Risk control is the process of identifying a risk and implementing changes that reduce the risk in order to protect the user of the product. The three types of risk management are product design, protective measures incorporated into the medical device, and labeling. Changing product design is the best method for managing risk, but it is not always a feasible option. At times, the financial cost to change a design is too great, and would end the project. The next best option would be to incorporate protective measures. One such example is the patient-controlled analgesia pump. When a patient experiences pain, they can manage it themselves with the press of a button. However, there is a limit to how much is dispensed over time. This protective mechanism prevents accidental overdose. The least effective is labeling. Warning labels can be placed on a medical device, but they can be overlooked.
Changing design may be cost prohibitive , but sometimes it has to be done, even if it cause financial stress for a company. The alternative is negligence, which can lead to criminal investigations or product liability. Product liability is the failure of product that cause damages such as unsafe product that results in injuries. Product liability is also an area of the law. Most countries have product liability law, which are apart of the civil code, or they have included strict liability within a comprehensive Consumer Protection Act.
In the United States, product liability law was created primarily through case law from state courts as well as the restatements of the law produced by the American Law Institute. The models created by the United States and the European Union are the two leading models for how to impose strict liability. Virtually every country in the world follows on of these two models.
Risk management is a planned process designed to identify, mitigate, and evaluate our exposure to risk. Risk control is a stage of risk management where it controls the specific activities to reduce exposure to risk. In a business, risk management identifies and assesses the risks which can lead to financial loss. By doing this, they can select and implement different risk controls to and evaluate the effectiveness of their controls.
Some risk controls financially, could be finding different vendors. Looking for to develop partnership with key companies.
Risk control should form part of the company`s broader health and safety plan providing a method to identify, control, and reduce the risks present in the workplace. The control of workplace risk is a practical, evidence-driven process; employers assess the work environment to identify risks present in the workplace—as well as the specific individuals at risk—before taking appropriate action to control those risks. Common types of specific risk control measures include good housekeeping practices, employee safety training, safety policies, use of safety drills, re-design of unsafe tasks, and the implementation of automated equipment.
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Another form of risk control during design is knowing the intended misuse scenarios and how they can be mitigated during design. Lets say they know a scalpel can cut easily and is sharp on all sides. The design can force the user to almost never interact with the sharp area (possibly retractable), even knowing that the scalpel can through multiple hands such as a nurse, scrub tech, and surgeon. There are multiple ways to know how products can be intended to be used and intended for misuse that can have factors of safety within them for a more safe product.
Another form of risk control may be in restructuring manufacturing processes. Therefore the risk management is not necessarily redesigning the product, but how it is made, to reduce risk of failure. In this case, the manufacturing process may be adjusted to include more checkpoints to ensure that damaged products do not pass inspection, and therefore never reach the patient. Or the product can be manufactured in a different way that leads to less defects.
