Biomedical Engineering Reference
In-Depth Information
TABLE 3.4 Auditing of the Risk Management Process [20,21]
Risk Management
Area of Scrutiny/Typical
Audit Level
Audit Questions
Policy/System
• The areas of application of QRM should be appropriately
defined in the company quality management system
• There should be an appropriate number of personnel with
relevant qualifications, experiences, and training. Their
responsibilities should be clearly defined
• Senior management is involved in the identification and
implementation of QRM principles within the company
Procedures
• Procedures exist for the Assessment Control (incl. risk reduction
and risk acceptance) and Communication of risk in various
areas within the quality management system
• Are there Regular Reviews of Risks?
• RM procedures are oriented toward patient safety
• The formality of approach should be commensurate with the
level of patient risk
• Show a logical approach to selection of methods and tools
Assessments
• Whether the QRM performed was integrated into the Quality
System?
• Was the process and documentation transparent and traceable?
• Were the formalized documented procedures followed?
• Was a risk problem or question well defined?
• Did the completed process address the risk problem/question?
• How was the decision made and documented?
• Was there appropriate communication throughout the process?
• Was a systematic approach applied?
• Were the selected methods/tools suitable?
• The key risks should have been adequately identified and
analyzed, with all relevant data having been generated and/or
considered.
• All data reviewed must be from a reliable database.
• The risk acceptance criteria must be adequate for the specific
situation in question;
• The risk-based decision(s) must be considered to be well
informed, science based and comprehensible. They must be
concordant with the preset acceptance criteria
• The assessments link to product quality
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