Introduction
In this blog post, our colleague Lars Pinxten, lead auditor with +10 years of experience in the pharmaceutical industry, takes you through the challenging world of auditing. From understanding the concept of first, second and third party audits to sharing practical tips and tricks for a successful audit.
Why Audits?
Audits act as valuable moments of reflection. They provide an opportunity to step out of the daily routine and deeply evaluate how processes actually work. The goal is not simply to check off a checklist, but rather to cultivate a corporate culture of continuous improvement. So it is very important to approach audit processes with a growth mindset.
The concept why first, second and third party audits?
There are three types of audits with entirely their own scope and purpose to ensure product quality and patient safety. Below is a schematic representation of the three types of audits:
First-party audits
- Definition: First-party audits, also called self-audits, are conducted by the organization’s internal team. It is 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.
- Type of Auditor: Internal staff or teams who are independent in 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 that contractual requirements are met.
- Type of Auditor: External parties who 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 establish compliance with external standards and regulations, thereby increasing the confidence of customers, regulators 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 with a set of skills. In the section below, we take a cursory look at some tips and tricks for auditors. These will help you in conducting your next audit.
First, we present the “six-step funnel model”. This model ensures that you stick to a structured and consistent approach during your audit. It ensures clear communication and effectiveness in questioning.
- Define the Framework:
Clearly define the purpose of the audit and the processes to be examined. Explain your presence and intended approach. - Establishing the Principles:
Identify applicable standards and regulations. Clarity of principles is crucial to effective communication. - Identify the Process:
Map the audited process. Start with open-ended questions and progress through the funnel to more specific and closed questions for a comprehensive understanding and conclusion. - Find Facts with MIDEZ:
Use the “May I Just See That” method to gather relevant information. Ask this question regularly and substantiate theories with practical examples. - Rate and Provide Feedback:
Evaluate findings and provide constructive feedback. Make sure the auditee understands and confirms the feedback. - Close the Audit Topic:
Conclude the discussion with clear, positive conclusions and recommendations or observations for improvements.
Second, we briefly add an overview of the key questions during each audit. Through these questions, each process can be audited and sufficient questions can be asked:
- What does the (internal) customer expect?
- What is the purpose of the process?
- What are the risks?
- Is the process “in control”?
Next, we briefly present some tools that can be used to successfully tackle any audit:
- Common Sense! – Combine rules and logic with practical wisdom.
- Visualize -Make processes visible for comprehensive understanding.
- PDCA Cycle – Embrace the cyclical model for continuous improvement.
- The 6M Method of Ishikawa:
Addressing the 6Ms (People, Resources/Machine, Materials, Methods/Measurement, Environment and Management) provides an in-depth look into the cause and effect analysis of the processes. Make connections and explore the underlying reasons for potential problems. - LSD – Listening, Summarizing, Questioning:
Ensure effective communication during audits. Listen carefully, summarize to understand and ask for confirmation if this is correct. Then ask through to bring out all the answers. - The 3Ps – Talk, Picture, Practice:
Embrace a holistic approach for complete understanding. Always check theory with practice (MIDEZ – May I Just See That).
Finally, we’ll give you a handout for effective reporting. Always report your findings in a stuccoed 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 a first look at different types of audits and offered helpful tips and tricks to start your next audit with confidence. Be sure to include these insights during your next quality assessment. If you need more information or support in conducting or preparing for audits, do not hesitate to contact us.
At Pharma Consulting & Partners, we embody the growth mindset of continuous improvement and put partnership at the heart of 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 constantly strive for improvement. We are ready to work with you to optimize business processes.
