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www.pharmacist.com DECEMBER 2015 • PharmacyToday 69
Abstract
Objectives: To explain strategies for identifying factors that contribute to medication errors and to define the process of failure mode and effects analysis (FMEA) and its role in health care quality improvement activities.
Data sources: National organizations that promote health care quality im-provement and medication safety and include discussion of FMEA. This informa-tion was supplemented with information from PubMed where appropriate.
Study selection: At the author’s discretion based on clinical relevance of the information presented to medication error prevention and the performance of FMEA.
Summary: Medication errors are an important issue facing the health care sys-tem. Experts have increasingly recognized that errors can be prevented by making the medication use system safer rather than relying on individual health care pro-viders to always perform perfectly. FMEA is a process used to proactively prevent medication errors rather than reacting to medication errors. The process allows FMEA team members to systematically evaluate the medication use process and determine the likelihood of a failure mode (i.e., an error), the likelihood that the er-ror would be detected, and the severity of the impact of the error on a patient. This information is then used to prioritize quality improvement activities and develop strategies that will improve the safety of medication use.
Conclusion: FMEA can be used to prevent medication errors in a wide range of health care settings and is a useful strategy for improving the medication use process.
Pharm Today. 2015;21(12);69–81
CPE
What could go wrong? Preventing medication errors before they happenAmerican Pharmacists Association
This manuscript was prepared by Judy Crespi Lofton, MS, on behalf of the American Pharmacists Association.
Learning objectives ■ Describe various types of medication
errors and the factors that contribute to them.
■ Explain strategies for identifying fac-tors that contribute to the occurrence of medication errors.
■ Define the process of failure mode and effects analysis (FMEA) and its role in health care quality improvement activities.
■ Describe how to use information gathered during FMEA to minimize the occurrence of medication errors, including the use of risk reduction and implementation strategies.
■ Identify common pitfalls that may occur when conducting FMEA.
The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (CPE). The ACPE Universal Activity Number assigned to this activity by the accredited provider is 0202-0000-15-228-H05-P.
Advisory board: Donna Horn, PharmD, Director, Patient Safety–Community Pharmacy, Institute for Safe Medication Practices, Horsham, PA; and Karen M. Ryle, MS, BSPharm, Associate Chief of Pharmacy, Ambulatory Care, Massachusetts General Hospital, Boston
Disclosure: Donna Horn, PharmD; Karen M. Ryle, MS, BSPharm; and APhA’s editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures, please see the APhA Accreditation Information section at www.pharmacist.com/education.
Development: This home-study continuing pharmacy education activity was developed by the American Pharmacists Association.
Accreditation informationProvider: American Pharmacists AssociationTarget audience: PharmacistsRelease date: December 1, 2015Expiration date: December 1, 2018Learning level: 2
ACPE number: 0202-0000-15-228-H05-PCPE credit: 2 hours (0.2 CEUs)Fee: There is no fee associated with this activity for members of the American Pharmacists As-sociation. There is a $25 fee for nonmembers.
www.pharmacytoday.org70 PharmacyToday • DECEMBER 2015
CPE PREVENTING MEDICATION ERRORS
ObjectivesThe purpose of this article is to explain strategies for identi-fying factors that contribute to medication errors and to de-fine the process of failure mode and effects analysis (FMEA) and its role in health care quality improvement activities.
Search methodology Data sources included national organizations that promote health care quality improvement and medication safety and include discussion of FMEA. This information was supple-mented with information from PubMed where appropriate.
BackgroundIn 2000, the Institute of Medicine (IOM) identified medica-tion errors as the most common type of health care error and reported that several thousand deaths can be attribut-ed to medication errors each year.1 This report, published as the book To Err is Human: Building a Safer Health System, led to broader recognition within the health care system that medication errors are a serious systematic problem requir-ing attention on the system level.1,2 The report stressed that errors were driven primarily by system-related factors rath-er than being the fault of individual health care providers.
The report led to the development of more robust ef-forts to prevent medication errors. The past decade has seen multiple systemwide initiatives designed to improve medication safe use, including expanded patient safety regulations from The Joint Commission (which sets annu-al National Patient Safety Goals designed to support safe medication use).
A preventable error?An oral anticoagulant is prescribed to S.R., a patient with atrial fibrillation, and S.R. subsequently experiences an intra-cranial hemorrhage (ICH). Is it possible that this event was due to a medication error?
Maybe.Novel oral anticoagulants are indicated for the reduction
of risk of stroke and systemic thromboembolism in patients with atrial fibrillation, and ICH is a known potential adverse event associated with oral anticoagulants. Therefore, it is possible that the ICH was an unfortunate adverse event.
However, appropriate prescribing of oral anticoagulants requires assessment of the patient’s risk for both stroke and bleeding. If these activities did not take place, then S.R.’s ICH may be attributed to a medication error.
According to guidelines from the American Heart As-sociation, the American College of Cardiology, and the Heart Rhythm Society, the need for anticoagulation in pa-tients with atrial fibrillation should be determined using the CHA2DS2-VASc scoring system. This system assigns one or two points for various risk factors and calculates a total score (Table 1).3 The score from the CHA2DS2-VASc system is used to determine whether patients are at low, moderate, or high risk for a stroke. According to these guidelines, it is reason-able to omit anticoagulation therapy for patients who are at low risk (score of 0). For patients at moderate risk (score of 1), clinicians can consider various approaches, including no an-tithrombotic therapy, treatment with an oral anticoagulant, or treatment with aspirin. Anticoagulation is recommended for patients who are at high risk, defined as a CHA2DS2-VASc score of 2 or greater.3
While the CHA2DS2-VASc score is used to identify pa-tients who would benefit from anticoagulation, it is impor-tant to weigh the benefits of therapy with the risks. Bleeding is the primary risk for patients receiving an oral anticoagu-lant. Bleeding risk should be assessed with the HAS-BLED tool (Table 2).4
The acronym HAS-BLED represents each of the bleeding risk factors. The HAS-BLED scores range from 0 to 9, with scores of 3 or greater indicating high risk of bleeding. Patients who are at high risk should not necessarily be excluded from treatment with an oral anticoagulant. Instead, they should be managed with extra caution and monitored more closely. Modifiable risk factors (e.g., uncontrolled hypertension, use of antiplatelet agents, nonsteroidal anti-inflammatory drugs [NSAIDs]) also should be addressed. In addition, patients should be educated about the risks of alcohol use.4
Renal function should also be assessed when prescrib-ing oral anticoagulants. Reduced doses are appropriate for patients with moderate to severe chronic kidney disease, and certain anticoagulants should be avoided in patients with end-stage disease or those who are on dialysis.3
S.R. is 68 years old but has no other risk factors on the CHA2DS2-VASc scale, indicating that his score is 1. Based on his age and use of NSAIDs and alcohol, his HAS-BLED score is 3. His renal function is normal. Therefore, he has a
Preassessment questionsBefore participating in this activity, test your knowledge by answering the following questions. These questions will also be part of the CPE assessment.
