SOP for Root Cause Analysis
SOP for Root Cause Analysis
1.0 OBJECTIVE:
To lay down a Procedure for Root Cause Analysis.
2.0 SCOPE:
This SOP is applicable to Root Cause Analysis for all Department.
3.0 RESPONSIBILITY:
QA (Officer/ Executive): Preparation, Distribution, Revision, Retrieval and Destruction of this SOP.
Issuances of RCA forms and maintain the RCA log Initiation of the Root Cause Analysis.
QA Manager: Review, Training and effective implementation of this SOP to all concerned Departments.
Respective Departments: Initiation of the Root Cause Analysis.
(Officer/ Executive)
Respective Departments: Training and effective implementation of this SOP.
(Manager)
4.0 ACCOUNTABILITY:
4.1 Head QA: Approval, Authorization, ensure Training and Implementation of this SOP. Selection of
RCA Team from Specific Department. To ensure retrieval of this SOP.
4.2 Respective Departments Head: To ensure Training and Implementation of this SOP.
5.0 DEFINITION:
5.1 Root Cause Analysis (RCA): Root cause analysis (RCA) is a problem solving technique for
identifying the root causes of problems or adverse events.
5.2 Root Cause Analysis is the method or Technique to identify actual cause (s) underlying the said
deviation, Incident, Market Complaint, OOS/OOT results or GMP non conformance.
6.0 PROCEDURE:
6.1 ISSUANCE OF RCA FORM:
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
6.1.1 Initiating department shall raise the request to QA for RCA Form on Format No., Titled “Request
Form for Issuance of Documents” of SOP.
6.1.2 QA shall assign a RCA No. in the format of “Root Cause Analysis Log” as shown in Annexure-I
and same shall be assigned in the “Root Cause Analysis Form” as shown in Annexure-II.
6.2 INITIATION OF RCA:
6.2.1 Manager QA along with Respective Department Head shall initiate RCA process as part of
Investigation of Deviation, Incident, Market Complaints, OOS/OOT results or GMP non
conformance.
6.2.2 Numbering System of Root Cause Analysis (RCA):
6.2.2.1 Root Cause Analysis No. shall be assigned by QA as RCA/DEPT.CODE/YY/NNN
Where,
RCA : Denotes Root Cause Analysis
/ : separator
Concerned Department Code: (i.e. PD, QA, QC, QM, ENG, WH, HR)
/ : separator
YY : Last stands for the last two digit of respective year (i.e.15 indicates the Year 2015,
16 indicates the year 2016and 17 indicates the year 2017 and onwards.)
/ : separator
NNN : Serial stands for the continuous serial number of RCA in the respective year (i.e.
001, 002,003…………..)
. Root Cause Analysis e.g. –RCA/QA/23/001
6.2.3 Same Root Cause Analysis No. shall be recorded on each format i.e. Root Cause Analysis by
Fish Bone Analysis as shown in Annexure-IV, Why-Why Analysis is shown in Annexure-VI
and Root Cause Analysis by Brain Storming presented in Annexure-III.
6.3 ROOT CAUSE ANALYSIS (RCA) TEAM:
6.3.1 Selection of Team for Root Cause Analysis for individual Root Cause Analysis shall be done by
Head QA on the basis of Qualification, Experience, Expertise, Technical Skills, understanding and
Logical Analysis of process and system.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
6.3.2 Name of RCA team members shall be recorded in format as “Root Cause Analysis Form” as
shown in Annexure-II.
6.4 ROOT CAUSE ANALYSIS (RCA) TOOLS:
6.4.1 Head QA shall select the Root Cause Analysis (RCA) tool with consultation with RCA Team.
1. Brain Storming
2. Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram).
3. Why-Why Analysis
4. Pareto Charts
5. Flow Chart
6.5 DESCRIPTION OF RCA TOOLS:
6.5.1 BRAIN STORMING:
6.5.1.1 Brainstorming is an effective tool to identify contributing factors by asking, “What might have
happened that would increase the likelihood for the event to occur”.
6.5.1.2 Brain storming a kind of free from all the ideas and shall be done in a structured way. Don’t
dismiss anyone’s ideas during brainstorming.
6.5.1.3 Brain Storming shall be performed in format as given in Annexure-III, Titled “Root Cause
Analysis by Brain Storming”.
6.5.2 FISH BONE ANALYSIS:
6.5.2.1 Fish Bone Diagram (Ishikawa Fish Bone/ Herringbone or Cause –and-effect diagram):
6.5.2.2 Fish bone diagram is an analysis tool to provide systematic way of understanding effects and
the causes that create those effects.
