failure mode and effect analysis workshop - · pdf filehfmea is a proactive means of assessing...

Failure Mode and EFFECT Analysis Workshop

Haifa S. Al Naimi RN, MSc, IRMcert, CPHRM, CPPS, PMP, CQA

Risk Manager

Ministry of Health

Prepared by Haifa Al Naimi RN, MSc, CQA,

CPHRM, CPPS, PMP ([email protected],

0540563941)

Haifa Al Naimi• PHC Nurse - NGHA (2007 – 2008)

• Quality & Patient Safety Specialist II- NGHA (2009 – 2012)

• Quality Specialist I-NGHA (2013 – 2016)

• Risk Manager - MOH (Oct, 2016 – now)

Education

• BSN – University of Dammam, KSA (2000/2006).

• Certified Manager , ICPM (2008-2009).

• CPHQ (2010).

• PMP (2010)

• American Board of Quality Assurance and Utilization Review Physicians ABQAURP (2010).

• MSc in Healthcare Policy and Management (Spec:QI), 2013 , UK.

• CPHRM, 2014.

• CPPS, 2016.

• Certified Quality Auditor, ASQ, 2017.

• International Certificate in ERM.

Prepared by Haifa Al Naimi RN, MSc, CQA, CPHRM, CPPS, PMP ([email protected], 0540563941)

Group Introduction تعارف

- How long in healthcare?

- How long in current position?

- What do you most hope to learn?


ه؟سنوات الخبره في الصح•

ك سنوات الخبرة في منصب•

الحالي؟

ماذا تريد أن تتعلم؟•

Benefits of Attending this Course:

• Key Tools and Concepts.

• Establishing Risk Management System.

• Preparing for professional exams in Patient Safety, Risk Managment, Project Managment.

• Job Interview.

• Leadership Position.


Introduction to -FMEA- Failure Mode and Effect Analysis Workshop

Haifa Al Naimi RN, MSc, CPPS,CPHRM,CPHQ,PMP

Prepared by Haifa Al Naimi RN, MSc, CQA,

CPHRM, CPPS, PMP ([email protected],

0540563941)

Benefits of attending FMEA Course:

• Preventive/Proactive patient safety tool.

• Certification Exams: CPHQ, CPPPS, CPHRM.

• Quality and Patient Safety Jobs interview.


http://www.google.com.sa/url?url=http://artacegypt.com/?courses%3Dcphq&rct=j&frm=1&q=&esrc=s&sa=U&ved=0ahUKEwie6IvRo6LOAhXFSBQKHWujDZoQwW4IGTAC&usg=AFQjCNH8S3k4q3GmMrgwnOIIR1YFCMZfPQ

http://www.google.com.sa/url?url=http://www.aha.org/certifcenter/CPHRM/&rct=j&frm=1&q=&esrc=s&sa=U&ved=0ahUKEwjngfDYo6LOAhUGtxQKHf_6APEQwW4IFTAA&usg=AFQjCNFiSKIW9V1pg04FLgSzdA_61p1ThQ

Course Objectives:• The participants will be Oriented to:

– FMEA tool definition.

– The steps of conducting FMEA.

– Process flow chart.

– Failure mode identification.

– Risk Scoring.

– Risk Prioritization.


FMEA

• Failure Mode: means the ways, or modes, in which something might fail.


Scenario :

• Today you got the good news that you abstract was accepted.

• On 10 Dec 2017, you are attending an international conference in Paris to present your research paper.


Process

Apply for the visa

Prepare document

Go to the appointment

Collect your visa

Check in

Book visa appointment


You booked your flight at 2 am on 9th

Dec 2017 from King Khalid International Airport


you missed your flight!!!!!!


WHAT can go wrong?

• Schengen Visa was not ready before your flight.

• Traffic to the airport (rush hour, car accident).


What can go wrong?

• Driver did not show up on time.

• Wrong passport.

• Old passport.


Analysis of the Failures


List of Failures or things that can go wrong

• Car accident.

• Visa.

• Passport.

• Strike.


