Every year, commercial and research laboratories await the Food and Drug Administration’s (FDA) annual audit of their establishment’s compliance to the strict requirement guidelines. The FDA regulations for laboratory environments are based on the ISO 17025 standard, which focuses on the level of competency and consistency in lab methodology. For companies conducting laboratory research, the ISO 17025 standard applies to pipettes, dispensers, diluters, and burets. So how do labs meet the FDA standards in every aspect of their establishment? Adhering to FDA regulations and ISO standards requires commitment from every employee involved in the organization.
Even the most professional establishments need a reminder in the basics of FDA audit approval; there is always room for improvement. Here are 5 helpful pieces of advice to help your team stay one step ahead of the FDA:
1. Educate yourself and your staff: This may seem obvious, but a company can’t adhere to regulations and standards if it’s not familiar with what those regulations are! Make the regulations visible to staff members by sending them in an email or posting them in lab spaces around the office. The information should be easy to understand and accessible to everyone in the establishment. The education of FDA regulations ISO 17025 standards should not be a one-time occurrence; instead, the information should be emphasized regularly to ensure proper calibration procedures.
2. Provide product/equipment training and demos: Take the time to ensure all staff members are safely using the equipment and products they work with. Train employees on new equipment, familiarize them with the risks, and demonstrate the proper techniques to guard against human error and the improper use of equipment. Provide staff with an understanding of health and wellness, risk management, proper cleaning and maintenance, cross-contamination prevention, and necessary safety precautions. A well trained staff will decrease the number of workplace-related injuries and illnesses.
3. Keep detailed records: Should a workplace injury, illness, or error occur, be sure to take extremely detailed records of the specific event. Other events such as product replacements, device malfunction, recalled products, and renovations should also be documented. The purpose of keeping detailed records is to maintain workplace organization, prevent and resolve conflict, and document events. If organized well, records are easy to reference, inexpensive, and provide set documentation of a specific occurrence.
4. Keep your equipment in top shape: To adhere to calibration management best practices, it’s important to schedule routine servicing for all equipment and products to ensure their safety and productivity. Replace parts well before the end of the life expectancy and retire equipment that has reached its expiration. Be sure to remove all expired products from stock shelves to prevent them from accidently going to market, since outdated products and equipment can cause potential harm to employees and consumers.
5. Invest in CAPA: CAPA, Corrective and Preventative Action System, is a procedure used by a variety of industries and establishments. CAPA is intended to prevent error, maintain ISO 17025 standards, ensure quality, respond to complaints, make improvements, and keep companies prepared for FDA audits. CAPA can establish a daily routine of proper protocol that ensures companies are FDA audit-ready in a moment’s notice. Many companies have had success in gaining FDA approval through the use of the CAPA system, as it provides direction for how to obtain the high standards of regulation.
Educate, train, record, maintain, and invest. These are the 5 pieces of advice TTE Laboratories has to offer for those involved in clinical laboratory research and testing. Remember, the core motivation for making the daily effort to prepare for FDA approval is to provide a safe and effective product that supports public health.