FMEA:

THE ULTIMATE
GUIDE FOR
SUCCESSFUL RISK
MITIGATION
By Yan Kugel
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01
 TABLE OF
CONTENT

1. What is FMEA?

2. Scoring Systems

3. What is ALARP?

4. How to Perform an FMEA

5. Congratulation!

6. FMEA Process Summary

02
WHAT IS FMEA?
FMEA is a powerful and proactive tool to identify
potential failures in processes or designs. Most
importantly, it allows you to take any scenario and
evaluate how devastating it would be to your
process or the consumer. According to the result,
you can decide how to approach the potential
problem and how much resources you should
allocate to prevent it.

The FMEA goes back to the 1940s. The U.S. military

used it for identifying all possible failures in a design,
a manufacturing or assembly process of weapons
and equipment. Their main concern – safety!

What Is the Abbreviation of FMEA?

The name FMEA describes the three steps that one has to undertake to finalize the procedure
using this analysis tool:

Failure mode – What can go wrong?

Effect – If something goes wrong, what impact would it have on a process, product, or the
consumer?
Analysis – What are the repercussions, and what should we do about it?

What is FMEA?
You work in the pharmaceutical industry and responsible for the health and safety of the
consumer. You cannot sit idly and wait for unwanted events to occur. Therefore, you must be
proactive and anticipate problems before they happen and minimize the incident’s risk. By
anticipating problems, you can prevent them and prepare for worst-case scenarios that can
severely impact the consumers or the whole business, no matter how unlikely the situations to
happen.

03
 WHEN SHOULD YOU USE
FMEA?

Here are some of the scenarios where you

should use FMEA:
When you design a new process
In cases where you consider changing
something in an existing process or
product
During an investigation of deviations
Routinely through the product/process
life cycle

The last three scenarios would be the most

common for those who work in operational
pharmaceutical production.

What Factors Does the

FMEA Evaluate?
The FMEA evaluates three factors that give you the power to determine which
incidents would be the most devastating to your process, product, or the
consumer.
How drastic are the consequences of the incident (Severity)?
What is the likelihood of the failure to happen (Occurrence)?
What are the chances for you to identify failure before it happens (Detection)?

Those three factors (Severity, Occurrence, and detection) give you the power to
determine which incidents would be the most devastating to your process or the
consumer.

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04
WHAT TYPES OF FMEA
ARE THERE?
Two types of FMEA may be relevant
for you in pharmaceutical
production.

1. Design FMEA (DFMEA)

2. Process FMEA (PFMEA)

You would approach both of the types in the same way. However, the
consequences and the way you approach the results would be different.
Therefore, it is essential to understand the difference between them to apply
them correctly.

DFMEA
You would use DFMEA during the design phase of the process. It would help you identify
problems that could arise from faulty design or technological deficiencies.

As a result of the DFMEA, you could:

Eliminate failures with critical impact
Lower occurrence of failures that you can’t eliminate by improving the design of the
process
Improve detection with additional control points or by implementing alternative
detection techniques
After conducting a good DFMEA, you should be aware of the problems that may arise during
manufacturing and be ready to face them.

PFMEA
You would use PFMEA to identify and rank failures in existing processes. In contrast to
DFMEA, you cannot eliminate failures, as those are part of the designed system. However,
you can improve the system by addressing the occurrence and detectability.

05
SCORING SYSTEMS
As mentioned above, FMEA evaluates the following parameters of an event:

Severity (S)
Occurrence (O)
Detectability (D)

During the analysis, you would assign numbers to each of the parameters. The higher
the number, the worse is the scenario.

After scoring each of the categories, you will need to multiple the scores. The result
will be a number which is called Risk Priority Number (RPN).

S x O x D= RPN
The value of the RPN will tell you whether the risk is acceptable or not.
But what numbers do you need to assign?

There is no definite system that you must use. Instead, you need to choose a suitable
scoring system for your organization and the process. Therefore, a team of experts
should carefully assign the scoring based on the scientific background, product
knowledge, and experience.

06
Here are several examples of scoring methods that you can refer to:

STANDARD SCORING SYSTEM

Standard FMEA works with numbers from 1 to 10. Each number has a meaning
behind it.

