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MEDICATION ERROR

2022
01 INTRODUCTION
Introduction

• Medication and medical errors occur throughout the United States.


• The system needs to be improved to afford patients with true quality
care.
• Health professionals, patients, and families must work together and
become educated about reducing all types of medical errors.
• 10 to18% of hospital injuries attributable to medication errors
• 44,000 to 98,000 people die in U.S. hospitals annually due to
medication errors
• $3.5 billion in annual costs in U.S. hospitals are due to medication
errors
Medication Errors

• IOM (Institute of Medicine, 2006) estimates that when all steps of


the medication administration process are taken into account,
hospitalized patients are subjected to an average of one medication
error per day.
• Studies addressing nurses’ perception of medication errors support
the existence of underreporting by nurses (Mayo & Duncan, 2004;
Stetina, Groves, & Pafford, 2005; Wolf & Serembus, 2004)
• Failure to administer a medication and administering a medication
late are the most underreported errors because some nurses
erroneously perceive that the patients will not be harmed in these
situations (Mayo & Duncan, 2004; Stetina et al., 2005)
Definition

• Medication Error : A medication error is the inappropriate or incorrect administration of a


drug that should be preventable through effective system controls.
• High Alert Medications : drugs with a high likelihood of causing serious harm.
• Adverse drug reactions : a response to a drug which is noxious and unintended, and
which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of
disease, or for the modifications of physiological function
• Adverse drug events : an injury resulting from medical intervention related to a drug,
which can be from preventable and nonpreventable causes
Medication Errors

• A medication error is the inappropriate or incorrect administration of a


drug that should be preventable through effective system controls.
• Medication errors result in pain, injury, and death.
• Medication errors usually occur more frequently than they are reported.
Medication Errors (Continued)

• Effects of medication errors


• Increased length of hospital stay
• Increased cost
• Patient disability
• Death
• Detriment to nurse’s personal and professional status, confidence, and
practice
High Alert Medications

• Medications that have been designated as high-alert drugs have the highest risk of
causing injuries due to errors.
These drugs are:

• Insulin
• Opiates
• Narcotics
• Injectable potassium
• Intravenous anticoagulants
Where it can happen?

• Anywhere …
• Based on the drug journey in the hospital …
• Purchasing – Store receiving – Pharmacy
• Pharmacy
• Outpatient
• Inpatient
• Daycare
Impact of Medication Errors

• Outcomes
• range from no effect to long-term disability or death
• Significance
• type of medication error
• health status of patient
• pharmacologic classification of drug involved
• route of drug administration,
• timing of drug administration
• cost to health care system
• damage to patient’s trust in care providers
Impact on Patient

• Factors:
• health status of patients
• magnitude of overdose
• damage as result of omission
• Financial Implications
• prolong hospital stays & increase health care expenses
• estimated to cost billions of dollars annually
• additional medical management
• legal fees & out-of-court settlements
• Never Events-not reimbursed by Medicaid
Loss of Trust

• Loss of faith in medical community


• from either experience or knowledge of event
• may choose to
• switch pharmacies or physicians
• hesitate to seek medical help
• seek nonconventional treatments from outside medical community
MEDICATION ERROR
2022
02 Causes of Medication Error
Stages of Medication Error

• First Stage : Prescribing and Ordering


• Second Stage : Dispensing
• Third Stage : Administering
The First Stage of Medication Errors

• Prescribing or ordering medication


• Errors are most prevalent when:
• Choosing a medication
• Choosing its dosage
• Choosing its schedule
The Second Stage of Medication Errors

• Dispensing of medication
• It is important to double-check medications against:
• A medication administration record (MAR)
• Another medication order
The Third Stage of Medication Errors

• Administration of medication and patient monitoring


• These are the responsibilities of the health care professional.
Additional Information

• The most common medication error concerns dosage


• Increased use of OTC drugs and herbals contribute to medication errors
• Medication errors must be reported as soon as they are noticed
Figure 8-1 Nearly half of fatal
medication errors occur in patients
older than 60 years of age.

