Managing Value Through Lean Validation

Part two of the two-part ‘Lean Validation’ series, “Managing Value Through Lean Validation” explores the management of value-added and non-value-added validation activities, how to create value and lean validation best practices.

Read | Part One – Lean Validation in GxP Organizations

Managing Value 

Validation is an integral process in every successful Quality Organization ensuring products meet both the requirements of the customer, as well as any applicable statutory instruments and regulatory requirements. This is achieved by providing documented evidence, or an ‘evidence trail’ to prove that an action, process or system within your company will consistently produce the desired end product. The validation process provides assurance that a company’s processes are operating effectively and builds confidence in the quality of the end-product.

However, validation can be an onerous, inefficient process – one which translates into increased costs for the business and can undermine a Quality Organization’s competitive edge in the market. Additionally, inefficient validation can also act as a ‘bottleneck’, preventing products from reaching the market in a timely manner.

Companies need to determine whether each step or process in their validation process adds value, or whether it is a waste of time & resources. To classify a process, step, or action as ‘value-add’, companies must ask: Is the customer willing to pay for this activity?

As a solution to these challenges, the concept of ‘Lean Validation’ emerged.  A lean validation approach continues to demonstrate compliance, whilst eliminating waste at all stages of the validation process. In short, the approach seeks to only retain steps, processes or actions within the validation process that add value and eliminate any that do not (“non-value add”). The result is a more efficient, ‘lean’ validation process, that decreases business costs and saves time.

However, the decision to adopt a lean approach to validation is a commitment, and requires ongoing effort by everyone in the company and buy-in across the organization – it is not enough to simply implement lean and expect it to work. Stakeholders must believe and trust in the evolving nature of their steps and processes; that the traditional ways of doing things might change, but for the better. The company must also take a strategic approach to validation whereby not only is successful validation sought, but more importantly, successful validation is achieved as efficiently as possible.

Creating Value 

The effectiveness of lean lies in the focus placed on value throughout the validation process. Companies need to determine whether each step or process in their validation process adds value, or whether it is a waste of time & resources. To classify a process, step, or action as ‘value-add’, companies must ask: Is the customer willing to pay for this activity?

Answering this question requires comprehensive understanding of your customers’ requirements. If it is of no value to the end customer, it should be scrapped, or at least re-considered. Companies must also question if the step or process is guaranteed to be done right the first time, and if it changes the product in some way. Anything that meets this criteria is considered to be value add, and everything else falls under the category of waste.

To identify waste in a validation process, a validation team might adopt ‘value stream mapping’, which entails mapping out the validation process by identifying the activities and steps that make up that process. Then, they would map out how the work is being completed by the team and identify any obstacles, delays, and bottlenecks.

Requirements Reign, Tracking is Tantamount

Companies can also encourage their teams to watch out for steps and actions that don’t add value to the validation process. They might consider the ‘Eight Wastes’, which are identified as being the largest areas of non-value adding activity, referred to by the acronym of ‘TIMWOODS’.

TIMWOODs was introduced in the 1990s when Toyota’s lean Production system was implemented in Western countries and is a framework from which all of the wasteful steps/activities in a process can be identified. The acronym stands for Transportation, Inventory, Motion, Waiting, Overproduction, Over-Processing, Defects & Skills and is covered in detail, in article one of this series.

Consider ‘over-processing’, for example, which happens all too frequently in traditional validation processes. This might include generating more detailed reports than required by the customer or including unnecessary signatories on a document.

The importance of not over-processing cannot be underestimated when it comes to saving time and resources.

Companies can begin to understand the level of processing needed by understanding the level of quality and expectation required by the customer. This will allow them to streamline their process significantly and eliminate any activities which do not provide value to the customer -or take the waste ‘Defects’.

From a validation perspective, this might entail poor ‘defect’ or ‘deviation’ management. Although it is essential for any validation project to manage defects or deviations which may occur during test preparation and execution; the tracking and management of deviations is also one of the largest culprits of waste production. Whether it be the tracking and management of deviation forms associated with test protocols or transferring information from a deviation form to a corrective action report, it is a significant drain on resources.

Automation as Lean Best Practice

With the birth of TIMWOODS stemming from the ground-breaking success of Toyota’s lean production system, it is no wonder that companies of today are eager to adopt the principles of lean thinking. Many are adopting lean best practices to streamline their validation processes.

For example, to eliminate the poor deviation management discussed previously, one could adopt automation as a lean best practice. Deploying an automated deviation tracking system would allow employees to create, modify, manage, and close any incidents (bugs, deviations etc) raised throughout the lifecycle of a project. Such systems have various categories of incidents you can choose from, and each type has its own workflow. Everyone involved can work on the resolution of the incident, and all discussions and information relating to its initiation through to its resolution is readily available and collated on that single platform.

Process Digitization as Lean Best Practice

Another prominent example of a lean best practice is process digitization. Growing companies continue to embrace technology and realize that the digitization of their validation process is a value-added endeavor. The conventional paper-based validation processes and systems is proving to be a major frustration, slowing down lifecycles, wasting resources, and increasing the risk of making errors with respect to compliance. Removing paper from every stage of the validation lifecycle is undoubtedly a lean best practice.

The concept of building quality into the validation process is also considered a best practice, which can be achieved with a best in its class paperless validation system. Rather than looking for protocol-based GDP errors and worrying about whether compliance is being met, a paperless system can minimize such errors, and have ‘ALCOA’ Data integrity best practices already built into the software. With the quality already built into the validation process, errors can be prevented before they occur, rather than tracking and looking for them downstream.

Adopting the art of lean thinking and integrating its best practices within an organization is a smart business move. Companies of today would be setting themselves up for success by beginning their journey towards lean, whether to increase their competitive edge, reduce costs, or to simply make their business operations a lot more efficient and scalable.

About the Author

Lauren McCutcheon holds a degree in Industrial Biochemistry
and works within Kneat’s Quality Assurance division as
Quality Assurance Analyst at Kneat.

References

1. ‘Lean Validation – Why it’s Important and How to Achieve it’, SL Controls, [https://slcontrols.com/lean-validation-why-its-important-and-how-to-achieve-it/]
2. ‘The 8 Wastes of Lean’, The Lean Way Blog,[https://theleanway.net/The-8-Wastes-of-Lean] 
3. ‘Mastering Regulatory Compliance Cybersecurity and Green Lean Validation’, IVT Network, [https://www.ivtnetwork.com/article/mastering-regulatory-compliance-cybersecurity-and-green-lean-validation-strategies-0]