Mohamed Anvar Deen

Manager-QC@Strides Shasun Pharmaceuticals , Looking for Job Change

Fish Bone or Ishikawa Tool for Root cause analysis

September 5, 2016 • 41 Likes • 9 Comments

Most commonly and widely used  among 7 QC tool is Fish bone or Ishikawa tool for root
cause analysis.

we need to list down the possible causes of a problem graphically so that everyone can
understand. The Fish Bone diagram is a graphic tool that helps in displaying the possible
causes of a problem or quality characteristic.

Usually Fish Bone diagram is also called as Cause & Effect diagram, but to differ here as
Fish Bone diagram only gives the list of probable causes that may or may not affecting the
quality parameter. Hence, I take it as a misnomer. The reason being, we need to establish
the Cause & Effect relationship downstream using scatter plot or Design of Experiments
and only after that we can say cause & effect relationship is established.

The Fish Bone diagram helps in listing down the possible causes of variation through
group discussion. It presents the list in a pictorial form, which is easily understandable,
it also increases process understanding and tells us to collect the data for possible causes
of variation.

It also categorizes the all possible causes of variation in 5 broad categories known as 5M
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Men (problem because of Human Factor)

Material (problem because of raw material/ Others)

Machine (Problem due to Machine)

Methods (problem due to the measurement system or the process)

Measurements (problem related to Instrument Measurements)

Environment 

1. MEN ( Human Factors)

-       Training

-       Analyst qualification in the particular test

-       Analyst Interview

o  Procedure followed

o  System verification

o  Data
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-       Solution preparation

o  Accuracy

o  Technique

o  Expiry

o  Storage condition

o  Segregation

-       Work load

2. MACHINE

-       Instrument Qualification

-       Instrument performance

o  Lamp Energy

o  Leaks

-      Electrical Spike

-      Instrument Calibration

o  Calibration validity (Done on and next due on)

o  List of OOC

o  Instrument failure history

o  Preventive maintenance ( Done on and next due on)

o  AMC

-       Instrument Setting & Parameters

o  Flow Rate

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o  Detector
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o  Temperature

o  Sample set

-       Autosampler

o  Vial positions

o  Vial Labeling

o  No of Injections per vial

3. Method

-       Method & sequence verification

-       Analytical Method validation

o  Solution stability

o  Robustness

-       Additional Experiments

-       Sample Conditions

o  Storage

o  Sample solubility

o  Sample dilution ( If any)

o  Sample preparation

4. MATERIAL

-       Glassware

o  Contamination

o  HPLC / GC vials

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o  Extraction
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o  Validity of the filters used

o  Volumetric Glassware

-       Column

o  Usage Details ( No .of Injections)

o  Condition

5. MEASUREMENTS

-       Detector

o  Performance ( Noise, spike)

-      CDMS ( Cinematographic Data Management System)

o  Integration parameters

o  Calculation

o  Degradation

o  Late eluting peaks

o  Trend

-       System Suitability

o  % RSD

o  Tailing factor

o  Bracketing standard

o  Similarity Factor

-       Other Data Review

o  Other Test ( Assay/ DCU/Elution)

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o  Additional
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 o  Historical data

6. ENVIRONMENT

-       Room Temperature

-       Humidity 

Written by

Mohamed Anvar Deen

Manager-QC@Strides Shasun Pharmaceuticals , Looking for Job Change

9 comments

Leave your thoughts here...

Dr. Patrick Druggan 3w

Quality Assurance and Compliance Manager at Ipsen

I'd add environment to the Ishikawa diagram too

Like Reply 5

Arturo Toledo 3w
Quality Management Specialist

Very usefull for fast answer during investigation of NC, deviations etc., mainly in process/situations
of low to moderate complexity. For higher complexity it is better to use Fault Tree Analysis, mainly in
advance based on all process knowledge available

Like Reply 3

Chris Kjellerup-Krönlein 3w
QA at ALK Abelló

In my opinion, Fish bone diagram can only be used to identify possible direct causes to the
problem/effect. When the possible causes are identified, use data to rule out the not likely causes.
Ending up with one or two most likely direct causes use 5xWhy to ask your way to the true root cause
and possibly contributing causes.

Like Reply 3

Heather Johnson, MSQM, PMP, ASQ CQA 3w

Global System Leader | Quality Management Expert |…

I also add Mother Nature/Environment to the diagram. Understanding what actually happened versus
what should happen (process mapping) helps the team to focus prior to the brainstorming session
which accompanies using this quality tool.
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 Like Reply 1

Sandeep Mahajan 2w
QA MANAGER at J.B.Chemicals & Pharmaceuticals Ltd.…

6 M should be included in fish bone diagram. Measurement should be the 6th M

Like Reply 1

There are 4 other comments Show more.

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