1. Which of the following actions would be considered an error of omission?a. Placing the wrong label on a prescription bottleb. Incorrectly calculating a dosage based on body weightc. Forgetting to place a warning label on a prescription bottled. Providing patients with inaccurate instructions for taking a
medication
2. How are failure modes prioritized for corrective action? a. Errors that are most likely to occur are addressed first.b. Errors that are least likely to be detected are addressed first.c. Errors that are easiest to address are corrected first.d. Errors with the highest risk priority numbers are addressed first.
3. Which of the following could be considered a drawback of FMEA?a. It is based on team members’ judgment and experiences rather
than objective assessments of the likelihood of an error to occur.b. It does not allow for prioritization of quality improvement efforts.c. It forces team members to act in “silos.”d. Individuals who are not involved in the FMEA team have no
opportunity to provide input in the process.
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CPE PREVENTING MEDICATION ERRORS
moderate stroke risk, indicating that treatment with an oral anticoagulant was an option but was not required, according to guidelines. However, he is also at high risk for bleeding, indicating that anticoagulant therapy was questionable and should only have been used with caution and thorough dis-cussion of risks and benefits.
A review of S.R.’s chart reveals that no HAS-BLED score is on file. Therefore, it appears that this information may have been overlooked when the anticoagulant was prescribed and dispensed.
Your conclusions upon reviewing S.R.’s file is that either his use of NSAIDs and alcohol should have been modified prior to implementation of anticoagulant therapy or that an-ticoagulant therapy should have been avoided at this time.
Types of medication errorsTo prevent errors, we must first understand what causes them. Quality improvement efforts that focus on address-ing a specific action of an individual health care provider are counterproductive because the individuals in the system become fearful of consequences and therefore are not forth-coming with information that could potentially be used to prevent future errors.5 Instead, voluntary reporting of medi-cation errors is now encouraged to allow for analysis of er-rors so that they can be prevented in the future. Following a serious error that results in patient harm, most organizations perform a root cause analysis (RCA) to determine what went wrong and to adjust the system to prevent it from happen-ing again. Such interventions can be effective for prevent-ing future errors of the same type. However, they do little to identify other types of errors or how to prevent errors before they happen.
What exactly is a medication error? The image of a med-ication error that often comes to mind is a wrong drug or wrong dosage error that results in harm to a patient. How-ever, many other types of errors result in suboptimal medica-
tion use and jeopardize patient safety. There are many approaches to defining and classifying
medication errors. The IOM report To Err Is Human defines an error as the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning).
The Committee on Data Standards for Patient Safety ex-panded the definition to also include errors of omission.2
The National Coordinating Council for Medication Er-ror Reporting and Prevention is even more comprehensive; it defines medication errors as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be relat-ed to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compound-ing; dispensing; distribution; administration; education; monitoring; and use.”6
Errors can be classified as errors of either omission (not doing something, such as forgetting to verify patient data) or commission (doing something you should not, such as select-ing the wrong medication from the shelf.) Another approach divides errors into four categories: knowledge-based errors, rule-based errors, action-based errors (i.e., “slips,” including technical errors), and memory-based errors.7
Knowledge-based errors occur because the provider does not know that a problem could exist. For example, not knowing that co-fluampicil contains penicillins and pre-scribing co-fluampicil to a patient who is allergic would be a knowledge-based error. On the other hand, a memory-based error occurs when the prescriber forgets that the patient is allergic to penicillin when prescribing an antibiotic. Rule-based errors include both applying a good rule improperly (e.g., overriding an alert that has important information) and applying a bad rule. Action-based errors involve doing something incorrectly, such as writing diltiazem instead of diazepam, or adding the wrong ingredient to a mixture,
Pause and reflectCould changes to the pharmacy’s system have prevented this outcome?
Table 2. Bleeding risk assessmentAbbreviation Risk factor ScoreH Uncontrolled HTN 1
AAbnormal renal or hepatic function (1 point each) 2
S Previous stroke 1
BBleeding history or disposition (anemia) 1
L Labile INRs 1E Senior adult, age > 65 y 1
DDrugs (antiplatelets, NSAIDs, or alcohol) (1 point each) 2
Total scoreAbbreviations used: HTN, hypertension, INRs, international normalized ratios; NSAIDs, nonsteroidal anti-inflammatory drug.Source: Ref. 4.
Table 1. Stroke risk assessment in atrial fibrillationAbbreviation Risk factor ScoreC Congestive heart failure/LVEF < 40% 1H Hypertension 1A2 Age ≥ 75 y 2D Diabetes 1S2 Previous stroke, TIA, TE 2
VVascular disease, prior MI, aortic plaque, PAD 1
A Age 65–74 y 1Sc Sex category: female 1
Total scoreAbbreviations used: LVEF, left ventricular ejection fraction; TIA, transient isch-emic attack; TE, thromboembolism; MI, myocardial infarction; PAD, peripheral arterial disease.Source: Ref. 3.
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CPE PREVENTING MEDICATION ERRORS
such as an infusion.7
Considering S.R.’s case, although the medication was dis-pensed correctly, it does represent a medication error that re-sulted from a variety of system factors, including prescriber and dispensing knowledge and training and requirements for prescribing and dispensing anticoagulants.
