Not so long ago, most manufacturing plants in the world were run by paper systems; work instructions, bill of materials, routings, recipes, quality testing, material movements, and a long list of others. In fact, many still are. It was the only option, and although far from efficient, it worked. Part of the push to implement initial Manufacturing Execution Systems was to get rid of paperwork, replacing paper with electronics in order to provide, gather and manage information required to perform and continually improve processes. Few who have made this transformation would want to go back to paper systems. It’s kind of like driving your grandfather’s Oldsmobile and then a current day vehicle. Other than for nostalgia, something corporations cannot afford as a business ethos, you just wouldn’t do it.
But there is one area of manufacturing, particularly in regulated industries such as pharmaceutical and medical devices, where paper still rules: Quality Control. Even plants that have moved to electronic systems often use a manual approach to reviewing production records. Before a product can be released into distribution, a quality engineer reviews all the batch or device history records – page by page – to ensure that every step and control check was executed and signed off. This means printing out and reviewing 20 to 100+ pages on every quality-related production activity. And, this is done for every product or production run!
In other words, highly paid, skilled engineers are spending a good portion of their time reading production reports while products wait to be released. Instead, wouldn’t it make more sense to manage quality by exception, using the data that’s already been captured in MES? Increasingly, best in class manufacturers are now reaching exactly that conclusion and striving to build the confidence to operate accordingly. Some have done this to a point where they are managing parametric release; shipping product before final quality data results are completed!
In release by exception, the QC engineer does not investigate production quality unless there is a significant deviation from the average, based on thresholds that are carefully established and automatically monitored. For example, if the acceptable temperature range for a given process is 40-45 degrees Celsius, and the data captured in MES is within that range, then no exception is generated. The QC engineer only needs to examine cases where thresholds have been exceeded or are approaching a control point. This is a very simple example, and certainly there are dynamic quality and specification data that would not easily fit this approach. But, envision what percentage of routine quality and process data could be removed from specific review! Highly automated process industries, like HPI or Oil & Gas have been doing this for years. No FDA to contend with, true, but the technology exists to manage this in regulated industries.
Controlling quality by exception is the next logical step in the evolution to paperless manufacturing. Simplifying the review processes to avoid reading 20-100+ pages of documents in order to address regulatory compliance is the next step. After all, the whole point of MES is to have directed manufacturing that reduces errors and improves quality, increases efficiency, provides real time visibility, and drives manufacturing process and performance improvements … the byproduct or goal, depending on how you look at it, is to generate with fully compliant paperless eDHR’s and eBR’s.
Why not use that same data for release by exception? It reduces costs, frees QC engineers to focus on real problems and probably most important of all, it decreases cycle time. Are you part of the best in class manufacturers that are now moving rapidly in this direction? If not, shouldn’t you?