Organizations need to address operational inefficiency; otherwise, they risk lower productivity, lost revenue, and even falling out of compliance with GxP and ISO standards. To solve those challenges and scale changes across complex workflows without missing a beat, companies need an effective process improvement plan.
The Harvard Business Review estimates that as much as $3 trillion is lost in U.S. economic output every year due to “excess bureaucracy”—the rigid, resource-consuming machine that chews up productive processes and spits out inferior versions that are inefficient and log-jammed. This macro trend has a tangible impact on individual organizations, too. According to Michael Mankins, a partner at the leadership consulting firm Bain & Company, the average company loses 25% of its productive power to organizational drag.
The solution is to focus on driving value and quality rather than just compliance and oversight. Quality managers should implement a goal-oriented process improvement plan to replace organizational drag and dysfunction with effective, value-based processes.
Pinpoint a Process That Needs Improvement
No organization has the time or the resources to fix every broken or inefficient process at once. Instead of trying to do it all, start with one area that needs attention and will net tangible results once improved.
Identify a process that leadership or customers see as an issue. This way, you can be sure the process improvement plan aligns with business priorities.
Identify a process that leadership or customers see as an issue. This way, you can be sure the process improvement plan aligns with business priorities, and you’re more likely to receive buy-in from company leadership. Otherwise, conflicting priorities might compete for your colleagues’ attention and get in the way of progress.
Analyze Current Outcomes and Set New Process Goals
You need to understand what’s currently working—and what isn’t—in order to solve inefficiencies and create better outcomes with your process improvement plan. Take the time to analyze the outcomes of the current process, and use what you learn to set process improvement goals for your plan.
Map out the current process from start to finish so you can understand the process flow. If the outcomes aren’t what you expect or need from a quality standpoint, going through each step will help you figure out where things are going wrong.
If you have an eQMS in place, it can provide insight into where an existing process is failing or causing issues. Software like ZenQMS’s Issues Module provides you with root cause analyses and effectiveness checks and allows you to create dashboards that measure process throughput and activity. You can quantify the issue with detailed data and tie your new process goals to something measurable.
Map out the current process from start to finish so you can understand the process flow.
Your process improvement method of choice will also come into play here, determining which tools you use to map out your existing procedures. For example, if you’re using the Lean methodology to improve a production process, you might use a value stream map to identify non-value-added process steps so you know what to remove.
Once you’ve analyzed and identified common issues, set tangible goals so you can craft a process improvement plan that achieves them. Goals also give you something to measure your progress against. For example, if current manufacturing process issues are lowering the first pass yield, the goal for your CAPA (corrective and preventive action) process could be to reach a first pass yield of 99%.
Redesign Your Process to Achieve Improvement Goals
With a measurable goal in mind, you can design a process that improves quality and leads to tangible business results. In this stage of your process improvement plan, you’ll create a new step-by-step approach based on what you learned during your analysis and mapping. Build on what’s working and eliminate what isn’t, introducing new steps where needed to achieve the highest quality outcomes.
Start by brainstorming solutions and potential fixes to the bottlenecks you’ve identified. Some of your ideas will likely come with their own challenges and risks; be proactive and anticipate how they might impact the overall process.
Assess what’s needed to put your process improvement plan into action and have a clear plan for leveraging those resources.
Depending on your process improvement method, your redesign might differ. Using Lean as an example, the goal is to cut down on process steps and materials that don’t add value. Your redesign should lead to a shorter, more streamlined process.
Redesigning your process might also mean resequencing tasks or steps to improve efficiency. For example: if one step (such as approvals or document signatures) is creating a backlog, move that step to earlier in the process, so there’s more time to complete it and see which tasks can be completed concurrently. If meeting quality standards is an identified issue, consider adding steps for checking or verifying compliance.
Assign a project owner and project managers as needed to round out this phase. These are the folks who will be responsible for implementing your new process. Assess what’s needed to put your process improvement plan into action and have a clear plan for leveraging those resources.
Implement Your Process Improvement Plan
Once your team agrees on a process improvement plan, it’s time to implement it. Establish an effective implementation plan to improve your new process’ results and to encourage staff to adhere to it.
The ZenQMS Document Module is a great tool for sharing and training documentation about the new process.
First, create a timeline and deadlines within your plan for your staff to stay on track with implementation. Your timeline should also include a period for assessing results, whether it’s a weekly assessment or every quarter. The check-in points will largely depend on how long it takes to implement the changes in full, as well as how long it’ll take to see and measure results.
Communicate the process improvement process with everyone on the team. The ZenQMS Document Module is a great tool for sharing documentation about the new process, as well as collaborating in real-time on questions or feedback.
If the new process will affect system integrations, automation, or anything similar, it’s critical you handle that smoothly during implementation. You can also leverage software like the ZenQMS Change Control Module to re-configure forms and stages to match the new process of record. Give your team members the ability to flag issues or setbacks and automatically assign tasks to address them.
Monitor and Optimize for Continuous Improvement
Your work isn’t over once the new process is officially launched, or even once you start seeing positive results. Keep monitoring for bottlenecks, inefficiencies, waste, and opportunities for improvement to stay efficient over time.
As you move forward with the new process, collect feedback from your team and leverage insights from your eQMS or other tools to see where you can continue to optimize. Measure your results against your goals and make adjustments where needed to continue improving.
Invest in a solution that helps you measure progress and achieve quality systems, not just process compliance.
Even if you set and reach a goal of “achieving 100% GxP compliance,” there’s always room to improve on quality. You might find a way to maintain the same level of compliance with a more streamlined process, for instance, creating more time for your team to focus on other valuable tasks. When you focus on continuous improvement, you’ll always be doing more to improve efficiency and results, and you can be confident you’re not falling behind on quality.
Invest in a solution that helps you measure progress and achieve quality systems, not just process compliance. ZenQMS makes it easy to analyze your existing processes and roll out a comprehensive plan for quality-driven improvement. Book a demo to make large-scale changes possible across your organization.
