Stepping into the world of auditing for the first time is an exciting experience, but also an extremely daunting one. Whether you’re conducting audits in the realms of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), or Good Laboratory Practice (GLP), there is a great sense of responsibility, and this can feel overwhelming at the start. As with most things, the ability to audit effectively comes with experience, but understanding the fundamentals at the beginning will set you up for success. So, what do you need to know to become a successful auditor? This guide will provide you with a roadmap to navigate your early days as an auditor and build a strong foundation for your career.

Why Are GxP Audits Important?

Before delving into how to establish the foundations as a new auditor, it’s important to understand why we audit in the first place. As an auditor, your role is to ensure that the auditee can perform their delegated duties to a high standard and in line with regulatory requirements. In many industries, it is vital to guarantee the safety, quality and integrity of a product and regulations are in place to ensure this. Audits are not about “catching out” the auditees; they are designed to identify non-conformance to the regulations that could potentially impact quality or safety. In a wider sense, GxP audits protect public health by helping to prevent issues that could lead to product recalls, regulatory penalties, or harm to patients. With this in mind, let’s move on to the steps you must follow to become an effective auditor.

Building a Strong Foundation as a New Auditor

Step 1: Educate Yourself

The first step in your journey is to build a strong knowledge base. To assess compliance with the regulations, you must have a solid understanding of those relevant to your audit. Your reading list will differ depending on the GxP you are auditing, as well as the location – i.e., the regulations in America differ from those in the EU. Examples of some key regulations and guidelines to familiarise yourself with are listed below:

  • GMP – FDA 21 CFR Parts 210 & 211 (Drugs), 820 (Medical Devices); EudraLex Volume 4 Part 1 including Annex 13 and other applicable annexes; ICH Q7 (for active pharmaceutical ingredients (APIs).
  • GCP – ICH E6 (R3); FDA 21 CFR Parts 50, 54, 56, 312, 812; EU Clinical Trial Regulation (EU-CTR) 536/2014.
  • GLP – FDA 21 CFR Part 58; UK Statutory Instrument 3106, as amended, and the OECD Principles of GLP.

It’s also a good idea to invest in training courses, attend workshops, and participate in webinars.

Step 2: Develop Analytical Skills

Next, let’s consider what skills you’ll need as an auditor. Analytical thinking is crucial, as it enables auditors to evaluate data, identify patterns, and determine potential root causes. During an audit, you’ll be presented with a range of data and documentation, and you must think critically to assess whether complex processes align with regulatory requirements. Attention to detail is also key in identifying potential discrepancies or non-conformities. To develop these skills, it’s good to practice using tools such as the 5 Whys or Fishbone Diagram to break down complex issues and identify root causes. Reviewing past audit findings can help you understand trends and improve pattern recognition. Additionally, observing experienced auditors can offer valuable insights into critical thinking and problem-solving approaches.

Step 3: Develop Interpersonal Skills

In addition to the technical skills mentioned in step 2, auditing also requires soft skills. One aspect you will not be able to predict during your audit is the reaction of the auditee. Receiving a notification of an audit is often stressful, and the auditee may feel apprehensive about your arrival. A skilled auditor is able to find a balance between maintaining a professional yet approachable manner. Your goal is not to scare the auditee into revealing information but to encourage cooperation and openness. This is achieved through building a rapport with the auditee and creating a comfortable environment. Active listening, empathy, and clear communication allow more accurate information to be obtained. To improve these skills, try role-playing audits to refine your interviewing techniques and consider looking up de-escalation tactics to handle any resistance or defensiveness from auditees effectively.

Step 4: Understand the Audit Lifecycle

While it may seem obvious, understanding the audit lifecycle is crucial for a smooth audit process. The audit process typically involves three main stages:

  1. Planning: Define the scope, objectives, and criteria to include these in an audit plan. Review relevant documents, such as contracts, standard operating procedures (SOPs), protocols, and previous audit reports. Preparation is key!
  2. Execution: The audit may be conducted on-site or remotely. This typically involves interviewing key personnel, reviewing documentation, and observing processes.
  3. Reporting and Follow-Up: The audit and any findings are documented in a clear and concise report. If required, this may include follow-up to ensure the responses provided by the auditee are sufficient to resolve the issues identified.

Step 5: Leverage Technology

The final step in becoming a successful auditor is using technology to your advantage. Luckily, we no longer live in an age where we must handwrite all our notes so a lot of time and effort can be saved by utilising technology, such as creating digital checklists to ensure nothing is missed and organising documents to ensure you have all the information available to you. Using online platforms also streamlines communication and document sharing during audits.

Navigating Common Challenges

Challenge 1: Resistance from Auditees

Auditees may perceive audits as punitive rather than constructive. To mitigate this, emphasise during the opening meeting that audits are collaborative efforts and an opportunity to improve processes. They should be beneficial for both the auditee and the client.

Challenge 2: Scope

Stick to the defined audit scope – this is often easier said than done. While it’s tempting to investigate every issue, deviating from the plan can lead to inefficient and incomplete audits. A top tip for this is to keep referring to your audit plan whilst conducting your audit to ensure you have covered everything required.

Challenge 3: Time Constraints

Audits are time-sensitive, and this can become quite stressful. You must remind yourself that auditing is a sampling exercise based on risk; there will never be time to look at absolutely everything. Effective time management and prioritisation are essential, and the auditor must weigh up whether to delve further into a potential issue or move on.

Tips for Long-Term Success

  1. Stay Current with Regulations
    Regulations evolve; therefore, to stay on top of any updates it’s a good idea to follow regulatory agencies and subscribe to industry newsletters, including the Tower Mains newsletter.
  2. Seek Mentorship
    Connect with experienced auditors who can provide guidance and share insights. Having a network of quality professionals to engage in conversation with is a great way to continue learning.
  3. Embrace Continuous Improvement
    Remember that every audit is a learning opportunity – take time to reflect on your experiences, seek feedback, and identify areas for improvement.

To conclude, becoming a proficient GxP auditor takes time and dedication. By understanding the GxP framework, honing your skills, and embracing a collaborative approach, you can ensure that your audit is both a productive and pleasant experience for those involved.

Another challenge faced by new auditors is travel. For tips on how to master productive and stress-free travel, check out this blog post: Travel tips for auditors – Tower Mains