Cold Chain University Blog

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Do You have a CAPA Driven Culture?

Tuesday, August 5, 2014 at 12:00 AM | Vivian Berni | Quality
Illustrated CAPA Process

Don’t frown.
It may be bittersweet,
despite the process,
you correct and prevent
that’s why we are loyal
to thee, oh CAPA.

All poetry aside, corrective and preventive action (CAPA) are a must do in today’s complex environment. No doubt that investigating the cause of a quality failure or cold chain logistical problem is something that bio pharmaceuticals and players in the life sciences and healthcare industry must do more frequently than in other sectors. The nature of the business warrants CAPAs to enable improvements to an organization’s processes with the objective of eliminating causes of nonconformities or other undesirable situations.

Within our LifeConEx culture, we are driven to achieve high quality standards. For this reason, CAPAs play an important role especially when it involves creating processes and action for preventive intervention.

Melissa Gumina

Melissa Gumina

Melissa Gumina, Quality Investigations Manager at LifeConEx, shares her thoughts on the subject, "Corrective and Preventative Actions (CAPAs) are essential to not only our investigations but to working with our partners, third party vendors and within our own internal structure. It shouldn't take an incident, deviation or issue to spark a CAPA. The importance of proactively working with all parties involved in the Cold Chain Transportation process benefits everyone involved but mostly the customer. We always strive to be sure that any and all CAPAs we complete will not only keep the particular issue at hand from happening again, but will also keep other possible issues from occuring in the future. CAPAs are not only about fixing what just happened, but they are about proactively 'preventing' other things from happening as well."

How would you define your culture?

Vivian Berni


Vivian Berni, Senior Advisor, Optimisation

I am a science and technology explorer who is connecting the dots within the life sciences and health care sectors. Logistics and supply chain management are just some of the many variables that I consider daily. Within LifeConEx/DHL, I’m keeping tabs on industry trends while looking for ways to optimise my customers’ business. Prior to this, I was a driver of innovation who was responsible for project implementations affecting customer journey, branding and ideation. Email thoughts, tips and questions to vivian.berni@lifeconex.com or follow me on Twitter @vivianberni.

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