What do we call this??Chances that your Visa will not be ready before Travel

Date


Probability/Likelihood ….– The probability of an event is the measure of the

chance that the event will occur as a result of an experiment.

– Examples: • The probability of weight regain after gastric band/sleeve is

>50%.

• 1 in 5 will regain their weight after the 1st year of surgery.

• The probability of employees changing their job every 5 years, is 60%.

• The probability of a smoker to get lung cancer by the age 60 is …..


Quantification التقدير الكمي لإلحتمالية


101

Rareنادر

Certainأكيد

Severity األثر:• Degree of harshness or sternness.

• Impact.


Quantification التقدير الكمي لألثر


101

Noneالضرر

Catastrophicكارثي

Let us applyProbabilityFailure

Likely

8

Schengen Visa Not ready before 9th Nov 2017

Possible6

Forgotten your passport

Possible6

Brought the Wrong Passport


Detection التنبوء بالخطر قبل وقوعه


Quantification التقدير الكمي للتنبؤ


101

Almost Certain

متيقن

Absolutely uncertainغير متيقن

Step Failure Severity Probability Detection

Way to the airport

Delay because of car accident

8 6 8

Wrong Terminal 5 6 4

Step


• Based on what you will take preventive /proactive action???


Prioritization

• FMEA Risk Priority Number (RPN) = Probability x Severity x detection

• 1 to 1000.

• Prioritize Top ones.


Step Failure

Seve

rity

Pro

bab

ility

Det

ect

ion

Risk Priority Number

Way tothe airport

Delay because of car accident

8 6 8 8x6x8 = 384

Wrong Terminal 5 6 4 5x 6 x8= 240


Healthcare Examples:


1- Accuracy of Surgical Counting:

• Process Step: Before incision Baseline count.

• Failures:

1. Counting Not Performed by two Person.

2. Instrument trays inconsistent in number of instruments.


1- Accuracy of Surgical Counting:

• Process Step: Count before skin Closure.

• Failures:

1- Added instrument are not recorded in count.

2- Confirmation bias of instrument packs.


2- Hemodialysis:

• Process Step: Intra-dialysis.

• Failures:

1- Infection.

2- Wrong Medication.

3- Missed monitoring of Patient Condition.


Group Exercise

20 minutes


Exercise 1: Identify the failures in the following

• Process 1: Order of Blood Transfusion.

• Group A - Steps:

– Obtain Informed Consent.

– Physician Order Type and Screen.


Exercise 1: Identify the failures in the following

• Process 1: Order of Blood Transfusion.

• Group B- Steps:

- Nurse complete the form, for type and screen or type and cross match.

- Nurse attached the informed consent to the request form and send to the blood bank.


FMEA


FMEA

• Failure Mode: means the ways, or modes, in which something might fail.

• E- Effect: Impact• A- Analysis:

– Probability.– Severity.– Detection.


History• Has been around for over 30 years.

• It was first developed by the US Department of Defense for use in systems design.

▪ Safety Engineers worldwide in:➢Aviation➢Nuclear power➢Aerospace➢Chemical process industries➢Automotive industries


Why Use FMEA?

▪ Aimed at prevention of failure.

▪ Doesn’t require previous bad experience or close call.

▪ Makes systems more robust (less prone to systemic failures).

▪ Focuses on how and when a system FMEA will fail, not IF it will fail.


Rationale for FMEA in Healthcare

Historically…

▪ Accident prevention has not been a primary focus of hospital medicine.

▪ Misguided reliance on “faultless” performance by healthcare professionals.

▪ Complex hospital systems were not designed to prevent or absorb errors; they are reactively changed and are not typically proactive.


• “Action Today can Prevent Crises Tomorrow”

quote


Highly Reliable Organization

• Principle:

– Preoccupation with Failures.


Tools of Change

Least

EffectiveMost

Effective

Forcing

Functions

Automation,

Computerization

Protocols, Pre-

Printed Orders

Standardization

Checklists

Information

Education

Rules & Double-

Checking

Effectiveness Scale

Inspection

Auditing

Proactive

Reactive

HFMEA is a proactive

means of assessing &

decreasing risk in your

organization!

