Vesna Janic

Benefits of Positive On-Site Inspection for Medical Device Development Companies

Audits and inspections are a regular occurrence in Life Science companies that operate under Health Canada, US FDA, EU MDD, or any other regulations and/or standards. The experience can be very positive or very stressful depending on how well prepared you are.

 

In preparation for an audit/inspection, both parties need to be clear on the purpose and scope of the audit/inspection. For the host, a clear agenda for the visit will assist in assembling documents and records and ensuring that the appropriate personnel are available on site. In most of the cases, the auditor/inspector has expertise in the audited area as well as knowledge of current and upcoming regulatory requirements.  The host’s responsibility is to ensure that the audit/inspection goes smoothly; therefore the host needs to establish a collaborative tone for the visit and ensure that the auditor has timely access to required resources and is able to fulfill his agenda.

The benefits of making this process as easy as possible are numerous:

  • The auditor/inspector will be more efficient in  the open working environment  and will be able to accomplish his/her tasks with minimal disruption to the organization
  • The host will get a valuable critique of the Quality Management System (QMS) that will help the organization to make necessary changes and improvements
  • The host will gain another valuable contact that will contribute to the audited company’s reputation and to his/her personal reputation in the industry

Some of the most important benefits occur once the inspector/auditor leaves the facility.  The auditee reviews the audit report, along with any notes taken during the audit, and starts preparing the response, if applicable. Consider not only the nonconformances, but also any suggestions and recommendations (opportunities for improvement). If the host has been successful in establishing a collaborative tone to the audit, the opportunities for improvement and the suggestions provided by the auditor can result in meaningful changes to the organization.

In our recent experience, our reputation for being well prepared for inspections as a medical device development and contract manufacturing firm, helped our client to go through successful Factory Inspection. The 3rd party inspector was able to complete Factory Inspection within 24 hours notice and our client was able to ship their products to the distributor without any delays.  Happy client, happy inspector, happy host. How perfect is that!?



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