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SOP for Root Cause Analysis

This Standard Operating Procedure (SOP) outlines the process for conducting Root Cause Analysis (RCA) within the Quality Assurance department. It details the responsibilities of various personnel, the definition of RCA, and the procedures for initiating and documenting RCA, including the use of specific tools like Fish Bone Analysis and Why-Why Analysis. The SOP aims to ensure effective identification and resolution of problems or adverse events in compliance with quality standards.

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Zeinab El-Zein
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0% found this document useful (0 votes)
715 views22 pages

SOP for Root Cause Analysis

This Standard Operating Procedure (SOP) outlines the process for conducting Root Cause Analysis (RCA) within the Quality Assurance department. It details the responsibilities of various personnel, the definition of RCA, and the procedures for initiating and documenting RCA, including the use of specific tools like Fish Bone Analysis and Why-Why Analysis. The SOP aims to ensure effective identification and resolution of problems or adverse events in compliance with quality standards.

Uploaded by

Zeinab El-Zein
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

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.

6.5.5 FLOW CHARTS:


6.5.5.1 Flowcharts are used in designing and documenting simple processes or programs. Like other
types of diagrams, they help visualize what is going on and thereby help understand a process,
and perhaps also find flaws, bottlenecks, and other less-obvious features within it.
6.5.5.2 There are many different types of flowcharts, and each type has its own repertoire of boxes
and notational conventions. The two most common types of boxes in a flowchart are:
 A processing step, usually called activity, and denoted as a rectangular box
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

 A decision, usually denoted as a diamond.


6.5.5.3 A flowchart is described as "cross-functional" which is divided into different that visually
distinguishes job sharing and responsibilities for sub-processes of a business process. It may
be arranged either horizontally or vertically.
6.5.5.4 This is describing the control of different organizational units. A symbol appearing in a
particular "lane" is within the control of that organizational unit.
6.5.5.5 This technique allows the author to locate the responsibility for performing an action or
making a decision correctly, showing the responsibility of each organizational unit for
different parts of a single process.

ANSI/ISO Name Description


Shape

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.

Terminal Beginning or ending of a program or sub-process. Represented as a


stadium, oval or rounded (fillet) rectangle. They usually contain the
word "Start" or "End", or another phrase signaling the start or end of a
process, such as "submit inquiry" or "receive product".

Process Set of operations that change value, form, or location of data.


Represented as a rectangle.

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).

Input/Output Input and output of data, as in entering data or displaying results.


Represented as a parallelogram.

Annotation Additional information about a step the program. Represented as an


(Comment) open rectangle with a dashed or solid line connecting it to the
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

corresponding symbol in the flowchart.

Predefined Named process which is defined elsewhere. Represented as a rectangle


Process with double-struck vertical edges.

On-page Pairs of labeled connectors replace long or confusing lines on a


Connector flowchart page. Represented by a small circle with a letter inside.

Off-page A labeled connector for use when the target is on another page.
Connector Represented as a home plate-shaped pentagon.

6.6 FILING OF RCA FORM:


6.6.1 After Root Cause Analysis, RCA Form of Departments shall be filed in QA and recorded in
“Root Cause Analysis Log” as shown in Annexure-I.

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Annexure-VI Root Cause Analysis by Why-Why Analysis

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:

Revision Change Control Details of Changes Reason of Effective Date Done


No. No. Changes By

Not Applicable Not Applicable New SOP


00
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE–I
ROOT CAUSE ANALYSIS LOG

Year:

Complaint / OOS/OOT

RCA Date of Closure

Reference CAPA No.


