The Global Harmonization Task Force Study Group 3 issued: “Implementation of risk management principles and activities within a Quality Management System” dated May 20, 2005. The full guidance is at the link provided.
This document discusses risk management activities to be considered for each aspect of a quality system from Management Controls to Design Control through Production, Service, and CAPA.
Annexes A presents commonly used risk estimation rating tables including hazard and likelihood scales. SoftwareCPR continues to recommend that for software and other systematic (not random) errors that could be contributing factors to hazardous situations, likelihood be applied only after attempts to identify risk control measures. In other words the risk table in Annex A would be useful for residual risk evaluation after an initial attempt at risk control. SoftwareCPR believes using this table initially to determine if any risk control is needed can lead to higher risk then is reasonably practicable or in some cases acceptable.
Annex B presents a typical flowchart of risk management consistent with the concepts of ISO 14971. Again SoftwareCPR cautions against misuse of the initial risk evaluation as discussed in the preceeding paragraph.
The GHTF is a voluntary international group of representatives from medical device regulatory authoriities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. GHTF guidances are non-binding. FDA is an active participant in the GHTF.