The new grad is highly conscientious and detail-oriented when it comes to safety—always has her hair tied back, never wears open-toed shoes. She reads the safety data sheet (SDS) before using chemicals and leaves the fume hood tidy, even putting away volatile chemicals left behind by others.
The experienced lab tech, however, has grown lax after working in the facility for several years. He’s the funny guy, the one who likes to scare newbies with small explosions made by throwing small amounts of catalyst into water. One time the washroom caught on fire because he improperly disposed of leftover acetone, but small lab fires aren’t unheard of.
Now ask yourself honestly—which one of these technicians do you think keeps better records? Who is more likely to identify an out-of-specification/out-of-trend (OOS/OOT) incident or notice a lab equipment maintenance/calibration issue? And most importantly, who is going to consistently produce the higher quality product?
The answer is simple—it’s the person with the safety mindset.
Lab Safety: A Quality Issue
While we tend to think of lab safety and quality in two separate spheres, the fact is they are closely linked. Someone who consistently acts in a high-risk manner is also likely to create product quality issues. Similarly, a person whose work quality is high risk is unlikely to adhere to safety protocols.
And there’s no question that for consumers, quality is safety. A mislabeled product can lead to serious human health risks, just as poor quality practices can lead to widespread contamination.
It’s the reason many in the pharmaceutical and medical device industries are borrowing strategies like bowtie risk assessment from other high-risk industries. Companies in aviation and oil and gas have long used this risk model to mitigate the risk of rare, high-risk events like plane crashes and wellhead blowouts.
On the left side of the bowtie model, you have preventive controls or barriers that prevent the loss of control event. On the right, you have recovery controls that mitigate the damage should the hazard break through those barriers.
Pharmaceutical companies recognize that they can apply this model to risks like widespread contamination events. It’s especially useful for rare events where you have little historical data or leading indicators on which to base key decisions.
Connecting Lab Safety and Quality
So how can you connect safety and quality in the lab? One way companies are doing this is by linking their Quality Management System (QMS) with their safety management program.
Integrated software allows you to consolidate the two into one system, reducing your IT footprint while giving you more robust data, and predictive intelligence to identify correlations between safety and quality events.
Integrated GMP Software allows you to:
- Track employee training compliance for safety and quality procedures in one place to monitor/report compliance.
- Automatically trigger new training requirements when you make changes in the Document Control (replace with link to SDS) system, such as changes to SDS records.
- Draw in data from quality records, employee training and nonconformances to better identify the root cause during Corrective and Preventive Action (CAPA) investigations.
- Incorporate Risk Management into various quality and safety activities, including supplier management, CAPA tracking and customer complaints.
Once you recognize that safety and quality are two sides of the same coin, you’ll find it’s much easier to improve performance in both. Ultimately, connecting lab quality and safety is a way to reduce costs and effort, mitigate business risks, while simultaneously reducing quality defects in the lab.