Standard Operating Procedure for Root Cause Analysis in Creams Production
1) Purpose
The purpose of this SOP is to establish a standardized process for conducting root cause analysis in creams production to identify the underlying causes of deviations, non-conformances, and other quality issues, and to implement effective corrective and preventive actions (CAPA).
2) Scope
This SOP applies to all personnel involved in the production, quality control, and quality assurance of creams. It covers all deviations, non-conformances, and quality issues identified during the production process.
3) Responsibilities
The Quality Assurance (QA) Manager is responsible for overseeing the root cause analysis process. All personnel are responsible for reporting quality issues and cooperating with root cause investigations.
4) Procedure
4.1 Initiation of Root Cause Analysis
4.1.1 Identify a quality issue that requires root cause analysis, such as a deviation, non-conformance, or customer complaint.
4.1.2 Notify the QA Manager and document the issue using the Incident Report Form.
4.2 Formation of Investigation Team
4.2.1 Form an investigation team led by the QA Manager and including representatives from relevant departments such as production, QC, and maintenance.
4.2.2 Assign roles and responsibilities to each team member.
4.3 Data Collection
4.3.1 Collect all relevant data related to the quality issue, including batch records, test results, equipment logs, and personnel statements.
4.3.2 Review the data for any immediate causes or contributing factors.
4.4 Conducting Root Cause Analysis
4.4.1 Use appropriate root cause analysis tools to identify the underlying cause(s) of the quality issue:
- 5 Whys: Ask “Why” multiple times until the root cause is identified.
- Fishbone Diagram (Ishikawa): Categorize potential causes into groups such as Man, Machine, Material, Method, Measurement, and Environment.
- Failure Mode and Effects Analysis (FMEA): Identify potential failure modes and their effects on the process.
4.4.2 Analyze the collected data using the selected tool(s) to identify the root cause(s).
4.4.3 Document the findings of the root cause analysis in the Root Cause Analysis Report.
4.5 Development of Corrective and Preventive Actions (CAPA)
4.5.1 Develop corrective actions to address the immediate cause of the quality issue.
4.5.2 Develop preventive actions to eliminate the root cause and prevent recurrence of the issue.
4.5.3 Assign responsibilities and timelines for implementing CAPA.
4.5.4 Document all CAPA activities in the Root Cause Analysis Report.
4.6 Implementation and Monitoring of CAPA
4.6.1 Implement the approved corrective and preventive actions according to the assigned timelines.
4.6.2 Monitor the effectiveness of CAPA to ensure the quality issue does not recur.
4.6.3 Conduct follow-up reviews to confirm the successful implementation of CAPA.
4.7 Documentation and Records
4.7.1 Maintain all records related to root cause analysis, including Incident Reports, Root Cause Analysis Reports, and CAPA documentation.
4.7.2 Ensure that all root cause analysis records are retained according to the company’s document retention policy.
5) Abbreviations, if any
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
SOP: Standard Operating Procedure
FMEA: Failure Mode and Effects Analysis
6) Documents, if any
Incident Report Form
Root Cause Analysis Report
CAPA Records
7) Reference, if any
ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
8) SOP Version
Version 1.0