SOP for Root Cause Analysis (RCA) / Root cause investigation procedure with template, Commonly used Root cause investigation tools
This SOP is describing the investigation process of the nonconformity to identify the main reason behind the occurrence of that nonconformity. This root cause investigation process is helpful to find the corrective action and preventive action (CAPA) for that identified nonconformity. This root cause analysis technique is used almost in all industries as a problem-solving technique.
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SOP for Root Cause Analysis (RCA) / Root cause investigation with
template, commonly used Root cause investigation tools
1.0 PURPOSE
This SOP is helpful to describe the identification of root
causes and supporting factors for Nonconformances/defect/nonconformity/problem.
Correct/eliminate recurrence or prevent the occurrence of that root cause. This
investigation is a connection between root cause and identified nonconformance,
defect, nonconformity.
2.0 SCOPE:
Applicable for all Quality problems, issues, or failures like product
complaints, OOS, OOT, deviations, and other non-conformances that need to investigate
where the causes or contributing factors are unknown. completion of the Cause
Investigation is required. Helpful for investigating the root cause of which is
likely to affect the product or process.
3.0 RESPONSIBILITY:
3.1 Root cause investigation team:
3.1.1 Developing and performing the investigation, identifying the root cause(s), and documenting the results of the
investigation and Cause Investigation.
3.1.2 Identify and evaluate the impact of nonconformance on product/process
/system.
3.1.3 Checking the content, accuracy and
completeness of the investigations performed.
3.1.4 Identify the action plan to eliminate
the root causes, and in determining Corrective Action and preventive action (CAPA) plan.
3.2 Quality Assurance:
3.2.1 Supporting and ensuring this process is
implemented, executed, and followed.
3.2.2 Advising the root cause investigation
team in determination of the root cause and evaluation of the effectiveness of
CAPA.
3.3 Quality Assurance Head:
3.3.1 Ensure appropriate Cause Investigation
process is performed for investigations.
3.3.2 Approve all Investigations / Cause
Investigation.
4.0
DEFINITION:
4.1 Cause:
Cause definition found in Deviation SOP
4.2 Root Cause:
Root cause definition found in Deviation SOP
4.3 Probable
/Assignable Root Cause:
Probable / assignment cause definition found in
Deviation SOP
4.4 Root cause analysis (RCA):
A class of a problem-solving technique for
identifying the basic factors or root causes of problems that trigger possible the occurrence of an adverse event on a process or product. The main goal of root cause
analysis (RCA) is to prevent a recurrence.
4.6 Corrective action and preventive action
(CAPA):
CAPA definition found in CAPA SOP
4.7 Remedial
Action:
Remedial action definition found in CAPA SOP
4.8 Corrective
Action:
Corrective action definition found in CAPA SOP
4.9 Preventive Action:
Preventive action definition found in CAPA SOP
4.10 CAPA
effectiveness:
CAPA effectiveness definition found in CAPA SOP
4.11
Nonconformance:
Nonconformance definition found in CAPA SOP
5.0 PROCEDURE:
5.1 Root cause analysis (RCA) is performed
after nonconformity observed.
5.2 Nonconformity where the root cause analysis (RCA)
maybe performed Deviation / Non-conformance report (NCR), Out of
specification (OOS), Out of trend (OOT), Internal Audits (self-inspection), Regulatory/Customers
Audits, Product Recalls, Product Complaints, AnnualProduct Quality Review (APQR)/ Product Quality Review (PQR), Calibration Review, Lab
Incidence, Return Good, Batch Failure, Stability Results, Risk assessment, Adverse
events, Management review meetings, etc.
5.3 Assign RCA team members which include concern
department head, at least one QA person, the person who are most familiar with the
processes and systems.
5.4 Some of the fundamentals consider for
performing RCA:
5.4.1 Basic knowledge of nonconformity /
incidents and investigations.
5.4.2 Understanding and knowledge of process /
systems/facility.
5.4.3 Data collection related to nonconformity.
5.4.4 Analysis of data for all contributing
factors.
5.4.5 Selection of appropriate Root Cause
Analysis (RCA) tools for investigation.
5.4.6 Determining all root causes of each contributing
factor.
5.4.7 Corrective Action and Preventive Action (CAPA), its implementation and
continual improvement.
5.5 Step by step root
cause analysis (RCA) procedure:
5.5.1 Describe the
problem/defect/nonconformity
5.5.2 Preparation of
investigation plan
5.5.3 Data collection and
analysis of causal factors
5.5.4 Evaluate probable causes
5.5.5 Recommended Corrective Actions and Preventive Actions (CAPA)
5.5.6 Check Effectiveness of
CAPA
5.5.7 Prepare summary
result
Briefly understand all the
above steps of root cause analysis procedures.
5.6 Describe the
problem/defect/nonconformity/ issue
5.6.1 Concern department should be clearly
and briefly describing the problem/ issues/ failure/defect/nonconformity that
need to be an in-depth analysis.
5.6.2 Root cause
investigation starts with a description.
5.6.3 Description should
include following points:
5.6.3.1 What is the issue /
problem? When and where it occurs? Who is responsible?
