Part 1 considered the inspection process. We now turn to the specifics of what FDA investigators generally focus on during a plant inspection.
Because there are no record keeping requirement in the umbrella CGMPs (21 CFR 110), investigators must rely entirely on can be observed directly or deduced from samples collected during an inspection, unless they demand records under the Bioterrorism Act of 2002 (www.fda.gov/oc/bioterrorism/Bioact.html). In the case of acidified and low-acid foods, they can supplement and support their observations from an examination of the required records. In all cases, however, investigators are well trained to look, listen, and draw conclusions from what they see and hear. The following lists those things for which investigators typically "look and listen". For more information, the reader is referred to the FDA Investigations Operations Manual, Subchapter 5.4 (www.fda.gov/ora/inspect_ref/iom/pdf/chapter5.pdf). The issues that follow are keyed to the relevant sections of the umbrella CGMPs.
110.10 Personnel
Identity of owners, partners or officers, and management officials/employees involved in the inspection
Attitude and actions of employees discharging their duties
Employee dress and cleanliness
Health of food-contact employees
Unsanitary employee practices
What employees tell the inspector
Employee education and training
110.20 Plant and grounds
Environmental factors that may contribute to rodent, bird, insect, or other sanitation problems
Design and condition of buildings
Toilet facilities
Company attitude toward maintenance
Waste and garbage disposal
Methods for preventing waste materials from being mingled with raw materials
Disposition of waste containing pesticide residues
Removal of moisture (condensate) and oil from central compressed air supply
Undrained loops in central compressed air supply
Standing water
110.35 and .37 Sanitary operations, facilities, and controls
Condition and appearance of the plant
Cleaning and sanitizing materials and their storage
Pest control program and effectiveness
Cleaning sanitizing of food contact surfaces
Adequacy of the water supply and plumbing
Floor drainage
Sewage disposal
Hand-washing and toilet facilities
Hand sanitizing stations in the manufacturing area
Rubbish and offal disposal
110.40 Equipment and utensils
Condition before processing begins
Cleaning of filtering systems
Sanitary condition of equipment
Prior history and cleaning procedures for leased equipment
Residue on conveyor belts
Cleaning, sanitizing, and storage of cleaning implements
Effectiveness of cleaning practices
Placement of mercury thermometers and light bulbs
Monitoring and replacement of UV lights
Nature, frequency, supervision, and effectiveness of sanitizing practices
110.80(a) Raw materials
Storage – pattern, rotation, housekeeping, accessibility for inspection, evidence of infestation
Handling procedures
Inspection practices
Use of “Food Chemicals Codex” to assure the use of only food-grade materials
110.80(b) Manufacturing processes
Whether and how hands and equipment are sanitized after contact with unsanitized surfaces
Methods for re-using scrap materials – e.g. soaking or hand kneading – to protect from microbial contamination
Ingredient handling -- contamination with filth; effectiveness of cleaning and inspection operations prior to or while adding to the process; lags during the process
Food additives -- legal; restricted to legal amount; packaging materials and waxes or chemicals applied to fresh fruit excluded during routine inspections
Color additives
Quality control -- inspection system; laboratory tests both on site and contracted; manufacturing code system
110.93 Warehousing and distribution
How well the food is protected during storage and transportation
Daily meetings with the investigator provide an opportunity to learn early in the inspection if the investigator has observed any CGMP deviations. Any deviations that can be corrected before the inspection is finished should be and the correction shown to the investigator (more about this in Part 3.)
Fred Hymes, Ph. D. has an extensive background in both general and quality management, and in the use of quality strategies to enhance performance through both breakthrough and long-term improvements. Prior to founding WFH Associates, Inc., Dr. Hymes was president and CEO of a small company; vice president, quality management of a multinational company; and general manager of a manufacturing and sales division of the same company.WFH Associates, Inc. provides expert assistance and training in the use of quality strategies and sound, cost-effective regulatory compliance to improve costs and gain competitive advantage. We assist companies seeking to implement an operational excellence process, improve product and/or service quality, obtain ISO 9001 registration, improve regulatory compliance, or upgrade their quality systems. Specific expertise includes: quality management and continual improvement; drug, medical device, and food cGMP compliance; and ISO 9001, ISO/TS 16949, and ISO 13485 implementation. You may learn more about WFH Associates at http://www.wfhassociates.com/Contact Dr. Hymes at http://www.wfhassociates.com/contact.php
