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Experiences from an Audit

Its mid-morning, and you’ve been called by your management to the ‘Audit Holding Pen’, the backroom next to the room where an external auditor is performing an assessment of your Quality Management System, your QA manager is in the room and already looking stressed and tired. 

About an hour later, you get called in, specifically to discuss a non-conformance report you raised 8 months prior. The audit room is quiet, but the auditor smiles and invites you to sit down next to them, and in front of your NC report. They ask you to explain what happened, what steps you took and how you investigated the non-conformance – but your mind goes blank. You can barely remember your name, let alone how you completed the investigation!…

For anyone who has been in an audit, they may have similar stories, but whatever the experience, it can be a very challenging environment, especially if you are new to audits.

The purpose of the audit is to make an independent assessment of your quality management system, or Quality/Regulatory ecosystem. This can be via a notified body, competent authority, customer or corporate party. The audits can be planned, or unannounced, and can vary in scope and length. 

With many diagnostics companies, the transition to EU IVDR, UKCA or transferring to the USA (FDA), having external audits is a new addition to your organisation. Handling an audit effectively is a key skill that takes years of practise, but there are some things you can do to give you best chance of success:

  • Build a process for audit management: When the auditor turns up on your doorstep, it is really important that everyone knows what to do. Who should receive them? Where can they go while you notify your team and organise your audit management?
  • Ensure management buy in: Strong leadership is key here, pull in whoever needs to be involved, this may be top or middle management depending on your organisation. Keep the communication stream going, this will give them a heads up on the audit progress, and allow you quick access to any expertise you may need.
  • Be clear on roles and responsibilities: While sometimes it is easier to control the audit within a closed group, the reality is that you may need the support of others throughout the day. If you are the main auditee, your time will be focused in the room. Establish a role outside the audit room who can coordinate documents, people and tea/coffee. Giving your staff experience of the audit process is a great development opportunity, we’ve all got to learn somehow!
  • Establish good quality culture: There is no substitute for building a strong quality environment around you. Building robust processes which are well understood and followed, will make the audit go much smoother! Establishing a good quality culture takes time, but adds real value and makes life much easier in the long run.
  • Build in mock audits into your quality system: If your team are new to external audits, why not perform a few mock audits in addition to your internal audit programme. It may be disruptive for a day, but the organisation will learn so much from it. It will also give people some additional confidence when it comes to the real thing.

Our team all have their own stories from grilling, or being grilled at an audit. We can help you in a number of ways:

  • Mock audit: We can be an independent external auditor, to come in and help your company test your audit robustness. We can use our audit management experience to interview your team and give you honest, constructive feedback on how you can effectively manage the process
  • Audit training: Our workshop events can help you establish a process to manage your audits, and help you assign the roles and responsibilities your team needs
  • In-audit support: Sometimes you just need a steady hand in the audit. We can sit with you in your audits and help you explain, justify and understand the audit requirements and outcomes. 
  • Post-audit support: We can help you understand, plan and implement any corrective actions from audit non-conformances

However you manage the process, the audit process should be seen as a positive experience, and it is critical to the continued growth and improvement of your quality management system. For more information, including how we can help you with your audits, book a meeting with our team.