Proactive Risk Assessment

(FMEA, HFMEA)


Examples From Healthcare for High Risk Processes:

• Medication Use

• Operative and other procedures.

• Blood use and blood components.

• Restraints.

• Care provided to high-risk population.

• Emergency or resuscitation care.


Typical Medications Used for FMEAs:

• Narcotics.

• Chemotherapy.

• Anticoagulant.

• Insulin.

• Neonatal medications.


FMEA Steps:

Let us go systematic


1- Select a Process:

• Select processes with high potential for having an adverse impact on the safety of individuals served.

• Use data.


Select High Risk Process:

Sources:

• SRS –Safety Reporting System.

• Brainstorms.

• Worker’s Compensation reports.

• Literature.

• Sentinel Event Alerts.

• Infection Control data.

• JCI.


The Example:

• Narcotic Drug Use Process.


2- Assemble Team.

• Multidisciplinary group who have hands-on experience with the selected process/procedure

– Include physicians!

• QM/RM role

– May be multifaceted

– CAUTION: Leader/Facilitator


Team

• Leader: Pharmacy.• Facilitator : Quality. • Scribe / Recorder: Pharmacist.(role change)• Process experts Process experts: Pharmacist. Include all areas involved in the process:

– Logistics.– Physicians.– Pharmacy aid.– Nurse.

• “Outsider”.– Admission office.

• Naïve person.• 6-10 optimal number.


3- Diagram The Process:

• Pick a manageable portion of the process .

• Example: Medication---Prescribing phase.

• Define beginning and end of process under analysis.

• Chart the process as it is normally done.


Narcotic Drug Use Process

Receive drug from pharmacy Vendor

Check drug into pharmacy

Dispense to the patient care are

Document drug administration and

record waste

Administer drug to the patient

Remove from stoke one does at a time as patient request

medication


Number the basic Steps

Receive drug from pharmacy Vendor

Check drug into pharmacy

Dispense to the patient care are

Document drug administration and

record waste

Administer drug to the patient

Remove from stoke one does at a time as patient request

medication

1

5 6

3

4

2


Diagram the Sub-process

Receive Request From Patient Care

are

Technician pull the narcotic drug

Narcotic and request set out to

be checked

Technician hand carries to the

patient care area

Technician assemble the drug

Pharmacist check the drug against the

request


Number the Sub-process Steps:


are



be checked


patient care area

Technician assembles the drug


request

3A

3E 3F3D

3C3B


4- Brainstorm all potential Failure Modes:

• People.

• Materials.

• Equipment.

• Methods.

• Environment.

• Failure Modes are the WHATs that could go wrong .



are

3A

Request Never Received

Pharmacy is closed

Request is blank


3C3B

Tech pulls the wrong drug

Tech does not pull the drug

Technician pulls the wrong quantity


be checked

Drug slips of the counter or falls

down

Technician forgets to set out on

counter


3D

Pharmacist does not check

Pharmacist checks only part of the

request

Pharmacist checks inaccurately

3F3E

Tech grabs partial

Tech mixes drugs and requests Technician Hijacked

on the way

Technician drops the drug/request


request

Technician assembles the drug


patient care area

Tech mixes drugs and requests


Number Each Failure


are

3A

Request Never Received

Pharmacy is closed

Request is blank


3C3B

Tech pulls the wrong drug

Tech does not pull the drug

Technician pulls the wrong quantity


be checked

Drug slips of the counter or falls

down

Technician forgets to set out on

counter

1

3

2

3

2 2

1 1


5- Identify root causes of failure modes

• Focus on systems & processes, not individuals processes.

• Asks why?, not who?

• Prospective application of RCA.

• Critical to identify all root causes and their interactions.


Process Step: Technician Pulls the narcotic drugWho is

responsibl

e?

Action /

Date OR

reason for

not actingRP

N

De

tect

ion

Fre

qu

en

cy

seve

rity

Potential Effects of

Failure

Potential Cause/s of

Failure

Potential Failure Mode

Description

Failu

re M

od

e

Nu

mb

er

4808610Patient

receives the

wrong drug

Look a like

packaging

Tech pulls

the wrong

drug

1

256884Nursing Unit

runs out of

stock

storage

location too

proximal

Tech does

not pull the

drug

2


Process Step: Technician Pulls the narcotic drugWho is

responsible?

