How to solve the four most common quality management issues in 2024

Solving quality management issues keeps your life sciences organization on the right side of the FDA. However, compliance isn’t the only benefit.

Excellence in quality management helps your organization produce the best medical devices on the market. It helps you get your device to market faster and gain a competitive advantage. Quality management can build your brand reputation and keep you from costly customer complaints and product recalls.

We've talked to companies of all sizes who got themselves into a bind with poor quality management practices and tools. Sometimes these issues were caused by scaling too quickly. Other times, it was a breakdown of people, processes, or technology. In every case, quality management shouldn't be viewed as an expense. It’s an investment into your company's long-term success.

Being able to recognize these four common quality management issues empowers you to excel where your competitors fail.

How to avoid the 4 most common quality management issues

In FY 2023, inspectors issued 720 483 observations to device manufacturers, including 252 warnings for inadequate Corrective and Preventive Action (CAPA). Inadequate complaint procedures were the second most common with 181 observations. There were 94 instances of inadequate procedures for nonconforming product, and 84 observations of poor purchasing controls. In total, these four categories comprised the clear majority of Form 483 submissions to device manufacturers.

Focusing your quality management efforts on CAPAs, complaint handling, nonconforming product, and purchasing controls is therefore a wise investment of your quality management resources. You can gain a regulatory and competitive advantage by avoiding the most common compliance pitfalls that plague the majority of life science organizations who find themselves on the bad list of regulatory bodies.

Problem #1: CAPA

CAPA is the top reason for 483 observations. CAPA quality management issues are generally caused by one of the following quality management snags:

• The organization isn’t following CAPA processes
• The organization's CAPA process doesn’t comply with cGMP
• The organization lacks a defined CAPA process or eQMS capabilities

This can occur for many reasons. Fast-growing pharmaceutical startups and scale-ups may delay building a CAPA process during the research & development phase of the product life cycle. A CAPA process may be built as an afterthought, instead of as a core part of the quality management system. In other cases, CAPA issues can arise due to under-involved management, underuse of CAPA, or ineffective root cause determination.

Absent management

CAPA is generally the domain of the quality management team. However, CAPA should not be the responsibility of just the quality team. CAPA is a cross-functional project which should involve the leadership team and all members of the workforce who are involved with the process being investigated. When management isn't highly involved, the quality management team can struggle to understand the bigger picture or create meaningful organizational change.

Underused CAPA

Life sciences organizations need to be judicious about applying CAPA processes. CAPA should be applied to address every breakdown in the quality management system or procedures. If you fail to apply CAPA procedures to issues, you could face major failures. CAPA should be a proactive tool for risk management to mitigate and correct issues before you’re facing customer complaints. FDA inspectors evaluate whether organizations consistently apply CAPA to systemic failures.

Missing the root cause

All too often, life sciences organizations conclude CAPA investigations by determining “human error” was the root cause of an issue. While human error may be the true root cause, the leg work to determine exactly why needs to happen—was it a failure of SOPs, training, or management? In other cases, there’s even less effort to determine the root. Organizations may identify the symptom of the true issue instead of the real reason the quality management system broke down. If you don’t get to the root, you risk facing the same issue repeatedly because the cause hasn't been corrected. Use eQMS data and a structured approach, like Pareto charts, to consistently get to the true basis of CAPA.

A CAPA procedure and systems aren’t optional. Once these foundational elements are in place, be sure to follow your process and perform the most thorough root cause investigation possible. Don’t let your team jump to a conclusion because you will miss the real fix 99% of the time if you rush through CAPA. Ineffective investigations threaten compliance, quality, and your ability to become the market leader.

Problem #2: Complaint Procedures

Creating a defined procedure for handling complaints is a business and regulatory requirement for life sciences organizations. Your procedures must follow the requirements listed in FDA 21 CFR Part 820.198. Some of the most common issues with complaint procedures include a lack of standardized processes and systems, poor management documentation, and ineffective customer care.