SEVERITY
Table 1: Traditional ratings for Severity of failure (s)

Effects Criteria: severity of effects

1 NONE (No effects no customer
will probably not notice) None
2 Very minor (Slight annoyance)
Very Minor
3 Minor (Slight annoyance)
4 Very Low (Customer Minor
dissatisfaction)
5 Low (Customer dissatisfaction) Very Low
6 Moderate (Customer
dissatisfaction)
Low
7 High (High degree
Moderate
dissatisfaction)
8 Very High (High degree High
dissatisfaction)
9 Hazardous with warning (Safety Very High
Regulatory consequences)
Hazardous with warning
10 Hazardous without warning
(Safety Regulatory consequences) Hazardous without warning
Level 0 2 4 6 8 10

S. Afr. J. Ind. Eng. vol.24 n.2 Pretoria Jan. 2013

07
OCCURRANCE
Table 3: Traditional ratings for occurrence of failure (O)
occurrence of failure (O)
Probability of failure (Occurrence)
<1-1500,000

1-150,000
Very High: Failure is almost
1-15000
Inevitable
1-2000

1-400
High: repeated failure

1-80 Moderate: Occasional failures

1-20
Low: Relatively few failures
1-8
Remote: Failure is unlikely
1-3

>1-2

0 2 4 6 8 10

S. Afr. J. Ind. Eng. vol.24 n.2 Pretoria Jan. 2013

DETECTION
Table 3: Traditional ratings for detection (D)
ratings for detection (D)
Criteria: Likelihood of detection
by design control Absolute Uncertainty

Very remote chance of detection ver Remote

Remote chance of detection
Remote
Very low chance of detection
Very Low
Low chance of detection
Low
Moderate chance of detection
Moderate
Moderately high chance
of detection
Moderate High
High chance of detection
High
Very High chance of detection
Very High
Almost certain detection
Almost Certain

0 2 4 6 8 10

S. Afr. J. Ind. Eng. vol.24 n.2 Pretoria Jan. 2013

Now, keep in mind that FMEA was not developed with pharmaceutical
manufacturing in mind. Therefore, having a scoring system with 10 points may not
always be optimal for every case. Especially when there are not enough statistics
to back up the claims. In many instances, people argue for hours whether the
correct score should be seven rather than eight.

08
You can learn more about the original scoring system in the article- Failure effects and
resolution of modes: a novel FMEA treatise for finalizing mould designs in foundries.

We will look at calculating RPN at a later stage.

WHO INNOVATIVE SCORING SYSTEM

World Health Organization (WHO) presented has presented a guide called Deviation
Handling and Quality Risk Management. They meant the guide for manufacturers of
prequalified vaccines for supply to United Nations agencies, and it has a very interesting
scoring system:

Detection
Table 4: Innovative rating for Detection (D) by WHO
High
2
Description
Control system in place has a high
Non existent
probability of detecting the defect or
Modrate
8 4 its effects
Control system in place could detect
the defect or its effects
Control system in place has a Low
probability of detecting the defect or
its effects
There is no control system to detect
Low
6 the defect

Occurrence
Table 5: Innovative rating for Occurrence (O) by WHO
Extremely low
2

Description

Highly Improbable to occur High Low

8 4

Improbable to occur

Probable to occur

Highly probable to occur

Moderate
6

09
Severity
Table 6: Innovative rating for Severity (S) by WHO Low Moderate
2 4
Description

Minor GPM non-compliance; no possible High

6
Significant GMP Non-compliance; possible
impact on patient
Moderate impact on yield or production
capability.

Major GMP non-compliance; probable impact

on patient;
Impact on yield or production capability.

Serious GMP non-compliance; probable serious

harm or death;
Impact on yield or production capability. Critical
54

This scoring system is excellent for investigating process deviations of aseptic products, as it doesn’t
leave room for error if there is suspicion of patient harm.

Here are examples of interpretations of the RPN:

Critical Major Minor

Description

Critical if RPN value >216: you must address

the event immediately and treat it as a critical
deviation
Major if RPN value >40 and <216: You must
address it in timely manner as a major deviation
Minor if RPN value <40: You must address it in
timely manner as a minor deviation

As you can see, with this scoring system, it doesn’t matter how low the occurrence and good the
detectability are. If the risk is critical, the RPN will be critical as well. Such scoring is not very common.

