SOP Guide for Pharma

SOP for Creating and Reviewing Risk Assessment Reports

Auditor

SOP for Creating and Reviewing Risk Assessment Reports

Standard Operating Procedure for Creating and Reviewing Risk Assessment Reports

1) Purpose

The purpose of this SOP is to establish a systematic approach for creating and reviewing risk assessment reports to identify, evaluate, and mitigate potential risks in workplace processes, ensuring safety and regulatory compliance.

2) Scope

This SOP applies to all activities, equipment, and processes across the organization that require risk assessments to prevent workplace hazards and ensure a safe working environment.

3) Responsibilities

  • Risk Assessment Team: Conduct risk assessments, document findings, and prepare the report.
  • Supervisors: Provide process-specific information and support the risk assessment process.
  • Safety Officer: Review and approve the risk assessment reports for accuracy and compliance.
  • Employees: Provide feedback during the assessment and adhere to the recommended controls.

4) Procedure

4.1 Planning the Risk Assessment

  1. Define Objectives:
    • Specify the purpose of the risk assessment, such as evaluating new equipment, processes, or compliance with updated regulations.

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  2. Assemble the Team:
    • Form a team of safety officers, supervisors, and subject matter experts to ensure a comprehensive assessment.
  3. Gather Relevant Information:
    • Collect process flow diagrams, equipment specifications, incident reports, and regulatory guidelines for the area under review.
  4. Establish Assessment Criteria:
    • Define the parameters for evaluating risks, including likelihood, severity, and exposure frequency.
See also  SOP for Responding to Electrical Fires

4.2 Conducting the Risk Assessment

  1. Identify Hazards:
    • Inspect the
workplace to identify potential hazards related to tasks, equipment, and the environment.

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  • Analyze Risks:
    • Evaluate each identified hazard based on the likelihood of occurrence and severity of consequences using a risk matrix.
  • Prioritize Risks:
    • Rank risks from high to low based on their potential impact and focus on addressing high-priority risks first.
  • Recommend Mitigation Measures:
    • Propose specific controls, such as engineering solutions, administrative procedures, or PPE, to reduce risks to acceptable levels.

    • 4.3 Preparing the Risk Assessment Report

    1. Document Findings:
      • Summarize identified risks, their assessment scores, and proposed mitigation measures in a clear format.

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    2. Include Supporting Data:
      • Attach relevant data, such as photographs, charts, and records, to support the assessment findings.
    3. Organize the Report:
      • Structure the report with sections for Introduction, Methodology, Findings, Recommendations, and Conclusion.
    4. Review the Report:
      • Ensure accuracy and completeness by having the report reviewed by the safety officer and relevant stakeholders.

    4.4 Reviewing and Updating the Report

    1. Conduct Periodic Reviews:
      • Schedule regular reviews to evaluate the effectiveness of implemented controls and update the report as necessary.

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    2. Address Changes:
      • Revise the report to reflect changes in workplace conditions, equipment, or regulations.
    3. Track Implementation:
      • Monitor the progress of mitigation measures and document their completion in the report.

    4.5 Communication and Continuous Improvement

    1. Share Findings:
      • Communicate the results of the risk assessment to employees and supervisors through meetings or training sessions.

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    2. Incorporate Feedback:
      • Gather input from stakeholders to refine the assessment process and improve future reports.
    3. Update Procedures:
      • Incorporate lessons learned into organizational policies and procedures to enhance workplace safety.

    5) Abbreviations, if any

    • PPE: Personal Protective Equipment
    • RCA: Root Cause Analysis

    6) Documents, if any

    • Risk Assessment Reports
    • Incident Reports
    • Corrective Action Plans

    7) Reference, if any

    • ISO 31000 Risk Management Guidelines
    • OSHA Risk Assessment Standards
    • NFPA 70E: Electrical Safety Standards

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Risk Assessment Report
    Hazard ID Description Risk Level Mitigation Measures Responsible Person Completion Date
    H001 Slippery Floor High Install Anti-Slip Mats John Doe DD/MM/YYYY

    Template 2: Risk Matrix
    Risk Level Likelihood Severity
    High Likely Severe
    Moderate Possible Moderate
    Low Unlikely Minor
    See also  SOP for Preparing and Maintaining Audit Trail for EHS Activities
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