{"id":6156,"date":"2026-10-15T15:22:55","date_gmt":"2026-10-15T15:22:55","guid":{"rendered":"https:\/\/pharmanomos.ch\/training-and-competencies-in-the-qms-how-to-demonstrate-that-staff-are-truly-prepared\/"},"modified":"2026-10-15T15:39:25","modified_gmt":"2026-10-15T15:39:25","slug":"training-and-competencies-in-the-qms-how-to-demonstrate-that-staff-are-truly-prepared","status":"publish","type":"post","link":"https:\/\/pharmanomos.ch\/en\/training-and-competencies-in-the-qms-how-to-demonstrate-that-staff-are-truly-prepared\/","title":{"rendered":"Training and Competencies in the QMS: How to Demonstrate That Staff Are Truly Prepared"},"content":{"rendered":"\n

In a pharmacy or a life sciences organization, quality also depends on the people who implement procedures, operating instructions, and controls on a daily basis.<\/p>\n\n

A Quality Management System (QMS) may have up-to-date SOPs, complete records, and formally defined responsibilities. However, if staff do not understand the procedures or are unable to apply them correctly, the system has an operational vulnerability. <\/p>\n\n

One of the most common mistakes is to consider training complete simply because an employee attends a session or signs a sign-in sheet.<\/p>\n\n

The signature typically serves as proof that a specific training activity has been recorded. On its own, it does not prove that the employee has acquired the necessary skills.<\/strong><\/p>\n\n

To manage training effectively, it is therefore necessary to distinguish between participation, learning, understanding, competence, and practical application.<\/p>\n\n

The goal is not to accumulate certificates, but to ensure that every person is prepared to perform their assigned tasks safely, consistently, and in compliance with regulations.<\/p>\n\t\t\t\t

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\n\t\t\t\t\t\t\tArticle Contents<\/strong>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t
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  1. From Participation to Effectiveness: Six Concepts to Distinguish<\/a>
  2. What requirements apply in Switzerland?<\/a>
  3. How to Create an Effective Competency Matrix<\/a>
  4. Onboarding and Initial Training: A Structured Process<\/a>
  5. Training Following the Revision of an SOP<\/a>
  6. How to Assess the Effectiveness of Training<\/a>
  7. Absences, Deadlines, and Periodic Updates<\/a>
  8. Linking Training, Nonconformities, Audits, and CAPA<\/a>
  9. Training KPIs: Which Metrics Should You Track?<\/a>
  10. Checklist: Is Your Training System Under Control?<\/a>
  11. The Most Common Mistakes in Training Management<\/a>
  12. Conclusion: An effective QMS can also be recognized by the competencies it fosters<\/a><\/ol>\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\n
    <\/div>\n\n

    From Participation to Effectiveness: Six Concepts to Distinguish<\/h2>\n\n

    Training is a process that involves several levels, each of which requires different types of evidence.<\/p>\n\n

    Concept<\/th>Meaning<\/th>Possible evidence<\/th><\/tr>
    Participation<\/td>The employee completed a training program.<\/td>Attendance Log<\/td><\/tr>
    Learning<\/td>He has gained new knowledge.<\/td>Test or Exercise<\/td><\/tr>
    Comprehension<\/td>Can correctly explain the content, purpose, and consequences.<\/td>Questions or practical examples<\/td><\/tr>
    Expertise<\/td>He or she possesses the knowledge and skills needed to achieve the expected result.<\/td>Skills Assessment<\/td><\/tr>
    Practical Application<\/td>Performs the task correctly in a real-world setting.<\/td>Work Observation<\/td><\/tr>
    Effectiveness of Training<\/td>The training produced the expected results and helps keep the process under control.<\/td>Follow-up Review and Indicators<\/td><\/tr><\/tbody><\/table><\/figure>\n\n
    <\/div>\n\n

    A real-life example from a pharmacy<\/h3>\n\n

    An employee is participating in training on managing temperature fluctuations.<\/p>\n\n

    Pass a test on storage temperatures and demonstrate that you know the procedure.<\/p>\n\n

    During a simulation, however, he does not know how to isolate the affected products or whom to report the anomaly to.<\/p>\n\n

    The employee has acquired some knowledge, but has not yet demonstrated the required operational proficiency.<\/p>\n\n

