Jon Speer, Greenlight Guru
CAPA Corner

Why You Must Have a Single Source of Truth for CAPA

By Jon Speer
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Jon Speer, Greenlight Guru

CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.

Corrective and Preventive Action (CAPA) is a major process that lives within the quality system of medical device companies. It is used by quality professionals to investigate and solve issues, identify reasons for fault, and initiate actions to understand the cause and prevent recurrence of issues found.

Yet, year after year CAPA remains one of the top reasons for FDA to issue 483 observations, typically due to inadequate processes or inconsistent adherence to regulatory requirements.

CAPA-related 483 observations are often a result of three main causes:

  1. Inaccurate determination of issues requiring a CAPA investigation
  2. Inadequate documentation of FDA-required data to assess the effectiveness of a CAPA investigation
  3. Ineffective quality systems used to gather and inspect data for proof of an effective and controlled investigation

Noncompliance issues that result in citations, although different in nature, have one typical commonality: The quality system used does not provide a single source of truth for the information being stored. Such systems are disconnected from one another and lack visibility into all functional areas of quality management.

Having a single source of truth for CAPA activities provides full visibility into all functional areas of a QMS. This closed-loop system connects all data related to your medical device pre- and post-market processes, allowing the entire quality system to be managed throughout the total product lifecycle.

To truly ensure the efficiency of your CAPA system, it’s important to fully understand both the benefits of having a single source of truth for CAPA and the challenges associated with a system that has numerous sources of truth.

Benefits of a Single Source of Truth for CAPA

For regulations relating to CAPA, FDA utilizes the phrase ‘quality data source’ which essentially means the data from any part of your quality system. The requirements focus on the data yielded by the quality system and processes instead of the quality of the data.

Quality data sources should live within a quality system that serves as your single source of truth to ensure that data is properly managed and accessible. A single source of truth for CAPA improves the quality system process, establishing one holistic unit and ensuring the QMS can be accurately and efficiently managed. The following are a few benefits.

Connect Quality Data Sources and Creates Traceability

When it comes to medical device CAPA investigations, any issue found could have stemmed from a number of potential sources, such as an internal quality audit, complaint or nonconformance. Without a single source of truth, it is difficult to uncover the original source of the problem and all of the contributing factors.

To have a strong QMS, you must have a strong CAPA process. And several QMS processes connect to CAPA. Everything from complaint handling, production and process controls to design controls.

Ultimately, CAPA should be used to address systemic issues. If you are tracking your data sources properly, a single occurrence of a quality event doesn’t necessarily warrant a CAPA — not unless the issue is severe, such as an adverse event causing patient harm.

Having a single source of truth that integrates all QMS processes within a closed-loop quality system allows medical device companies to identify when and how to address issues through means of a CAPA investigation.

Manage the QMS as a Whole

The main benefit of having a single source of truth is the ability to manage the QMS holistically. Managing a QMS with a holistic approach to CAPA allows data and information to be housed in one, easily-accessible location, which in turn allows companies to clearly identify issues that can impact several quality subsystems.

The total product lifecycle is made up of several components that must be managed within a quality system, such as records, documents, and change controls, management controls, design controls, customer feedback, complaints, audits and CAPAs.

Having a single source of truth for all of these subsystems enables team collaboration on preventive and corrective activities, and ensures quality practices for product and process improvement.

Act Proactively Rather Than Reactively

Most medical device companies with good CAPA processes still have room for improvement. A large chunk of CAPAs are initiated as a reactive response to quality events. This means, in those instances, companies waited for something to happen before taking action. What if a patient is harmed as a result of this reactive approach? Or a device is shipped with faulty parts and the entire batch needs to be scrapped?

One proven way you can prevent scenarios such as these is by implementing a data-driven QMS that provides leading indicators about potentially serious issues before they even happen. A single source of truth for CAPA assists in identifying issues well before causing harm.

This is done through a QMS that allows for data-driven decisions to be made using a proactive approach. A proactive approach isn’t simply recommended; it is necessary for assuring the highest standard of safety and quality of a medical device.

Challenges with Multiple Sources of Truth for CAPA

Independent quality systems with multiple sources of truth introduce several challenges.

Lack of Cross-Functionality. CAPAs rarely involve an issue that affects only one quality subsystem. When a CAPA is initiated,the issue is almost always cross-functional. When quality sources are not integrated with each other in a single connected system, it discourages collaboration amongst a cross-functional team, making it challenging to identify the issues and their impacted areas.

Before finishing a CAPA investigation, you have to verify and record the effectiveness of your corrective actions in order to confirm the controls that were implemented will prevent future occurrence. If your systems are not adequately connected within a single source of truth, inefficiencies and red flags will come to light.

Delayed Resolutions. One of the biggest challenges for medical device companies is that they’re often depending on lagging data to dictate which actions are needed to resolve an issue, for example, a complaint or nonconformance. If a company is relying on lagging data, the timing around resolutions of the issue will follow suit.

By using a closed-loop quality system that provides a single source of truth for CAPA, all quality system data is stored in a single location, allowing the opportunity for proactive actions to be rolled out for timely resolutions.

Poor Root Cause Determination. If the root cause of an issue goes undetermined, the product or process that’s impacted will continue to encounter the same issues. Unfortunately, this is a major concern when it comes to CAPA since multiple, disconnected quality systems will require a more in-depth analysis to pinpoint issues in relation to one another.

Fixing a problem that exists in one quality system may resolve the issue in the short-term, but without full connectivity in your QMS, the systemic issue will continually arise.

Inefficient Regulatory Strategy. While international organizations and regulatory bodies provide guidelines that serve as concrete sources of information for device professionals to educate themselves on the processes and procedures that need to be followed, these resources are far from comprehensive and often lack the prescriptive details manufacturers are seeking.

Most requirements do not provide instructions for how manufacturers should implement and maintain a quality system and, for some, that is where it can get tricky. If you depend on these documents as your exclusive blueprint, you will miss out on opportunities for continued improvement and innovation.

Most medical device companies regularly conduct integrated management reviews, which require key stakeholders to conduct an in-depth assessment of their quality system and its effectiveness. But regulators need more than just confirmation that a general review took place — they need substantial proof that details those activities. Without a single source of truth and a closed-loop quality system, the objective evidence required can be difficult to provide.

The Best Single Source of Truth for CAPA Is a MDQMS Solution

Success has everything to do with how your company manages its quality system. As the medical device industry continues to evolve, we need to increase our focus on process and data integration within our quality systems. This helps to ensure True Quality is at the forefront of all activities relating to your medical device.

Choosing to manage your business with an inadequate quality system that relies on multiple disconnected data sources is not only a waste of time and resources, but can also lower the quality, safety, and efficacy of your product. For those who don’t want to forfeit the bedrock of your operations, seek out innovative technology to streamline the improvement process and prevent potential issues from ever occurring.

Ultimately, the best QMS solution with a single source of truth for managing CAPA is a medical device specific QMS (MDQMS) solution. The medical device industry is expectant of topnotch quality, speed and trust. Investing in a reliable MDQMS that comes equipped with a single source of truth for CAPA can improve your processes and the quality of your medical devices now and into the future.

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