Sunteți pe pagina 1din 4

SENSORY EVALUATION LABORATORY

FOOD AND NUTRITION RESEARCH INSTITUTE

STANDARD OPERATING
PROCEDURE MANUAL

SOP-4.3-2-0
Page 1 of 4
Revision No.: 0
Effectivity Date:

CREATION, REVISION AND APPROVAL OF


DOCUMENTS

1.0 Purpose
This document gives the general procedure for the creation, revision and approval of
documents.
2.0 Scope
This generally applies to all documents for internal and external use of FNRI-SEL.
3.0 References
PNS ISO/IEC 17025:2005, General requirements for the competence of testing and
calibration laboratories
4.0 Definition of Terms
Refer to *vocabulary section*
5.0 Responsibility
5.1 All personnel involved in SEL are entitled to file a request for creation and/or revision
of documents.
5.2 The Document Custodian is responsible for handling all requests, and keeping and
updating of created and revised documents.
5.3 The Document Review Committee and the Quality Manager are in charge of
reviewing and approving all creation and revision of documents, respectively.
5.4 The Laboratory Manager is responsible for authorizing the access and issue of
documents.
6.0 Procedure
6.1 Creation and Approval of Documents
6.1.1. A Request for Creation/ Revision of Documents form (F-SOP4.3-2-1-0) is
accomplished by the initiating person and submitted to the document
custodian.

_____________________________________________________________________________________
Copy No. : ________________________________

Document Type: _________________________

Reviewed by: ______________________________

Approved by: ___________________________

This document shall not be copied in whole or in part; if not stamped in red, this document is uncontrolled.

SOP-4.3-2-0
Page 2 of 4

FNRI-SEL
CREATION, REVISION AND
APPROVAL OF DOCUMENTS

Note: Request No. (Controlled by the document custodian) in FSOP4.3-2-1-0 is as follows:


00-0000
Year
Request series no. (01, 02 )
6.1.2. The request is consulted with the document review committee. If the
request is approved, a draft of the document is created by the person who
initiated the creation of the document.
Note:
a. Created instruction/ procedures manual should have the
following sections:
1.0 Purpose
2.0 Scope
3.0 References
4.0 Definition of Terms
5.0 Responsibility
6.0 Procedure
7.0 Related Documents
b. Created sensory evaluation procedures manual should have
the following sections:
1.0 Scope
2.0 Principle
3.0 Reference
4.0 Definition of Terms
5.0 Materials/ Reagents
6.0 Test Condition & Requirements
7.0 Procedure
8.0 Scoresheets
6.1.3. The draft is submitted to the document review committee for comments
and/or approval.
6.1.4. The draft is edited and finalized by incorporating the comments of the
document review committee.
6.1.5. The edited draft is returned either for further revisions or approval of the
committee.

__________________________________________________________________________________________
This document shall not be copied in whole or in part; if not stamped in red, this document is uncontrolled.

SOP-4.3-2-0
Page 3 of 4

FNRI-SEL
CREATION, REVISION AND
APPROVAL OF DOCUMENTS

6.1.6. If already approved, a document code and effectivity date is designated by


the document custodian.
6.1.7. A final document is produced and signed by a member of the document
review committee and the quality manager. The original copy is scanned to
retain an electronic copy in the master file. Access to this copy is
authorized by the laboratory manager.
6.1.8. Controlled copies issued to appropriate copyholders are sourced from the
electronic copy in the master file.
6.1.9. The new document is enrolled in the masterlist of documents (F-QM4.3-10) and in the document register (F-QM4.3-2-0).

6.2 Revision and Approval of Documents


6.2.1. A Request for Creation/ Revision of Documents form (F-SOP4.3-2-1-0) is
accomplished by the initiating person and submitted to the document
custodian.
6.2.2. If the revision requested does not require a technical review, the document
custodian can immediately endorse the request for approval of the quality
manager. Otherwise, the request is consulted with the document review
committee.
6.2.3. If the request is approved, a draft is created and submitted to the
committee for comments and/or approval.
6.2.4. The draft is edited and finalized by incorporating the comments of the
document review committee.
6.2.5. The edited draft is returned either for further revisions or approval of the
committee.
6.2.6. If already approved, the document code is updated and effectivity date is
designated by the document custodian.
6.2.7. A final document is produced and signed by a member of the document
review committee and the quality manager. The original copy is scanned

__________________________________________________________________________________________
This document shall not be copied in whole or in part; if not stamped in red, this document is uncontrolled.

SOP-4.3-2-0
Page 4 of 4

FNRI-SEL
CREATION, REVISION AND
APPROVAL OF DOCUMENTS

to retain an electronic copy in the master file. Access to this copy is


authorized by the laboratory manager.
6.2.8. Controlled copies issued to appropriate copyholders are sourced from the
electronic copy in the master file.
6.2.9. Copies of the document preceding the revision is collected and destroyed.
Electronic copy in the master file is transferred to obsolete file.
6.2.10. Revision made to the document is recorded in the master list of
documents (F-QM4.3-1-0) and in the document register (F-QM4.3-2-0).
7.0 Related Documents
7.1
7.2
7.3

F-QM4.3-1-0
F-QM-4.3-2-0
F-SOP4.3-2-1-0

Master List of Documents


Document Register
Request for Creation/ Revision of Documents

__________________________________________________________________________________________
This document shall not be copied in whole or in part; if not stamped in red, this document is uncontrolled.

S-ar putea să vă placă și