Preventing medication errorsThe health care system is complex, and multiple factors con-tribute to most errors, rather than any one single act. The 2007 IOM report Preventing Medication Errors: Quality Chasm Series described an error in which an overdose of a medica-tion resulted in the death of an infant. The child was mis-diagnosed and subsequently received a 10-fold overdose of a medication that should have been administered via I.M. injection but was administered via I.V. The report detailed many failures that occurred throughout the medication use system that allowed the error to occur (Table 3).2
It should be evident as you review the table that the er-ror could have been prevented at many steps throughout the process. An RCA can identify these sources of errors and drive quality improvement errors to prevent similar errors in the future. But, what if these errors could have been pre-vented in the first place? How can the health care system be improved to make patient care safer overall?
Using FMEA to prevent errorsFailure mode and effects analysis (FMEA) is a strategy for analyzing potential sources of medication errors before er-rors occur. The FMEA process was originally developed by the military in the 1950s and was adopted by the aerospace industry in the 1960s. It has been widely adopted by many industries since to proactively prevent errors that could have disastrous consequences. Within health care, FMEA is used to improve patient safety in numerous settings. FMEA is rec-ommended by The Joint Commission as a method for proac-tive assessments.8
FMEA looks at the design of the system to assess what could go wrong and to design processes that will prevent an error from occurring in the first place. Rather than relying on 100% accuracy of health care providers, FMEA is based on the premise that errors are likely to occur even among in-dividuals who are highly trained, competent, and conscien-tious. It acknowledges that poor judgment and human error are part of the human experience and that it is not possible to fully eliminate individual human error. Therefore, the sys-tem must be set up to compensate for the limits of human ability.5
When conducting FMEA, team members systematically identify sources of error (i.e., failure modes) and determine the potential impact of those failures (i.e., effects analysis). FMEA focuses not simply on the processes that are per-
formed to complete a task; it also analyzes the underlying systems within which the processes operate. FMEA can then identify which parts of the process and system should be ad-justed to prevent errors from occurring.9 This allows for pre-emptive action so that the system will be designed to prevent errors.
FMEA processFMEA involves several steps, as follows.
Step 1. Determine what to evaluate. The first step is to select the activity or process to be evaluated. Performing FMEA for the entire pharmacy and all its processes and sub-processes would be overwhelming and impractical. There-fore, the FMEA should address a discrete topic such as use of a high-risk medication or the introduction of a new medi-cation into the pharmacy. Alternatively, the FMEA could be based around a process such as medication ordering, dis-pensing, or administration.
Step 2. Select team members. Next, identify the mem-bers of the FMEA team. Ideally, several staff members should be involved in the FMEA process, including individuals who are involved in various steps throughout the process. For example, within a hospital, a medication-related FMEA could include administrators, pharmacy staff, physicians, residents, nurses, patient safety experts, and individuals involved in transporting the medication. In an ambulatory care setting, team members might include the pharmacy manager, head technician, purchaser, corporate leadership, and others.
FMEA teams may have a leader who directs the process and reconvenes the team at a later date to assess the effective-ness of interventions. This leader may be involved through-out the FMEA process or at an administrative level to direct the team’s activities.
Encourage team members to openly share their experi-ences, particularly if they have ever experienced a near-miss or error. It is important to stress that this information is pro-tected and shared in the spirit of collaboration and quality improvement.
Step 3. Identify the steps of the process being evaluat-ed. Depending on the complexity of the process being evalu-ated, identifying all the steps can be a lengthy process. All members of the team should be involved and reach agree-ment that the steps accurately describe the process. Creating a flowchart to map out the steps is often a useful strategy to visualize the process. This can be done with a computer pro-gram or simply by using a whiteboard or post-it notes and flip charts. Table 4 shows an example of steps that could be identified for prescribing and dispensing a medication.
Step 4. Identify the failure modes, causes, and effects. Next, the FMEA team should list all possible failure modes (i.e., anything that could go wrong) for each step in the pro-cess. For each failure mode, all possible causes should be identified.
Asking questions that are used during an RCA may be
Pause and reflectAs you review Table 3, consider what systems-level approaches could have been implemented to prevent this error from occurring.
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CPE PREVENTING MEDICATION ERRORS
helpful when the causes of the failure mode are not readily apparent. Questions to ask include the following:10
■ Why might the failure occur? ■ When might the failure occur? ■ What might cause the failure to occur? (from a process
perspective) ■ Where might the failure occur?
For example, questions to ask when assessing the failure mode of selecting the wrong drug include the following:
■ Does the drug name look or sound similar to another drug name?
■ Will a drug with a similar name be listed in close proxim-ity on computer order entry screens?
■ Is the dosage or concentration clearly listed on the pack-age?
■ Will the product be stored near another product with a similar package?
■ Could stocking processes lead to the drug being stored in the wrong location?This information should be organized in a table, similar
to the example shown in Table 5. It is important to note that this FMEA is simply an example. While many vulnerabilities are consistent among facilities, there is variability based on numerous system and process factors. FMEA must be per-formed at each individual facility to identify location-specific sources of failure and to customize the improvements need-ed to reduce the risk of errors.
Step 5. Prioritize failure modes. To determine how to target quality improvement efforts, the team should identify a risk priority number (RPN) for each failure mode. The RPN is based on the likelihood that the error would occur, the likelihood that the error would be detected, and the severity
Table 4. Example of steps in prescribing and dispensing an anticoagulantStep Description1 Patient assessment and diagnosis2 Anticoagulant selection3 Anticoagulant prescribed4 Order sent to pharmacy5 Order entered into pharmacy computer6 Pharmacist review of safety and appropriateness7 Prescription preparation8 Pharmacist verification of medication before dispensingSource: Ref. 9.
Table 3. Sources of failure in each phase of the medication use system that led to an errorPhase Element Example of failure modes that occurredPrescribing
• Patient information • Incomplete clinical information led to decision to treat infant for congenital syphilis.• Patient education and communication dynamics
• Ineffective communication occurred with parents, including language barriers about the possibility of congenital syphilis and available treatment options.
• Drug information • Insufficient drug information for a nonformulary drug that was rarely used led to a prescription being written unclearly.
Ordering
• Drug information • Insufficient drug information for a nonformulary drug that was rarely used along with an unclear prescription led to a 10-fold overdosage.
• Staff education and staffing patterns
• Lack of staff with specialized training in use of the medication in question resulted in error.
