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, Annual Product 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)
5.8.5.8 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 Brain storming / 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 Selecting 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
9.1 Root cause investigation form
FAQ:
1. How do you investigate root cause?
Some important steps of root cause investigation:
1. Describe the problem/defect/nonconformity
2. Preparation of investigation plan
3. Data collection and analysis of causal factors
4. Evaluate probable causes
5. Recommended Corrective Actions and Preventive Actions (CAPA)
6. Check Effectiveness of CAPA
7. Prepare summary result
2. What is root cause analysis in pharmaceuticals?
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.
3. Can a single person conduct a root cause analysis?
Yes, a single person also can do a root cause investigation. But, the group can cover a lot of points, take into account everyone’s thoughts and take less time for root cause investigation. Hence, more chances to get proper root cause in the group or team.
4. What is an example of root cause?
The fundamental reason due to which deviation occured is root cause. Refer example of deviation/nonconformance with proper root cuase is explained in details.
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