Every ISO and GMP-certified organization must have internal audit programs. Those are critical for identifying risks, issues and improvement opportunities. However, bringing external auditors, in addition to the internal ones, will provide you with enormous advantages. In this article, you will learn why it is so, and how to use it to your benefit.
Here are the five reasons, why you must work with external auditors:
#1 – Impartiality!
Auditors, even internal ones, must be impartial! They must have only the quality of the product and the well-being of the patients in mind. They shouldn’t care about the reaction of their collegues nor fear the response of their supervisors regarding the findings. Unfortunately, it is not always the case. Internal politics and relationships often influence the outcome of an internal audit because the lead auditor is concerned with the repercussions. Those could be a backlash from collegues, resentment from the management, and extra work for the QA department. As a result, many issues remain unaddressed and could surface during a regulatory inspection. By hiring external auditors, you will avoid those problems because “Poking the bear” is not an issue for them.
#2 – Better Regulatory Compliance
External auditors can help identify areas where practices are no longer compliant with new cGMP regulations. An external auditor can also pinpoint where your compliance efforts may be lacking, and so you can make improvements. Since external auditors have no reason to be anything but honest about your compliance status, you can rely on the independence of the investigation and the recommendations they provide.
#3 – Routine Blindness
I’m sure that people in your organization are incredible experts. They understand the processes and GMP. However, you stop seeing its weaknesses and issues when used to methods, environment, and software. For example, think about the last time you have seen a new scratch on your car. At first, you got irritated and kept noticing it each time you approached the vehicle. But after a while, you have stopped paying attention to it and forgot about it altogether. The same can happen to any issue you have uncovered at your work, which didn’t get fixed in time. Now, guess who will detect it very quickly? Yes, the regulators! They will notice it right away as they see it for the first time. But, so also an external auditor, whom you should bring in beforehand!
#4 – Credibility
Internally and externally, your quality procedures will carry more weight if an external auditor has vetted them. External audits offer an unbiased glimpse into the GMPs of the organization. They will impress regulators and clients, showing them that you go the extra mile to ensure compliance and patient’s safety!
#5 – Process Improvement
Hopefully, your external audit will turn up nothing significant. In this instance, however, an outside auditor might find areas to improve your internal controls or automate specific processes to be more efficient. While you don’t have to implement these recommendations immediately, knowing where waste and inefficiency originate will allow you to revise a plan to address the problems over time.
Summary
I trust that those five reasons made it clear for you just how critical it is to have an additional external pair of eyes to look at your processes and facilities.
It’s important to hire External GMP Auditors to inspect your facility. Experts always bring something different and new to offer, and they can help you optimize your GMP practices like never before. Besides catching any errors, external auditors can give you valuable insights on how to increase productivity.
If we can support you with Auditing or Training, contact us now to arrange a meeting!
You can send us an email Info@qualistery.com or scroll down to book a meeting online. 👇
Yan is the founder and managing director at Qualistery GmbH. Through his vision, GxP professionals worldwide can stay updated with current industry trends without breaking the bank.
