8 Keys To Successfully Implementing A Pharmaceutical Process Improvement
By Michael Esposito, TrainReach Consulting, LLC
Imagine you've just spent the last several days with colleagues developing a map to revise a problematic or inefficient process in your business. For the purposes of this discussion, let's say it’s a pharmaceutical supply chain improvement, and you are in charge of scheduling production for several products that are in high demand and are critical to the company's continued success.
The existing process involves way too many handoffs from the time an order is placed for existing products to the time that the products reach the warehouse and are ready for distribution. Upper management is concerned about potential backorders, and your team wants to reduce cycle time while retaining an acceptable level of quality. You have access to Six Sigma Black Belts, the IT department, a cross-section of high-level decision makers in each of the key areas of the process, contractors and consultants who are brought in to address specific issues, and energetic project managers who are good motivators and are committed to the success of the whole endeavor. The overarching goal is to make the entire organization more agile.
Now, it’s time to implement your process improvement. Simple, right? Wrong! There are many ways in which proposed improvements can bog down, but there are also ways to counteract these negative forces and move forward with your improvement. In this article, I'll describe the most common obstacles to implementing a process improvement and share practical steps on how to overcome them.
Process Implementation Pitfalls
I have participated in many process excellence activities over the span of my career in pharma — which has encompassed brand-name drugs, generics, biologicals, OTC medications, and devices — covering the entire spectrum of drug development, manufacturing, and distribution. If there was a common denominator among these activities, it was that mapped processes were rarely implemented in the way they were originally laid out.
This led to ample grumbling among my colleagues, who had one more reason to be cynical about the promises that were made at the beginning of the process mapping exercise. In general, these complaints were not motivated by the jockeying for position characteristic of cross-functional projects. Instead, they represented the frustrations of sincerely committed participants who had invested a lot of time and energy in attempting to improve the process.
One legitimate reason why a process that looked good on paper ultimately fails to meet expectations is that it encounters unforeseen complications — there are too many steps involved, other data needs to be gathered, a necessary signatory was overlooked, an unanticipated issue surfaces after the process mapping is completed. These difficulties naturally multiply when the change affects multiple individuals and departments in the company, which in turn has an effect on outside vendors and contract manufacturers or packagers that interact with the company.
Often, it turns out that insufficient resources were allocated for the critical post-implementation period, which means users have to lean hard on already-overworked subject matter expert colleagues. Life goes on and product will still be made, but you know from "water-cooler conversations" that there is discontent in the ranks.
In other cases — such as in the OTC or generic world — the pace of work makes the ideal process impractical, because it would take too long given the amount of decision-making time you and your colleagues possess. This is often the reason why elaborately designed processes, developed with all the right tools and facilitated by expensive outside consultants, fall short of the mark.
Conversely, in pharma or biologicals, there is a tendency toward inertia, due to longer lead times. (I have attended more than one long meeting that dealt with the addition or deletion of only a few words from a physicians' insert).
Finally, employees’ workload, or a cumbersome approval process involving several layers of management, can get in the way of any meaningful process improvement.
Best Practices For Implementing Process Improvements
How do you overcome all the pitfalls to process improvement? Here are some suggestions that you can apply quickly to keep implementation on track.
1. Don’t go too high up the chain.
Ideally, you want to keep the level of management involved low enough in the organization to reduce the approval time, but high enough so the process improvement will actually stick. Though job titles vary from company to company, turnaround time can increase when you go above the director level, in particular a senior director or VP of a given department or division within the company. Keep in mind that upper management schedules are subject to lengthy business trips and emergencies of many types. If upper management involvement is inevitable, make their part of the process as simple as possible and easy to execute when they are away from your site.
2. Expect (and plan for) problems.
Think through the potential issues that can occur, for example when computer software does not perform at a critical time. I recall an instance when the document management system that contained all the company’s SOPs and change controls was unavailable for three days (an eternity), which required acrobatics from the document control department to make hard copies available. You have to paint a visual picture for colleagues of what potentially can go wrong, especially since some of them may be attached to an idea that adds complexity to the process. Your negotiation skills may be tested, but the rewards will be substantial.
