The Lean Qualification and Validation (LQV) Workstream group was graciously hosted at the GlaxoSmithKline headquarters in Brentford, UK this past March to kick-off the team’s first face-2-face after several months of long-distance conference calling. The team has been commissioned to identify ways to reduce waste in the qualification and validation of new equipment and facilities.

To help get the team on its feet and baseline the industry, a survey of 23 questions was answered by 11 of the 16 sponsoring companies participating in the workstream. The survey sought to help frame up the team’s perspectives around:

• Where is the industry regarding its journey to becoming more risked-based?
• What approach are company’s currently taking regarding risk-based QV?
• Is there a significant driver necessitating a move to a more risked-based approach?

The LQV group reviewed the responses and began to come to an understanding of where the industry sits today based on those who responded. Overall, more than 90 per cent of companies surveyed are currently using or are well on their way to adopting risk-based approaches.

But what does “using” or “adopting” mean? This is where the differences in approach begins to emerge. The survey found that by “using” or “adopting” a risked-based approach, companies are actively incorporating risked-based qualification and validation approaches along a broad spectrum with influence by guidelines and standards such as ICH, ISPE, and ASTM e2500 to various degrees.

So, is there a problem with how companies are doing it now? Should the industry make a move towards a riskier approach? The survey provided some light on these questions. Based on the survey results it was abundantly clear that reducing compliance risk and QV cost are not going to be sufficient motivators for the industry as companies are generally satisfied with their current approach. Approximately 80 per cent of the companies indicated that QV activities do not comprise more than 20 per cent of a project’s budget and very few regulatory findings or company risks were identified involving their current practices.

With this said, the survey helped spark and direct the team’s brainstorming to truly identify what companies are feeling when it comes to efficiency in qualification and validation of equipment and facilities. However satisfied companies may be, all companies which responded indicated that change to their QV strategies are being considered or implemented. But why change? Based on our survey’s question around current QV pain points, companies responded with examples that demonstrated over-production, over-processing, waiting, rework, and a myriad of other signature wastes in lean manufacturing. As a manufacturing industry, we all recognize there is room to improve.

Is there a less wasteful method for QV that can be accomplished without jeopardizing the high marks of the current compliance strategy? How will this improved method get implemented across the industry? When will this improved method get implemented?Can we implement something for existing facilities? All questions the team plans to tackle. Enter the SIPOC…

As the team is only beginning to face the task at hand we are excited to see what a group of the brightest minds from the world’s leading companies in medicine manufacturing paired can cook up.

Written by Drew Graves, Catalent