“TrackWise helped us to implement all the modules easily along with required IT infrastructures and helped us to harmonize the process across sites.”

The post Voice of Customer: Jagdish Meghrajani, Senior Manager IT @ Zydus, | Digital Transformation Journey with TrackWise QMS appeared first on Honeywell.

To reduce harm to patients and users, proactively detect signals and trends, and continuously improve the quality and safety of medical devices through real-world evidence, quality risk management must successfully integrate with the quality management system.

Let’s consider the benefits of integrating quality risk management with the quality management system (QMS).

Why Risk Management is Getting Harder

Regulations are bringing more scrutiny from regulators on the risk management processes for medical devices and combination products. The European Union Medical Device Regulation (EU MDR) and ISO 14971:2019 requirements are bringing the full burden of risk management to medical devices and combination products.

Risk management in the new era is a big undertaking that spans all lifecycles of product development and means tracking practically every system and process in your enterprise, from product planning, design, and changes to manufacturing activities and more through to post-market surveillance.

A Better Approach to Risk Management

To be effective, all your risk management efforts must be interconnected. Information must be handed off between departments in a way that keeps complexity from leading to confusion. These teams include personnel from quality, regulatory affairs, clinical affairs and many more who speak about similar topics in different ways. It’s a lot to ask of cross-functional teams from every part of your organization to coordinate so much data frequently enough to be useful when they are working in siloes.

An integrated risk management approach will:

• Reduce harm to patients using your products
• Detect signals and identify trends for effective root cause analysis and decision making
• Improve quality and safety continuously
• Ensure acceptable quality
• Resolve process and product deviations and nonconformances quickly
• Expedite approvals and market authorization
• Comply with standards and regulations

Transform Your Risk Management Process

Over the years, the constantly evolving expectations of risk management have resulted in many manufacturers developing complex, ineffective risk management processes. These changes span over three decades and include the European Directives, ISO 14971-1:1998, ISO 14971:2000 and more. The EU MDR and ISO 14971:2019 have added to the burden of manufacturers staying on top of changing regulatory expectations for medical device risk management.

Compliance with the EU MDR and ISO 14971:2019 from planning to production and post-product information collection requirements will take a lot of resources and will fail to deliver high quality for those relying on outdated risk management methods.

Manual risk management methods are not good enough anymore—they consume resources, slow down decision making, and don’t deliver the quality improvement and risk reduction that organizations need to compete.

Are you ready to take your risk management process to the next level?

Download our white paper, “A Data-Driven Approach to Quality Risk Management,” to learn how to take a data-driven approach to risk management.

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1. The process is too time-consuming: Conducting risk assessments can be a lengthy process, especially for large and complex organizations. 

2. The process is too manual: If the risk assessments are conducted manually, they may not be as effective or efficient as they could be, leading to frustration on the part of the quality manager. 

3. Results are not meaningful: Sometimes, risk assessments can produce results that are not meaningful or actionable, which can lead to frustration and a sense that the process is not adding value. 

4. Lack of resources: Conducting risk assessments may require significant resources, including personnel, time and budget and the quality manager may feel frustrated if these resources are not available. 

5. Lack of standardization: If there is no standardization in the risk assessment process, it may be difficult to compare results between different areas of the organization or between different organizations, leading to frustration and confusion. 

6. Results are not acted upon: If risk assessments are conducted but the results are not acted upon, the quality manager may feel frustrated that the process is not having the desired impact. 

Technology and software can help mitigate these challenges. Quality management software can provide a centralized platform for tracking, managing and reporting on quality data and processes. This can help streamline and automate many of the manual and repetitive tasks associated with quality management, freeing up time for quality professionals to focus on higher-level tasks. 

For example, a quality management system (QMS) can assist with risk assessments by automating the risk assessment process, making it easier to identify potential risks and prioritize them for mitigation. The software can also provide real-time data on process performance, which can be used to identify areas for improvement and track the effectiveness of improvement initiatives. 

In addition, a QMS can help with process improvement by providing tools for documenting, monitoring and controlling processes and by enabling continuous monitoring of process performance to identify areas for improvement. The software can also provide access to historical data, which can be used to identify trends and patterns that can inform future improvements. 

