failsafe_fmea

8/3/2019 FailSafe_FMEA

1/7

Quality risk managementprinciples areused eectively in many areas o business and government

including nance, insurance, occupational saety and public

healthand by the agencies regulating these industries.

Risk managements widespread use isnt a surprise because

every product and every process has an associated risk. But

while there are some examples o the use o quality risk man-

agement in the medical product manuacturing industry, they

are limited and do not take ull advantage o what risk manage-

ment has to oer. Ater all, inadequate or ineective quality

risk management can harm patients, product users and com-

pany value.

Fail-Safe

FMEAI 50 WordOr Le Faiintomanaerisk

putsconsumersandentireoranizationsinjeopardy.

Usinfaiuremodeandeffectsanaysis(FMEA)canhepidentifyriskbutisntenouhtoavoidpotentiadisaster.

BycombininFMEAwithothertoos,orani -zationscanensuretheirproductswontharmthepeopetheyresup-posedtohep.

Combinationofquaitytooskeep rik i check

byJosRodruez-PrezandManueE.Pea-Rodruez


2/7

January2012QP 31

Risk ManageMent


3/7

QPwww.quaityproress.com2

The current ocus o the U.S. Food and Drug Admin-

istration (FDA) on risk-based determination requires

that regulated industries dramatically improve their

understanding and use o hazard control concepts.

The appropriate use o quality risk management

can help organizations comply with regulatory require-

ments, such as good manuacturing practices or good

laboratory practices.

Quality risk management is a valuable component

o an eective quality systems ramework. It can, or

example, help guide the setting o specications and

process parameters or manuacturing, assess and mit-

igate the risk o changing a process or specication,

and determine the extent o deviation investigations

and corrective actions.

An eective quality risk management approach can

ensure a high-quality product by providing a proactive

means to identiy and control potential quality issues

during development and manuacturing. Additionally, it

can improve decision making i a quality problem arises.

exp

Risk combines the probability o occurrence o harm

with the severity o that harm. Quality risk manage-

ment supports a scientic and practical approach to

decision making during the lie cycle o a product. It

provides documented and reproducible methods to ac-

complish the quality risk management process based

on current knowledge about the probability, severity

and detectability o the risk.

But each stakeholder perceives dierent potential

harms, computes dierent probabilities and assigns

dierent severities. In relation to medical products, al-

though there are many dierent stakeholdersinclud-

ing patients, medical practitioners, government and the

industry as a wholeprotecting the patient by manag-

ing risk should always be o the utmost importance.1

The manuacture and use o any medical product

necessarily involves some degree o risk. The risk to

product quality is just one component o overall risk.

Product quality must be maintained throughout the

product lie cycle so the characteristics that are impor-

tant to product quality remain consistent.

Eective quality risk management can also acili-

tate better and more inormed decisions, assure regu-

lators o a manuacturers ability to deal with potential

risks, and positively aect the extent and level o regu-

latory oversight.

Manuacturers o regulated products are required

to have a quality management system and processes

or addressing product-related risks. These processes

or managing risk can evolve into a standalone man-

agement system. While manuacturers may choose to

maintain these two management systems separately, it

may be advantageous to integrate them because doing

so could eliminate redundancies and lead to a more e-

ective management system.

to ch h owRisk management is a complex subject because each

stakeholder places a dierent value on the probability

o harm occurring and its severity. As one o the stake-

ip

Tabets

Bisterpacks

Formedpart

Feeder

Fierbisterpacks

Sensoradjustment

Printed

adjustment

Inkribbon

Temperature

Presstime

Fiedbister

packs

Foi

Poc p Faocpco

P s

Op

Competebisterpacks

Incompetebisterpacks

Acceptedbisterpacks

Rejectedbisterpacks

Printedmateria Seaedbisterpacks

Unseaedbisterpacks

Partial proce map for tablet packagig /FIgURE1


4/7

January2012QP 33

holders, the manuacturer makes judgments relating

to the saety and perormance o a medical product,

including the acceptability o risks.

Traditionally, risk is assessed and managed in a

variety o inormal ways based on a compilation o

observations, trends and other inormation. That ap-

proach can provide useul inormation that supports

the handling o complaints, quality deects, deviations

and resource allocation. But with a more ormal ap-

proach, industry and regulators can assess and manage

risk using recognized risk management tools:

Basicriskmanagementfacilitationmethods,such

as fowcharts and check sheets.

Failuremodeandeffectsanalysis(FMEA).

Faulttreeanalysis.

Hazardanalysisandcriticalcontrolpoints(HACCP).

Hazardoperabilityanalysis.

Preliminaryhazardanalysis.

Riskrankingandltering.