    The training must be supplemented with practical instructions and a new assessment.<\/p>\n\n

    This approach is consistent with the competence management requirements set forth in ISO standards and with the need to ensure that the QMS is effectively implemented.<\/p>\n\n

    <\/div>\n\n

    What requirements apply in Switzerland?<\/h2>\n\n

    Staff training must be evaluated by distinguishing between legal obligations, the requirements of applicable standards, and best organizational practices<\/strong>.<\/p>\n\n

    <\/div>\n\n

    Legal and Regulatory Obligations<\/h3>\n\n

    For pharmacists who practice under their own professional responsibility,Article 40 of the Federal Act on University Medical Professions (LPMed)<\/strong><\/a> requires the continuous updating of professional knowledge and skills.<\/p>\n\n

    The requirements that are actually applicable must be verified, taking into account cantonal provisions and any relevant professional regulations.<\/p>\n\n

    For pharmaceutical activities subject to the relevant authorizations, theOrdinance on the Authorization of Medicines (OAMed)<\/a><\/strong> sets forth specific requirements regarding personnel.<\/p>\n\n

    Specifically, Articles 3 and 11 require that personnel be competent and trained for the tasks assigned to them, in the contexts of manufacturing and importing, respectively, with the provisions extended to wholesale trade and export.<\/p>\n\n

    For activities subject to GDP, Chapter 2.4 of the European guidelines referenced in the Swiss framework provides for initial and continuing training, record-keeping, and periodic, documented evaluation of effectiveness.<\/p>\n\n

    Please note:<\/strong> GDP requirements for wholesale trade should not be automatically extended to all activities of a retail pharmacy.<\/p>\n\n

    <\/div>\n\n

    Quality Standards and Best Practices<\/h3>\n\n

    ISO 9001:2026 serves as a voluntary guideline for quality management systems, unless its applicability is mandated by certification, agreements, or specific requirements.<\/p>\n\n

    ISO 10015:2019<\/a><\/strong> provides guidance on competency management and staff development.<\/p>\n\n

    In practice, a competency matrix, a training plan, and documented assessments help translate these principles into practical tools.<\/p>\n\n

    There is no one-size-fits-all training frequency that can be applied indiscriminately to all organizations: the frequency and checks must be determined based on the organization\u2019s activities, risks, and relevant requirements.<\/p>\n\n

    <\/div>\n\n

    How to Create an Effective Competency Matrix<\/h2>\n\n

    The competency matrix is a tool that allows you to link people, roles, activities, and training requirements.<\/p>\n\n

    For small organizations, a single controlled file may be sufficient, provided it is kept up to date, accessible to authorized personnel, and integrated into the QMS.<\/p>\n\n

    <\/div>\n\n

    Define the requirements by role<\/h3>\n\n

    The first step is to identify the activities that are actually being carried out.<\/p>\n\n

    In a pharmacy, these duties may include receiving and storing medications, monitoring temperatures, dispensing medications within the scope of one\u2019s professional qualifications, handling complaints, and addressing deviations.<\/p>\n\n

    Next, the necessary competencies are defined, distinguishing between those who need to be familiar with a procedure, those who must apply it, and those who are authorized to supervise or make certain decisions.<\/p>\n\n

    <\/div>\n\n

    Example of a Competency Matrix<\/h3>\n\n
    Activities<\/th>Position in question<\/th>Required Level<\/th>Verification<\/th><\/tr>
    Managing Temperature Fluctuations<\/td>Warehouse Staff<\/td>Authorized Independent Enforcement<\/td>Simulation<\/td><\/tr>
    Dispensing of Medications<\/td>Pharmacist<\/td>Required Professional Skills<\/td>Field Evaluation<\/td><\/tr>
    Complaint Handling<\/td>Designated Staff Member<\/td>Implementation of the SOP<\/td>Case Study<\/td><\/tr>
    CAPA Management<\/td>Quality Manager<\/td>Analysis and Oversight<\/td>Case Review<\/td><\/tr>
    Document Management<\/td>Staff Involved<\/td>Proper Use of SOPs<\/td>Operational Verification<\/td><\/tr><\/tbody><\/table><\/figure>\n\n

