How Technology Can Benefit Your Quality Control and Prevent Costly Recalls

Dave Edwards
Chief revenue officer
MasterControl

When the news broke recently that Global Pharma, Apotex, and Pharmedica were voluntarily recalling tens of thousands of eye drops for potential contamination, leaders at every life sciences company breathed a sigh of relief that it wasn’t them. Few challenges could be more damaging to a company in our industry than a failure of safety protocols.

More than 1,321 recalls were issued last year for human drug products that were defective or violated laws enforced by the U.S. Food and Drug Administration. That was the highest figure in the past three years, according to a USA TODAY analysis¹ of FDA data.

The truth is, life science companies have access to all the tools they need to mitigate contamination, but quality events are continuing to happen at high levels. With all this available technology, why aren’t more organizations taking advantage so they can deliver safe and effective products to the market?

Here are a few avenues company leaders can consider for integrating quality and manufacturing and powering their processes with technology:

Tackling the obstacles and overcoming resistance to change

The worst nightmare for any manufacturing company is having to issue a safety recall. First and foremost, you are devastated by the possibility that anyone has been harmed by your products. Especially in life sciences, patient safety must always be our central concern with every decision.

Beyond those primary concerns, a safety recall can quickly destroy your customers’ trust in your company and products. Given the high stakes of manufacturing failures, it’s hard to understand why more companies aren’t taking advantage of the technology available to prevent them.

One of the biggest obstacles is simply that change is difficult and expensive. Manufacturing leaders face a lot of pressure to produce quickly, increase productivity, and lower costs. Companies are also generally reluctant to overhaul a process that has worked for them.

The idea that a company needs to spend more money on safety—especially if it hasn’t had to navigate a recall or similar problem recently—rarely goes over well in the C-suite. Until it’s too late, of course. Then it’s less of a choice, and more damage control.

Leaders always must navigate the tension between providing high safety standards and cost savings. At the same time, avoiding risk may mean companies embrace a willingness to spend whatever is needed to ensure they pass safety standards.

Leaders must take time to think through their safety processes and understand that even long-standing protocols can fail if they aren’t backed by technology. The real risk lies in not making the safety of your customers the highest priority.

Breaking down silos between quality and manufacturing

Another major problem is identifying and eliminating the silos around your manufacturing teams and your quality control teams. Technology can help them operate as two sides of the same coin, but each group will begin to focus on different outcomes if they are completely independent from each other.

The quality team will spend a great deal of time and resources documenting a quality management system (QMS), including controlling the many versions of documentation and making sure people are properly trained. However, enforcing the QMS, such as making sure an operator follows a specific set of work instructions, is complicated by outdated, paper-based records that cannot be easily audited. Failure to embrace technology tools makes the entire process more expensive and less reliable.

The quality team is required to review every step of the manufacturing process upon completion. When a company is relying on legacy systems instead of next-gen tech tools, that generally means a lot of writing information on paper documents and trusting it’s all correct at the time of record. This certainly isn’t the best course of action, given that the average rate of human error in pharma manufacturing is 92%.² Tearing down the silos between your quality team and your manufacturing team will enable both to work together, enforcing your QMS in a manufacturing execution system.

This is a great connection that creates step-by-step workflows while tracking data inputs in real-time, making sure your products are within specification, the operators were properly trained at the time of manufacture, and all steps were completed according to the work instructions and standard operating procedures. An electronic production record allows specific guardrails and limits to be enforced, alerting operators on the spot whenever there is a deviation, so you can address the problem with an absolute minimum of waste while also ensuring the highest product safety and efficacy.

Forging strong connections between quality and manufacturing is important for any company, but it's especially critical in industries where faulty products put lives at risk. Technology will help put all the pieces together.

Building confidence in your processes

Early in my career, I was the manufacturing manager in a production facility that created test probes for the multimeters that electricians use to test current and voltage. If an electrician is working on an air conditioning unit, for example, they would use this multimeter to ensure there is no power running to the wires they are working on, among other things.

When creating the probes, the step with the highest degree of risk was when we crimped the probe to the wire. If we didn’t get it exactly correct, it could produce a false negative and lead to someone being electrocuted.

Our testing process was to take one probe for every 100 that came off the line and clamp it in a machine that would pull it apart, recording the results on a piece of paper. The facility ran 24 hours a day, so, as the manager, I had no choice but to rely on the accuracy of the testing paperwork.

Processes of this type, with paper slips and manual review, are still common in many industries today, including life sciences. This is not an indictment of any of the well-trained operators — it’s just that we have the tools to radically improve those processes that eliminate a lot of the possibility for error.

Even today, in many cases leaders are relying on people writing down results, presuming they are being checked in-line, and hoping nobody is hurt by their products. It’s shocking this is still a standard procedure, given that technology exists to ensure high quality without decreasing productivity.

Building greater confidence in manufacturing and safety processes across your organization depends on executing every step the right way—it has to be correct, every single time. That type of consistency and trust has everything to do with best practices: good operators, good training, good leadership, good process, full accountability, and complete visibility.

Companies can avoid disastrous recalls and costly breakdowns in safety by embracing the technology that already exists in the marketplace. This will often require overcoming objections, breaking down the silos between quality concerns and manufacturing efforts, and improving confidence by seeing improved results.

References

1. Pollaro, Bianca. (February 2, 2023). Drug, Blood Pressure Medication Recalls: Full ist of FDA Recalls Since 2012. USA Today. https://www.usatoday.com/story/news/2023/02/02/fda-drug-blood-pressure-medication-recall-database/11032830002/
2. Dedeurwaerder, Thibaut; Iacovelli, Daniele; Leydon, Eoin; Patel, Parag. (August 6, 2018). How Data is Changing the Pharma Operations World. McKinsey & Company. https://www.mckinsey.com/capabilities/operations/our-insights/how-data-is-changing-the-pharma-operations-world