Вы находитесь на странице: 1из 6

Doc.

SGR /FSMS / SOP 01


GMP MANUAL Issue Status 01
STANDARD OPERATING PROCEDURE Revision Status 00
Date 01-04-2012
CONTROL OF DOCUMENTS
Page 1 of 6

1. PURPOSE

To ensure that document and data pertaining to the Food Safety


Management System are controlled through proper review, approval,
distribution and change control.

2. SCOPE

All documents pertaining to Food Safety Management System.

3. RESPONSIBILITY

FSMS Team Leader.

4. PROCEDURE DESCRIPTION

4.1 Food Safety Management System Documentation

4.1.1 The Food Safety Management System Documentation will have the
following framework.

- Food Safety Policy, Food Safety Quality Objectives and


Organizational Structure.
- Food Safety Management System Manual.
- Good Manufacturing Practices Manual – Standard Operating
Procedures and their related formats.
- Good Hygiene Practices- Sanitary Standard Operating
Procedures and their related formats.
- Work Instructions, Guidelines and Reference Documents
- GMP/GHP/HACCP Records.

4.2 Preparation and issue of Documents

4.2.1 All Food Safety Management System related documents shall be controlled at
Preparation, approval and issue stage.

PREPARED BY APPROVED BY
Doc. SGR /FSMS / SOP 01
GMP MANUAL Issue Status 01
STANDARD OPERATING PROCEDURE Revision Status 00
Date 01-04-2012
CONTROL OF DOCUMENTS
Page 2 of 6

4.2.2 The following identification reference method is adapted to all documents (other
than records / formats).

SGR / FSMS / D XX

Where,

SGR represents SGR (777) Foods Pvt Limited.

FSMS represents Food safety Management System

D represents type of document / Manual

e.g. SOP- Standard Operating Procedure


SSOP- Sanitary Standard Operating Procedure
ANNX - Annexure
WI – Work Instruction
G- Guidelines
L- List
POL- Policy

XX represents serial number

4.2.3 The process approach for the control of documents is as follows:

Input(s) Process ( es ) Output(s) Interaction(s)


 Type of documents  Preparation,  Approved All
(Internal and approval documents. departments.
external). review and  Availability of
 Preparation and issue to the required
approval. relevant documents at
 Reviewing and departments. respective
issuing authorities.  Analyzing the departments.
 Document change  Practicing all
distribution list. requisitions documented
 Authorities for and revising procedure
updating external the documents
documents as applicable.
PREPARED BY APPROVED BY
Doc. SGR /FSMS / SOP 01
GMP MANUAL Issue Status 01
STANDARD OPERATING PROCEDURE Revision Status 00
Date 01-04-2012
CONTROL OF DOCUMENTS
Page 3 of 6

4.2.4 The preparation, approval and issue authority for various documents are given as
below.

Sl. Responsibility for


Document
No. Preparation Approval Issue
Food Safety Policy, FSMS Team Leader MD FSMS Team
Food Safety Quality Leader
1. Objectives and
Organizational
Structure
Food Safety FSMS Team Leader MD FSMS Team
2. Management System Leader
Manual
Good Manufacturing FSMS Team MD FSMS Team
Practices Manual – Leader/Concerned Leader
3. Standard Operating Dept Head
Procedures and their
related formats
Good Hygiene FSMS Team Leader/ GMO FSMS Team
Practices- Sanitary Concerned Leader
4. Standard Operating Department Head
Procedures and their
related formats
Concerned GMO FSMS Team
Department Head/ Leader
5. Work Instructions
FSMS Team Leader

FSMS Team Leader/ GMO FSMS Team


Concerned Leader
6 Formats
Department Head

PREPARED BY APPROVED BY
Doc. SGR /FSMS / SOP 01
GMP MANUAL Issue Status 01
STANDARD OPERATING PROCEDURE Revision Status 00
Date 01-04-2012
CONTROL OF DOCUMENTS
Page 4 of 6

4.2.5 The document copies with respect to Food Safety Management System shall be
given as below.

Master Copy

Master Copy is the copy with the original signatures. This copy shall be
available with FSMS Team Leader.

