Sample Medical Device SOP Page




1.1.1        HA minimizes product risk to a level that is as low as reasonably possible and acceptable to the User. The results of the Hazard Analysis are updated when new hazards are identified and as the project progresses. It is a living document that grows as the product develops and more detailed knowledge is gained.

1.1.2        Nonconformances found in incoming inspection or in-process Product which are being considered for use as is are to be analyzed for risk.

1.1.3        The HA shall be reviewed as part of the change control process to assure that approved changes do not introduce Hazards.

1.1.4        The HA shall be reviewed, as a minimum, at every Design Review to ensure that design changes have not affected Product Risk and that Hazards and mitigations are factored into the design.

1.1.5        The HA results shall be verified to be effective in reducing the risk as planned.

1.1.6        The HA shall be reviewed and updated as necessary 3 months, 6 months, and 1 year following Product release. After 1 year the review shall be conducted at approximately 1 year intervals during the life of the Product.

1.1.7        As suggested by ISO14971, it may be helpful in understanding the logic of the process to consider “Hazardous Situation” as well as “Hazard”. Theoretically, a Hazard may exist but can do no “Harm” until “Events” cause a “Hazardous Situation” to develop. An example : a “hazard” is line voltage; the “event” is vibration of the wires, the “hazardous situation” is exposed wiring (due to rubbing); the “harm” is death or serious injury by electrocution. 

1.1.8        The HA should not degenerate into semantics debates. It is more important to evaluate risks than to get all the terms applied correctly in the matrices described below.

1.1.9        Failure data obtained from similar products may be used as guidance for the Hazard Analysis.

1.1.10    Reasonably foreseeable misuse of the device shall be documented by the HA team. This documentation of qualitative and quantitative characteristics that could affect the safety of the device shall be used as input to the Hazard Analysis. The documentation shall be included in the Hazard Analysis Report.

1.1.11    Risks are reduced by identifying single point root causes of the Hazardous Situation and applying mitigations. Risk reduction has these priorities:

·         1st: Design modification

·         2nd: Protective measures

·         3d: Safety information in labeling

1.1.12    Potential Hazards typically considered in Risk Analysis include, but are not limited to:          Chemical Hazards          Mechanical Hazards          Thermal Hazards          Electrical Hazards          Radiation Hazards          Biological Hazards          Software Hazards 

1.2         Human Factors Engineering

1.2.1        The principles of Human Factors Engineering (HFE) are introduced into the analytical technique of HA. HFE evaluates scenarios that result in Use-Related Hazards. Integrating HFE with HA ensures that the determination of potential risks includes not only those typical Hazards mentioned above but also those Use ­Related Hazards associated with interactions between Users, Products, and the environment.