1. Purpose
The purpose of this Standard Operating Procedure (SOP) Deviation Control is to outline the procedures for identifying, documenting, investigating, and managing deviations from established processes, procedures, and specifications within [Company Name]. This SOP Deviation Control aims to ensure effective deviation handling, root cause analysis, corrective actions, and preventive measures to maintain product quality and compliance.
2. Scope
This SOP Deviation Control applies to all departments and personnel involved in manufacturing, quality control, regulatory affairs, and any processes subject to deviation within [Company Name]. It encompasses the deviation identification, assessment, investigation, and resolution processes.
3. Definitions involved in Deviation Control
3.1 Deviation:
A departure from approved processes, procedures, specifications, or quality standards.
3.2 Critical Deviation:
A deviation that could potentially impact product quality, safety, efficacy, or regulatory compliance.
3.3 Major Deviation:
A deviation that has the potential to impact product quality but is not critical.
3.4 Minor Deviation:
A deviation that does not significantly affect product quality or compliance.
4. Deviation Identification and Reporting
5. Identification of Deviations
5.1 Any employee who identifies a deviation from established processes, procedures, or specifications shall promptly report it to their supervisor or relevant department.
5.2 Deviations may be identified through routine quality checks, inspections, audits, or any other relevant activities.
6. Deviation Report Preparation
6.1 The supervisor or relevant department shall initiate a formal Deviation Report using the designated template.
6.2 The Deviation Report shall include details such as the description of the deviation, its impact, potential risks, affected batches or processes, and initial assessment of severity.
7. Deviation Assessment and Investigation
8. Initial Assessment
8.1 Upon receiving the Deviation Report, the Quality Control team shall conduct an initial assessment to determine the severity and potential impact of the deviation.
8.2 The initial assessment shall guide whether the deviation is categorized as critical, major, or minor.
9. Root Cause Analysis
9.1 For critical and major deviations, a cross-functional team shall be formed to perform a thorough root cause analysis.
9.2 Root cause analysis shall identify underlying factors contributing to the deviation and potential weaknesses in the process.
10. Corrective and Preventive Actions (CAPA)
10.1 Based on the root cause analysis, appropriate corrective actions shall be determined and implemented to address the immediate issue.
10.2 Preventive actions shall be proposed and implemented to prevent recurrence of similar deviations in the future.
11. Deviation Review and Approval
12. Review and Approval Process
12.1 The completed Deviation Report, along with the investigation findings and proposed CAPA, shall be reviewed and approved by relevant departments, including Quality Assurance and Regulatory Affairs.
12.2 Approvals shall be documented and recorded in the Deviation Report.
13. Communication
13.1 Affected personnel, including relevant departments and stakeholders, shall be informed of the deviation, its investigation, and the implemented corrective and preventive actions.
14. Deviation Closure and Documentation
15. Closure
15.1 Once the implemented corrective and preventive actions are deemed effective, and the deviation is satisfactorily addressed, the Deviation Report shall be marked as closed.
15.2 Closure of the deviation shall be approved by Quality Assurance.
16. Documentation and Archiving
16.1 The completed Deviation Report, along with all relevant investigation documents, assessments, and approvals, shall be documented and archived for future reference and regulatory compliance.
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