The benefits of an MES System in non-conformity handling

  

Overview 

In highly regulated industries such as pharmaceuticals, medical devices, or aerospace one key aspect of manufacturing is how to handle nonconformities (NCs). In any production process there will be error and uncertainty. Processes will fluctuate, inputs will change, humans will make mistakes, and many more. Regulations such as 21 CFR 820.90 and ISO 9001 provide a general guideline on how to deal with NCs in a regulated industry. With these guidelines, companies will develop their own Quality Management Systems (QMS) and quality procedures to ensure user/patient safety and compliance with regulations. Of course all of this applies whether or not a manufacturer has an MES system, but it is important to think about how an MES system fits into NC handling and the benefit it can provide when handling NCs.  

Looking at 21 CFR 820.90 and ISO 9001, there are some common themes on how and requirements on how NCs should be addressed. 21 CF 820.90 requires that procedures address the following steps: 

1. Identification 
2. Documentation 
3. Evaluation 
4. Segregation 
5. Disposition 

ISO 9001 has similar guidance:

1. Identify 
2. Record (similar to Documentation and Evaluation in 21 CFR 820.90) 
3. Control (similar to Segregation and Disposition in 21 CFR 820.90) 

Identification 

The first step in a NC process is to scope the issue at hand. Issues such as equipment malfunction, human error, supplier quality issues, and more will show up no matter how many controls are in place. Depending on the severity of the issue identification an scoping of an issue can be a straightforward process that can be done within minutes by a skilled operator or require a long investigation led by the quality team. For example, an oven malfunctioning during a single run may lead to all product in the oven to be contained for that single run. However, if an oven thermocouple is out of calibration and it could not be determined when that happened, the scope of such an issue will be more difficult to determine.  

With an MES system, the data needed to scope such an issue already exists. All product that went through the oven will have been recorded. In an MES, allowing the user access to reliable data allows for decisions to be made in a timely matter and prevents risk of escapes.  

Documentation/Evaluation 

One of the most important aspects of a regulated industry for everyone from an operator to an engineer to management is documentation. A common saying is "if it wasn't documented, then it didn't happen". In the context of NC management, many details are needed so that issues are properly addressed. One of the main flaws of a paper NC process is that historical data is not readily available. Documenting the investigation, scoping, disposition, and corrective actions are all vital for both day to day activities and an audit. If quality is dealing with a recurring issue, having fast and convenient access to historical data streamlines the evaluation process and lets quality focus on the root cause of any NC. 

Segregation/Disposition 

The handling of any NC product always needs to be handled with care. When there is potential to impact users/patients, having reliable controls is key. In a paper process, these controls will primarily be procedural. Product may be moved to a quarantine area where only authorized personnel are allowed move product. Even with the procedures and a quarantine area there is always the potential for human error, with someone reading a picklist incorrectly or segregating the wrong material. With an MES, electronic controls provide an additional layer of security in the form of electronic segregation. Once product has been identified to be NC, an electronic hold can be placed on the product and no transactions can be allowed.  

Summary 

The benefits of having an MES for NC procedures have many common throughlines. On one hand, everything being done in a paper process is still compliant with the FDA or any regulatory standard. An MES is not "more compliant" than a paper process, but one of the common themes is the increased efficiency. A quality engineer being able to quickly find historical data and trends allows them to focus more on process improvements. Providing operators and supervisors on the floor with the tools to help them navigate nonconformances can empower them and improve the communication between operations and quality. Paper/manual processes contain many of these "hidden" costs/wastes that are just accepted as the way the processes have always been. Nonconformance handling is just one part of manufacturing where digitization provides value. 

How FrontWell Solutions can help 

In any successful MES implementation, it is important to have the appropriate expertise to ensure seamless integration. Frontwell Solutions has expertise in software, manufacturing, and quality within the life sciences industry. Each company and even site have their own procedures or interpretation of procedures which can lead to difficulties implementing an MES. Frontwell’s experienced consultants have navigated NC product procedures and worked on digitization projects in many industries, so we can provide clients with industry best practices and improve quality and compliance. 

 

  Author: Jay Wang