Kasco Sandor / Shutterstock


Why Medication Errors Occur

• Use of incorrect abbreviations


• Miscommunication
• Missing information
• Lack of appropriate labeling
• Environmental factors
• Poor management
Causes of Medication Errors

• Wrong patient
• Incorrect route
• Incorrect drug
• Incorrect dose
Causes of Medication Errors

• Incorrect time
• Incorrect technique
• Incorrect information on the patient chart
Manpower
MEN adequacy,
Competency
• Machines, IT Systems,
MACHINES Technology

MATERIALS• Tools

METHODS • SOP, WI

ENVIRONMENT • Illumination, Space


Area. Cleanliness

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MEDICATION ERROR
2022
03 Drug Dose Calculations
Calculating Medication Dosages

Three Steps
1. Verify the drug available is the same
measurement system as the drug
dosage desired (convert if needed)
2. Reduce to lowest terms
3. Calculate dosage quantity to be
administered

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Drug Calculation Methods

• Fraction Method
• 600 mg = 200 mg
x tablets 1 tablet
Solve for x
• Ratios or Proportion Method
• 600 mg : x tablets :: 200 mg : 1 tablet
• Solve for x

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Drug Calculation Methods (cont.)

• Desired over Available Method

Desired units (conversion factor) x

Quantity of drug form = Quantity to give

Quantity available (x conversion factor)

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Forms of Oral Medications

• Capsules
• Cannot be broken or divided
• If amount to be given is more than 0.5, round to next whole number
• Tablets
• Only divide if scored
• Coated tablets are not to be broken
• Liquids
• May be measured in a medication cup, syringe, or calibrated dropper

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Scored and Unscored Tablets

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Parenteral Medications

• Medication available in three forms:


• Prefilled syringe labeled with specific dosage
• For example: meperidine (Demerol) 100 mg in 1 mL
• Single-dose ampule or multiple-dose vial labeled with a specific dosage per volume
• For example: epinephrine (Adrenalin) 1:1000 in 0.1 mL
• A vial with powder that requires a specific fluid be added to it to obtain a specific
dosage (Reconstitution)

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Insulin

• A critical medication that replaces the insulin not being produced by the patient’s
pancreas
• Insulin comes in a standardized measure called a “Unit”
• Smallest amounts may be given; errors are critical

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U-100 Vial

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Insulin (cont.)

• Strengths
• U-100 (100 Units of insulin per 1 mL)
• U-500 (500 Units of insulin per 1 mL)
• Preparation 5 times stronger, rarely used
• Syringe
• Calibrated in Units also
• Tuberculin syringe used in emergency
• Minims used; 16 minims = 1 mL

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U-100 Syringe

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Tuberculin Syringe

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Intravenous Medications

• Medications administered into the vein


• IV push

• IV hanging by gravity (flow rate formula)

• IV pump (mL/min or hr)

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Flow Rate Formula

• Gtts/min =
Volume to be administered × gtt factor Time in minutes

• Drop factor of tubing:


Macrodrip = 10, 15, or 20 gtt/mL
Microdrip = 60 gtt/mL

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Learning Objectives

• List the rule used to calculate medication dosages for children


• Calculate flow rates for infusions for children

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Clark’s Rule

• Formula

Weight of the child


________________ x Adult dose = Child’s dose
Weight of the adult

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Body Surface Area

• Body surface area (BSA) = the total tissue area


• A nomogram is used to easily calculate the BSA in square meters
• BSA formula
Surface area of the child (M2) × Usual adult dose
Surface area of an adult (1.73 M2) = Child’s dose

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Dimensional Analysis

• Steps
• Numbers in the dosage calculation problem are placed on a grid along with their
labels
• The labels are cross-canceled to assure only one label is left (one for answer)
• Numbers in calculation are placed along grid next to their labels

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Dimensional Analysis (cont.)

• Numbers are cross-canceled


• Numbers are multiplied across the top and bottom of the grid to yield a fraction
• The fraction is divided, and the remaining label is applied to the answer

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MEDICATION ERROR
2022
04 Strategies To Reduce Medication Error
Reducing Medication Errors

• Employ an adequate number of staff


• Use standardized measurement systems
• Use error-tracking systems
Reducing Medication Errors

• Review of original drug orders


• Compile medication profiles
• Provide suitable work environments
Reducing Errors in Health Care Facilities

• Automation allows drug storage cabinets to maintain an accurate


inventory.
• Risk management departments minimize errors and examine risks.
Reducing Errors in
Health Care Facilities

• Avoid:
• Expired medications
• Transfer of medications between containers
• Overstocking
• Dangerous abbreviations
• Reference materials that are not up to date
Results of Medication Errors

