Why self-inspections or internal audits are…

Getting the most out of an internal audit

We want to emphasize that internal audits offer more benefits to your company:

Get to know the departments better

Being “on-site” with the auditee will allow you to see what is currently happening if they are facing any challenges, and what the plans are for the future.

Perhaps they are facing resource issues, supplier problems, or thinking about implementing new systems. You can ask more specific questions and see if there is anything you can do to support them. Always remember to spot any activities that could trigger your change management, non-conformities, or supplier management process.

If so, this is a perfect time to explain why these activities require your involvement as a quality department and what otherwise would be the potential regulatory or compliance risks.

Increase understanding among auditees

Try to set aside some time to explain why certain processes are in place. Auditees may not understand why certain quality processes such as change management and supplier qualification are necessary or why they need to be documented. The internal audit is a perfect time to explain to them the purpose behind such processes and what the consequences would be for patients and for the company if the procedures are not followed.

Creating more understanding will certainly result in a better relationship with the quality department, which is beneficial to both parties.

Collect feedback from auditees and spot opportunities

While talking to the auditee, make sure you also note any feedback that is given. Due to changes in personnel or systems, it may very well be that certain processes have become less effective. Or it is possible that a certain process has been introduced from higher up (e.g. management or global organization), but at the departmental level, it is very time-consuming and therefore inefficient.

The auditee’s feedback may be used to update procedures or even to bring about a process change, so be sure to document it. The internal audit is a perfect place to spot these opportunities for improvement. Showing that you listen to the auditee will certainly improve your relationship with the quality department.

Check compliance before external audit

Internal audits can also be used as a readiness check just before external audits by a competent authority, notified body or customer. By setting up specific audit criteria, you can check your compliance and readiness for the external audit. This is even more important after, for example, the implementation of a major change in the QMS, such as a new regulation, a new customer or a new product.

Don’t forget to set up the necessary corrective and preventive actions to show the external auditor that you are aware of any non-conformities and that you are working on actions to resolve them. This is preferable to having to admit to an external auditor that you were unaware of these non-compliances.

Conclusion: leverage _all_ the benefits

This blog post has given you some insights into why internal audits are an essential part of your QMS and how you can get the most benefit from them. Beyond the legal requirements to determine if your QMS meets guidelines and standards, they can provide more benefits.

Internal audits allow you to: