(SOP) Process Audit in SAP

[Former Member]

Hi

I need some valuable inputs on a query. Our client is a leading Pharmaceutical. They used to audit their own process to see whether it is being followed as per SOP or not. They want to bring the audit process in SAP.

can someone advise how that can be done?

thx

CR

[Martin_H · Accepted solution]

Hi Cristina,

Your question is not fully clear:

1. Do you want to check if the processes you have implemented in SAP run "as designed" or
2. do you want to implement the auditing process (and the whole audit management topic) itself in SAP?

For 1, you would have to look on analysis tools that check the SAP system for log data in order to analyze process deviations. SAP Process Observer or a wide range of 3rd party tools are available for this topic.

For 2 you can check SAP help on the implementation of the SAP Audit Management module.

Regards
MH

[Former Member · Accepted solution]

Martin,

for example, we have a SOP saying that we have to calibrate our weighing scales every month due to its sensitivity in pharmaceutical companies. 

Our client used to do a process audit separately to follow whether SOP is being followed or not. infect for each SOP they have to make an audit procedure to ensure the SOP is being followed properly. Process audit is being done frequenctly and later the do not get any non conformance then they reduce the frequency of audit and severity.

Our client is looking to incorporate this process audit process in SAP. now how can we do it?

CR

[Martin_H · Accepted solution]

Hello Cristina,

in this case you should indeed take a look at the SAP Audit Management module. You might implement the process audits as part of their audit program.

If they also use SAP to document their calibration results then you can reference from the audit management to the calibration results. If they do not, you might also consider on implementing the calibration management process in SAP.

Regards

MH

[Former Member · Accepted solution]

Hi CR, To record all detail you have to implement audit management process in your system. In audit management initially you have to maintain certain questions in system then after testing you have to enter result. Then valuate this result for audit test result. below link may be helpful to you for configuring the audit management. http://www.sdn.sap.com/irj/scn/go/portal/prtroot/docs/library/uuid/10a2e951-0106-2e10-3faa-a2a905590...

[Former Member · Accepted solution]

the link is useful, I am looking into it, but meanwhile i will keep this thread open for more ideas/solutions.

thx

CR

[Former Member · Accepted solution]

Martin its not just calibration. it could be related to safety procedure, quality SOP or any  SOP which audit department wants to audit and record results.