• Quality control • Lack of maximum-dose warning on computer system resulted in lack of detection of an order for a 10-fold overdosage.
Dispensing
• Quality control • Lack of maximum-dose warning on computer system resulted in a 10-fold overdos-age of a medication being prepared and dispensed.
• Labeling, packaging, and nomenclature of drug
• Lack of unit dose system led to dispensing of two full syringes of medication that did not have a warning label indicating “for I.M. use only.”
• Staff education • No staff education was given for nonformulary drug. • Drug information • Insufficient information on the volume of medication that can be safely administered
to neonates led to dispensing the medication with directions to administer five I.M. injections to neonate.
Administration • Drug information • Insufficient drug information about various forms of penicillin G along with lack of information about dosage route in drug references led staff to believe that one drug was the brand name for another drug when they were two distinct products. Because staff mistakenly thought the two drugs were the same product, they did not recognize the problem with I.V. administration and decided to administer the drug via I.V. to avoid painful injections.
• Competency • Hospital had unclear prescriptive authority definitions that created a situation in which a nurse practitioner assumed authority to change the route of administration.
• Labeling, packaging, and nomenclature
• Manufacturer’s warning indicating “I.M. only” was not prominently placed on the syringe and was not seen.
Abbreviations used: I.M., intramuscular; I.V., intravenous.Source: Ref. 2.
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CPE PREVENTING MEDICATION ERRORS
of harm if the error reached the patient. For the likelihood of occurrence, the lowest score indi-
cates that the event is very unlikely to occur, and the high-est score indicates that the event is very likely to occur. For the likelihood of detection, the lowest score indicates that the failure mode is very likely to be detected, and the highest score indicates it is very unlikely to be detected. For severity, the lowest score indicates that it is very unlikely that harm
will occur, and the highest score indicates that it is very likely that severe harm will occur. For example, if a patient receives loratadine instead of desloratadine, it is very unlikely that the patient will experience any harm. On the other hand, pre-scribing an anticoagulant to a patient with a contraindication could result in serious injury or death.
Researchers have reported using different scales to rank each item. For example, some use a 1 to 5 scale, while others use a 1 to 10 scale.9,11 An example of a scale used in one setting is shown in Table 6.11 It is important to note that because the analysis is conducted prospectively, there are no actual data upon which to base the assessment of the likelihood of oc-
Pause and reflectDo the steps and possible failure modes identified in Table 4 and Table 5 align with the processes in your institution? How would you modify the steps and failure modes for your setting?
Table 5. Example of failure mode and effects analysis for prescribing and dispensing a medicationSteps Failure mode Failure causes Failure effectsPatient assessment and diagnosis
• Incorrect diagnosis/ medication unnecessary
• Knowledge deficit, lack of needed laboratory information
• Patient receives unnecessary medication
• Contraindicated drug • Knowledge deficit, not aware of current or prior treatment, drug–disease interactions,unreliable patient history
• Patient receives contraindi-cated drug
Selection of medication to prescribe
• Selecting the wrong drug • Knowledge deficit, patient data not available
• Patient receives wrong drug
Medication prescribed • Wrong dosage, frequency, form, or route of administration
• Knowledge deficit, information about drug not available
• Overdose or subtherapeutic dose/therapy does not meet standard of care
• Unsafe concomitant therapy • Prior therapy not discontinued, inadequate drug reconciliation, drug interaction not identified
• Increased risk of adverse events
Order sent to pharmacy Order not received in pharmacy • Communication mishap • Delay in therapy• Delay in receiving/processing • Pharmacy workflow issues, inadequate
staffing, environmental factors, interruptions• Delay in therapy
• Order misunderstood • Illegible order, misunderstood abbrevia-tions, misread decimal point, sound-alike/look-alike names, faxed order unclear
• Patient receives wrong drug, wrong dose
Order entered into pharmacy computer
• Order entered incorrectly • Poorly designed software, absent/ineffec-tive alerts, look-alike drug names
• Patient receives wrong drug, wrong dose
• Order entered in the wrong patient profile
• Similar patient names, lack of second patient identifier, illegible order, poorly designed software, environmental factors/interruptions
• Delay in therapy, medication dispensed to wrong patient, wrong patient receives medication
Pharmacist review of safety and appropriateness
• Order not reviewed/evaluated by pharmacist
• Time constraints, environmental factors, interruptions
• Incorrect therapy possible, delay in therapy
• Indication/appropriateness not verified
• Lack of necessary patient information, inadequate reconciliation process
• Patient receives wrong therapy, wrong dose
• Contraindication/interactions/unsafe dose or route of administration not detected
• Knowledge deficit, nonformulary drug, lack of necessary patient information, inadequate computer alerts
• Contraindicated therapy, inappropriate therapy, wrong therapy, wrong dose
Prescription preparation
• Wrong drug, dose, concentration, drug form
• Look-alike/sound-alike drugs stored near each other, look-alike drug sent from wholesaler, label ambiguity, inappropriate preparation technique, knowledge deficit
• Patient receives wrong therapy, wrong dose
• Wrong packaging/labeling applied
• Inappropriate technique when preparing medications, knowledge deficit, environmental factors, interruptions
• Patient receives wrong therapy, wrong dose
Pharmacist verification of medication before dispensing
• Check not completed • Inadequate staffing, time constraints, inefficient workflow
• Error not detected
• Check failed to detect error • Human factors, environmental factors, check does not include review of initial order
• Error not detected
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currence or detection. Rather, the score is determined by the FMEA team members’ judgment. Each member of the team should have an opportunity to provide input on assignment of the RPN.
The three scores are then multiplied to calculate the RPN. For example, if the risk of “wrong dosage selected” has a like-lihood of occurrence of 3, a likelihood of detection of 6, and a severity of 6, then the RPN would be 3 × 6 × 6 = 108. Using a 1 to 5 scale, the lowest possible score is 1, and the highest possible value is 125. Using a 1 to 10 scale, the highest pos-sible score is 1,000. An example that focuses on the prescrib-ing and dispensing of anticoagulant medication is shown in Table 7.
