True inspection readiness is about the integrity of a company’s entire system.
In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often, companies scramble to head off issues when an inspector shows up. This might get you through the immediate inspection, but it is a short-term fix that can perpetuate more significant issues down the road.
In my work at Life Cycle Engineering, where I advise clients on improving operations, I emphasize that true inspection readiness is much more than just making sure equipment is running. Rather, it reflects the integrity of a company’s entire system.
The state of a company’s maintenance and reliability programs, from documentation to operational processes, serves as a vital indicator of its overall health. A plant that lacks these supporting elements will likely be in a state of substandard performance, which manifests in inconsistent equipment availability, low throughput and subpar product quality—and high levels of stress when the FDA inspector shows up.
At the heart of inspection readiness is one simple idea: stay proactive. Your assets and people need to be dependable, not only to pass inspections, but to consistently ensure safe, high-quality products reach patients. Ultimately, cutting corners or running subpar maintenance programs can lead to recalls, unexpected shutdowns and, most critically, potential harm to patients.
The Cost of Reactivity
A reactive plant often has processes, people and documentation that are not up to par. This includes insufficient training, poor documentation and parts management and inadequate organizational structures for work review. When inspectors arrive, they aren’t just looking at the equipment but rather assessing these program elements to determine the overall health of maintenance and reliability programs. Gaps can be quickly exposed, leading to citations, corrective actions or costly downtime.
I’ve seen indicators missed numerous times. At one facility, a process pump installed by a technician didn’t have all of the shipping materials removed, and those materials degraded over 3–4 weeks, contaminating the product. The net result was a market value loss of over $30 million. A lack of proper technician training and spare parts handling were contributing factors to this event. An FDA investigation of the incident showed program gaps that had led to critical products not being available to patients. If this practice had recurred at the site, it could also have led to a regulatory finding.
The takeaway here is clear: Waiting for a problem is riskier and far more expensive than preventing it in day-to-day operations. Identifying red flags or poor health indicators is a key component of staying ahead of an operational system. If you have questions about your processes, colleague training or quality of your documentation, your plant may not be inspection-ready. It is worth investigating to head off a full-blown crisis.
Anatomy of a Healthy Program
When assets are in top condition and all supporting elements are aligned as a result of a robust compliance program, employees can focus on improving processes, ensuring data accuracy and delivering consistent, high-quality products. True readiness comes when proactive reliability programs are part of everyday operations and teams view inspections not as a stressful exam, but as a routine and holistic check on the business.
A proactive inspection program starts with control and accountability. The health of a program involves multiple, equally important elements:
- Clear organizational governing procedures consisting of organizational charts, role-specific job descriptions and clearly defined program elements.
- Data-driven reliability strategies such as calibration and maintenance plans, material management, condition-based monitoring, planning and scheduling, and accurate CMMS/CCMS data.
- Solid maintenance and calibration schedules executed consistently by trained personnel.
- Robust documentation and auditing practices that go beyond mandated requirements, including systems for tracking potential product impact, managing change control and ensuring compliance through transparent, readily available records.
These elements work together to provide a clear picture of operational well-being and help leaders catch issues early, before they become regulatory findings. While perfection is not needed, a commitment to consistent self-assessment and monitoring of internal programs and processes is. When an issue does arise, it should be documented thoroughly, with an action item implemented to close the gap.
This proactive approach shifts the dynamic significantly. If an inspector identifies a similar gap, it’s a much more productive conversation to state that you self-identified the issue and are already working to remediate it. This turns the inspection from a reactive scramble into a confident confirmation of operational excellence and a demonstration of your continuous improvement program.
Staff play a major role in this program, and their role should not be overlooked. Technicians and operators are the people closest to the equipment, so their training programs are a core element of a plant’s operations. Their engagement is crucial in partnering with quality teams to explain the why and how behind inspection readiness. Further, opening up lines of communication for feedback is crucial, as these individuals or teams may be the first to communicate red flags pointing to poor program health. Additionally, their insights often uncover opportunities to improve processes, reduce risk and optimize performance. Including technicians and operators in proactive walkthroughs and readiness tours can keep them engaged and make compliance a true group effort.
Proactive inspection readiness goes beyond the health of equipment and truly benefits every part of an operation. By contrast, reactive approaches may get a site through a single inspection, but they leave plants vulnerable in the long run. The central element of operational excellence is embedding reliability and compliance best practices into a company’s DNA.
