Advanced process control technologies allow the collection of a large amount of data on multiple parameters. Several industries have begun to implement them, including the healthcare industry. The benefits of these technologies are many, ranging from a better knowledge of processes to increased quality and significant cost savings. Alcimed details one of the areas that forms Industry 4.0: review and release by exception, guided by MES – Manufacturing Execution Systems.
The principle of review and release by exception is simple but requires a very fine knowledge of the process. It is necessary to know the critical quality attributes of a product and the behavior of the process according to the variations of any parameter that can influence quality (called critical parameter). By monitoring all these parameters over time, it can then be said that, as long as the critical process parameters remain within their ideal operating range, the manufactured product will have the expected quality.
Review by exception and release by exception
Review by exception consists of the automatic review of production batch records, requiring special controls only when exceptions occur (parameters outside their ideal range, user comments, voluntary or accidental changes to a part of the process, etc.). It is based on a real-time timestamped control of many parameters throughout the process. In the pharmaceutical industry, this method of review by exception has been known for many years. Although far from being fully implemented by the industry, review by exception is used by most large groups on some of their lines, but also by medium-sized groups.
Release by exception takes this concept beyond the production department alone, including not only review by exception, but also other parameters such as environmental sterility control, post-production testing, etc. It aims at releasing a batch on the market if no exception has been created, automatically and in real time. Much more complex to implement than review by exception, release by exception is currently present on a very small number of lines worldwide.
These two concepts could not exist without MES – Manufacturing Execution Systems, software that guides the process for users and verifies each step, centralizes data from all sensors on the production line and from the user interfaces, and generates exceptions if they occur, thanks to pre-programmed rules.
Impacts of review and release by exception on the business
The benefits of this technology are many, particularly in terms of time and money saved during production, increased throughput, and improved product quality.
The process is also more guided, thanks to the use of barcodes and the request for signatures and approvals by the MES throughout the process, ensuring that the steps are carried out in the right order. Human error is therefore reduced.
Changes in roles should also be expected:
- Firstly, manual input tasks are reduced to a minimum, so operators spend more time controlling the line.
- Secondly, there is a paradigm shift in trust, where more trust needs to be put in software helping with decision making, and less in humans.
- Finally, the skills required will evolve, particularly in favor of dual skills in IT and process automation.
Prerequisites and maturity to implement MES – Manufacturing Execution Systems
The prerequisites for the implementation of these MES – Manufacturing Execution Systems are numerous!
First, the technical prerequisites form a major barrier to the use of MES. Companies need:
- A robust and correctly parameterized IT infrastructure,
- Hardware such as sensors, barcode scanners or control tablets,
- As well as a thorough knowledge of the process, its critical parameters and the ideal ranges for each of the parameters.
Second, the organizational prerequisites are also multiple, and include:
- Need for user training,
- System qualification and validation,
- Data organization,
- Management of user expectations,
- Availability of financial, time and human resources, as well as an agile multidisciplinary team throughout the parameterization process.
These prerequisites, coupled with the high cost and complexity of the system, the significant changes in both technical and regulatory requirements, and the psychological barriers to radically changing the way things work, mean that the maturity of these systems is still quite low at the moment for smaller companies, and even large groups have not implemented them on all lines.
But strong levers – regulatory approval and the ever-increasing need for industrial performance – mean that the adoption of MES – Manufacturing Execution Systems for review by exception is skyrocketing, regardless of company size.
Because of its many advantages, review by exception is bound to become more widespread in the future, and release by exception may also see its use increase in the more distant future. These computerized approaches are gaining momentum to address current issues by protecting the integrity of information and breaking down data silos, enabling effective communication of this data at the corporate level around the world, monitoring, analyzing, and even optimizing processes in real time. Alcimed supports its customers in these technical and organizational challenges on this hot topic in the industry 4.0.
About the author
Benjamin, Great Explorer in Digital Health and Project Manager in Alcimed’s Life Sciences team in France