An introduction to Lean Validation

An introduction to Lean Validation: reduce waste and make the validation lifecycle flow

Lean Validation is an approach that harnesses the methods and activities from Lean Manufacturing Principles (i.e. The Toyota Way) that can provide an overarching structure to plan and develop a validation system that is successful and ensures that all planned activities performed within the system can demonstrate with confidence that the validation will fulfil the requirements for quality and safety, with special regards to the areas of:

• Risk Management
• Validation Change Control
• Project Management

As mentioned by Wong, W. and Chatterjee, B. (2007), traditional validation is based on

meeting corporate and market demand — regardless of the cost to the stakeholders of the company. The old adage “validate anything that moves but don’t move anything that’s already

validated” sums up the traditional view of validation. This mindset essentially

discourages innovation and continuous improvement and is partly why validation is perceived as a necessary evil rather than a value-added activity. Despite extensive

sampling and testing, companies are often unable to achieve process stability. Processes fail because the drivers for stability have not been properly identified and eliminated or controlled. Validation and it’s back bone that is Risk Management is not a once off effort but a living,breathing part of the business model.

In his book Liker calls the Toyota Way, "a system designed to provide the tools for people to continually improve their work."^[1]The system can be summarized in 14 principles.
According to Liker, the 14 principles of The Toyota Way are organized in four sections: I) Long-Term Philosophy, II) The Right Process Will Produce the Right Results, III) Add Value to the Organization by Developing Your People, and IV) Continuously Solving Root Problems Drives Organizational Learning.

These 14 principles can be easily transferred to the application of risk based Lean Validation:

Section I — Long-Term Philosophy

The first principle involves managing with a long-view rather than for short-term gain. It’s all in the planning as they say, plan the work and work the plan, validation and the use of validation master plans (VMPs) are no exceptions to this rule.

Section II — The Right Process Will Produce the Right Results

The next seven principles are focused on process with an eye towards quality outcome. Following these principles, validation work processes can be redesigned to eliminate waste (muda) through the process of continuous improvement — kaizen.
By performing a gap analysis of the current validation infrastructure will identify the “muda” and asses how robust the system is in regards to business and regulatory risks.
Utilizing kaizen techniques can help simplify the validation suite of documents that rationalize procedures, guidelines and macro-driven templates.
Simplification of the review and approval processes is also part of the principle of measured production rate (heijunka), as a level workload helps avoid overburdening people and equipment (muri), but this is also intended to minimize waste (muda) and avoid uneven production levels (mura).

Section III — Add Value to the Organization by Developing Your People

Human development is the focus of principles 9 through 11. Leadership needs to be embraced by all the key stakeholders in the validation system through the likes of a Validation Review Board supported by a dedicated valiation team. Driven with the judegement of success by their team acheivements rather than their individual efforts help minimise the cultural resistance of change. Ensuring that the lean validation principles are ingrained in all team members is perhaps the most difficult hurdle to overcome in the run up to a regulatory inspection.
Engineering has evolved primarily to satisfy commercial needs; however, there are certain elements of engineering by way of associated risks that have regulatory significance. The ISPE C&Q baseline guide addresses this particular issue with an impact assessment tool; a simple and effective way of separating commercial risk from regulatory risk.
Section IV — Continuously Solving Root Problems Drives Organizational Learning

The process of developing a robust diagnostic tool that is Lean Validation lends itself to the final principles. By becoming a "learning organization" which continually reflects on its practices and strives for improvement.

In summary, the main benefits that a Lean Validation driven organization will have is a transparent validation process that flows throughout the total lifecycle, waste is minimized with a strong emphasis on a right first time approach. Furthermore a lean validation organization promotes a scientific & data-driven process and encourages a preventative approach to quality issues and encourages a proactive control of all risks and uncertainty while improving transparency within the organization and with associated regulatory bodies & agencies.

Lean validation will always have the greater compliance needs in mind, not only safeguarding the products, and the people who use them, it will be seen in so many respects to safeguard 'the company’.

1^ Liker, J. 2004. "The 14 Principles of the Toyota Way: An Executive Summary of the Culture Behind TPS",