    An internal scale can distinguish between basic knowledge, supervised performance, and autonomous performance.<\/p>\n\n

    The matrix should also include the name, status of the qualification, any operational limitations, the date of the verification, and whether an update is required.<\/p>\n\n

    The required competency must be defined before assessing whether it has been acquired<\/strong>; it cannot be automatically inferred from length of service.<\/p>\n\n

    To learn more about the integration of these tools into the company’s systems, it is helpful to consult the article on Quality Management Systems in Swiss Pharmacies<\/a>.<\/p>\n\n

    Onboarding and Initial Training: A Structured Process<\/h2>\n\n
    <\/div>\n\n

    Hiring a new employee is one of the most critical moments for assessing skills.<\/p>\n\n

    Onboarding should include a process that is commensurate with the assigned responsibilities, rather than being limited to simply handing out documentation.<\/p>\n\n

    Example of a Training Program<\/h3>\n\n
    Phase<\/th>Activities<\/th>Highlights<\/th><\/tr>
    1. Entrance<\/td>Verify qualifications and requirements for the position<\/td>Initial Checklist<\/td><\/tr>
    2. Orientation<\/td>Introduction to QMS, Responsibilities, and Procedures<\/td>Training Log<\/td><\/tr>
    3. Mentoring<\/td>Supervised Performance of Tasks<\/td>Coaching Worksheet<\/td><\/tr>
    4. Evaluation<\/td>Test, simulation, or practical observation<\/td>Documented outcome<\/td><\/tr>
    5. Authorization<\/td>Confirmation of Activities That Can Be Performed Independently<\/td>Approval by the person in charge<\/td><\/tr><\/tbody><\/table><\/figure>\n\n

    For example, a new warehouse employee may initially receive shipments under supervision.<\/p>\n\n

    Only after demonstrating knowledge of controls, record-keeping, and incident management will the individual be authorized to work independently, within the scope of their role.<\/p>\n\n

    The duration and procedures for each phase must be determined internally based on the activities and risks involved.<\/p>\n\n

    <\/div>\n\n

    Training Following the Revision of an SOP<\/h2>\n\n

    A change to a procedure does not necessarily require the same type of training for all staff.<\/p>\n\n

    An impact assessment of the revision must be conducted.<\/p>\n\n

    An editorial correction may require only a simple, verified communication. A change in responsibilities, decision-making criteria, or critical operations, on the other hand, may require specific training with a practical assessment. <\/p>\n\n

    An effective process includes:<\/p>\n\n

      \n
    1. identification of the changes and the people involved;<\/li>\n\n\n\n
    2. assessment of the risk and the required level of training;<\/li>\n\n\n\n
    3. communication about the new version and targeted training;<\/li>\n\n\n\n
    4. skills assessment when required;<\/li>\n\n\n\n
    5. Confirmation of authorization prior to the independent implementation of the modified activities.<\/li>\n<\/ol>\n\n

      Example:<\/strong> If the SOP for managing refrigerator alarms is modified, the relevant staff should be able to demonstrate how to recognize, report, and handle an incident in accordance with the new procedure.<\/p>\n\n

      Change control must also take into account the SOP\u2019s effective date and any individuals who have not yet received training.<\/p>\n\n

      Does your training plan demonstrate your skills?<\/h3><\/div>
      <\/div>

      An up-to-date matrix and complete records are useful, but not always sufficient to demonstrate that procedures are being followed correctly.Pharmanomos Sagl supports pharmacies and life sciences organizations in structuring training plans, competency matrices, and assessment methods integrated into the QMS.<\/strong>The goal is to build a system that is proportionate, documentable, and truly sustainable.<\/p>

      Request an evaluation of your training program<\/span><\/a><\/div><\/div><\/div><\/div>\n\n
      <\/div>\n\n

      How to Assess the Effectiveness of Training<\/h2>\n\n

      The verification process should be defined as early as the planning phase, by selecting methods consistent with the expected outcome.<\/p>\n\n

      <\/div>\n\n

      Assessment Methods<\/h3>\n\n

      Knowledge Test:<\/strong> useful for verifying theoretical requirements, criteria, and instructions.<\/p>\n\n

      Simulation:<\/strong> suitable for infrequent but critical situations, such as a product recall or a thermal anomaly.<\/p>\n\n

