strategy

Why do 3 out of 4 Major Projects fail to Realize Original Goals?

Even when Life Science companies have a very good quality vision and strategy how come there is a high risk of failure to succeed anyway? 3 out of 4 major change projects fail to realize original goals, but why? Execution of the strategy involves the whole company whereas strategy design typically only involves a smaller group. The strategic journey of the projects initiated to reach the quality vision is just as much a change management task as well as a strategic design task to top management. The complexity in communication, planning and execution meets more barriers.

Most often...

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Why are we so Bad at Aligning the Quality Strategy?

Quality leaders and professionals are struggling to stay ahead of new requirements and guidelines reshaping the Life Science landscape. A number of requirements is enforced throughout the company’s value chain giving us a hard time keeping up. Being the final part of the value chain e.g. by approving documents the quality organization most often has to compensate for and contain previous delays. While working under constant time constraint and pressure QA easily gets caught up in everyday tasks which unfortunately does not leave much room for reflection, strategic thinking, or optimizing...

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A Quality Vision and Strategy Meeting Future Needs in R&D

A Quality Vision and Strategy Meeting Future Needs in R&D

The Life Science marketplace is changing by globalization. The ability to differentiate ones products from those of the competitors becomes increasingly important. When approving a new drug the regulatory authorities need evidence for comparative or better effect of the new drug than that already being on the market. Health care delivery is moving much closer to the end-user. The end-user sets higher requirements to the drug and delivery system. Generica and biosimilar products threaten to compete the...

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Fact Based and Shared Transparency in Quality Costs

Different interests, subcultures, paradigms and beliefs about quality may exist in the company and in top management. It can be very difficult to agree on specific quality improvement projects and investments if we do not agree on the quality vision and strategy, as these projects may be both extensive and costly. One way to cut through the different perspectives in the organization is to help the decisions being fact based and create a transparency in the quality costs and quality drivers – in essence create a diagnostic tool.

Fact based and shared transparency in quality costs...

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A Quality Vision and Strategy Meeting Future Needs in the Supply Chain

The Life Science Industry have to navigate in a rapidly changing environment. Globalization as well as the increase in drug shortages, recalls and counterfeit products drives changes in the supply chain. Both manufacturing and delivery will have to be more flexible, stable and secure. New technologies are developed to facilitate flexibility, stability and security calling for increased specialized knowledge and skills. The need for more flexibility combined with increased complexity in technology and skills may enhance outsourcing. In turn, this requires more collaboration and strategic...

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A Quality Vision and Strategy Meeting Future Needs in Sales & Marketing

The Life Science Industry have to navigate in a rapidly changing environment. The marketplace is changing by globalization, by new concepts of medicine pricing, and by health care delivery moving much closer to the end-user. Based on the increased pressure on pricing and patient requirements, the ability to differentiate ones products from those of the competitors will become increaslingly important. Processes in R&D are under pressure to reduce time and costs to bring new products to market and meet the world’s unmet medical needs. Both manufacturing and delivery is required to be...

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4 Important Elements of an Effective Quality Strategy

The importance of having an effective Quality Strategy complementing your Business Strategy is often overlooked. A goldmine of potential quality improvements and quality costs reductions may be hiding in your business ready and ripe to be effectuated.

By far the most companies have a Quality Manual and Quality Policy as required and recommended by the authorities (ISO 9001:2015, ICH Q10), but do they also have an effective long term Quality Vision and Strategy?

In our experience, many companies have a quality strategy, but the question is if it is “just” a colorful 1-pager...

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