Simple Sample – WinCC Unified Audit Basis - GMP (Good Manufacturing Practice).

Hi,

As from WinCC Unified V17 it is possible to use GMP (Good Manufacturing Practice) to register sensible operations production changes. It is the special interest to the pharmaceuticals industry, the food and beverage industry.

It is possible to record data from three situations:

• By user action: Value of relevant tag was changed by user, for example, in a slider or IO Field. The system record the change automatically for all predefined relevant tags.
• By system functions (“InsertElectronicecord”): for example, linked to buttons events.
• By script: records could be created by scripts, e.g. linked at objects change events.

There is also three type of entries

• Without Acknowledgment: record are created without user interaction
• With Acknowledgment: user should acknowledge the event
• With Acknowledgment: user should acknowledge the event and should give a comment (manual input or selected form predefined text list)

A detailed information about GMP could be get in the TIA Information system (show help) under “Visualizing process (RT Unified)”, “Options (RT Unified)”, “WinCC Audit (RT Unified)”

Configuration steps:

1. Add Audit trail system certificate
   1. Open WinCC Unified Certificate Manager (e.g. in "C:\Program Files\Siemens\Automation\WinCCUnified\WebConfigurator\WinCC_CertManager.exe").
   2. Click on “Create new certificate authority…” (if it has not yet been created), fill in the data, in particular the validity of the certificate and the password and click in create.
   3. Select the root text, right mouse click and select “Add device…” (if it has not yet been created), fill in the fill in the PC name and IP address.
   4. Select the Device, right mouse click, “Add Audit Trail system certificate…”, fill the data, in special the validity.
2. In the project:
   1. If the operator has to justify the production changes he makes, it will be necessary to create a text list listing the possible causes for this: WinCC Unified project tree, Text and graphic list, Text list tab, add new, choose a selection that match with the case (e.g. Bit number (0-31)), Text list window division: give the entries for each cause.
   2. WinCC Unified project tree, “Runtime settings”, Good Manufacturing Practice, check the checkbox “configuration conform to GMP”, set the created text list on “Reasons for GMP-relevante tags:”. An Audit log file will be defined automatically. E.g. the default values are OK, for a fist test, but you can check the settings o “project tree, WinCC Unified application, logs, tab “Audit trails”.
3. In the HMI Tags
   1. For each Tag GMP relevant: Select the tag, properties, “Good Manufacturing Practice”, select “GMP Relevant”. If the user should give some confirmation about the change, change the default value “none” to “Acknowledge”. If a comment is required for the changes, select the checkbox “Comment required”.

TIPs:

• Change the scripts that use Audit functions from synchronous to asynchronous in the script open menu (click on synchronous text), else the script will show error in await instruction.
• E.g. the Audit logs can be observed by the report system but it could be also easily exported with the scripting, in special with the Snippets – HMI Runtime – Audit Trail – Export electronic records as CSV or Snippets – HMI Runtime – Audit Trail – Read Electronic records (to trace them the WinCC Unified Trace viewer). The scripts should be adapted in start and end date and the file name / path (optionally the CSV header / trace comments could also be adapted). You can set start dates in the past and end dates far into the future (20 years from now, for example) to export the entire database
• There is a specific source (Audit) for selection of the WinCC Unified Reporting sources. If something was manipulated (cyber-attack, for example) in the Audit data, the report will show it in colors both in header as in body.
• For each tag changes there will be two entries in the Audit data: first row describe “the intention” and the second row the “system reaction” (e.g. accepting the change).

Sample project

Hi,

Generally, you can see the logs on report system, and it will show the check the integrity results.

I don’t know any official reference that it runs with Audit viewer (I supposed that it will not run).

The data base could be exported as csv, but I don’t know any instruction that export as database directly.