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.