      Operational observation:<\/strong> This method allows you to assess how a person performs a real-world task.<\/p>\n\n

      Review of Records:<\/strong> Allows for verification of accuracy, completeness, and compliance with procedures.<\/p>\n\n

      Follow-up monitoring:<\/strong> This allows you to observe whether errors are decreasing and whether performance remains adequate.<\/p>\n\n

      For example, after completing training on the handling of incoming goods, the manager can review a sample of subsequent shipments, verifying product identification, documentation, and the handling of discrepancies.<\/p>\n\n

      A good immediate result does not automatically guarantee that skills will be maintained over time.<\/p>\n\n

      The methods and frequency of inspections must be proportionate to the risk, the frequency of the activity, and the available evidence.<\/p>\n\n

      <\/div>\n\n

      Absences, Deadlines, and Periodic Updates<\/h2>\n\n

      Managing absences is essential to prevent people who are not up to date from performing tasks that have changed.<\/p>\n\n

      If an employee is absent during a relevant training session, the QMS should require that the employee make up the training before being assigned the relevant tasks independently.<\/p>\n\n

      In the meantime, it may be necessary to continue providing supervision, restrict certain tasks, or assign them to already qualified staff.<\/p>\n\n

      To monitor the situation, it is helpful to keep a log that includes training status, internal deadlines, make-up sessions, assessments, and responsibilities.<\/p>\n\n

      Periodic updates may be triggered by revisions to SOPs, new tools, regulatory changes, incidents, audit findings, or needs identified during competency assessments.<\/p>\n\n

      For activities subject to GDP, these procedures must also be included in the applicable continuing education program.<\/p>\n\n

      A more detailed look at the distribution framework is available in the article \u201cGDP in Switzerland: What It Is, Who It Applies To, and How to Implement It<\/a>.\u201d<\/p>\n\n

      <\/div>\n\n

      Linking Training, Nonconformities, Audits, and CAPA<\/h2>\n\n

      Training should not be a standalone process, but an integral part of QMS improvement.<\/p>\n\n

      During audits, it is possible to verify whether staff are familiar with and follow the relevant procedures. More information is available in the article How to Effectively Prepare for Quality Audits<\/strong><\/a>. <\/p>\n\n

      When a nonconformity arises, it is necessary to assess whether the issue stems from a lack of knowledge, understanding, or competence.<\/p>\n\n

      However, it is incorrect to automatically attribute every mistake to a lack of training.<\/p>\n\n

      An ambiguous procedure, an inadequate tool, or an ineffective organization may be the real causes of the problem.<\/p>\n\n

      Retraining is an appropriate corrective action when it addresses a genuinely identified deficiency.<\/p>\n\n

      In the CAPA process, effectiveness must be verified using relevant evidence, as explained in the article Effective CAPA: From the Root Cause to Verifying Effectiveness<\/strong><\/a>.<\/p>\n\n

      <\/div>\n\n

      Training KPIs: Which Metrics Should You Track?<\/h2>\n\n

      Even a small pharmacy can use just a few metrics to assess the state of its competencies.<\/p>\n\n

      KPI<\/th>Calculation Method<\/th><\/tr>
      Completion of Training<\/td>Completed training sessions \/ scheduled training sessions \u00d7 100<\/td><\/tr>
      Skills Assessment<\/td>Positive tests \/ total tests \u00d7 100<\/td><\/tr>
      Expired Formations<\/td>Training sessions past the deadline \/ scheduled training sessions \u00d7 100<\/td><\/tr>
      Coverage of Critical Roles<\/td>Critical roles with qualified personnel available \/ identified critical roles \u00d7 100<\/td><\/tr><\/tbody><\/table><\/figure>\n\n

      It is also helpful to examine the deviations associated with gaps in training, distinguishing them from those caused by other factors.<\/p>\n\n

      KPIs should not be interpreted in isolation: a 100% participation rate does not equate to 100% training effectiveness.<\/p>\n\n

      Monitoring objectives, thresholds, and frequencies must be defined and justified by the organization, without automatically attributing them to regulatory requirements.<\/p>\n\n

      <\/div>\n\n

      Checklist: Is Your Training System Under Control?<\/h2>\n\n