Risk Assessment for Line Clearance


(Tapan Gajjar) #1

In my pharma company, as a current practise we are mentioning end time of line clearance in Line Clearance Checklist.
But we can not find out how much time taken by supervisor for performing Line Clearance activity.
Now we will going to implement Electronic Batch Record, so in Electronic Batch Record, any supervisor will done the Line Clearance activity in 1 Minute. Just he will login and do only tick mark on every check point of line clearance and done the Electronic Signature. So Any Auditor can easily find out that this supervisor take only 1 min for line clearance, make a question.
So Can any1 send me this type of Risk Assessment format for Line Clearance Actual time?


(Ankur Choudhary) #2

Same is also done in paper batch record. Supervoser tick mark the checkpoints there also. I am unable to understand the difference and the point you want to make.


(Tapan Gajjar) #3

In paper batch record supervisor mention only END TIME of line clearance. He not mention the START TIME of line clearance activity. So on paper batch record we can not find out how much time taken by supervisor for line clearance.
But when u are going to ELECTRONIC batch record, in that when supervisor start the line clearance activity, he will Log in (log in Time will come in Audit trial report) with his username & password. Then after completing line clearance activity, he will put his ELECTRONIC sign (time & date comes in audit trial report).
So my point is that any1 can do just log in and put tick mark in electronic batch record and just do e-sign and finished his line clearance activity within 1 min also. So it will make a Auditor question, in 1 min how line clearance is possible?

Sir i am waiting for your valuable reply…


(Ankur Choudhary) #4

In this case, you can log in to the system to mention the start time and after that do check the line clearance physically. After completion of line clearance physically come to the system again and tick mark the checkpoints and sign electronically to put end time.
hope this helps


(Tapan Gajjar) #5

Yes sir, now my point is that Can we can put a control on system that if any1 log in for start the line clearance activity then after 10 or 15 min system will allow him for the e-sign for completing the line clearance activity?
Before 10 or 15 min he can not complete the line clearance activity…
Can we put this type of control?


(Ankur Choudhary) #6

@Tapanpgajjar this depends upon the software you are using. Contact your software vendor for the same.


(Manoj Singh) #7

If you set the time 10 minute in software and actual time taken for line clearance is 8 minute then you will be fail in data integrity.


(Tapan Gajjar) #8

Manoj sir, thats why i am discussing this point, we cant fix any time like 10 min, 15min etc. Because there is no any base on which we can fix minimum time req for line clearance like 10 min or 15 min.
But can any1 share me the risk assessment of this actual time req for line clearance?
I just want risk assessment for this.


(Sajjad Ahmad) #9

for this prepare a SOP for line clearance including procedure for line clearance and time designated for line clearance.Mention Time range e.g 5_10 min ot 2_5 min etc acc to your procedute.and at the time of audit if any one ask about time then refr SOP.