• In hospitals, medication errors are the most common causes of


morbidity and preventable death.
• Also, financial penalties may be assessed, and legal actions may result.
• Thorough investigation and documentation lead to prevention of future
errors.
Reporting Medication Errors

• Health care professionals should use the FDA’s MedWatch program to


report medication errors.
• Other related organizations include:
• National Coordination Council for Medication Error Reporting and
Preventing (NCC MERP)
• Institute for Safe Medication Practices (ISMP)
• The Joint Commission
Documenting Medication Errors

• The patient’s medical record should be updated with complete


information about medication errors.
• Incident reports (occurrence reports) should also be completed for risk
management.
Documenting Medication Errors

• Root cause analysis of documentation may be used to prevent future


errors from occurring and to reduce potential risks.
Strategies

• Assessment of patients’ use and knowledge of medications


• Planning of medication therapy and understanding of every step that
will occur
Strategies

• Implementation of all proper procedures to ensure accurate use and


monitoring
• Evaluation of correct outcomes and adverse effects
Categories of Medication Errors

• A – having capacity to cause errors


• B – occurred errors that did not reach patient
• C – errors that reached patient without harm
• D – errors that could have caused harm
• E – errors that might have caused harm and required intervention
Categories of Medication Errors

• F – errors that might have caused harm and required hospitalization


• G – errors that might have caused long-term harm
• H – errors that required intervention to sustain life
• I – errors that might have caused the patient’s death
Reconciliation of Medications

• Polypharmacy is receiving multiple medications, sometimes for the


same condition, that have conflicting actions
• It is most common in older patients
• Keeping track of patient medications as health care providers are
changed is called medication reconciliation
Safe Medication Administration

• Prescription
• Licensed providers must have authority within their state to write prescriptions
• Includes telephone/verbal orders
• Telephone orders: Write it down, read it back, get confirmation
• Verbal orders: Repeat and verify all verbal orders for accuracy

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Safe Medication Administration

• Nurses play an important role in preventing errors


• Practitioner who administers a drug shares liability for injury, even if medical order
was incorrect
• Verify safety of drug order by checking a reliable drug reference

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Institute for
Safe Medication Practice (ISMP)

• Identifies unsafe
• Abbreviations
• Acronyms
• Symbols
• Error Prone Abbreviations http://www.ismp.org/Tools/errorproneabbreviations.pdf

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“Do Not Use” List

• Joint Commission has an official “Do Not Use” list of medical abbreviations
• Official Do Not Use list
http://www.jointcommission.org/assets/1/18/Do_Not_Use_List.pdf

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Do Not Use

• “U” (unit)
• IU (international unit)
• Q.D, QD, q.d., qd (daily)
• Q.O.D, QOD, q.o.d., qod (every other day)
• SC (subcut, or subcutaneously)
• Trailing zero (X.0 mg)
• Lack of leading zero (.X mg)

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Safe Medication Administration

• Six Rights of Safe Medication Administration


1. Right patient
2. Right drug
3. Right dosage
4. Right route
5. Right frequency/time
6. Right documentation

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1. Right Patient

• Correctly identify patient prior to medication administration; of the three most common
causes of medication errors, failure to accurately identify a patient is the most common
• Joint Commission requires two (2) unique patient identifiers – neither can be the patient’s
room number
• Compare armband with medication administration record
• Ask the patient to state his name and date of birth or name and ID on arm band
• Compare picture to patient
• Technological advances to prevent errors

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Right Patient

• Tell patient at time of administration what medication and dosage is being administered –
patient has Right to Know!
• Patient may question drug or dosage
• Provides an opportunity for medication teaching

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2. Right Drug

• Check medication 3 times to ensure the right drug by checking the medication label
against the order or MAR during the administration process:
• On first contact with drug
• Prior to measuring
• Pouring, counting, or withdrawing
• After obtaining the drug, just prior to administration

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Right Drug

• Be aware of distractions
• Do not multitask during drug administration
• Use bar-coding scanning when available
• Be knowledgeable about the drug’s actions, indications, and contraindications

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3. Right Route

• Consult a drug information source to confirm correct route


• May need to change or clarify forms or routes of the drug for safe medication
administration
• NPO status
• Nasogastric or surgically inserted tubes
• Time-released or enteric-coated medications

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4. Right Frequency / Time

• Order should include frequency of administration


• Use safe abbreviations
• Joint Commission has identified q.d. as being transcribed as q.i.d.
• Q.D. needs to be written as daily

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5. Right Dose

• Illegible prescriber’s handwriting, a transcription error, miscalculation of the amount, or


misreading the label can result in errors of an incorrect dose of medication
• Carefully read and clarify drug orders
• Recheck labels
• Have two nurses double-check potent medications
• Common sources of errors
• Insulin
• Consult drug references
• Accurate dosage calculations – main purpose of course!!

