The Basics of a
Risk Management
Plan Sample.



One uses the risk management plan sample to determine safety and health risk during the product life cycle. For medical device risk management you need to consider the hazards and potential harm during the entire use of the product. This includes products that have a couple of minutes of use to products that are used for long periods of time.

The plan states your control methods to avoid the safety risks. The plan includes design elements that prevent the risk and external controls such as instructions, warnings, equipment limits, and alarms.



QMS Requirements

Some Quality Management Systems may require your systems to include risk management. This holds true for medical manufacturing. However, if your product affects public safety, you should consider implementing risk management within your company. ISO 9001 does not require risk management but ISO 14971 requires this system.

Your QMS needs to address:

  • Key activities or systems that address safety issues
  • Ensure appropriate safety issues input into the QMS
  • Review safety issue feedback and act upon it.

Your quality management system scope defines your risk management and includes

  • Applicability
  • Extent
  • Principles
  • Activities

Risk Questions and Concerns

Consider these questions when determining your risk management plan sample…

  • What are the possible risks?
  • What can go wrong?
  • How can someone get hurt?
  • If this “event” happens, what may happen?
  • After you determine the risk then analyze possible solutions?
  • What can we do to minimize this risk?
  • What can we design differently?
  • What can we do to prevent this risk from occurring?
  • How can we improve the risk information we share with the end users?

When determining your basics of risk management consider these areas during the design and development process

  • Characteristics
  • Purchasing
  • Production
  • Handling
  • Shipping
  • Servicing
  • Inspection
  • Acceptance

Hierarchy of risk control protection

  • Safety by design
  • Device features that protect the users
  • Written information such as warnings and instructions

Risk Management Plan Sample Steps.

  1. Create a policy to determine risk acceptability criteria
  2. Identify potential hazards with regards to the product
  3. Estimate the risk for each hazard
  4. Compare the estimated risk to the acceptability criteria (known as risk assessment)
  5. Implement risk control, actions to reduce the risk below the acceptable criteria
  6. Communicate the risks internally and externally
  7. Review feedback / complaints and reevaluate the plan.

Required Documentation to Support Risk Management

  • Overview risk management procedure
  • Risk Management Plan
  • Risk Acceptability criteria
  • Risk reduction action plans
  • Feedback and corrective action reviews
  • DFMEA
  • Risk Reviews

To meet medical device risk management standard you need an overview document that states how you manage risk.

  • Control the possible risks
  • Document the risk issues
  • Review the risk plan
  • Improve risk issues

The documentation must follow your documentation system.


Supplier Control

If you are a manufacturer who depends on suppliers for processing, you are the primary responsible party for risk management. You cannot blame your supplier(s) for your lack of risk management with regards to your manufactured product.

If your supplier changes or implements a new process change, as a manufacturer you must consider the risk of the change. In this case you;

  • Review the change
  • Assess if new risks have been discovered
  • Compare the estimated risk to the acceptability criteria (known as risk assessment)
  • Assure supplier implement risk control, actions to reduce the risk below the acceptable criteria

Risk Management during Design and Development

The design team designs the product to minimize the potential safety risks during the product lifetime. They try to create the design so the risk is below the acceptability criteria. Of course, it’s everyone’s benefit if the design prevents safety issues from occurring in the first place, but this is not always possible.

The risk management plan sample includes considering design prevention features and the need for future controls such as warning, instructions, and manufacturing controls. Identify risk issues starts with considering the medical device’s intended use, its characteristics and its environment.

Designers need to consider the data from post-production information of similar devices. This post production data comes from complaints and feedback from end-users.

In addition, designers should incorporate manufacturing controls and consider manufacturing controls from similar products.

During the design, the designing team considers hazards and potential hazards. They consider the devices use, features, and the environment. Not only are the designers concerned about end use but they need to be concern about the manufacturing hazards of the equipment.


Review of the Risk

The design of the risk management plan sample needs to be formally reviewed. The review includes assuring the designers addressed all hazards, potential harm, and risk. In addition, the review team assesses the control of the risks


Multiple Product Risk Assessment

If the product is use with other products then risk assessment must be given to each separate product and the combination of the products. Assess the risk to each individual unit and the product system.


Read this interview with someone who works within the occupational risk managment field.


After reviewing this article on a Risk Management Plan Sample see here for more on the ISO 9001 definition
See here for the specific definition of risk management,



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