Mistake Proofing Pharmaceutical Production and Documentation Processes

As a follow up to the post, Using Operational Excellence Techniques to Understand and Solve Business Problems, Emerson’s Michalle Adkins shared a great story of one pharmaceutical manufacturer’s path to justify technology to help their business objective to reduce deviations, eliminate redundant work, and improve production efficiency, including the product release process.

The current method of operations included paper batch records and manual data transcriptions throughout the work process. As a result, batch release times were not optimal due to the time involved with paper record reviews by the Quality and Production departments. In addition, the effort involved in releasing a batch included many non-value added steps. Over 20% of the atypical events found were due to manual recording errors. Mistake proofing the process would deliver economic benefits with faster batch release times, less required labor, and fewer quarantined or discarded batches.

The manufacturer had an existing manufacturing execution system (MES) at its various facilities, but it was centered on the historization of simple automated processes. Some examples included data trending and recording as well as comments and e-signatures. The system was minimally connected with the control system via OPC. The other major issue was the MES was customized for each site, and the manufacturer’s approach is a “configure, not customize” approach for site validation.

To achieve the sought level of mistake proofing would require close integration between the MES and control system. This mistake proofing approach required the inclusion of complex automated and manual processes with long residence times to be incorporated automatically into the batch records.

Michalle described the project team’s focus on building organizational consensus in the project conception and identification of requirements. The project team was comprised of representatives from key departments with overall site leadership sponsorship. Team members represented Operations, Quality, IT, Engineering, Automation, Plant Management, Corporate Management, and Validation departments.

Syncade suiteA key part of the process was the delivery of a prototype to visually show how mistake proofing could be accomplished and how the requirements could be realized. The team followed the Operational Excellence process and involved members from the corporate automation and information technology (IT) teams.

The prototype timeframe was 3 months and included the MES recipe integrated with their DeltaV control system. The team included members of the Life Sciences consulting team to provide system setup, proof of concept criteria development, implementation & testing, presentation assistance, and proposal development for project implementation.

The Syncade MES applications in the prototype included Recipe Authoring, Electronic Batch Records, Equipment Tracking, Materials Management, Weigh and Dispense, Document Control and Archiving, and the Security and Audit application modules.

The process to develop functional requirements grew out of an initial draft developed by the manufacturer. Paper records were deconstructed with mapping all of the data entry and parameter fields in the MES and DCS. Definitions were developed for S88 unit operations, parameters, recipe-specific values, operator text displays, sequencing logic including manual steps, and signature requirements. These functional requirements were reviewed and revised with stakeholders representing each of the functional departments.

Based on this iterative process, the prototype was designed, built and tested. Prototype presentations were given to smaller groups by department to allow focused questions and feedback based on the perspective of the department. A justification based on the Operational Excellence process was developed and tangible benefits identified through value stream improvements in reduced document handling time, document review time, data entry time, calculations and document rework.

Other tangible benefits included reduced inventory, storage, material losses, and deviations/event comments. Intangible benefits included greater focus on true product quality, greater availability of information and the empowerment it provided staff members at all levels. This approach better organized the information to spot improvement opportunities including the identification of situations to apply Process Analytical Technology (PAT) methods. The benefits were quantified and return on investment (ROI) calculations were performed for overall project justification.

The prototype was a proof of concept of both the integrated MES technology as well as the project implementation and validation strategy. The project continues along the path to achieve the sought business objectives. Michalle and the consulting team have an Ask The Experts page to discuss your Life Sciences-related operational challenges.

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3 comments

  1. Chris Amstutz says:

    A key aspect of the prototyping approach was the use of Lean tools and techniques during the prototyping exercise allowing the prototype design to be linked directly to the business benefits. This allows for value engineering and a real understanding of the benefits the solution will provide.
    We’ve seen it countless times where there’s little to no connection between the User Requirements Specification (URS) and the expected business benefits. The URS is that bridge and not an end point as outlined in a previous blog post at http://www.emersonprocessxperts.com/2012/02/using-operational-excellence-techniques-to-understand-and-solve-business-problems/

  2. Jim Cahill says:

    Chris, Thanks for your comment and highlighting the importance of LEAN in the prototyping process. #PAuto

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