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6. Right Documentation!

• The nurse MUST document administration of the drug


• If it’s not documented… it wasn’t done!
• Document AFTER administration of medication
• NEVER leave meds at patient’s bedside
• With computerized delivery system, a second scan is done as a signature
• Omitting documentation can result in over or under medication
• PRN medications is most problematic in over medication

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Computerized Systems

• CPOE – computerized physician order entry


• Avoids illegible writing
• All patients admitted to the facility receive a barcoded armband
• The eMAR and barcoding system uses mobile carts with laptops, tethered barcode
scanners, or desktop computers with wireless scanners to read barcode labels on
medications and patient armbands
• Automated Dispensing Machines
• These do NOT prevent medication errors!!!

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eMar

• The nurse views the eMAR screen and reviews the patient's medication list and verifies
with the physician orders.
• eMAR alerts the nurse about the next dose due, overdue doses, or cautions about
medications
• Nurse takes the cart to the patient, scans the medication and the patient's wristband.

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Reminders

• Check labels carefully


• Follow Six Rights of medication administration
• Be aware and adhere to facility’s policies on medication administration

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Reminders

• Check medication three times before administering


• Identify if the form is appropriate for the route
• If unsure of order, clarify prior to administration

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Reminders

• When you give a medication, you are responsible if an injury occurs even if the order was
incorrect.
• When you receive an order, make sure it is safe.
• If you are not familiar with the medication, look it up in a reliable reference such as a
Nurse’s Drug Handbook, Hospital Formulary, hospital pharmacy intranet
• YOU are the last line of defense between a safe or not safe medication administration.

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Caution

• Stay alert to the guidelines and restrictions of the Joint Commission, the ISMP,
and your own health care facility regarding abbreviations and medical notation
- Acceptable medical communication is subject to abrupt change
MEDICATION ERROR
2022
05 Incident Reporting
• Objectives
• Describe the responsibilities and procedures for reporting and investigating
• Incidents / near-miss incidents
• Spills, chemical releases
• Injuries, occupational illnesses
• Equipment or property damage
• Transportation incidents
• Fires or explosions
• Security issues

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Objectives
Describe the importance of investigations in:
• Determining the root causes of incidents
• Determining corrective and preventive actions
to prevent similar incidents.
Describe the importance of initiating
investigation immediately after the incident
situation is under control.
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• Definitions
• Incident –
• Any unplanned event or near miss occurring inside the facility boundaries affecting
employees, processes, contractor employees, or visitors.
• Any off-site events involving company products or equipment in transit or at customer
sites
• Incident Owner –
• The manager, supervisor or designated person responsible for the facility, area or
activity where the incident occurred.

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• Definitions
• OSHA Recordable Cases –
• All work related illnesses and deaths, and those work related injuries which result in:
• Loss of consciousness,
• Restriction of work or motion, transfer to another job, or require medical treatment
beyond first aid and/or use of prescription medications.
• Initial Notification–
• A brief communication providing basic details of an incident

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• Definitions

• Investigation Team –
• Consist of personnel who shall investigate and analyze the incident.
• If an incident involves contractor personnel, then non-involved contractor employees
may be included as team members.
• Management personnel knowledgeable of investigation methodologies and
techniques shall be included in the incident investigation.

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• Definitions
• First Aid –
• Any treatment and subsequent observation of minor scratches, cuts, burns, splinters,
and so forth, which do not ordinarily require medical care or use of prescription
medications.
• Such treatment and observation are considered first aid even though provided by a
physician or registered professional personnel.

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• Responsibilities
• All personnel are responsible for:
• Notifying their immediate supervisor of all incidents immediately.
• Participating in generating the initial notification
• Participating in incident investigations as needed.
• Participating in generating the investigation report
• Completing corrective and preventive actions as assigned.

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• Responsibilities
• Facility Manager or Shift Leader, or Control Room Operator is responsible for:
• Being the Incident Owner for all incidents that occur within their area of
responsibility.
• Documenting initial incident details.
• Contacting regulatory agencies if necessary.
• Assigning personnel to the incident investigation team.