Simplified Scoring System

Here is a simplified scoring system of 1 to 3 that can suffice for most scenarios during a risk
assessment of a process or a quality control deviation:

10
Detection
Table 7: Simplified rating for Detection (D) 3.0

Description 2.5

Control system in place has a high probability

of detecting the defect or its effects 2.0

Control system in place could the defect or its 1.5

effects
1.0
Control system in place has a low probability of
detecting the defect or its effects 0.5

0.0
High Moderate Low

Table 8: Simplified rating for Occurrence (O)

3.0

2.5

2.0
Description
1.5
LOW: Improbable to occur

1.0 MODERATE: Probable to occur

HIGH: Highly probable to occur
0.5

0.0
low Moderate High

Table 9: Simplified rating for Severity (S)

3.0
Description

Minor GMP Non-compliance; possible impact 2.5

on patient
patient on yield or production capability.
2.0

Significant GMP Non-compliance; possible

1.5
impact on patient
Moderate impact on yield or production
capability. 1.0

Serious GMP Non-compliance; probable serious

0.5
harm or death : Critical
impact on yield or production capability.
0.0
Minor Moderate Critical
Here is a possibility for RPN translation:

11
Here are examples of interpretations of the RPN:

Critical Major low

Description

Critical if RPN value >12: Take Immediate

action!
Major if RPN value >6 and <12: Careful
evaluation is required to confirm that risk is
tolerable: otherwise. take action!
Low if RPN value <6: Noactions or
modifications are required

To evaluate the scores that fall under ‘Moderate’ and check whether an action is required, you need to
familiarize yourself with the term ALARP.

What is ALARP?
As Low as Reasonably Practicable (ALARP) is a tolerable risk region. It is an acceptable
risk level that you cannot reduce any further without spending resources that are not
proportional to the risk. In other words, the benefit doesn’t justify the invested money,
time, and effort.

The United Kingdom’s parliament introduced this concept in 1974 as part of the Health
and Safety at Work Act, and Its goal is to maintain safe working conditions, eliminating
any risk to the health of the employees. Although ALARP has a work safety connotation,
the concept has spread to different industries worldwide, including engineering, medical
device, and pharma.

Intolerable risk: If the risk is in this region, you cannot demonstrate and must take action to
reduce the risk whatever the cost is.

Tolerable risk If the risk falls in this region, then you must perform a case-specific ALARP
(if ALARP): demonstration.

Broadly acceptable If the risk falls in this region, you can demonstrate that you achieved ALARP
risk: by referring to standards and established best practice procedures.

12
 Intolerable Risk 100%

Tolerable Risk 65%

ALARP
Broadly Acceptable Risk 40%

ALARP Illustration 15%

Using ALARP in Combination with FMEA

Here is how you can use it in combination with an FMEA – You will need to look at the
events where RPN falls between the acceptable and the not acceptable region (yellow).
Then, you will want to weigh the consequences of the harmful events against the
resources you need to invest in lowering the score.

There are no specific rules that define what risks can stay within the ALARP limit and
which you must reduce. However, there are some questions you can ask yourself to help
you reach the right decision:

1. Is best practice implemented for this process step?

2. What else can you do to reduce the risk?
3. What additional control can you introduce to the process?

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 After you have mapped the possible changes that you can make to reduce the risk,
you and your team must consider:

1. What risk reduction would the change bring?

2. How much would it cost?
3. How long would it take?
4. What benefits would the initial investment bring in the long run?

If you can prove that the sacrifice in resources is too high compared to the
reduced risk, you have reached ALARP. Therefore, the risk is tolerable. Otherwise,
you need to invest the resources and reduce the risk to the broadly acceptable
area.

How to Perform an FMEA

I have broken the FMEA performance in to seven stages, to make the process
clearer.

Stage 1: Define the Objective

Decide what the goal of the FMEA is and what you want to achieve. Depending on
your goal, you would use a suitable FMEA template.

Choosing FMEA Template

Here is an example of a standard FMEA template (the adjustable part):

Process Step/input Potential Failure Mode

What is the process step or In what ways could the step

feature under investigation? or feature go wrong?

FMEA, the first customizable part.

In this part of the standard FMEA you follow this steps:

1. At first, You will map your processes and list everything in the column Process
Step.
2. Afterward, you will brainstorm everything that could go wrong.

However, for the best results, you should modify the FMEA for your purposes. That way,
it will be easier to stay focused on the goal.

14
Modified FMEA Template (Example Nr. 1- Out-of-Specification Investigation)

You got an out-of-specification result in a final product. Therefore, you would assess
whether it has an impact on the safety and efficacy of the drug. In this case, your
FMEA template would look like that:

Deviation Potential Failure Mode

In what ways could the OOS

What is the investigated of
impact the quality of
deviation?
product?

