Medical Device & Diagnostic Industry
Magazine [3]
An MD&DI July 1997 Column
HELP DESK
FDA's new quality system regulation emphasizes employee training more than ever before. To satisfy the agency's new requirements as well as produce quality products, companies must evaluate almost every aspect of their operation and develop a training program before instructing new hires, explains John E. Lincoln, principal of J. E. Lincoln and Associates (Tooele, UT).
How can one define training requirements for manufacturing departments, determine who is a qualified trainer, and document fully that an employee is trained and qualified to perform a manufacturing task?
According to regulatory agencies such as FDA, medical device manufacturers must define and document how they meet regulatory requirements. FDA's new quality system regulation, specifically 21 CFR 820.25(b) Training, states, "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions."
ANSI/ISO/ASQC Q9001-1994 states, "Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training, and/or experience, as required."
With these guidelines in mind, companies should design their training system to meet their specific needs as well as the environment or culture in which it will work. Designers should consider company size, the degree of top-management support, the risk of the operation to product safety and efficacy, the available employee pool, employee skill levels, and the growing cultural and language diversity in the workplace.
How can one define training requirements for manufacturing departments?
First, consider product and process (the technology):
- Evaluate nonconformance and complaint data on the same or similar products or processes to look for common problems.
Next, evaluate personnel (the human-to-human, human-to-process, and human-to-product interface). At the very least, include and implement the following as part of a facility's written procedures:
- Job descriptions for each major position, based on the product and process analysis listed above.
Such training should be conducted with new hires or internal transfers immediately, and continuously and periodically thereafter, with the amount, type, and interval of training determined by data and desired results.
How can one determine who is a qualified trainer?
Companies should develop and implement a defined "train-the-trainer" program. Do not rely only on individuals who currently perform the activities to train replacements; this may perpetuate mistakes, faulty techniques, and folklore. Training should draw from a knowledgeable source as much as possible, whether that is the current operator, the department supervisor or manager, R&D personnel, the product or process engineer, or sales and marketing representatives--whoever is most familiar with the product or process at the point or points where training is required.
Training must address the reasons why an activity is required, and its downstream results. Such reasons should be part of the design history file and the device master record product or process database (drawings and standard operating procedures). As much as possible, such information should be codified in computerized or written form, under change control, with at least one of the signatories being the most knowledgeable as to why a task is necessary (the original source, if still available).
The trainer's trainer should be qualified by education or experience and may be in-house or external. Reasons for selection should be documented. The next tier of trainers should show documentation of periodic training by the trainer's trainer. Newly trained personnel should provide written appraisals of training received, and then be closely monitored by a team, supervisor, or other experienced operator in the position to help evaluate effectiveness of the trainer and the training.
How can one document fully that an employee is trained and qualified to perform a manufacturing task?
As mentioned above, human resources or the department supervisor or manager must maintain written records of the employee (name, employee or social security number, etc.), description of training received, trainer, date, and the time and location of training. If training is not specifically defined by standard operating procedures or a similar document, a copy of the lesson plan or agenda should be part of the file. Again, such records should be reviewed whenever a person is transferred to a new area, assigned another responsibility, or reviewed annually. Such review should be documented with a signature and date. The employee should be given the chance to check the accuracy of his or her record periodically.
Continued monitoring of process or product performance by manufacturing, quality systems (quality assurance), or engineering is required. Companies can use control charts, Pareto analysis of the number of defects per million, nonconformance reports, or field data (service records and complaints) and trending. Annual quality systems regulation compliance audits can be used to prove the effectiveness of training, and to document the abilities and qualifications of all personnel, as well as to indicate where adjustments and resources are needed.
The goal of any in-house program should never be just to meet a regulatory requirement or management quality mandate. The goal should be to develop systems and personnel capable of making defect-free products that safely and effectively meet customer needs and expectations, while reducing falloff, rework, and time to market. If done conscientiously and repeatedly and if documented, training can reduce a company's potential product problems and regulatory exposure, while providing measurable indicators of improvement and growth.
"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives [4]. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail helpdesk@devicelink.com [5]. You can also use our on-line query form [6].
Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.
Readers are also encouraged to send comments on the published questions and answers.