4.2.2 Control of documents - Evidence of document review

ISO 22000 says

4.2.2 Control of documents
b) to review and update documents as necessary, and re-approve documents,

Is it a requirement to have an objective evidence of the review activity (e.g. signature of a reviewer in the footer of document etc)? We show the "prepared by" and "approved by" of documents by signature. I don’t think it’s practical to revise bunch of documents to add "reviewed by".

What would you advice?

You can get an electronic signature or place the names of the person as long as it is stated in the manual that all documents are reviwed by XXXXX before being implemented.

Regards

Ajay

I don't think that's what it means. I read it as a review will take place if the contents need to change (e.g. because of audit or incident) but also there should be a formal 'review' which you should document (I used to do yearly) and record that even if the contents haven't changed, the procedure, policy has been reviewed to confirm suitability. You could add this to your document control document or it is something qpulse is excellent at recording.

You can get an electronic signature or place the names of the person as long as it is stated in the manual that all documents are reviwed by XXXXX before being implemented.

Regards

Ajay

You are right Dr Ajay. Signing something can be a method of approval but it isn't the only method. But do we need to revised all the documents to add "reviewed by"? According to ISO 22000 4.4.2 Review and re-approve is required after a document has been changed.

I don't think that's what it means. I read it as a review will take place if the contents need to change (e.g. because of audit or incident) but also there should be a formal 'review' which you should document (I used to do yearly) and record that even if the contents haven't changed, the procedure, policy has been reviewed to confirm suitability. You could add this to your document control document or it is something qpulse is excellent at recording.

Just hitting the bolded part.

Ok, it should be spelled out in Control of Documents Procedure. How about other documents other than Control of Documents Procedure? I mean other procedures, instructions, SOPs, etc? Do I need to revise them to include "reviewed by"?

Just hitting the bolded part.

Ok, it should be spelled out in Control of Documents Procedure. How about other documents other than Control of Documents Procedure? I mean other procedures, instructions, SOPs, etc? Do I need to revise them to include "reviewed by"?

You misunderstand me. Yes it should be in that procedure but what I was saying was presumably you have a list of current documents with the issue number and date? Could you add a review date and reviewed by column to this to prove a document has been reviewed? Electronic signatures would be ideal but if you can't do that you could keep one copy of the document in a file signed and dated by the reviewer when it's reviewed. That way you don't have to change all your documents (and hence revision numbers) every time they're reviewed if there are no changes.

You misunderstand me. Yes it should be in that procedure but what I was saying was presumably you have a list of current documents with the issue number and date? Could you add a review date and reviewed by column to this to prove a document has been reviewed? Electronic signatures would be ideal but if you can't do that you could keep one copy of the document in a file signed and dated by the reviewer when it's reviewed. That way you don't have to change all your documents (and hence revision numbers) every time they're reviewed if there are no changes.

While you were talking about the "list" of current documents with the revision number and effective date, perhaps I was talking about the "actual" documents. I am sorry to cause confusion on this. Maybe my question was not clear and I need to elaborate a little bit more.

4.2.2 Control of documents says
a) to approve documents for adequacy prior to issue,
b) to review and update documents as necessary, and re-approve documents,

From the above statement, perhaps the process of first/initial approval doesn’t call for a review but for adequacy. Let say we released the document:

(Header)
Rev. 0
Effective date 01-30-2011


(Footer)
Prepared by: Approved by:

xxxxxxxx xxxxxxx

Said document was implemented by the process owner from the document took its effect, 01-30-2011, and being implemented until a need for review comes up. Let me show the “proposed footer” followed by my question:

(proposed footer)
Prepared by: Reviewed by: Approved by:

Xxxxx xxxxxxx xxxxxx

Now, my questions are:

1) Do I need to add "reviewed by" to show that the document is still valid and fit for the purpose?
2) Do I need to revise all existing documents and add "reviewed by" in the actual documents?

As I said before, I think not as IMO (although others disagree) any change to a document means you need another issue number and issue date as otherwise you are saying it's ok to carry on using a document without the "reviewed by" bit on it and that will tie you in knots when you come to audit. My suggestion was much simpler and required less work IMO.