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tnngwira

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Posted 28 March 2017 - 02:23 PM

I have been writing documentation for ISO 22000 certification for our winery (Linga Winery in Malawi) and have not not found an example of how to write the two documents above Are there  any guidelines that I can follow sincce I am knew to ISO 22000?



Tracey Richardson

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Posted 03 April 2017 - 06:09 PM

Here is what I have:

 

Document Control 1.     Purpose

The purpose of this procedure is to provide guidance in establishing responsibilities and procedures for preparing, revising and controlling quality related documents. The initial release, distribution, and control of quality related documents and changes thereto shall be through a formal documented process, which allows for traceability of the documents.  Documents are controlled to ensure that the current revision is always used.

 

2.     Scope

This guide is applicable to quality related documents such as procedures, instructions and forms that prescribe manufacturing operations and processes; inspection and test procedures; operating and maintenance procedures; monitoring procedures.

 

3.     References and Applicable Requirements 3.1.  Document Template TMP001 3.2.  Quality System Document Creation Process FC005 3.3.  Quality System Document Change Process FC006 4.     Document Control Procedure

Only authorized staff can make changes to existing documents

·       where to find the documents

·       handling of obsolete documents

·       responsibility for reviewing and keeping them current

·       record retention policy

o   where completed records are stored

o   how long completed records are stored

 

4.1.   Document Preparation, Review, Approval and Distribution

The information for document control is entered as a footer within the document, will be on each page and will include the following elements. This will include:

·       Document title

·       Identification number

·       Revision number

·       Page X of Y

·       The following disclaimer “© XXX Inc. All rights reserved. This document contains XXX Inc. confidential and/or proprietary information belonging to XXX Inc. and/or its related affiliates which may not be reproduced or transmitted in any form or by any means without the express written consent of XXX Inc.”

Once a new document has been reviewed and approved, it is the responsibility of the document creator to publish the document within 5 working days of document approval.

4.2.   Document Labeling, Storage, and Handling 4.2.1.      Quality documents are classified in the following categories:

a)     Standard Operating Procedures (SOP)

b)     Work Instructions (WI)

c)     Forms (FM)

d)     Flow Charts (FC)

e)     Guidelines (GL)

f)      Template (TMP)

g)     Lists (LST)

h)     Training (TNG)

i)       HACCP Prerequisite (PREREQ)

4.2.2.      For each category, the Document ID will start with the acronym of the document category followed by a 3-digit number. Numbers will start at 001 and go up. 4.2.3.      All electronic forms will be controlled by software versioning. 4.2.4.      All documents are initially released at the “0” revision level and go up by one number for released revisions. 4.2.5.      Documents will be stored in the GMP-SOP folder in the XXX. 4.2.6.      A Master List will list all of the current SOP’s, work instructions, forms, etc., with links to those documents will be retrained on the XXX. This list will contain the document identification number, title and current revision number. (Add Link) 4.2.7.      A Master Binder of Forms will be available in the Quality office for occasions that the electronic devices may fail and records can still be obtained. Copies of the forms can be made only from this binder. The forms will remain current and updated by the Quality Specialist. 4.2.8.      Revisions will be controlled in a sheet within the Master List called a Log of Changes. It will include:

·       the name of the document

·       details of the change

·       who made the change

·       date of the change

·       the document control information for the revised document (the new current version)

·       the name/signature of who authorized the change 

·       assurance that employees affected by the change were retrained

4.2.9.      Log entries will be made at the time of the change and not delayed. 4.2.10.   It will not be necessary to track changes to formatting or when correcting typos. 4.3.   Document Changes 4.3.1.      Quality Systems Documentation is reviewed at minimum on a yearly basis to ensure that policies remain relevant and current. 4.3.2.      Recommendations to change the Quality Systems Documentation may be established during a XXX Internal Audit. These changes will be itemized in a XXX Internal Audit Finding. 4.3.3.      Any individual recognizing the need for a change or revision to a quality related document shall request the change through email. The revision request will be reviewed and discussed with upper management. 4.3.4.      If the preparer of the original document and approver(s) agree with the proposed change the preparer of the original document shall revise and update the revision status of the document and present it to the approver(s) for formal review and approval. 4.3.5.      The person(s) who approved the original document shall review the revision and if they agree, sign and date the revised document. 4.3.6.      After the revision has been approved, the Quality Specialist will update the Master List and the revision log. If the change involves a new form, the Master Binder will be updated. 4.3.7.      After publishing the document, there is no access to obsolete revisions, to prevent confusion. 4.3.8.      The training presentation will be review by the Quality Specialist and changes will be made as necessary. 4.3.9.      If either the preparer of the original document or the approver(s) does not agree with the request for change, objections or concerns shall be discussed with the person who requested the change and attempts shall be made to resolve the differences. If the differences cannot be resolved at that level, they should be taken to successively higher levels of management until they are resolved. 4.4.   Record Retention

All quality related documents/records shall be maintained for a period of 5 years.

4.5.   Record Disposal

All quality related documents shall only be disposed with the approval of the Quality Specialist.

 

 

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Note:  3rd party documents cannot be controlled. They are not yours. I would suggest to set up a page with internet links. That page can be controlled, but not the actual third party documents.



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