After completing this process, the FMEA team can iden-tify the failure modes with the highest RPNs as the failure modes associated with the likeliness to cause the greatest harm. These failure modes should be the priorities for qual-ity improvement activities so that limited resources can be used wisely. In the example in Table 7, the top five RPNs are highlighted.
Step 6. Identify actions to reduce harm. Next, the FMEA team should develop a plan to reduce harm from the highest-ranking failure modes by analyzing each element of the pro-cess and exploring strategies that could prevent or mitigate the failure mode. Table 8 lists general strategies that can be used to reduce harm from failure modes.
Redesigning the process to reduce the likelihood of fail-ure modes requires assessing which steps in the process should be eliminated, modified, or implemented to reduce the risk. Principles of process redesign include the follow-ing:10
■ Reducing reliance on memory ■ Incorporating checklists and protocols ■ Incorporating redundancy ■ Improving information access ■ Reducing hand-offs ■ Standardizing procedures, displays, and layouts ■ Using forcing functions ■ Simplifying procedures ■ Adopting standardized forms or order sets for prescrip-
tions (practical in health care systems but not community pharmacies)
■ Adjusting workflow processes ■ Modifying environmental factors ■ Reducing interruptions
Certain types of interventions are more relevant to certain types of errors. For example, knowledge-based er-rors can be addressed through education and training or through computerized decision-support tools.7 These types of interventions may also be helpful for technical errors. Rule-based errors could be addressed by modifying the rules. Memory-based errors are often the most difficult to address but can be managed through systems that support appropriate actions, such as checklists, redundancies, and computerized systems.
Software systems that support safe use are often used as a system improvement to reduce errors. However, it is important to acknowledge that while such systems can re-duce some types of errors, they may introduce new potential sources of error and should also be carefully implemented and subjected to ongoing quality improvement efforts. New systems should also undergo FMEA prior to their implemen-tation.
Table 9 provides examples of actions that could be imple-mented to address the highest RPNs from Table 7.
Step 7. Implement the proposed changes. The FMEA team should discuss and analyze each of the proposed changes to assess whether they will change the RPN. Clearly communicate the proposed changes to all other individuals who are involved in the process, and give them an opportu-nity to provide input before the change is implemented.
After redesigning the process, conduct a FMEA on the new process and pilot test it before widespread implemen-tation to prevent creating new, unforeseen errors. Soliciting regular feedback throughout the pilot phase as well as con-ducting a formal assessment after a predetermined period are important components of the pilot phase. If the pilot proves successful, the changes can be implemented on a wid-er scale. Following widespread implementation, the process should again be reviewed to assess whether improvements in the RPN were made and determine whether the FMEA was effective. The FMEA team leader or other administrators should interview or reconvene members of the FMEA team as part of the quality improvement process for this review.
Table 6. Sample failure mode and effects analysis rating scaleOccurrence Detection Severity
Score Failure mode probability Score Likelihood of detection Score Severity of injury1 Remote (~1 in 10,000) 1 Very high (detected 9/10 times) 1 No injury, or only patient monitoring
2 Low (~1 in 1,000) 2 High (detected 7/10 times) 2Temporary injury needing additional intervention or treatment
3 Moderate (~1 in 250) 3 Medium (detected 5/10 times) 3Temporary injury with longer hospital stay or increased level of care
4 High (~1 in 100) 4 Low (detected 2/10 times) 4 Permanent effects on body functions5 Very high (~1 in 20) 5 Remote (detected 0/10 times) 5 Death or permanent loss of major body functionsSource: Ref. 11.
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Tabl
e 7.
Exa
mpl
e of
failu
re m
ode
and
effe
cts
anal
ysis
for p
resc
ribin
g an
d di
spen
sing
an
antic
oagu
lant
Step
sFa
ilure
mod
eFa
ilure
cau
ses
Failu
re e
ffect
s
Like
lihoo
d of
oc
curr
ence
(1
–10)
Like
lihoo
d of
det
ectio
n (1
–0)
Seve
rity
(1
–10)
Risk
pr
iori
ty
num
ber
(RPN
)
Actio
ns
to re
duce
oc
curr
ence
of
failu
rePa
tient
as
sess
men
t and
di
agno
sis
• Inc
orre
ct d
iagn
osis
/m
edic
atio
n un
nece
s-sa
ry
• Kno
wle
dge
defic
it, la
ck o
f nee
ded
labo
rato
ry
info
rmat
ion
• Pat
ient
rece
ives
un
nece
ssar
y
med
icat
ion
28
812
8
• Con
trai
ndic
ated
dru
g• K
now
ledg
e de
ficit,
not
aw
are
of c
urre
nt/p
rior
trea
tmen
t, dr
ug/d
isea
se in
tera
ctio
ns,
unre
liabl
e pa
tient
his
tory
• Pat
ient
rece
ives
co
ntra
indi
cate
d dr
ug
28
812
8
Sele
ctio
n of
m
edic
atio
n to
pr
escr
ibe
• Sel
ectin
g th
e w
rong
dr
ug• K
now
ledg
e de
ficit,
pat
ient
dat
a no
t ava
ilabl
e• P
atie
nt re
ceiv
es th
e w
rong
dru
g4
86
192a
Med
icat
ion
pres
crib
ed• W
rong
dru
g do
sage
, fr
eque
ncy,
form
, or
rout
e of