EXAMPLE: OOS pH

Example of an FMEA template for an investigation of a deviation

Modified FMEA Template (Example Nr. 2- Comparing Raw Materials)

Old Raw Material New Raw Material

Attributes and Attributes and

specifications specifications

EXAMPLE: pH 6-8

In this example, you want to change the supplier of critical raw material. In such
a case, you would have to assess whether the change may influence the drug
product. E.g., a different manufacturing method of raw material, packaging,
transport, etc. EXAMPLE: pH 6-9.5

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 Stage 2: Identify the Variables

The foundation of performing a successful FMEA is identifying each step of a

process or the items you want to analyze.
As an example, let us look into the following short example:
A company manufactures a drug with a highly potent active pharmaceutical ingredient
(HPAPI).
Let’s assume we want to do analyze the process of preparing popcorn in the
microwave. We all know how complicated this process can be. As getting from white
and tasty, popcorn to scorched charcoal is a matter of seconds.

Let us look at this delicate process, where so much can go wrong:

1. Remove plastic overwrap

2. Unfold the bag and place it in the middle of the microwave with the marked side
up.
3. Microwave at 1000 mW
4. Listen carefully! And stop the microwave as soon as the popping sound ratio slows
to down a pop every 2 seconds
5. Remove the hot bag from the microwave, and open it by pulling the sides. Beware
of hot fumes.

Here how it would look like in the FMEA table (For simplicity, only steps 1 and 2):

Process Step/input

What is the process step or feature under

Step Nr
investigation?

1 Remove plastic over wraps

Unfold the bag and place it in the middle of

2
microwave with the marked side up

Example of how to input process steps into an FMEA

TIP: Always work as a team and never do an FMEA by yourself. Otherwise, the result will be biassed and inaccurate.
Therefore, choose five people from different areas of expertise for the best output.

16
 Stage 3: Brainstorm potential failures

At this stage, you would sit down with your team and brainstorm anything that can
go wrong. You can use mind-maps or idea boards before writing the FMEA table’s
failures to improve the process.
To keep it simple, let us look at the third step only (Microwave at 1000 mW). In this
phase, the operator must set the power correctly to the required setting. There are
at least two possible failures here: The operator sets the capacity too low or too
high. If he puts it too high, the popcorn will burn. If he sets it too low, the corn kernel
won’t pop.

What is the Process In what ways could the step or What is the impact on the
step or feature under feature go wrong customer if this failure is
investigation not prevented or corrected

Temperature too high Popcorn will burn

Microwave at
1000mW

Temperature too Low Popcorn will not burn

Example of how to input process steps into an FMEA

TIP: Always work as a team and never do an FMEA by yourself. Otherwise, the result will be biassed and
inaccurate. Therefore, choose five people from different areas of expertise for the best output.

Stage 4: Assign SOD Scores

After listing all the possible failures, it is time to evaluate them, and you would do it
according to the previously discussed parameters – S, O & D.

For this example, we will use the simple scoring system of

1- Low Risk / Low Occurrence / High Detectability

2- Moderate Risk / Moderate Occurrence / Moderate Detectability
3- High Risk / High Occurrence / Low Detectability

17
 Tip: Add additional columns to the FMEA, where you can justify each of your decisions and document them.
Remember that everyone must understand the results even if he weren’t part of the team. Additionally, even
people on the team can forget the reasons for the decisions.

For this, let’s take a scenario that relates better to the pharma industry, than the
preparation of popcorn.
We will look at some of the stages of biotechnological production processes:

1. The purity of the inoculum

2. pH
3. Sterility of final bulk

Process
Values Potential Failure mode
Step/Input

What is the process step or What are the required In what ways could the
feature under Specification step or feature go wrong
investigation?

1.1 Contaminated
culture media
Purity of the Inoculum N/A

1.2 Material Failure

2.1 sensor, utilities (CO2)

software failure
pH >7.02

2.2 Operator Error

Sterility of final bulk Contamination of final

N/A
bulk

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 Now comes the critical part, of assigning the right severity scores to each of the parameters S, O and D.

