Numerous companies in recent years have received FDA warning letters that cite training deficiencies. The general statement found in these warning letters, prior to listing the specific inspection finding, is usually something similar to the following actual quotes:
- Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities; and failure to implement your training procedure, as required by 21 CFR §820.25(b).
- Failure to establish procedures for identifying training needs, ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). Specifically...
Why do companies receive warning letters that cite training issues? There are many reasons, including lack of oversight, lack of sufficient training funding, budget cuts, inadequate resources, lack of knowledge of training requirements, or simply being too busy to take the time to train and document.
The reason training is part of the Quality System Regulation (QSR) and ISO 13485 is that companies with adequate training manufacture higher quality products with fewer problems. This makes FDA happy and keeps customers satisfied, but it tends to upset product liability attorneys, since effective training may decrease their business. Training is just good financial business practice—regulatory compliance should only be a by-product.
In a down economy, one of the first things that clueless companies will scrimp on is the training budget. From the perspective of overall financial risk, this is ludicrous. Proper training will reduce the number of product defects, decrease product liability risks, improve efficiencies, and decrease the ancillary costs of defects (such as costs associated with CAPA, redesign, dealing with FDA in enforcement resolution and so forth). It will also keep customers returning, and improve morale by decreasing interdepartmental bickering and wasted time dealing with problems and compliance headaches.
All medical device manufacturers should implement an effective training program that shields them from receiving a warning letter that cites training. Follow these simple steps.
Set up a procedure that is followed and audited. It should be simple and straightforward and include these key activities:
- Assess each employee's training needs
- Plan how to provide and track the training that has been identified
- Implement the actual training and monitor its effectiveness
- Document the training each employee receives in detail on a form that can be easily audited during an inspection
- Track progress and reassess each employee's training needs periodically or whenever there is a change of position or task
- Audit the training records and compliance to the training procedure periodically and independently
To effectively implement training, it is important to consider the type of training that will be provided. There are generally two types of training: task-specific training (such as manufacturing instructions) and process-related training (quality system, design control, risk management, software quality procedures, and so forth). Usually, task-specific training is performed by a supervisor or someone who is knowledgeable about the specific manufacturing operation needed during production. Process-related training involves understanding and properly implementing processes or procedures. This type of training is most effective when everyone who is affected by the process is trained together in multidepartmental teams, for example. When everyone understands everyone else's roles and responsibilities, confusion and conflict are minimized. Process-related training can be done effectively onsite by using highly trained and experienced internal resources or by using expert external resources such as consultants or training companies. Individuals needing general process requirements training can typically learn about process requirements during training programs offered by external training companies.
In summary, FDA enforcement issues related to training and many other resulting enforcement issues due to poor or nonexistent training can be effectively eliminated by investing in and implementing a robust training program that will greatly benefit the company financially, with customer relationships, and employee morale.
Brent Noblitt is a Senior Partner and co-founder of Noblitt & Rueland, a 20-year old professional firm providing regulatory and technical training/consulting services to medical device manufacturers around the world. Consulting and training services provided include medical device FDA and international regulations and include quality system issues as well as submissions. Noblitt has a MS in bioelectrical engineering from Purdue University as well as an MBA from Pepperdine University. For more information about Noblitt & Rueland, view its listing in the Consultants Directory or go to the company's website.