Keep It Clean
Keep It Clean
What would an FDA inspector think if he walked into your dental lab and knew that you were manufacturing something for his mouth? Most dental labs ensure that their equipment is well-maintained by having preventive maintenance schedules and performing required preventive maintenance, but how about the maintenance of your overall facility?
An article in a recent Quality Progress magazine really caught my eye. It told a story about an FDA investigator arriving at a facility to perform an inspection. After the initial opening meeting the inspector asked for a tour of the facility. As they entered the warehouse area they observed a lizard and a mouse in the warehouse area. The investigator then toured the manufacturing area and saw unshielded overhead fluorescent lights directly over manufacturing areas, cartons of raw materials and finished product sitting on the floor, signs posted that hairnets were required, but not everyone was wearing one, and also filthy floors and cluttered areas. If this wasn't enough the inspector then asked for a maintenance person to help him lift some ceiling tiles to check conditions above the tiles. Lo and behold, what did he see - six decomposing mice, an infestation of flies feeding off the mice and a nest of cockroaches. According to this article, the inspector announced that the inspection was over, but after speaking with his manager, he would report back within 24 hours. He returned later that afternoon with a federal marshal who asked everyone to vacate the building and then padlocked all of the doors.
Since you are manufacturing regulated products, it's critical that you pay close attention to the overall cleanliness of your facility. FDA''s Quality System Regulation is quite clear on this requirement in Sections 820.70 (b) Environmental control, (e) Contamination control, (f) Buildings and Section 820.150 Storage.
- Environmental control. 820.70(b) states that each manufacturer shall establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality.
- Contamination control. 820.70(e) states that each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.
- Buildings. 820.70(f) states that the building shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.
- Storage. 820.150 states that each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution.
Here are some areas to consider when assessing whether or not your quality system is properly addressing cleanliness of your facility:
- Do you have a pest control service for the inside and outside of your building?
- Are workbenches cluttered?
- Is your facility designed to provide sufficient space for operations?
- Is dust visible on countertops, workbenches, shelves, equipment, pipes?
- Are patient contact materials such as porcelain left on workbenches in open containers during the work day and after workers leave?
- Is contamination of materials a likelihood in your work environment?
- Are materials requiring environmental controls maintained within those controls?
- Is your cleaning service or cleaning staff trained on the use of harsh chemicals where they could contaminate materials and/or product?
- Are your HVAC and other suction systems on a regular maintenance schedule to ensure change of filters regularly?
- Do your workers complain about the cleanliness and/or cluttered condition of your facility? If so, what have you done to correct the situation?
Perform an audit of the sections of the Quality System Regulation noted above. Then use the nonconformances discovered during that audit to implement corrective actions that will maintain an acceptable overall clean facility environment. It might even increase the morale of your workers and make it a safer place to work.