Purchase Departments

SOP for Procurement Audit and Review

SOP for Procurement Audit and Review

Procurement Audit and Review – Standard Operating Procedure

1) Purpose

To establish a standardized process for conducting audits and reviews of procurement activities to ensure compliance with internal policies, regulatory requirements, and continuous improvement within the pharmaceutical purchase department.

2) Scope

This SOP applies to all procurement activities and processes subject to audit and review within the pharmaceutical purchase department.

3) Responsibilities

Procurement Manager: Responsible for overseeing the audit and review process and ensuring corrective actions are implemented.
Internal Audit Team: Responsible for planning, executing, and reporting on procurement audits.
Procurement Team: Responsible for cooperating with auditors and implementing corrective actions.

4) Procedure

4.1) Planning the Audit:
4.1.1) Develop an annual audit plan outlining the scope, objectives, and schedule for procurement audits.
4.1.2) Identify key areas of focus based on risk assessment, regulatory requirements, and past audit findings.
4.1.3) Communicate the audit plan to relevant stakeholders.

See also  SOP for Supplier Audits

4.2) Conducting the Audit:
4.2.1) Prepare an audit checklist and gather necessary documents and data for the audit.
4.2.2) Conduct the audit by reviewing documentation, observing processes, and interviewing personnel.
4.2.3) Evaluate compliance with internal policies, regulatory requirements, and best practices.

4.3) Reporting Audit Findings:
4.3.1) Document audit findings, including areas of non-compliance, observations, and best practices.
4.3.2) Prepare an audit report summarizing findings, conclusions, and recommendations.
4.3.3) Present the audit report to senior management and relevant stakeholders.

4.4) Corrective Actions:
4.4.1) Develop a corrective action plan to address audit findings and prevent recurrence.
4.4.2) Assign responsibilities and timelines for implementing corrective actions.
4.4.3) Monitor the implementation of corrective actions and verify their effectiveness.

See also  SOP for Procurement of Hazardous Materials

4.5) Follow-Up Reviews:
4.5.1) Schedule follow-up reviews to ensure corrective actions have been implemented and are effective.
4.5.2) Document the results of follow-up reviews and update the audit report as necessary.

4.6) Continuous Improvement:
4.6.1) Regularly review and update audit procedures based on feedback and changes in regulations.
4.6.2) Use audit findings to identify opportunities for process improvement and implement changes accordingly.

4.7) Documentation and Record Keeping:
4.7.1) Maintain detailed records of audit plans, checklists, reports, and corrective actions.
4.7.2) Ensure documentation is complete, accurate, and readily available for audits and future reference.

5) Abbreviations, if any

  • None

6) Documents, if any

  • Audit Plans
  • Audit Checklists
  • Audit Reports
  • Corrective Action Plans
  • Follow-Up Review Reports
See also  SOP for Supplier Deviation Management

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211, ISO 9001:2015
Industry Standards: Best practices in procurement audit and review

8) SOP Version

Version 1.0

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