By Pharma Consulting
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Körber Process Landscape™ system for faster MES recipe development
Körber has created within its Business Process Management service framework a unique method called Process Landscape™ that allows customers to achieve target processes much faster and more easily.
The system eliminates parallel and extraneous process steps through pre-harmonization allowing users to develop, for example, Manufacturing Execution System (MES) recipes up to 75% faster than previously.
The use of digitally integrated MES has become increasingly important for pharmaceutical production due to rising demands for effectiveness, assured quality, overall equipment efficiency, and minimized total cost of ownership (TCO) by maximizing data integration and automation. To avoid falling behind competitors, pharma manufacturers must speed up recipe development, verification, and administration in order to support efficient production. To this end, it is crucial to analyze and harmonize processes before attempting to introduce MES or develop detailed recipes for new product groups.
Körber Business Process Management recognizes that process harmonization is a key area in which customers can differentiate for advanced cost-competitiveness and gain strategic advantage. In simplest terms, it’s far more effective to optimize and clean up processes before commencing detailed development of recipes, etc. Further, maintaining a clear overview of processes keeps bespoke projects on schedule, ensures high quality and reduces operating expenditure (OPEX) costs particularly by up to 30%.
The Process Landscape™ was developed to allow harmonization of processes before introducing MES and commencing recipe designs within the system. Preventing repeated, parallel or particularly laborious process steps can allow recipe development up to 75% faster.
Implementing Process Landscape follows a basic two-step methodology:
Step 1: Record current processes
First of all, the current ‘as is’ processes are captured in depth by physically following movements of relevant people involved and watching all the steps of machine operation and its documentation. Körber BPM analysts can document the entire procedure, using a unique standardized method than can form an effective work tool for both the current and target process design. This makes it possible to control meetings in a process-oriented and effective manner, to identify open points for clarification, and to always find the right level of detail.
Step 2: Define harmonized target processes
With current processes clearly recorded and understood, the customer can now define the future ‘To be’ process landscape. This involves coordinating the main topics of a system landscape according to ISA-95 by integration of ERP, logistics, and automation layers. This is then followed by consolidation of results from the actual observed processes as well as the preparation of the draft target process (harmonization of language, uniform delimitation of sub-processes and standardization).
At the same time as the target process is defined, an ongoing fit gap analysis is carried out with regard to the functional content of a future MES system or scheduled upgrades. Any identified gaps are taken into account according to the evaluation. As soon as the current and target process landscapes are available, they form the basis for all further roll-out activities.
Process Landscape follows a modular design philosophy that makes it possible to test the effectiveness of process harmonization in distinct and isolated processes like line clearance or format change. Such sub-processes can be evaluated and documented within 10 to 15 days, along with a precisely formulated action plan. Each successful exercise can then form a customer building block than can be verified and reused within other recipes.
Körber can support customers in every single step from initial Business Process Management consultancy through to integration of Manufacturing Execution System with potential for full Pharma 4.0- digital integration.
Detailed Process Landscape advantages include:
- Up to 75% faster production of MES-recipes
- Up to 30% OPEX savings
- Easy-to-use: standardized method according to ISA-95 & ISA-88
- Modular proof of concepts (e.g. for line clearance or format change)
- Reusable templates for MES prototype recipes
- User Requirement Specification (URS) documentation included
- Free initial consultation (even on-site)
- Built on more than 20 years of experience in MES & business processes
- Demonstrated customer loyalty of more than 97%