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How agile is your quality system?

New research for the life sciences sector

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In a rapidly evolving market, the application of agile frameworks becomes increasingly important to evolve quickly and ensure sustainable long term success. Agile frameworks used to be solely applied to software and hardware projects. Now, leaders in life sciences are applying them to their organisations to improve operations and foster innovation. But within regulated environments, quality systems are usually designed to provide stability and adhere to compliance, hindering organisations from realising their full potential.

To investigate how companies rate the agility of their current quality system, and the areas in which they want to improve on to achieve what we call an 'Agile Quality System', we surveyed over 40 senior executives and representatives from some of the world's largest life sciences organisations.

An Agile Quality System will allow companies to:

  • significantly improve their ability to adopt innovation
  • increase the speed, and decrease cost, of regulatory compliance
  • meet customers' safety requirements more effectively.

Companies want to increase the agility of quality systems by almost 50%

It's clear that organisations want to increase the agility of their quality system. And when we look across three stakeholder groups – quality system owners, quality function associates and quality system internal users – we can see they have differing views on the current and desired agility of their quality systems – indicating a lack of a common understanding or vision. It's therefore important for communication to improve if interests of all stakeholder groups are covered and they are to agree on common goals.

It's also important to recognise the desired agility isn't necessarily the maximum that can be achieved. If companies are to find the best solution for their quality system, they need to carefully analyse the needs of the related organisation and people – and resolve any perception differences.

Current and Desired views

Companies want to see a significant increase in agility across 10 principles

To increase the agility of quality systems, 10 principles need to be adhered to. The highest desired increase is for principles two, 'focus on value beyond compliance' (+73%), five, 'foster a variety of viewpoints' (+74%), seven, 'strive for simplification' (+58%) and nine, 'maintain continuous quality' (+58%). In contrast, little value is seen in further increasing the agility for principle four, 'build strong network and relationships' (+13%).

10 PRINCIPLES DIAGRAM

Each principle has a different impact on quality system agility

Companies have a strong desire to increase the agility for principle two – and this is also the most relevant driver for the overall agility. In other words, focusing on value beyond compliance has the biggest impact on increasing the overall agility of the quality system.

Principles four and seven also score highly as good drivers for the overall agility of the quality system. While the respondents desire a 58% increase in the agility for principle seven, on average they are only looking for a small increase in the agility for principle four. This is short-sighted, however, as the data clearly shows the latter plays a big role in driving the overall agility of the quality system.

IMPACT diagram

How to realise the full potential of an Agile Quality System

Life sciences companies can leverage the benefits of an Agile Quality System by focusing on four areas:

  • Strategically strive for value beyond compliance
  • Foster a quality culture that supports an Agile Quality System and increases engagement
  • Strengthen agile expertise and information management
  • Focus on simplifying processes and procedures.

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