records maintained as a part of statutory and regulatory
requirements.
4.6.2 The records are also maintained in the computer and such records need not be printed. In such
cases the files for such data is operated by authorized person to avoid damage of records and
data by unauthorized person. The backup of computer data is taken by user department to
protect such records from loss or damage, periodically (as and when changes are done in
present file). Also, passwords are used, wherever necessary, and identified by concerned
authorized person to establish control.
4.7 Protection of Records
4.7.1 Necessary precautions are taken to protect the records from unauthorized person and loss of
data from hard copy or electronic medium. Accesses of records are restricted to managerial level
or those involved in day-to-day activities, in a routine manner. If they are required to be referred
to by other person / department, availability is facilitated.
4.7.2 The backup of computerized data is taken by computer department to protect from loss or
damage as and when changes are carried out in the files.
4.8 Disposition of Records
4.8.1 After completion of files / registers / books, the period of record is written on the cover page of
such record file and preserved up to the retention period mentioned in the master list of records

Prepared And Approved By Signature Page


Management Representative 2 OF 3
PRO_SYS_04
Doc.Ref.No:
Procedure for Rev.No/ Issue Date 0 / 01-05-2023

Control of
Records
or as per contractual requirements. New record is started with the same record identification
number but date of completion is not put unless it is completed.
4.8.2 After completion of retention period, records are preserved for more time / disposed-off by
concerned functional head responsible for maintaining these records by any of the means
described below:
1. Tearing-off/shredding.
2. Burning
4.9 Different types of records are retained for period specified in a contract or by internal
requirements in an environment that will ensure retrievability.
4.10 Management Representative regularly reviews the method of recording all the quality system
records to ensure that they continue to satisfy the requirements.
4.11 Customer Requirement
4.11.1 In case where stipulated in the contract or legally, retention of records for period different (more)
from that is already laid out. This is intimated by Top Management / Marketing Head to
concerned functional heads, to follow that requirement. Also Functional Heads identify such
records by recording “To Be Retained Up To ______”. Also such file is positively identified to
take care of above requirements.
4.11.2 The records are made available for evaluation by the customer or his representative, if
contractually required as evidence of product conformity to the specified requirements.
4.12 Functional Heads and Management Representative keep master list of records in Systems file.
Master copies of all the formats approved by Management Representative / Functional Heads
and used in the respective areas are kept in master format file of Management Representative.

5.0 References
5.1 Customer Order Files.

6.0 Enclosures Nil.

7.0 Format / Exhibits


7.1 F/SYS/04 Master List of Records.
7.2 E/SYS/01 Document Codification System.

Prepared And Approved By Signature Page


Management Representative 3 OF 3

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