Paper on glass
Batch processes are very varied, across different industries and within a specific industry. My work takes me mainly into the pharmaceutical sector where a whole suite of production methods exists. But what is on my mind today is the extensive use of paper based operations for both executing the work order and recording critical data. I would like to open your eyes to using some key pillars of zenon Ergonomics together, coupling good user interfaces with the Batch Module and the strong reporting capabilities within zenon Analyzer or zenon Supervisor.
Electronic Batch Records
Using an operator to execute commands from a sheet of paper and asking him or her to record events and critical data manually on paper, is prone to so many openings to errors and missing data. The fun doesn’t stop there, several Standard Operating Procedures (SOP’s) and Batch Records (BR) are needed for each batch, which all need to be collated, analysed, documented and reported on. This is an extensive manual activity costing a significant percentage of the revenue, which is heavy on errors, personnel motivation, and limits the future dimension of the company’s possibilities.
The reason why these practices are present is clear, as the SOP’s and batch records are established within the Quality Management System. To change this is a mountain of hassle and significant cost.
But we can change this…
Outside the world of zenon, other reporting systems do exist; these are mainly positioned to business reporting with their links to the process being arbitrary, and understandably they have no process understanding. On the other side of the field are the batch system producers, now these do know process, but reporting is either not a feature or a very weak function.
Cutting to the chase, the roots of zenon are grounded from the beginning in process knowledge and control. Our reporting system zenon Analyzer competes one-to-one as a business reporting agent. These environments are homogeneous, focused here with an ISA 88 Batch Module, strong user interfaces, archiving, and reporting.
Now we have talked previously about intelligent connectivity to industrial systems, networks, etc. This is not the only possibility. What I am talking about today is intelligent connectivity to the operator and business systems.
The batch engine, has phases and operations which promote the user to execute certain tasks and record data, in the correct sequence, at the right time. When the batch is complete, the individual SOP’s and batch records have been recorded and stored electronically, the reports can be generated automatically without a person in sight, and no data is missing, deviations are zero, the process has been encapsulated by the batch engine, with only the fingers and eyes of the operator needed to complete the execution.
The initial advantage here are that paper is eliminated, the established SOP’s don’t change, and there has been no modification or addition to the control structure of the processes. The original quality mechanisms remain untouched. But with better results, strong reports, confident production, and increased quality. The operator is motivated, with access to all information via a tablet. And finally the production is released with increased speed, and with less dollars consumed by the manufacturing chain.
The advantages don’t stop at the initial operations, reviews of Electronic Batch Records (EBR’s) in the pharmaceutical industry reveal a wider benefit of quality and significant cost reduction.
- Shorter release times, collation of data is reduced, review is a simpler process with all information present
- Right first time is increased from 47% to 90%
- Records with errors reduced from 38% to 18%
- Missing entries reduced from 22% to 8%
- Corrections down from 66% to 18%
In addition to the hard figures, my feeling on EBR systems is the confidence such a production environment creates, opening the avenue for more flexibility in production, the ability to widen the portfolio of products, with the difference on profit margins being night and day from the antiquated paper heavy days.