2016 Health for Humanity Report
2016 Health for Humanity Report
2016 Health for Humanity Report
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Product Quality, Safety & Reliability
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At Johnson & Johnson we care deeply about patients and consumers, doctors and nurses, mothers and fathers. High product quality and safety are critical to the people we serve. In addition, from a business perspective, they help us earn their loyalty, protect our strong reputation and ensure we have a healthy and future-ready, thriving business. Product quality and safety are not only our top business priorities, but also obligations embedded in Our Credo-driven culture. In living up to Our Credo commitment "In meeting their needs, everything we do must be of high quality."

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High quality requires a focus on prevention of deficiencies, prompt recognition and correction of those that do occur, and a process for continuous improvement.

For the benefit of our customers, we continue to look at quality and safety throughout all phases of product lifecycles. Health and safety impacts, as well as product performance, are assessed for all product categories in each business segment throughout the world. These assessments may lead to voluntary product field actions when prudent, based on our quality policies and standards. GRI 416-1

The Johnson & Johnson Quality & Compliance organization ensures the consistent implementation of our Quality Policy and Quality Policy Standards across the Johnson & Johnson Family of Companies. The Johnson & Johnson Quality Policy governs our operating companies to help ensure they design, make and deliver our products in a consistent way.

All employees around the world are expected to follow the Johnson & Johnson Quality and Compliance Core Objective in developing their annual Goals & Objectives, reinforcing that everyone is responsible for quality and compliance.

Measuring Compliance

Operating in a state of consistent compliance is essential for all sites in the Johnson & Johnson Family of Companies. A closed-loop, independent audit approach is in place to help ensure facilities and external manufacturing sites operate in compliance with our Quality Policy and Quality Policy Standards, as well as health authority requirements.

We have a clear and systematic process in place to remediate compliance gaps and minimize their impact on the customer experience. Results, status, and progress are all reported to business leaders and the Johnson & Johnson Family of Companies’ governing bodies to help them support their sites’ efforts to achieve compliance in a timely manner. Regular updates on this topic are provided to the Regulatory, Compliance & Government Affairs Committee of the Board of Directors.

Our quality and continuous improvement approach also includes a Management Review Process. This process requires the executive management of each of our operating companies to drive quality improvements by reviewing its Quality System every six months to ensure its suitability, adequacy and effectiveness.

Decisions on quality matters are made through the Quality organization and medical safety decisions are made through the Office of the Chief Medical Officer. When escalated, independent Quality Review Boards (Quality, Medical Affairs, Medical Safety, Regulatory representation) within each business unit make decisions independent of commercial considerations to ensure products in the market continue to meet their defined requirements.

Resulting from these efforts, Johnson & Johnson is achieving an integrated and proactive approach to quality and continuous improvement.

Additionally, we are exploring new ways to continue fostering our proactive quality culture and use our expertise to engage in leadership roles with external stakeholders for collaboration on future regulations. This will ensure the Company continues to deliver safe and effective products to improve the lives of patients and customers.

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In over 505 regulatory inspections of our internal sites conducted by worldwide health authorities, no significant regulatory findings were identified.

From 179 independent audits completed at our internal sites, the majority resulted in no critical findings. We put corrective actions to independent audit findings in place and tracked them to successful completion. The independent audit program was expanded in 2015 to include priority external manufacturing sites. In 2016, the program included 200 audits at our external sites. Findings and associated corrective actions are being tracked to successful completion.

We attained more than 35 percent reduction in the total field actions regarding recalls of product from the U.S. marketplace compared to 2015.

In May 2016, Johnson & Johnson brought back the landmark Kilmer Conference—the premier global forum on sterility assurance and sterilization—with more than 300 pharmaceutical and medical device leaders attending from across industry and health authorities. The primary focus for this event was on connecting Sterility Assurance end-to-end of the supply chain; innovation; and developing talent for the future. Johnson & Johnson hosted eight Kilmer Conferences between 1976 and 2003, helping to shape the field of sterility assurance and sterilization on which the company was founded. Conference proceedings are available in a searchable e-book format on the Association for the Advancement of Medical Instrumentation website.

In 2016, Johnson & Johnson’s Animas Corporation was notified through the Johnson & Johnson Vulnerability Disclosure program of a cybersecurity issue with the OneTouch® Ping® insulin pump system, specifically that a person could potentially gain unauthorized access to the pump through its unencrypted radio frequency communication. The probability of unauthorized access was determined to be extremely low; however, Johnson & Johnson worked with the appropriate regulatory authorities and security experts to ensure patient safety and security. Johnson & Johnson sent notifications to both patients and health care professionals notifying them of the risk and actions they could take to mitigate it. The steps taken by Johnson & Johnson and our Animas Corporation in response to this issue were recognized by the U.S. Food and Drug Administration (FDA) as the proactive and collaborative behavior they are looking to see from medical device manufacturers and the security research community, utilizing an approach intended to best protect patients.

Continuous Improvement Examples

Quality Excellence in Execution, a program designed to reinforce quality culture and performance, was deployed across more than 100 manufacturing sites delivering significant reduction in manufacturing-related field actions, quality holds, and non-conformances over the last three years. Deployment continues with recently acquired businesses and the Johnson & Johnson Deliver organization.

The Johnson & Johnson Proactive Supplier Quality Programs are designed to prevent quality issues, identify quality risks and improve quality performance of our supply base. One of our programs is the Supplier Quality Academy which provides training for our suppliers and supplier-facing employees on strategic competencies that deliver overall quality and performance of the end-to-end supply chain. We have also deployed the Supplier Quality Excellence in Execution program to accelerate supplier maturity development and quality performance.

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2016 Health for Humanity Report

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