Transcripts
1. About the Course: Hello, everyone. This is the introduction
lecture of course and I will make a quick summary for you to know what awaits you. At first, we will start with
the root cause analysis, including fishbone, FDA and 55, which is the most important
part of this course because all the next steps will be connected with that
root cause analysis. Therefore, I just
want you to make extra focus for this
root cause section. Just in the next step D six, we will start to develop corrective and
preventive action plans and we will understand
their differences, how we are addressing these actions according
to the root cause. In the same step, we
will also start to review and update PFMEA, process failure mode
and effects analysis, which is another key
point of this course. In the seven, we will
verify and validate these corrective and
preventive actions with some techniques like
reproduction of defects. At the last step D eight, we will start generating lessons learned cards and following at colosre Audit and
recognizing and celebrating at the
end of each step, we will have case study to reinforce our learning
with practice. We will go through
with one problem to understand the logic
between all the steps. For example, in D five, we will make a root
cause analysis for a problem in the following step, D six, we will have actions against the root cause that we have done in
the previous step. If you are ready, let's start.
2. Overview the 8D Steps: 80, it stands for the
eight disciplines, a structure problem
solving methodology. In D one, we identify the problem using the
5w2h methodology. In D two, we analyze
similar parts and processes to ensure
they aren't at risk. In D three, we conduct
an initial analysis, construct non detection points, and check the basic
process conditions to ensure everything
is in order. In D four, we develop a containment action plan based on the data from
the previous steps. This is an important step
because it is very extinguished the fire and reduce the tension in the working environment. Now in this course, we will begin with the
root cause analysis. We will use effective
tools here, including the fish
bone analysis, faulry analysis, acronym is FDA and five fs root
cause analysis. This step is a milestone
in problem solving because all the subsequent steps depend on the outcome
of this analysis. In these six, we will focus on corrective and
preventive actions. This is where we develop counter measures based on
the identifier root causes. We will understand the
difference between the corrective actions and
the preventive actions. In this step, we
will also learn how to review and update PFMEA, process failure mode
and effects analysis. These seven is the action
validation step where we verify the implemented actions
and attempt to reproduce the defect to ensure
actions are effective. And the final step, D eight is lessons
learned and closure. This is the last step where we capture the lessons learned, conduct a closure audit to ensure everything
is done properly, and finally, celebrate
the team and close. This is the 80 structure that we will go
through together. One more information
in this point, you can see various 80s
in different industries. Steps can slightly differ according to the company
that you work in. It is quite normal. But in this course,
we will follow these steps which are
extremely comprehensive, detailed and well structured.
3. D5 Introduction to Root Cause Analysis: Root cause analysis is the core of a problem
solving study, verifying the underlying
reasons of the problem. Here, we will deep tie with special tools like
fishbone analysis, faulty analysis, and
five fis analysis. We will find both occurrence and non detection root
cause of the problem. This distinguish is
important because both are quite different points which caused the
problem to come out. In the meanwhile,
we will investigate the systemic root cause of the problem as well
as the technical one. Now let's take a look
why we are using this fishbone FDA and fi five and let's understand how
they are showing us, finding the root cause. The first step to start the root cause
analysis is fishbone. Here we will make
it brainstorming to identify potential causes. I am saying potential because those causes are not
verified yet here. We will just write down
every idea that comes from the team later then we will
move those to FDA analysis. Here, we will verify
whether they are really the contributor
of the problem or not. We'll compare the
good and bad status to see the exact differences. And after that, finally, we will move those verified case to five fives root
cause analysis. And here we will find the
root cause by asking why. This is the method to
find the root cause, and we will do this for both occurrence
and non detection.
4. Fishbone Diagram: Fishbone analysis, also
known as Ishikawa, is a brainstorming
technique used to explore potential
causes of a problem. It consists of several
fundamental categories. There are people, machine, material, method,
and environments. This is the fishbone diagram. At the head, we
write the problem and then we raise
potential causes from brainstorming and place them under the relevant headers. The reason behind
these categories, method, material,
machine, people, and environment, is that they fundamentally cover every step of the manufacturing processes. However, this doesn't mean
that we can't add more. If needed, we can include additional headers to make fishbone analysis
more specialized. For example, you can add
design if method is not a broad enough category or measurement specifically
for non detection analysis. But for now, we will
stick to the five. Now let's take a closer look at the headers in the fishpond
diagram and what kind of potential cases we define
under each. First, method. This refers to
process standards. We basically question whether the standards are
correct or not. Potential casos here may
include incorrect procedures, unclear work instructions or
ineffective process steps. Next is material. This covers anything related
to raw material, components or the part itself. For example, issues like
low quality materials, contamination or out of tolerance products
can be identified. And the next is machine. This represents the equipment, tools or technology
involved in the process. Potential causes under
this category can include machine malfunctions,
lack of maintenance, machine breakdowns or
other equipment issues, and next is people in
the other word man. This refers to human
related factors such as lack of training, operator errors, miscommunication
or workload issues. And lost is environment. This includes
external conditions that may impact the process. Factors like temperature change, humidity, lighting,
noise, vibrations, as well as the
process tidiness and FIFS related issues can
all affect outcomes. By organizing potential causes
under these categories, we enjoy a structured
and logical approach to identifying the root cause of a problem in the next steps. Now let's talk about how
we use this diagram. In the fishbone diagram, we first define the
problem at the head. Then based on that problem, we write potential causes
under the relevant has. Let's take an example. The problem is that, let's say, whole diameter is
out of tolerance. To address this,
we will identify potential causes
through brainstorming. Now let's bring
in some examples. Incorrect cutting
parameters under method, lack of training under people, lack of instruction, material
deformation, and more. Basically, we are just
throwing out ideas and listing potential causes
that jure nothing is missed. At this stage, we don't yet know if the issue is caused
by material deformation, machine problems,
operator training, or maybe environmental factors. We simply write down every
idea without judgment. Best result of the
fishbone analysis is the one that is done
with sufficient people, not crowded but less as well, because we need to
hear all perspectives to ensure nothing is overlooked. A more important
question is also, how do we guide the team
effectively in this stage? First, if you are leading
the problem solving team, especially for the root
cause investigation, you should familiarize
yourself with the process, especially if you
don't work directly on the shop floor because understanding the
problem details and having even a basic grasp
of the process will help you engage the team and encourage them to
share their ideas. Most importantly, we
should avoid judging ideas at this stage and ensure
others don't judge either. Because if people feel their ideas are being
dismissed or criticized, they may hesitate to contribute
and we don't want that. Instead, we should create
an open environment where everyone feels comfortable
sharing their thoughts, feedback because in this phase, there is no bad idea. So if we go back to
the fishbone diagram, the next step after identifying the potential causes
is to evaluate them. You might ask, shouldn't we avoid judging the content
as we just discussed? Yes, during brainstorming,
we shouldn't judge because we want to capture every idea from the team. But once that phase is over, before moving to the
verification step in FDA, we need to filter them. This is important because
otherwise we will have to verify every single item in the next step faulty analysis, which could lead to unnecessary
time and even costs. The best way to filter this
cause is through voting, a simple voting process. You can ask the
team, what do you think about the
temperature variations? If the majority
agrees that it is not relevant, eliminate it. Don't waste time on it and repeat this for all the
items that you have. And after this
elimination process, the remaining ones become all
filtered potential causes. These are the ones that to
be moved to FDA analysis. However, if there are any
doubts during this elimination, it is important to keep those items and move
them to the next step. The goal of this
elimination is simply to remove unnecessary items
to avoid wasting time. But if you have doubts, you should insist on
keeping the item.