Controlled Copy

Its circulation is controlled and bears stamp seal as “CONTROLLED COPY”


(Green Color) on each page. Whenever any revision is made in any one of
the documents, all the Controlled Copy Holders shall be issued with the
amendments, to be incorporated and attested by issuing authority (FSMS
Team Leader).

Uncontrolled Copy

Uncontrolled Copy means all those copies that need not be controlled for
distribution and revision status. It bears stamp seal as “UNCONTROLLED
COPY”.

Obsolete Copy

“OBSOLETE COPY” is an obsolete version of the Master Copy. It bears


stamp seal as “OBSOLETE”.

4.2.6 The issue of any document shall be controlled by the respective issue
authority (FSMS Team Leader). In the event where the issuing authority is not
Clearly specified, the person who approved the document will be responsible for
issue control.

4.2.7 FSMS Team Leader shall maintain a file, Master List of Documents
related with Food Safety Management System.

4.2.7.1 Issue / Distribution Of Documents:

PREPARED BY APPROVED BY
Doc. SGR /FSMS / SOP 01
GMP MANUAL Issue Status 01
STANDARD OPERATING PROCEDURE Revision Status 00
Date 01-04-2012
CONTROL OF DOCUMENTS
Page 5 of 6

4.2.7.1.1 FSMS Team Leader shall decide the distribution of each document and the
same shall be recorded in the Document Distribution List

4.2.7.1.2 FSMS Team Leader has the authority for issue of documents, arrange to
get requisite number of copies (as per Document Distribution List) and then
stamp them as ‘CONTROLLED COPY’.

4.2.7.1.3 FSMS Team Leader shall issue the documents and take the
acknowledgement from the copyholder as per the distribution sheet in the
Document Issue / Acknowledgement Register

4.2.7.1.4 FSMS Team Leader shall maintain a Master List of Documents & Revision
Status , which shall be updated after receiving the
acknowledgement from the authorized copyholders. The authorized
custodian of documents shall also maintain a Master List of Documents &
Revision Status held by him/her.

4.2.7.1.5 The initial issue status of the entire document is “Issue 01” and the
“Revision status is 00”.

4.2.7.2 Re – Issue :

4.2.7.2.1 The first nine revisions of any document carry “Issue 01” status.

4.2.7.2.2 When the number of revisions exceeds 9, the entire DOC shall be re-issued
with the subsequent number 2, 3, 4 etc respectively for every 9 revisions.

4.2.7.3 Document Changes:

4.2.7.3.1 Any department head may raise a request for need for document change
through a Document Change Requisition Note and shall submit
the request to the FSMS Team Leader.

4.2.7.3.2 FSMS Team Leader shall scrutinize the nature and reason for change (shall
consult concerned department heads, if required) and shall decide on
incorporating the change.

4.2.7.3.3 The amended document shall have its revision status changed to the next
PREPARED BY APPROVED BY
Doc. SGR /FSMS / SOP 01
GMP MANUAL Issue Status 01
STANDARD OPERATING PROCEDURE Revision Status 00
Date 01-04-2012
CONTROL OF DOCUMENTS
Page 6 of 6

revision number. Effective date for implementation shall also to be noted.

4.2.7.3.4 The recipients of the amended documents shall hand over the
“OBSOLETE” documents to FSMS Team Leader.

4.2.7.3.5 FSMS Team Leader shall destroy all the obsolete copies except his/her
copy, and he/she shall file the same in a separate file after stamping the
document as “OBSOLETE” for future reference.

4.2.7.4 External Documents

4.2.7.4.1 FSMS Team Leader shall maintain the documents relevant to organization
activities, received from external organizations, agencies, and statutory and
regulatory requirements.

4.2.7.4.2 These external documents shall be made available to users through FSMS
Team Leader, whenever required and changes in these documents
whenever received shall be effected as required.

5 RECORDS

Format Number Name


Master List Of Documents & Revision
SGR/FSMS/TL F01
Status
Document Distribution List
SGR/FSMS/TL F02
Document Issue & Acknowledgement
SGR/FSMS/TL F03
Register
Document Change Requisition Note
SGR/FSMS/TL F04

6 REFERENCES

All the Documents of Food Safety Management System.

PREPARED BY APPROVED BY

Вам также может понравиться