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Schering-Plough

System Dynamics’ implementation of Maximo Work Order Processing as a Paperless System

Schering-Plough (Avondale) Company (SPAC) is a Pharmaceutical API Manufacturing Plant based in Rathdrum, Co. Wicklow, Ireland.  SPAC use IBM Maximo as part of their Maintenance Management Process.  As SPAC is regulated by the IMB and FDA, Maximo is a validated System.

The Challenge

In 2004, System Dynamics installed Maximo in SPAC, replacing their legacy, AS400-based Maintenance Management System, Maintracker.  The project required compliance with regulatory requirements (FDA / IMB) and included Data Migration from Maintracker, Maximo installation and customisation and training, all under the Schering-Plough System Development Lifecycle.
Up to 2007, Maximo printed Work Orders and any attached Maintenance Work Instructions  (MWI) for all Preventative Maintenance (PM) and Corrective Maintenance (CM) Work Orders.  The completed signed Work Orders were retained as the record of note.  This involved scanning and verifying the completed manual Work Orders to their Document Management System (Zyimage).
The challenge for SPAC was to remove the dependency on scanned paper records as part of the Work Order Processing.  Validation was required under the Schering-Plough World Wide Quality Standard as Work Order Processing / Preventative Maintenance is a critical process for FDA / IMB compliance.   

The Approach

System Dynamics worked with Engineering, Maintenance, Validation and Information Systems Departments within SPAC. 
The requirements, design, development and testing phases were undertaken, followed by extensive Validation testing to formally test the changes.  This consisted of an Installation Verification (IV) for Configuration changes and a Functional Verification (FV) for the new process / screens / reports / document attachment processes. 
Throughout the process, the existing Requirements Traceability Matrix (RTM) was updated to reflect the validation of new requirements identified within the URS.

The Solution

By extending the use of Maximo, all Users now interact directly with the electronic Work Order:

  • Craft Coordinators use a new report to assign Craft(s) to the Work Order and to inform the Craft(s) of the Work Orders assigned.
  • Crafts review the electronic Work Order.
  • Crafts update details directly to the electronic Work Order.
  • Craft Coordinators / Engineering Planning review completed Work Orders and add additional comments if necessary.

New Training Modules were developed for all users to provide training in the following:

  • Crafts direct interaction with Maximo, to enter work details. 
  • Attachment of MWI documents and Service Receipts to Work Orders by Crafts and Craft Coordinators.
  • Checking of the content of the completed work, closing of Work Orders and tracking of Work Orders for Craft Coordinators and Engineering Planning.

The Benefits

The implementation of Maximo Work Order Processing as a Paperless System has provided SPAC many immediate and long-term benefits including:

  • Maximo becomes the Record of Note for Work Orders carried out by the Maintenance Department, replacing Zyimage.
  • All relevant information including Labour and Materials are recorded directly to Maximo.  Where MWIs need to be printed and annotated, the printing is controlled and the documents are attached directly to the relevant Work Order.
  • Removal of printing of Work Orders and MWIs provided a direct cost-saving.
  • Users interact directly with the Work Order.  Maximo controls the information entered to ensure that it is valid and accurate.
  • Administrative Staff no longer need to scan all completed Work Orders into Zyimage.
 

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