Identifying the 4 Most Common Problems With Your CAPA Process


    Over the years, we’ve heard from thousands of life sciences start-up founders and quality managers. As an industry-leading quality management system (QMS) vendor, we get a lot of questions related to corrective and preventive actions (CAPA).

    In recent years, CAPA has quickly become the go-to quality management framework for aspiring life sciences startups and scale-ups. Unfortunately, achieving rapid CAPA adoption, especially during early growth, can feel like herding cats.

    With so many moving parts and systems to activate and manage, how do you know where to start? Suffice it to say that optimizing the process can make even the most seasoned quality professional thinking about calling it quits.

    Making matters even more complicated, major laws and regulations — including ISO 13485 and ISO 9001 — require life sciences organizations to activate stringent CAPA processes. 

    If you’re planning on building a CAPA process, hurdling these kinds of challenges is the difference between rapid CAPA success and total disaster. 

    To this end, we’ve identified the four most common problems with teams’ CAPA processes. Using these insights, you can design an expert-level quality and compliance system.

    The 4 Most Common CAPA Process Problems to Avoid 

    An effective CAPA process helps quality teams to identify areas of nonconformity and activate the appropriate countermeasures needed to prevent and resolve quality issues.

    The U.S. Food and Drug Administration (FDA) places considerable emphasis on teams’ CAPA processes, and for good reason: An ineffective CAPA process places patients at risk. 

    As a result, teams must place patient health and safety at the forefront of all medical device or biopharmaceutical product quality and performance activities. 

    As you carve your path toward an effective CAPA blueprint, here is a list of the major CAPA process problems that you must avoid at all costs. 

    1. Limited Communication across Departments

    Poor cross-departmental communication can create massive gaps in your CAPA process. Unfortunately, nonconformities often result in a snowball effect of cascading quality issues. Failure to communicate these issues only exacerbates the problem.

    An effective CAPA process requires total alignment across the entire life sciences organization. When quality or compliance issues occur, team members must first identify the problems and then communicate the issue to all relevant stakeholders.

    For the best results, encourage team members to communicate the following information:

    • Where did the quality/compliance issue occur? 
    • Why did the quality/compliance issue occur?
    • How might the organization respond to the quality/compliance issue?

    If you’re looking for help, an electronic quality management system (eQMS) is an effective solution designed to improve cross-team collaboration and communication. 

    Most quality management systems come equipped with powerful reporting features purpose-built to help teams identify and respond to quality and compliance issues. Many teams rely on these types of quality management solutions as the organization’s single source of truth related to product quality, conformity, and more.

    Is your team communicating as effectively as possible? If not, it might be time to reassess your processes, procedures, and tooling.

    2. Being Reactive Instead of Proactive

    Many early-stage life sciences startups and scale-ups make the mistake of responding to quality and compliance issues retroactively. 

    However, a proactive approach to quality and compliance limits the number of unforeseen roadblocks that your team must hurdle during product design, development, and distribution.

    When building a new medical device or biopharmaceutical product, it’s easy to rest on your laurels. But just when you think you’re finally ready to bring your new product to market, a quality issue thwarts the entire plan. 

    Unfortunately, these unexpected quality impediments prevent even the most forward-thinking life sciences companies from scaling successfully.

    RELATED READING: How to Shrink the Medical Device Approval Timeline

    3. Poor Root Cause Determination Methods 

    Effective root cause determination methods serve as the backbone of the CAPA system. If you don’t get to the root cause of the issue, the problem is bound to recur. 

    To avoid running into the same issue over and over again, we recommend following the 6Ms of Production (manpower, method, machine, material, milieu, measurement) methodology when determining a root cause. 

    In short, this system encourages quality teams to develop a holistic approach to quality and compliance through the successful identification of systems, processes, and procedures used to deliver effective (or ineffective) manufacturing outcomes.

    “Understanding how these factors impact the process and establishment of standards are key steps in strengthening production processes,” recommends KaufmanGlobal.

    4. Overly Complicated CAPA Documentation

    At the end of the day, your CAPA process should be perfectly in tune with your companies’ quality objectives. It should be well-documented — but not overly complicated or difficult to understand, either.

    There are clear consequences for poorly defined CAPA processes. In fact, the FDA’s Office of Regulatory Affairs (ORA) routinely issues infractions related to the improper documentation, activation, and management of CAPA processes.

    An eQMS is an invaluable solution that life sciences companies can use to properly document, distribute, and assign CAPA procedures. In fact, many advanced quality systems even ship with automated reminders to facilitate improved issue response. Instantaneously assign quality professionals to compliance issues and activate daily or weekly notifications to keep them on the pulse of new or emerging quality issues. 

    RELATED READING: 5 Amazing Medical Device Document Management Tips

    Use a Quality Management System to Improve CAPA Processes

    Now that you have a better understanding of the CAPA process and the major pitfalls that you need to avoid on your path to building an effective CAPA response, it’s time to ensure that your broader quality management systems are up to par. 

    Which begs the question: Are there gaps in your organization’s quality management processes?




    To date, we’ve helped hundreds of quality professionals maximize the effectiveness of the quality management procedures – and we can do the same for your growing life sciences start-up or scale-up! 

    Just ask the folks over at CGX.

    “We wanted a flexible QMS system to develop products for a range of markets,” said Spencer Linton, vice president at CGX. “It also had to be scalable as we grow with projects, personnel, and sales.”

    After reviewing other solution providers on the market, CGX decided to leverage our proven and results-driven eQMS.

    We’d love to help you use quality as a competitive advantage, too.