About Competence Management

The Importance of Competence Management

Article 19 of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Pharmaceuticals and Quasi-drugs (GMP Ordinance) issued by the Ministry of Health, Labour and Welfare mandates that manufacturers implement “education and training” for personnel in a planned manner. In understanding this regulatory requirement, there is an extremely important point: “education” and “training” are fundamentally different concepts.

In English, these are clearly distinguished as “Education” and “Training.” To understand this difference, let us consider a familiar example: the process of obtaining a driver’s license.

Attending classroom instruction at a driving school corresponds to “Education.” In classroom instruction, students acquire knowledge about traffic rules, the meaning of road signs, and driving theory through lectures. However, no matter how excellent one’s performance in classroom instruction may be, classroom instruction alone makes it impossible to actually drive a car safely. Knowledge alone is insufficient.

What is essential next is on-road training. This corresponds to “Training.” In training, the instructor demonstrates actual driving operations, and then the student takes the wheel themselves, acquiring driving skills while operating the accelerator and brake under guidance. A similar approach is necessary in the workplace. Senior employees or experienced supervisors demonstrate actual work procedures, after which the trainee performs the tasks themselves while receiving feedback and developing proficiency. This type of on-the-job training is also called OJT (On the Job Training).

Findings from Audits

In my work conducting audits of pharmaceutical manufacturers, there is a recurring issue that I repeatedly discover. That is, while many companies properly create and maintain records of “education” implementation, records of “training” implementation are rarely created or have become perfunctory.

Article 19 of the GMP Ordinance clearly requires the creation and retention of education and training implementation records. Not only education records but also training records are equally important. Training records must document who provided training to whom, when, what content was covered, and to what extent the trainee acquired the skills. It is also required to evaluate the effectiveness of training and implement additional training as necessary.

The Importance of Competence Matrices (Skill Maps)

Furthermore, to properly manage the competence of each staff member, it is necessary to create and maintain competence matrices (skill maps). A competence matrix is not merely a tool for recording the current situation. Its purposes are multifaceted.

First, it enables understanding of the competence distribution across the organization. Information such as what specialized personnel are assigned to which departments and whether competence for specific tasks is concentrated in only one person (the risk of knowledge monopolization) can be grasped from a bird’s-eye view.

Second, it identifies future training needs. Prior to the start of manufacturing new products, introduction of new equipment, changes in regulatory requirements, or modifications to manufacturing methods, it enables prediction of what training will be needed and to what extent, allowing for the construction of systematic education and training programs.

Third, it realizes appropriate personnel placement and work distribution. In forming project teams, filling vacancies due to leave or retirement, and responding to fluctuations in workload, the competence matrix becomes an indispensable source of information.

Accurate Understanding of Competence

Incidentally, in practice, there are cases where “competence” is misunderstood as synonymous with mere “skill.” However, according to ISO 19011:2018 (Guidelines for auditing management systems) issued by the International Organization for Standardization (ISO), competence is defined as follows:

Competence: ability to apply knowledge and skills to achieve intended results

As is clear from this definition, competence is insufficient if one merely “possesses” knowledge or skills. Competence is demonstrated only when the following three elements are integrated:

1. Knowledge: Theoretical understanding, understanding of procedures, understanding of regulatory requirements, etc.
2. Skill: Ability to actually perform tasks, problem-solving ability, judgment, etc.
3. Application Ability: The ability to integrate knowledge and skills and “achieve intended results” in actual work situations

In other words, a person who has abundant knowledge but no practical experience, or a person who has practical experience but does not understand the theoretical background, cannot be said to possess true competence. Only when one possesses both knowledge and skills and can reliably achieve expected results by appropriately utilizing them can one be evaluated as having competence for that task. A mere intellectual or knowledgeable person cannot be said to have competence.

Creating Competence Matrices and Evaluation Criteria

In creating a competence matrix, it is important to clearly define the competence items required in each department and set graded evaluation criteria for each item. Regarding the number of evaluation levels, it is common to set 3 to 5 levels depending on the size of the organization, complexity of operations, and precision of management.

Here we present an example of a 5-level evaluation. Note that the assignment of numerical levels (whether higher numbers indicate higher levels or lower numbers indicate higher levels) varies by company, but the following shows the method commonly adopted:

5-Level Competence Evaluation Criteria (Example)

Level	Evaluation Criteria	Description
Level 5	Instructor Level	Complete understanding with the ability to instruct others. Can propose procedure improvements and perform troubleshooting.
Level 4	Expert Level	Can fully perform assigned tasks independently. Can handle irregular situations.
Level 3	Independent Level	Can perform tasks independently under normal circumstances. Can make standard judgments.
Level 2	Beginner Level	Can perform tasks under guidance or as an assistant. Understands basic procedures.
Level 1	Inexperienced Level	Not assigned to the task or has not received education and training.

An important principle in applying these evaluation criteria is that not all personnel need to achieve Level 5 in all items. It is sufficient if the necessary set of competencies is secured for the organization as a whole. In other words, it is important to appropriately distribute and deploy skill sets within the department and build a system of mutual complementation.

For example, for the operation of analytical instrument A, multiple people have competence at Level 4 or higher, and at least one of them has reached Level 5 instructor level. Meanwhile, for analytical instrument B, which is used less frequently, one person is at Level 4 and several others are at Levels 2-3—such an arrangement is realistic.

Competence Evaluation Implementation Methods

Competence evaluation must be implemented following clear evaluation processes to ensure objectivity and fairness.

Evaluators are typically direct supervisors or education and training managers. Evaluations are conducted regularly (usually once or twice a year), and also as needed upon new assignment, change in job duties, introduction of new equipment, or after implementation of education and training.

As evaluation methods, the following combinations are recommended:

1. Knowledge Assessment: Written tests, oral examinations, e-learning tests, etc.
2. Skill Assessment: Practical tests, observation of actual work performance, review of work records, etc.
3. Comprehensive Assessment: Continuous work performance, problem-solving ability, track record of improvement proposals, etc.

International Standards and Latest Regulatory Trends

The importance of competence management is also emphasized in the international pharmaceutical quality system framework.

ICH Q10 (Pharmaceutical Quality System Guideline) positions securing personnel with appropriate competence as an important element for effective operation of the quality system.

The PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) GMP guidelines also specify in detail requirements regarding personnel qualifications, experience, and abilities, emphasizing the importance of continuous education and training.

In ensuring data integrity, which has been particularly emphasized in recent years, personnel competence serves as an important foundation. It is essential that personnel handling data possess appropriate competence and understand the importance of data and the principles of data integrity (ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available).

Conclusion

Competence management is not merely document creation or record-keeping work. It is the core of strategic human resource management for forming an organizational quality culture and promoting continuous improvement.

By properly implementing and recording both education and training, accurately understanding and evaluating competence, and using competence matrices to optimize organizational competence as a whole, we can ensure product quality, comply with regulatory requirements, and ultimately contribute to patient safety and health.