Applying Operational Excellence Concepts to Biopharmaceutical Processing - Translate the concepts into practical application and reduce waste. - BioPharm International


Applying Operational Excellence Concepts to Biopharmaceutical Processing
Translate the concepts into practical application and reduce waste.

BioPharm International
Volume 21, Issue 11

"Trading Up" to Reduce Staff Underutilization

Table 2
One of the biggest wastes identified in Lean is staff underutilization relative to their qualifications.10 One approach is to eliminate or streamline unnecessary or lower-value tasks (e.g., inefficient meetings, overly restrictive policies, unneeded reports, multilevel approval steps, repeated information requests). Tasks that support key objectives and portfolio elements are prioritized; others are deferred or stopped. Unavoidable low impact tasks are reassigned: Technicians rather than engineers can assemble equipment, approvals can be delegated to lower level but knowledgeable staff, and routine assays can be outsourced or transferred to appropriately skilled analysts. Once this work is removed, the freed staff "trade up": they take on more appropriate skill level work from peers or superiors.

The Right Amount of Automation

Automation also avoids having highly skilled staff perform mundane tasks10 (although it requires highly skilled staff to maintain the automation system itself). Before using automation to reduce workload, however, non-value added activities in the workflow should be eliminated.17 Automating non-Lean processes makes inefficiencies harder to eliminate. Identifying the right amount of automation is important: Too much automation increases costs and reduces reliability; too little reduces potential efficiency gains.18


5S encompasses an approach to sort (eliminate unused items), set in order (arrange items based on how and where they are used), shine (clean and catch up on maintenance), standardize (keep the area organized using visual indicators such as labels), and sustain (monitor and maintain). It is a structured, low cost method that empowers first line (bench) staff to "cLean" (i.e., clean and make Lean) and organize work areas to eliminate unproductive actions.19 One key concept is point-of-use storage (POUS) for consumables (e.g., storing supplies near the associated equipment).17 Movement and return of shared equipment after use and co-location of equipment for related processing activities also are addressed. Applications range from organizing supplies and raw materials for improved accessibility to improving the searchability of documents and data.

Co-location/Cellular Manufacturing

Another opportunity for process improvement is at the interfaces of groups or group members, particularly where in-process work is handed off.20 When linked processes are placed close together, either physically or managerially, efficiencies are gained. In fact, often improvement can be realized by simply paying more attention to a workgroup. This is known as the "Hawthorne effect" in which productivity increases independently of any imposed changes—its principal cause being the attention given to the workgroup.21

A production cell is the arrangement of equipment (and/or dedication of personnel) such that progressive processing occurs without waiting or additional handling. In one example, a co-located crossfunctional integrated team9 was created for a vaccine project; initially, 80% of personnel were about 20% dedicated; afterwards, personnel were 100% dedicated, speeding up meetings and decision-making.22 In another case, process development and manufacturing groups were co-located to foster collaboration and increase synergies.23,24 In another example, a quality assurance person was co-located at a plant to permit batch record review directly after batch completion, reducing the mean number of atypicals from 42 to 19 almost immediately.25 Others realized a substantial reduction in days required for analytical release testing by eliminating hand-offs and redundant work, as well as synchronizing steps.9

Table 1 lists many potential additional applications of operational excellence concepts to biopharmaceutical processing, demonstrating that there are many opportunities to recast current thinking within the industry to achieve efficiencies.

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