By Scott Durlacher, Navigant Consulting
While written procedures are required under FDA’s Quality System Regulation (QSR), even the most well-written procedures are collections of words that are often inscrutable and, when taken as a whole, difficult to understand at a systemic level. To better understand your own company’s quality system, I recommend process mapping to generate a visual depiction of that quality system.
Visual tools, such as flow charts and process maps, can present a significant amount of information in an easy-to-digest format. Furthermore, people tend to retain information better when it is presented visually. Flow charts, process maps, and other visual tools not only hold value for existing management and employees, they also help to bring new employees — or existing employees in new roles — up to speed in an effective, efficient manner. Finally, and most importantly, proactive use of process mapping and visual aids to understand your quality system can help to ensure better inspection outcomes.
A Classic Scenario: 483 In Hand, What To Do?
An FDA Investigator has just walked out the door and left you holding a 483 with multiple observations. You ask yourself, how did we get here? The answer is not always easy, and may be the result of a combination of factors. However, rest assured that it did not happen overnight, and thus will not be resolved overnight.
As an FDA Investigator told me a few years ago during an inspection, “once is an anomaly, twice is a coincidence, and three times is a trend.” If an observation escalates to the point of a 483, it is often the result of the investigator seeing a trend, which raises concerns about the adequacy of one or more quality system elements. As soon as that FDA investigator leaves, the focus must shift to addressing the 483 findings. Various approaches may be used, but each typically consists of:
- Execute an assessment of risk and impact
- Determine if any immediate actions or interim measures are necessary
- Identifying the root causes
- Create corrective action plans
Addressing a 483 observation is an involved, disruptive, and costly undertaking. Remediation activities are time consuming, requiring multiple resources to take on additional responsibilities above and beyond those normally required by their role.
An Alternate Scenario: Be Proactive
What if a company invested the same effort and rigor into the development and monitoring of its quality system as it would commit to 483 damage control? What if the company, through the use of process mapping and visual aids, truly understood its own quality system before an FDA inspection?
I ask because issues identified by FDA and documented in a 483 are often systemic. Process mapping is a valuable approach for getting an overall picture of a system, and helping to identify weaknesses and breakdowns in the system. When mapping a quality system element that has been identified as deficient by the FDA, it sometimes becomes painfully obvious why there were issues.
A best practice is to proactively map what your procedures say, what the people doing the work say, and the actual FDA requirement. Ideally, these all align. However, in practice, they are sometimes significantly different, resulting in inefficiencies and risks to your business.
Process mapping is not limited to identifying issues, though. It can also be leveraged, when developing a quality system, to help ensure that all processes operate in an optimal state. Think of the quality system like the back of a pocket watch, in that all the components must fit together and work in harmony for it to function optimally. Focusing on only one component, without understanding how it fits and interacts with the other components, will result in a sub-optimal system.
For example, when mapping a corrective and preventive action (CAPA) process, it is important to capture how other processes (or components) — such as risk management, nonconformances, complaint handling, internal audits, and purchasing controls — interact with the CAPA process to ensure the efficient and effective flow of information. It is also important to note that some processes — for example, document control, records management, training, and change management — are foundational and support all quality system elements.
But, before process mapping and developing an appropriate quality system, it is necessary to clearly understand your business’ strategic goals and objectives, since these will impact how the quality system is structured and where emphasis should be directed.
Picture your business as a table: The table top represents the business strategy, and the legs represent the supporting elements (systems and controls; infrastructure and facilities; management and resources; finances and legal). These legs must not only support the table top, but they have to withstand outside forces pressing down on the table top, such as competition and changing regulations. If any leg is weak, then the table top will not be stable. In other words, there is an increased likelihood that desired business goals and objectives will not be achieved. Other potential issues include breakdowns in knowledge and data management, employee dissatisfaction and turnover, and compliance risks.
Continuous Improvement Is Key
Once business goals and objectives are clearly understood, direct your attention toward developing and implementing an appropriate quality system that focuses on continuous improvement as a core value. There are four phases to continuous improvement: Identification, Reaction, Proactivity, and Monitoring.
Issues can be identified through a number of channels, including internal audits, third-party audits, complaints, and nonconformances. Once an issue is identified, the business reacts. This can include containment, immediate actions, interim measures, root cause analysis, corrective actions, and remediation. Following remediation of the identified issues, the business (ideally) is proactive and takes preventive actions to drive toward sustainability. It is at this point that the business achieves operational efficiency, improved resource utilization, and increased profitability. The final phase, and potentially the most important, is ongoing monitoring, which provides a closed-loop feedback system to ensure the processes in place are functioning properly, and to help identify any potential issues.
Proactive Mapping vs. Reactive Remediation: Which Do You Prefer?
With so many benefits, why is it that many companies remain averse to using visual tools? Generally, the rationale seems to be that an existing word-based quality system already is in place, and the company does not want to take the time to update to something more visual. Many companies are content to make incremental updates, failing to realize that the quality system is dynamic (see the four phases of continuous improvement above). However, market demand, organic growth, and acquisitions can quickly outgrow the original quality system, rendering it inadequate to effectively support and protect the business. The result is increased business and compliance risk. In such cases, it is not a matter of if, but when there will be a breakdown.
Thus, whether you are developing a quality system for the first time or addressing an existing quality system’s shortcomings, brought to light through internal monitoring or third-party audits, utilization of process maps and other visual tools — combined with incorporating the four phases of continuous improvement — can be the difference between the business thriving or simply surviving. Which would you prefer?
About The Author
Scott M. Durlacher is a Director at Navigant Consulting, Inc., providing guidance and assistance regarding FDA regulatory compliance and quality system matters for clients ranging from startups to multi-billion dollar international corporations. Scott has over two decades of diverse industry and consulting experience, including serving in senior regulatory, quality, engineering, and operations roles in the medical device, biotech, and biologics sectors. He holds a master’s degree in mechanical engineering from Purdue University and a bachelor’s degree in biomedical engineering from Vanderbilt University; Scott also is a member of the Regulatory Affairs Professionals Society, Drug Information Association, and the American Society for Quality.