©JASONMcCONNELL 2025 ALL RIGHTS RESERVED
Failure Modes and effects Analysis (FMEA)
Exam Study Guide 100% Verified.
Proactive risk assessment - Answer✔increases understanding within the organization about the
complexities of process design and management and what could happen if the process fails
benefits of proactive risk assessment - Answer✔1. identification of actionable common causes
2. avoidance of unintended consequences
3. identification of commonalities across departments/services/units
4. identification of system solutions
joint commission - Answer✔has standards which require hospitals to select one high-risk
process and conduct a proactive risk assessment at least q 18 mo
- represents *minimum requirement*
FMEA is a... - Answer✔tool for proactive risk assessment
FMEA - Answer✔proactive risk assessment tool designed to promote patient safety by mapping
out the process of care, then identifying potential failures that may occur in this process, in
order to understand how and why errors or failures occur
failure modes - Answer✔different ways, or modes, in which a particular process or subprocess
step can fail to accomplish its intended purpose
effects analysis - Answer✔refers to studying the consequences of those failures
1
, ©JASONMcCONNELL 2025 ALL RIGHTS RESERVED
uses of FMEA in pharmacy - Answer✔1. clinical pharmacist interventions in ICU
2. pharmaceutical care at peds hospital DC
3. CPOE system implementation
4. gravimetric IV workflow software system
5. med admin
6. chemotherapy admin
7. drug prescribing
8. high alert drug use
9. drug shortages
10. antiretroviral therapy delivery
...and many more
FMEA process - Answer✔1. define the topic
2. assemble the team
3. graphically describe the process
4. identify failure mode for each step
5. identify the effects (severity) of each failure mode
6. identify the causes of each failure mode and how likely each is to occur
7. identify the controls in place to detect the failure and the likelihood of detectability
8. calculate the risk priority number
9. develop actions and outcome measures for highest scoring failure mode causes
10. implement actions and monitor
defining the topic - Answer✔high-risk or high-vulnerability process
- potential for safety issues, new tech, new applications of existing tech, hx of errors in the
process, potential for important regulation issues, mission-critical processes
2
Failure Modes and effects Analysis (FMEA)
Exam Study Guide 100% Verified.
Proactive risk assessment - Answer✔increases understanding within the organization about the
complexities of process design and management and what could happen if the process fails
benefits of proactive risk assessment - Answer✔1. identification of actionable common causes
2. avoidance of unintended consequences
3. identification of commonalities across departments/services/units
4. identification of system solutions
joint commission - Answer✔has standards which require hospitals to select one high-risk
process and conduct a proactive risk assessment at least q 18 mo
- represents *minimum requirement*
FMEA is a... - Answer✔tool for proactive risk assessment
FMEA - Answer✔proactive risk assessment tool designed to promote patient safety by mapping
out the process of care, then identifying potential failures that may occur in this process, in
order to understand how and why errors or failures occur
failure modes - Answer✔different ways, or modes, in which a particular process or subprocess
step can fail to accomplish its intended purpose
effects analysis - Answer✔refers to studying the consequences of those failures
1
, ©JASONMcCONNELL 2025 ALL RIGHTS RESERVED
uses of FMEA in pharmacy - Answer✔1. clinical pharmacist interventions in ICU
2. pharmaceutical care at peds hospital DC
3. CPOE system implementation
4. gravimetric IV workflow software system
5. med admin
6. chemotherapy admin
7. drug prescribing
8. high alert drug use
9. drug shortages
10. antiretroviral therapy delivery
...and many more
FMEA process - Answer✔1. define the topic
2. assemble the team
3. graphically describe the process
4. identify failure mode for each step
5. identify the effects (severity) of each failure mode
6. identify the causes of each failure mode and how likely each is to occur
7. identify the controls in place to detect the failure and the likelihood of detectability
8. calculate the risk priority number
9. develop actions and outcome measures for highest scoring failure mode causes
10. implement actions and monitor
defining the topic - Answer✔high-risk or high-vulnerability process
- potential for safety issues, new tech, new applications of existing tech, hx of errors in the
process, potential for important regulation issues, mission-critical processes
2