6.5.2.3 Design of the diagram looks like the skeleton of a fish where the product / process is the main
spine, the effect is the actual nonconformance, and the secondary spines are the different
factors or causes that could have affected or “caused” the deviation (i.e., Method, Machine,
Materials, Man, Measurement, Milieu etc.).
6.5.2.4 Each cause or reason for imperfection is a source of variation. Causes are usually grouped into
major categories to identify these sources of variation. The categories typically include:
6.5.2.4.1 Methods: How the process is performed and the specific requirements for doing it, such as
policies, procedures, rules, regulations and laws.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
6.5.2.4.2 Machines: Any equipment, computers, tools, etc. required to accomplish the job.
6.5.2.4.3 Materials: Raw materials, Packaging Materials, In-process Materials etc. used to produce the
final product.
6.5.2.4.4 Man: Personnel involved with the process.
6.5.2.4.5 Measurements: Data obtained from the process that is used to evaluate its Quality.
6.5.2.4.6 Milieu (Environment): The conditions, such as location, temperature, and humidity in
which the process operates.
6.5.2.5 Creation of Fish Bone Diagram:
6.5.2.5.1 Write the problem in the right side box (Appear as head of Fish Skeleton) in format as given
in Annexure-IV (Format can also be prepared on larger Paper size as per requirement).
6.5.2.5.2 Label each bone of the fish with probable causes (6M’s) Methods, Machines, Materials,
Manpower, Measurement and Milieu (Environment).
6.5.2.5.3 Continue asking, “Why is this happening?” to find out Sub factor and write down on tertiary
spines.
6.5.2.5.4 Continue until you no longer get useful information as you ask, “Why is that happening?”
and record by drawing quaternary spines.
6.5.2.5.5 Analyze the results of the fishbone after team members agree that an adequate amount of
detail has been provided under each major category. Do this by looking for those items that
appear in more than one category. These become the ‘most likely causes”.
6.5.2.5.6 For those items identified as the “most likely causes”, the team should reach consensus on
listing those items in priority order with the first item being the most probable” cause.
6.5.2.5.7 Example of causes/Reasons of non-conformance that may be identified by fish bone diagram
are as follows (but not limited to):
6.5.2.5.8 Methods (Process): Method may include no procedure, wrong, invalidated, poorly
communicated procedure or practices are not same as written procedure.
6.5.2.5.9 Machine (or Equipment): Incorrect tool/machine parts selection, poor maintenance or
design, defective equipment or tool, out of calibration, unqualified, inappropriate capacity,
contaminated/unclean, not operated as per written procedure.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
6.5.2.5.10 Material: Material may include defective material, wrong material, contaminated material,
Mix-Up in material; Material from un-approved source, inappropriate sampling and testing
etc.
6.5.2.5.11 Man: Unauthorized to operate, unskilled and untrained, insufficient number of manpower,
not performing his/her assigned role.
6.5.2.5.12 Measurement: Measuring device not calibrated/ out of calibration, Procedure not followed
as per written procedure, defective instrument.
6.5.2.5.13 Milieu (Environment): Temperature/humidity out of specified limit during
processing/storage, Grade of area not maintained, insufficient/inappropriate light and
process carried out in wrong area.
6.5.2.5.14 Sub cause shall be identified further by brainstorming to explore the potential root cause
using the questions as given in Annexure-V, Titled “Questionnaire for Sub Cause
Identification”. These questions are given for guidance and not limited, any more questions
can be considered.
6.5.2.5.15 Each question shall be answered to find out any abnormal finding. Such abnormal finding
may further analyzed using Why-Why analysis tool or any other suitable method to reach to
Root Cause.
6.5.3 WHY-WHY ANALYSIS:
6.5.3.1 The “Why-Why” refers to a series of sequential questions (i.e. each response given is asked
“why”, normally from 3 times up to getting root cause for a particular case). This exercise
allows a thorough understanding of the underlying or root causes of the issue under
consideration.
6.5.3.2 Why-Why analysis tool can be used alone or in conjunction with Fish bone diagram tool.
6.5.3.3 Root cause identification by using Why-Why Analysis shall include the following steps:
6.5.3.4 The Problem shall be written in format as “Root Cause Analysis by Why-Why Analysis”
given in Annexure-VI.
6.5.3.5 Ask why the problem happened and write down the answer below the problem.
6.5.3.6 If the answer written in first instance doesn`t identify the root cause of the problem again
question why, shall be repeated and the answer shall be written.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
6.5.3.7 The question shall be asked 3 or more times if required until the team reaches to the Root
Cause of the Problem.
