Quality Event Management 101: 5 Best Practices

The question “what to do when things go wrong” lies at the heart of quality event management (QEM). It comes down to both science and art. It requires a sophisticated statistical skill set and involves a lot of experience to design quality management processes and execute them efficiently.

I recently spoke with Cassie Wulle, a quality director for a large, Salt Lake City-based medical device designer and manufacturer. She used a slightly different analogy. “It’s like a pinball in a pinball machine,” she said. I see her point and the accuracy of her comparison. QEM may appear random and reactive with a number of moving parts and players. But it’s really about focusing resources to guide the ball as it moves through various obstacles and safely deliver it directly into the goal.

It isn’t helpful to try and reduce the scope and complexity of QEM with a quick list of how-tos , especially if you’re not actually in the trenches. However, this article will break down some foundational definitions and concepts for those who may be new to the industry or are searching for new solutions to reduce their work burdens.

General Quality Event Management Definitions

• A quality event is essentially an occurrence that a) threatens the safety or efficacy of a product or reveals it, or b) threatens the intended outcomes of a quality/manufacturing process or reveals it. “What I see a quality event being is any event that impacts quality in some way that requires action, resources, investigation, organization, and documentation,” Wulle said. Quality events should serve as a flag for potential quality problems, merit scrutiny, and may require remediation to prevent enforcement actions.
• Quality event management is the development and execution of formalized workflows to identify, contain, investigate, resolve, and prevent said quality events. That’s just the visible half of QEM. The invisible half is the experience and expertise that a skilled quality professional brings to the table. QEM involves the coordination of various quality subsystems, processes, and personnel.

Common Quality Event Processes in Regulated Industries

Trying to standardize processes and even the terminology for each event is a useful exercise that makes it easier to work from the bottom line of codified regulations. However, QEM remains a subjective science and the interpretations of code and the exact terminology used can vary from one organization or professional to the next. Often, one quality event is closely related to another, which blurs the distinctions.

The industry you work in and even the specific company that you work for will determine the types of quality events that you encounter. Some events may be specific to certain phases of the product life cycle. Other issues are not actually product related. Events may relate to materials, products, processes, personnel, or even the quality management system (QMS) itself.

Deviation

A deviation occurs when someone or something doesn’t follow a written procedure. The U.S. Food and Drug Administration’s (FDA) regulation outlining production and process controls for finished pharmaceuticals states that, “written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.”¹ Written production and process control procedures are designed to assure product safety and efficacy. Any occurrence that deviates from the written procedures must be recorded and justified – or corrected if necessary. Unintended and unaddressed deviations may lead to other quality events. Deviation management is a common task when you are trying to keep any system in control. Remember the pinball board.

Out-Of-Specification

A specification is any pre-determined parameter with which a product, process, service, or other activity must conform.² Failure of an ongoing analysis, a laboratory test, a finished drug, medical device, label, or package to meet its specifications means it deviates from standard expectations and is “out of bounds.” This increases the likelihood of missing the goal. Any out-of-specification (OOS) must be reviewed, evaluated, and investigated. If your quality event management process proves an OOS, it may require that you trigger a nonconformance.

Nonconformance

Nonconformity means the nonfulfillment of a specified requirement according to the FDA’s quality system regulation (QSR) for medical devices.³ Any defective material or product from a supplier on through manufacturing that fails to meet specifications falls into this category. Each manufacturer is required to “establish and maintain procedures to control product that does not conform to specified requirements.”⁴ Nonconformance software allows quality professionals to do just that. Without a concession or rework, a nonconformance could mean game over for the actual nonconforming material or product. Consequently, disposition is a related process that often accompanies a nonconformance.

Customer Complaint

A complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device or other product after it is released for distribution. This is a postmarket concern that occurs downstream, directly impact customers, and consequently can take a very high priority. Complaints can seriously impact the cost of quality (COQ) because more time and resources have been invested at this point in the product life cycle. According to FDA regulations for both pharmaceuticals⁵ and medical devices,⁶ companies are required to maintain complaint files that show they have received, reviewed, evaluated, and processed complaints in a uniform and timely manner.

Corrective Action/Preventive Action (CAPA)

Depending on the severity or systemic nature of an event, you may need to initiate a corrective action/preventive action (CAPA). A CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future. There are two primary objectives for any CAPA. First, to determine why a quality event has occurred. Second, to prevent it from happening again. The FDA outlines procedures for CAPAs pertaining to medical devices in 21 CFR 820.100.⁷ These procedures can effectively be applied to quality events generally before they reach critical mass.

