Freyr Solutions and Services
- Freyr proposed a team of 4 compliance resources.
- Worked with the quality analysis team of the customer.
- The SOPs to be written were broadly classified as organization (Governance) level SOPs and department-level (Regulatory SOPs).
- Rationalizing the governance SOPs to align with the parent company to ensure consistency, compliance, and efficiency.
- Validating the Regulatory SOPs for a stabilized process for minimizing the risk of non-compliance and associated consequences.
- Initial submission of draft SOPs.
- Submission of final SOPs for integrated management system service.
- Understanding Requirements: A thorough analysis was conducted of each management system's requirements that were to be integrated into the IMS.
- Audit Findings: The auditee responded to the findings and clarified all the discrepancies.
- Prepare Audit Report: The audit findings, including observations, non-conformities, and areas of improvement, were documented in a comprehensive audit report.
- Documentation: Developed documentation for the IMS, including policies, procedures, manuals, and forms.
- Risk Assessment and Management: Conducted a risk assessment to identify potential risks and opportunities associated with the integrated management system.
- Review and Update: IMS ensured effectiveness and relevance to the organization's needs.
- Baseline SOPs that can withstand the Regulatory audit were prepared.
- Audit-ready processes established.
Streamlined audit processes and enhanced efficiency were achieved by proposing on-site audits for multiple products across various sites and geographic locations, utilizing a single auditor from Freyr's global pool.
