In our company documents are maintained separately, i.e ., formats separately , SOP’s or WIN’s separately… The formats will be cross referred to that particular SOP or WIN.
Suppose if a process or any stage requires addition of format apart from the existing format how it will be or can be done ??
We follow the addition of formats as F1,F2… retaining the same format number(i.e., Dept Code & Format No. e.g., PR 01) . My doubt is, in case if one more format is included (F2) to the already existing (F1) format w.r.t processing stage , what will be the status of revision number & effective date of the newly included format.
Does this will not create any confusion during document traceability or updation, since two different revision number & effective date of the format exists for the same format number.
I think in your case since your SOP number comes with Format numbering too like F1,F2 … the best solution is you can add R1,R2.
You can write F1/R1
F1/R2
F2/R1
F2/R2
Where R1 ,R2 stands for revisions.This has to be written properly in your primary SOP that is SOP number system.Where every revision R1,R2,R3 have an alphabet R and a suffix number like 1,2 …ETC.
Basic GMP : To avoid confusions use always unique no. system & ofcourse one can not eliminate the possibility of superseded document concept. Utilize the revision no. philosophy as well.
Basic GMP : To avoid confusions use always unique no. system & ofcourse one can not eliminate the possibility of superseded document concept. Utilize the revision no. philosophy as well.
Happy Reading ![/quote]
we make changes to the documents when ever required.
then why documents are reviewed periodically ?
Changes in Philosophy
Changes in System
New Staff appointment
Training and Understand ability
Failure of a particular process
SOPs should also be in line in place.
The above factors make or force or periodically review SOPs or any Documents that are live and applicable to the system.