Avoid the pitfalls and realize powerful benefits
By Fred Greulich
The concept of 5S has emerged as the most critical Lean tool across virtually all industries, including life sciences, because it is arguably the foundation on which practically all other improvement tools and waste elimination initiatives rest. As organizations embark on the journey to “World Class” operations using Lean concepts and tools, management is confronted with the question as to where to begin. The answer is often 5S with its many benefits, including:
- Reduction of wasted motion and time spent looking for tools and materials
- Reduction of material and equipment selection errors
- Reduction of material and equipment inventory
- Improved workplace orderliness and cleanliness
- Improved workforce safety, productivity, and morale
- Improved preparedness for a regulatory audit
- An always ready showcase for customers/visitors
Plus, for contract manufacturers, the ability to demonstrate the use and results of 5S is many times a key differentiator when marketing their services.
In addition, 5S is a good place to start since it’s generally regarded as “the lowest Lean hurdle,” meaning that getting people to rally around 5S is relatively easy because its benefits — including identifying ”what’s in it” for the individual — are fairly obvious and uncontroversial. After all, if the workforce can’t embrace implementing a tool that will make their job easier, safer and less stressful, how will they ever rally around the implementation of Lean solutions down the road that are potentially more controversial and difficult to implement?
Also, the concept of “a place for everything and everything in its place,” which is the backbone of 5S, allows for ease in identification of waste and non-conformance when the workplace is not in proper order. This focus on the identification and elimination of waste is, after all, the most basic tenet of Lean and, while most life science companies clearly understand the need for and practice excellence in keeping the workplace “clean,” they are often very poor at keeping that same workplace “organized” and “orderly.”
Another often overlooked benefit is that 5S, particularly the “Standardize” and “Sustain” elements, compel the organization to apply the principle of standard work and a high degree of discipline to making 5S successful. One might observe that, in the highly regulated world of pharmaceuticals and biotechnology, development and execution of standard work in the form of SOP’s and batch records is already second nature. While this is true for processes directly related to product manufacturing, our experience says that it is far from true for most other business processes. While 5S certainly applies very well in manufacturing environments, it’s important to note that it applies equally well in other parts of the business, from Development to Regulatory Affairs to the many back office functions present in any life sciences enterprise.
So, with the wide-ranging applicability and all the benefits associated with 5S, why do so many organizations, including life sciences, have such difficulty with implementation and sustainment? The basics of 5S are not complicated or difficult to understand and the 5S elements themselves are pretty straightforward:
Sort – Clean up; eliminate what’s not needed
Set in Order – Organize; put things at the point of use, in the amount required
Shine – Clean the work area
Standardize – Establish work methods and schedules to maintain cleanliness/order
Sustain – Implement metrics, auditing, recognition systems
The landscape is covered with many examples of 3S (Sort, Set in Order, Shine), but few good examples where all of the 5S elements have taken root. These implementations basically amount to one-time clean-up campaigns that fall far short of achieving the benefits previously outlined. In these “3S implementations,” 5S is not viewed as a system that needs to evolve and be managed over time, which is the real trick to 5S success. Many of us can relate as we take on the routine garage- or attic-cleaning ritual. Clearly, by the mere fact that we perform this activity every spring, we are not changing our basic behaviors and habits, which is what’s required for 5S to truly take root.
While on this topic, let’s discuss some of the other pitfalls to avoid in designing and implementing a successful 5S system. These fall into four categories – Leadership and Governance, Scope Definition, Training and Resource Allocation, and Measurement and Follow Up.
Leadership and Governance
First of all, it is of paramount importance for leaders to communicate and constantly reinforce the connection of 5S with key business objectives. Viewing 5S as a “flavor of the month” initiative — with no firm, high priority connection to the overall direction and success of the business — will certainly lead to its failure.
Additionally, as with virtually all the elements of Lean implementation, 5S implementation success is predicated on active leadership and a solid governance model to ensure a foundation is set to support and nurture the system.
As mentioned earlier, 5S success is based on changing habits within the organization. Leadership must start by setting the proper example. If a desk or office is in a constant state of disorganization, paperwork or other items are misplaced, “in boxes” are overflowing, and so on, it’s difficult to credibly counsel others in the organization about the need to apply 5S.
Also, leadership must be willing and able to offer real-time and constructive feedback to the workforce, particularly during 5S implementation and in the time period immediately after, when the new behaviors will either take root or succumb to inertia and revert back to pre-5S behaviors. Meaningful and targeted feedback provided during the course of daily operations will go a long way to solidifying new behaviors and reinforcing the importance of 5S success in the eyes of leadership.
In our experience another key factor driving 5S success is ensuring someone, a “5S process owner,” is responsible for looking out for the ongoing health and evolution of the 5S system. This is not to be confused with being responsible for performing the daily work of keeping the area clean and organized, which is the responsibility of each and every employee; rather, the 5S process owner ensures the system is healthy and up to date. For example, ensuring that new employees are properly trained on 5S and that 5S standard work is kept up to date to reflect new equipment or processes in the area, that 5S audits are being completed and that auditors are being consistent. The role is much the same as that of an owner for any business process. Without this person, it’s easy for 5S, particularly in its early stages, to get off track and not get the care and feeding it needs to flourish.