Let’s start with the Severity:

Q: What impact would contamination of the inoculum have on the final product and the
process if you don’t detect the failure in time?
A: The impact would be severe, and it doesn’t matter what causes it- Material failure or
medium contamination. Such an event poses a high risk to consumers, as it can harm their
health. The impact on the process is also severe because even if you detect the issue at a
later stage, you would need to stop everything and start over. It means that the score
would be – 3.

Process Potential Potential

Values

SEVERITY (1-3)
Step/Input Failure mode Failure mode
What is the impact on
What is the process step or What are the required In what ways could the the customer or process
feature under investigation? Specification step or feature go if this failure is not
wrong prevented or corrected?

1.1 Contaminated
culture media Adverse effect on
N/A 3
Purity of the Inoculum health and safety /
interruption of
1.2 Material Failure
inoculums

FMEA example: High risk.

After Severity, let’s take a look at Occurrence:

Q: What causes the step or feature to go wrong? (how could it occur?)

A: In this case, we have multiple options:
1.1 Contamination during preparation – Operator, doesn’t follow best practice aseptic
technique.
– People are the main cause of contamination in clean rooms. It doesn’t happen all the
time, but it may occur, even with good training. Therefore, we will give it a score of 2.
2.2 Contaminated raw materials.
– Such contamination is rare, as in this case, both the manufacturer and the QC lab
messed up. Therefore, I would give it a score of 1.

19
 Process Potential Potential

Occurrence (1-3)
Step/Input Values
Failure mode Causes
What Causes the step or
What is the process step or What are the required In what ways could the feature to go wrong ?
feature under investigation? Specification step or feature go (How could it occur?)
wrong?

1.1 Contamination
1.1 Contaminated during preparation-
culture media Operator doesn’t follow 2
Purity of the Inoculum best practice aseptic
N/A technique

1.1 Contaminated raw 1

1.2 Material Failure
materials

FMEA example: Two possible occurrence rates, depending on the cause of the event.
Pay attention to the fact, that one failure may have multiple causes. Therefore, it is vital to
explore all possible options.

Now, let’s move to detection:

Q: What controls exist that either prevent or detect the failure?
A: In this scenario, we would name the quality tests we use, such as Microscopic
detection methods. Those methods are good but are not perfect. For example,
researchers have found that PCR methods are 10-fold more sensitive to detect
parasites than microscopy. Therefore, I would give those detection methods a
detection score of 2.

Process Potential Current

Values
DETECTION (1-3)

Step/Input Failure mode Controls

What is the process step What are the required In what ways could the What controls exist that
or feature under Specification step or feature go either prevent or detect
investigation? wrong? the failure?

1.1 Contaminated
culture media Macroscopic/
N/A microscopic 2
Purity of the Inoculum
detention methods
1.2 Material Failure

FMEA example: Detection rate is moderate.

20
 Now, we have finished investigating one feature in the process. Afterward, you would need
the same assessment for each step or feature in the process. It may be two more
assessments, or 1000, depends on your process. Therefore, you need to take each step
seriously and input the same good amount of energy into it.

In our example, I have presented two additional steps, which I would leave to you as an
Exercice:

Process Potential Potential Failure

Step/Input Values
Failure mode Effects
What is the impact on
What is the process step or What are the required In what ways could the the customer or process
feature under investigation? Specification step or feature go if this failure is not
wrong? prevented or corrected?

2.1 sensor, utilities Viability and

(CO2) software failure glycosylation pattern
affected depending
pH >7.02
on duration &
magnitude
2.2 Operator Error

Contamination/
Contamination of final Adverse effect on
Sterility of final bulk N/A
bulk health and safety/
lot rejection

Stage 5: Assess the Results

After assigning the S, O, and D scores, we come to the fun part of calculating the
RPN score and evaluating the risk (According to our system). I’ll remind you that
calculating the RPN score is easy. You just need to multiply the S, O, and D
numbers by each other. Here is the result from our case above:

Process Potential Potential Potential

Current
OCCURRENCE (1-3)

Step/Input Controls
SEVERITY (1-3)

DETECTION (1-3)

Failure mode Failure mode Causes

What is the impact on What Causes the step or
RPN

What is the process What controls exist that

In what ways could the the customer or process feature to go wrong ?
step or feature under either prevent or detect
step or feature go if this failure is not (How could it occur?)
investigation? the failure?
wrong prevented or corrected?

