Biomedical Engineering Reference
In-Depth Information
TABLE 3.1 Agency-Observed General QRM Deficiencies [7]
System Level (Policy/Procedure) Deficiency
Risk Assessment Deficiency
No consideration given to QRM
Inappropriate application of QRM
Inadequate or no assessment of
impact on product quality
Improper implementation
Lack of evidence supporting decisions
Variable tolerance of risk
Lack of process understanding and/or
regulatory requirement
Systematic approach not applied to the
review of assessments.
There is a desired outcome and risk
management is used to justify it
(invalid assumptions—suit the
desired outcome)
3.2.1 General System Expectations
There is an expectation that organizations have a high level risk management
policy document that defines [8,9]:
• areas of the business where QRM will be applied;
• risk management methods/tools to be used;
• responsibilities of management and individuals engaged in risk assessments;
• who owns the risk decisions;
• how risk is documented and controlled;
• methods and timing for reviewing and communicating risk;
• standard guides on ranking and accepting risk; and
• risk management training and resourcing.
There are additional requirements that lower level tactical procedures exist,
providing evidence that risk management is imbedded into the quality manage-
ment system. Specific guidance on individual risk management tools is expected,
as are updated procedures in the following areas [10]:
• deviation management;
• investigations;
• complaints;
• change control;
• validation;
• computer systems;
• premise and equipment design and operation;
• supplier evaluation;
• annual reviews; and
• sampling.
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