What is a Mock audit?
A mock audit is an audit that is conducted to the requirements that a manufacturer has to meet. In order to get an objective and professional audit it is usually conducted by a consultant with experience from e.g. Notified Body (EU) or Regulatory entities (FDA, TGA, CFDA etc.). The audit is normally conducted as “Hats on – Hats off”. It is conducted as the NB/Regulatory entity normally would (Hats on). Every now and then the auditor will pause the audit to provide feedback to the auditees. The feedback can be on how to answer a question, or how to interact during the audit (Hats off). A typical Mock audit is a full system audit. It can also be with a more limited scope depending on the clients needs or the activities at the site being audited.
Why Mock audit?
If you are selling your medical devices under the rules of the FDA you are probably familiar with the term Mock audit. However, in the last couple of years there has been significant changes to the regulatory landscape. This has increased the need for Mock audits to also cover ISO 13485:2016, MDSAP and MDR (Medical Device Directive 2017/745). The transition MDSAP for manufacturers selling in Canada, showed that manufacturers often struggle with fully complying with the new requirements. Trying to transition to a new standard or a new regulatory requirement like MDSAP is complicated. Not having the system properly evaluated prior to and during transition can be unnecessarily burdensome. The consequences can be serious, from delay of certification to additional audits, or in the worst case to a loss of the sales in Canada.
What is the benefit?
A Mock audit is a very good burn test of a manufacturers QMS. Using a deep dive approach to determine the level of compliance, and combining it with the feedback to auditees during the audit is one of the best ways to learn how to handle an audit. It not only provides insight on strengths and weaknesses. It also provides insight into how auditees respond to the audit situation, and how they can improve their responses to get better audit results.
Having a Mock audit performed at regular intervals can also provide ongoing training. This is especially helpful when key staff has changed – as it inevitably does over the years.
When you have a Mock audit you are not obliged to tell your Notified Body about the outcome of the audit! This is however dependent on your not using it as documentation for your internal audit. This gives you an opportunity to identify and address issues prior to your MDSAP audit and not divulge any sensitive information.
For further information about how Quality-Audit can help you with your current medical device compliance challenges:
Please use the contact form, or call for an informal discussion on +45 31 44 40 24.