Quality
People living with a chronic condition expect outstanding quality from the products they use every day over a lifetime. When product safety is called into question, it leads to a general mistrust from consumers and raises awareness of the need for vigilance on quality matters.
Governments are becoming increasingly vigilant about ensuring that healthcare products live up to high quality standards in order to safeguard the safety of consumers and interests of society. More regulation and monitoring of product safety are being introduced worldwide, through, among other things, inspections to ensure that facilities employ Good Manufacturing Practice (GMP).
Performance 2007
Novo Nordisk is in compliance with regulatory demands, even in light of an increasing number of inspections. Novo Nordisk received more than 70 inspections during 2007. None of these revealed any major non-compliance with regulations.
Novo Nordisk has not received any complaints or warning letters from the US Food and Drug Administration (FDA) in 2007 in fact, the US Food and Drug Administration is using the Novo Nordisk insulin production facilities in Clayton, North Carolina, US, as a better-practice training site for its inspectors. Novo Nordisk requires the same GMP standards wherever it operates in the world.
Novo Nordisk experienced only one recall from the market in 2007, which was related to a printing error on the label of Norditropin SimpleXx® 10 mg/1.5 ml Penfill® in Croatia.
Any breaches of advertising and marketing regulations with significant impacts are reported to Corporate Legal. The risk-monitoring process monitors such incidents. Novo Nordisk does not consolidate the records of such breaches in local markets at corporate level, but such records are kept – for regulatory authorities to inspect – by local management.
The same procedure applies to complaints regarding breaches of consumer privacy.
Novo Nordisk's approach
Novo Nordisk puts quality front and centre. The Quality Mindset is one of the fundamental management principles in the Novo Nordisk Way of Management: “Everyone must continuously improve the quality of their work.”
Overall, Novo Nordisk follows a ‘cut-no-corners’ philosophy in the way new products are developed and improved. The commitment to quality is outlined in the company's Quality Policy. Quality is defined as meeting the expectations and needs of customers and society. The quality management system, including audits, ensures continuous improvements and optimal use of internal standardisation.
The quality management system also describes procedures, management systems and compliance mechanisms related to product information and labelling.
As a pharmaceutical company that markets its products worldwide, Novo Nordisk must adhere to national and international requirements for products and production. The American Food and Drug Administration (FDA) sets the global standard with which Novo Nordisk complies.
Novo Nordisk does not have specific policies regarding consumer privacy.
Strong focus on quality
The focus on quality across the organisation is being integrated through a Quality Mindset that encourages all employees to work across organisational boundaries and share what they have learnt. Some 11,000 separate quality action plans are consistently tracked. There has been a significant improvement in timely adverse event reporting, and customer surveys indicate an improvement in the level of customer satisfaction.
Since 1999, Novo Nordisk has been conducting biannual Customer Satisfaction Programmes in order to better understand and meet customer's needs. These studies evaluate the expectations of healthcare professionals and patients, along with their level of satisfaction on a wide range of parameters related to the company image, the sales force and the patient services.
The results are used to identify and prioritise areas for quality improvement. On this basis, action plans to improve costumer satisfaction are drawn up and implemented in all markets until the next study is carried out. This continual process ensures that Novo Nordisk is on the cutting edge of the changing customer needs with Novo Nordisk’s products and services.
Since the beginning of the satisfaction programme, the level of satisfaction has increased among Novo Nordisk’s customers. More specifically, these satisfaction programmes have helped confirm Novo Nordisk's leadership position in diabetes products and haemostasis management. Customers also recognise the company's efforts in patient education and its diabetes heritage.
Regulatory Affairs is responsible for ensuring regulatory license for current and future products responsive to Novo Nordisk's worldwide business needs. Its task is to minimise time to marketing authorisation while ensuring compliance. To that end, interaction with key agencies and other critical stakeholders is part of the mandate, as is understanding and communicating relevant legislation to customers and partners. The proper conduct of regulatory affairs activities has considerable economic importance for Novo Nordisk.
Managing risk
Quality is also closely linked with managing risk. Any incidents where patients’ wellbeing or lives are at risk will imply major reputational risks as well as risks of costly compensation payments in the event of product liability claims. If the company were faced with a global product recall, it would at the same time be at risk of losing its marketing authorisation, there would be substantial financial losses and it would negatively impact the inventory situation.
Novo Nordisk has also introduced cLEAN®, the Novo Nordisk version of the LEAN production philosophy, which automotive manufacturer Toyota has used with great success. (The ‘c’ refers to ‘current’.)
cLEAN® is a way of thinking, a production philosophy and a new and smarter work culture that seeks to reduce any kind of ‘waste’ in the work processes, be it ideas not realised, inefficient work routines or costs. It is being implemented throughout Product Supply, including production facilities, laboratories, support functions and administrative units. Its goal is optimisation throughout the supply chain by shortening lead times and focusing on zero defects, simplicity and continuous improvement.
See an overview of voluntary code compliance, key products or awards with respect to social and/or environmental responsibility that Novo Nordisk is qualified to use or has received.
This page has been reviewed by PricewaterhouseCoopers as part of its assurance of Novo Nordisk’s non-financial reporting. Please refer to Audit and assurance for a full description of the conclusions and the nature of assurance offered.