These tools need to be adapted or specic uses.

Quality risk management methods and the supporting

statistical tools can be used in combination. The com-

bined use o these tools provides fexibility that can

acilitate the application o quality risk management

principles.

The degree o rigor and ormality o quality risk

management should refect available knowledge and

be commensurate with the complexity or criticality o

the issue being addressed.

sc ppochWithin pharmaceutical and medical products manuac-

turing, ew tools are more useul than FMEA. In one o

itsguidesforindustryICHQ9:QualityRiskManage -

mentthe FDA summarizes some o the most com-

mon risk management tools. Among the tools men-

tioned is FMEA.

The FDA writes in section I.2, FMEA provides or

an evaluation o potential ailure modes or processes

and their likely eect on outcomes and/or product

perormance. Once ailure modes are established, risk

reduction can be used to eliminate, contain, reduce or

control the potential ailures. FMEA relies on product

and process understanding. It methodically breaks

down the analysis o complex processes into manage-

able steps. It is a powerul tool or summarizing the im-

portant modes o ailure, actors causing these ailures

and the likely eects o these ailures.2

Furthermore, it mentions that FMEA can be used

to prioritize risks and monitor the eectiveness o

risk control activities.3 The guide denes FMEA and

discusses areas o application but does not provide a

method to carry out an eective FMEA. For that rea-

son, a systematic approach is needed.

That approach consists o three interrelated tools: a

process map, a cause and eects matrix (also called a

prioritization matrix), and an FMEA. Instead o using

the FMEA template rom the beginning o the process,

lets analyze the ailure modes or the inputs that have

a larger eect on the critical customer requirements.

Process map: As opposed to the commonly used

fowchart, the process map is a high-level tool that

ocuses on process steps, as well as their inputs and

outputs. One o the main uses o the process map is to

identiy process inputs that cause high variability.

The process map usually consists o six to 10 boxes

that represent major steps in the process. For each

step, the inputs and outputs are identied. Figure 1

shows an example o a partial process map or a tablet

packaging acility.

Cause and eects matrix: Ater the process

map is developed, the prioritization process begins.

Many companies start to ll in the FMEA template at

this stage. That isnt a good practice because in many

processes, the most critical steps are located near the

middle or toward the end o the process.

Those who use the beginning-to-end approach are

likely to be exhausted by the time they start to analyze

the critical steps. For that reason, it makes sense to

add this intermediate tool.

Risk ManageMent

a ffcv r mm pproch ur

high-quality product by provd m o

dfy d corol potetial quality iue.


5/7


A cause and eects matrixnot to be conused

with the cause and eects diagram or shboneis

used to analyze how a process input aects process

outputs. To develop a cause and eects matrix, ollow

these six steps:

1. Identiy the customer requirements and write them

in the upper columns.

2. Assign a rating on a scale with one being the least

important and 10 the most important. These ratings

are assigned rom the customers perspective.

3. Using the process map, list the process steps and

process inputs in each row.

4. For each process input, analyze how it aects each

customer requirement using the ollowing scale:

0=theinputdoesnotaffectthecustomer

requirement.

1=theinputhasahardlynoticeableeffecton

the customer requirement.

3=theinputhasamediumeffectonthecus-

tomer requirement.

9=theinputhasastronganddirecteffecton

the customer requirement.

5. Cross-multiplytheratingsfromstepstwoandfour.

For each row, multiply the value o the process in-

put and its corresponding customer requirement.

Add those cross-products at the end o each row.

6. Sort the values rom step ve in descending order.

The end product o using this tool is a list o the

process inputs that have the biggest eect on the cus-

tomer requirements. In this way, you can ocus the de-

velopment o the FMEA on those process inputs that

really matter to the customer and leave unimportant

issues or later analysis.

Eventually, you should analyze all the process in-

puts and how they could ail. But the key takeaway is

knowing where to ocus your eorts. Table 1 shows

an example o the tablet packaging cause and eects

matrix already sorted in descending order.

FMEA: Ater completing the cause and eects ma-

trix, you can start to ll in the FMEA template. Instead

o the beginning-to-end approach, analyze the ailure

modes o the inputs that are strongly related to cus-

tomer requirements.

Using the cause and eects matrix, select the pro-

cess step or input. For that process step or input, con-

sider the possible ways it could ail (the ailure mode).

Then, or each ailure mode, determine the result i it

ails (the eect).

Ater identiying the eects, make a quantitative

assessment o the severity. Typical scales range rom

one (no severity) to 10 (critical to human saety). A-

ter the severity rating is assigned, identiy the potential

causes o the ailure mode. In this stage, dont think

about causal actors or the immediate causes. Instead,

ocus on potential root causes.