Action / Date

OR reason for

not actingRP

N

Det

ect

ion

Fre

qu

ency

seve

rity

Potential Effects of

Failure

Potential

Cause/s of

Failure

Potential Failure

Mode DescriptionFa

ilure

Mo

de

Nu

mb

er

192684Nursing unit

is over or

under stock

Illegible

handwriti

ng

Technician

pulls the

wrong

quantity

3

Technicia

n is

distracte

d

Package

are in

random

order


6- Prioritize failure modes:

• Score frequency of failure mode.

• Score detectability of failure prior to the impact of the effect being realized.

• Score severity of effect of failure mode.


7- Calculate The Risk Priority Number


Hint

• If severity = 10 always address the failure.

• Use group discussion.

• If no consensus between the team, use higher rating.

– Use reasonable worst case scenario.


7- Redesign the Process.

• Apply strategies to:– Decrease severity.

– Decrease probability.

– Increase detection.


7- Redesign The Process.

• A behavior-shaping constraint, also sometimes referred to as a forcing function or poka-yoke, is a technique used in error-tolerant design to prevent the user from making common errors or mistakes.


7- Redesign The Process

• Don’t just pick training and policy development…why??

• Go for permeant fixes when possible.

• Elimination of the step or function is very strong action.

• Sometimes you might have to accept that some failure modes are “unfixable”.


• Weaker Actions:– Actions that depend on the staff to remember what is written in the policy.

• Intermediate Actions:– Actions that depend on the staff to remember, but provide tools to help

staff.

• Strong Actions:– Actions that don’t depend on the staff to remember to do the right thing.


Weaker Actions:

• Double check.

• Posters.

• New procedure, policy, memo.

• Training.

• Additional analysis.


Intermediate Actions:

• Eliminate/reduce distractions.• Checklists.• Eliminate look a like sound a like.• Read back.• Software enhancement.• Increase staffing.• Decrease workload.• Enhance communication, documentation.


Strong Actions:

• Simplify the process.

• Standardize equipment or process to reduce variation.

• Conduct test before purchase of equipment.


Strategies examples:

MOST EFFECTIVE1. Forcing functions (Poke Yoke)2. Automation, computerization3. Protocols and preprinted orders4. Standardization (of equipment)5. Checklists 6. Rules and double-checking7. Education8. InformationLEAST EFFECTIVE


FMEA Steps

1. Select a process.2. Assemble Team.3. Diagram The Process.4. Brainstorm Potential Failure Modes and determine their effects.5. Identify the causes of failure modes.6. Prioritize Failure Modes.7. Redesign the Process.8. Analyze and test the changes.9. Implement and Monitor redesigned process.


• For Highest RPNs identified, brainstorm actions for change.

• Use effective strategies wherever possible.

• Identify responsibility for action.


Implement and Monitor redesigned Process

• Communicate reasons for change.

• Find change agent.

• Define the indicators.

• Share result.

• HRO Principle???– Sensitivity to operation.


Group Exercise 260 minutes


Each Group select 1 FMEA

1. Anticoagulant Therapy.2. Surgical Count.3. Patient Fall.4. Infant Abduction.5. Blood Transfusion.6. Code Red, Grey, Yellow.7. Food Service.8. Hemodialysis.9. Cardiac Cathetarization.


Remember

• FMEA project has no value if no recommendations are implemented.

• The critical step in FMEA is following up and making things happen.


• Start small and get success early on.

• Narrow Narrow.

• Can use different team members from the same department for different parts of the process (substitution of team players) versus RCA not able to do that.


Gains using FMEA

• Safety minded culture.

• Proactive problem resolution Proactive problem resolution.

• Robust systems.

• Fault tolerant systems Fault tolerant systems.

• Lower waste and higher quality.


Publication


• Any Question


failure mode and effect analysis workshop - · pdf filehfmea is a proactive means of assessing...

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