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 Four Most-Common Quality Management Issues
Last year, inspectors issued 966 483 observations to device manufacturers, including 354 warnings for inadequate Corrective and Preventive Action (CAPA). Inadequate complaint procedures were the second most common with 229 observations. There were 142 instances of purchasing control issues, and 138 observations of insufficient process validation. In total, these four categories comprised 89 percent of 483 warning letters to device manufacturers.
RELATED READING: Why Did Medical Device FDA 483 Letters Drop 6.2% Last Year?
Focusing your quality management efforts on CAPA, complaint handling, purchasing controls, and process validation is 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.
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.
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 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: 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. According to a late 2018 statement by Deputy Commissioner Anna Abram, purchasing risks are ever-present and pervasive at every stage of the global supply chain.
Unknown suppliers are a huge risk, according to 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.
Problem #4: Process Validation
Testing every device or drug isn’t possible or practical, which is why organizations test the quality management process instead. Process validation is the act of subjecting a process to such intense evaluation that all outputs are likely to meet design and quality standards every single time.
The US FDA defines process validation as a “means [to] establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” Section 820.75 specifies in part that:
- “The process shall be validated with a high degree of assurance and approved according to established procedures.”
- “Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated procedures.”
Doing process validation right the first time isn’t simple or cheap. However, performing a comprehensive process validation the first time is worth the investment by saving you time and money later. Validation can feel like a waste of precious revenue on your first lots. However, not putting your process through the paces under “actual commercial use conditions” will mean missing out on an opportunity to identify and fix last-minute issues before they become costly production problems.
"There are process validation issues that have been common this year – they just continuously seem to happen," said FDA investigator Ben Dastoli in a presentation at MedCon 2019 in Cincinnati, Ohio. According to Dastoli, the most common process validation pitfalls include failure to identify all processes which require validation, ignoring variables or worst-case conditions, and insufficient statistical sampling.
Identify all processes which require validation
As FDA investigators walk through a facility, they review manufacturing instructions. Dastgoli has found that gluing, layer-crimping, and reagent mixing are commonly missed processes in pharma. “I always encourage all the managers at a company to walk the entire manufacturing floor,” he says.
Firms don’t always consider variables during validation studies, which means validation is ineffective.
Use sound statistics for sampling
Statistically significant sample sizes are determined by the risk level presented by a failure. FDA inspectors like Dastoli look closely to determine risk during an inspection, and that validation has been repeated enough times for “meaningful and consistent” results.
Test worst-case conditions
Identify variation, reliability, and repeatability across all components of the manufacturing process, including raw materials, components, and equipment.
Address validation failures
“As investigators, we often come across problems that are simply dismissed for reasons such as operator error,” says Dazstoli. If failures arise during the validation process, it’s crucial to investigate the true root cause and take corrective actions, including process revalidation if necessary.
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.