Is your company vulnerable to recalls, reputational damage, and regulatory issues because of quality management process problems? A single major product recall in the life sciences industry can cost $600 million in recall processes and warranties. This $600 million price tag can double quickly when you account for lawsuits.

The life sciences industry is littered with stories of companies that failed to take their own quality management pulse. Recently, a California-based medical device manufacturer filed bankruptcy just two days after announcing a 510(k) device clearance. AirXpander’s product had been suspended in Australia after four years of market approval, due to a possible link with anaplastic large cell lymphoma. The costs of this quality issue were simply too high to absorb.

Quality management process failures occur long before life sciences companies face worst-case scenarios such as patient harm, reputational damage, or bankruptcy. Recognizing and reacting to the top six signs of quality process issues is your ticket to taking a safe product to market.

6 Indications Your Quality Management Process Is Dysfunctional

It’s dangerous to take the attitude that your quality management process is “good enough.” A system that’s sufficient during the startup or scale-up stage of your company’s lifecycle could break as soon as you start to grow.

A paper-based document system might be functional for now, but it’s a risky bet as you expand. If an FDA auditor surprises you with an inspection, will you be prepared to pass the audit? Or will you find yourself rushing to hide outdated documents or scrambling to find the current ones?

A dysfunctional quality management process can be corrected if you know the signs to look for.

1. You Aren't Audit-Ready

Only 38% of medical device professionals are "very confident" their company could pass a surprise inspection, according to a 2019 survey. That’s an 8% decrease in regulatory confidence compared to 2018. Organizations worry the most about documentation compliance, including traceability, design files, and audit trails.

While the same study shows 15% of industry pros are confident they’d fail a surprise audit, most (47%) aren’t quite sure if they’re compliant.

If you’re unsure of audit readiness or struggling to achieve true quality, it’s wise to measure yourself against industry best practices and benchmarks. Assess how your company stacks up for risk of adverse findings, readiness to scale, and other best practices by taking Qualio’s simple, self-guided 20 question Quality Score survey.

Where are the cracks in your quality processes? Get your Quality Score now. New call-to-action

2. You're Still Using Paper

The FDA frequently cites documentation failures in warning letters. In early 2019, an India-based drug manufacturing facility was cited for “failure to establish an adequate quality unit,” including the use of paper-based systems.

  • cGMP documents were observed being “shredded in an uncontrolled manner.”
  • A binder of documents was hidden in a 55-gallon drum in the facility scrap yard.
  • Paper documents were disposed of without review by the quality unit.

The FDA’s findings weren’t the first warning to this manufacturer. The result was deferred approval for 10 pending drug applications. While this example is extreme, it’s still a valuable lesson about appropriate document management. Paper systems can quickly become an unmanageable barrier to compliance and quality. It’s much easier to lose or overlook documents and required signatures if you’re routing binders through the organization.

Paper systems may appear to work, but they can quickly become unmanageable as life sciences startups and scale-ups grow. The right time to address the risks of paper is long before you’ve found yourself stashing non-compliant binders with the trash. The best QMS software options centralize documents and create simple workflows for gathering compliant signatures and approvals.

3. You Don't Know Where Your Quality Policy Is Located

A 2018 FDA warning letter to an Austrian drug manufacturer cited numerous missing quality policy documents, including a complete absence of SOPs for:

  • Process validation
  • Cleaning validation
  • Packaging
  • Labeling
  • Line clearance
  • Sampling
  • Change controls
  • Deviations

The organization had no master records for production, which meant they had no way to ensure batch consistency. Employees were working without any quality guidance or benchmarks, which resulted in an Import Alert on the company's drug product.

Most process breakdowns aren’t the result of completely missing information. More often, it’s a result of access issues. This can occur really easily if you’re relying on shared cloud folders, an intranet, or paper systems to manage your quality policies. Your cloud folders can quickly become a mess when documents are saved to the wrong place, or someone forgets to name a file correctly. Before too long, employees are working off outdated documents, or worse, flying blind since they can’t find their SOP.

Across industries, the average employee spends 2.5 hours each day searching for information they need to do their job. In life sciences, each wasted hour searching for SOPs can spell a loss of competitive advantage. If an inspector asks to see your quality policy and you can’t find it, it can also result in a citation. Get ahead of document access breakdowns with a QMS system that offers version control, keyword search, and document tagging, so finding a policy is never an expensive issue.

4. Your SOPs Aren't Available at Points of Use

Your organization is required to ensure that SOPs are available at the point of use. If FDA inspectors observe employees working without SOPs or employees using outdated SOPs, you could receive any number of warnings for “failure to follow a process.”

It’s possible to comply with paper, but it’s not practical. Many companies distribute books of “official” SOP copies to each employee. This can meet regulatory requirements if you keep these binders up-to-date, but it’s expensive and time-consuming to go this route.

Making SOPs available at the point of use is easiest with electronic systems, such as an eQMS that complies with all Part 11 requirements for secure access, audit-readiness, and eSignatures. Cloud-based QMS can provide an advantage for laboratory employees with mobile applications that can be conveniently accessed via tablet or smartphone in the workspace.

5. Quality Is One Person or Division's Job

"Every single one of our employees, regardless of role, knows that quality is non-negotiable,” says Medtronic’s Product Quality statement. In Fiscal Year 2018, 95% of Medtronic’s global employees at 350 locations in 150 countries completed the Annual Quality Training Certificate.

Medtronic is the largest medical device manufacturing org in the world. On their quality policy page, they state, "we manufacture safe, high-quality products not only to further our Mission, but also to build trust, reduce reputational risk, and improve operational efficiency."

Notice that they didn't say, "We manufacture safe, high-quality products to pass FDA inspections." Medtronic also doesn’t say, “our quality unit knows that quality is non-negotiable.” They focus on quality management because it’s a winning move for their patients and profits.

Quality frameworks have begun to emphasize the value of quality-driven culture. ISO 9001:2015 highlighted leadership’s responsibility to create, maintain, and promote a QMS. If quality isn’t a focus of every employee in the organization, you’ll struggle to achieve the kinds of continual improvement activities needed to win in a competitive marketplace.

6. CAPAs are Too Frequent or Open Too Long

Last year, CAPA deficiencies were the single most common reason the FDA issued warnings to life sciences companies. One device manufacturer was cited for ineffective CAPA because they failed to adequately monitor data during a two-year period of corrective and preventive action. The company failed to notice that several measurements fell below quality thresholds.

CAPA issues aren’t always egregious. In many cases, they’re the result of busy staff who overlook open investigations or QMS software that makes it hard to monitor data across quality processes.

Some of the most common signs a quality system is failing are CAPAs which are left open for too long without resolution. Repeat process failures is another red flag to inspectors since it can indicate you’re not looking at the big picture. Finally, too many CAPAs aren’t always a good thing. An abundance of open CAPAs could indicate that you’re not really getting to the root cause of quality events.

A CAPA management software like Qualio can simplify tracking and investigation and helps you understand big-picture quality trends in real-time, so you can respond proactively before a non-conformance becomes a quality complaint.

Future-Proof Your Quality Management Process

The best way to fail-proof your quality management process is to proactively solve common issues before they spiral into customer complaints or product recalls. Adopting an eQMS that’s purpose-built for the life sciences industry can mitigate the most common process-based risks like missing documents or CAPA disasters.

The Qualio eQMS is specifically designed to meet the needs of startup and scale-up life sciences companies. These types of organizations need a QMS software that is simple, easy-to-use, and scalable. Learn more about the Qualio solution here.

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