Date of Issuance of

RCA Closed By
Reference Deviation /

(Sign & Date)


Department

RCA Logged

(Sign & Date)


Concerned

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE–II
ROOT CAUSE ANALYSIS FORM

Root Cause Analysis No.: Date of Issuance:


Reference (Deviation/ Incident/Market Complaint/OOS/OOT/Non-Conformance) No.:
Problem Description:
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________

RCA Team
S.No. Name Designation Department

Head QA:
(Sign & Date)

Selection of RCA Tool: Fish Bone Diagram/ Why-Why Analysis/Brainstorming

S.No. Name Designation Department Signature

Head QA:
(Sign & Date)
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE–III
ROOT CAUSE ANALYSIS BY BRAIN STORMING

Root Cause Analysis No.: Date:


RCA Team:
Reference (Deviation/Market Complaint/OOS/OOT/Non-Conformance) No.:
Describe the Non Conformance

What’s the problem?

Idea Generation

Idea Selection

Recommended Action Plan

Details of Brain Storming Session: Implementation of Action Plan

S. Idea Details Idea Idea Recommended Responsibility TCD Remark


No. Champion Selection Action Plan i
f

a
Sign & Date Sign & Date Sign & Date Sign & Date n
(RCA Team) (RCA Team) (Department Head) (Manager QA) y

Reference CAPA No.: Required Not Required


If required mention CAPA No.:
Review Comments by Head QA:
Name: Sign: Date:

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE–IV
ROOT CAUSE ANALYSIS BY FISH BONE ANALYSIS

Root Cause Analysis No.: Date:


Reference (Deviation/ Incident/Market Complaint/OOS/OOT/ Non-Conformance) No.:

Man Method Material

Problem

Machine Measurement Milieu


(Environment)

Identification of root cause(s) on the basis of fish bone diagram:


1. Man
Conclusion:

2. Method
Conclusion:

3. Material
Conclusion:

4. Machine
Conclusion:

5. Measurement:
Conclusion

6. Milieu (Environment):
Conclusion
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Main Root Cause(s)/Probable Root Cause(s) of the discrepancy:

Corrective & Preventive Actions:

For responsibility & timeline of Corrective & Preventive Actions refer CAPA No.:

INVESTIGATION REPORT APPROVALS


---- Prepared By Concerned Reviewed By Concerned Approved By
Department Department Head Head QA
Name
Designation
Sign & Date

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

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE–V
QUESTIONNAIRE FOR SUB CAUSE IDENTIFICATION

Root Cause Analysis No.: Date:

Reference (Deviation/ Incident/Market Complaint/OOS/OOT/ Non-Conformance) No.:

Principal Cause: Method (Process)

S.No. Question Yes No NA Remarks


1. Was the written procedure available in respective Area?
2. Was the written procedure approved and of current version?
3. Was the procedure followed?
4. Was any step of operation done wrongly?
5. Was the sequence of operation followed properly?
6. Was the each step of operation carried out for specified time &
within specified specifications?
7. Any Other Question (If any, Please Specify)

Note: Put “√” mark in applicable column

Conclusion: Following Sub Causes identified from above Analysis.


1.
2.
3.

Principal Cause: Machine

S.No. Question Yes No NA Remarks


PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

1. Was the Machine/ Equipment qualified?


2. Was correct change Parts/Tools used?
3. Was the Machine/Equipment Calibrated?
4. Was the Machine/Equipment of appropriate Capacity?
5. Was the Machine/Equipment Cleaned before start of operation?
6. Was line clearance taken before start of Operation?
7. Was the Machine/Equipment labeled properly?
8. Was the correct program selected in PLC of Machine/Equipment?
9. Was the Machine/Equipment operated as per written procedure?
10. Was the Machine/Equipment used within operating Range
11. Whether Machine parameters were set as per approved procedure?
12. Was any breakdown observed during the process?
13. Is there any wear & tear observed?
14. Any Other Question (If any, Please Specify)
Note: Put “√” mark in applicable column

Conclusion: Following Sub Causes identified from above Analysis.


1.
2.
3.

