ComplianceFebruary 25, 2021

Here’s Why Poor Quality Costs You More Than You Think

Product contamination is simply not an option for pharmaceutical drug companies. If a defective medicine gets to a patient, the consequences are catastrophic and in the worst cases, fatal.

End user safety is always the main driver for drug companies to ensure product quality. Though, these companies also want to avoid costly recalls and investigations if the affected product gets to market—investigations and lawsuits that could drag on endlessly for years and continue to rise into billions of dollars.

Most manufacturing quality experts agree that the cost of a defect will typically increase tenfold at every major processing point, unless the defect is caught early on. Once a defect is taken to production, the cost to the business multiplies ten times, through product rework, reprocessing or investigation time.

Costs exponentially go up by 100 if the defective product then gets distributed, requiring a detailed recall and investigation process, on top of the potentially devastating consequences of harming a patient. The clearest path to containing these costs is to detect defects before production starts—via an incoming inspection or routine monitoring process.


It is a given that managers would notice product rework and product delays first. These are the most immediate consequences of a quality issue. But there is an entire backlog of issues that, if left unchecked, snowball into costly events of great consequence. Poor quality leads to many more costs than simply having to manage immediate delays at the plant.

Bad habits can make hidden costs balloon. Many costs go undetected because of poor business practices and, quite simply, an inability to accurately report on processes. The right technology and the right digital system can help here.

When keeping track of all production processes: who did what, when and how in a digital system, every detail of the operation is auditable. A good control of work system ensures this traceability and can be used to meet Good Manufacturing Practices (GMP) guidelines.

Meeting high GMP standards boils down to a few questions:

  • Can you tell if your equipment has been properly calibrated?
  • Can you ensure staff are properly trained and competent?
  • Can you trace your processes from beginning to end with controlled documents?
  • And most importantly, can you prove all this to an auditor?

Digital records of exactly what was done in the plant are searchable and reportable. Quality and operations teams are able to trace back undesirable events with confidence, and procedures can be reviewed efficiently.

Without good management systems in place, escalating costs, as a result of poor quality, are unavoidable. Product rework and delays are just the tip of the iceberg.

Tina Amirtha
Product Manager at Wolters Kluwer | Enablon