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Be Proactive, Not Reactive!

When looking at the cycle of maintaining your Quality Management System (QMS), you face the same challenge as many companies. You go through a rough audit, you fix the issues, you complete effectiveness verification and then you move on to business as usual. The next audit comes and the cycle repeats. While your QMS requires you to perform preventive actions (PAs), you find that the PAs you implement are not sufficient to ensure that you come out of an audit with zero or near zero audit findings. On the other hand, the companies who achieve outstanding audit results are putting themselves on the right trajectory by being proactive, not reactive. To break the cycle of rough audits, you too must prepare well, so that you know what to expect before the audit takes place.

Being prepared for your upcoming audit will make a difference. When it is done right, you will be able to identify gaps that otherwise you could easily miss. When the preparatory activities are done at the right time, you will have the opportunity to address those gaps before the audit is performed. This will increase your chances of having a successful audit outcome, which is important for several reasons. You are doing your job by fulfilling your responsibilities, your company will gain credibility with customers and partners, and the effort will be appreciated by the team. Everyone likes to be recognized for a job well done.

Coming out of an audit with an outstanding result speaks not only about the team’s ability to be prepared for the audit, but most importantly about the team’s ability to correctly perform their job consistently. The good work done in regular day to day activities by the whole team, pays off when they support successful audit outcomes. The company's leadership plays an important role in this. They need to be there for the team, support and motivate them to strive for excellence and to celebrate the team's success. Likewise, a successful audit outcome speaks not only about the team, but also about the leadership behind them. Being prepared for your upcoming audit is a team effort, not a quality task. Involve your team, spend time preparing, but most importantly do the right thing every time. Visit us at to see the ways we can support your team in preparing for your upcoming audit and maintaining an audit readiness mindset, which ultimately supports the company’s success. Be proactive, not reactive!

Oscar Garcia - President, QES Medical LLC

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