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Risk management for your manufacturing

In today's complex world of manufacturing it is the prudent owner or operator of a manufacturing company that integrates risk management into his production process. By integrating risk management in the design and development process the successful business owner takes a proactive step in minimizing all loss.Yet a note of caution should be extended here for the risk management process to be successful it should be introduced early in the design process and diligently managed throughout a product's life cycle.This risk management process can become extremely crucial in some industries.For example, successful risk management is critical to the design and development of safe and effective medical devices. To many manufacturers view risk management as an isolated activity that must be performed merely to fulfill a regulatory requirement. This is often due to a misunderstanding or confusion as to what risk management really does.

By educating manufacturers about the methods of risk management this provides manufacturers with tools that will improve their design and development efforts. The end results include device designs that are safe and effective, a shorter and more-efficient design and development timeline, and fewer post launch problems. Risk management when it is done correctly can involve the development and transfer of safe, reliable and effective devices in the manufacturing process.This in turn reduces costs and monitors risk through a device's life cycle. It is extremely important that some fundamental principles be applied to the risk management process for the most successful and thereby most profitable design to be achieved.These need to be closely integrated with the total design and development effort.Some of this are-

- Risk management needs to become part of a effortless flow between design and development.This allows the product to proceed through the life cycle without major gaps in risk management analysis.
- Risk management needs to evolve with the device.The design of the manufactured device may need to evolve due to production or service concerns and the risk management attached to the device should evolve as well.
- The control of the design should be equal to the risk associated with it.Certain items while being manufactured will need more intense monitoring for risk management.This is usually judged by the final purpose of the device.For example a pharmaceutical company will need higher levels of risk management than anther type of firm.
- Risk management testing should be thorough, complete and easily traceable. This allows for adequate verification and validation of a safe, controlled design. If the risk management testing does not link possible hazards and requirements with the associated design it is a waste of time and effort.
- Risk management should provide a foundation for decisions regarding the acceptability of device safety and efficacy.If the risk management is not able to provide this information processes should be evaluated and reformulated on the design end.
- The selected risk management processes should be able to transfer throughout the life of the device. Risk assessments, reductions, controls and monitoring should be able evolve with the design throughout the product life cycle.
- Risk management should meet and hopefully exceed the regulatory expectations for the design.Risk management can be a tool to be applied so that the desired outcome is reached in terms of the needs of the product.

Risk has always been present in the manufacturing industry. Now that risk must be channeled within the design of products being manufactured to help manufacturing companies make better and safer products.By using risk management in the manufacturing setting companies can also not just produce a better product but a more cost-efficient one as well which ultimately benefits us all.

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