BY
TALHA USMANI
( T A L H A U S M A N I @ H O T M A I L . C O M )
ROOT CAUSE ANALYSIS

What is Failure?
 Failure refers to the state or condition of not
meeting a desirable or intended objective, and may
be viewed as the opposite of compliance.
 Failure investigation is the process of collecting
and analyzing data to determine the cause of a
failure.
 An Investigation is set by an event —either a laboratory
investigation, a manufacturing inconsistency, a
regulatory or internal audit, or a customer
complaint. “Any of these investigation records are
entered into a CAPA system.

Cost of Failures

OBJECTIVES OF INVESTIGATION
 Corrective Action: Eliminate detected nonconformity
and avoid recurrence
 Preventive Action: Prevent nonconformity
occurrence
 To identify other similar situations and take
preventive actions
 Regulatory Requirement (ICHQ10)

QUALITY OF INVESTIGATION
 The investigation should be thorough, timely,
unbiased, well-documented, and scientifically sound
(ref: Guidance for industry, Investigating OOS).
 Investigation team members:
Investigator (QA) – Who will insure implementation
of corrective and preventive action
Process owner – Who performs the process
Quality Control - Who test the product
Subject matter expert – Who knows the process
Any relevant person

Often the Stated Root Cause
is the Quick, but Incorrect Answer
For example, a normal response is:
Equipment Failure
Human Error
Initial response is usually the symptom / outcome,
not the root cause of the problem. This is why Root
Cause Analysis is an essential and productive tool.

HOW TO START RCA
 1. Growth Mindset
Everything can be changed or improved, it
just needs effort and practice.
 2. Positive Attitude
Be optimistic and expect
favorable outcomes

The Shoes Story
 Many years ago two salesmen were sent by a British shoe
manufacturer to Africa to investigate and report back on
market potential.
 The first salesman reported back, "There is no potential
here - nobody wears shoes."
 The second salesman reported back, "There is massive
potential here - nobody wears shoes."
 This simple short story provides one of the best examples
of how a single situation may be viewed in two quite
different ways - negatively or positively.

HOW TO START RCA

Most Important
 The most important thing in any root cause analysis
is to avoid intentional or unintentional bias
otherwise the actual problem will remain
unidentified and lead to reoccurrence in future.
 Make sure all ideas are considered without criticism
 The investigation team should be fully aware of the
standard process and must have sound knowledge.

NO BLAMING

FOR EVERY ACTION THERE IS EQUAL AND
OPPOSITE REACTION

3Rs OF TEAM WORK

UNSOUND TEAM WORK

SOUND TEAMWORK & SYNERGY

Steps in Investigation
1. Identification
2. Impact of the problem / Risk Assessment:
3. Immediate Action
4. Root Cause Investigation
5. Action plan
6. Implementation and follow up

1. Identification
Define the problem. For efficient investigation, the problem
should be clearly defined.
2. Impact of the problem / Risk Assessment
Risk to its customers and/or the company (i.e. risk to the
patient related to the quality, efficacy or safety of the product;
risk for the reputation of the company; risk of adverse
regulatory actions; financial risk)
Steps in Investigation and CAPA

Steps in Investigation
 3. Immediate Action: First preference is to protect the
customer / Consumer / patient. Immediate action is
necessary when the quality, efficacy or safety my be
comprised by the problem. Immediate action may be:
 Product recall
 Blockage of the stock of a product
 Rejection of a batch
 Interruption of the production (i.e. until problem is
assessed and fixed)

Steps in Investigation
4. Root Cause
Investigation
A systematic approach
should be applied to ensure
that no potential root cause
is lost through focusing only
on a few set of assumed root
causes. Conduct
brainstorming session with a
group of experts with
different background using
Ishikawa diagram to collect
potential root causes.
Finding the primary root
cause is essential for
determining appropriate
corrective and/or preventive
actions.

Brainstorming
 Write the topic / problem statement on flip chart /
board.
 Encourage idea generation.
 Give equal opportunity to participate
According to studies, 60-75% of the talking in
traditional brainstorms is done by a few people.
Prevent this „Uneven Communication Effect‟.
 All ideas / suggestions / opinions are recorded
 There should be no evaluation or discussion when
ideas are given. (Write first, talk second)

Field Trip – The three “ACTUALS”
 Go where the work is actually done
 Talk to the people who actually do the work. (involve
them rather than investigate them)
 See what actually happens

5 Why‟s Approach
A simple tool for drilling down on the problem
statement until the root cause is identified by asking
“WHY” 5 times. It is applicable in cases when looking
at one major cause and needs drill-down to arrive at
one root cause.
Find the right person who can
answer the 5 Why‟s.
Use other RCA tools if you are
getting misleading answers

Example: 5 Why‟s Approach

Ishikawa Approach
 Fish Bone Diagram / Cause and effect diagram (6Ms
approach): It is applicable when looking at
numerous major causes and needs drill-down
probing to arrive at numerous root causes based on
their cause and effect relationships
 Cause and effect diagram is designed keeping the
process flow chart in consideration.

How to apply Ishikawa Approach
 Process flow chart / diagram is drawn
 Brain storming is done on process flow diagram and
all probable root causes are written by dragging a
line from the fish bone.
 Evaluating each probable root cause by performing
different test / activities.

Ishikawa Diagram

6Ms definition
 Material: incorrect, degradation, packaging, storage.
 Man (People): training, verbal miscommunication, staff
changed, attitude problem.
 Machine: Defective, not maintained, rusty, operating
parameters.
 Method: deviations in execution, incomplete instruction
in SOPs, frequent changes without intimation.
 Measurement: equipment calibration, lab error,
supervision, in-process tests.
 Environment: temperature, humidity, work area.

Steps in Investigation
5. Action plan / CAPA:
What is CAPA?
A system for implementing…
1. Corrective actions resulting from the investigation of
complaints, product rejections, non-conformances, recalls
deviations, audits, regulatory inspections and findings
(ICHQ10)
2. Preventive actions resulting from trends from process
performance and product quality monitoring (ICHQ10)
 The plan assigns responsibilities and due dates for
implementation.
 Enough detail must be included regarding the required action
and the expected outcome.

Difference b/w correction, corrective action and
preventive action

6. Implementation and follow up
 Implement corrective and preventive actions and verify their
effectiveness.
 The actions that were taken are documented.
 Have all recommended changes been completed and verified?
 Did the actions correct or prevent the problem with adequate
assurance that the same situation will not happen again?
 Have all objectives been met?
 Has training been performed to ensure that all affected
employees understand the changes that have been made?
 Was an assessment made that the actions taken have not had
an adverse effect on other properties or aspects of a product or
process.
Steps in Investigation

THANK YOU!