6.5.3.8 After Identification of Root Cause (s), CAPA shall be initiated as per SOP, Titled “Corrective
Action and Preventive Action (CAPA)”.
6.5.4 PARETO CHARTS:
6.5.4.1 Pareto Charts are the Vertical bar chart that illustrates relative importance of the factors or
causes that contributes to a particular problem or situation.
6.5.4.2 Pareto Charts illustrates problem factors or causes in order of severity according to frequency
or cost (impact, risk) of occurrence.
6.5.4.3 Also called 80:20 rule or 80/20 rule or the Pareto principle. Only afew (20%) of the problem
causes or factors will account for most (80%) of the problem or opportunity.
Examples: Number of errors by batch record type, Status of pending record revisions by department.
Number of pending work requests by approval phase Order the bars from highest to lowest.
Flow line Shows the program's order of operation. A line coming from one
(Arrowhead) symbol and ending at another. Arrowheads are added if the flow is not
the standard top-to-bottom, left-to right.
Decision Conditional operation determining which of two paths the program will
take. The operation is commonly a yes/no question or true/false test.
Represented as a diamond (rhombus).
Off-page A labeled connector for use when the target is on another page.
Connector Represented as a home plate-shaped pentagon.
7.0 ABBREVIATIONS:
CAPA Corrective Action and Preventive Action
Ltd. Limited
No. Number
QA Quality Assurance
RCA Root Cause Analysis
S. No. Serial Number
SOP Standard Operating Procedure
8.0 ANNEXURES:
ANNEXURE No. TITLE OF ANNEXURE FORMAT No.
Annexure-I Root Cause Analysis Log
Annexure-II Root Cause Analysis Form
Annexure-III Root Cause Analysis by Brain Storming
Annexure-IV Root Cause Analysis by Fish Bone Analysis
Annexure-V Questionnaire for Sub Cause Identification
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
9.0 DISTRIBUTION:
Master Copy Quality Assurance Department
Controlled Copy No. 01 Quality Assurance Department.
Controlled Copy No. 02 Quality Control Department.
Controlled Copy No. 03 Production Department.
Controlled Copy No. 04 Human Resource Department (HR).
Controlled Copy No. 05 Engineering Department.
Controlled Copy No. 06 Warehouse Department (Store).
Controlled Copy No. 07 Information Technology Department
10.0 REFERENCES:
ICH Q9 Quality Risk Management, November 2005
Root Cause Analysis for Drugmakers; 2013
11.0 REVISIONHISTORY:
ANNEXURE–I
ROOT CAUSE ANALYSIS LOG
Year:
Complaint / OOS/OOT
RCA Closed By
Reference Deviation /
RCA Logged
Remarks
RCA Form
Incident / Market
By QA
RCA No.
Ref. No.
Details
S. No.
Note: Text in Header Row is only for representation and Text direction (Orientation) in Log shall be in horizontal
position (Left to Right).
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
ANNEXURE–II
ROOT CAUSE ANALYSIS FORM
RCA Team
S.No. Name Designation Department
Head QA:
(Sign & Date)
Head QA:
(Sign & Date)
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
ANNEXURE–III
ROOT CAUSE ANALYSIS BY BRAIN STORMING
Idea Generation
Idea Selection
a
Sign & Date Sign & Date Sign & Date Sign & Date n
(RCA Team) (RCA Team) (Department Head) (Manager QA) y
Note: RCA by Brain Storming can be prepared in soft copy on the prescribed format containing the same
format number and shall be approved by Head QA.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
ANNEXURE–IV
ROOT CAUSE ANALYSIS BY FISH BONE ANALYSIS
Problem
2. Method
Conclusion:
3. Material
Conclusion:
4. Machine
Conclusion:
5. Measurement:
Conclusion
6. Milieu (Environment):
Conclusion
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
For responsibility & timeline of Corrective & Preventive Actions refer CAPA No.:
Note: Investigation by fish bone analysis can be prepared in soft copy on the prescribed format containing the
same format number and shall be approved by Head QA.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
ANNEXURE–V
QUESTIONNAIRE FOR SUB CAUSE IDENTIFICATION
ANNEXURE – VI
ROOT CAUSE ANALYSIS BY WHY-WHY ANALYSIS
Question: Why
Ans:
Question: Why
Ans:
Question: Why
Ans:
Question: Why
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
Ans:
Question: Why
Ans:
For responsibility & timeline of Corrective & Preventive Actions refer CAPA No.: