Welcome and thank you for joining part 2 of our webinar on assessing a team’s workload and building a sustainable schedule under EU MDR, presented by GLOBAL Regulatory Writing and Consulting.
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So in the previous discussion, Luke went through some very careful considerations for planning and assessing your team’s workload. These are important critical steps to take to set your team up for success, but most if not all of us have put together a perfect plan only for some unforeseen variable to pop up and mess up our plan. Events such as delayed or escalated CERs, notified body responses, audits, or device acquisitions can mess up your scheduled workload. Similarly, team member capacity can change with time away for PTO, medical or family leave, or even have employees leave for a new position. While we can’t predict the future, we can set ourselves up for success knowing these disruptions can and will happen so we can take some steps to prepare ourselves and our team accordingly. Today we will go through some strategies for reacting to disruptions as well as some strategies for proactively accounting for disruptions.
In the following slides, we will go through an example of how we might need to adjust our schedule as a reaction to a new task. So at this stage, we followed all the steps that Luke covered in webinar one - I highly recommend you go check it out if you haven’t already. So let’s say we follow Luke’s guidance and put together an initial schedule based on our portfolio devices and associated projects. We have also taken into account writer capacity. So in putting together our schedule, we are estimating that each of our four writers should spend about 80% of their time on their writing work. So each month, each of our writers should spend about 130 hours on writing work.
So here is an example layout for our team members and their workload. In this view, we are using color to track the type of project and the number of hours that each writer is expected to dedicate to a given project each month is delineated in each cell. Your scheduling tool will likely include other information, such as the project name, but since we are just focusing on the overall workload for this exercise, we are not going to worry about project names for this part of the discussion. So in this example, we are looking for project schedule and time distribution for the first 6 months of 29025. We have a rough estimate of how many hours we expect each type of project to take, and we have also included some PTO that our team members have planned in advance. We distributed the work so each writer has about 130 hours of writing work assigned to them each month. So as written, the schedule works pretty well. Each of our team members has an appropriate amount of work - they are not going to be overwhelmed but they also won't be bored. There is not a ton of wiggle room, but the schedule should accommodate most small variables. If a team member has to take a few days off for vacation or illness, that time can be absorbed. Smaller projects, for example a Notified Body Response with only 1 or 2 questions for a writer, could also be absorbed. But let’s explore what happens if there are larger schedule disruptions.
So let’s say that in early February, you get questions from a Notified Body and they are pretty involved questions, maybe more than what you might typically see. So you are estimating that this will take about 75 hours, or close to 2 weeks of work for one of your writers. Now let’s say that your team policy is that the author of these documents should author the response. So in this example, let’s say that Sam was the author for this response. Clearly Sam doesn’t have an extra 75 hours in his schedule to absorb this extra work without going into overtime, and since your team’s policy is to avoid overtime at all costs, we need to get creative. There are a few things we can do here depending on our team members and the projects that they have scheduled. So one option that we have is for Sam, we can pause on some of his other projects, extend his deadlines, and reduce his non writing time. In this example, Sam is going to prioritize completing his writing assignments, including that new notified body response. This change to his schedule means that in February, March, April, and May he will dedicate a higher percentage of his time to writing work. In some cases, it will be close to 100% of his time spent on writing work in order to meet deadlines and absorb that extra 75 hours. This is probably going to put a little extra strain on Sam for a few months, but it is temporary and it does avoid disruptions to the rest of the team. Support for some of his non-writing tasks might also be needed because Sam’s not going to have time for meetings or other administrative tasks if we are adjusting the schedule this way.
Another option we might have would be to redistribute some work across the team. This will temporarily reduce non-writing time for multiple team members, but distribute the work a little more evenly. So in this case, we are going to have Sam give out assignments from his ongoing project so that the project continues while he dedicates some of that time to the Notified Body Response. This will result in a busier February for the rest of the team, and it might require that non-writing work across the team is paused, but the time spent on the extra work is limited only to February and shared evenly across the team.
