Root Cause Analysis

Presenting to: Presenting by

Dr. M.P. Venkatesh
Asst. Professor,
RA Group, Chandan M S
Dept. of Pharmaceutics, 1st M.Pharm
JSSCP, Mysore.
 Introduction
• Root Cause Analysis (RCA) is a popular and often-used technique that
helps to answer the question of why the problem occurred.

• It seeks to identify the origin of a problem using a specific set of steps, with
associated tools, to find the primary cause of the problem, so that you can:
a. Determine what happened.
b. Determine why it happened.
c. Figure out what to do to reduce the likelihood that it will happen again.

• RCA assumes that systems and events are interrelated. An action in one
area triggers an action in another, and another, and so on. By tracing back
these actions, you can discover where the problem started and how it grew
into the symptom you're now facing.
 Introduction
• Whenever regulatory authorities any where in the world perform an audit
of a drug manufacturer, one of their most frequent findings remains the
inadequate performance of the investigation of deviations.

• Authorities expect stakeholders will carefully investigate deviations to

identify non-compliance, intervene and then evaluate the effectiveness of
that intervention.

• Without adequate investigation and root cause analysis (RCA), those

stakeholders cannot effectively identify and design successful
interventions.

• A tool such as RCA uses a defined critical analysis approach in evaluating

the reason for a deviation or nonconformance.
 Introduction
• As such, RCA represents an extremely helpful investigative tool in
identifying why something continues to occur or, in the absence of any
actual occurrence, why a firm might experience a series of problems.

• RCA provides necessary feedback on an organization’s operational

performance, it also costs it both in resources and time. For that reason,
industry analysts recommend that organizations may choose to investigate
only those events where they believe they have a significant amount to
learn.

• Whether or not an organization conducts a full-blown RCA, it should track

all deviations as to location, type, frequency and whether they are new or
repeat events.

• In fact, industry experts believe firms should track even those unexpected
events not classified as deviations because they will yield valuable baseline
information.
 Process
Identify the
Problem

Monitor the Define the

system Problem

Corrective Understand the

action problem

Identify the
root cause
• Identify : Identify the problem by using a “risk-based” approach; it must determine
the probability of a negative event and its consequences.

• Define : Try and use SMART principles, i.e. Specific; Measurable, Actions
oriented; Realistic; Time constrained.

• Understand : Check the information, obtaining real data regarding the problem,
gaining a clear understanding of the issues.

• Identify the root cause : Determine and prioritize the most probable underlying
causes of the problem.

• Corrective Action: Make corrective actions to at least mitigate or preferably

eliminate the causes.

• Monitor the system : After the measures have been determined and implemented the
success of the adopted approach needs to be monitored to prevent the consequence.
 Example
• During an investigation into an incident, a requirement comes to light that
analysts must have their test methods out on the bench while they prepare
their samples.

• One analyst (let’s call her Mary) violated this requirement numerous times
and, there-fore, the team decided Mary represented the root cause of the
incident.

• Why? Because she failed to follow proper procedure.

• Subsequently, an investigator visited the lab and spoke with Mary.

• While there, the investigator noticed the very small size of her workstation
and those of her colleagues.
 Example
• The investigator asked Mary to show her test methods, which had been
sealed in binders in such a way that they could not be removed. Indeed, to
prepare her samples appropriately, Mary simply could not work with her
binder open on the bench.

• Furthermore, she had alerted her supervisor to the problem, to no avail.

• Thus, Mary’s failure to follow procedures was not the root cause.

• Instead, it lay deeper than that. First, the environment made it virtually
impossible for analysts to have the test method out on the bench while
performing an assay. Second, Mary had discussed the problem with her
supervisor, who failed to act appropriately to solve the problem.
 Tools of RCA
RCA can involve the use of many tools,
• 5 Why’s
• Brainstorming
• Process mapping
• Cause-and-effect diagram
• Fault Tree
 5 Why’s (Gemba Gembutsu)
• 5 Why’s can sometimes be referred to as Gemba Gembutsu.

• 5 Why's typically refers to the practice of asking, five times, why the
failure has occurred in order to get to the root cause/causes of the problem.

• No special technique is required or form is required, but the results should

be captured in the Worksheet.

• 5 Why’s are best used when tackling a simple RCA.

• The “5 whys” method requires the investigator to start with a precise and
focused problem statement, then take the problem statement.
 Why? Answer and Observation

Why was Zone A contaminated by S. aureus? Because operator caused contamination.

Why did operator cause contamination? Because operator was not present during
training regarding plant hygiene.

Why was operator not present during training? Because operator was on vacation.

Why was there no training follow up when he Because there is no procedure defined for
returned from vacation? follow up of missed training.

