Optical Archiving of Batch Records (PP-PI)

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SOURCE: http://help.sap.com/erp2005_ehp_07/helpdata/en/d7/e22576408e11d1896b0000e8322d00/frameset.htm

Use

In the SAP application component Production Planning for Process Industries (PP-PI) , you can create, optically archive, and approve batch records to document the production and processing of your batches. This enables you to meet one of the main requirements laid down in the guidelines on Good Manufacturing Practices (GMP).

Note Note

If you have materials that are not subject to batch management, you can create order records instead (see Storing Order Records (PP-PI) ).

Integration

To create a batch record for the batch, the Batch record required indicator must have been set for the order types of the relevant process orders (see Customizing below).

In the material master record ( Work scheduling view), you specify the materials for which you want the system to create batch records. You may not perform the following actions for batches of these materials unless the batch record has been approved:

  • Taking the usage decision for incoming inspection lots of the batch

  • Changing the batch status from Restricted to Unrestricted

You can still create batch records if you have not made this setting in the material master record. However, the batch records then only serve documentation purposes.

Prerequisites

Technical Implementation
Header Record of the Batch Record

Every batch record has a header record that manages the version data of a batch record, its status, the data about batch record approval, and the links to the archive documents. The header record is stored in the SAP system. It is signed when the batch record is approved and can only be deleted after a certain availability period defined in Customizing.

Documents of the Batch Record and Archiving them

Batch records can be comprised of the following documents:

  • Documents with system data

    Except for the browser-based PI sheet, system data is compiled in SAPscript documents and optically archived via SAP ArchiveLink.

    The browser-based PI sheet is an XML document that is prepared as an HTML document using an XSL style sheet and is then loaded into the SAP HTML control for maintenance. The following information is archived:

    • The XML document of the PI sheet plus the data entered during PI sheet maintenance

    • A copy of the XSL style sheet tailored to meet the requirements for archive display

    • A copy of all files referred to in the style sheet, except for HTML files

      Note Note

      Hyperlinks contained in the document are retained. The files called by these hyperlinks, however, are not archived.

      Text symbols that refer to language-specific texts are replaced by the text to which they refer when archiving the PI sheet. The text is inserted in the language that was used when archiving was triggered or that was assigned to the relevant step when the archiving job was scheduled.

  • Attachments of any files from external systems

    You also use SAP ArchiveLink to transfer these files to the optical archive of the batch record. To do so, you must define your own document types for the object type Batch record: version and the corresponding document class.

The table below provides an overview of the document types that are available for the batch record in the standard system. Which of the system documents you want to archive on your batch records, can be defined specifically for materials and plants in Customizing for Batch Records . If required, you can include attachments manually in your batch records.

Document Types for the Object TypeBUS3053001 Batch Record: Version

Document Type

Description

Document Class

PIEBRCONTE

Batch record: table of contents

PDF

PIEBRVERS

Batch record: version data

PDF

PIEBRDEVIA

Batch record: deviations

PDF

PIEBRORDER

Batch record: process order

PDF

PIEBRMATLI

Batch record: material list

PDF

PIEBRPRLOS

Batch record: inspection lot

PDF

PIEBRPOC

Batch record: browser-based PI sheet

HTM

PIEBRSHEET

Batch record: ABAP list-based PI sheet

PDF

PIEBRMESSA

Batch record: process messages

PDF

PIEBRUSER

Batch record: user-defined data

PDF

EBR_DOC

Batch record attachment: DOC

DOC

EBR_RTF

Batch record attachment: RTF

RTF

EBR_PDF

Batch record attachment: PDF

PDF

User-defined

Any external file as attachment

Appropriate file type

Note Note

Document type PIEBRUSER has been defined for customer-specific enhancements of the batch record. The SAPscript form and print program for this document type have only been defined as a template that you can tailor according to your own requirements.

Storage System

In general, you can use any type of storage system for SAP ArchiveLink. However, to comply with the requirements laid down in the guidelines on Good Manufacturing Practices (GMP), we recommend using only optical archives for your batch records.

Batch Record Approval

You approve batch records by executing one digital signature or by carrying out a signature strategy .

The basis component Secure Store and Forward (SSF) is used to realize the digital signature in the SAP System. It provides several different signature methods . If you use the user signature as your signature method, you need an external security product that is linked to the SAP System using SSF.

Customizing and other Settings

To archive and approve batch records, you must make the following settings in the SAP system:

  • ArchiveLink Customizing: In the IMG, choose Start of the navigation path SAP Web Application Server Next navigation stepBasis Services Next navigation stepArchive Link End of the navigation path .

    Note that the optical archive in which you store your batch records should be linked to your SAP System via the HTTP Content Server Interface.

  • Customizing for the batch record

    This includes settings for

    • The status profile of the batch record

    • The digital signature

    • The contents and layout of the SAPscript documents to be archived

      If required, you replace the SAPscript forms and print programs used in the standard system by your own ones.

      You make the settings for the XSL style sheet of the browser-based PI sheet in the Business Document Service (see Definition of Contents and Layout of Archive Documents ).

  • Settings for the batch record in Customizing for Process Orders

    In the order type-dependent parameters, you must set the Batch record required indicator for the order types that you want to use to manufacture the batches to be documented. This also ensures that process orders cannot be deleted until the relevant batch records have been archived.

  • Settings for the batch record in Customizing for Process Messages

    Process messages that you want to include in the batch record must be sent to the process message records as order-related messages. Therefore, you must make the following settings in Customizing of the message category:

    • You must assign destination PI01 (process message record) to the relevant message category.

    • You must assign a characteristic for the order number to the message category and then assign this characteristic to the target field PROCESS_ORDER of the process message record.

  • Browser settings for the PI sheet

    To display the browser-based PI sheet and the archive document, you need the Microsoft Internet Explorer, Version 5.0 or higher. Note that the settings you make for the Internet Explorer also apply to the PI sheet.

  • An output device must have been defined on the Defaults tab page in your user profile.

Further Preparations

To archive and approve a batch record, you must note the following when you process the relevant application data:

  • The Batch management indicator must have been set in the material master record ( Work scheduling view).

  • All process orders that belong to the batch record must have status Approval granted

    For more information on the approval, see Creating Process Orders with Approved Master Recipes in the Production Planning – Process Industries (PP-PI) component.

  • All process orders that belong to the batch record must have status Batch record required .

    This status is assigned to orders when they are released, provided that the Batch record required indicator has been set in their order type (see Customizing above).

    Caution Caution

    If more than one process order has been created for a batch and the Batch record required indicator has not been set for all of them, you cannot create a batch record for this batch.

    If, however, a batch record already exists for a batch, all process orders created for it are assigned the status Batch record required . This means that they are included in the batch record even if this has not been defined in the order type.

  • All process orders that belong to the batch record must have status Closed or Technically completed .

    Caution Caution

    When you close an order, the system does not check whether all process messages for the order have been sent successfully. To make sure that all message are transferred to the batch record, check the message status and message logs in the message monitor first.

  • All PI sheets that belong to the batch record must have status Completed, Terminated , or Discarded.

  • All inspection lots that belong to the batch record must have statuses Batch record required , Inspection close completed , and Lot locked for batch record .

  • The usage decision must have been taken for all inspection lots that belong to the batch record and do not have inspection lot origin 04 Goods receipt .

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