adm
inis
tra-
tion
• Kno
wle
dge
defic
it, in
form
atio
n ab
out d
rug
not
avai
labl
e• O
verd
ose
or
subt
hera
peut
ic d
ose/
ther
apy
does
not
mee
t st
anda
rd o
f car
e
33
872
• Uns
afe
conc
omita
nt
ther
apy
• Prio
r the
rapy
not
dis
cont
inue
d, in
adeq
uate
dr
ug re
conc
iliat
ion,
dru
g in
tera
ctio
n no
t ide
nti-
fied
• Inc
reas
ed ri
sk o
f ad
vers
e ev
ents
58
832
0a
Orde
r sen
t to
phar
mac
y• O
rder
not
rece
ived
in
phar
mac
y• C
omm
unic
atio
n m
isha
p• D
elay
in th
erap
y3
18
24
• Del
ay in
rece
ivin
g/pr
oces
sing
• Pha
rmac
y w
orkf
low
issu
es, i
nade
quat
e st
aff-
ing,
env
ironm
enta
l fac
tors
, int
erru
ptio
ns• D
elay
in th
erap
y3
18
24
• Ord
er m
isun
der-
stoo
d• I
llegi
ble
orde
r, m
isun
ders
tood
abb
revi
atio
ns,
mis
read
dec
imal
poi
nt, s
ound
-alik
e/lo
ok- a
like
nam
es, f
axed
ord
er u
ncle
ar
• Wro
ng d
rug,
w
rong
dos
e3
58
120
• Ord
er e
nter
ed
inco
rrec
tly• P
oorly
des
igne
d so
ftw
are,
abs
ent/
inef
fect
ive
aler
ts, l
ook-
alik
e dr
ug n
ames
• Wro
ng th
erap
y,
wro
ng d
ose
23
848
Orde
r ent
ered
in
to p
harm
acy
com
pute
r
• Ord
er e
nter
ed in
the
wro
ng p
atie
nt p
rofil
e• S
imila
r pat
ient
nam
es, p
oorly
des
igne
d so
ft-w
are,
env
ironm
enta
l fac
tors
/inte
rrup
tions
• Del
ay in
ther
apy,
m
edic
atio
n di
spen
sed
to w
rong
pat
ient
, w
rong
pat
ient
rece
ives
m
edic
atio
n
22
832
Phar
mac
ist
revi
ew o
f saf
ety
and
appr
opria
te-
ness
• Ord
er n
ot re
view
ed/
eval
uate
d by
pha
r-m
acis
t
• Tim
e co
nstr
aint
s, e
nviro
nmen
tal f
acto
rs,
inte
rrup
tions
• Inc
orre
ct th
erap
y
poss
ible
, del
ay in
th
erap
y
65
618
0a
• Ind
icat
ion/
appr
opri-
aten
ess
not v
erifi
ed• L
ack
of n
eces
sary
pat
ient
info
rmat
ion,
in
adeq
uate
reco
ncili
atio
n pr
oces
s• W
rong
ther
apy,
w
rong
dos
e6
88
384a
• Con
train
dica
tion/
in-
tera
ctio
ns/u
nsaf
e do
se
or ro
ute
of a
dmin
istra
-tio
n no
t det
ecte
d
• Kno
wle
dge
defic
it, n
onfo
rmul
ary
drug
, la
ck o
f nec
essa
ry p
atie
nt in
form
atio
n,
inad
equa
te c
ompu
ter a
lert
s
• Con
trai
ndic
ated
th
erap
y, in
appr
opria
te
ther
apy,
wro
ng th
erap
y,
wro
ng d
ose
68
838
4a
www.pharmacist.com DECEMBER 2015 • PharmacyToday 77
CPE PREVENTING MEDICATION ERRORS
SummaryFMEA is a risk management strategy that enables collabora-tive team efforts to proactively improve the safety and qual-ity of the medication use process. The interdisciplinary na-ture of the process allows for a more comprehensive analysis
of safety than other approaches that retrospectively review the causes of errors.
One advantage of FMEA is that it draws on team mem-bers’ experiences with near misses by allowing input on situ-ations in which errors in the process occurred but were iden-tified before they reached the patients. This allows correction of these situations before another error occurs that does reach the patient. Lessons can be learned from the team’s ex-periences that prevent harm.
Another advantage of FMEA is that it allows for iden-tification of priorities for quality improvement efforts. The collaborative and interdisciplinary nature of the process fa-cilitates acceptance of changes to the medication use process that support safety. Furthermore, the FMEA process increas-es awareness of medication safety issues.
However, while team members bring their experience with the medication use process, the FMEA process is based
Tabl
e 7.
Con
tinue
d • Wro
ng d
rug/
dose
/co
ncen
trat
ion/
drug
fo
rm
• Loo
k-al
ike/
soun
d-al
ike
drug
s st
ored
nea
r eac
h ot
her,
look
-alik
e dr
ug s
ent f
rom
who
lesa
ler,
labe
l am
bigu
ity, i
napp
ropr
iate
pre
para
tion
tech
niqu
e, k
now
ledg
e de
ficit
• Wro
ng th
erap
y,
wro
ng d
ose
33
1090
Pres
crip
tion
prep
arat
ion
Phar
mac
ist
verif
icat
ion
of
med
icat
ion
be-
fore
dis
pens
ing
• Wro
ng p
acka
ging
/la
belin
g ap
plie
d• I
napp
ropr
iate
tech
niqu
e w
hen
prep
arin
g
med
ictio
ns, k
now
ledg
e de
ficit,
env
ironm
enta
l fa
ctor
s, in
terr
uptio
ns
• Wro
ng th
erap
y,
wro
ng d
ose
33
872
• Che
ck n
ot c
ompl
eted
• Ina
dequ
ate
staf
fing,
tim
e co
nstr
aint
s,
inef
ficie
nt w
orkf
low
• Err
or n
ot d
etec
ted
26
896
• Che
ck fa
iled
to
dete
ct e
rror
• Hum
an fa
ctor
s, e
nviro
nmen
tal f
acto
rs,
chec
k do
es n
ot re
view
initi
al o
rder
• Err
or n
ot d
etec
ted
26
896
a Top
five
RPN
s
Pause and reflectDo the actions identified in Table 9 sound reasonable? Would it be feasible to implement similar changes in your practice?
Table 8. Actions to reduce harm from failure modesFailure mode
Likely to occurUnlikely to be detected
Likely to cause severe harm
Assess causes and determine if any can be eliminated or modified to reduce the likelihood of the failure mode.
Identify events that could occur prior to the failure mode that could indicate that the failure might happen.
Identify signs and symptoms that indicate a failure mode has occurred, and train staff to recognize these signs and symptoms and perform early intervention.
Add constraints to the system that cause the error to be impossible to make.
Add a step to the process to prevent the failure mode.
Provide resources, such as antidotes, at points of care where immedi-ate action may be required.
Add verification steps such as alert screens or independent double-checks.
Add technologi-cal alerts, such as adding an alarm to a device to indicate when an unsafe situ-ation is likely.
