STANDARDS OUTLOOK Keep It Clean Filthy facilities can sink an entire organization

TANDARDS OUTLOOK

Keep It Clean

Filthy facilities can sink an entire organization

by Les Schnoll
With all of the standards that have been around for decades—not to mention good old common sense—most organizations do a fairly decent job of maintaining their equipment through preventive maintenance and calibration.  
Unfortunately, many organizations fail to adequately assess their overall facility environment, forget or are unaware of the need to ensure their buildings are clean and well-organized, and meet organizational and regulatory requirements—until the arrival of an investigator from the U.S. Food and Drug Administration (FDA), Department of Agriculture or a state’s Department of Health.
Facility maintenance should be a higher priority, particularly for organizations that manufacture regulated products, such as medical devices, pharmaceuticals and food. I’ve crossed paths with organizations that have failed to pay close attention to these crucial areas of cleanliness, organization and compliance, and their stories usually are similar. The following example is cobbled together from those experiences and should serve as a cautionary tale.
It could happen
An FDA investigator arrived at an organization’s facility and announced he was going to perform an inspection. It had been a few years since someone visited, and an assessment of current compliance was sorely needed.
After the initial activities were completed—the presentation of credentials and applicable notice of inspection, as well as an opening meeting—it was time for a facility tour. As the director of quality and the investigator entered the warehouse area, they observed the following:

• Overhead and personnel doors were open.
• A lizard was inside the building adjacent to one of the open personnel doors.
• A mouse was sitting on top of a pallet of raw materials, munching on the contents of one of the cartons.

The investigator didn’t say anything at this point but asked to see the manufacturing area. As they walked through that part of the facility, they saw:

• Unshielded overhead fluorescent lights directly over manufacturing areas.
• Cartons of raw materials and finished product sitting directly on the floor.
• Signs posted throughout the area stating hairnets were required, yet no one in the area, including the director of quality and the investigator, was wearing one.
• Filthy floors and a cluttered area with no indication of proper storage.

The two proceeded to the finished goods warehouse. The investigator looked at several different products and noted the labels on the cartons identified storage conditions of between 65°F and 85°F and 25% and 40% relative humidity. There were no monitoring devices in the area, and when the inspector took out a thermometer to check the temperature, he got a reading of 92°F. He didn’t have a means to measure humidity, but it was sticky in the area, and there was condensation on the windows.
At this point, the investigator asked to have someone from maintenance help him lift a few of the ceiling panels so he could check the conditions above the dropped ceiling. A maintenance operator arrived at the warehouse with a ladder and removed three tiles, and the investigator climbed the ladder to see what was there.
Unfortunately, he found six decomposing mice, an infestation of flies feeding off the mice and a nest of cockroaches. The investigator announced the inspection was over. He said he needed to go back to the office and speak with his manager, and that he would report back within 24 hours.
Later that afternoon, the investigator returned to the site accompanied by a federal marshal, who asked everyone to vacate the building and then padlocked all of the doors. The investigator announced that due to the lack of equipment and facility controls, the regulatory agency was shutting down the operation until corrective actions were taken and their effectiveness confirmed.
What do you do?
After the initial panic subsided, clearer minds agreed serious corrective action was needed. A cross-functional team of personnel and external consultants was chartered to implement permanent changes to get the organization back into the good graces of the regulatory agencies. The team held its initial meeting and created the following list of actions:

• Train personnel in equipment and facility controls requirements.
• Select and approve a licensed pest-control operator to perform inspections at least monthly.
• Fully assess the facility to ascertain other potential regulatory violations.
• Develop a corrective action plan, and host weekly meetings to ensure the plan stays on target and that implemented actions are effective.
• Perform appropriate actions to achieve compliance in a timely manner and submit biweekly status reports to the regulatory agency so it knows its concerns are being taken seriously.
• Issue purchase orders for covers to place over fluorescent lighting in all areas to eliminate potential product adulteration.
• Rodent and insect-proof all doors, windows and other potential entry areas into the facility, and examine weather stripping to ensure it is intact and effective.
• Implement a 5S program to reduce and eliminate clutter.
• Issue purchase orders for stands and tables to be used for product storage, thus eliminating the need to store product directly on the floor.
• Deep clean floors, walls, equipment and ceiling to remove areas of infestation.
• Install new ceiling.
• Train personnel in the proper use of mandated clothing, such as hairnets, and revise personnel policy to include escalating consequences for failure to comply with organizational and regulatory requirements.
• Install calibrated environmental monitoring equipment—such as ones for temperature, humidity and particulates—with daily monitoring and recording of measurements.
• Initiate biweekly environmental monitoring audits.
• Include project updates during management review meetings, with associated action plans if the project does not stay on schedule.
• Assess management personnel to determine whether the right people are in the right roles, and execute personnel changes as required.
   

The consequences

The corrective action plan took six months to complete at a cost of $6 million (and counting). That included $500,000 per month in lost revenue, $750,000 in costs associated with the corrective action project, $2 million associated with recalling adulterated product and $250,000 in additional permanent personnel.
What could not be measured was the cost of bad publicity. The regulatory agency published the action, which was picked up by the media. As a result, the organization was constantly in the news for its contamination problems. Still outstanding are costs associated with lawsuits that continue to be filed by people who suffered health consequences associated with their use of the product or for pain, suffering and mental distress.
The regulatory agency performed a follow-up inspection after being informed by the company that its corrective action plan was completed and that it was ready to be assessed. Results of the follow-up inspection are still pending. Regardless of its outcome, however, the damage to the organization’s products, bottom line and reputation has been done.
Fortunately, it’s not necessary for your organization to share the fate of the one in this story. By performing regularly scheduled assessments as prescribed in regulatory documents such as Code of Federal Regulations Title 21,¹ you can ensure your facilities—and your reputation—remain spotless.

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Reference

1. U.S. Food and Drug Administration, Code of Federal Regulations Title 21, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.