Reviews

After a quality event (or issue) occurs, it is necessary to review how it was handled. An issue review is an opportunity to target specific areas of your QMS and how they interrelate. Have you truly achieved closed-loop quality or is an event still disrupting operations? It is helpful to have some sort of event analyzer to identify related and recurring events and weigh their impact. Regulated companies must undergo periodic quality management reviews (QMRs), which entail scrutinizing a QMS, along with any issues, in its entirety.8 Reviews are a great opportunity to focus on continuous improvement.

Top Quality Event Management Pain Points

When I asked Wulle what she considers to be the top pain points related to quality event management, she answered, “The fact that they occur at all.” Yet, they inevitably do. She went on to explain that even though the events are unplanned, they still require timely and comprehensive action, the mobilization of qualified personnel, and the utilization of other resources. Appropriately resourcing events and ensuring personnel are properly trained in QEM is challenging because the skills of investigating root causes, analysis, and coming up with effective corrections are difficult to train on.

Forecasting and foreseeing problems is another challenge she highlighted. Statistical process control (SPC) is an essential tool. But quality personnel also must ensure they’ve covered each step of the process, evaluated the impacts, and considered any possible failures that can occur. “Being thorough,” as she calls it, is as much a matter of being able to see what’s missing as seeing what’s there. It’s an ongoing task of redesigning the process as you go.

Best Practices for Quality Event Management

Certain approaches can help quality professionals practice more efficient quality event management.

1. Continually monitor QEM processes to be thorough. Ideally, resolve problems early in the product life cycle. Standardize your QEM procedures with best-practice templates wherever possible yet keep them dynamic enough to match the unplanned nature of events. Don’t ignore the small stuff that can balloon into a critical issue.
2. Go back and evaluate the effectiveness of your efforts. Evaluation criteria should be based on the specific root cause. Are they measurable, achievable, realistic, and effective over a defined period of time?
3. Find the balance of software automation and skilled resource allocation to discover and effectively manage quality events when they occur. Preserve your quality resources with automation and optimize your human resources with adequate training. Be prepared to mitigate unique or novel problems.
4. Adopt an attitude of risk management that filters through every quality system and every quality process all the time. Each action or change must be measured against risk and reward. Design your quality event management processes to leverage your company’s proven processes, culture, and strengths.
5. Ensure your QEM practices align with executive business objectives. Establish open communication both horizontally and vertically to establish a culture of quality and support closed-loop quality event management. Reduce duplication of efforts and increase their visibility.

Digital Quality Event Management Tools

Thorough quality event management typically spans various management systems and activities, including supplier management, audits, document control, training, change control, postmarket surveillance, and even validation. “That would take a pinball wizard!” I hear you saying. Depending on the size of an organization, it can actually take several.

An integrated quality event management software solution allows companies to connect key quality channels and personnel more easily across the organization, both upstream and downstream throughout an entire product or process life cycle. Each channel and/or phase generates useful data. Once it is recorded electronically, it can be used for analysis and problem solving.

Customization Is Key

As skilled quality professionals use their expertise to refine their processes, they need tools that can match it. By adopting advanced process solutions, quality organizations can move closer to achieving the level of digital maturity necessary to support their quality management maturity. When asked what important features efficient quality event management software needs to have, Wulle replied, “More and more customization is available. We’re able to create something that’s perfect for us so that we can continually grow.”

Digital tools allow quality professionals to make quality event management more efficient in the following ways:

• Update and centralize documentation that everyone can access.
• Automate workflows with enhanced or dynamic options, data thresholds, and preset values.
• Use compliant electronic signatures to support remote reviews and approvals.
• Expand and automate training capabilities to remain compliant and achieve business objectives.
• Reduce and resolve non-critical events earlier and link directly with corrective and preventive action software when escalation becomes necessary.
• Revisit and analyze past and current quality events as well as track, trend, and predict more easily.

Conclusion

Proficient quality event management takes practice. No single process necessarily follows the same path as another. However, it gets a lot easier with the right tools. Purpose-built quality software solutions are designed to reduce the number of quality events that can adversely impact your CAPA system. At the very least, an electronic document management system gets everyone on the latest version of the same page.

Digitizing and automating QEM where possible will allow you to work toward resolutions more quickly. Finding a quality event management software solution that allows you to efficiently execute the primary objectives of QEM is a valuable resource. Investing in the right solution will ultimately lead to a more efficient quality management system upstream and consequently reduce the cost of quality down the line.

References:

1. 21 CFR 211.100, U.S. Food and Drug Administration.
2. 21 CFR 820.3, U.S. Food and Drug Administration.
3. Supra note 2.
4. 21 CFR 820 Subpart I, U.S. Food and Drug Administration.
5. 21 CFR 211.198, U.S. Food and Drug Administration.
6. 21 CFR 820.198, U.S. Food and Drug Administration.
7. 21 CFR 820.100, U.S. Food and Drug Administration.
8. 21 CFR 820.20, U.S. Food and Drug Administration.