In highly regulated industries, audits are or should not be just a compliance checkbox — they are a cornerstone of ensuring patient safety and supply chain resilience. Yet, many organizations struggle to get the full value from their audits. When mismanaged, audits can drain resources, delay projects, and completely miss their function.
Below, we explore three of the most common mistakes our customers make when it comes to audits, and how you can avoid them.
1. Failing to Link Audits to Continuous Improvement
Too often, audits are treated as a one-off event rather than a tool for driving long-term improvement.
- The problem: when findings are handled only by the Quality team, valuable insights are lost to other functions that could benefit from them. This siloed approach means organizations miss opportunities to strengthen supplier relationships, negotiate better contracts, inform R&D priorities, or enhance business intelligence. Over time, treating audits as a “Quality-only” business undermines competitiveness and cross-functional alignment of all parties.
- How to avoid it: Position audits as a cross-functional improvement tool. Share and analyze findings beyond Quality — with Procurement, R&D, Supply Chain, and even Finance. For example, compare API suppliers over time or across regions to identify performance trends; assess which suppliers are investing in new technologies that improve reliability; integrate quality and delivery metrics into supplier scorecards for contract negotiations; use audit outcomes to guide R&D sourcing strategies or inform business intelligence dashboards.
Audits can provide insights that, when shared cross-functionally, create business value for the whole organisation.
2. Underestimating Resource Requirements
Audits demand both time and expertise, but at times organizations underestimate what it takes.
- The problem: Teams may schedule audits without properly allocating skilled auditors or enough preparation time. In some cases, organizations lack the internal expertise needed for highly specialized audits, especially in areas like sterile manufacturing or complex biologics. Even more critically, audits are sometimes launched without collecting the necessary background information from suppliers. Rushed or under-prepared audits often fail to uncover key risks, leading to rework, compliance gaps, or even regulatory findings down the line.
- How to avoid it: make sure the scope of the audit is crystal clear. From that, build a realistic resource plan for every audit that covers both people and information. On the human side, ensure auditors have the right expertise, preparation time, and stakeholder access. On the data side, collect relevant inputs before the audit, like contractual agreements, previous audit outcomes, records of complaints, incidents or deviations, data on delivery metrics. Having this context upfront allows auditors to focus on the most relevant risks.
A well-resourced audit is not just about staffing it correctly: it’s about equipping the team with the right information to make the audit meaningful and efficient.
3. Treating All Audits the Same
One of the biggest pitfalls is approaching every audit with the same process, regardless of the context. Audits are not “one-size-fits-all.”
- The problem: it is common to rely on generic audit templates that fail to capture the nuances of specific projects, suppliers, or manufacturing processes. This can result in overlooking critical risks or wasting time on areas of little relevance. The results are missed risks, redundant findings, or failing to satisfy regulators.
- How to avoid it: Tailor your audit strategy to your organization’s specific needs. For example, a company in the early stages of developing a new drug may require a customized audit that zooms in on R&D risks, while a large manufacturer with a broad product portfolio may benefit more from a broad audit that assesses systemic issues.
Moving Beyond Mistakes: Choosing the Right Approach
Avoiding these pitfalls starts with making a deliberate choice between audit strategies. Do you need the laser focus of a customized audit or the holistic oversight of a broad audit? Each has its place — and selecting the right one can make the difference between producing paperwork and driving real quality improvement.
In the video below, you will gain practical insights when to use each type of audit, how they align with organizational goals, and best-use scenarios.
Download our expert video: “Customized vs. Broad Audits: How to Choose the Right Approach”, and learn how to make your audits a true lever for continuous improvement.