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• Responsibilities
• Facility Manager or Shift Leader, or Control Room Operator is responsible for:
• Leading and conducting incident investigations.
• Communicating with Maintenance when design issues or equipment failures may be
involved in the incident.
• Defining and recommending corrective and preventive actions.
• Verifying all corrective and preventative actions assigned during the incident
investigation are completed.
• Communicating to employees incident summaries.

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• Procedure for Investigation
• An Incident Investigation shall begin immediately after securing the scene.
• If the area is quarantined, the investigation shall not commence until release of the
quarantine.
• Documents associated with the incident should be attached to incident file.
• The Investigation Team shall produce an Investigation report including corrective and
preventive actions.

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• Preparation for Investigation
• An effective incident investigation starts before an incident occurs with a well designed
investigation procedure. The following information will provide guidance when
conducting an investigation:
• ORGANIZE AN INVESTIGATION TEAM.
• As few as two or as many as four employees.
• The size of the team may vary based on the type of incident.
• Must include at least one employee of supervisor responsibility.

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• Preparation for investigation
• ASSEMBLE AN INVESTIGATION KIT.
• This kit may include a camera, paper/pens, reporting forms and any information such
as notes on investigation.
• SECURE THE ACCIDENT SCENE.
• Asses the situation to prevent additional accidents from occurring based on hazards.
• Attend to any immediate medical emergencies.
• Preserve any evidence at the scene. DO NOT ENTER AN ACCIDENT SCENE UNTIL IT
HAS BEEN CLEARED FOR SAFETY.

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• Doing the investigation:
• Identifying and collect evidence –
• This must be done quickly.

• Identifying contributing factors –


• Can include procedure violations or employee knowledge.

• Photographing the accident scene –


• Take pictures necessary to reconstruct the scene. Take close and long range.

• Sketching the accident scene –


• Will provide information that a photo will not.

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• Doing the investigation:
• Writing notes –
• Notes should be written as soon as possible while information is fresh.
• Notes, emails, communications should be initiated as soon as possible by
personnel involved in the incident
• Consider who, what, when, where, how and why.

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• Doing the investigation:
• Interviewing affected parties or witnesses –
• Prepare interview questions. Ask questions but let the employees describe their
observations. Take notes during the interview. Get facts, don’t assign blame or
criticize. Don’t focus on expense of the damages or legal issues. End the
interview on a positive note.

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• Determining root cause
• 1. REVIEW ALL EVIDENCE.
• This will include all information collected
• 2. DETERMINE THE ROOT CAUSE.
• To determine the root cause, you must first identify contributing factors (symptoms).
As an example, an employee’s action may have caused the accident, but why did the
employee perform this action.
• This could have been the result of procedural violations or lack of training.

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• Determining Corrective Actions
• 3. DEVELOP CORRECTIVE AND PREVENTIVE ACTIONS.
• A root cause may be a mechanical problem or personnel issue.
• Corrective and preventive actions are implemented to eliminate or reduce the chance
of another accident.
• Actions are determined by the following methods; input from employees, hazard
assessments, safety committees.

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• Communicating to others in the organization
• 4. COMMUNICATE RESULTS.
• To effectively communicate the findings of the investigation, a final report must be
completed.
• The Company will communicate investigation reports through a safety meeting.

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• Approval & Closure
• An Incident Report is ready for approval and closure when
• The investigation is completed,
• The root cause has been identified
• Corrective actions have been implemented.
• The Facility Manager is responsible for final closure of the incident record.

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MEDICATION ERROR
2022
06 Root Cause Analysis
Course Content

COURSE WHAT IS ROOT BENEFITS PROBLEM EXAMPLES


OBJECTIVES CAUSE? SOLVING
PROCESS

ROOT CAUSE REVIEW ADDITIONAL


“HINTS” RESOURCES

103 Root Cause Analysis


Course Objectives

Understand the
Upon completion of this
importance of
course, participants
performing root cause
should be able to:
analysis

Understand the
Identify the root cause
application of basic
of a problem using the
quality tools in the
problem solving process
problem solving process

104 Root Cause Analysis


ROOT CAUSE =
What is root cause?

