An Emerson fellow blogger, Alan Babbitt, and his Emerson Global Life Sciences Blog was first to the scene to cover a great Bioprocess International article, Hurry Up and Wait? The article, by Emerson senior Life Sciences industry consultant, Michalle Adkins, describes the problems manual processes have on product cycle times for highly regulated process manufacturers. For these manufacturers, particularly those in the biotech and pharmaceutical industries, the documentation collected with the manufacturing of a product is as important as the product itself. The product can’t be released for sale until the documentation is complete.
Michalle highlights the goal for these regulated manufacturers:
The ultimate goal is to produce both the product and its accompanying documentation correctly the first time, and to do so minutes after the drug or biologic is manufactured. We realistically understand that attaining this ultimate goal is a stretch. But ways and means are available that have repeatedly demonstrated how possible it is to move companies closer to achieving “right-the-first-time” every time (RTFT-ET).
Of course, many, many things stand in the way of achieving RTFT. Michalle enumerates several such as missing/illegible data, missing/illegible signatures, transposed numbers, and incorrect equipment logbook entries. Manual processes are fraught with opportunities for errors and mistakes to occur. They also can cause cycle time slowdowns with issues such as incorrectly located materials, incorrect inventory levels, procedure steps accidently skipped, incorrect manual additions to batch, etc.
Michalle cites a Mark Puich article on what’s required to close these gaps in operational performance–engaging company leadership, assembling capabilities, working together, and leveraging vendors. Internal squabbles can be significantly reduced, and organizational focus and funding are possible with engaged leaders. Given the de-staffing trend that has occurred over the last many years, assembling capabilities requires an extended team with industry experts and vendor teams. Beyond the obvious meaning of working together are opportunities to unify efforts across the industry with regard to regulatory policies and standards. Vendors can help with available technologies and standards.
A good process to follow suggests Michalle is Lean Six Sigma (LSS). She describes it:
…an adaptation of traditional six sigma’s DMAIC methodology combined with efficiency-improvement methods popularized by lean manufacturing. Among the associated tools an experienced LSS consultant will apply are kaizen, failure mode and effects analysis (FMEA), value-stream mapping (VSM), collaborative diagrams, design of experiments (DoE), business process mapping, quality systems, fishbone diagrams, and quality function deployment, among others.
Just like what was advocated in a recent greenhouse gas emissions post, Michalle recommends you begin with the “low-hanging fruit” and find the easiest, fastest projects to tackle to improve cycle times. The goals of these projects should be expressed in financial return:
…such as increasing profitability by 5%, exceeding 10% ROIC [return on invested capital], increasing RTFT from 95% to 99.99% while improving customer satisfaction.
Michalle describe an experience-based, hypothetical example following the DMAIC methodology to uncover and prioritize the opportunities. Often less obvious sources of operational improvements are uncovered such as inventory cushioning to address long cycle times. Comparing this analysis to available industry benchmarks focuses the improvement opportunities. Executing some of the low-hanging fruit projects helps build organizational momentum for the harder but higher return opportunities.
Michalle summarizes her thoughts:
Smart executives understand that it is really about breaking away from the daily skirmishes that cause a company to “hurry up and wait.” Applying LSS is one of the best ways to achieve that.
I encourage you to read this article if your organization’s cycle times and operational efficiency need improvement.