Revision date for SOP (Standard Operating Procedures)
- Thread starter mpfizer
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Re: Revision date for sop
Some kind of revision indicator must be on the document, but not necessarily the date. Is there something on the SOP that shows what version it is? It could be a number, letter, date, etc.
Some kind of revision indicator must be on the document, but not necessarily the date. Is there something on the SOP that shows what version it is? It could be a number, letter, date, etc.
Patricia Ravanello
Quite Involved in Discussions
Re: Revision date for sop
There has to be a periodic Management review of the Management System, including controlled documents such as the Standard Operating Procedures (SOPs). Controlled documents are typically controlled by means of a "Revision Number", or a "Revision Date", or both.
Example: SOP-0001 Internal Audit, Revision: 4, Revised: July 4, 2009
ISO 9000 requires:
The evidence that the review of the Management System (and its documentation) is usually demonstrated through the revision number and/or revision date (as well as in the records of the minutes of Management Review). Even if no changes are ever required, the revision number/date should appear on SOPs, and all controlled documents, and evidence of review must be maintained.
Patricia Ravanello
There has to be a periodic Management review of the Management System, including controlled documents such as the Standard Operating Procedures (SOPs). Controlled documents are typically controlled by means of a "Revision Number", or a "Revision Date", or both.
Example: SOP-0001 Internal Audit, Revision: 4, Revised: July 4, 2009
ISO 9000 requires:
5.6 Management Review
5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.
This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.
This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
The evidence that the review of the Management System (and its documentation) is usually demonstrated through the revision number and/or revision date (as well as in the records of the minutes of Management Review). Even if no changes are ever required, the revision number/date should appear on SOPs, and all controlled documents, and evidence of review must be maintained.
Patricia Ravanello
Re: Revision date for sop
Thanks for your reply we have everything as shown in your example but the auditor states that we should also have "next revision date"
we can only put a date after we revise.
but he insists that we should revise the document on a specific date even if there are no changes
Thanks for your reply we have everything as shown in your example but the auditor states that we should also have "next revision date"
we can only put a date after we revise.
but he insists that we should revise the document on a specific date even if there are no changes
B
brahmaiah
Re: Revision date for sop
V.J.Brahmaiah
You should tell the auditor to go back for a correct training.
V.J.Brahmaiah
M
machrk
Re: Revision date for sop
our docs show revision number and last revision date - we control the review and revision of documents through an access database - most docs are reviewed every 2 years with some done annually
some of my auditor team are of the view that all reviewed procedures must not only show revision number and revision date - but also review date
to have a mandatory update to docs just to show review date would lead to extra work - we have 8000 people on site and thousands of controlled docs - and we have to go on extra leave due to global financial crisis - I have been told to take 13 weeks over the next year
so we need to prevent any unnecessary work to avoid overload and mental stress
cheers
machrk
thanks to all for these responses
our docs show revision number and last revision date - we control the review and revision of documents through an access database - most docs are reviewed every 2 years with some done annually
some of my auditor team are of the view that all reviewed procedures must not only show revision number and revision date - but also review date
to have a mandatory update to docs just to show review date would lead to extra work - we have 8000 people on site and thousands of controlled docs - and we have to go on extra leave due to global financial crisis - I have been told to take 13 weeks over the next year
so we need to prevent any unnecessary work to avoid overload and mental stress
cheers
machrk
Patricia Ravanello
Quite Involved in Discussions
Re: Revision date for sop
Mpfizer:
There is no obligation to have the next revision date on the document, however, in your procedure covering the "Control of Documents and Records", you should state a minimum review period for your procedures...lets say, for example, "All Level 2 documents (SOPs) shall be reviewed once yearly". Then the "Revision Date" anniversary becomes the next review deadline, and you don't have to add another date to your documents.
That way, your documents basically expire after one year, and you've achieved what your auditor is looking for without adding more dates to your documents.
Patricia
Mpfizer:
There is no obligation to have the next revision date on the document, however, in your procedure covering the "Control of Documents and Records", you should state a minimum review period for your procedures...lets say, for example, "All Level 2 documents (SOPs) shall be reviewed once yearly". Then the "Revision Date" anniversary becomes the next review deadline, and you don't have to add another date to your documents.
That way, your documents basically expire after one year, and you've achieved what your auditor is looking for without adding more dates to your documents.
Patricia
Kales Veggie
People: The Vital Few
Please ask your auditor what clause in the standard you are not compliant with or can show you a sanctioned interpretation for "this requirement".
Auditors, based on their experience, might offer best practice suggestions, but can not make it a requirement when it is beyond the standard.
If it is a suggestions, politely say that you will take into consideration.
Always ask the auditor the "why" question.
D
db
I am going to disagree with a lot of what is being said here. I don't know of any requirements to review your documents. I know of no requirement stating that you have to have an expiration date, or a next revision date. I am not opposed to having documents with expiration dates, but we need to separate what is required from what is useful.
The closest to a requirement I can find is "b) to review and update as necessary..." [4.2.3]. The key words here are "as necessary". If a process changes, then you need to review the documentation to see how the change affects the document. This is not a requirement from the standard, but a necessity related thing.
If your auditor is telling you, you need a "next revision due" date, one of two things are in play. 1) the auditor is putting requirements where there are none, or 2) the auditor is seeing something in your system that indicates you may have process changes that are not reflected in your documentation, and the auditor feels you are not reviewing the documents in a necessary fashion.
The closest to a requirement I can find is "b) to review and update as necessary..." [4.2.3]. The key words here are "as necessary". If a process changes, then you need to review the documentation to see how the change affects the document. This is not a requirement from the standard, but a necessity related thing.
If your auditor is telling you, you need a "next revision due" date, one of two things are in play. 1) the auditor is putting requirements where there are none, or 2) the auditor is seeing something in your system that indicates you may have process changes that are not reflected in your documentation, and the auditor feels you are not reviewing the documents in a necessary fashion.
Patricia Ravanello
Quite Involved in Discussions
Earlier in this thread, I attached the following:
5.6 Management Review
5.6.1 General
5.6.1 General
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.
This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives
.This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives
The Standard doesn't spell out everything...i.e. revision/expiration date. How you achieve this requirement (5.6.1) and convince your auditor that you're doing it is up to you.
Patricia
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