Source: Ref. 9.
www.pharmacytoday.org78 PharmacyToday • DECEMBER 2015
CPE PREVENTING MEDICATION ERRORSTa
ble
9. A
ctio
ns to
add
ress
failu
re m
odes
with
hig
hest
RPN
s
Step
sFa
ilure
mod
eFa
ilure
cau
ses
Failu
re e
ffect
s
Like
lihoo
d of
oc
curr
ence
(1
–10)
Like
lihoo
d of
det
ectio
n (1
–10)
Seve
rity
(1
–10)
Risk
pri
ority
nu
mbe
r (RP
N)Ac
tions
to re
duce
oc
curr
ence
of f
ailu
reSe
lect
ion
of
med
icat
ion
to
pres
crib
e
• Sel
ectin
g th
e w
rong
dr
ug• K
now
ledg
e de
ficit,
pa
tient
dat
a no
t av
aila
ble
• Pat
ient
rece
ives
w
rong
dru
g4
86
192
• Req
uire
dia
gno-
sis
to a
ccom
pany
pr
escr
iptio
ns, s
eek
clar
ifica
tion
dire
ctly
w
ith p
resc
riber
, add
co
mpu
ter a
lert
s fo
r lo
ok-a
like
and
soun
d-al
ike
drug
s.M
edic
atio
n pr
escr
ibed
• Uns
afe
conc
omita
nt
ther
apy
• Prio
r the
rapy
not
di
scon
tinue
d, in
adeq
uate
dr
ug re
conc
iliat
ion,
dru
g in
tera
ctio
n no
t ide
ntifi
ed
• Inc
reas
ed
risk
of a
dver
se
even
ts
58
832
0• I
mpr
ove
med
ica-
tion
reco
ncili
atio
n pr
oces
ses,
impl
emen
t sy
stem
ale
rts
that
re
quire
con
firm
atio
n of
pat
ient
sta
tus.
Phar
mac
ist r
evie
w
of s
afet
y an
d ap
-pr
opria
tene
ss
• Ord
er n
ot re
view
ed/
eval
uate
d by
pha
rmac
ist
• Tim
e co
nstr
aint
s,
envi
ronm
enta
l fac
tors
, In
terr
uptio
ns
• Inc
orre
ct
ther
apy
poss
ible
, de
lay
in th
erap
y
65
618
0• M
ake
wor
kflo
w
mod
ifica
tions
, im
-pr
ove
staf
fing
leve
ls,
doub
le-c
heck
pro
cess
.• I
ndic
atio
n/ap
prop
riate
-ne
ss n
ot v
erifi
ed• L
ack
of n
eces
sary
pa
tient
info
rmat
ion,
inad
equa
te re
conc
iliat
ion
proc
ess
• Wro
ng th
erap
y,
wro
ng d
ose
68
838
4• M
ake
wor
kflo
w
mod
ifica
tions
, req
uire
di
agno
sis
to a
ccom
-pa
ny p
resc
riptio
ns.
• Con
trai
ndic
atio
n/in
ter-
actio
ns/u
nsaf
e do
se o
r ro
ute
of a
dmin
istr
atio
n no
t det
ecte
d
• Kno
wle
dge
defic
it,
nonf
orm
ular
y dr
ug,
lack
of n
eces
sary
pat
ient
in
form
atio
n, in
adeq
uate
co
mpu
ter a
lert
s
• Con
trai
ndic
ated
th
erap
y, in
appr
o-pr
iate
ther
apy,
w
rong
ther
apy,
w
rong
dos
e
68
838
4• S
et u
p co
mpu
ter
aler
ts th
at c
heck
for
cont
rain
dica
tions
an
d fla
g th
e ne
ed fo
r pa
tient
info
rmat
ion.
www.pharmacist.com DECEMBER 2015 • PharmacyToday 79
CPE PREVENTING MEDICATION ERRORS
on team members’ subjective perceptions and judgments. Objective systematic observations of the likelihood of an er-ror or its detection are not included in the process. There-fore, FMEA should not be the only component of efforts to improve the safety of the medication use process. Rather, FMEA should be coupled with other strategies such as ongo-ing reporting of near-misses as well as thorough review of processes and procedures if an error does occur. In addition, clinical best-practice guidelines and evidence-based inter-ventions should be implemented to promote standardization and reduce errors and adverse events.12
References1. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: build-
ing a safer health system. Washington, DC: National Academy Press, Institute of Medicine; 1999.
2. Aspden P, Wolcott J, Bootman JL, Cronenwett LR, eds. Preventing medication errors: quality chasm series. Washington, DC: National Academy Press, Institute of Medicine; 2007.
3. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guide-line for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;129:2071–104.
FMEA resources FMEA Info Centre www.fmeainfocentre.com
Institute for Healthcare Improvement FMEA Tools http://app.ihi.org/Workspace/tools/fmea/AllTools.aspx
Institute for Safe Medication Practices www.ismp.org/tools/FMEA.asp
National Coordinating Council for Medication Error Reporting and Prevention www.nccmerp.org
Pause and reflectReview S.R.’s case and the actions to address failure modes in Table 9. Could some of the actions listed in Table 9 have prevented S.R.’s ICH? For example, if the system required the presence of a HAS-BLED score prior to prescribing an anticoagulant, could his ICH have been prevented? Could such changes improve the use of anticoagulants in your practice? Are they feasible changes, and what would need to happen to implement them? What other types of provider education, patient education, or system requirements could have improved the medication use process?
4. Lane DA, Lip GY. Use of the CHA(2)DS(2)-VASc and HAS-BLED scores to aid decision making for thromboprophylaxis in nonvalvular atrial fibrillation. Circulation. 2012;126:860–5.
5. Latino RJ. Optimizing FMEA and RCA efforts in health care. ASHRM Journal. 2004;24:21–28.
6. National Coordinating Council for Medication Error Reporting and Prevention. About Medication Errors. www.nccmerp.org/about-medication-errors. Accessed October 6, 2015.
7. Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009;67:599–604.
8. Joint Commission on Accreditation of Healthcare Organizations. An introduction to FMEA: using failure mode and effects analysis to meet JCAHO’s proactive risk assessment requirement. Failure Modes and Effect Analysis. Health Devices. 2002;31:223–6.