5. Fault Tree Analysis (FTA): Fault analysis or
FDA in acronym. In FDA analysis, we verify the potential causes identifying the Ichi Cava
diagram to determine whether they are
contributing factors or not. Our fundamentals are
standard requirement, good part or status and
bad part or status. The logic is to demonstrate
the difference between good and bad by referencing
the standard requirement. FTA analysis table simply
consist of these key elements. The first and the second columns are for potential causes. We just move the
potential causes from the fishbone analysis to the second column and we write the fishbone factors
like machine, method, material, or others
in the first column. In the fishbone analysis, we only identify the potential causes
without verifying them. But here we will determine whether there are
actual causes or not. The next column is
the standard column where we identify what
the standard required. For example, if the
potential causes is lack of maintenance, which is under the machine
factor in fishbone, let's say, then we need to check
the relevant standard that defines that
maintenance requirements. That could be a maintenance
procedure or instruction. For the example, let's say, maintenance instruction
and stating like laprocation must be
done every 500 hours. At this stage, we first
define the standard, which is maintenance
instruction for this example and then state the requirement
of that standard, which is lubrication
every 500 hours. Next is the good
part or status olum. We use both part and status because sometimes the
root cause is related to the condition of a part and sometimes it's about
the operational status. Here we write the good
condition for comparison. However, a good part
doesn't necessarily mean it meets all the
standard requirements. It simply means this part
didn't have our problem. If the problem is
machine breakdown, we write the actual maintenance
value of the time when the machine was working properly as we look for
the good part data. For this line example, if the machine was
operating well previously with abrication
every 500 hours, we can refer that maintenance
record as the good part. We capture abrication
done every 500 hours. The good part,
which we didn't see the issued problem is the same with the
standard requirement. Next is we have the bad
part or status coolum. Here we identify
the bad condition where the problem
actually occurred. If the issue is
machine breakdown, we check what the
abrication interval was at the time of failure. Let's say there was no
labrication for 1,000 hours. This simply states the situation
at the time of failure. At the time we produce
not okay parts, we hadn't done labrication
for 1,000 hours, but at the time we
produced good parts, abrication had been
done every 500 hours, we simply wrote down the actual status for
both good and bad. At this point, we have both good and bad
conditions documented. The good part complies
with the standard and the bad part doesn't
comply with the standard. And now we will assess this situation with
four simple questions. First, we need to ensure whether the standard is
correct or not because sometimes the standard may have lack of information or
even be completely wrong. For example, if the
standard requirement didn't specify the frequency of
lubrication for this example, we will say the
standard is not okay, so the answer would be no. But in this example, lblcation is every 500 hours
is clearly identify, so we confirm that is okay, the answer will be yes. And the next is is the good
part okay with the standard. The standard requirement states the abrication must be
done every 500 hours and the good parts condition is labrication already
done every 500 hours. Since this match,
the answer is yes. The next is the bad part
okay with the standard? The requirement is
lubrication must be done every 500 hours as per the
maintenance instruction. But the bad parts condition is no lubrication for 1,000 hours. This doesn't comply
with the standard, the answer will be no. The final question is, is there a direct link between this cause
and the problem? Here we simply evaluate the
conditions by considering all the answers we gave for the standard and the good
and the bad part statuses. The previous three
answers of yes and no determine this final result. Let's continue from this
example to understand better. In this example, we
confirm the standard is okay and the good part
follows the standard, but the bad part doesn't
follow the standard. This difference shows there's
a link with the problem, the answer will be yes. Because it is obvious that
for this potential cuss, we produce a good part that
complies with the standards. But when we check
the Nooky parts production data, we see that. At that time, we didn't
comply with the standard. This is very clear difference, which means we will make
a further investigation into this case in the five
Fs root cause analysis. However, before going
to five fives analysis, it is always useful to try
to reproduce the defect by using the same deviation in this specific cows line item. It is to ensure that this factor is directly
causing the problem. For example, we should
keep machine not lubricated for 1,000 hours
like in the bed part status, and after that, if we see
the problem comes out, then we can absolutely ensure that it is directly
linked with the problem. While this method is very
useful and recommended, where it is possible, it is not always possible
at this stage. If the analyzed item is a technical thing that
can be simulated quickly, it is very good
and we can try to reproduce quickly to ensure. However, for example, for this labrication
line item example, we should wait for
1,000 hours without applying any labrication just to simulate this failure mode, which is not possible
and not make sense. As long as it is possible, we should try to
reproduce the defect to demonstrate direct linking. If the final answer is yes, this means the potential cause is no longer just potential. It is a verified cause. It must be investigated further using the F fives
method in the next step. But if both the
good and bad parts comply with the standard, then the answer will be no. So this potential
causes is eliminated as this doesn't contribute
to the problem. There are a few
different possibilities here that we need to consider. Let's go through a
slightly different example and understand different
possibilities. At this time, the potential cows and the standard are same, but good and bad part
status are different. The good part is no
lubrication for 1,000 hours and the bad part is
lubrication every 500 hours. Here, the good part doesn't
comply with the standard, the good part answer is no. But the bad part complies
also with the standard. The second answer is yes. What about the last questions? Direct link to the problem. Even though the good part
deviates from the standard, the analysis shows that lack of maintenance is not the
cause for this line item. There must be another factor
leading to machine breakdown because if the lack of
maintenance were the real cause, then the bad part should also
fail to meet the standard. But here, we don't
have the situation, meaning this potential cause is not the real cause
of the problem, there is no need to move to further investigation in FI FIS as part of this
problem solving study. However, even though
this deviation is not related to
our current issue, we should still fix it to
ensure that compliance. It is not relevant
to our problem, but it is a potential
concern and could cause other
issues in the future. We should also fix this
out of this eight study. Let's go through one
different example with another possibility. But the good part and the bad part don't comply
with the standards, no lubrication for 1,000 hours. So this point is a
bit tricky because it is obvious that we
produce good parts with this deviation and we hadn't done lubrication
for 1,000 hours, which is out of the requirement and we didn't have an issue. On the other hand,
the same situation happened when we
produced the bad parts. So it seems this is not
the cause of the problem. However, this might be
one of the contributors. For example, when it combines
with some other causes, the problem can occur. This indicates that lack of
lubrication alone is not a direct cause even though it
deviates from the standard, but it may be a
contributing factor when combined with other
conditions led to the failure. So for the answer
to direct link, we can put a question
mark in this example because we are not sure yet whether it is a
direct cause or not. However, we should still investigate further
in the 55 analysis, even though the cause is
not verified yet because the obvious fact here is that both good and bad part don't
comply with the standards, this might be a potential
contributor to the problem. Now we have completed the
fault tree analysis and we will continue with
the last step of the root cause
analysis, which is 55.
6. 5 Whys Root Cause Analysis: Five fs analysis is the final step in
identifying the root cause. We started by identifying the potential causes using
the fishbone diagram, and then we moved those potential causes to FDA
analysis for verification. Finally, we take the
verified causes into the five fs analysis to
determine the true root cause. F fs analysis is a
straightforward, step by step investigation. First, we write
the verified case which come from
the FDA analysis. Then we start asking
the question of why repeatedly until we
find the root cause. The key is that each
answer must be data based, not subjective or
estimated and each why answer should take us one step
closer to the root cause. This deep investigation
method is quite powerful as well
as the straightforward. Let's go through
a simple example to better understand this. Let's say we have a problem of machine breakdown
and we created a fishbone diagram and then made an FDA analysis and found the
real cause of the problem, which is motor overheated. We know that. This is the
cause of the problem, but we don't know yet
why did motor overheat. We will learn this with the 55 root cause
analysis. Let's start. The first question is
why did motor overheat? The answer is because
the coolant system was not working properly. Then why wasn't the cooling
system working properly? Because the coolant
level was too low, why was the coolant
level too low? Because there was a leak
in the coolant hose. Why was there a leak
in the coolant hose? Because the hose was worn out
and not replaced in time. And then why was the hose
not replaced in time? Because there was no
preventive maintenance plan for the checking
the coolant system. This is our root cause. What we have done
is proceeding step by step and each
answer is databased. We got closer to
the root cause with each answer and
finally, we found it. It is a lack of maintenance
plan for the coolant system. To ensure we answered correctly, we can cross check by
asking so to the backward. This is a verification.
Let's do this. There was no preventive maintenance plan for
the coolant system, so that the worn out hose
was not replaced in time, so that there was a leak
in the coolant hose, so that coolant
level was too low, so that the coolant system
wasn't working properly, and so that motor overheated. We basically verified
our answers and it definitely looks correct
according to our example. One other point here is
sometimes we may have two or even more different
sub answers after a question. This means you can have two or more root causes
for one verified cause. Let's quickly go through an
example to see how it works. For this example, let's
use the same scenario. We started with the root
cause of the verified factor, which was the motor overheating and the first three
answers are the same. Why did motor overheat Because the cooling system was not
working properly, and why? Because the coolant level
was too low and why? Because there was a leak
in the coolant hose. Now let's imagine that.
The third question, why there was a leak in
the coolant hose has two different answers leading us to two different root causes. The first answer is that the
one we already identified, lack of a maintenance plan. But we also have a second
root cause and it is about low material
quality of the horse. We asked the same question, why there was a leak in
the coolant hose, but identify two answers. The first one is the hose worn out due to lack of
maintenance plan, and the second one is the horse
material was low quality. Both of these are
varied root causes of the motor overheating issue. The root causes we
identify here are technical root causes which are common to all problem
solving studies. However, we have also one
more type of root cause, which is systemic root cause. This is generally not
done for every problem solving study and not a
mandatory requirement, but it undercovers all the
underlying systemic causes and helps you build
a robust system. Let's move on to the next
lecture and see how we do this.
7. Systemic Root Cause: Systemic root cause is the cause of the
technical root cause. Basically, we just ask one
more why to identify this. This final answer will lead us to lack of
standardization, which is the
systemic root cause. Let's take the previous
root cause example. The root cause that we
have identified was no preventive maintenance plan for checking the coolant system. Now let's go one step further
and ask one more why. Why there was no preventive
maintenance plan for checking the coolant system. The answer is because there is no structural procedure and
strategy for maintenance. In the other word, lack of structured
maintenance procedure. That is the reason
for the lack of maintenance for checking
the coolant system. Here, this final answer is
our systemic root cause, which highlights the lack of standardization and the systemic
factor behind the issue. While systemic root
cause analysis is not commonly applied
in the industry, it is very useful to include
this because this approach allows you to implement preventive actions easier
in the next phase. This concludes the
root cause analysis, so now we will continue
with the case study.
8. Explore the Case Study: We will proceed with
a case study for all the steps after
the theocal lectures. We will use the same
case study that we went through in the previous
course, D one and D four. But let's do a quick recap for those who haven't taken
the previous course. We are a bonnet hinge
manufacturing company and our customer is
a car manufacturer. Basically, we
produce bonnet hints and ship those to them. We received a problem
from the customer. The issue was a misalignment in the second hull
of the bonnet hinge. Due to this misalignment, the customer was unable to assemble the hinge
onto their cars. Basically, the whole position
on the hinge was incorrect. Let's bring the visuals of the bad and good part to see
this difference clearly. This hinge consists
of two components. The one with the three hose is not okay due to the position
of the second hull. Now let's go through our production process
of the bonotinge. First, we receive
sheet metals from our supplier which
are then stored in the receiving
material warehouse. Next, these sheet metals are fed into the
press operations. In the first press operation, we produce the first sempduct
and these semi products are then stored in the
intermediate storage area located by the production line. After that, we produce
a second semi product, which like the first is stored in the intermediate
stock area by the line. In the final operation, we assemble these two sempducts to produce the
complete bono hinge. The finished products
are initially stored in the
intermediate stock area and then move to the
shipment warehouse where they await for dispatch. From there, we ship the complete bono things
to our lovely customer. In summary, our production
process involves creating two semi products
that are assembled to form the final
product, the bono hin. Now, looking at our issue, the faulty component is produced in the second
press operation. Therefore, our focus in the production
process will be here. The second press operation is the key area that we
need to investigate, as this is where the
failure occurred.
9. Case Study - Fishbone for Occurrence: In this lecture, we will start the root
cause analysis for the occurrence through the as study using the
fishpond diagram, which is our first tool. We will identify the potential
causes for the occurrence, which is the first part of
the root cause analysis. Now let's start the
fishbone analysis. The problem was bonnet hinge
second hole mislocated. In this study, we
will investigate the potential causes of the
issue for the occurrence. We will make a
brainstorming session to identify the
possible reasons for the problem specifically by focusing on occurrence reasons. We should try to have
expert people in the team during this study,
but at the same time, some fresh minds can bring
different perspectives, a mix is always beneficial as much as
possible, of course. During this brainstorming
with the team, we don't interrupt
or judge any idea. We just listen and write exactly what is said to
encourage participation. And once we identify all
the potential causes, we will make a pre
elimination to avoid wasting time in
the next step FDA. Now let's start identifying all potential causes
with the team. We have a lot of different
potential causes. Some of them may be
quite irrelevant, but others can be directly
related to the problem. Now that we finished
writing all, let's make a pre
elimination with the team. This can be done through an open discussion or a voting system. But the best method
is to convince as many people as
possible in the room. Let's start from the method. Insufficient tool
setup checklist. The problem is that
a specific hole is consistently in the wrong
position over a period of time. So this suggests that the tool setup was incorrect
from the beginning, since the part cannot produce incorrectly unless the
tool itself is misaligned. Insufficient tool
setup checklist could be a contributing factor. So therefore, we don't
eliminate this as we want to keep it for
the next level analysis. It can be a factor
in the problem. Next is lack of
change management. In this case, a specific hole was consistently misaligned. This potential case suggests
that the tooling setup was altered at some point
and not properly controlled. If any modifications were
made to the tooling, they should have been
properly documented, verified, and reverted
if necessary. But something could have gone
wrong if this is relevant. It seems highly relevant
to the failure mode and requires further
analysis in FDA. Next is no tool
maintenance plan. The absence of a tool
maintenance plan that includes tool conditions checks could allow such issues to
persist over time. Regular maintenance
should include tool conditions, it is relevant. We can absolutely review this
potential factor in FDA. Now let's continue
from the material. First is sheet metal elasticity. The variations in
sheet metal elasticity could cause warping
or deformation. But this issue specifically relates to the
whole misalignment, we eliminate this as it is
not relevant to the problem. Next is sheet metal thickness. If the material thickness
were inconsistent, it could lead to general issues with the whole shape
or maybe depth. However, since misalignment is occurring in a
specific direction, this is not relevant ta. Last one in the material section is material contamination. Material contamination
such as dirt or foreign particles can affect
the quality of the part, but it typically results in surface defects or
imperfections, maybe. However, there will be no impact on the
consistent whole position. No need to make further
analysis for this. Now let's continue
from the machine. First is incorrect setting
of machine parameters. The issue is that
a specific hole was consistently wrong position. This suggests that tooling misalignment rather than an
incorrect machine settings. If machine parameters
such as pressure, speed or stroke length
were incorrect, we would like to see defects like inconsistent
hole positions, deformations, or
improper cutting rather than a consistently
misaligned hole. It seems that we can eliminate
this potential factor. Next is insufficient
press tonnage capacity. The issue is consistent
hole misalignment, not general tool deformation
or insufficient press force. If the press had
insufficient tonnage, we will likely see a
general part deformation, not just a misaligned hole. T us, this is not
relevant to the issue. Next is lack of maintenance. The issue is misalignment
of the punch, not due to wear or damage
from the lack of maintenance. If maintenance for the cause, we will see more widespread
tool issues or general wear, not a specific misalignment. Let's eliminate
this one as well. Last is inconsistent
press calibration. If the press calibration
were inconsistent, it could cause slight variations in the punch alignment
during the production, even if the tool
setup was correct. But the point is our second hole is misaligned, not
the other holes. If calibration were the issue, all the holes will be affected, so we can eliminate
this as well. Now we move on to the people
in the other word man. It is inadequate training
on punch alignment. If the relevant operators lack training on proper
punch alignment, they may fail to notice
misalignment during the setup, so this could lead such issues. It is worth investigating
further in FDA. Next is environmental factors. We have just one factor here, which is poor lighting
in the setup area. Poor lighting is not
a strong cause for incorrect adjustment
of such large tools. Therefore, we can eliminate
this potential cause as well. So now we have identified all potential causes for the occurrence with
fishbone analysis. Now we will make
further analysis in FDA for total four different
potential causes from here. Let's go to the next lecture and see how we do this analysis.
10. Case Study - FTA for Occurrence: This is our FTA table,
fault analysis. Now we will bring
the potential causes that we have identified in fishbone analysis and analyze whether they are
really a cause or not. Let's start with the first one insufficient to setup checklist. This comes from the method
category in fishbone. Here, we will evaluate whether the checklist was
sufficient to prevent this issue The standard and
the requirement here is that the two setup
checklist must include punch alignment verification to ensure correct hole placement. Now let's check the
good part or status. During the production
of good parts, was this checklist used and did it include punch alignment? The answer is yes. The checklist included punch
alignment verification. But what about the bad parts? Were we using the same checklist when we producing
the not okay parts? The answer is also yes. The checklist included punch
alignment verification. So now let's evaluate
what this means. First, we check the
standard itself. The requirement is the
two setup checklist must include punch
alignment verification, and we confirm
that. This is okay. So the answer is yes. And next, we check whether the good part complies
with the standard. The answer is yes, again because it meets the requirement
that we defined. And then we check the bad part. The answer is, again, yes, because the checklist included this requirement even
during bad part production. So at this point, we see that there is no
difference between the bad and good parts for this specific line
item, but seem okay. That means there is no direct link between this
factor and the problem. Since these potential causes doesn't contribute to the issue, we just eliminate it
from further analysis. So there is no need to move
this to five fs analysis. The next one is lack
of change management. In this case, there is
no documented standard, but the expectation is that any temporary change
in tool setup must be properly documented and reverted before
production resumes. Let's check the good
part or status. To do this, we will review the production or tool
revision history. Here we see that no
modifications were made to the tool since
production run started. Production followed
the standard setup. But in the bad part,
the punch position was modified for a trial but wasn't
reverted back afterward. Which led to continuous
misalignment in production after the trial. Clearly, a test
trial was conducted, but it wasn't managed properly. Now let's check the standard. The expectation is that any
temporary tool change must be properly documented and reverted before production resumes,
which makes sense. However, we don't have the
standard documented anywhere. It is just an expectation for this type of
modification activities. We confirmed that
the standard is not okay because it is
not written anywhere. It is just an expectation. So for the next step,
we will consider their status by treating the
expectation as a standard. In that case, the good part complies with the expectation. So the answer is yes. But the bad part doesn't comply with the expectation.
So the answer is no. Now, is there a direct link between these cause
and the problem? Yes, because the bad part
doesn't comply while the good part does comply
according to the expectation. On top of that, we don't even have the standard
documented anywhere. So this lack of change
management absolutely needs to be investigated by
Fis root cause analysis. Our next potential cause for fish Bon is no tool
maintenance plan. The standard requirement is that a maintenance plan
must be in place, and it should include
tool condition checks to ensure long term stability. Now, let's check the
good part or status. Here, we need to verify
whether the maintenance plan existed and was valid during
the good part production. Based on the
maintenance records, we see that the maintenance plan exists and included the
tool condition checks, meaning that process follow
the defined structure. Now let's check the bad part. When the failure occurred, we again see that
the maintenance plan exists and included
tool condition checks. The maintenance process
itself was not missing and the same conditions apply to both good and bad
part production. Now let's check the final
yes and no questions. The requirement states that the preventive maintenance plan must include two
condition checks. In this case, we confirm that such a plan exists
and documented. The standard is okay. That means our answer is yes. For the next questions,
both good and bad parts are under the same
maintenance conditions. They comply with the standard. The next two answers
are also yes. There is no direct link because both good and bad parts were under the same
maintenance plan. There was no difference between them regarding
this factor. Therefore, this factor is eliminated from
further investigation. Next is inadequate training
on punch alignment. Here we are checking whether
the operators received proper training on how to verify punch alignment
during setup. Let's start with the standard. The requirement is
that operators must receive training on punch
alignment and during, they can correctly verify its positioning
before production. In this case, the standard exists and defines the
training requirement. We confirm that the standard
is okay at the moment. Now let's check the
good part or status. During good part production, the operator had
received training, but training didn't sufficiently emphasize punch
alignment verification. Now let's check the bad part. Here we see the same situation. The operator was trained, but the training lacked enough
focus on punch alignment. So training conditions were identical for both good
and bad part production. Since the standard is okay, but neither the good nor the bad part comply
with the standard. So both answers are no. So the last question, direct
link with the problem, we are not completely sure yet because both answers are no, we cannot confirm
it's a direct cause, but it might be a strong
contributor factor maybe. So we mark it with
question mark and carry it forward to F five's analysis for further investigation. Now we have completed
verification of four different potential
causes in the fault analysis. We confirmed two of them as
actual causes of the problem. Now we will move them to
F F root cause analysis, which is the final step of
the root cause investigation. Let's move on to the next
lecture and see how we conduct FF root cause
analysis for these causes.
11. Case Study - 5 Whys for Occurrence: So now we are going to conduct
a 55 root cause analysis for the causes we have verified in the previous FTA analysis. Our first verified cause is
lack of change management. So let's start by asking the
question of why and diving into the underlying reasons behind this lack of
change management. First, let's start
with the question. Why was there a lack
of change management? So instead of starting
with a problem, which is the whole misalignment, we directly ask that
question because this case has already been verified
in the FDA analysis. Our answer is because there was no documented rollback process after temporary tool change. Now let's move to
second question. Why was there no documented
rollback process? The answer is because the
change management procedure for temporary tool adjustment
was not clearly defined. Here we already identify
the technical root cause. So our management procedure was unclear when it came to the
temporary tool adjustments. So this is the technical
root cause of the problem. That means if we had
a clear procedure in place for managing
temporary tool adjustments, we wouldn't have had this
whole misalignment problem. Now let's take it to
one step further and ask one more why to explore
the systemic root cause. Why were the change
management procedure for temporary tool adjustments
not clearly defined? The answer is because
the organization lacked the awareness to anticipate the risks with
temporary tool change. This is the systemic root
cause of the problem. So by starting directly
from the verified cause, we have shortened the
five fis process, and that's completely fine
because our aim here is to conduct a precise analysis to
get to the real root cause. However, in some cases, some customers may ask for a detailed step by step breakdown of the
five fis process. And in those cases, you can directly start with the
problem instead of the cause. So for example, why
was the second hole mislocated Be second
punch position was not correct in
the tool, and why? Because it was modified by
the tool maintenance team for a trial and not reverted
back afterward. And why? Because there was no
documented rollback process after temporal change. The result is same. We just
extended the 55 process. Let's continue with the
other casts from FDA, which is inadequate training
on punch alignment. Why was the training on
punch alignment inadequate? The answer is because the
training content didn't sufficiently cover
punch alignment verification during the setup. Now let's move to
second question. Why did the training content not sufficiently cover punch
alignment verification? Because the training scope
was not clearly defined to ensure all standard requirements
were fully covered. This is the technical root
cause of the problem. If the training scope was prepared by covering
all the requirements, punch alignment would have been clearly addressed
during that training. But we can still ask
one more question to understand the systemic
root cause under it. Why was the training
scope not clearly defined to ensure all standard
requirements were covered? Because there was no
structured qualification or competency requirement for those preparing the training content. This is the systemic root
cause of the problem. In the technical root cause, we address that specific
training content and if we correct this, we would have eliminated the issue for this
specific problem. But now we know one more issue. We don't have a structured
qualification system for those who prepare
training content and this gap can cause
different problems in different process
and different parts because this is a
systemic root cause. Now we can also verify
the logic of this root cause analysis by asking so
basically a cross check. Let's do it together. We
will start from the end. There was no structure
qualification or competency requirement for those preparing
training content. So that training scope
was not clearly defined, and so that training content
didn't sufficiently cover punch alignment verification.
You see the logic, right? Instead of asking why
in a straightway, we just ask so starting from
the end for a cross check. One another point
in this analysis, you might ask the
issue origin was change management
since they didn't revert back to the
punch after the trial. Why do we have a root cause here for punch
alignment training? Well, one problem might
have multiple root cause. For example, in this case, lack of training could be a contributing factor because the tool training was not
covering punch alignment. We detected this gap in the FDA analysis
and verified that both the okay and
not okay conditions in FDA show this deficiency. Therefore, this must absolutely be addressed and be resolved. This concludes the root
cause occurrence case study. Now let's move on to the next
and analyze non detection.
12. Case Study - Fishbone for Non-Detection: For the non detection,
we will start with fishbone again
by identifying the potential causes which are relevant to controlling
of the part in that time. Basically, we will focus why we didn't detect
the failure part. Let's start the
brainstorming and identify all potential causes
raised by the team. First is no control
for hil position. This should be checked in FDA because it is directly
relevant to the failure mode. Our issue was the
misalignment of the second hole on
the bonnet hinge. If there was no proper
control in place or if the existing controls were
not effective enough, this could have contributed
to the problem. As a team, we identified
this as a risk factor and decided to investigate it further in the fault
tree analysis. Next is insufficient control
to detect the failure mode. This is also an important
point because if the current control
methods were not sufficient to detect
the misalignment, we need to understand why. Maybe the inspection
method was not capable or the frequency
of checks was too low. Since this directly relates to the non detection
aspect of the issue, we are taking it to the
FDA for further analysis. Now let's move on to
the machine category. First is lack of MSA
on control fixtures. MSA is measurement
system analysis. If the measurement system
itself was not capable, then even if a check was done, it might not have
been effective, we decide to take this to
FDA as it can be relevant. Next is lack of calibration
of control fixtures. Calibration is necessary to maintain measurement
accuracy over time. If the control fixture was
not properly calibrated, it could have led to
false acceptances, meaning misalignment holes
might have passed inspection. Therefore, this is a potential contributing factor
to the non detection, and we mark it with cross
to further analysis in FDA. Last one in the machine section is assembly fixture deformation. The assembly fixture
is also used for enduring proper alignment
during the assembly process. If any deformation or mole function occurs in
the assembly fixture, it can lead to improper
alignment of the parts, making it impossible
to detect the issues. Therefore, this
might be relevant to potential contributor
for the non detection. Let's mark it for
further analysis in FDA. Now let's move on to the people category,
in other words, man. First is lack of training. Training gaps can lead to
improper execution of control. For example, if operators
weren't trained well enough, they might not have followed
the correct procedures. This could be a
contributing factor and it should be analyzed in FDA. And second is
inadequate supervision. Spervision for the controls is not a requirement
and expectation as all responsibilities
were already clearly outlined in the
responsibility matrix. So therefore, as a team, we eliminate this
potential cause. And the last one is FFS is
not proper under environment. This is also another one that we eliminate rather than
moving to FDA because the problem is not
singular and it is quite unlikely to influence
the control mechanism in such kind of non
singular problems. So that's why we eliminate this. Now let's move to FDA
for verification.
13. Case Study - FTA for Non-Detection: Now we bring the
potential causes from fishbone analysis to
verify in this FDA table. Let's start. First is no
control for whole positions. It is from method in
fishbone diagram. Here we check whether there's a control for the
whole position or not. We will not check the control is done because this line
is not about that. I just questions whether we have control mechanism
in place or not. Let's go through the
questions in table. Process standard
and requirement. It is PFMEA, process failure
mode and effects analysis. There are two controls. First is five parts every
hour at press production and second is 100% frequency
at assemble fixture. Regarding good parts, control
plan has the controls, and regarding the bad parts, control plan has the controls
as well, no difference. So that standard is okay. Good part is okay according to the standard and bad part also okay according to standard. That means there
is no direct link. Problem is not about
this potential cast, so we eliminate this. Next is insufficient control
to detect the failure mode. Again, it's coming from method. Here we will check whether
the current controls are enough to detect the whole misalignment
failure or not. Again, here, we will not check the control
is done or not. We will check the current
controls capability to ensure they are enough. Our requirement for
these potential causes is current controls must
detect the whole misalignment. This is the requirement that we expect from the
current controls. Regarding good part and status, current controls detect the whole misalignment.
They are capable. And same for the
bad part because we had same controls
in the control plan. So the standard is okay. Good and bad parts are
comply with the standard. Therefore, there is
no direct link with the problem and we eliminate
these potential cows. Next is lack of MSA
on control fixture. MSA stands for measurement
system analysis, which is the methodology to
verify the control systems. It is different
from calibration. Standard is MSA must be done every year and result
of MSA must be okay. When we check the status of MSA for both good and bad
parts, it seems okay. MSA done just one month before the problem
happened, it is vd. There is no problem for MSA. Therefore, standard is okay, good and bad parts are
comply with the standards, we say yes for both them and there is no direct
link with the problem. This one eliminated. Next is lack of calibration
of control fixtures. Here we will check
the calibration status on the time period, both good and bad
parts production. Standard is control
fixture calibration must be done yearly. Let's
check the good part. What we had in that time, control fixture calibration was vet when we produce good parts. Regarding bad parts, it is control fixture
calibration wasn't vet when we produced bad parts. It clearly shows that
there is a problem here. Let's bring that control fixture
to understand it better. This is the control
fixture and it controls three holes of that
part in this way. But the problem is,
it doesn't have a valued calibration
at that time. So let's continue
the other questions. The standard is
okay, so we put yes. Good part is okay
according to the standard. So this is also yes, but the bad part is not
comply with the standard. So that is no, and the result is there is a direct
link with the problem. So we will move this
to fi five Root cause analysis for
further investigation. Next is assemble
fixture deformation. It is formation. The requirement is no deformation on
assembly fixture. However, when we check
the assemble fixture, we see that second
pin is missing, which is the control point
for the whole existence. The requirement
is no deformation on assemble fiixture
and the good part is no deformation
and assembly fixture and all control
pins are in place. This shows that there was no issue when we
produced the good parts, which were okay for
whole alignments. Let's check the bad part.
Second pin is missing. When we produce the bad part, second pin is assemble
fixture is missing. Let's bring that assemble
fixture to better understand. This is the assembly fixture. Two semi products are placed
and assembled in that time. Three holes are being
controlled by those three pins. That means if the parties
assemble it, then holes exists. But if you see a bad situation, the second pin of the
fixture is missing. Therefore, it couldn't detect defect during this
assembly operation. Let's continue to
other questions. Standard is okay.
The answer is yes, good part is comply
with the standard, so it is yes as well, but the bad part
is not comply with the standard because
second pin is missing. The answer is.
Therefore, there is a direct link here which
needs to be analyzed in Fifi. Nexus from the people, in
other words, human error. It is lack of training. Here we will check
the control operators have the relevant
trainings or not. Our standard requirement
is operators must be trained for the control fixture and assembly
fixture checks. This is the
requirement according to that potential cause. The good part is trained
operators work at that time. Let's check the bad
part. It is same again. Operators had the training when bad parts were produced.
Standard is okay. Good part and bad parts are also okay
according to standard, there is no direct link
about the lack of training. This one eliminated. This was the end of the non
detection FDA analysis. Now we will move these
two verified case from the non detection into the 55 root cause analysis and we'll make a
further investigation.
14. Case Study - 5 Whys for Non-Detection: So now we are going to conduct the 55 root cause analysis
for the non detection. Our first verified case from
FTs lack of calibration. Let's start by asking why. Why was the control
fixture not calibrated? The answer is
because it was sent to calibration and
not returned in time. Now as you see, the root
cause forks to two ways. That means we have two
different causes of this. So let's proceed
at the left side. Why was the production continued while the fixture was
still in calibration? The answer is because
there was no clear rule preventing production from
running without the fixture. Why? Because process
controls didn't include a mandatory check for fixture availability
before production. Why? Because the
production startup approval process hasn't got
the full equipment list. This is our root cause
because obviously, if we had a full
equipment list in the production startup
approval process, this control would have done in a structural way so that
we could detect this. Now let's ask one
more why to go a bit more deep to understand the systemic issue
underlying of it. Why was the equipment list not properly considered in the
production startup approval? The answer is because there
was no formal procedure to ensure all required equipment was checked before
production started. This is the systemic root cause behind that technical
one because it shows the lack of standard approach and
once we solve that, the technical root
cause will not be repeat in the next time. We want Skip to put full equipment list in the production
startup approval form because we will have
a formal procedure to describe how to create
these control forms. Now let's continue
from the right side, which is going through
a different way. First cause was the fixture was sent for calibration
and not return in time. The next question
of why should be why there was no
alternative control method. The answer is because no backup inspection method
was defined and why because no contingency plan in place for the alternative
control options like CMM or other manual
measurement methods. So this is the second root
cause of the problem. Second technical root cause. So let's ask one
more question to see underlying reason of this
lack of contingency plan. Why we don't have
a contingency plan for alternative control options? Because there is no
document requirement to establish alternative
inspection methods. This is the underlying cause, which is the systemic reason. So if we solve this,
that means we will prevent the risk of
no contingency plan, which is the
technical root cause. Let's continue with the other
verified cuts from the FDA, which is assembly
fixture deformation. So let's ask why why did the
assembly fixture deform? The answer is because
second pin was missing, which is for checking the
alignment of the oil, and why? Because the second
pin was remote for maintenance and was not
reinstalled, and why? Because there was no
formal maintenance step to ensure all parts of the fixture were checked and reinstalled correctly
after maintenance. And why because
maintenance instruction of the equipment didn't include a step for confirming that all fixture components were checked and
reassembled properly. This is our root cause, the technical root cause of the assemble fixture
deformation. Let's ask one more why to
see lack of main standard. Why didn't the
maintenance instruction include this verification step? The answer is because the maintenance procedure didn't emphasize the importance of enduring the fixture
functionality and condition before it
was used in production. This is the systemic root cause. We chose the lack
of main standard. This was the end of the root
cause for the case study. Now we will quickly
summarize what we have done in
this whole section.
15. Summarize D5 Root Cause Analysis: Summarize the root cause
analysis and key takeaways. At first, we started with the Ichikawa, in
the other words, fishbone analysis,
which led us to identify potential
causes of the problem. We focus on the
problem and throw the ideas which can
cause the problem. These ideas were the
potential causes and after a quick check, quick filtration with the team, we move these to fault
three analysis, FDA. Here, we verify those with a few questions by comparing
the good and bad parts. In this analysis, some
of them verified, but some of them
just eliminate it because they were not
relevant with the problem. Those verified cause moved to five fives annals and
investigated deeply, which is the final step
of the root cause. We have found both technical and systemic root
cause in five fives. While technical root cause was
the origin of the problem, systemic was more about the
lack of standardization, which affects more area. Distinguish is important because in the next step during
the action plan, we will link the
corrective actions with the technical root cause and also we will link
the preventive actions with the systemic root cause. Additionally, we touched the verification
of the root cause, which is important to ensure
we answered correctly. It was like a cross
check by asking so starting from the
end to the backwards. This was the end of the root
cause analysis and now let's make a quick quiz to
reinforce our learning.
16. D6 Introduction to Corrective & Preventive Actions: Corrective and
preventive actions. In this step, we will understand the difference of
these two types of action and learn how to
create a robust action plan. In the previous step D five, we identify the root cause both for occurrence and
non detection. Now here, our aim
is to define and implement action against
these root cause. In a simple say, eliminate
the root causes. After that, we will
review and update PFMEA, process failure mode
and effects analysis. We have occurrence and non
detection root causes. Underneath, there are technical
and systemic root cause. Again, both for occurrence
and non detection. Here in action plan, we will fix the technical
root cause with the corrective actions
and we will fix the systemic root cause with
the preventive actions. The planning of these
actions will be in a simple format like action, responsible, due date,
and action date. Now let's move on to
the next lecture and see how we will create
this action plan.
17. Corrective and Preventive Actions (CAPA): Corrective and
preventive actions. In this step, we will understand the difference of
these two types of action and we learn how to create a
robust action plan. In the previous step D five, we identify the root cause both for occurrence
and non detection. Now here, our aim is to define and implement actions
against the root causes. In a simple say, eliminate
the root causes. Corrective and preventive
actions can be identified in a simple
timing plan format. At first column, we
have reference number, then the root cause column to link the root cause
with the action. Next is the action type, whether it is corrective
or preventive. Then the action itself, that means what we will do
against that root cause. After that, responsible,
who will conduct or lead the action and the due
date for a clear timing, and finally, actual date of
the action implementation. Now let's make an example
to understand how it works. Let's say we have a problem of machine breakdown and our root
cause for the occurrences, no preventive maintenance plan. Since this is a
technical root cause, our action to fix it
will be corrective. Simply, preventive maintenance
plan will be created. Action responsible
and the due date have also been
identified like that, and once the action is done, then the actual date to be
written in the last colum. So how do we know that the action we put here
corrective or preventive? Well, the answer is simple. If you take action to fix
the technical root cause, then it is corrective
in this example, because you correct,
you fix the root cause. But if your action fixes
the systemic root cause, then it is preventive. Let's put here a systemic
root cause of it. It is lack of structure
maintenance strategy, which is the cause of that no preventive maintenance plan. Simply here, if we take
action against this one, like a comprehensive procedure for maintenance activities
will be created, this action will fix directly
the systemic root cause. Therefore, it is preventive. Alternatively, you can
also think like that. If you have one root cause and didn't deep dive
for a systemic one, let's say, if your action is fixing that root
cause, it is corrective. But if it prevents the
reoccurrence of the root cause, then it is preventive. In this perspective, you
can see this example. Creation of
maintenance plan will fix the first root cause, which is the
technical root cause. But when we create
the procedure, it will prevent the
reoccurrence of this first root cause.
This is the logic. This distinction is
simple but crucial to identify your action as
corrective or preventive. This action plan is not
about the problem itself. It's about the root causes
that we identified because the problem should have been fixed in containment actions, either in temporary
or a robust way. But here in corrective and
preventive action plan, we focus on the root causes. In the other words, the underlying reasons of
the problem itself. One other thing is we can have multiple actions for
each root cause. For example, we can
add one more action here as training will be organized about
maintenance procedure, which is feeding the second
action here because we should also think about
the impact of our actions. If there are other
affected standards with our current action, we need to also
update this as well. And the last point regarding
the timing of the actions, we should try to provide
early dates as quality issues are always priority both for the customers
and operations. While there is no global
rule, in general, definition of the root cause and planning of the actions
can be targeted as ten days and full
eight decomplation can be set as 30 days. But as I said, it is
completely depending on the customer that you work
with and your own standards.
18. Understanding PFMEA (Extra session to understand the logic of PFMEA): FMEA, failure mode
and effects analysis. This is a proactive
tool that help us evaluate and analyze potential risk and
take action to prevent failures
before they happen. It's a structured
and robust method to identify risks in
production process, design, or even entire systems. There are different
types of FMA, such as design FMEA, process FMA, or system FMA. In problem solving studies at
manufacturing environment, we mostly use PFME
because PFME is used to identify the process risks and define controls against us. Here in AT study, this is one of the key
standard that we need to review and update according
to the failure mode, root cause, and the actions
that we have identified. In AT studies, we don't
make a full FMEA study. We just review and
update it where it is necessary as
part of the AT study. But to do this, we need
to know how it works. In this lecture, we will
learn its whole logic. This is a process FMA template, which is Edge forth revision. Let's review these columns to
understand their function. First column is process where
we have the operation step. So if we proceed with
a simple example, let's say, our process step
is drilling operation. And second, is requirement. Here we identify the
requirements of this operation. So what we expect from
this drilling process? Let's say we expect
a hole in ten millimeter plus and -0.05
millimeter diameter. Next question is
potential failure mode. Here we ask what are the failure modes of
this requirement. For this example, if we expect ten millimeter diameter
with 0.05 tolerance, then it can be
smaller or greater. These are the failure
modes of this requirement. For this example, let's just
say diameter is smaller. Diameter can be smaller
than 9.95 millimeter, which is lower tolerance. This is a failure mode. Next is potential effects
of this failure mode. Here we evaluate the potential
effects of the failure. For this example, what does
smaller diameter cause? Let's say, it causes an assembly
problem in the process. Counterpart doesn't fit,
impossible to assembly. This is the potential result
of this failure mode. Next one is severity rating. Here we rate these
potential effects of the failure mode out of ten. We have a table to do
this, starting from one, which means no dissonable
effect to ten, which means safety or
regulation issues. For this example, this
is about process effect. There is no customer effect for this failure mode because if they cannot assemble the part, it will not be even
sent to the customer. Therefore, we will use the
second coolum in this table. And we can rate eight, which is very high because there's a risk to
stop production. Next to it, you see class olume. This is about the product or process special characteristic. If there is. For example, if you are familiar with
the technical drawings, you can see some
special characteristics such as CC or reverse Delta. This special
characteristic mostly come from the product or function or maybe safety or
maybe for regulation reasons. These symbols are changed depending on the organization
and the customer. But for this example,
this characteristic doesn't have any classification. Next is potential
causes of the failure. Here we identify the
underlying reasons of the potential failure mode. For this example, we said that this characteristic can be
smaller than the requirement. That was the failure mode. We should consider
what can cause that dimension is smaller
than 9.95 millimeter, which is the lower
tolerance of so let's identify drill bit were. So this is a drilling operation, and if the tool deform
or wear in time, then hole can be smaller. By the way, there
might be a lot of different causes that
we can identify here, but we will go through
in a simple way just to understand the logic. Next is occurrence, and just next to it, prevention control. So here, before rating to occurrence out of
ten with the table, we first identify the
prevention controls because we will consider both causes and the
prevention controls when we rate occurrence. Let's identify the
prevention controls. Here we think that
what can we do to prevent drill beat wear? How can we prevent this or decrease the possibility
of its occurrence? Prevention controls address the potential causes
of the failure. Let's identify two
measures here. First is production
startup check to ensure drill bit
is in good condition, and second, is changing the drill bit for
every 4,000 parts. We have basically two
preventions in place. Now we will rate the
occurrence accordingly. That 0.1 of the important
thing is constant the quality problems of other similar parts or
processes if available. Because if you have a lot of problem in another
similar product, although you have the
same preventions, then the occurrence
rate will be very high. But for this example,
let's say we don't have much failure for
the other similar parts. We just put three as it
is a low possibility, which means one in 100,000
as estimated frequency. Next one is detection control. Here we assume that
failure is occurred. Regardless of the occurrence possibility, it just occurred. How could we detect the
failure mode or it's error, which is the cause
of the failure mode. If we can directly detect the
cause of the failure mode, which is drill bit with some automatic
control, let's say, that's the best
because you detect the error before it
becomes a failure mode, but that is not always possible. If we cannot award
or detect the error, then we need to detect the
failure mode directly, which is the whole
diameter is smaller than 9.95 millimeter
for this example. How can we detect this? Checking as visual or putting some camera controls or
having a control fixture. Let's identify a gauge control. Go and no go gauge. We will do this control
for five parts per hour. The frequency is also important, but all other control details are identified in
the control plan. For PFMEA, this level of
detail might be enough. Now the detection rating. According to this control, what would be the detection
score out of ten? We can rate as six because it
is failure mode detection, post processing by operator through use of
variable gauging or in station by operator
through use of attributing gauging
like go and nog gauge. It is 66 is the proper for
attribute type of control, which is in station. Now the last is RPN
risk priority number. Here we multiply
these three scores, severity, occurrence,
and detection, and the result is our RPN score, which is 144 for this example. This number is important
to see the priorities. So for example, if you
have three items and if one's RPN is 200 and
the other is just 30, then you should focus on 200 RPN and make some
more improvement, either in prevention
or detection controls to reduce the number. These extra improvement actions are taken in the right section, which starts with
recommended action. In case an improvement needed, we can identify new actions here and re evaluate
the score again. For example, if we
put a Pokao control, then the detection
score decreased from 62 or maybe one according
to the Pokao control type, then the RPN number
would be reduced. Let's make one. Let's say recommended action
is a camera control. Basically, camera will check the whole diameter automatically and if it is out of tolerance, it will lock the line which is a secure and robust
control method. And next coolum responsibility and targeted are
also identified like this and the next is action taken is blank because
we didn't apply it. It will be done later. We
just planned it at the time. NIF scores are severity is
not changed, still eight, severity never change
unless the part design or some requirements change
because even you put a better control mechanism or even you put some prevention
actions to avoid 100%, let's say, severity is still
the same because it just considers the result
when it happens. If it happens, the
result is same, then the severity is same. No matter we put some
Pocaok controls to eliminate to occurrence
or perfect detection. Severity is always same, so it is eight again. Occurrence can be changed if
you put better preventions. But in this example, it is three because camera control
is about the detection, not about the prevention. Therefore, occurrence
is not changed, it is three, but the detection
is now three, as you see. We decrease it 6-3. According to the
detection table, three is failure mode
detection in station by automated controls that will detect discrepant part and
automatically lock it, which is exactly matching
with our nv camera control. Now the latest RPN
is seven to two. But if it put some
automatic control to detect directly the
drill bit are, let's say, which is the cause
of the failure mode, then we could rate a
two because it prevents the failure mode by
detecting the error itself. These kind of controls are
generally called S pokaok. These are mostly rated as one
or two in detection table. So now we did a
simple example for the process failure mode
and effects analysis. This is the main
logic of P FMEA, and once the FMEA is completed, control plan is
created accordingly, which includes directed
controls like control type, control frequency, controller, whether it's a
machine or operator, the characteristic to be
controlled reaction plans in case failure detected
et cetera as I said, in problem solving study, we don't set up a process. We just analyze a
failure mode to resolve. So therefore, we don't make a whole PFME study
or are control plan. We just review and update if necessary because
at that time, it's already in production. So the necessary documents
must already be in place. We just review and
update them accordingly. Now let's move on to the
next lecture and learn how we review and update
PFMEA in AT studies.
