Effective and Compliant Medical Manufacturing Training Programs

How many employees in your company have checked “read and understood” and signed a training record this year? Hopefully, they did indeed read and understand the procedure, but it does not mean they are competent in the activity or the training was effective.

In “Harry Potter and the (Philosopher’s) Sorcerer’s Stone,” Professor Flitwick starts class with a simple levitation spell and asks the students to levitate a feather. Seamus Finnigan read, understood, and recited the levitation spell (“it is LeviOsa, not LevioSA” – Hermione Granger), but he blew up the feather he attempted to levitate. In Harry Potter and the Half-Blood Prince, poor Seamus attempted to brew the Draught of Living Death potion in Professor Slughorn’s class hoping to win a vial of Felix Felicis (Liquid Luck). Although he was reading and following the recipe in the book, he caused an explosion that sent him flying across the room, leaving him with singed eyebrows.

Seamus’ misadventures in the classroom might be humorous for readers and watchers of Harry Potter, but these explosions would not be funny in a manufacturing facility. Seamus’ mistakes also remind us that reading and understanding training material does not replace actual hands-on training for procedures and work instructions.

Rules and Regulations

As always, we should start with the exact verbiage of the requirements. Both 21 CFR § 820 and ISO 13485 require that training is sufficient, documented, and effective:

21 CFR § 820.25 Personnel
(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
(b) Training. 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.

ISO 13485:2016 Section 6.2 Human resources
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

The organization shall document the process(es) for establishing competence, providing needed training, and ensuring awareness of personnel.

The organization shall:

a) determine the necessary competence for personnel performing work affecting product quality;
b) provide training or take other actions to achieve or maintain the necessary competence;
c) evaluate the effectiveness of the actions taken;
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;
e) maintain appropriate records of education, training, skills and experience (see 4.2.5).

NOTE: The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided.

Identify Training Needs

There are two aspects to identifying training needs: procedures that apply to a specific job and how to prove effectiveness for each of those procedures. A starting point for this is having job descriptions, including educational and experience requirements, for each job in the facility. Generally, companies will have a training matrix that identifies all the procedures required for each job position, including the higher-level ones like hygiene, safety, training, and traceability as well as the job-specific ones like cleaning, inspection, invoicing, auditing, or laser marking. The matrix is important to determine at a glance if an employee is trained on the most recent revision of necessary procedures, and it provides consistency for training in a specific department. In most cases, functional units will include multiple job types and descriptions, which allows for assigning training based on the department’s function.

The second, equally important aspect of training needs is that the company must have documented proof of training, understanding, and, where applicable, ability to perform the tasks outlined in the procedure. As clarified in ISO 13485, the “methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided.”

In the case of a machine shop, procedures like hygiene may allow for “read and understood” to be sufficient training. In the case of a pre-sterile packaging process performed in a cleanroom, however, hands-on training and a test to confirm competency in hygiene and gowning might be required. The risk associated with a team member not following a gowning procedure for the cleanroom and infecting pre-sterile goods is much higher than for those working on the shop floor because components will be cleaned before being shipped to the customer.

Thinking of poor Seamus in potions class, consider what training and efficacy testing would have prevented his eyebrow-singing accident. Potions class at Hogwarts could easily be considered dangerous, and one would identify that each student should be trained in safety equipment (wearing goggles, for example) and fire safety. To prove the effectiveness of the safety equipment training, the teacher could have every student don their safety gear by following the instructions, which would involve the students performing the activities outlined in the procedure. For fire safety, however, the teacher should not start a fire for each student to extinguish, so having a lecture to explain the procedure and asking a few questions to confirm understanding would be acceptable training.

As a quality auditor, I have seen many ways of proving training effectiveness: written exams, verbal exams, observation of the tasks being performed, on-the-job training, quality monitoring (inspection), etc. There’s no pre-determined method of documenting a team member’s mastery of a process, so companies can be both creative and complete in their methods. One aspect required for all training plans is that the training and results be documented.

Education and Experience

The easiest way to determine the required education and experience for a job starts with the job description. An engineering position requires an engineering degree, a machinist position might require either certification or experience, and a potions teacher position requires both magical education and experience. The training files should include copies of degrees, certifications, and resumes, and those documents should match up with the requirements included in the job description. The training file for an engineer should contain proof of completion of an engineering curriculum, usually in the form of a college degree. The machinist’s training file might contain a certificate of completion for an academic training course and/or a resume with verifiable professional experience.
Professor Slughorn’s training file for his position as a potions master should contain both his degree from Hogwarts and his proof of receiving an “Outstanding” score on the Potions Ordinary Wizarding Level (O.W.L.) exam.

The Magic of a Comprehensive Training Process

Many companies are hesitant to put significant effort into their training program because it can be expensive and time-consuming, and any time spent training is time that’s not spent producing. This is a short-sighted view of its importance.

While “magic” might be a strong word to use, a comprehensive training process can save the company thousands of dollars in reduced non-conforming products and audit findings. I participated in a facility audit where it was revealed that approximately 85% of the CAPAs found “human error” was the root cause of the failure. This statistic points to one or both of these company characteristics: lazy root cause analysis and/or a poor training process. Because this statistic is an obvious justification for an auditor to dig deeper into the non-conformance, CAPA, and training systems, it’s likely there will be multiple findings requiring mitigating activities and costs to the audited company.

Improvement of internal training processes, including effectiveness checks, will reduce your non-conforming products because well-trained team members are less likely to make mistakes. It will reduce your audit findings, which cost time and money to mitigate, and it will reduce the number of CAPAs that have to be handled. 

 

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Meredith P. Vanderbilt, director of consulting at Empirical, is an internationally known medical device regulatory affairs consultant unafraid to communicate directly and honestly with regulatory bodies and clients about strategies and submissions to provide compliant and high-quality devices to the market.