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.

As an orthopaedic device manufacturer, you must define the requirements for each job (commonly, job descriptions are formally issued into QMS), evaluate the people in those jobs in terms of defined performance and acceptance criteria, develop a gap examination for each person (e.g., yearly evaluations) and then create a plan to close those gaps.

Organizations typically provide general education and training for full time, part-time and contract personnel tailored to the person’s job assignment. Such training and education should cover:

  • Core competency of the business
  • Health, safety and environmental regulations
  • Quality policy and other internal policies
  • Employee’s job description
  • Procedures and instructions of relevance to them

What sometimes goes unaccounted for is the training and re-training involved with the understanding and production of defective product, ineffective systems and subsequent regulatory issues aligned with the outcomes. Because you’re trained, doesn’t mean that you’re competent. This is begrudgingly realized when quality data evidences that negative trends are aligned with possibly compromising the safety and effectiveness of the orthopaedic device. If a facet of the root cause is concerned with training per se, one could conclude that either the training wasn’t effective or the trainee, to one degree or another, is incompetent (by default). Re-training is not always part of the corrective action or even the quick correction that must be taken. It takes competent people, in any case, to drive the workings of the QMS in the orthopaedic industry.

Process-Driven Roles and Responsibilities
Process orientation is directly affected by planned and documented development initiatives that can at least include: (1) formal, in-class procedurally-driven learning, (2) planned work assignments aimed at developing certain skills and competencies, (3) self-study/“read and understand” modules aligned with job function and documented, formal assessment used to evaluate progress in development, as well as to accredit or certify that the employee has gained required competencies and knowledge. These initiatives will certainly assist in effective learning and development using behavior, knowledge, skills and innate abilities necessary for successful performance in a job. Employees and employers can assess these competencies against those required for a specific job function and then take steps to acquire or improve any necessary competencies (as documented).

Identifying the lack of competency for defect modules within the organization can serve as the standard or criteria for determining the level of success (or lack of success) when operating in a defined QMS. This approach is influential because assessments based on the competencies provide the organization with an indication of the extent to which employee workplace behavior has improved (or not). For example, pre- and post-defective occurrences when measured and then documented could be an indicator as to the effectiveness of training, as well as enabling formally defined job expectations.

In order to accomplish these goals, medical device manufacturers must ensure that they have employees who can safely, effectively and efficiently perform their assigned jobs—which leads me to the original purpose of the article, competence-based training and development, because people are one of an organization's most valuable assets. By having a well-designed competence-based training and development process, the organization will be able to ensure that it has the right people, with the right skills, at the right time, to produce safe and effective medical devices. If that goal is not realized, one could say that the trained individuals are, in fact, not competent. This means that a competence-based process needs to focus on building the knowledge and skills needed in a particular job to reduce defectives.

Employee Training Plans
Development planning typically involves creating a documented training plan for each employee. A training plan should be individually-tailored and contain process-oriented activities aimed at increasing know-how in specific competencies to meet established procedural as well as individual goals. The supervisor and the employee have a joint responsibility for developing and implementing this training plan. The role of the supervisor is to ensure that the employee has the support and the resources needed for successful development. Once you have identified the various opportunities for development, you need to identify the one or two competencies where development will provide the most benefit to reducing defectives as well as promoting the employee’s goals and objectives.

Training plans are commonly developed once a year and linked to employee evaluations. These plans should include the learning goals or specific performance outcomes to be achieved, respectively. The goals should be written in measurable terms, and the employee and manager should have a clear idea about what successful achievement of goals looks like. Also, this training plan should be viewed as a living document and reviewed periodically to ensure that the activities continue to support established goals of the company as well as the individuals involved.

To ensure that development takes place, the employee and supervisor should establish, using a documented process, a set of deliverables for tracking and measuring progress. This includes identifying how to measure progress, who will measure progress and how often progress should be addressed. When evaluating progress, it is imperative that this competency challenge be tied to company goals and objectives as well as defectives related to the employee’s job function.
Just because you are trained, doesn’t mean that you are competent.

Lastly, the employee and supervisor should assess progress toward the development goals. Based on the results of this assessment, the training plans may need to be adjusted accordingly.

Concluding Statements
For any job, it is possible to identify the functional, personal and business competencies required for planned and successful performance. Once identified, these competencies can be used for selection or development of employees and summarily the potential reduction of defectives realized at the medical device operation.

A competency-based training system includes more than just training courses related to job performance. It identifies the level of competence required for different levels of performance within a given work function.

Looking at the competencies required for different job levels would allow companies to set professionally-driven developmental goals for its employees. Once competencies are defined, training can be organized to support performance at all levels in the company from entry-level to upper management. Yes, this initiative is not just for production workers making orthopaedic medical devices or components. The level of competence required for performance can be established and measured versus quality data trends and opportunities.

An FDA Inspection or a Notified Body Audit will cover the methods you established to determine competency, evaluate employees, and then evaluate how your company takes action when defectives are realized. All of these activities require objective evidence, in the form of records, to demonstrate your QMS operation is running effectively and efficiently.


John Gagliardi has had success over the past 43 years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. John can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it.."

MidWest Process Innovation, LLC
513-573-0085 (phone)


Continue learning from Mr. Gagliardi: Attend his educational sessions at OMTEC 2013 in Chicago. Badges copy

Design Review-Systematically Examining and Evaluating Design Requirements
Wednesday, June 12, 10 a.m.-11 a.m.

Design review is one of the key design control elements in a quality system. This session will provide research, development and design professionals insight on why OEMs should review designs, as well as information on meeting design review requirements, preparing for reviews and different types of design review meetings.

Purchasing Controls-Challenges of Compliance in a World Market
Wednesday, June 12, 2:45 p.m.-3:45 p.m.

The establishment and maintenance of requirements, including quality requirements, is essential for orthopaedic manufacturers when dealing with component suppliers, consultants and contractors. The ability to meet specified requirements is important when evaluating the suppliers and service providers, worldwide. This session will walk through the six phases of establishing controls: planning, selection of potential suppliers, supplier evaluation and acceptance, finalization of controls, delivery, measurement and monitoring, feedback and communication, including the Corrective Action and Preventive Action process.