Can software simplify my risk assessment?

A risk assessment is not about creating enormous amounts of paperwork, but rather about identifying practical actions to control the risks related to the medical device. By integrating the risk management process into your entire QMS, companies can fix issues that expose them to risk in the initial design and engineering stages when it’s less expensive and time-consuming to do so.

Every company must able to precisely assess risk levels across product lines, business processes, and business units in real time. If the risk assessment systems in use are manual, it is hard to track, record and preserve up-to-date documentation. An automated risk management solution can bring all risk activities and documentation together.

What are the key factors to consider when implementing risk management solutions?

A risk management solution should be directed to comprehensive and transparent supervision of risk activities. They should be based on ISO 14971 guidance and combined with a flexible system where a company can create its own Risk processes, including approval workflows, and defining risk varieties and action plans. It should provide a step-by-step sequence of tasks with appropriate explanations and cautions that makes it possible for risk or quality managers, even with little experience, to appropriately perform their risk related tasks.

So, what companies should be able to do within it?

Companies should be able to do complete risk assessment within it according to ISO 14971, starting with Identification of hazards and risk estimations for each hazardous situation. They should be able to define exact hazards for a medical device with a foreseeable sequence of events, hazardous situation, and harm. Of course, risk should be in charge of Risk Manager, so there should be an option for him to give consent that potential hazards and all other elements have been included and described correctly (basically, to approve defined).

Next step should be Risk Evaluation, where risk score should be calculated according to severity and likelihood ranges, based on what should be defined if further steps are required – mitigation of risk if its level is high. It would be a great feature if the solution can provide automatic CAPA process, in order that complete traceability is shown.

After defined CAPA for defined hazard, the solution should lead to the next step – Risk Control, where the company should identify risk control measures that are appropriate for reducing the risk to an acceptable level, according to which risk re-assessment should be done to calculate new risk score and define if there is residual risk or not.

If the residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the company should gather and review data and literature to determine if the medical benefits of the intended use outweigh the residual risk. The solution should provide an option to input this information as a step of risk process – in Risk benefit Analysis.

As standard requires, before releasing for commercial distribution of the device, the company should carry out a review of entire risk process – to verify if risk plan is completely implemented and if the residual risk is acceptable. This information should be recorded as a risk report. So, it would be great if risk solution has the option to export all inputted information as a summary document which will contain all passed steps in risk assessment and which could be used as Risk report.

Such risk platform will increase the effectiveness, where the company will spend limited time and energy tracking risks and planning mitigations instead of managing a tool. It gives quality and regulatory teams a consistent means of performing dependable risk assessments. The automated risk management system allows companies to evaluate critical events more carefully and help them properly evaluate whether or not corrective measures are effective. Effectively managed risks help companies achieve their goals.

So, to answer the question in the title: Yes, the solution defined in such a way will simplify your risk assessment!

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15 replies to “Can software simplify my risk assessment?”

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  7. David says:

    I had the opportunity to test qmsWrapper, but not really satisfied with the Risk when it comes to CAPA. There is just one small field to include my CAPA finding, but our CAPA is a way to complex. It requires root cause investigation, then corrective and preventive actions and verification at the end. It’s entire process and each step needs to be documented of course. You’ll agree that it overcomes that small field.

    1. Jason says:

      David, I hope you can help me. I am e medical device specialist and currently looking into the best software that can help me with CAPA. Is there any recommendation you can share with me apart from this software you use?

      1. Paula Clements says:

        Hi Jason! I see you’re looking for the solution for CAPAs and risk management. We are using Orcanos solution as QMS software and it has an integrated module for the risk assessment and we perform our FMEAs. We are able to customize risk settings and relate requirements to a specific risk. You can even generate reports.

    2. Luca Miller says:

      Hi David! We use Wrapper for our QMS. I agree that it’s a little bit primitive solution when we are talking about CAPA. But, we found a way to overcome it. We have a process for handling our CAPAs. When risk needs to be mitigated, assigned co-worker in my team (after receives the task to do the mitigation), starts the CAPA process. Our process is pretty much what you have mentioned (with the steps). Also, there is an option to relate the mitigation task and process, so it’s clear to which it refers. I agree, there is a lot of manual work. It would be great if this is automatized.

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