The causal or contributing factors that, if


corrected, would prevent recurrence of the
identified problem

The “factor” that caused a a problem or defect and


should be permanently eliminated through process
improvement

The factor that sets in motion the cause and effect


chain that creates a problem

The “true” reason that contributed to the creation


of a problem, defect or nonconformance

105 Root Cause Analysis


What is root cause analysis?

• A standard process of:

❖ identifying a problem
❖ containing and analyzing the problem
❖ defining the root cause
❖ defining and implementing the actions required to
eliminate the root cause
❖ validating that the corrective action prevented recurrence
of problem

106 Root Cause Analysis


Benefits

By eliminating the root cause…


You save time and money!
• Problems are not repeated
– Reduce rework, retest, re-inspect, poor quality costs, etc…
• Problems are prevented in other areas
• Communication improves between groups and
• Process cycle times improve (no rework loops)
• Secure long term company performance and profits

$$ Less rework = Increased profits! $$


107 Root Cause Analysis
When should root cause analysis
be performed?

When PROBLEMS occur !!

108 Root Cause Analysis


How does it differ from what we do now?

USUAL APPROACH
Firefighting! Problem
Problem
Immediate Containment reoccurs
Identified
Action Implemented elsewhere!

PREFERRED APPROACH
Immediate Defined Solutions are
Solutions
Problem Containment Root Cause applied across
validated
Identified Action Analysis company and
with data
Implemented Process never return!

109 Root Cause Analysis


Money Talks

State the problem in terms of


dollars!
• Determine how much each occurrence of the
problem costs the company
• $$$ speaks the language of management
• Justifies any spending on root cause analysis
and corrective actions
• Prioritizes financial impact of problems

110 Root Cause Analysis


How does it work?

Defect found at “Customer”…


PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

“Customer” can be
Internal or External

111 Root Cause Analysis


How does it work?

Contain the problem…


PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Nothing is allowed to further


escape to the customer

112 Root Cause Analysis


How does it work?

Contain the root process…


PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Nothing is allowed to further


escape to the next process

113 Root Cause Analysis


How does it work?

Prevent the problem…


PROCESS PROCESS PROCESS PROCESS
A B C D

CUSTOMER

Corrective action implemented


so root cause of problem does
not occur again!

114 Root Cause Analysis


Corrective Actions

3 types of Corrective Action:

Immediate action

– The action taken to quickly fix the impact of the problem so the “customer” is not further
impacted

Permanent root cause corrective action

– The action taken to eliminate the error on the affected process or product

Preventive (Systemic) root cause corrective action

– The action taken to Prevent the error from recurring on any process or product

115 Root Cause Analysis


Examples of Corrective Actions

Immediate (step #3)


All current batch of paperwork re-inspected by another
worker for same type of problem
Permanent (step #5)
Form changed to mandate completion of certain fields

Preventive (step #5)


Similar forms with same fields used all over in
company are changed to “mandatory”

If preventive not addressed, problem will return!!

116 Root Cause Analysis


Examples of Corrective Actions

Immediate (step #3)


Part removed and replaced in product, retested

Permanent (step #5)


Product redesigned to account for part variability

Preventive (step #5)


Design process changed to require variation
analysis testing on similar supplier parts

If preventive not addressed, problem will return!!

117 Root Cause Analysis


The Difference between
Permanent vs. Preventive Corrective Actions

Permanent Preventive
• Trained employee on proper machine use • Made training a requirement to new
employees working in that area

• Changed product design to make parts • Changed design guidelines to not allow
easier to assemble manually for use of part in full scale production

• All documents that are critical to project


• Specific customer document critical to
are identified with red folders
project is identified with red folder

• Update all customers with latest software • Check for those software bugs added to
revision to fix problem checklist and performed prior to release
of software

• Fallen patient given full-time assistant to • Process developed to identify “at risk”
provide help moving around hospital patients for falls who require assistant

• Ethics training developed and provided


• Employee fired for ethical violation to all employees

118 Root Cause Analysis


Problem Solving Process

Identify
8 Problem 2

Validate Identify
Team
7 3
Problem
Follow Up Immediate
Plan Solving Action

Process
Complete Root
Plan Cause

Action
6 Plan 4

5
119 Root Cause Analysis
1
8

Step #1
2
7 3
6 4
5

Identify the Problem


Very important!

•Clearly state the problem the team is to solve


– Teams should refer back to problem statement to
avoid getting off track
•Use 5W2H approach
– Who? What? Why? When? Where? How? How Many?

