Page 74 - Safety Risk Management for Medical Devices

Risk Management Process 53

11.2 RISK MANAGEMENT FILE
One of the earliest actions in the risk management process is the creation of a RMF.
The RMF is a repository of the risk management artifacts. The purpose of the RMF
is to enable easy and prompt access to the risk management artifacts. The RMF can
take any form that supports its purpose. For example, the RMF could be in paper
form, in folders and cabinets, or it can be in electronic form as a collection of files in
a computer. It can even be an index to files that are in different locations.
The RMF should have a keeper—a person who is responsible for its upkeep and
maintenance. This is particularly important after product development is concluded and
the product is released. This is because risk management is a living process which con-
tinues for as long as the product is in the market. Therefore the risk management arti-
facts are periodically updated and need to be properly filed in the RMF.
The Standard [3,7] does not prescribe a list of items that must be in the RMF. But
the following is a potential list of items that could be found in an RMF:

• RMP
• Top-Down analyses, e.g., Fault Tree Analysis
• PHA
• Design FMEAs
• Software FMEAs
• Process FMEAs
• Use-Misuse FMEA
• RACT
• RMR(s)
• Records of reviews and approvals of risk management artifacts
• Clinical Hazards List (CHL)
• Harms Assessment List (HAL)
• Benefit risk analyses
• Verifications of implementation of Risk Controls
• Verifications of effectiveness of Risk Controls
• Log of production and postproduction activities

11.3 RISK MANAGEMENT PLAN

ISO 14971 [3,7] requires that a RMP be created at the beginning of the risk manage-
ment process. The RMP should include the following elements:
1. Purpose and scope
• Scope should identify what phases of product development process are
addressed in the plan. It is possible to initially write a plan for the early