It is ISO-14971 that determines how to carry out risk management in the manufacture of medical devices. This norm establishes the standards and specifications with which the manufacturing process must comply. The problem, however, is that these standards and specifications do not appear in the standard with a clear structure and that is why some producers find problems when putting them into practice. In the case of Triana plastic industries, our risk management process is carried out in six steps.

The six steps of the risk management process in pharmaceutical product production

1. Creation of the file and risk plan

The creation of the risk file and the risk plan in the manufacture of medical devices should be the first step in managing them.

The file is the medium where all the risk management elements are recorded, and it can take any form, from a paper file to its electronic equivalent. Its function is to offer access to the elements that you mention. Here are some of them:

  • Risk management plan
  • Product analysis
  • Preliminary risk analysis
  • Control table and risk allocation
  • Risk management reports
  • Verification of the implementation and effectiveness of risk controls

This risk file must be kept by a responsible person who oversees its maintenance and data entry; in such a way that they are consistent and reliable.

The risk management plan should be created early in the risk management process in medical device production and may contain the following elements:

  • Purpose and scope of the medical device in production.
  • Description of the product, its functions, elements of which it consists, use for which it is manufactured, etc.
  • Risk management strategy, which must ensure that the final product is as safe as possible.
  • List of risk management actions
  • Tools for risk management
  • Responsible human team


2. Preliminary risk analysis

Preliminary risk analysis in medical device production is a technique used early in the product development process. Its purpose is to help identify any type of danger or dangerous situation that may arise during the different phases of production, when the product is not yet finished.


3. Identification of risks in the production of medical devices

Immediately afterwards, the risk identification phase is entered, in which the risks are considered by the time the product is finished. For this phase to be truly effective, producers, such as IP Triana, must know all the risks associated with their product, as well as the best ways to mitigate them.


4. Estimación del riesgo

Once the risks that can be associated with the manufacture of a given medical device have been estimated, the actual estimation or analysis phase of the same arrives, which is the heart of the risk management plan. At this time, a table is drawn up that includes the risks associated with each component of the product and those of the product itself once finished.

From this moment on, specific control mechanisms can be assigned.


5. Control and risk reduction in the manufacture of medical devices

In this phase, it is determined whether it is possible to reduce and even eliminate residual risks that occur in the manufacture of medical devices. If the investigation determines that the answer is positive, new control mechanisms will be implemented.


6. Risk reports

The last step in a complete risk management process in the manufacture of medical devices is the preparation of the corresponding report, which will be detailed and will include all the risks found, analyzed, and addressed during the process.

Our commitment to risk management

IP Triana prides itself on its commitment to innovation, efficiency, and quality, which would not be possible without excellent risk management. Contact our team and entrust us with the production of your medical device.

Our goal is customer satisfaction. Do not hesitate, contact us, and entrust us with the manufacture of your pharmaceutical packaging.


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