120 Root Cause Analysis


1
8

Step #1
2
7 3
6 4
5

5W2H
Who? Individuals/customers associated with problem
What? The problem statement or definition
When? Date and time problem was identified
Where? Location of complaints (area, facilities, customers)

Why? Any previously known explanations


How? How did the problem happen (root cause) and
how will the problem be corrected (corrective action)?
How Many? Size and frequency of problem

121 Root Cause Analysis


1
8

Step #2
2
7 3
6 4
5

Identify Team
When a problem cannot be solved quickly by an
individual, use a team!

• Should consist of domain knowledge experts


• Small group of people (4-10) with process and
product knowledge, available time and authority to
correct the problem
• Must be empowered to “change the rules”
• Should have a designated Champion
• Membership in team is always changing!
122 Root Cause Analysis
1
8

Step #2
2
7 3
6 4
5

Key Ideas for Team Success

• Define roles and responsibilities


• Identify external customer needs
• Identify internal customer needs
• Appropriate levels of organization present
• Clearly defined objectives and outputs
• Solicit input from everyone!
• Good meeting location
– near work area for easy access to info
– quiet for concentration and avoiding distractions

123 Root Cause Analysis


1
8

Step #2
2
7 3
6 4
5

Roles and Responsibilities

• Champion: Mentor, guide and direct teams,


advocate to upper management
• Leader: day-to-day authority, calls meetings,
facilitation of team, reports to Champion
• Record Keeper: Writes and publishes minutes
• Participants: Respect all ideas, keep an open mind,
know their role within team

124 Root Cause Analysis


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Step #3
2
7 3
6 4
5

Immediate Action

• Must isolate effects of problem from customer


• Usually “Band-aid” fixes
– 100% sorting of parts
– Re-inspection before shipping
– Rework
– Recall parts/documents from customer or from storage
• Only temporary until corrective action is
implemented (very costly, but necessary)
• Must also verify that immediate action is effective

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Step #3
2
7 3
6 4
5

Verify Immediate Action

Immediate action = activity implemented to screen,


detect and/or contain the problem

• Must verify that immediate action was effective


– Run Pilot Tests
– Make sure another problem does not arise from the
temporary solutions

• Ensure effective screens and detections are in place


to prevent further impact to customer until permanent
solution is implemented.

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Step #4
2
7 3
6 4
5

Root Cause

• Brainstorm possible causes of problem with team


• Organize causes with Cause and Effect Diagram
• “Pareto” the causes to identify those most likely or
occurring most often
• Use 5 Why? method to further define the root cause
of symptoms
– May involve additional research/analysis/investigation to
get to each “Why?”
• Must identify the process that caused the problem
– if root cause is company-wide, elevate these process issues
(outside of team control) to upper management to address

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Step #5
2
7 3
6 4
5

Corrective Action Plan

• Must verify the solution will eliminate the problem


– Verification before implementation whenever possible
• Define exactly…
– What actions will be taken to eliminate the problem?
– Who is responsible?
– When will it be completed?
• Make certain customer is happy with actions
• Define how the effectiveness of the corrective action
will be measured.
– (Pareto charts, Paynter charts, check sheets, etc…)

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Step #5
2
7 3
6 4
5

Verification vs. Validation


(Before) (After)

• Verification
– Assures that at a point in time, the action taken will
actually do what is intended without causing another
problem

• Validation
– Provides measurable evidence over time that the action
taken worked properly, and problem has not recurred

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Step #6
2
7 3
6 4
5

Complete Action Plan

• Make certain all actions that are defined are


completed as planned

• If one task is still open, verification and validation is


pushed back

• If the plan is compromised, most likely the solution


will not be as effective

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Step #7
2
7 3
6 4
5

Follow Up Plan

• What actions will be completed in the future to


ensure that the root cause has been eliminated by
this corrective action?
• Who will look at what data?
• How long after the action plan will this be done?
• What criteria in the data results will determine
that the problem has not recurred?

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Step #8
2
7 3
6 4
5

Validate and Celebrate

• What were the results of the follow up?

• If problem did reoccur, go back to Step #4 and re-


evaluate root cause, then re-evaluate corrective
action in Step #5
• If problem did not reoccur, celebrate team success!

• Document savings to publicize team effort, obtain


customer satisfaction and continued management
support of teams

132 Root Cause Analysis

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