Overall, a QMS can play a crucial role in helping a company maintain quality, reduce risks and improve process performance over time. 

The post Unlock the Secrets to Streamlined Risk Assessments and Process Improvements  appeared first on Honeywell.

Successful CAPA management ensures that any quality control issues that appear unexpectedly in the manufacturing process can be addressed quickly and efficiently, with new or revised processes implemented to ensure that these issues are minimized and corrected elsewhere where the same conditions may exist. But many organizations have not yet adopted an effective CAPA process. In fact, many are still using manual tools like spreadsheets and paper-based systems to manage and track CAPAs.

Let’s explore the needs and effectiveness of CAPA and the elements prevalent in a successful system.

Addressing Quality Issues and Incidents

Regardless of industry, professionals must always maintain a manufacturing environment that is free of any potentially damaging pollutant, contaminant or impurity that may result in a flawed or even harmful product.

Quality issues and incidents can become even more of a challenge when government regulations are introduced.

Minimizing Risk and Meeting Compliance

The importance of minimizing risk and ensuring compliance with regulatory issues while upholding an efficient and profitable operation is a balance companies continue to seek, and many are able to do so.

But despite organizations’ best efforts to implement processes and systems for maintaining control over the manufacturing environment, it’s impossible to ensure that incidents never happen. When these incidents do inevitably arise, it’s vital that companies be prepared to deal with them as quickly as possible.

Closed-Loop CAPA Management Transforms the Process

This is where CAPA management emerges as an essential process. In theory, CAPA management should be the hub of an organization’s quality management initiatives. It should allow an organization to log events and problems, investigate these events and problems to determine root cause, propose corrective and preventive action plans to ensure that issues are anticipated and become a non-issue for the future, and measuring the effectiveness to ensure the root cause has been eliminated.

This kind of system usually involves an approach that includes a holistic quality management solution for tracking these issues and enabling efficient handling. 

The Building Blocks of Effective CAPA

A closed-loop CAPA management system can effectively reduce an organization’s quality issues. There are five elements of effectively managing corrective actions:

• Create a centralized CAPA system
• Implement electronic incident tracking
• Discover, define and execute corrective action
• Use CAPA for continuous improvement
• Measure and report

We detail each of these steps in our eBook, “Taking the Burden out of Corrective and Preventive Action.” Read more to learn how you can start transforming your CAPA process.

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However, some companies skip steps in the RCA process or inadequately perform the process. This leaves them with challenges like limited time to focus on the right things, using the wrong RCA tool, a poor corrective action process and ineffective training.  

To perform an RCA correctly there are essential steps that must be taken. First, let’s look at common types of root causes that most companies must deal with.  

Types of Root Causes 

RCA analyzes and identifies multiple types of root causes. There are three common types that can cause failures including:  

Physical Causes: A physical cause is when a tangible item fails. For example, if an MRI machine at a hospital stops working and prevents a patient from receiving the proper health care, this is a physical root cause.  

Human Causes: This type of root cause is when one person or several team members does something incorrectly. Human error will often lead to a physical cause, e.g., a hospital’s quality management team didn’t perform an MRI machine’s scheduled inspection, which caused it to fail. 

Organizational Causes: An organizational root cause is when a system or process that an organization uses to do its jobs is faulty. For example, if a hospital’s quality control department mistakenly thought it was the patient safety department’s responsibility to inspect the MRI machine and nobody corrected them, this is an organizational root cause. 

How to Perform a Root Cause Analysis in 5 Steps 

To go through the RCA process effectively, follow the five steps below:  

1. Define the Problem

Analyze what you see happening and identify the precise symptoms to form a problem statement. 

2. Gather Data

Before you can move on to identifying the underlying problems, you must collect and evaluate all aspects of the situation. Performing a case study, incident investigation or accident analysis are a few common ways to accomplish this step. 

3. Identify Causal Factors

Now with your data in hand, it’s time to look for as many causal factors as possible that could have led to your problem. 

