Ethicon LLC has zero product recalls
Routine quality checks at every stage of the manufacturing process contribute to zero product recalls.

2012 IW Best Plants Winner: Ethicon - Employee Engagement Results in Zero Product Recalls

Plant flourishes by getting it right the first time.

In an industry that has been plagued by product recalls, the medical devices built at Ethicon San Lorenzo, a Johnson & Johnson company based in Puerto Rico, stand apart. In the plant's 24-year history, there has never been a product recall. 

And given the volume of producing 110 million units yearly of non-absorbable sutures with over 2,500 SKUs, that is no small feat. Additionally the plant manufactures topical skin adhesive Dermabond, polypropylene meshes (used for hernia reparation) and Surgicel (blood clot-inducing material).

"Our quality record is due to the desire of all employees to get it right the first time,"  explains Adnyl Grovas, QA director. The plant's metrics bear this out. Since 2008 non-conformances have been reduced 50% while human error has decreased by 60%, contributing to an overall 98% rate of the products manufactured being correct the first time. 

Ethicon LLC manufacturing plant informationThe structure underpinning these accomplishments is a system named "Do it Right Framework." It has nine pillars, including: management oversight, mistake proofing, risk management, training and education and change management.

"How we have handled change management is the key to our success. By being transparent with our metrics as well as our competitive position, both within the industry and within the corporation, I have made clear to our associates the reasons for the changes that were made," states plant manager Marinelba Rosado.

In order to compete within J&J for the opportunity to launch new products, the plant has established a strong partnership with marketing and R&D to get new products to market on time and design them for manufacturability. The plant has already begun manufacturing a new type of suture for 2014, the first time in 15 years that the plant has produced absorbable sutures.

Other works in progress include the next needle generation for cardiovascular surgeries called Everpoint, and a new formulation for Dermabond called Dermabond Advanced.

"The site is now positioned as one of the top innovative sites in information technology infrastructure and automation within the organization," says Francisco Muniz, process excellence manager.

Enabling innovation is the emphasis on lean which began when the plant started automating production lines in 2006. No regular employees have lost their jobs as a result of these automation efforts. Instead employees were trained in both lean management and change management, with 65% of the exempt population having at least a green belt certification. All employees have had some type of lean training.

With lean and other improvements, the company has seen productivity gains of 8.5% over the last three years.

Improvement in employee engagement is yet another reason for stronger metrics. Concerted efforts to make sure everyone clearly understands the objectives of the plant has raised the employee engagement score from 62% in 2005 to 96%. 

Moving from plant floor engagement to community engagement, the plant is employing a program called Connect whose vision is to "strengthen the trust in our products and organization by connecting ourselves as one entity with our customers and community through the exchange of knowledge and active participation." Supporting activities include clients participating in procedures, supplier visits and an open house for the community at large. 

To demonstrate how the greater community benefits from their efforts, all employees are shown a video featuring Dr. Gonzalez Cancel, a cardiovascular surgeon, explaining how he uses the products and which attributes are essential to positive outcomes.

"Each of us understands that the products we manufacture can be placed in our loved ones. What we manufacture saves lives," says Rosado.

For more on the 2012 Best Plants winners' amazing achievements, click here.

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