Quality Initiatives Audited

Driving a Proactive Quality Culture Through Human-Performance Management

 

We at Lonza are absolutely committed to our reputation as an innovative leader in quality performance within all of our offerings along and beyond the healthcare continuum. Just as in the realm of workplace safety, achieving superior quality requires constant vigilance and rigorous continuous improvement programs and processes.

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In 2017 our major manufacturing sites in Portsmouth, NH (USA), Singapore (SG), Porrino (ES), Visp (CH) and Nansha (CN) and Slough (UK) successfully passed strict regulatory audits. Those audits were just 15 of the 25 successful regulatory inspections conducted at our Pharma&Biotech sites worldwide. Our Pharma&Biotech network worldwide also underwent 135 customer audits; and here, too, we have successfully addressed customer concerns and observations. And where we face quality challenges, such as at our site in Walkersville, MD (USA), we provide teams of experts to assist the site.

We recognize that human performance is a key factor for superior and sustainable quality. Indeed, many of the process-related deviations across the biopharmaceutical industry are currently attributed to human errors, which impact safety, quality and security of supply.

The Error Prevention System (EPS) is built on the backbone of our Operational Excellence program. Each is a vital parts of Lonza’s global quality initiative, whose aim is to engage all employees in systemic thinking and achieving excellence in all that we do throughout Pharma&Biotech businesses, sites and functions. We have a similar, quality-focused initiative in our Specialty Ingredients businesses, many of whom also face strict regulatory requirements for ingredients intended for human health, hygiene and wellness.

Our Error Prevention System, launched in 2014, engages operators and other experts to establish error-proof standard operating procedures, work instructions and batch records, as well as learning and qualification modules. It also harnesses automation where possible to simplify operations and to ensure vital equipment is operating at optimal levels.

For example, EPS and other quality initiatives have reduced deviations across all Lonza Pharma&Biotech sites worldwide from 2014 to 2017 by approximately 50% – at the same time, production output increased around 30%. Of greater importance, customers are impressed by the EPS program delivering often-dramatic reductions in manufacturing issues related to their products.

To get human performance to the next level, best practices throughout the Lonza network are embraced and leveraged as standardized processes and trainings. As an example, the Lonza Pharma&Biotech Academy governs harmonization of training curricula and makes sure that training delivery follows state-of-the-art learning methodologies in order to ensure "quality at source," which is one of  Lonza's Pharma&Biotech strategic pillars.

The bottom line, however, comes through seeing tangible improvements – site to site and across the organization. Evidence shows that human performance efforts are preventing negative outcomes by powerfully engaging operators and others in proactive and preventive efforts that create a more positive working environment. The ultimate objective of these efforts is to enhance patient health and safety by manufacturing products of the highest quality for the healthcare continuum markets.