How to prepare for a painless audit?

An audit is the verification of activities – process or quality system in order to ensure compliance with some requirements.

As such audits always generate tension and anxiety – because you know that some stranger is coming to check your work and could give you a failing grade!

So no matter how much you think you are prepared, you try to get rid of (LOL… reduce) the tension and save your nerves…in the vain hope of a painless audit?

Painless = prepared, the more prepared, the more painless.

First thing, prepare your employees! Each team member should be aware of the quality policy, quality objectives and procedures within the company. Of course, they don’t need to memorize this. Every employee should at least know where to “find it”.

“The employees shall be properly trained to understand the QMS principles and the company’s strategy to achieve quality management objectives as well.”

The next step is to make sure the document and record lists have been updated. Start by making sure that nobody is using obsolete documents. Then yes, you should check that all documents are reviewed, approved and communicated to everyone involved.

This one will your Quality manager adore – ensure all procedures and processes are performed correctly. This will be accomplished by reviewing them periodically. Why is this necessary? Well, procedures and processes are a roadmap for day-to-day operations. They ensure compliance with laws and regulations and give guidance for decision-making.

Evaluation of the findings from previous audits must be addressed. All non-conformities must be appropriately recorded, investigated and actions need to be in place, in progress or concluded by the time of the audit. Corrective actions that have been executed and closed need to have a proper verification of its efficiency.

Preparing an audit takes a lot of time and effort. So, your preparation should start on time. Don’t procrastinate! The day of the audit is not the time to start collecting the documents on the list.

Even with good preparation, a quality management system that will be audited can be archaic, because a lot of time wasted in search of papers and data trapped within the different sections of the organization. Sometimes, most employees do not have any idea where they are kept.

A good quality management system must govern the activities of the organization, monitor work progress, observes how the products and services are being delivered, support change management and also give room for improvement. The best solution is for firms to invest in an electronic quality management system. They might seem a bit of a pain at first, but at audit time, they become painless!

In the following series of articles, I will try to describe how to prepare for audit per each point using benefits of eQMS.

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7 replies to “How to prepare for a painless audit?”

  1. be i am says:

    Hey there! Would you mind if I share your blog with my facebook group?
    There’s a lot of folks that I think would really enjoy your
    content. Please let me know. Thank you

    1. Alexander says:Author

      Hello. Feel free to share our articles.

  2. Nice post. I learn something totally new and challenging on blogs I stumbleupon on a daily basis.
    It will always be helpful to read through articles from other writers and practice a little something
    from their web sites.

  3. Laura Hayden says:

    I think there is no way to prepare for an audit. Auditors always find a way to surprise you… True story: during an audit, the auditor asked us who validated our system is according to ISO 13485:2016 (we had ISO 13485:2003 certificate and transition period almost end)?! I was shocked, I thought that’s the purpose of his visit. His solution was we to perform internal audit, BUT someone external needs to do it and that was nonconformity. So, he had to hire a consultant in order to “validate” our system. Don’t want to mention the cost of it!

  4. Mila says:
    1. Alexander says:Author

      Thank you, Mila for sharing that article with us.

  5. Moore Jackson says:

    It is of extreme importance to be always prepared for any audit. Definitely in order to pass successfully we as company leaders must embrace our team to learn as mentioned all procedures, rules, and regulations in order to achieve goals and the expected quality. If we don´t start from there, then audits will be always a pain in the head…

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