ISO 22000 FSMS Policies, Procedures, and Forms Bizmanualz.

com

Document #: Title: Print Date:

FS1000 DOCUMENT CONTROL 2/1/2006
Rev #: Prepared By: Date Prepared:
0.0 2/1/2006
Effective Date: Reviewed By: Date Reviewed:
11/18/2005 2/1/2006
Approved By: Date Approved:
2/1/2006
Standard: ISO 22000:2005, clause 4.2.2

Policy: To control Food Safety Management System documents, ensuring that

everyone responsible for food safety is working according to the same set
of procedures and guidelines.
Purpose: To define the methods and responsibilities for controlling documents used
to provide work direction or set policy; and to define methods for
document revision, approval, and distribution.
Scope: This procedure applies to all documents required by the Food Safety
Management System. Documents of internal or external origin are
included.

Responsibilities:
Document Control is responsible for controlling the Food Safety
Management System Manual, all procedures and instructions related to
the Food Safety Management System, and all external documents that
are required by the Company’s FSMS.
Department Managers and supervisors are responsible for ensuring the
relevant versions of documents are available at the points of use and that
they are legible. They may also be responsible for reviewing and
responding to change requests in a timely manner.
Engineering is responsible for control of drawings (external and internal)
and bills of material.
The Food Safety Team is responsible for reviewing all procedures and
instructions at least annually to ensure documents remain current.
The Food Safety Team Leader is responsible for reviewing requests to
change FSMS-related procedures and work instructions and directing the
Food Safety Team through such reviews.

Definitions: Controlled Document – Document that provides information or direction

for performance of work within the scope of a given procedure.
Characteristics of control include such things as revision number (letter),
signatures indicating review and approval, and controlled distribution.

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Document - Information and its supporting medium. The medium may be

paper, magnetic, electronic, optical computer disc, photograph, or sample.
External Document – Document originating outside the Company (e.g.,
customer drawings, industry and/or international standards, vendors'
equipment maintenance manuals) that provides information or direction
for the performance of activities within the scope of the Food Safety
Management System.
Food Safety Management System (FSMS) – Ordered, well-documented
system designed to result in safe food.
Internal Document – Document of internal origin (developed entirely by
or completed by the Company) that provides information or direction for
the performance of activities within the scope of the Food Safety
Management System. Examples include, but are not limited to, the
procedures contained in this FSMS manual.
Uncontrolled Document – Document removed from, or never a part of, the
controlled document system. Uncontrolled documents may not be used to
provide work direction or information necessary for the performance of
work. Uncontrolled copies of documents may be used as training aids.
Procedure:

1.0 PROCEDURE AND WORK INSTRUCTION FORMAT

1.1 Procedures and instruction should use this document as a template.
1.2 If any of the headings are not applicable they may be deleted.
1.3 All procedures and instructions must have the Procedure Name, Revision and
Page Number in Page X of Y format on each page of the document.
1.4 All procedures and instructions must show approval signatures on the first page or
cover page. Electronic versions may show the approving parties' names typed but
in any case, Document Control shall keep a signed paper "master" copy of each
document.
1.5 Electronic files shall be named using the document number, the title, and the
revision (e.g., “FS1000 – Document Control – rev 0.2”)

2.0 TEMPORARY CHANGES TO DOCUMENTS

2.1 For many reasons, temporary changes to the Food Safety Management System
may be needed. Temporary changes must be defined and controlled.
2.2 Temporary changes shall be brought to the attention of affected Department
Management.
2.3 If a document (e.g., for a procedure) does not exist, Department Management may
develop a temporary document, which must bear the Manager's name, title, and
current date. If an existing document (e.g., procedure) needs changes,
Department Management shall red-line, initial, and date the changes on the

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existing document. Whether the document in question is new or altered, it must

be legible and identifiable.
2.4 Department Management shall submit changes to the Food Safety Team Leader,
who shall review, initial, and date the changed document.
2.5 If temporary changes bypass any part of the HACCP Plan, the changes require the
approval of Top Management, who shall also review, initial, and date the
document.
2.6 Temporary change documents must include the range of dates in which the
changes are valid and the scope of applicability. Temporary documents may not
be used for more than two weeks without being made permanent.

