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Just Because You’re Trained, Doesn’t Mean You’re Competent

Competency as defined by Training magazine, July 1996:             

“A cluster of related knowledge, skills, and attitudes that affects a major part of one’s job (a defined role or responsibility), that correlates with performance on the job, that can be measured against well-accepted standards, and that can be improved via training and development. Competencies are gained through a multitude of ways—life experience; formal education; apprenticeship; on-the-job experience; self-help programs; and, yes, training and development programs. All of these together contribute to job competence in an employee.”

This Strategy Starts at “The Top”
To put an organization’s policy into effect, top management must establish clearly-defined objectives that the medical device company can aim for (and employees can target). In setting objectives and goals, timeframes for achieving these targets are usually established.

The QS Regulation and ISO 13485 Standard calls for objectives not only for the Quality Management System (QMS), but also for products and services. These objectives can only be driven by competent employees. People make this happen. Realizing that process-oriented defectives are not always the fault of these employees further emphasizes the requirement for competent individuals to fulfill the goals and objectives of any organization. This approach goes a long way toward establishing successful outcomes.

Quality objectives should be realistic and related to achievable and measurable outcomes, such as:

  • Meeting the requirements (customer, regulatory and other) for products and services
  • Meeting the planned schedule that is aligned with daily intentions for quality
  • Identifying prospects for improvement and defective reduction
  • Identifying new post-production opportunities involved with commercialization and the safety and effectiveness of their medical devices

Groups within the organization typically establish group objectives, which follow from the overall organization objectives and relate to the specific activities of the group and then, of course, to the individual employee.

Orthopaedic device organizations have an obligation to establish comprehensive, competency-based employee development processes in high risk areas. These processes are challenged when realizing and then trending information received because of, for example, customer complaints, internal and external audit findings, non-conforming products, adverse events (correlated with medical device reporting and medical device vigilance), root causes associated with corrective and preventive actions, defined scrap levels on the production lines, re-validation occurrences, indulgent re-design occurrences, trends concerning workmanship criteria, forced remedial actions (the quick fixes) and incoming non-conformances from suppliers just to name a few.

…And Then It Becomes Part of a Company’s Culture
These manufacturers must maintain records that show what competencies an employee possesses. Records are also kept of the training an employee has received and any results of that training. The records, which show that the training course has been successfully completed and that competence has been achieved, can be simple or complex based upon the risks involved, e.g. the class of the device, the complexity of the QMS and the size of the company (number of employees). At the simplest, these records may consist of “sign-off” to confirm that personnel can now use certain equipment, carry out specific processes or follow certain procedures. The records should include a clear statement that a person is now deemed competent to do the task for which they were trained. The effectiveness of any further education and training should be re-evaluated, after a period. Yearly evaluations confirm that the competence achieved is continuing.

The medical device QS Regulations and ISO 13485 require that manufacturers have enough people to perform all of the required tasks and that everybody is competent to do her job. The regulations also require four elements of competency: education, training, background or skill and experience. While all four elements are similarly important, the regulations and standards place special emphasis on training. Characteristically, the manufacturer has the greatest control of training, especially related to the company’s policies, processes, procedures and work instructions. As a result, the regulation and standard require an effectiveness evaluation of this training or other actions to satisfy internal requirements.