What to expect when you are hosting an Inspection/Audit
By Sandra Gonzalez 10May2024
The Host plays a critical role in ensuring transparency, cooperation, and compliance during the inspection/audit process, ultimately contributing to a successful outcome. It is very important to prepare and plan activities prior to the Inspection/Audit. Here are some key responsibilities of the host during an inspection/audit:
1. Prepare the Inspection/Audit Team (War room). Set pre-Inspection/Audit meetings to make sure that relevant trends observed are managed. Relevant critical investigations were properly communicated, unfinished relevant investigations are updated as much as possible to demonstrate control of the processes. Discuss team roles and emphasize the importance of each role and expectations. Discuss potential Inspection/Audit schedule. Designate Point of Contact (POC) for the different areas or critical process, investigations, or issues.
2. Prepare initial briefing documents presenting the site including description of the facility, what is being produced (list of products relevant to the Inspection/Audit), Organizational charts, relevant facility layouts and overview of the relevant process (include main procedures). These can be delivered to the Inspector/Auditor prior to the Inspection/Audit or at the introduction of the Inspection/Audit. This demonstrates that the site is prepared and in control of the facility.
3. Ensure that the Inspectors/Auditors have access to all areas, documents, records, and personnel relevant to the audit. Politely ask to read site procedures, if necessary, to facilitate the entrance of controlled areas.
4. Be available to offer assistance by answering questions, providing clarification, and assisting the Inspectors/Auditors in navigating the facilities and understanding the processes. This shows transparency of the processes.
5. Facilitate interviews by arranging and coordinating interviews with Employees or Stakeholders as required by the Inspectors/Auditors. Make sure Subject Matter Experts (SME) are available on-site or can be easily contacted during the Inspection/Audit.
6. Ensure that all required documents, records, policies, procedures, and reports are readily available for review. Maintain document labelled and organized for easy retrieval for the duration of the Inspection/Audit. Documents related to relevant critical processes or critical investigations should be already in the Audit room (War Room), reviewed and ready to be presented to the Inspector/Auditor.
7. Keep management informed of the progress of the Inspection/Audit, any findings, and any corrective actions that may be needed. Daily briefings after each Inspection/Audit date. Manage potential findings prior to the next Inspection/Audit day with actions taken or to be taken, as much as possible.
8. If any issues or concerns are identified during the Inspection/Audit, the Host should work with the Inspectors/Auditors to address them promptly and effectively.
9. Depending on the type of Inspection/Audit, successful completion may result in certification, accreditation, or continued compliance with regulations or standards. The Host may be responsible for implementing any corrective actions, monitoring progress, and ensuring compliance with any recommendations.
The main point to take as a Host is “PLAN AND BE PREPARED”. The Host can help create a positive and efficient Inspection/Audit experience that leads to a successful outcome for the organization.
SbyS group can help you strategize/train/assess/act on your next Inspection/Audit and prepare/coach/ mentor the Host, Management and Audit Team to thrive during the process. With over 25 years of experience managing successful Inspection/Audits to a variety of customers with different challenges, SbyS has helped clients to reach goals improving the inspection/Audit status. We also provide detailed assessments of your quality systems, identify current problems, risks and trends to recommend actions, and work with the Staff in continuous improvement of the processes.