12.7.2021 Team ZenQMS

    5 Examples of Process Improvement and How Each Impacts Your Team

    In highly regulated industries, 63% of companies see compliance issues as a barrier to growth, leading to lost revenue and damaged trust with consumers, regulators, and employees alike.

    Putting process improvement mechanisms in place will make your team more efficient, eliminate compliance issues, and effectively address sources of waste and poor patient outcomes. Here are five real-world process improvement examples that contribute directly to improved quality for life sciences organizations.

    1. Developing a Standard Operating Procedure (SOP) to Escalate Software Bugs

    When your team encounters a software bug, it’s going to impact their ability to get work done. They’ll either need to spend time finding a workaround, which isn’t very efficient, or they may not be able to use the software at all. Creating a standard operating procedure (SOP) that team members can use to report bugs will help developers resolve them more efficiently.

    Your SOP should (ideally) be a centrally accessible document that team members can reference to understand the procedures and protocols to follow to escalate bugs, instead of asking their peers or waiting for instructions. The type of SOP you draft will depend on your specific process, but a step-by-step or flowchart format will likely work best.

    To handle software bugs efficiently and proactively, draft an SOP that instructs team members:

    • How to flag the issue
    • Who to contact about it
    • How to communicate priority level

    The SOP should include a way to assess risk and impact if the bug isn’t fixed. This way, developers can focus on the most pressing issues that are potentially leaving you out of compliance, disrupting productivity, or creating negative patient or customer experiences.

    2. Running an Internal CGMP Compliance Audit

    Pharmaceutical manufacturers need to comply with strict Current Good Manufacturing Practice (CGMP) regulations to ensure that medications and pharmaceuticals are safe for people to consume. Conduct an internal compliance audit to assess your organization’s compliance with GMPs to ensure that facilities and equipment are in good condition, staff is well-trained, and processes are producing quality products.

    The International Society for Pharmaceutical Engineering (ISPE) provides a GMP audit checklist you can use to audit your manufacturing facility. Use this checklist to guide your own internal audit. Organize your audit by factory system(including personnel, facilities and equipment, etc.).

    Delegate responsibility for audit steps and processes, and use up-to-date SOPs to carry out the audit in a timely manner.Have a plan for taking corrective actions based on your team’s findings. For example, if you find that some team members lack the required training, come up with a timeframe for them to complete the training and provide the resources for them to do so.

    3. Creating Templates for Clinical Study Reports (CSRs)

    Clinical study reports are documents that drug companies submit to regulators as part of the process of gaining approval for new treatments. They explain why the trial was done and detail the results. Create a template for your CSRs to save time during the medical treatment application process and give regulators a thorough, accurate report of findings from your study.

    Creating templates up front will streamline the document drafting process for your team, so they don’t have to start from zero every time. Templates also help maintain the same quality standards from one report to the next.

    You should store your CSR template and note the most up-to-date version using an electronic QMS, instead of paper-based storage.


    Develop a template to ensure that any CSR you create complies with FDA and ICH guidelines for these reports. Establish the structure and pertinent info to include in the template so that your team just needs to follow what’s already there when it’s time to draft a new CSR.

    Follow the FDA’s ICH Structure and Content of Clinical Study Reports guidelines to create a CSR template for your organization. The guidelines are already quite specific, but adjust your template to present the info in a meaningful, easy-to-consume way based on your study and findings. Here’s one example of a CSR template from Novartis.

    You should store your CSR template and note the most up-to-date version using an electronic QMS, instead of paper-based storage, so that it’s easily accessible to your team.

    4. Minimizing Inventory Waste in Medical Device Manufacturing

    Excess inventory is one example of waste in a manufacturing process. Manufacturers can use the lean Six Sigma process improvement methodology to minimize this type of waste in medical device production.

    Use the DMAIC (Define, Measure, Analyze, Improve, Control) cycle to identify which components of your process are causing the excess in inventory. Here’s how the DMAIC cycle might look for you in this example, based on iSixSigma’s detailed steps:

    • Define your goals of reducing inventory waste by a measurable percentage or amount
    • Measure existing process data (performing inventory counts and observing lead times, required lot sizes, and more)
    • Analyze data through inventory modeling to see which variables have an impact
    • Improve the process by developing countermeasures to address root causes (such as high forecasting errors)
    • Maintain your new standard for inventory counts and continually improve your process to further reduce waste

    5. Reducing Hospital-Acquired Infections in Patients

    Nosocomial infections [or hospital-acquired infections (HAIs)] are a real threat to patient health. According to the CDC, one in 25 U.S. hospital patients is diagnosed with at least one infection related to hospital care every year. Introduce process improvements to reduce HAIs and improve patient outcomes.

    Catheter-associated UTIs (CAUTIs) are a common example of an HAI. One way of reducing the risk of CAUTIs for patients is using catheters only when necessary and removing them as soon as possible, according to the CDC. Mount Sinai Hospital implemented a “Lose the Tube” initiative to encourage the early removal of catheters in an effort to reduce CAUTI rates.

    Hospital unit medical directors asked each provider if their patient needed a urinary catheter. They also educated clinicians on the specific scenarios when a urinary catheter should be used. By introducing these process improvements, Mount Sinai was able to reduce the average per-person “catheter days” and successfully reduced CAUTI rates from 2.85 per 1,000 catheter days to 0.23 per 1,000 catheter days.

    In your own hospital setting, you can introduce similar measures to lower HAI rates. Provide more clinical education to providers, introduce daily queries or checks to determine what’s truly necessary for patient care, and use electronic surveillance/detection tools to detect which patients have catheters in place and for how long.

    Improve Quality Outcomes by Managing Process Improvements With ZenQMS

    There are tangible quality benefits to implementing process-improvement techniques at your organization, regardless of the specific setting or industry. But you’ll see the best outcomes when those improvements are managed seamlessly through a reliable, scalable electronic QMS. ZenQMS software gives you tight control over process documents and manages changes to your organization’s procedures so that you can deliver quality outcomes for your patients and your business.

    Learn more about ZenQMS and how our software drives intelligent quality for life sciences organizations.

    Published by Team ZenQMS December 7, 2021
    Team ZenQMS