Option three is probably the easiest in terms of scheduling and resourcing but might be the most complicated in terms of logistics, and that is to enlist temporary support for overflow work. So in this case, we are going to pull in Christian. Christian is a 1099 that our department has used before, we know he does good work, and he’s very familiar with our projects. So here we show the schedule assuming that Christian is going to take some overflow work from Sam so that Sam doesn’t have to do overtime. We could of course have Christian take on more hours so that Sam can have time for non-writing tasks, or Christian could take on fewer hours if say one of our other writers had some extra capacity to take on some overflow work from Sam as well.
So those are three possible solutions for our relatively easy situation. We went into this scenario with some advantages – we had a schedule that followed Luke’s guidance, and we knew that our writers probably weren’t going to be at 100% capacity at all times, so our schedule had some wiggle room. We also had a Notified Body Response that was pretty big at 75 hours, but 75 hours is not a huge number of hours to absorb. There certainly could be other disruptions that require more hours, more effort, over longer periods of time. We also had multiple writers on our team who could take on some extra work, and in this example we had an external contractor who was able to take on work immediately. However there are a lot of other things that can happen to require you to adjust your resourcing plan.
On the screen here we see a list of some of the more common disruptions that we see to our clients’ schedules. So this certainly isn’t an exhaustive list, but it also demonstrates the broad range of time and hours needed to accommodate these disruptions. So while we can’t also predict the future, we can implement some strategies early on like building a schedule that can lessen the burden on our writing team and help us avoid major problems if and when these disruptions occur.
So we can’t 100% crises proof our schedules, but we can take some measures that set ourselves up for success. One of the first things we can do is determine what risks do we face to our schedule. Similar to the exercise we did on the previous slide, we want to think about what can happen and also how likely it is that any given disruption will happen. Maybe it is likely that your team will have a lot of Notified Body Responses, but it is unlikely there is going to be a surprise acquisition this year. Next, let’s consider what is important for our company culture and priorities. For example, is our management open to hiring additional writers if needed? Is the team expected and comfortable with putting in over time? Once we’ve identified areas of flexibility, we can identify some strategies and then determine which strategies or combination of strategies make the most sense for our team in preparing for disruptions.
One option that might be available to us to set up our schedule for success is to plan to start projects earlier than necessary, and frontload as much work as possible. So instead of the situation where you have a writer like Daniela, with projects that are back to back to back, you have her start some of her projects early. So instead of giving ourselves two months to do a 250 hour project, we can start this project a few weeks early and work ahead of schedule. That way, if we need to pause on a project to tackle an urgent surprise task, our original project deadlines aren’t really at risk. This also could have the added bonus of some increased efficiency if you have ongoing projects. So if one writer has multiple projects going on in this case here, they will always have tasks they can do to keep projects moving forward. So let’s say then project one, Danila is waiting for some input from a stakeholder. She has plenty of work for project 2 that she can work on. And that way, if a surprise happens in say March or April, she is already ahead of schedule on project two. So again the benefits for this approach are that it allows all the writers have flexibility to absorb unexpected work, it protects projects against missed deadlines, and it allows writers to continue to work independently.
One potential downside of this strategy is it leaves the projects overlapping if your writers are starting every project early, and each writer is only working part-time on any given project. It can also make the project management a bit more cumbersome, and if you are expecting a lot of schedule disruptions maybe this is ok and something that your team can absorb, but it might not be worth the extra effort if the likelihood of a disruption is low. Ultimately this strategy is a great option to consider if you have a team of strong and independent writers who all face a reasonably high likelihood of disruptions throughout the year.