1.1 Contamination during

1.1 Contaminated
Adverse effect on
preparation- Operator doesn’t 2 Macroscopic/ 12
culture media follow best practice aseptic
Purity of the Inoculum 3 microscopic
health and safety / technique 2
detention methods
interruption of
6
1.2 Material Failure inoculums 1.1 Contaminated 1
raw materials

FMEA Example: Calculating RPN

21
 As a reminder, here is the scoring system we have chosen for this example:

Critical Major low

Description
Critical if RPN value >12: Take
Immediate action!

Major if RPN value >6 and <12:

Careful evaluation is required to
confirm that risk is tolerable:
otherwise. take action!

Low if RPN value <6: Noactions or

modifications are required

According to this system, one failure has two causes. One is a high-risk cause, while the
second one is moderate. It means, that we must address both of the issues, although with
different priorities, or more correctly, with a different endgame in mind.

What I mean by that, is that we must address the high-risk event (contaminated culture
media) and find a solution, no matter the cost. On the other hand, we have the Moderate
Event (Material failure) which we can address through ALARP evaluation. If we can prove
that we have achieved ALARP, we won’t have to introduce any changes regarding it to
the system.

However, it is wise first to address the high risk event, in any case, as the solution may
reduce the risk for both of the events. And, that’s exactly what we will be doing in the
next stage.

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22
 Stage 6: Assigning Corrective and Preventive Actions (CAPAs)
In this stage, you need to start thinking about solutions to the problems. Remember, that you
cannot influence the severity, therefore you need to concentrate on improving detection
and/or reducing the occurrence rate of the event.
How can we reduce the RPN score in our case? As I mentioned, microscopic tests are not
perfect, so we could introduce better detection methods, such as PCR. Thus, improving the
Detection score to 1.
Now, let’s take a look at the wonders that one improvement can do:

Current Action
Potential Action

OCCURRENCE (1-3)
OCCURRENCE (1-3)

Controls Resp taken

SEVERITY (1-3)

SEVERITY (1-3)
Causes DETECTION (1-3) Recommanded

DETECTION (1-3)
What are the Who is responsible What actions were
What Causes the step
RPN

RPN
What controls exist that recommended actions for making sure the completed ( and
or feature to go wrong for reducing the actions are when) with respect to
either prevent or detect
? occurrence of the cause completed? the RPN
the failure?
(How could it occur?) or improving detection?

1.1 Contamination during

preparation- Operator doesn’t 2 12 New device 3 2
Macroscopic/ Introduce a noval 1 6
follow best practice aseptic John XYZ was
microscopic detention detection method
3 2 qualified and
technique methods
validated
6 1 3
1 1
1.1 Contaminated raw 3
materials

FMEA example: CAPAs

And look at that! With one action we managed to reduced the risk of both events!
Material failure is now in the green area, and with the purity of inoculum we managed to
reduce the risk to an area, where we can explore ALARP.

Tip: When you assign CAPAs, make sure to assign responsible people and think
about all the required procedures, such as validation.

Hurray, we are done with this forever!

Well… not quite.

23
Stage 7: FMEA Life Cycle
After coming up with CAPAs, you need to ensure that the assigned people perform them on
time.
Make sure you distribute the FMEA as widely as you can to get good feedback about the
results.
However, the FMEA doesn’t rest even when all the CAPAs are closed. You must review each
process regularly and make performance checks to make sure your CAPAs were effective.
Remember, problems don’t go away as soon as you sign a paper. You must actively track
the trends and update the FMEA accordingly.

Congratulation!
You did it! After reading this manual, you should clearly understand what FMEA is and how to
apply it correctly.
However, your journey towards mastery of risk management mastery doesn’t end here. There
are still many tools and approaches you must learn to become a real risk mitigation champion
in your environment! So keep learning and make sure to visit our free GMP webinars.

FMEA Process Summary

1. At first, You will map your processes and list everything in the column Process Step.
2. Afterward, you will brainstorm everything that could go wrong.
3. Then, you will assess the impact of the event if it takes place. This will determine the
event’s Severity (S).
4. Consequently, you will contemplate the reason for the event’s occurrence and its
probability. This will determine the Occurrence (O) score.
5. After that, you will have to review the controls you have to detect the event before it
happens. This will determine the Detection (D) score.
6. Finally, you will see multiple scores SxOxD and get your RPN.
7. You will then determine how to act following your scoring system.
8. You will then create CAPAs and a follow-up timeline.
9. Review the FMEA again after a suitable amount of time to make sure no new risks arise.

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