The Art of Auditing in the Life Sciences Industry: An In-Depth Look Through the Eyes of a Lead Auditor

Why Audits?

Audits serve as valuable moments of reflection. They offer an opportunity to step back from the daily routine and thoroughly evaluate how processes actually operate. The goal is not simply to check off a checklist, but rather to cultivate a corporate culture of continuous improvement. It is therefore crucial to approach audit processes with a growth mindset.

Why first-, second-, and third-party audits?

There are three types of audits, each with its own scope and purpose for ensuring product quality and patient safety. Below is a schematic representation of the three types of audits:

First-party audits

• Definition: First-party audits, also known as self-audits, are conducted by the organization’s internal team. They involve a critical self-assessment of processes and systems.
• Purpose: The purpose is to ensure internal compliance with regulations and standards, as well as the continuous improvement of processes.
• Auditor Type: Internal employees or teams who are independent of the processes being audited.

Second-party audits

• Definition: Second-party audits are conducted by external parties, such as customers or suppliers, who have a direct interest in the organization’s performance.
• Purpose: The purpose is to manage supplier or customer relationships, ensure quality, and ensure that contractual requirements are met.
• Auditor Type: External parties that have a business relationship with the organization, such as customer auditors or supplier auditors.

Third-Party Audits

• Definition: Third-party audits are conducted by independent external organizations that have no direct interest in the performance of the audited party.
• Purpose: The purpose is to determine compliance with external standards and regulations, thereby increasing the trust of customers, regulatory bodies, and stakeholders.
• Type of Auditor: Independent external auditors, certification bodies, or authorities.

Auditor Tips & Tricks

Getting started as an auditor requires not only expertise but also a strategic approach backed by a set of skills. In the section below, we’ll take a brief look at some tips and tricks for auditors. These will help you conduct your next audit.

First, we present the “6-step funnel model.” This model ensures that you maintain a structured and consistent approach throughout your audit. It promotes clear communication and effective questioning.

1. Define the Scope:
   Clearly define the purpose of the audit and the processes to be examined. Explain the reason for your visit and the intended approach.
2. Establish the Principles:
   Identify applicable standards and regulations. Clarity regarding principles is crucial for effective communication.
3. Identify the Process:
   Map out the process being audited. Start with open-ended questions and work your way through the funnel toward more specific and closed-ended questions to ensure a comprehensive understanding and conclusion.
4. Gather Facts Using MIDEZ:
   Use the “May I See That?” method to gather relevant information. Ask this question regularly and support theories with practical examples.
5. Evaluate and Provide Feedback:
   Evaluate findings and provide constructive feedback. Ensure that the person being audited understands and acknowledges the feedback.
6. Close the Audit Topic:
   Conclude the discussion with clear, positive conclusions and recommendations or observations for improvement.

Second, we’ll add an overview of the key questions to ask during each audit. These questions allow you to audit any process and ensure that sufficient questions are asked:

• What does the (internal) customer expect?
• What is the purpose of the process?
• What are the risks?
• Is the process “under control”?

Next, we’ll briefly present a few tools that can be used to successfully approach every audit:

• Common Sense! – Combine rules and logic with practical wisdom.
• Visualize – Make the processes visible to ensure a comprehensive understanding.

• PDCA Cycle – Embrace the cyclical model for continuous improvement.

• The 6M Method or Ishikawa Diagram:
  Addressing the 6Ms (People, Resources/Machinery, Materials, Methods/Measurement, Environment, and Management) provides an in-depth look at the cause-and-effect analysis of the processes. Identify connections and investigate the underlying causes of potential problems.
• LSD – Listen, Summarize, Ask Follow-Up Questions:
  Ensure effective communication during audits. Listen attentively, summarize to ensure understanding, and ask for confirmation that your understanding is correct. Then ask follow-up questions to uncover all the answers.
• The 3Ps – Talk, Picture, Practice:
  Adopt a holistic approach for complete understanding. Always check theory against practice (MIDEZ – May I See That?).

Finally, here’s a quick tip for effective reporting. Always report your findings in a structured and well-reasoned manner. To do this, follow the PEBI method:

• P – Problem: What is the problem?
• E – Requirement: Why is the problem a problem?
• B – Evidence: What are the facts?
• I – Impact: What is the impact? How significant and serious is the problem? Minor – Major – Critical

Conclusion

This blog post has given you an initial overview of different types of audits and offered useful tips and tricks to help you approach your next audit with confidence. Be sure to keep these insights in mind during your next quality assessment. If you need more information or support in conducting or preparing for audits, please don’t hesitate to contact us.

At Farma Consulting & Partners, we embody the growth mindset of continuous improvement and prioritize partnership in every audit. Our experienced auditors not only offer their expertise but also have a deep understanding of the pharmaceutical industry. We guarantee that your processes meet the highest standards and are constantly striving for improvement. We’re ready to work with you to optimize your business processes.