5.6.3.2 What is the actual
/ expected procedure/result?
5.6.3.3 Don’t mention about the solution to the problem in the
description.
5.7 Preparation of
investigation plan:
5.7.1 Concern department
should prepare investigation plan and approved within 3 working days after
initiation of nonconformity/problem.
5.7.2 Investigation plan
should be approved by the quality head.
5.8 Data collection and
analysis of causal factors
5.8.1 Concern department
should collect and review data for the investigation purpose.
5.8.2 Collected data should
be analyzed for the root cause identification.
5.8.3 During analysis if the requirement of additional data then collects additional data.
5.8.4 Investigate the
adverse event/problem/issue sequentially and arranged data sequentially.
5.8.5 Below are the sources
for data collection (but not limited):
5.8.5.1 Personnel interviews,
Personnel qualification, knowledge, experience, and training.
5.8.5.2 Review of related
logbooks, records, process, laboratory data, photos, videos.
5.8.5.3 Visit the area
where the problem occurred.
5.8.5.4 Description of Process,
Equipment, Facility.
5.8.5.5 Suitability of Equipment,
facilities, and utility systems
5.8.5.6 Calibration /
preventive maintenance of the equipment/instruments.
5.8.5.7 Environmental monitoring
5.8.5.8 Suitability,
accuracy, the effectiveness of Standard operating procedures (SOP)
5.8.5.9 Working conditions of
area
5.8.5.10 Verification of raw
Materials, packing material for identity, quality, safety, strength, purity,
efficacy and accuracy.
5.8.5.11 Resource
availability like sufficient manpower, material, etc.
5.8.6 During analysis if
applicable start with risk assessment, design FMEAs and use appropriate
investigation tools to complete the investigation.
5.8.7 The data analysis should
establish the cause and effect relationships associated with the defined
problem
5.9 Evaluate probable causes
5.9.1 During the collection
and analysis of data. Data should be arranged sequentially which is helpful for
the identification of the root cause.
5.9.2 If the concerned department
unable to identify the root cause then identify the probable cause which may be
responsible nonconformity.
5.9.3 Select following
tools or techniques for the investigation of the root cause.
5.9.3.1 Ishikawa Diagram / Fishbone Diagram / 6 M
5.9.3.2 5 Why technique
5.9.3.3 Fault tree analysis
5.9.3.4 Cause-effect analysis
5.9.3.5 Brainstorming / Grouping Technique
5.9.3.6 Hypothetical Technique
5.9.3.7 Kepner – Tregoe Technique
5.9.3.8 Process Mapping – Workflow diagram
5.9.3.9 Separating Root Causes from probable Causes
5.9.3.10 Identifying Inconsistency
5.9.3.11 Failure mode effect analysis (FMEA)
5.9.4 The problem-solving procedure will continue until the root cause is determined using proper tools.
5.9.5 Potential root cause should
be identified and documented.
5.9.6 All potential causes
should be evaluated with the supporting facts and generate documented evidence.
5.9.7 Allow only the
potential causes that support the facts. Eliminate identified causes that are denied evidence.
5.9.8 Eliminated potential
causes should verify any hypothesis/assumption that may be a potential cause.
5.9.9 If any
assumption/hypothesis is found to be linked with fact, that eliminated the root cause
consider as the potential root cause.
5.10 Recommended
Corrective Actions and Preventive Actions (CAPA)
5.10.1 After evaluation of
the proper root causes take corrective action and preventive action (CAPA).
5.10.2 This action plan
helpful to avoid prevent the reoccurrence of the
problem/issue/nonconformity.
5.10.3 Implement the recommended solution in the action plan after root cause identification.
5.11 Check Effectiveness
of CAPA
5.11.1 Refer Corrective action and preventive action (CAPA) SOP to check effectiveness criteria of CAPA
5.12 Closure of CAPA
Refer Corrective action and preventive action (CAPA) SOP for the closure of CAPA
5.13 Prepare summary
result:
5.13.1 Prepare summary of
the result after completion of the nonconformity.
5.13.2 Summary should be
including following details:
5.13.2.1 Details story of
the nonconformity from start to end.
5.13.2.2 Supporting data
collected during the investigation for traceability purpose
5.13.2.3 Details about the
investigation tool
5.13.2.4 CAPA report
5.13.2.5 Effectiveness
Check Criteria
5.13.3 Summary should be
writing in such a way that any person can easily understand during reading.
6.0 ABBREVIATIONS
SOP – Standard Operating Procedure
RCA – Root Cause
Analysis
CAPA - Corrective Action Preventive Action
FMEA – Failure mode
effect analysis.
7.0 REFERENCES
7.1 ICH Q10: Pharmaceutical Quality System
7.2 21 CFR Part 211.22: Responsibilities of quality control unit
7.3 21 CFR Part 211.100: Written procedures; deviations
7.4 21 CFR Part 820.90: Nonconforming product
7.5 21 CFR Part 820.100: Corrective and preventive action
7.7 ISO 13485: Section 8.5 Improvement
8.0 HISTORY
Not Applicable
9.0 ANNEXURES
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