Effective Quality Auditing: The Pillar of Assuring Compliance with a Reliable Quality Auditing

In simple terms, effective auditing means being capable of identifying issues if they genuinely exist at a site. However, it goes beyond just pointing out flaws—effective auditing is about understanding associated risks and addressing them proactively. As we often say, if an audit isn’t effective, can it truly be called an audit?

In the pharmaceutical industry, effective quality auditing plays a pivotal role in ensuring the safety and efficacy of medicines that patients worldwide rely on. With a wealth of experience conducting over 350 quality audits across 30+ countries and reviewing even more as a reviewer, I’ve observed a glaring gap in the effectiveness of many audits performed today.

In simple terms, effective auditing means being capable of identifying issues if they genuinely exist at a site. However, it goes beyond just pointing out flaws—effective auditing is about understanding associated risks and addressing them proactively. As we often say, if an audit isn’t effective, can it truly be called an audit?

In the pharmaceutical industry, effective quality auditing plays a pivotal role in ensuring the safety and efficacy of medicines that patients worldwide rely on. With a wealth of experience conducting over 350 quality audits across 30+ countries and reviewing even more as a reviewer, I’ve observed a glaring gap in the effectiveness of many audits performed today.

Key Principles for Effective Quality Auditing

1. 1. Prepare Thoroughly
      Familiarize yourself with the site before the audit. Identify high-risk areas that require attention and prioritize these during your inspection. Preparation is key to uncovering potential issues.
   2. Stay Focused
      Avoid getting lost in lengthy explanations. Once you have the answer you need, move on. Time is valuable, and staying focused ensures you cover all critical aspects.
   3. Take the Lead
      Always choose the areas or documents you want to inspect, rather than allowing the auditee to steer the process. As auditors, we must control the narrative to uncover genuine insights—like selecting a dish to eat instead of leaving it to the chef.
   4. Dig Deeper
      Never stop at merely noting down observations. Probe deeper into identified issues to uncover their root causes. Often, what seems minor at first glance can reveal significant risks when scrutinized further.
   5. Foster a Cooperative Atmosphere
      A stressed environment hinders open communication. Create a positive, collaborative atmosphere where auditees feel comfortable sharing information.
   6. Be Attentive to Delays
      If a requested document or topic takes unusually long to produce, it may indicate underlying issues. Follow up persistently to ensure nothing is overlooked.
   7. Examine the Details
      Don’t rely on surface appearances—dig into the specifics. The real issues often lie hidden in the details, so get as close as possible to the processes, areas, and records under review.
   8. Maintain Professional Boundaries
      Remember, you’re doing your job, and the auditee is doing theirs. Effective auditing is about collaboration, not conflict. Ultimately, it’s all about ensuring patient safety.

The Responsibility of a Quality Auditor

Quality auditing is not just a task—it’s a profound responsibility. The outcomes of your audits directly impact the quality of medicines consumed by patients worldwide, including your own loved ones. Therefore, every auditor must approach their role with dedication, diligence, and integrity.

For those who are also consultants, it’s important to separate the consultant mindset from the auditor role during audits. This distinction allows you to maximize your effectiveness as an auditor and maintain objectivity throughout the process.

A Call to Action

Quality auditing is the backbone of pharmaceutical integrity. A reliable Quality auditing service provider ensures adherence to a thorough, risk-based, and professional approach, allowing auditors to drive meaningful improvements that safeguard public health.

At PHARMALANE UK, we prioritize the execution of audits by our auditors to ensure they are conducted with the utmost effectiveness, thereby providing our clients with a truthful representation of supplier quality. In several instances, we have identified significant issues during audits, which have allowed our clients to address these gaps or even terminate relationships with non-compliant suppliers. This is crucial for our clients, as engaging with suppliers that do not adhere to regulatory standards can compromise product quality and attract scrutiny from regulatory authorities. Consequently, over 650 clients worldwide trust us for their supplier quality audit needs. Contact us today if you wish to have your audits conducted with the highest level of effectiveness.

If you have additional tips or insights for aspiring Quality Auditors, we’d love to hear them! Share your thoughts in the comments and contribute to fostering a culture of excellence in auditing.

Drafted by:
Mr. P. B. Tank,
CEO, PHARMALANE UK