SOP Guide for Pharma

SOP for Conducting Waste Audits and Inspections

Auditor

SOP for Conducting Waste Audits and Inspections

Standard Operating Procedure for Conducting Waste Audits and Inspections

1) Purpose

The purpose of this SOP is to establish a standardized method for conducting waste audits and inspections to assess waste management practices, identify areas of improvement, and ensure compliance with environmental regulations and organizational policies.

2) Scope

This SOP applies to all departments generating, handling, and managing waste in manufacturing units, laboratories, offices, and storage facilities.

3) Responsibilities

  • Audit Team: Plan, execute, and document waste audits and inspections.
  • Department Heads: Ensure availability of records, access to facilities, and cooperation during audits.
  • Supervisors: Implement corrective actions based on audit findings.
  • Environmental Health and Safety (EHS) Officers: Review audit results and verify compliance with regulations.

4) Procedure

4.1 Preparing for Waste Audits

  1. Define Objectives:
    • Determine the purpose of the audit (e.g., compliance check, process improvement, waste reduction).
    • Identify key performance indicators (KPIs) to measure, such as waste segregation accuracy or reduction rates.

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  2. Develop an Audit Plan:
    • Create an audit schedule covering all relevant departments and facilities.
    • Assign responsibilities to team members for specific tasks (e.g., inspecting storage, reviewing records).
    • Prepare checklists based on regulatory requirements and organizational policies (Annexure 1).
  3. Notify Stakeholders:
    • Inform department heads and supervisors about the audit schedule.
    • Ensure all necessary documents (e.g., waste logs, manifests, disposal certificates) are
available for review.

4.2 Conducting Waste Audits

  1. Inspection of Waste Segregation Practices:
    • Verify that waste is segregated according to the organization’s guidelines (e.g., color-coded bins).
    • Ensure hazardous, non-hazardous, and recyclable waste streams are properly labeled and separated.

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  2. Review of Waste Storage Areas:
    • Inspect storage areas for compliance with safety and environmental standards (e.g., ventilation, spill containment).
    • Check for proper labeling and maintenance of storage containers.
  3. Documentation Review:
    • Examine waste generation logs, storage records, and disposal manifests.
    • Ensure documentation is accurate, up-to-date, and compliant with regulatory requirements.
  4. Evaluation of Waste Disposal Practices:
    • Verify that waste is disposed of through authorized vendors.
    • Check for availability of disposal certificates and transport manifests for hazardous waste.
  5. Assessment of Employee Awareness:
    • Interview personnel to evaluate their understanding of waste management policies and procedures.
    • Identify gaps in training or awareness and document them for corrective actions.

4.3 Reporting Audit Findings

  1. Prepare an Audit Report:
    • Summarize observations, non-compliances, and areas for improvement in the Waste Audit Report (Annexure 2).
    • Include photographic evidence, if applicable.
    • Provide specific recommendations for corrective actions and process improvements.

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  2. Communicate Results:
    • Share the audit report with department heads and the EHS team.
    • Discuss findings and proposed corrective actions in a review meeting.

4.4 Implementing Corrective Actions

  1. Action Plan Development:
    • Collaborate with supervisors to develop a corrective action plan addressing audit findings.
    • Assign responsibilities and deadlines for each action item.

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  2. Follow-Up Inspections:
    • Conduct follow-up inspections to verify the implementation of corrective actions.
    • Document the outcomes in the Corrective Action Log (Annexure 3).

4.5 Continuous Improvement

  1. Trend Analysis:
    • Analyze audit results over time to identify recurring issues and trends.
    • Use the insights to improve waste management policies and training programs.

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  2. Policy Updates:
    • Revise waste management policies and procedures based on audit findings and regulatory changes.

5) Abbreviations, if any

  • EHS: Environmental Health and Safety
  • KPI: Key Performance Indicator

6) Documents, if any

  • Audit Checklists
  • Waste Audit Report
  • Corrective Action Log

7) Reference, if any

  • EPA Waste Management Guidelines
  • OSHA Hazard Communication Standard
  • ISO 14001 Environmental Management Systems

8) SOP Version

Version: 1.0

Annexure

Template 1: Audit Checklist
Audit Area Inspection Item Compliance Status Remarks
Segregation Color-coded bins in use Compliant/Non-Compliant ...

Template 2: Waste Audit Report
Date Auditor Name Department Observations Recommendations
DD/MM/YYYY John Doe Production ... ...

Template 3: Corrective Action Log
Issue Action Taken Responsible Person Status Completion Date
... ... ... ... DD/MM/YYYY
See also  SOP for Segregation of Incompatible Hazardous Chemicals
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