3. Limit your scope.
If the process is very large and spans multiple departments, determine how much of the process is within your control, or the control of a small group with whom you interact frequently and have a good working relationship. You may not be able to influence the entire process, but if you can get your colleagues to agree to an improvement in your immediate area, you and they can reduce steps and keep projects moving. If you are responsible for a later part of the process that routinely gets shortened because earlier task are not finished on time, you will need any cycle time reductions you can get.
4. Observe and solicit input.
You also have to test your process by first conducting at least one dry run before implementation, and then observing it as it's actually happening after implementation, perhaps more than once. You will need to check in with stakeholders at various points during both of these tests, and collect feedback on the process, with the purpose of tweaking it as necessary and keep the improvements going.
5. Communicate progress and results.
Post-implementation, you will need to share information on successes and challenges to those directly affected by the changes. As implementation proceeds, be prepared to demonstrate how the process has actually improved, either by metrics or testimonials, to build support and momentum.
If you have a communications team that can do these tasks for you, you are fortunate. If the responsibility falls on your process improvement team, select an individual — or ideally two — with sufficient bandwidth to document and communicate the progress at least weekly, provided that there are changes that the group needs to know about.
6. Keep written updates succinct.
My colleagues were bombarded with media communications and thoroughly jaded about on their overuse. Two types of communication that warrant special caution are emails and documents on SharePoint sites.
If you have to use emails, keep them short and to the point. There is a level of detail that is appropriate for your audience, and a certain amount of trial and error is inevitable to achieve a suitable balance between too little and too much.
SharePoint sites can crash when too many documents are uploaded. And even when they are operational, finding documents among their many folders and subfolders can be a challenge, which can lead to their contents being ignored. Often it is the intern or recent college graduate among your ranks who is the expert in organizing SharePoint sites and making them intuitive.
7. Avoid long meetings.
Meetings and conference calls take time away from day-to-day responsibilities and make schedules even more difficult to manage. You know as well as I do that a great deal of “meeting” time is spent waiting for people to join, engaging in casual conversation or sidebars, and managing distractions from smart phones and laptops.
Make your meetings short and productive with as few participants as possible. When the number of attendees surpasses an optimal amount, the quality of participation decreases, depending on the tasks involved. Four to six attendees is a good rule of thumb for a working meeting. (For more on this topic, check out the excellent article Is Your Team Too Big? Too Small? What's the Right Number?) Make sure that others who are not directly involved at least know your progress and can ask questions.
8. Be selective about what to include in an SOP.
A word of caution: Be careful how much of your process improvement you decide to capture in an SOP. Sometimes what is considered a best practice gets inserted into the SOP, which then obligates all users to follow that step in that particular way, without deviation or exception. When an SOP is too restrictive, deviations will inevitably surface, and with them investigations, CAPAs, and potential 483s.
Other documents can be used to capture activities that do not carry a compliance requirement. Limit your SOP changes to those that are absolutely necessary for clarity and consistent execution of critical steps. Capture additional details in a lower-level document, such as a work instruction, job aid, or user manual.
It Starts With You
Agile methodology isn’t limited to organizations or teams. Individuals within an organization can also be agile — even in a complex pharma environment — and acquire a reputation for getting things done effectively. You also may be able to ease your colleagues' angst about change in general and make it easier for them to adjust, which will in turn help you develop successful long-term working relationships. Build up a number of these wins, and company stakeholders will feel the relief of an improved process, earning you their gratitude.
About The Author
Michael Esposito has 30 years’ experience in the pharmaceutical industry and 13 years’ experience in GMP training and document management. He has worked for Wyeth Pharmaceuticals, Pfizer, and Johnson & Johnson's McNeil Consumer Healthcare Division in a variety of areas, including packaging, project administration, quality assurance, government contracts, translations, systems training, and international operations. He collaborated on the development and implementation of the training portion of the consent decree work plan for McNeil and revised their introductory GMP course. Michael is a member of the training organization GMP TEA and is fully fluent in Spanish. His areas of interest include systems training, training effectiveness, post-training user support, process improvement, and sustainable packaging. You can reach him at meesposito@gmail.com.