Implementation of SOPs

GOOD MANUFACTURING PRACTICE (cGMP) QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000
1

in my ISO quality system, I want to revise all the instructions & procedure given for ISO and make SOPs.

So can I prepare SOP with new format and make it as First version (initial version), and similarly follow it for all departments. Will it in anyway have impact on ISO reaudits.

Your suggestion will be valuable.

2

I would not advise this, the change must be detailed in the revision history of the previous revision as you need to show traceability to previous approved versions.

In the revsion history of the SOP detail all the changes you are making to the structure of the document.

3

So…we do have to mention in new format of SOP details of …

  1. Previous Revision No.
  2. The changes made in previous SOP

But if the SOP Numbering system and Revision numbering system changes then what is the solution ?

Eg. Revision No. (Previously) : 01
Version No. ( Currently) : X0.

Thanks,
Sharmi Shah.

4

Graham is completely right that the audit trail from version to version must remain intact.

We recently did somethings similar when we changed all our document numbering system and we used a field for a legacy document number to retain the traceability.

So for example:

Our change control procedure used to be called SOP/QBD/038 and was at issue 8.

It is now called 1003120 and is issue 1.

The new document (1003120) makes reference to the previous version so the audit trail can be followed.

I hope that helps!

Cat

5

What is the difference between version and Revision ?
The version is applicabe for the Higher level documetation system, Revision is the something which is given for the Level 3 and Level 4 documents.
We need to clarify this thing at first.
e.g.

your SOP may have the Version :01
and Revision 02

i.e. you have the documentation ystem having version 01
and that pertucular SOP has the revision 01.
If you are doing moduification in the SOP you will have

Version :01
and Revision 03

Now,

If you changing the whole system of the numbering or major change in the documetation system which have impact on the total SOP’s and Formats etc
then you will have to revise the version of the documentation system
Hence you will have

Version :02
Revision : 01 or 00 ( first document) as applicable in your system.

Hence the revisions will start from first and will change the version.

You have to put both the version number and revision number on the SOP.
I think this will help.

Comments in the subject will be appreciated.

Anil

6

Hi,

Thanks very much for this comment. It help me to think about my ideals.

Tks again and pls keep posting.