Principal Cause: Material

S. Question Yes No NA Remarks


No.
1. Were right materials of right A.R. No.& grade used in manufacturing?
2. Were the used materials approved?
3. Was the line clearance taken before starting of Dispensing?
4. Were the environmental conditions of dispensing area meet with
specifications?
5. Was the dispensing performed as per written procedure?
6. Was the exact quantities dispensed as per BOM/BMR/BPR?
7. Was any incident observed during dispensing operation?
8. Was the cleaned dispensing tools used in dispensing?
9. Was the dispensed material properly packed?
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

S. Question Yes No NA Remarks


No.
10. Was the dispensed material properly labeled?
11. Were the materials verified on production floor?
12. Was any spillage observed during manufacturing?
13. Was there any observation regarding to any of materials during
Manufacturing/handling?
14. Any Other Question (If any, Please Specify)

Note: Put “√” mark in applicable column


Conclusion: Following Sub Causes identified from above Analysis.
1.
2.
3.

Principal Cause: Man

S. Question Yes No NA Remarks


No.
1. Is the person qualified enough to perform the assigned work?
Is the person having enough experience to perform the assigned
2.
work?
3. Was the person trained to perform the assigned work?
4. Was the personnel followed proper gowning during operation?
5. Were the personnel in good health & hygiene condition?
Was any of person wear wrist watch, jewelry, bangles, rings etc.
6.
during operation?
Was the sufficient number of personnel available to perform the
7.
activity?
8. Were the Procedure & specification interpreted properly?
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

S. Question Yes No NA Remarks


No.
9. Any Other Question (If any, Please Specify)

Note: Put “√” mark in applicable column


Conclusion: Following Sub Causes identified from above Analysis.
1.
2.
3.

Principal Cause: Measurement

S. Question Yes No NA Remarks


No.
1. Was the measuring device in calibrated state?
2. Was the measuring device cleaned?
3. Was the measuring device repaired before the use?
4. Is the display of measuring device working properly?
5. Is there any defect in Measuring device?
6. Was the written operating procedure available?
7. Was the written procedure followed for measurement?
8. Was any problem observed during measurement?
9. Any Other Question (If any, Please Specify)
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Note: Put “√” mark in applicable column

Conclusion: Following Sub Causes identified from above Analysis.


1.
2.
3.

Principal Cause: Milieu (Environment)

S. Question Yes No NA Remarks


No.
1. Was the Process/Operation carried out in designated area?
2. Was the Area qualified?
3. Was the process area clean at the time of start of Process/Operation?
4. Was the area sanitized at defined frequency?
5. Was the temperature & Relative Humidity within specified limit?
6. Is the intensity of light in the Area proper?
7. Was the operation carried out under specified light condition (i.e.
Monochromatic Light)?
8. Was there any observation related to Temperature & Relative
Humidity during Process/Operation?
9. Was there any breakdown in HVAC during Process/Operation?
10. Is the area in good state of condition?
11. Is the door of the area properly closed?
12. Is the door interlock of the Area work properly?
13. Door interlock of Material entry pass- box/Hatch work properly?
14. Is the area free from rusted/ unclean articles (Tools/Machine Parts
etc.)?
15. Any Other Question (If any, Please Specify)

Note: Put “√” mark in applicable column


PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Conclusion: Following Sub Causes identified from above Analysis.


1.
2.
3.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

ANNEXURE – VI
ROOT CAUSE ANALYSIS BY WHY-WHY ANALYSIS

Root Cause Analysis No.: Date of Issuance:


Reference (Deviation/Incident/Market Complaint/OOS/OOT/Non-Conformance) No.:
Problem Description:
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________

Question: Why

Ans:

Question: Why

Ans:

Question: Why

Ans:

Question: Why
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE


Department: Quality Assurance SOP No.:
Title: Root Cause Analysis Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Ans:

Question: Why

Ans:

Main Root Cause(s)/Probable Root Cause(s) of the discrepancy:

Corrective & Preventive Actions:

For responsibility & timeline of Corrective & Preventive Actions refer CAPA No.:

---- Prepared By Concerned Reviewed By Concerned Approved By


Department Department Head Head QA
Name
Designation
Sign & Date

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