19. Review PFMEA: Now we will understand
how we review and update PFMA in AT studies. This PFM is from the same
example but extended with different operations
like chafing and packaging in addition
to the drilling. First, the part is drilled, then chafing
operation for the H, and finally is packaging. Now let's imagine we have
a quality problem about contamination and we made
some root cause analysis, identify some actions,
and now we need to review PFMA part
of this AT study. First thing that we
need to do is finding the relevant failure mode
here, relevant line item. Here it is contamination
on the part, which is in the
packaging operation. We have this failure mode. That means we have already evaluated the
contamination risk. The only thing that
we'll do updating this failure modes line item according to the new
findings and actions. But if we didn't have this failure mode in
PFMEA, let's say, we will need to create a new line item for the
contamination failure mode. So for this case, the
quality problem of the contamination caused by
dirty working environment, the potential cause is not here as we just found it
in the analysis. What we do is just adding
it here. That's it. Regarding the current
prevention controls, we say no control because here we show the status during
the failure occurrence. All inpmpt action
will be identified in the recommended action
section in the right side. According to this data, we
now rate the occurrence. Since we already have a
failure for contamination, which was caused by dirty
working environment, and since there is no
prevention control for that, we rate high and put seven by using the
occurrence ranking table. Regarding the detection control, it is same. We check visual. Therefore, detection rate
is same with the above and the risk priority
number is now 196. Now we will add the controls that come from the action plan. Let's say we adapt five a check at each startup
to prevent dirtiness. We add this action in the recommended
action section and we re evaluate the rating score. Severity is still same for
occurrence reduced 7-3, which is low now because we improve the prevention by
adding a five a control. And detection is still say we didn't change
anything. It is seven. The RPA module which
is obtained by multiplying of these
three numbers is now 84. As we did this update just
after the action plan, the action stays open because we didn't
complete the actions yet. We didn't define
this control yet. Therefore, it is in progress
status, not completed. We can face different examples in various production types. But if we understand the logic, it is quite straightforward. This was the end of
PFMERview lecture. Now we will continue
with the case study.
20. Case Study - CAPA for Occurrence: Let's start the action plan
with occurrence root cause. Here is the root cause that we did for lack of
change management. So our actions should
cover all these points. The ease way is always starting from the
technical root cause, and it is the second line. And the action we will
take according to technical root cause,
will be corrective. So it is change
management procedure for temporary tool adjustment
were not clearly defined. So let's take an
action for this. Change management
procedure will be updated. Rollback process
will be added and temporary tool adjustment
will be detailed. This action fixes
that root cause. This is corrective.
We also identify the responsible deadline
regarding the root cause column. It is just to show the
link with the action, so we can just put
a reference number of root cause rather
than typing go. Now we will take
an action against the systemic root cause
which is just underneath. It has lacked awareness
to anticipate the risk associated with
temporary tool change. Here we should think about what can we do to
improve this point? This will absolutely be preventive because
it will prevent the technical root cause while fixing the
systemic root cause. Let's identify conduct
risk awareness training on how temporary tool change
can create unexpected risk. While this action is addressed
the system of root cause, we can also add one more
to standardize this. Let's say, implement a
simple risk assessment step before applying any
temporary tool change. With this action, we will have standardized this robustly. Let's bring the other
occurrence root cause. It training scope was
not clearly defined. To fix this, we can define a corrective action like
revise the training scope to ensure punch alignment
verification and related failure
risks are fully covered. It's pretty
comprehensive action. We also define action Owner
as Atak and the due date. As part of this action, we also organize a training
for punch alignment to ensure all relevant teams have the necessary
knowledge according. Now let's bring the systemic
root cause to remember. There was no structured
qualification or competency requirement for those preparing
training content. Here the question is, how will we prevent
this in the future? In a different project
with a different team, we can make the same
mistake because we didn't put some
standardization yet. Preventive actions
are exactly for that. If you identify some
requirements to the system, we can prevent this to reoccur in the future.
Let's write it. Define qualification and
competency requirements for training developers. This action will provide a standardization
because we will prevent incompetent people
to prepare training content. Now, we completed the corrective and
preventive action plan for the occurrence root causes. Now let's move on to
the next lecture of study and create action
plan for the non detection.
21. Case Study - CAPA for Non-Detection: We'll create an action plan
for the non detection. Let's bring the
root cause analysis that we have done
in the case study. The verified cause was lack of calibration. Let's remember it. We had a control fixture
for checking the whole of the semi products and the control was being
done in that way. If the fixture passes, then the whole
locations are okay. But the problem was that we
identify in the FDA analysis, this fixture was not in place because it was
sent to calibration. Here in the root cause analysis, we should take action for
both sides because we have two separate root cause
for the lack of calibration. Let's start with
the first section. Here, our technical
root cause was production startup
approval process hasn't got the full
equipment list. If you also read
the previous case just above it, number three, it says fixture
availability control is not included in
production startup checks. Here, as a corrective action against this
technical root cause, we should update that production
startup approval process to include full equipment
list and also we should put some checklist to ensure
those equipments are checked before starting to product
if you see the number five, which shows the
systemic root cause, as there was no formal procedure to ensure all
equipments are checked, we should develop some procedure or policy to address this. Let's speck to the
action plan now. First action as already considered for the
technical root cause, update production startup
approval process, and create a checklist of
all required equipments. This is a corrective
action and it covers the technical root cause. Let's see the other
actions that we have. Develop standard
operating procedure. This action source the
underlying reasons of the technical root cause
or in the other word, it address directly the
systemic root cause. Therefore, this is our
preventive action. Here, we also put one more action as training
for the operators and supervisors about
the NIV procedure to ensure everyone understands
the NIV procedure. This action is part
of the action above, identified to support it, it is preventive as well. So we hit one more
root cause section in the same analysis about
lack of calibration. Therefore, we will also get
some actions about this one. The first root cause,
which is a technical, no contingency plan in place for alternative
control options. So we should create
contingency plan for alternative control options
in production process. And regarding the systemic one, which is just underneath it, since there is no
documented requirement to establish alternative
inspection methods, we should put some
documented requirement to standardize this application. Now let's see the
action plan what we can put in place for
those lag points. First action against the lack of contingency plan is
create contingency plan and identify alternative
control options such as CMM or
visual inspection. Since the relevant cause was about the lack of
control fixture, because Vasanto calibration and the production continued
with that control fixture, this action will provide an alternative control when the control fixture
is not available. So if you give an
example, it will be like, if the relevant control
fixture is not available, use three D CMM. This is the alternative
equipment to make this check. Basically just an
alternative control, which is also mandatory
for the control plans. So this was the first
corrective action. Now let's see the second one. It is provide
training on when and how to use alternative
inspection methods. This action is a
training action, and it will provide a
basic understanding to the controllers. So since it addressed the same root cause and
support to just action above, it is a corrective
action as well. Now let's put a
preventive action to address the
systemic root cause. It is ensure that contingency plans are
included in the control plan. Control plans are the
fundamental document of production processes. Those are the standard
documents that includes all the
process controls. This action states that
we should identify an alternative control for each single control item
in the control plan. This is fairly enough
for the standardization. Now let's do this for the last root cause
of non detection. It was about the assembly fixture deformation
at the process. If you remember, how
was it, as you see? This was the assembly fixture which was used to assembly of two sempducts as well as the
whole control with the pins. But the problem that
we verified in FDA, it was the middle pin of
the fixture was missing. So when the defected part introduced that fixture,
it was passing. That was the second
cause of non detection. Now let's remember
the root cause of it. The number four, which is
a technical root cause, maintenance instruction
doesn't have a control step to ensure all fixture components have been checked and assembled properly. We should update
this maintenance instruction accordingly, and we can also create some checklist for the
maintenance operators to ensure. And regarding the
systemic root cause, which is the number five, maintenance procedure doesn't
emphasize the necessity of enduring fixture
functionality and condition after the maintenance. Here, we need to update this procedure and add
this as a requirement. Now let's back to
the action plan. The first action is updating
maintenance instruction, which address the
technical root cause. Therefore, it is a
corrective action. And the second action to develop
a standard checklist for maintenance operators to ensure all fixture components
are correctly installed. Again, this action is also
corrective as it still address the technical root cause as an additional action
after the one above. And the last action is update standard maintenance
procedure to highlight the necessity
of fixture verification. This action is addressing
the systemic root cause, therefore, it is preventive.
