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Procedure Title Purpose Comments
Risk Management Policy
The purpose of the risk management policy is to define risk principles and establish a policy for the formal management of risk.
This policy is the basic corporate policy for the management of risk associated with products (under development and in the market), manufacturing processes, equipment, computer systems, product distribution, etc.
Risk Management Procedure This procedure defines a method for risk management that is applicable to formal risk management efforts. This procedure has been crafted to follow ISO14971, "Medical devices – Application of Risk Management to Medical Devices."
Failure Mode and Effect Analysis This procedure defines a process for conducting a Failure Mode and Effect Analysis (FMEA). FMEA is a structured method for evaluating the risks associated with potential failures of a system or piece of equipment.
Fault-tree Analysis This procedure defines a process for conducting a Fault-tree analysis. Fault-tree analysis is a structured method for evaluating the risks associated with potential failures of a system or piece of equipment.
Hazard Analysis and Critical Control Point Assessment This procedure defines a process for conducting a Hazard Analysis and Critical Control Point assessment (HACCP). HACCP is a risk analysis tool used to identify the risk associated with process control points by determining if variability, difference or failure could affect process reliability or effectiveness.