A second option that can help your team adjust to schedule changes is to unevenly distribute the workload and assign less official work to one or more writers. In this strategy, one of our writers is purposefully assigned fewer official projects than your other team members. Instead of a situation like this where you have everyone assigned projects evenly at the beginning of the year, so say everyone has three projects that they are covering in the first two quarters, and then when emergency projects pop up they go to your strongest writer, so in this case Daneila, where she has not only her regular workload but some emergency projects. So instead of a situation like this, let’s say that we set up our schedule to account for those high likelihood emergency projects and instead of having Daneila take on the same number of projects as the rest of her coworkers, she is officially assigned fewer projects but spends her free time supporting her teammates - either Chelsea or Patrick - when she doesn’t have emergency projects, and when those emergency projects pop up she is able to pause on her support work, take on those emergency projects, and the entire team is carrying the load a lot more evenly. So some of the benefits to this approach is that it limits disruptions to the entire team. In that example, Chelsea and Patrick knew that they were responsible for these projects and that Daniela would support them as needed. When Daniela has to pause to prepare for that, and Daniela doesn’t have to troubleshoot how to resource her projects correctly when she is able to focus just on the emergency projects. It provides ongoing support and backup for scheduled projects, so in the even that your designated less work writer has projects that aren’t assigned to them, they are able to support and provide backup for other projects. So if someone needs to take time away, or work on something else, they have a designated backup for those projects.
This approach can also act as training support for less experienced writers. So in these cases, if Daniela is our most experienced writer that is going to take on all those emergency projects, her providing support to both Chelsea and Patrick can be a great learning opportunity particularly if Chelsea and Patrick are newer and less experienced writers. Some of the risks involved with it is that it requires you to have a Daniela on your team – you have to have a strong experienced writer that can take on any project and provide any support needed. This approach doesn’t work if you leave one of your least experienced writers available for emergency projects; it has to be someone who is capable of taking on anything that might happen.
It also requires a culture of agility and strong communication project management. You have to have a team that works closely together and ready to be flexible and move tasks around as needed. So ultimately this may not be a perfect situation for every team, but it is great for a team that has great collaboration that is likely to experience high volume and more frequent disruptions.
The third strategy that we will discuss today is a pretty simple one, and that is to reach out for help. If you have reliable help that you can call on for support in times of need, you can avoid a lot of the resourcing challenges that we covered in this presentation. When you have support from outside your department, you can keep a consistent workload for your team without committing to additional full-time team members. So instead of a situation like this, where again we have Daniela with a bunch of projects back-to-back as well as some emergency projects, we can pull in Christain – our 1099 friend from earlier – and have him support on those projects so that none of our team members are overloaded. Some of the benefits of this is it allows your team to keep a consistent and predictable schedule, you are not asking people to go into overtime, and you are not asking them to juggle a bunch of projects all at once, it safeguards against overwork and burnout which is really important if you have a team of strong writers that you want to keep on your team. It also allows you to adjust the type and amount of support based on need. Maybe you don’t need help for the month of February but in March you could really use another person. With contractor support or members of another department that are cross-trained, you can call for help when you need it but only when you need it.
Some of the downsides to this approach is that it requires coordination in advance. So for example, if you are going to be training team members from other departments or identifying and contracting with other contractors, you need to make sure those people are prepared and ready when you need them. You don’t want to start cross-training only when your department is overloaded. It also might require approval from the executive team, and require designated budget, so making sure you have those conversations early can make sure you have that support lined up for when your team needs it most. So ultimately, having additional contractor support is perfect for a team with large amounts of extra work at unpredictable times, and/or if you need supplemental staffing.
So throughout this webinar series, we have established that having a solid plan at the beginning of the year or quarter is essential. This plan should take into account your team's strengths and workload capacity, your device and project portfolio, and the likelihood and type of disruptions. You should design this plan with strategies in place for surprise changes to the workload or team capacity. Finally, many solutions to scheduling challenges require investing time and planning before the problems arise. Lay the groundwork so that your team has backup by beginning cross-training or contracting efforts early.
Thank you so much for joining us in part 2 of this webinar series! We sincerely hope you will join us for part three. Along the way, please don’t hesitate to reach out if your team could benefit from our resourcing analysis and plan. Please contact us at info@globalrwc.com. Thank you.
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