These are labeled as potential causes because

causes have not come into play yet. This is one mis-

conception about an FMEA. Its dened as a proactive

tool to identiy and prevent the way in which a pro-

cess, product or system could ail. But in most cases,

r of poco co

10 9 7 7

1 2 3 4 5

Correct

amoundof

tabletsper

blisterpack

Completely

sealedblister

packs

Nobroken

tabletsin

blisterpacks

Blisterpacks

foilisnot

burned

Tota

Poc p Poc p

9 Seain Temperature 0 9 0 9 144

10 Seain Presstime 0 9 0 9 144

3 Fiin Machinespeed 9 0 3 0 111

4 Fiin Feeder 9 0 3 0 111

6 Automaticinspection Sensoradjustment 9 0 3 0 111

12 Seain Foi 0 9 0 3 102

Caue ad effect matrix /TABlE1


6/7

January2012QP 35

FMEAs are used ater the ailure has occurred. That

issue will be addressed later.

Ater you identiy the potential root causes, rate

the probability o occurrence on a scale rom one (low

probability o occurrence) to 10 (high probability o

occurrence). Then determine the current controls used

to detect causes or ailures and rate their eectiveness

on a scale rom one (controls are 100% eective) to 10

(controls are not eective).

At this point, you can calculate the risk priority num-

ber (RPN) by multiplying the severity, occurrence and

detectability indices. But thats not the end o the FMEA

process. The next step is to sort the table in descending

order o RPNs. In that way, the inputs with higher RPNs

(most critical to the customer) will be located at the top

o the table, while those with lower RPNs (least critical

to the customer) will be toward the bottom o the table.

Not sorting RPNs rom highest to lowest is another

error many organizations make. This is the essence o

the FMEAto prioritize eorts to prevent the most crit-

ical inputs to ailure. It does not mean you wont man-

age the least critical inputs; its a matter o prioritizing.

This is aligned with what the FDA expects: that an

organizations actions are commensurate with the risk

to and impact on patient saety.

Ater calculating and sorting the RPNs, the real

work begins. At this stage, its possible to identiy and

implement actions to reduce the RPN. Ater those

actions are implemented, the new RPN must be cal-

culated. This is the undamental nature o the FMEA

processcontinuous improvement. Table 2 shows an

example o an FMEA or a tablet packaging process.

m h

At this point, you can integrate the FMEA process with

one o the systems used most requently by an FDA-

Risk ManageMent

Pocp/p

Pofod

Pofffc

s

eveity

Poc

Oc

cuece

Ccoo

D

etectio

rPn aco

codd

re

poibility

aco

s

eveity

Occuece

D

etectio

rPn

Whatistheprocessstep/input

underinvestigation?

Inwhatwaysdoesthekeyinput

gowrong?

Whatistheimpactonthekey

outputvariables(customer

requirements)orinternal

requirements?

How

severeistheeffecttothe

customer?

Whatcausesthekeyinputtogo

wrong?

How

oftendoescauseoffailure

modeoccur?

Whataretheexistingcontrols

andprocedures(inspectionand

test)thatpreventthecauseof

thefailuremode?should

icludeasOPumbe.

How

wellcanyoudetectcause

orfailuremode?

Whataretheactionsfor

reducingtheoccurrencesofthe

Causeorimprovingdetection?

Whosresponsibleforthe

recommendedaction?

Whatarethecompletedactions

takenwiththerecalculated

RPN?Beuetoiclude

completiomoth/yea.

Seain/temperature

Temp.toohih

Burnedbisterpack

10Wronsettin

6Vericationofbatchrecord

7 420

Provide

infraredtemperaturedevicetooperator

M.Pea

Temperature

deviceimpemented(8/11)

10 4 2 80

Seain/temperature

Temp.toohih

Bisterpacknotseaedcompetey

9Wronsettin

6

Vericationofbatchrecord

7 378

Provideinfraredtemperaturedevicetooperator

M.Pea

Temperaturedeviceimpemented(8/11)

9 4 2 72

Seain/presstime

Toomuchtime

Burnedbisterpack

10Machinenotsetpropery

5


7 350Provideavisuadispaytoseetimeeapsed

J.Rodriuez

Visuadispayimpemented(10/11)

10 3 2 60

Seain/presstime

Notenouhtime

Bisterpacknotseaedcompetey

9

Machinenotsetpropery

5


7 315

Provideavisuadispaytoseetimeeapsed

J.Rodriuez

Visuadispayimpemented

9 3 2 54

RPN=riskprioritynumberSOP=standardoperatinprocedure

Failure mode ad effect aalyi for tablet packagig /TABlE2


7/7


regulated industry: the corrective action and preven-

tiveaction(CAPA)system.