Another frequent pitfall involves organizations attempting to implement 5S on a “stand alone” basis or in small “islands.” Although it may not be possible, because of resource availability and other priorities, to implement 5S all at once, there should be a time-based plan developed early on to implement 5S across as broad a footprint as possible. Too often we see organizations attempt to implement in only one area — for example, one biologics suite — and have no idea regarding if or when they would expand to the remaining suites, storerooms, labs, etc. This frequently leads to a key issue – expecting people to change habits and manage one way in the “5S area” while continuing to work with people and in areas that operate under the old, disorganized framework.
In order to have any reasonable chance of long-term success, the conversion to the 5S system must be “complete” and performed within a reasonably quick timeframe. The idea here is to expeditiously move the organization to adopt 5S over as large a footprint as possible, both in terms of geography as well as people involved. The quicker and more broadly the “new” 5S model is rolled out, the better the chances that it will become the new standard and the “old” behaviors will have less of a chance of re-emerging. The overarching concept is to, as quickly as possible, get a critical mass of areas and people operating under the 5S model to send the message that the organization is serious about making change and to help fend off the inertia of the organization reverting to “old” behaviors.
Another pitfall of 5S implementations is not addressing related business processes. For example, in a recent biologics suite 5S implementation, a specific area was established to perform the filter testing process and a portable cart was designed on which to perform the valve building process. Previous to the 5S implementation, these two processes were very frustrating and time consuming, since employees were continuously walking around looking for tools, materials, and parts. While these changes were appropriate and had the potential to reduce the cycle times for these two processes significantly, a process wasn’t implemented to ensure that the new point-of-use work stations were always stocked with the required items in the amounts needed. Initially, the development of re-stocking processes was missed, putting key elements of the 5S implementation at significant risk.
Finally, many organizations fail — or at very least make the 5S rollout difficult — by not choosing the right area and population with which to begin. Organizations should begin in an area where the benefits and results will be both significant and very visible to the overall company. In life science organizations, this typically points to manufacturing areas and not, for example, the second floor management conference room! Also, it’s important to begin the 5S rollout in an area where there’s a leader who is a credible advocate for the process. Having someone championing the effort early on who garners the respect of others and has practical knowledge regarding 5S will go a long way toward ensuring success.
Training and Resource Allocation
5S implementation failure in this category often stems from inadequate training at the onset. Since, as we discussed earlier, organizations frequently fall into the trap of implementing “3S,” it is important to ensure employees are well educated about not only the mechanics of performing all 5S elements, but also about 5S being a process to be nurtured and improved over time. It’s very easy to be lulled into thinking 5S is so simple that very little education is required and, as a result, the urge takes over for employees to jump right in and start “cleaning up.”
The other pitfall that frequently occurs in this category is not having Resources available, either real time or very quickly thereafter, to help make the physical changes identified during a 5S implementation. In a regulated environment it is often not possible to rearrange equipment, modify storage of process parts, etc. on a realtime basis because of the impact on certified processes.
However, much of the “Sort” and “Set in Order” work of 5S often involves items that don’t need to be managed this way, for example the labeling and storage locations for gloves, SOP manuals, ladders, and the like. One biotechnology organization we recently worked with utilized personnel on the back-shifts to make many of the physical changes, since there was more resource availability and less activity during these shifts. Having resources available to make changes as the team goes through the 5S process keeps energy and momentum alive, eliminates a long list of next step items to manage, and reinforces the “go do” mandate of Lean. This also sends a message to the organization that this isn’t “business as usual” and we won’t unnecessarily wait days or weeks for change to occur.
Additionally, there will likely be many areas that need to have 5S implemented in a life sciences organization that aren’t part of manufacturing process areas, e.g. storage areas, maintenance/facilities shops, office areas. In these areas where regulatory compliance issues aren’t a concern, making physical changes as real time as possible should be a key goal.
Measurement and Follow-Up
Finally, 5S implementations often succumb to the failure to develop a closed loop system to manage the fifth, and arguably most critical, “S” – Sustain. Not instituting a robust measurement system coupled with a “system of consequence” for the workforce is often the downfall of 5S implementations. Instituting an audit process is a key tool to not only measure but also manage 5S performance and the continuous improvement process. In the life sciences industry audits are not unusual and, therefore, instituting a 5S audit process is typically not very difficult.
But an audit process alone is not enough. Often missing is a system that does something with the 5S audit results. After all, who cares if his 5S area gets a 50-point score out of 100 or a 99 point score, if there is not a negative consequence for the former and a rewarding consequence for the latter? For example, a company we recently worked with had in place a process by which they paid monthly bonuses to operating employees based on the performance of a small set of metrics over which the employees themselves had direct control. A quantitative target for 5S audit performance was established and integrated into this bonus process, cementing the importance of 5S within the organization along with providing a very visible “system of consequence” for performance. By doing this, sustainment of 5S has not been a significant issue in this organization.
In this article we have discussed a number of the key pitfalls that prevent life science organizations from having success in implementing 5S and enjoying the multitude of attendant benefits. When these pitfalls are viewed as a group, an observation can be made that those organizations that manage 5S implementation as they would the implementation of other key business processes, have the greatest success. Elements of active leadership, training, measurement, and performance management all need to come together to form an integrated system.
Conversely, those organizations that don’t make such a commitment frequently fail. If your organization embarks on a series of clean up campaigns or “3S” implementations, recognize them for what they are, and be prepared to do them over again next spring!