Quality

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Quality

Historically, in the pharmaceutical world, quality means regulatory compliance. But in Novo Nordisk, quality is a concept of three; customer quality, regulatory quality and business process quality.

People living with a lifelong condition, such as diabetes or haemophilia, expect outstanding quality from the healthcare products they use every day. If product safety can be questioned, it leads to their general mistrust of the products and it increases their awareness of how the manufacturer handles quality matters. To Novo Nordisk customer quality is about the safety, efficacy and convenience of our products.

Governments are becoming increasingly vigilant about ensuring that healthcare products live up to high quality standards in order to safeguard patients and the general interests of society. More regulation and monitoring of product safety are being introduced worldwide, among others through inspections, to ensure that production facilities employ Good Manufacturing Practice (GMP). To Novo Nordisk regulatory quality is about being in compliance and possibly even beyond compliance.

Society as a whole wants pharmaceutical production to be cost effective and responsible in terms of environmental issues and social and ethical behaviour. Everybody at Novo Nordisk continuously works on improving the quality of the company’s business processes.

Compliance performance 2008

Novo Nordisk has delivered a very solid quality performance throughout 2008.
Novo Nordisk continues to be in compliance with regulatory requirements, even in light of the increasing demands by authorities. Our robust compliance status is recognised both by Novo Nordisk’s internal audits and by authority inspections.
In 2008 Novo Nordisk

• welcomed 95 inspections by authorities. This is an increase compared to 2007 (71 inspections) primarily due to more reported GCP inspections (8 in 2007 and 29 in 2008). None of these revealed any critical non-compliance with regulations
• did not receive any warning letters from the US Food and Drug Administration (FDA) or any other authority
• experienced two recalls from the market. The number of recalls has been constant over the past five years despite a significantly growing business volume. The two recalls were related to :
  • 2008-03-05 Incorrect temperature during transportation of Novo Nordisk products in Finland
  • 2008-08-29 Cliché error on NovoNorm 2 mg in Iraq

• saw an overall decline in the frequency of customer complaints.

Novo Nordisk continues to do this by:

• ensuring that the safety reporting is operated in full compliance with authority requirements on time and quality
• requiring the same GMP, GLP and GCP standards wherever Novo Nordisk operates in the world
• monitoring risk. Any breaches of advertising and marketing regulations with significant impact 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.
• applying the same monitoring and reporting procedure to complaints as the procedure for breaches of consumer privacy.
  

Novo Nordisk's quality approach

Novo Nordisk approaches quality from a variety of angles; and all with a view to how best to ensure and improve the quality of our work in relation to customer demands, regulatory demands and demands for optimised processes. Cornerstones of our quality approach are described in the following.

Quality mindset

Quality in Novo Nordisk is defined as meeting or exceeding the expectations and needs of customers and society.

Novo Nordisk is fully committed to delivering products and services of high quality and this commitment is deeply rooted in the Quality Policy and fundamental principles in the Novo Nordisk Way of Management. This is also known as Quality Mindset.

A strong Quality Mindset encourages all employees to work across organisational boundaries, share knowledge and experience and continuously improve the quality of their work. Quality Mindset is at the heart of quality throughout the company.

Quality systems

Quality in Novo Nordisk is managed via a solid management system which describes management of business processes. The descriptions include a set of compliance and improvement mechanisms as well as half-yearly quality management reviews at all executive management levels.

Every year specific quality improvement targets are set and monitored throughout the year.

Several methodologies are applied to constantly ensure the continuous improvement of the quality of Novo Nordisk’s products and services.

Optimisation of processes

In 2002 cLEAN®, the Novo Nordisk version of the LEAN production philosophy, was introduced in the production areas. Since then the philosophy has successfully spread in the company and also to non-production areas.

cLEAN® is contributing to quality in the whole value chain by focusing on reducing any kind of ‘waste’ in the work processes and on doing things right first time.

Keeping up with regulatory demands

Being a pharmaceutical company which 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.

Moreover, Novo Nordisk constantly surveys the environment for new requirements to which the company must comply.

Putting customers at centre stage

Novo Nordisk conducts Customer Satisfaction Programmes biannually in order to better understand and meet customers' 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 customer satisfaction are drawn up and implemented in all markets. After two years the next study will be carried out. This continual process ensures that Novo Nordisk is at the cutting edge of the changing customer demands to Novo Nordisk’s products and services.

Managing risk

Quality is closely linked with risk management. Any incident where patients’ wellbeing or lives are at risk will imply major reputation risks as well as risks of costly compensation payments in the event of product liability claims. If the company was faced with a global product recall, it would also be at risk of losing its marketing authorisation, having substantial financial losses and seeing a negative impact on the inventory situation. To avoid such a situation, risk management is an integral part of how we handle quality matters.

The future: Taking quality to the next level

Having delivered a very solid quality performance for several years, Novo Nordisk is now preparing to take quality to the next level.

This is done by setting up an ambitious long-term aspiration for quality leadership as part of the constant striving towards business excellence. Over the coming years, the aspiration will be translated into concrete short-term and mid-term targets in the company and progress will be measured as part of the balanced scorecard on a regular basis.

The quality leadership aspiration is driven by Novo Nordisk’s Quality organisation which is ready to embark on the future. Next steps will include the introduction of quality risk management in second half of 2009 as part of the half-yearly quality management reviews at all executive management levels.

Furthermore the Quality organisation will also introduce a systematic measurement of Quality Mindset, starting with a pilot in 2009 within the Quality organisation.

Finally in 2009, the Quality organisation will initiate a systematic approach to further optimise business processes in Novo Nordisk. Selected quality business processes will enter as ‘first wave’ in an overall optimisation programme.

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