Risk Management File (RMF)

The Risk Management File (RMF) is the central repository of evidence/complete audit trail that confirms hazards were identified, risks were evaluated, appropriate controls were implemented, and the remaining risk is acceptable. It contains the records for all things risk management.

The RMF is a mandatory output of the risk management process, ensuring accountability and traceability for every identified risk associated with a device or process. It is conceptually similar to a Design History File (DHF) or a Technical File, as it gathers critical evidence.

Mandatory Documentation and Content

A Risk Management File (RMF) is the comprehensive collection of records and documented information that demonstrates an organization has systematically executed and maintained its Risk Management process throughout the entire product lifecycle, in accordance with standards such as ISO 14971.

The RMF is required to hold all evidence demonstrating that the risk management plan has been followed and that all required analysis and mitigation steps have been performed:

RMF Contents

The RMF contains all the evidence needed to show that hazards are identified, mitigated, and further evaluated once mitigations have been implemented.

Traceability Requirement

Specifically, the RMF must contain traceability for each hazard to the associated risk analysis, risk evaluation, risk controls, and the evaluation of residual risks.

Traceability Detail

The file does not necessarily need to be a massive collection of every associated document, but it must include clear references to those documents.

For example:

• If labeling is a risk control measure (mitigation), the RMF must include a reference to the specific label (usually by its document number).
• If verification or validation reports were generated to prove the control was effective, references to those verification or validation document numbers are required.

Required Inputs and Process Integration

The RMF documents the sequence of events and decision-making within the risk management cycle:

Risk Control Evidence

The evidence of the implementation and verification activities for all risk control measures must be made part of the RMF. This evidence must be traceable to each hazardous situation identified during the risk analysis.

Risk-Benefit Rationale

For the residual risk evaluation, the RMF must document that the risk was adequately controlled and the risk-benefit rationale determined the benefit to outweigh the risks. If the residual risk is documented as unacceptable, the design and development should be halted.

Revised Risk Documents

When new post-production data necessitates a review of the existing risk analysis, any revised copies of the risk assessment documents (including analysis, estimation, controls, and residual risk evaluation) must be documented and added to the RMF.

Lifecycle Management and Review

The RMF is essential for maintaining risk management activities throughout the life of the product and proving compliance during final review:

Ongoing Activity

Risk management is an ongoing, cyclical process, and the RMF serves as the record of this continuous activity throughout the product lifecycle.

Pre-Release Review

Prior to commercial release, a comprehensive review confirms that the entire risk management process was implemented, the post-production risk management activities are planned, and the residual risk evaluation is documented and acceptable. This review is confirmed by examining the documentation, including the Risk Management File.

New Devices

A new Risk Management File (RMF) must be established for each device type. Although documents from a similar existing device can be leveraged as a starting point, each device must have its own file with clear traceability.

Review Documentation

When the management team reviews new post-production data, the documentation of all decisions or actions taken during that review must be added to the RMF.

Analogy for Understanding the Risk Management File (RMF)

Suppose the entire Risk Management process is a courtroom trial, with the Hazard as the accused, the Risk Estimation as the severity of the crime, and the Risk Controls as the safeguards imposed by the judge. In that case, the Risk Management File (RMF) is the complete, indexed trial transcript and evidence binder.

The RMF contains the initial charges (Risk Analysis), the verdict on the inherent threat (Risk Estimation), the justification for every safety requirement applied (Risk Control measures), and the final ruling that the remaining risk is acceptable (Residual Risk Evaluation). Crucially, it doesn't just contain the final report; it contains references (traceability) to the engineering documents, validation tests, and labeling changes that prove those controls were implemented and verified, ensuring that every safety decision is permanently documented and traceable.

‍