22. Case Study - PFMEA Review: FME review. Now you see a complete process FME
of the case study part. It includes each
process of the part. Let's bring the process
from the case study. First process is stamping. It is where we produce the
first semi product and the line items on PFMEA are
here, blue highlighted ones. The second process
is stamping again. This is the second sempduct that we had a quality claim for that part in the study because the second hole was misaligned. The third one is assembly, where we assemble
these two parts. Their PFME section is also here. Now let's find our issued line where we have the
failure mode of hole misalignment
because that was the failure mode that we
received from the customer. So this is our line. It is under second semi product, piercing Corporation and under assembly hole
position requirement. The failure mode
is hole position is out of tolerance, mislocated. This is exactly our
focus point to update. Now let's go step by step. Regarding the potential effect, bolt cannot be
assembled or fors. This is still valid
because that was the issue at customer line and they
couldn't assemble the part. Now let's see the potential
causes of the problem. They are misaligned piercing
tie or punch and tool were. We started updating
from this point because we had a few root
cause of that problem. The first cause is piercing
punch wrong placement and the second is inadequate control of engineering change process. Regarding the current
preventive controls, it was not exist, so that means no control. Therefore, occurrence of
these points are quite high. We rate it as seven. According to the FMEA
occurrence table. Detection controls
are still same. We didn't change or add a new control and
the reason of it, it wasn't unsuccessful because of the control
type or frequency. It was unsuccessful
because of lack of calibration and maintenance
of this control fixture. All this is about
the effectiveness, not the control itself. Therefore, we rate it as four, which is the same considering
the above controls. Because the mechanical
pin action which is written above already applied, so we will not consider
that like a new action. We can directly write here in the nv line as part of
the current action. The RPN is 224, it is quite high number, but now we will
reduce this because we already planned corrective
and preventive actions. These were specific
training activities for the punch alignment and rollback process for
the temporaries. In the new rating at the
right side, as you see, severity and detection same, but we reduce their
occurrence rating according to the
occurrence table. Their new RPN is 96 and
the second one is 64. So now we update the PFME
according to factors that we identify in FDA 55 root cause
analysis and the actions. We didn't bring
all the root cause and actions here
because, for example, the contingency plan action is just about the
alternative controls, which should have already been
defined on control plans. On the other hand, the control fixture maintenance
checklist action, which was planned to ensure all control fixture components in place and properly working, just about the effectiveness
of current gauge controls, which were already defined. So we didn't change
anything about those. That was the end of the lecture. Now we will summarize corrective
and preventive actions.
23. Summarize D6 Corrective & Preventive Actions (CAPA): Corrective and
preventive actions, we basically first
listed the root cause, both for occurrence
and non detection, including the technical
and systemic root cause. We identify corrective
actions against the technical root cause and
for the systemic root cause, which are the lack of standards, we identify preventive actions that provide standardization. Developing of action plan can be seen in one of the
easiest section of eight process because once the
root cause are identified, only thing that you should do is put some actions to fix this. That is basically correct. However, the key
point is actions should cover all the
lack points through the root cause
analysis because root cause analysis can just state
that lack of procedure. However, we should also identify action training after creating a procedure where
it is necessary. Therefore, it is very important to develop
this action plan with the relevant stakeholders to
cover all relevant areas. Other point is actual date. We just identify the actions. However, once they
are completed, we should record its actual
date here in the same table. One other thing is action
deadlines. Due days. The deadlines can vary
depending on the action type, their difficulties because while some actions can be
completed in a few days, others can take few weeks
and sometimes even months. But the priority is always
try to complete as soon as possible in line with the determined dates in the
action plan, of course. In that point, we need to agree for the action
plan and dates with both action owners
and customers as well. Once we identify
the action plan, we need to review and
update PFMEA accordingly, which is another key
point in the step. This was the end of corrective
and preventive actions. Now let's make a quick quiz
to reinforce our learning.
24. D7 Introduction to Action Validation & Effectiveness Check: The previous step,
we had identified the corrective and preventive actions against the root cause. And in this step, we will
validate those actions to ensure they have been completed
and working effectively. Our first step will be the
verification of the actions. We'll simply verify whether they are completed and
working effectively. Second step will be the
reproduction of defect, which is the other key point. We will try to
reproduce the defect by intervening the
process to ensure the defect can still be occurred or not after the
actions implemented. Now let's dial in and understand
how we do these checks.
25. Action Validation & Effectiveness Check: Our first step is
verification of the actions. This is quite straightforward because we just go to
the right place and check to ensure that
the actions are in place and working
effectively. We should observe the
actual place and actions, we should get
unnecessary details from the production to really be
sure that everything is okay. This is a very key point
because your limited time to check might not be enough to see some disruptions
if there is. It is very useful to
get feedback from the process supervisors or operators at the
relevant process. After this check, if
everything is okay about the actions,
we can confirm. This verification should cover all the actions in
the action plan. For example, if this is a
standard document action, then you should check
the updated content and sureties embedded
than the relevant system. Or if it is a physical action in an operation
process like here, then you should go to the
real place and check. Second step is
reproduction of defect. This is crucial
because in this point, we try to reproduce the
defect to ensure whether our actions address the root
cause and solve the problem. We had already applied reproduction defect in FDA
analysis, if you remember. But at that time,
the aim was injuring the potential cause is really causing the
problem itself or not. So we had simulated the
failure mode by providing same conditions according to the relevant line item in FDA. But here we will
do this to ensure that we cannot produce
a defect anymore. After the actions,
it is to confirm that our actions
addressed properly. Because in this step, D seven, if we still able to
reproduce defect by manipulating something
in the process, then that means our
actions are not effective. We should turn back and evaluate our actions
in that case. Let's give some practical
example to understand. For example, problem
occurred due to changing of
machine parameters, and our actions were about keeping stable of these
machine parameters. So in this point,
we should try to manipulate those
machine parameters during the production running. So if we can change it, then that means our
action is not effective. Defect is still able to so we should turn back to actions
and evaluate again. Another example, let's say our problem is
wrong placement of the part during
assembly operation and we apply the Poka
yoke to avoid this. In that point, we
should try to put the part in wrong position
again to see the result. If Pokoke is effective, it will not be possible
to manipulate it, which is our expectation. We just try to simulate
the conditions. Let's give another example. The problem is different
reference of part welded in welding operation
and our action is adapting sensor control
for part identification. For the reproduction of defect, we can try to put
different part there again to ensure that sensor
is detecting it or not. If it detects the wrong part, then we cannot produce a defect, which is the expected
result in this step. Basically, our aim here is
to ensure that we cannot produce a defect in no way after the
implementation of the actions. For the AT, we can
document this like defect reproduction
study has been done and failure mode cannot be produced after the
implemented detections. We just tick the second
validation action. However, there might
be some cases where defect reproduction
trial is not possible. For instance, if
the issue is due to a design failure
and the design has been changed or if it involves a die problem
that requires maintenance, it may not be feasible
to reproduce a defect. In such scenarios, once
the die is modified once the modification is done and no longer
produced a failure, diverting the die to simulate the failure mode is not
possible and not make sense. Thus, this reproduction of defect approach
generally applies to conditions where we can manipulate the
production process. Another important
point in these works, we should provide the
necessary conditions to avoid any mistake because reproduction of defect is a risky operation due to
working out of the standard. Therefore, it must always
be under control by relevant supervisors or managers from the relevant
operation team. For example, all the
parts that produce in this period must be isolated
because they can be defect. Another important point is
health and safety, of course. It must be managed
always by the teams who are authorized for
the relevant process. During these shop
fuller controls, we can also conduct
process audits which is more comprehensive and apply some failure
mode analysis studies such as diverse FMEA. Kind of applications
are more structured, but can vary depending on the
organization you work in. So in case you do,
you can document these actions like process
audit was conducted, no NC was detected. Actions have been verified, which is for the
action verification. And for the second, verse FMA study was conducted, no issue was found. Failure mode cannot be reproduced after the
implemented actions, which is for the
defect reproduction. But at minimum, we should
verify the actions in place and ensure that defect
cannot be produced anymore. And sometimes we
might have to monitor the action effectiveness for
a time period in some cases. For example, process has been
monitored for four weeks, no issue was detected, and this kind of monitoring
actions might be considered if the defect
is very rare and singular. So you might want to
check the process in a time period in such cases. But this is not
always possible in the automotive industry,
especially, because obviously, you need to complete all
study in a very limited time and submit to your AD to the internal or
external customer. This was the end of the lecture. Now we'll continue
from the case study.
26. Case Study - Action Validation & Effectiveness Check: Regarding the case study
for action validation, the first thing that we will
do is verifying the actions. It is to ensure these have been applied and
working properly. Let's bring an action
from the previous step. The first action is updating
change management procedure and adding rollback process with temporary tool adjustment. Here, we directly
check the procedure to ensure these
requirements are added. We checked it and verified that. All necessary items, document updated properly and embedded into the quality
management system, which is important to provide document control and then
cascade it properly. Perfect. First action
done, we verified this. Let's bring another one from the occurrence
action plan again. This is conduct risk
awareness training on how temporary tool chains
can create unexpected risk. We can demonstrate
this by getting the training attendance report. System always needs
a demonstration. We need to have a proper way to demonstration
according to our actions. We check the training
content and verify that. It covers the points of how temporary tool chains
can create risk. We got the training
attendance report, so we verified this one as well. Let's bring one more from the
non detection action plan. It just develop a
standard checklist for maintenance operators to
ensure all fixture components, including pins are
correctly installed. This is a document action. However, it should also be checked in the maintenance area, in the shop photo
area because this is a form and it need to be
used by the operators. We need to ensure
their access to this and their understanding
on how to use. We check this and verifying
that form created, all necessary components
added to check, and operators have access
to form in the chat floor. Now, in case any maintenance, they will check the fixture
conditions to ensure all components are in place
and correctly installed. Perfect. We verified
this action as well. We are doing this
verification properly to all the actions both for
corrective and preventive. Occurrence and non detection. After that, we document this verification
on 80 step D seven. Actions have been checked
and verified in Gamba. Gamba is a Japanese terminology, that means actual place. Instead of shop flow
or the actual place, gamba can be used. Now we need to ensure that the actual defect cannot
be produced anymore. We will check the shop floor. Let's remember the
defect occurrence first. It was whole misalignment. This was the press
and this black part is the one arm of bontinge. Operation is done and pierce three holes, three
aligned holes. This was the normal condition. Now let's look at
how did it occur, how the failure occur. As you see, the second hole is not align in
the second visual. It is not in the middle of the part like we did
in the left visual. The reason was second punch in the tool was
incorrectly placed during an engineering
changing and it was not reverted
after the trial. Afterward, we investigated
the root cause and took necessary
actions against this. But for the
reproduction of defect, this is not a
failure mode that we can reproduce by
manipulating the process. Basically, this case is not feasible to directly
reproduce the defect. However, through a simulation during
the tool maintenance, we verified that the defect cannot be reproduced
after implementing the new actions because we put specific checks and tool
rollback process in place. Consequently, we
validate this step as defect cannot be reproduced after the implemented actions.
27. Summarize D7 Action Validation & Effectiveness Check: D seven action validation and
effectiveness check step, we verify the actions by
checking them in action place. We verify whether the action is in place, is
working properly. If there's a standard
document action, the relevant teams
are aware of it. Another check was the
defect reproduction. While it was not always
possible to make this trial directly
in proper cases, we should try to reproduce the defect to ensure
our actions are effectively working and
avoid defect reoccurrence. Other point was about
the checking method. We can conduct process audits or reverse FMA study to confirm
the production process, the actions, and also the current and potential
failure modes. This was the end
of this section. Now time for a quick quiz.
