Name of Policy:

Failure Mode Analysis Process

THE UNIVERSITY OF
Policy Number:
3364-144-21 TOLEDO
Ix72
Department: Quality Management
Approving Officer: Sr. Vice President & Executive Director, VP
Responsible Agent: Administrator, Hospital Development
Effective Date: 8/20/2012
Scope: Quality Management Initial Effective Date: 111112006
___ New policy proposal
___ Major revision of existing policy
(A) Policy Statement
_--=-x-=---_ Minor/technical revision of existing policy
___ Reaffirmation of existing policy
It is the policy of University of Toledo Medical Center (UTMC) to select a high-risk process at least once every
18 months to target for Failure Mode and Effect Analysis (FMEA) review in an effort to proactively address
patient safety, risk reduction, and loss prevention.
(B) Purpose of Policy
To describe how to conduct Failure Mode Analysis (Proactive Risk Assessment)
(C) Procedure
Process Selection:
1. The Quality & Patient Safety Council will select a high-risk process to review based on the following
sources of information:
.:. Processes that affect a large percentage of our patient population;
.:. Processes that have been identified as problem-prone;
.:. Processes that do not statistically compare with benchmarking data when available;
.:. Processes with a significant potential for error;
.:. Processes that are being introduced to the system or one being reengineered;
.:. Processes that impact patient safety;
.:. Review of sentinel events, National Patient Safety G6als, and lor patient safety literature; and
.:. Communications from the Department of Health, The Joint Commission, or similar agencies.
Processes that have variable input, are complex, non-standardized, heavily dependent on human
intervention, and/or performed under tight or loose time constraints are ideal candidates for consideration.
FMEA Team:
1. A multidisciplinary team that is closely associated with the selected process shall be assigned by the Quality
and Patient Safety Council, consisting of a facilitator and subject matter experts.
FMEA Process:
1. The team will conduct reviews and document the analysis in the following steps:
.:. Describe and consecutively diagram the process .
:. Identify sub-processes .
:. Analyze and brainstorm each step for potential failure modes (breakdown) and determine their effects .
:. Prioritize the failure modes by utilizing the hazard-scoring matrix of severity and probability ratings. (as
per attachment).
Policy 3364-144-21
Failure Mode Analysis Process
Page 2
.:. IdentifY outcome measures and responsible individuals to complete the recommended actions .
:. Reassess the efficacy of the corrective actions/redesigned process.
2. Upon completion of the FMEA, the results will be reported to the Quality & Patient Safety Council and
other appropriate leadership groups within the organization.
3. The team will recommend methods of communicating the results throughout the hospital, including any
necessary education plan.
4. The team may be reconvened at any time to address issues identified with the corrective action plans.
5. Copies of the FMEA reports will be maintained in the Quality Management department.
6. FMEA is a quality review process and thereby protected from disclosure.
Healthcare FMEA Steps
STEP 1 Define the FMEA Topic
A. Define the topic of the Healthcare FMEA along with a clear definition of the process to be studied.
STEP 2 Assemble the Team
A. The team is to be multidisciplinary including Subject Matter Expert(s) and a facilitator.
STEP 3 Graphically Describe the Process - This is a tool that mayor may not be used in displaying all the
steps in the process.
A. Develop and verifY the flow diagram (this is a process vs. chronological diagram).
B. If the process is complex identifY the area of the process to focus on (take manageable bites).
C. IdentifY all sub-processes under each block of this flow diagram ..
D. Create a flow diagram composed of the sub-processes. (Hint: It is very important that all process and sub-
process steps be identified before proceeding.)
STEP 4 Conduct a Hazard Analysis
A. List all possible/potential failure modes for each component step in the process. Transfer the steps in the
process and failure modes to the FMEA Worksheet. (Hint: This is the step in the process where the
expertise and experience of the team really pays off. Use various methods including brainstorming and
cause and effect diagramming to identifY potential failure modes.)
B. Determine the potential effect of the failure mode. IdentifY the potential outcome of the failure to the
patient.
C. Determine the Frequency, Severity and Detectability of the potential failure mode and rate on a scale of 1-
10. Reference the FMEA worksheet for rating scale and record this number on the FMEA Worksheet.
D. Determine the risk priority number (Frequency x Severity x Detectability) for each failure mode and rank
from highest to lowest priority.
Policy 3364-144-21
Failure Mode Analysis Process
Page 3
STEP 5 Actions and Outcome Measures
A. Determine the priority steps in the process to be addressed, list possible proximate and root causes.
B. Determine actions and metrics. Assign responsible persons, and due dates for addressing and monitoring
baseline data collection to address problems.
C. Review results of any data collection.
D. Assign responsible party for implementing changes.
FMEA Worksheet
10 - Frequent: May happen
several times a year
7 - Occasional: May happen a
few times a year
4 - Uncommon: May happen
2 to 5 times a year
1 - Remote: May happen
sometimes in 5 to 30 years
10 - Failure that can result in death or
serious hann
7 - Failure that can cause non-serious
and/or harm significant patient
dissatisfaction and/or resulting in
expenditure of money for follow-up
care
4 - Minor event; increased length of
stay
1 - Failure not noticeable or would not
affect the delive of service
. potential FaiJure .

.. ...... . - _.. . =. ;-;:(IdentifY-:the : .. -Failure Mode
c poten'tial-failures -_- (Iden-dfythe
(
. h .-' foreach .. " potential
- e.g.; mac me step In -:
-- part) ... ' .. '-.. . .c.... ) ,._,...... outcoID.e .. o .. f.the
..... process .... '.... . ..
. ......- ... . . ... faIlure to
can be more than- . t... - t.)
one per step palen
E. Remonitor for sustainability of changes implemented.
Approved by:
Marge cFadden, RN, DNP
Administrator, Hospit 1 Development
Date
'f) <:J:) -I ().
Scott Scarborough, PhD Date
Sr. Vice President & Executive Director, UTMC
Review/Revision Completed By:
Lau/'i Oakes
Policies Superseded by This Policy: 37-21
10 - Error likely to be discovered <
50% of the time before
harming/reaching patient
7 - 50% of the time
4 -70% of the time
1 - > 90% of the time
Detect
ability
(Potential
. for
Disco"ery
FlO)
ReviewlRevision Date:
5/22/08
7/7/11
8/20112
Risk
PrioritY
Number
(RPKf

Sevfi,
Detect)
Next Review Date: 911/2015
Rank