Many organizations devote valuable resources to

aproactiveFMEA.OthersfocusontheCAPAsystem

to manage the ailures within their processes. A select

ew get the maximum benet o combining both.

The true preventive actionsactions implemented

to eliminate the root causes o nonconormances be-

ore they occurcan be easily identied via an eec-

tive FMEA initiative. That means you can identiy the

potential ailure modes and their root causes, and then

implement the actions required to prevent the occur-

rence o those causes.

But, in an imperect world, ailures occur. When

that happens, an organization immediately activates

itsCAPAsystemtoinitiateaninvestigationgearedto

nding the root causes and implementing the appro-

priateCAPAs.4 In the vast majority o situations, those

systems work independently. But do they need to?

True preventive actions can be identied using the

FMEA tool. Then, those actions are incorporated into

the preventive action portion of the CAPA system.

When a failuredoesoccur, theCAPA system isacti-

vated. But because potential ailure modes and their

causes are part o the FMEA initiative, a disconnect ex-

ists.Forthatreason,theCAPAsystemshouldprovide

eedback to the FMEA tool to revise and update the

FMEA accordingly.

Fmea o wo

Oten, organizations ace situations in which the FDA

alertsthemofthewronguseofsometools.Hereare

excerpts rom two warning letters issued by the FDA

regarding the incorrect application o the FMEA tool

during the past decade:

1. Lack o integration o the FMEA process

with a perormance test. An organization received

customer complaints about its tubing, which was as-

sembled incorrectly. As part o the investigation, the

organization conducted a perormance test, the result

o which showed that the incorrect assembly did not

aect the product.

But the organization did not update its FMEA,

which stated that the incorrect assembly compromised

the unctionality o the device.5 As a result, it let itsel

vulnerable to uture occurrences o the same issue.

2. Lack o defnition o the FMEA indexes or

severity, occurrence and detectability. An orga-

nization received customer complaints about device

ailures, so it rushed to develop a reactive FMEA based

solely on the major cause o complaints: contamination.

When it developed the scales to rank severity, oc-

currence and detectability, it did not provide a ratio-

nale or each scale. The organization only provided the

indexes and the calculated RPN.6

These two examples show how the use o FMEA

alone isnt enough to guarantee product quality. While

FMEA is a proactive tool within an organizations risk

management system, it is a dynamic component that

must be handled correctly using the ollowing tips:

PerformanFMEAusingateamworkapproach.

Use a systematicmethod to complete the FMEA

with help rom a process map, and cause and eects

matrix.

Prioritizetheorderinwhichtheprocessinputswill

be evaluated using the FMEA tool.

SortRPNsindescendingorder.

Identifyallpotentialrootcauses.

IdentifyandimplementCAPAsforeachrootcause.

Recalculate RPNs after CAPAs are implemented,

not beore.

Doing so will ensure your FMEA is as eective as

possible and your products are sae in the hands o the

people theyre meant to help. QP

REFEREnCEs1. irol Orzo for sdrdzo, ISO 14971:2007Mdica

dvicsAppicatio o risk maamt to mdica dvics .2. U.s. Food d Dru admro, gudc for idury: Q9 Quly R

Mm, 2006.

3. ibd.

4. Jo Rodruz-Prz, CAPA or th FDA-Ratd Idstry, asQ QulyPr, 2010.

5. U.s. Food d Dru admro, RD Mdcl Mufcur ic. 2/7/11,

www.fd.ov/cc/forcmco/wrlr/ucm242822.hm.

6. U.s. Food d Dru admro, Vpohrm ic. 12-Ju-06, www.fd.

ov/cc/forcmco/wrlr/2006/ucm075943.hm.

JOS RODRguez-PRez is prsidt o Bsiss ex-cc Costi Ic. i Bayamo, Prto Rico. Hard a doctorat i scic rom th uivrsity ograada i Spai. Rodr-Pr is a sior mmbr

o ASQ ad a ASQ-crtifd qa ity ir, aditor,maar, Six Sima Back Bt, biomdica aditor,HACCP aditor ad pharmactica gMP prossioa.H is aso th athor oCaPa for h FDa-Ruld

idury (ASQ Qaity Prss, 2010).

MAnuel e. PeA-RODRguez is a costat atBsiss excc Costi Ic. H ard a JrisDoctor rom Potifca Cathoic uivrsity i Poc,Prto Rico, ad a mastrs dr i irimaamt rom Cor uivrsity i Ithaca, nY.Pa-Rodr is a sior mmbr o ASQ ad aASQ-crtifd qaity ir, aditor, maar adSix Sima Back Bt.

Risk ManageMent

failsafe_fmea

Documents