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Column - Risk management is more than a spreadsheet


In a previous article, we discussed several causes that lead to product malfunctions and how to mitigate them. In this article, we’ll see how moving from a document-based risk management approach to a data-driven risk management approach can help mitigate product failures.

Mitigation of the risk of failure is one of the most important disciplines for medical device manufacturers to achieve, and over the past two years it has become an increasingly difficult discipline to master due to:

  • Government and industry compliance regulations have been greatly expanded in recent years
  • More and more complex products
  • Paper-based or offline risk management processes

Changes in regulatory requirements, namely the latest updates to the Medical Device Single Audit Program (MDSAP) adopted by regulatory authorities in the United States, Canada, Japan, Brazil and Australia, as well as that the European Medical Device Regulations (MDRs), have an impact on manufacturers of medical devices.

These regulatory changes were introduced to improve product quality and the safe use of these devices. They were also introduced to provide manufacturers with better insight into the complete product lifecycle through improved quality metrics and a more efficient inspection process.

Additionally, medical devices are becoming increasingly complex, driven by rapid innovation, market demand, and the incorporation of software into these devices. Systems within systems must successfully interact with other systems, internal and external to the product itself, to function properly. Each of these factors adds risks and opportunities that must be identified, analyzed, accepted, mitigated or exploited early in the design process.

The increase in product complexity has also led to a dramatic increase in product data. However, it is not the volume of product data that makes risk management processes increasingly difficult to execute. This is how medical device companies manage their processes today.

Paper Process Challenges

Many companies work with manual, paper-based or disconnected processes. Different departments, each with their own processes, create content and data resulting from their individual tasks, decisions and goals. The data exists in Word or Excel files or other in-house systems. This translates to content and data living in widely dispersed emails, laptops, desktops and remote servers that are not under the control of change management.

Managing risk assessments in this way is prone to errors, including dead links, deleted data, and insufficient artifacts to describe the certainty of approvals. The data-based risk assessment report cannot be trusted to represent the process of determining the current status, risk management history and mitigation it describes. Ultimately, such a system presents risks to end users and stakeholders, as well as to the business relying on the risk management process to safely bring a product to market.

Connect risk management to product data

Naturally, risk management should not be managed in disparate databases, documents or unconnected systems. The risk management process generates live content and data that needs to be linked to other content and data generated during the design process. Change should be tracked as part of an overall change process. A recommendation can trigger a chain reaction of changes that create a web of relationships. Test plans and results may affect changes in design, materials, packaging, documentation, or manufacturing processes. If Failure Modes and Effects Analysis (FMEA) process data is an isolated instance of data unrelated to other data in Word, Excel, Access Db or Lotus Notes, it is very difficult to develop a correct and up-to-date risk management assessment. It is essential that risk management content and data is managed under a change control system capable of establishing, tracking and reporting the impact of identified risks, their assessment, recommendations and resulting design, product and process changes.

Running risk management in a product lifecycle management (PLM) system allows you to connect your risk management data to your product data. This allows you to create a web of data where risk analysis and mitigation processes are directly connected to exact product data, with a relationship to all data and with full traceability of all product processes. quality and change that can be performed as a mitigation process.

You can easily identify and analyze where to make changes to a product, incorporate updates to a manual, or make a change to documentation. When all data is connected and updated throughout the process, from start to final change, the Risk Traceability Matrix is ​​automatically generated with no manual updates required.

With risk management in PLM, you become data-driven rather than document-driven. You can create a connection between risk identification, risk analysis, risk mitigation, risk traceability matrix and requirements, and all this data is automatically connected to your device.

The risk of failure is real and must be managed for patients, operators, external equipment and the environment. Risk management becomes increasingly difficult as product complexity evolves, software replaces many mechanical functions, and the volume of product data continues to grow. Now is the time to create a more connected and streamlined process for data integration.



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