4. Determine the Root Cause(s)

Use root cause analysis methods, which we’ll outline below, to discover the root causes of each causal factor. 

5. Recommend and Implement Solutions

Once you know the root cause, you can recommend preventive action to ensure the problem never happens again and then develop a timeline and plan for implementing your solution.  

Popular Root Cause Analysis Methods 

The goal of RCA is to recognize all the underlying causes of a problem. Using an analysis method is a useful tool to accomplish this task. Some popular root cause analysis methods are: 

The Five Whys: This is a problem-solving strategy that consists of asking “Why did this problem happen?” and then following the answer up with a series of additional “But why?” questions until you get to the root cause of the problem. 

Change Analysis: This method meticulously examines all the changes leading up to an event in hopes of discovering risk management strategies. This is particularly useful when there are many possible causes. 

Failure Mode and Effects Analysis (FMEA): FMEA is one of the first systematic failure analysis methods and is a step-by-step guide for recognizing all potential failures in a product, business process or service. Once you’ve pinpointed each failure in a system, you can then assess the effects of those failures one by one. 

Get to the Root Cause of the Issue

The RCA tools above can be used to help you spot potential flaws in your solution before they happen.  

Resources About Root Cause Analysis:

• On-Demand Webinar: Root Cause Analysis – Getting to the Root of the Issue and Getting it Right
• Blog: Uncovering the Root Cause and Overcoming Challenges Along the Way
• Blog: Root Cause Essentials: Unleash the Power of Your Mind with Mind Mapping
• Blog: Root Cause Essentials: Using the PDCA Approach to Support Continuous Improvement
• Podcast: Flipping CAPA on its Head with Prevention and Understanding the True Root Cause

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The event brought together speakers from over 10 countries who have the common belief that we are better together. 

We all understand that the life sciences industry is experiencing rapid growth and regulatory complexity. The COVID pandemic has brought out big shining neon lights and placed them around the importance of science, technology and innovation. 

In today’s market if you want to succeed you must embrace both “digital” and “transformation.”  

Leaders seem to understand the digital part but our failing tremendously on the transformation side. 

It is important to remember the definition of transformation—transformation is a dramatic change. It is an alteration. It is not doing the same thing we did thirty years ago but now using a computer. 

Industry 4.0 is the state of digital transformation and 4.0 will leverage big data, the industrial internet of things, and AI (Artificial Intelligence) with real-time actionable data generation to analyze, solve and enable smart decisions. It uses technology to transform business processes and culture, envisions new business models, and delivers value to customers. 

And making data actionable—with insights to power both human decision-making—and real-world automation is driven directly at the edge. 

This is the key to our future. 

All these needs are fueling a wave of digital innovation across our industry. RQA provided a forum to collaborate, educate, and to share how we can harness data and digital to move our industry forward and accelerate with Quality 4.0 through connected life sciences. 

Over the course of 2 days this conference dove into: 

• GCP theories, practices, and remote audits 

• Virtual compliance training 
• Vendor selection and oversight, remote working 
• Inspection readiness, MDR and IVD, quality compliance, writing SOPs (Standard Operating Procedures), six sigma, challenges of RA professional 
• The requirements of the clinical phase, practical quality management system (QMS) in clinical sites 
• Risk-based approaches, proactive corrective and preventive action (CAPA)  

• Understanding Part 11, data integrity, cyber security, and audit trails with digital technology. 
• Future—QbD (Quality by Design), design of experiment, internal quality audits 
• The importance of quality culture   

This event provided fresh insight and innovative ideas into the future of quality. We are in the right place at the right time to build partnerships and collaborate with peers in the life science industry. 

I also had the opportunity to present the topic, “Re-Defining Quality Audits for a Digital World.” During this session, we discussed the benefits of taking a digital approach to internal quality audits, common barriers to effective audits, and how you can overcome those challenges. 

This was a fantastic event. Readers, I hope that you will all continue to be innovators and embrace innovative technologies that will improve patients’ lives, not just today but in the future. 

We’ll be talking more about these innovative technologies at Sparta Connection from June 6 –9. I’d like to invite you to join us there and continue the conversation around tools that continue to shape the future of quality.  

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