3.0 DOCUMENT REVISION

3.1 The Food Safety Team Leader is responsible for coordinating with Department
Managers to review all procedures and instructions at least annually and update
them, as required, to ensure documents remain current.
3.2 Anyone may submit a new document or changes to an existing document, as
necessary. To submit a change, the requestor shall print a copy of the document
and mark ("redline") the requested changes on the copy. If changes are extensive,
a new document may be typed and submitted with a copy of the original. The
requestor shall clearly identify, initial, and date all such changes.
3.3 The requestor shall submit changes to his/her Department Manager for review.
The Department Manager, after reviewing the requested change(s), shall complete
a FS1000-1 – REQUEST FOR DOCUMENT CHANGE (RDC), indicating the
nature and reason for the change. He/she shall submit the FS1000-1 with the
changed document to the Food Safety Team Leader for review.
3.4 The Food Safety Team Leader shall review the change request to ensure ISO
22000 compliance.
 If the request for change is not in compliance with the standard, the Food
Safety Team Leader shall notify the requestor of the reason for the denial and
explain the changes needed to bring the request into compliance.
 If the request is ISO 22000 compliant, the Food Safety Team Leader shall
determine who else needs to review the change and submit the change and the
FS1000-1 form to those individuals (the document review team) for their
review.
3.4 The document reviewers shall consider the change and the reason for it and
determine if the change is warranted.
 If the document review team approves the requested changes, the Food Safety
Team Leader shall assign a Document Change Number (DCN) on FS1000-2 –
DOCUMENT CHANGE CONTROL and submit the new or changed
documents, with the appropriate approvals and the FS1000-1 form, to
Document Control for typing and formatting. Document Control shall update

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the document, index the revision, update the document status on FS1000-2,
and update the revision history on the document.
3.5 Document Control shall notify the document review team via e-mail when the
revised document is available for a “final” review. Reviewers shall indicate
intended approval or submit comments via e-mail. If comments are substantive,
Document Control shall incorporate the comments and contact the document
review team for another review.
3.6 When all document review team members indicate their intent to approve,
Document Control shall circulate the final document(s) to obtain signatures.
When the required signatures have been obtained, Document Control shall update
FS1000-2 with the new revision number and revision date for changed
documents, or with all required information for new documents.
3.7 Document Control shall make sufficient copies for distribution to all locations
indicated on FS1000-3 – DOCUMENT CONTROL DATABASE. Document
Control shall stamp “Controlled Copy” in red on each paper copy before
distributing.
 Document Control shall pull the master copy of the previous revision, mark it
“Obsolete”, and file it in the historical files (archives).
 Because the electronic version will not show signatures, the current Master
Copy is maintained as evidence of review and approval.

4.0 DOCUMENT DISTRIBUTION

4.1 Flow diagrams, engineering drawings, and other technical documents are
distributed by the responsible department, either electronically or via hard copy.
Obsolete drawings and other technical documents are to be returned to the
responsible department when revisions are distributed.
4.2 Document Control shall maintain a database of all controlled documents (FS1000-
3 – DOCUMENT CONTROL DATABASE). Documents of internal origin and
external origin (e.g., customer drawings, national or international standards that
may be used or referenced) shall be maintained in separate lists or databases.
The document control database should contain, at a minimum, the following
information on each document:
 Document Number;
 Document Title;
 Current Revision number or ID;
 Revision Date;
 Responsible Department; and
 Document Location

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4.3 Document Control shall distribute hardcopy documents only to the locations
shown on the database and shall remove and destroy any previous versions of
procedures or work instructions.
 Document Control shall distribute electronic versions of documents by
moving old revisions to the OBSOLETE folder, moving the new revisions to
the RELEASED folder, and notifying affected parties in a timely manner.
 All electronic documents moved to the OBSOLETE folder shall be
assigned expiration dates. When a document’s expiration date is reached, it
shall be permanently removed from electronic storage.
4.4 External documents are controlled only for distribution. All external standards
should be purchased through Document Control, to ensure they are added to the
External Document list and are properly controlled and distributed.

5.0 DOCUMENT CONTROL PROCESS REVIEW

The Food Safety Team Leader shall review the document control process on a
regular basis (annually, at a minimum) with Document Control, to ensure that all
food-safety-related documents are being controlled effectively and that the
process continues to meet Company, statutory/regulatory, and standards-based
requirements.
Effectiveness Criteria:
 No obsolete documents in use
 Average time to release document changes
References:
A. Food Safety Manual
 FSM 4.2.2 – Control of Documents
Records:
 Signed master copies of documents.
 FS1000-1 – REQUEST FOR DOCUMENT CHANGE (RDC)
 FS1000-2 – DOCUMENT CHANGE CONTROL
 FS1000-3 – DOCUMENT CONTROL DATABASE

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Revision History:

Revision Date Description of changes Requested By

0.0 2/1/2006 Initial Release

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FS1000-1 – REQUEST FOR DOCUMENT CHANGE (RDC)

Date: RDC No.:

Originator:
Document title and publication date:
Page / chapter / paragraph number:
Description of problem, opportunity or reason for request (define in detail):

Solution recommended (if known) date action required by:

Comments:

Department manager approval:

Recommended solution to problem or postponement/dissolution of request
(attach all necessary documentation to support response)

Approved By: Date:

PROCEDURE FOR COMPLETING FORM
1) Complete top section of this form except for RDC number
2) Obtain Department Manager's approval
3) Forward original to the Food Safety Team Leader who will assign RDC number (Note: one
copy will be returned to originator with RDC number assigned. If the related process owner is
not the originator, the request will be forwarded to the process owner for action.
4) The process owner will take action and if appropriate will proceed with an RDC.
5) The Food Safety Team Leader returns a copy to Originator upon resolution of request.
Distribution: Original - RDC File Copy 1 - Originator

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FS1000-2 – DOCUMENT CHANGE CONTROL

Date:
DCN#:
RDC#:

PART I

Doc. or Description of Change, Documents Action Effective

Part No. affected and reason(s) for change(s) Code(s) Date

Change Action Required

Make/Order New Document:

Current Docs:  Use until depleted  Return for credit  Scrap  Save for
spares

Rework Docs:  In stock  In process  Finished goods

Service Repair:  Reference only  Field doc change  Notify customer
Other:
Comments:

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PART II

To assure an orderly, controlled and complete implementation of a change to all aspects

of related documentation, the following checklist should be completed along with
appropriate revisions and updating of all copies of documents. Attach additional paper
for instructions or comments if necessary.

Affected Date
Document Item Yes/No Description Assigned To Finished

Engineering/Manufacturing
Specifications Sheet  
Bill of Materials  
Manufacturing Procedures
(Preparation Manuals)  
Testing Procedures  
Inspection / QC Procedures  
Procurement Documentation  
Labeling  
Packaging  
Service Manuals  
Drawings  
 
 

Sales/Marketing
Product Literature  
Price Catalog  
 
 

Regulatory Compliance
FDA  
Government Contracts  
 
 

Authorization(s): Engineering Authorization(s): Food Safety

By: By:
Title: Title:
Date: Date:

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FS1000-3 – DOCUMENT CONTROL DATABASE

Document Rev Rev Responsible Document

Document Title
Number Num Date Department Location
FS1000 Document Control 0.0 12/30/05 Document Control Document
server
FS1010 Food Safety Records 0.0 12/30/05 Food Safety Document
server
FS1020 Management Responsibility 0.0 12/30/05 Management Team Document
server
FS1030 Competence, Awareness and 0.0 12/30/05 Human Resources Document
Training server
FS1040 Job Descriptions 0.0 12/30/05 Human Resources Document
server
FS1050 Prerequisite Programs 0.0 12/30/05 Food Safety Document
server
FS1060 Hazard Analysis Preparation 0.0 12/30/05 Food Safety Document
server
FS1070 Hazard Analysis 0.0 12/30/05 Food Safety Document
server
FS1080 HACCP Plan Management 0.0 12/30/05 Food Safety Document
server
FS1090 Purchasing 0.0 12/30/05 Purchasing Document
server
FS1100 Supplier Evaluation 0.0 12/30/05 Purchasing Document
server
FS1110 Receiving and Inspection 0.0 12/30/05 Manufacturing Document
server
FS1120 Manufacturing 0.0 12/30/05 Manufacturing Document

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Document Rev Rev Responsible Document

Document Title
Number Num Date Department Location
server
FS1130 Identification, Labeling, and 0.0 12/30/05 Manufacturing Document
Traceability server
FS1140 Control of Monitoring and 0.0 12/30/05 Quality Assurance Document
Measuring server
FS1150 Control of Nonconforming Product 0.0 12/30/05 Quality Assurance Document
server
FS1160 Internal Audit and System 0.0 12/30/05 Food Safety Document
Validation server
FS1170 Corrective Action 0.2 12/30/05 Food Safety Document
server
FS1180 Continuous Improvement 0.0 12/30/05 Food Safety Document
server
FS1190 Product Recall 0.0 12/30/05 Food Safety Document
server
FS1200 Emergency Preparedness and 0.0 12/30/05 Food Safety Document
Response server
FSMS 100 Food Safety Manual 0.0 12/30/05 Food Safety Document
server

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