28. D8 Introduction to Lessons Learned & Closure: So far, we addressed the root cause with corrective
and preventive actions. We check the action
effectiveness and now we have come to the end. In the step, we
will close the 80, but we need some additional
things to do before this. First, we will capture
lessons learned. We should document
the lessons that we learned from
this eight study. This will basically
summary of problem, root cause, and
implemented action. The importance of it, this will be considered
in the NIV projects. For example, they will
design the process or product by considering
these lessons learned. Lessons learned are one of the significant know
how of companies. Therefore, they are the
fundamental of this step. Afterwards, we'll
make 80 closure audit to ensure all steps
completed properly, and then we'll complete this
80 by celebrating the team.
29. Lessons Learned: Lessons learned. As
the name suggests, it's a lesson that we have
learned through the process. This is a deployment
and a promotion tool to capture the key outcomes of
a problem solving study. This is quite straightforward. It is simply a before and
after statement of the action. Let's make an example to
understand this better. So now you see an example
of a lessons learned card. At the top left side, we have registered information like Lessons door number,
lessons door type, whether it is coming
from occurrence or non detection, 18 number, which is to
understand from which 80 and also part
or product number. And next to it, we
summarize the problem. And after that, we
bring the root cause analysis in FFiveFrame
and finally, we put the visual of
solutions in before and after format and indicate the implementation
action just as below. This is a simple format
of a lessons learn card. Let's review what does it tell? This is a non
detection sss learned as indicated at the
register table. Problem was sharp bur on the
screwing hole of one part. It was detected by the customer
at the assembly operation and this bur caused a minor
injury to the operator. Let's review the root cause
analysis through to five pis. It Burr was missed
during the inspection. Why? Because operator
didn't detect a part during that
visual control and why? Because it was too small
to detect as visually. The next question
is why was checked then as visually if it
is difficult to detect. The answer is because improper
control method selection. The selected control
method was not proper to detect
this failure mode. Clear. Then we can
ask one more why because the risk was
not predicted in PFMEA, process failure mode
and effects analysis. So what we have done against
this route because as seen on the picture before we
had a visual control, but now we adapted a camera
control to detect the birth. As a summary, camera
control adapted and PFME control plan also updated
for this failure mode. This lessons learned card or LL card in an acronym tells us, visual control is not sufficient to detect
small burs on the part. You should adapt a camera
control rather than a visual and the risk needs
to be considered in PFMEA. This is what we understand from these lessons learned card. Now just imagine
you are starting a NIV project in the production in the
same production plant, and you will produce a
similar metal part like that. Instead of putting
a visual control for this failure mode, you could probably
consider to adapt a camera control because
you learn to lesson. Visual control is not
effective for the small burs. Lessons learned are one of the main input of
the NIV project. It is important to capture
this to avoid future problems.
30. 8D Closure Audit: ATO ort is the final
step in our AT process. In this point, we
will ensure that. Did we complete each
steps properly? This is a self assessment
of all the process. We will check each point
and if we have some gap, we will go back and correct it. So we have five questions for each discipline and simply
we just assess the results. If we meet the criteria, then we select ok.
On the other hand, some of the questions might
not be applicable for the 80. In those cases, we just put NA, not applicable and we might face some failures for some of the questions if we
don't meet the criteria. For those, we just
put noto for those, we need to fix this by using a simple action plan
in the same form. And once there is no not okay, the result will
look as accepted, which means 80 can be closed. Now let's go through
the questions. For the D one, we
basically check, did we use five WTH? Do we have visuals for
the problem statement? Do we have problem definition both for customer and supplier? This is on applicable if the issue comes
from the customer. So if we do this AT
study internally for a problem regardless of customer or any
other stakeholder, then this question
will be just NA. And the last one, did we notify teams in the company
about the problem, which is a simple mail share
or can be a QRQmiting, maybe AI, if the company work in N principles or any other
communication method according to the
organization that you work. D two simply checks three main points about the
similar parts and processes. If we miss the evaluation of the other similar process or other version of the
parts or customer plans, we should turn back to
D two and update it. D three, is the initial
analysis questions. Which are about the shop for basic checks or
gamba walk in the other we ensure we had initial analysis
for non detection, which was required for a
robust containment action plan and basic condition
checks in the process, which are like machine
parameters are okay, operator trainings are okay. Is there any anomaly in
the process, et cetera? So some basic initial checks. D for containment action. First, we check a defective or suspected parts,
table prepared, which is for dirty
batch analysis, and then sorting
activities to ensure no bad part sent
to the customer. Afterwards, containment action. Here we ensure that
containment action plan developed and completed. Next is the five. Here we check heavy
done fishbone analysis, fault analysis, and five fives root
cause analysis for both occurrence
and non detection. As the last question about
the systemic root cause here, have we formed the systemic
root cause through the five fives analysis
if applicable. To document the
systemic root cause is not a mandatory task in AT studies as long as the preventive actions prevent the root cause happening again. However, it is extremely
important to unfold underlying systemic issue about the lack of standardization. Next section is the six corrective and preventive
action questions. Here we basically check that our corrective actions address the root cause and our preventive actions
prevent that root cause. As a last important
point here is PFMEA process failure mode
and effects analysis. We should check to ensure it
was reviewed and updated. The seven is action
validation step, and here we ensure heavy completed corrective
and preventive actions and check their effectiveness
to they work effectively. There are two questions about the capability and measurement system analysis in this section. These are not always applicable. Regarding the capability,
the index is CP and CPK. If the problem is not
singular, let's say, and if there are
some variation issue about the part
dimensions, for example, we should consider to have
some capability analysis to verify that
process is capable. Or let's say if we did some
improvement or changing on the part geometry or in the process directly like
changing of the machine, for example, we should ensure whether process
is still capable. But other than, these
are not required always. Next is MSA in this section, which is necessary
for the verification of measurement method by constrt the variables like
operator and part as well. Again, this is not
always required. For example, if you adopt a
new camera control method to the process like a camera
control or a gauge control, for example, we will need
to verify those with MSA. But other than if
it is not relevant, then it is not required. Last question in D seven is
reproduction of the fact. We ensure that this
study has been done and defect cannot be reproduced
anymore after the actions. And last step is D eight. Here, we should ensure that lessons learned
captured properly. So once all is done and if
there is no Nok status, the result will be
acceptable and we will be ready to celebrate
the team to close the AD.
31. Team Celebrate & Recognition: Team celebrate and recognition. At this stage, you
can just relax because all steps
have been completed. Here, as the 80 leader, we ten people in the team, recognize their efforts and contributions and
close the in the step, people tend to just close
the 80 and go away. But a recognition, which
might be a small thank you via mail or a
recommendation comment on your company database is really
important to keep people motivated and let them know that you aware of their effort. One other thing at this point, if you receive this
problem notification from the customer or from
an internal audit, let's say, then we should submit this 80 to get their
approval to close. This might be a customer for the external quality problems or maybe a sponsor for the
internal quality problems. Once you think to
people who work in the eight study and get approval from the
sponsor or customer, then you can close the 80.
32. Case Study - Lessons Learned & Closure: Case study of last step D eight, we will start with
the lessons learned. We had a few root
cause in D five, that means we should prepare these LL cards for all of them. But in this case study, we will just make one to keep it simple.
Let's have a look. We identify the
basic information at the top left area
like part number, eight number, lessons
learned type, and number, and bring the problem
definition here with a summary of five WTH and bring the root cause from D
five step and identify the visual statement of the
actions as before and after. At before we already had
change management procedure, but there was no
rollback process and no risk assessment which are identified in the root
cause analysis as well. Now in the corrective
and preventive actions, we improve these processes, so updated this procedure. We clearly show
this statement in the after with the
updated procedure. Now we have a lesson
learned card for our eight. In the AT audit,
we simply review the questions and answer
them according to our 80. For the initial steps, D one, D two, D three and D four, we identified problem with 5w2h, both customer and supplier. We used visuals and
published the problem. We had done similar parts
and process analysis very detailed and we conduct initial analysis
at the shop floor. Finally, we had developed content action plan with
a defective part table, so all is okay. Regarding the D five, we made a very detailed
root cause analysis, but we didn't make reproduction
of defect for FDA causes because it was not possible to revert back to tool
to produce bad part. So all this section is okay, but the reproduction of
defect in FDA is NA. And regarding D six, we developed corrective
and preventive action plan and implemented properly. We also updated PFMEA. So this section is also okay. In these seven, we verified corrective and
preventive actions, and we also tried to reproduce
a defect in the process. So all the actions were in place and they
were working well. Regarding the
capability and MSA, these were not
applicable for our case. So they are NA. And the last question, lessons
learned are also captured. So that's it. There is no gap
and the result is accepted. Now, all this big study done, we completed the full 80 and received a customer
approval for IT. So we than our team, or stakeholders
and close the 80. So if we populate the steps
respectively in the eight, first we confirm that if any further standard updated
including FMEA control plan, maybe product specifications
or other main procedures. This should have
already been done in the six corrective
and preventive actions. Here we just identify these updated standards
as reviewed and updated. Lessons learned
created a T audit completed without a gap, and team recognized, and customer approval has
also been received. This shows that
80 is closed now.
33. Summarize D8 Lessons Learned & Closure: D eight, we started with lessons learned where we
captured the problem definition, root cause and implemented actions with before
and after visuals. Lessons learned were
important for know how, which is key to success for following projects
in the future. And after that, we conducted
80 closure audit to ensure each step in 80 problem
solving study is okay. And next, we completed the 80 by celebrating and recognizing
the and of course, getting customer or sponsor approval where it is required. This approval was also
important because if you had a quality problem raised by an external or
internal customer, you cannot just close problem solving study without
getting their confirmation. If it is fully internal and
inside the department only, then quality manager approval is enough or the one who is
assigned by the organization. Once all is done, we populated the final
step respectively, the first FMEA control plan and other specification
update confirmation, and then lessons
learned, at the audit, and team recognition, and
the customer's approval.
34. Congratulations!: You have just completed
the course on master at problem solving
root cause analysis, D five to the eight, so a big congratulations. That means you now know how to perform effective
root cause analysis, define corrective and
preventive actions, validate their
effectiveness, update PFMEA, and close problem solving
studies with lessons learned. And more importantly, you
now have the confidence to apply these tools in
real world situations. If you found this
course helpful, I would really appreciate if you could leave
a quick review, even just a few words. And also, if you
haven't get yet, don't forget to check
out my previous course, which covers the first part of the AT problem solving study, D one and D four. Thank you again. I wish
you a continued success in your professional journey
wherever you are in the world.