Why was there no procedure defined for fol- Because the SOP was not updated according
low up of missed trainings? to Quality Module.
 Brainstorming
• Brainstorming remains probably one of the most popular tools in RCA.

• It is most effective when used early in the process.

• The group meets and puts all the facts on the table, saying, “this is what we
know,” while continuing to look for any other potential root causes.

• While brainstorming represents a kind of free-for-all of ideas, it can and

must be done in a structured way.

• Don’t dismiss anyone’s ideas during brainstorming.

• Indeed, the goal remains to capture every possible idea, not challenge them
individually.
 Brainstorming
• A team should refrain from making judgments during this process, given
that it has not evaluated any data nor applied any problem solving tools.

• After the team does gather all the necessary and pertinent information, it
can then evaluate and challenge that information.
 Process Mapping
• Process Mapping represents a visual representation of a process.

• It can be used as an analysis tool when evaluating a process to uncover a

potential root cause.

• Process mapping is an excellent way to break down, step-by-step, what

could prove to be a contributing factor to a problem.

• Most processes we follow today are mapped out by a flowchart.

• Flowcharts organize information about a process in a graphical manner

thus making it clear what is impacted.
 Process Mapping
• Whether your problem has a documented process or not, this can be a
really useful tool to understand what is going on.

• Although there are good templates in Microsoft PowerPoint and Visio,

you can just as easily use a wipe board or pen and paper.

• For example,
 Say a problem occurs at step 32 of a manufacturing process, yet an in-
process sample appeared within specifications.
 Then at step 62, someone identifies a problem.
 Thus, the investigation should focus on what happened between steps 31
and 62.
 Cause & effect diagram
• Also known as Fishbone diagrams and Ishikawa diagrams is a visual
representation which can help to analyze the root cause of a problem.

• This useful technique is used for more complex RCAs.

• This type of diagram identifies all the potential processes and factors that
could contribute to a problem.

• A basic Cause and Effect template can be found in Microsoft Visio, or just
use PowerPoint.

• The value of using the fishbone diagram is to dig deeper, to go beyond the
initial incident report, to better understand what in the organization’s
systems and processes are causing the problem, so they can be addressed.
 Fault Tree
• This is a graphical technique that provides a systematic description of the
combinations of possible occurrences in a system, which can result in an
undesirable outcome.

• This method can combine system and human errors for occurrence of the
problem & relies on the experts’ process understanding to identify causal
factors.

• This tool evaluates system (or sub-system) failures one at a time but can
combine multiple causes of failure by identifying causal chains.

• The results are represented pictorially in the form of a tree of fault modes.
At each level in the tree, combinations of fault modes are described with
logical operators (AND, OR, etc.).
 Advantages & Disadvantages

• Longer lasting solution

• Real World Problems
• Safer Workplace
• Provides necessary feedback on an organization’s operational performance
----------------------------------------------------------------------------------------------
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• Extra Effort
• Extra Time
• Extra Money
 Conclusion

• Having a deviation occur and jumping in to fix it without investigating the

root cause is akin to treating the symptoms of a medical condition without
trying to cure it.

• If someone breaks a leg, a request for painkillers may naturally follow.

However, those painkillers won’t heal the broken leg; nor will a “quick
fix” approach resolve a deviation.

• Likewise, if someone addresses only the symptoms of an adverse event,

the problem itself will almost certainly reoccur (or never vanish in the first
place). And at that point, of course, it will require constant fixing.
 Conclusion

• RCA represents the best “medicine” for any adverse event. It both fixes the
symptoms and helps uncover the reason why the event occurred in the first
place.

• The process helps identify the origin of a problem, using a specific set of
steps and specific tools, to find the problem’s primary cause.

• RCA may be applied to almost any event; determining how far to go in the
investigation requires some knowledge and judgment.
 
• Conducting RCA can help to change an organization from one that just
reacts to problems to a system that solves problems before they spiral out
of control. More importantly, RCA can reduce the likelihood of such
problems ever recurring.
 References
• http://www.fdanews.com/ext/resources/files/archives/1011301/Root%20Ca
use%20Analysis%20for%20Drugmakers-ExecSeries.pdf
Root Cause Analysis for Drugmakers-ExecSeries.pdf

• Mini guide to root cause analysis; By Geoff Vorley MSc. MCQI ;

Published by Quality Management & Training (Publications) Ltd PO Box
172 Guildford Surrey United Kingdom GU2 7FN
ROOT CAUSE ANALYSIS.pdf

• http://www.pharmaguideline.com/2017/06/fishbone-tool-of-investigation.h
tml

• http://www.pharmamirror.com/knowledge-base/pharmaceutical-dictionary/
fault-tree-analysis-fta/
Thank You