RELATED READING: The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance

No standard procedure

Without a standard approach and system, such as cloud-based QMS software, complaints can easily get lost or overlooked in an email inbox or paper files. Organizations need a standardized procedure for collecting complaint data to follow-up appropriately, and when necessary, escalate complaints to adverse events.

Ineffective management documentation

Documentation is critical to using customer complaints for quality management. Documenting management’s response to customer complaints is critical for quality improvement and compliance. Transparent quality management software can be crucial to effectively track complaints and resolution. If management can’t see the big picture, it’s likely leadership will struggle to fully address the root cause of customer grievances.

Customer care

Customer feedback is vital to the success of your organization. If your customers never receive a follow-up or appropriate customer care, your brand satisfaction and reputation metrics can suffer.

A defined procedure is critical, and organizations need a system for collecting and analyzing complaints. Your quality management system should support analysis and comprehensive investigation. You should avoid incomplete analysis of complaints that tie issues to a common root cause. Sometimes, there are nuances that make a new customer complaint different from other complaints in some way. Avoid jumping to conclusions, and ensure your complaint handling process is compliant and viewed as an opportunity for improvement.

Problem #3: Nonconforming product

Product that 'does not conform to specified requirements' is symptomatic of a weak quality management system. This symptom must be treated alongside the cause.

Failure to build adequate procedures to address nonconforming product clocks in at 3 on our list of the most common medical device quality issues.

Identify a process for spotting nonconforming product

Stepping up your quality assurance activities, such as inspections, audits and sampling, will help you find product that doesn't meet your quality requirements

Root cause analysis improvement

Enhance your methodology for conducting root cause analyses for nonconforming products. Implement standardized procedures to identify underlying causes and contributing factors for better problem resolution

Rework policy and procedure

Focus on creating policies and procedures for reworking non-conforming product, including retesting any reworked product to ensure it conforms

CAPA

There's lots of crossover between our Form 483 observation categories. Get a robust CAPA process in place, as mentioned above, to address nonconforming product, and support it with specific processes and procedures relating to how nonconforming product is addressed, discarded, reworked and released safely

Problem #4: Purchasing Controls

“A supply chain is only as strong as its weakest link,” said former FDA commissioner Scott Gottlieb. “Every link in the chain must be secure and reliable.” The widespread heparin contamination in 2018 serves as a lasting lesson of the importance of purchasing controls. Purchasing risks are ever-present and pervasive at every stage of the global supply chain.

Unknown suppliers are a huge risk, according to FDA Deputy Commissioner Anna Abram. FDA investigations have revealed that some manufacturers and compounders are unaware of the true identity of their suppliers, since they source from middlemen. Another risk frequently occurs when suppliers change processes, and this change goes undetected by manufacturers. Ineffective supplier oversight can mean unknown risks when your supplier’s quality suddenly drops.

Effective purchasing controls start with a standardized process for qualifying suppliers. Abram urged life sciences organizations to think of supplier relationships as “partnerships,” and to view supplier oversight as a lifecycle responsibility.

It’s more important than ever to use known suppliers. Ensure if you change suppliers based on price, you’re not sacrificing the quality of your APIs or absorbing product risks. Sometimes, saving a few dollars can cost your company tenfold in a recall.

Finding the Best eQMS for Your Company

Quality management issues can have a significant impact on the long-term success of your company. Organizations risk a 483 observation during an FDA inspection, but this isn’t the only potential outcome. Failure to follow CAPA procedures and identify the true root cause of issues can cause repeated problems and avoidable costs. Ineffective complaint handling can jeopardize brand reputation and customer relationships. Purchasing control breakdowns can be linked to unreliable input quality, and speeding through process validation won’t get you trustworthy results.

A strong enterprise quality management system (eQMS) is a necessity to avoid the most common quality management concerns which plague device manufacturers of all sizes. By adopting the right solution during the startup or scale-up phase, you can build your organization on a strong baseline for effective CAPA, supply chain management, and complaint handling. Qualio is the first cloud-based QMS specifically designed for fast-growing life sciences organizations and based on the latest FDA and ISO guidance.