Revision of SOP and addition of new format

(Ravi) #1

If i have one SOP with revision no. 03 (for eg. SOP No. QAD-002/03) for document control and in this SOP their is only one format (No. - QAD-002/F01/03).
Now the question is that , if a external audit is conducted and advised to add a new format for any particular procedure which is not already in the SOP then what format no. i have to mention on that one new format, and second thing is that, if a new format is added in any SOP then the SOP revision no. will extend to next or not. Suggest me that either newly added format no. will have the same revision no. as like format no. 01 or it will start from 00 (either QAD-002/F02/03 or QAD-002/F01/00 or anyone else).
My SOP for SOP does not have any procedure to mention the format no. in the condition mentioned above.

(Dr. Ahmed Mohamed Awad) #2

you will have a new version after adding the additional form
i.e. revision no. 04
i.e Form No. QAD-002/F02/03

(Hemalatha) #3

Version of the SOP will be changed while the format will be 00. Sop version will be 4.

(Meenakshi Gupta) #4

Only revision no of sop shall be changed.newly introduced format shall be having version no.00

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(Ravi) #5

Much thanks to all experts.

(Pragnesh) #6
  1. You need to mention the numbering procedure of the Format No. for the supporting Annexure.
  2. Add the clause like,
    a. During the revision of the SOP if changes are only limited to the procedure and do not have any impact on the procedure in that case SOP is required to revise but not necessary to change the version number of the format.
    b. In the case of the new introduction of the Format and not required the existing Format than Existing Format number should be obsolete and New Format should be given from F02.
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