9. Institute for Healthcare Improvement. All FMEA tools. http://app.ihi.org/Workspace/tools/fmea/AllTools.aspx. Accessed October 14, 2015.
10. American Society for Healthcare Risk Management. Strategies and tips for maximizing failure mode and effect analysis in an organiza-tion. J Healthc Risk Manag. 2002;22:9–12.
11. Lago P, Bizzarri G, Scalzotto F, et al. Use of FMEA analysis to re-duce risk of errors in prescribing and administering drugs in pae-diatric wards: a quality improvement report. BMJ Open. 2012;2(6).
12. Schriefer J, Leonard MS. Patient safety and quality improvement: an overview of QI. Pediatr Rev. 2012;33:353–9.
www.pharmacytoday.org80 PharmacyToday • DECEMBER 2015
CPE PREVENTING MEDICATION ERRORS
CPE AssessmentInstructions: This assessment must be taken online; please see “CPE information” sidebar for further instructions. The online system will present these questions in random order to help reinforce the learning opportunity. There is only one correct answer to each question.
1. Which of the following actions would be considered an error of omission?a. Placing the wrong label on a prescription bottleb. Incorrectly calculating a dosage based on body
weightc. Forgetting to place a warning label on a prescription
bottled. Providing patients with inaccurate instructions for
taking a medication
2. Applying the wrong label to a prescription bottle can be classified as which of the following types of medi-cation errors?a. Knowledge-based errorb. Memory-based errorc. Rule-based errord. Action-based error
3. In the patient case S.R., which of the following actions would most likely have prevented the occurrence of his intracranial hemorrhage?a. Double-checking the patient’s weight to ensure
proper dosageb. Performing a more thorough patient assessment and
modifying risk factors before treatmentc. Verifying that the medication was appropriate based
on the patient’s diagnosisd. Confirming the prescription with the prescriber
4. Not knowing the appropriate route of administration for a specific medication can be classified as which of the following types of medication errors? a. Knowledge-based errorb. Memory-based errorc. Rule-based errord. Action-based error
5. Insufficient drug information for a nonformulary drug that is rarely used can be classified as which of the following types of medication errors?a. Knowledge-based errorb. Memory-based errorc. Rule-based errord. Action-based error
6. Which of the following pieces of information is in-cluded in a FMEA table?a. Rates of medication errors that have occurred in the
past.b. Comparisons of the facility’s error rates with rates in
other facilities. c. Likelihood that an error will be detected.d. The individual who is at fault if the error occurs.
7. What is the highest possible risk priority number that can be assigned when conducting FMEA?a. 100b. 125c. 1000d. It depends on the scale being used.
CPE informationTo obtain 2.0 contact hours (0.2 CEUs) of CPE credit for this activity, you must complete the online assessment and evaluation. A statement of credit will be awarded for a passing grade of 70% or better on the assessment. You will have two opportunities to successfully complete the as-sessment. Pharmacists who successfully complete this activity before December 1, 2018, can receive CPE credit. Your statement of credit will be available upon successful completion of the assessment and evaluation and will be stored in your My Training Page and on CPE Monitor for future viewing/printing.CPE instructions:1. Log in or create an account at pharmacist.com, and select LEARN from the top of the page; select Continuing Education, then Home Study
CPE to access the Library. 2. Enter the title of this article or the ACPE number to search for the article and click on the title of the article to start the home study. 3. To receive CPE credit, select Enroll Now or Add to Cart from the left navigation and successfully complete the assessment (with randomized
questions) and evaluation. 4. To get your CPE credit, click “Claim” on the right side of the page. You will need to provide your NABP e-profile ID number to obtain and print
your CPE transcript from CPE Monitor.Live step-by-step assistance is available Monday through Friday from 8:30 am to 5:00 pm ET at APhA Member Services at 800-237-APhA (2742) or by e-mailing education@aphanet.com.
www.pharmacist.com DECEMBER 2015 • PharmacyToday 81
CPE PREVENTING MEDICATION ERRORS
8. An important distinction between root cause analysis (RCA) and failure mode effects analysis (FMEA) is that only FMEAa. Applies to all types of medication errorsb. Is relevant to all types of health care settingsc. Seeks to prevent errors before they occurd. Can use a team approach to analyzing errors
9. Which of the following is the first step in conducting a FMEA?a. Determining what to evaluateb. Selecting FMEA team membersc. Identifying sources of errorsd. Reviewing errors that have occurred
10. How are failure modes prioritized for corrective ac-tion? a. Errors that are most likely to occur are addressed
first.b. Errors that are least likely to be detected are ad-
dressed first.c. Errors that are easiest to address are corrected first.d. Errors with the highest risk priority numbers are
addressed first.
11. Which of the following actions would best mitigate the risk of severe harm if a patient erroneously re-ceives a medication? a. Stocking medication antidotes at points of careb. Educating the patient about the purpose of the medi-
cationc. Adding warning labels to the medicationd. Requiring computerized prescription order entry
12. Which of the following actions would best mitigate the risk of a failure mode with a low likelihood of detection?a. Educating the patient about the purpose of the medi-
cationb. Adding alarms to the system that can indicate when
an error has occurredc. Adopting standardized forms or order sets for pre-
scriptionsd. Require computerized prescription order entry
13. Once an action has been selected to address the failure mode, the FMEA team should firsta. Seek input on the likely benefits of the action from
other individuals who will be involved in its imple-mentation.
b. Conduct a pilot test of the action.c. Conduct a root cause analysis.d. Implement the action throughout the organization.
14. Which of the following statements about measuring the effectiveness of a FMEA is true? a. FMEA’s effectiveness can only be measured by as-
sessing error rates before and after it is conducted.b. Effectiveness can be measured by conducting a
FMEA on the new process and calculating a new RPN.
c. FMEA is subjective; therefore, its effectiveness can-not be measured.
d. A FMEA is considered effective only if all future er-rors are eliminated.
15. Which of the following could be considered a draw-back of FMEA?a. It is based on team members’ judgment and experi-
ences rather than objective assessments of the likeli-hood of an error to occur.
b. It does not allow for prioritization of quality im-provement efforts.
c. It forces team members to act in “silos.”d. Individuals who are not involved in the FMEA team
have no opportunity to provide input in the process.
Recommended