30 Chapter 30: Training and Skills Assessment

Competent, well-trained personnel are essential to ensuring the safe, accurate, and compliant preparation of non-sterile compounded products. To meet regulatory expectations and uphold patient safety, pharmacies must implement structured training and skills assessment programs supported by clear policies and procedures. These programs establish the baseline knowledge and practical competencies required for both compounding and cleaning roles, while also ensuring ongoing compliance with NAPRA standards, quality assurance requirements, and local regulatory guidelines. This chapter outlines the purpose, development, implementation, and documentation of these critical programs, as well as the procedures for performance evaluation and corrective action.

1. Purpose of Training and Skills Assessment Programs

Training and skills assessment programs ensure that:

• All compounding and cleaning personnel have the knowledge and competencies needed for safe, accurate non-sterile compounding.
• Compounding activities meet standards of practice, quality assurance (QA) requirements, and patient safety expectations.
• Compliance with both the NAPRA Model Standards and provincial/territorial regulations is maintained.

Policies and procedures must be developed to guide these programs systematically.

2. Development of Policies and Procedures

Policies and procedures for training and skills assessment must:

• Clearly define training requirements for all personnel involved in compounding and cleaning activities.
• Establish competencies for each role (e.g., pharmacy managers, compounding supervisors, regulated staff, non-regulated staff, cleaning personnel).
• Specify onboarding training for new hires before they begin independent compounding or cleaning tasks.
• Outline continuing education or retraining intervals (e.g., annually or when there are updates to procedures, standards, or equipment).
• Describe corrective actions for staff who fail to demonstrate competence.

Key Required Elements to Cover (based on the NAPRA guidance templates):

• Overview of non-sterile compounding standards.
• Workplace health and safety practices, including PPE usage.
• Standard Operating Procedures (SOPs) for each type of preparation.
• Cleaning and maintenance procedures for compounding areas and equipment.
• Quality assurance procedures (e.g., documentation, verification steps).
• Hazard identification and emergency response protocols.

3. Skills Assessment Programs

A formal skills assessment program must:

• Assess practical competency — staff must demonstrate safe and correct technique for all assigned tasks.
• Use a documented checklist or evaluation form based on observed performance.
• Include theoretical knowledge testing (e.g., quizzes or verbal questioning) where applicable.
• Document results and corrective actions for any deficiencies.
• Establish frequency of re-assessments — typically every 12 months, after significant changes to SOPs, or after incidents of non-compliance.

Example Skills Assessment Components:

• Accurate weighing, measuring, and mixing.
• Correct use and cleaning of equipment.
• Proper use of PPE.
• Adherence to hygiene and cleaning protocols.
• Correct documentation practices.

4. Documentation Requirements

All training and assessment activities must be formally recorded and kept on file, including:

• Training records for each employee (date, content covered, trainer signature, trainee signature).
• Skills assessment forms showing specific competencies assessed, results, assessor name and signature, and any corrective actions taken.
• Retraining records if additional instruction was necessary.
• Attendance records for any in-house or external continuing education related to compounding.

Retention of these records must comply with provincial/territorial pharmacy regulatory authority requirements (typically, at least 2–3 years or longer depending on local rules).

5. Maintenance and Review

Policies and procedures for training and skills assessments must:

• Be reviewed at least every 3 years, or more frequently if:
  • There is a change in standards (e.g., NAPRA updates),
  • New equipment or new types of compounds are introduced,
  • Significant personnel or process changes occur,
  • Deficiencies are identified during QA audits.

Be revised and updated promptly when changes occur, with appropriate retraining conducted.

Summary Table:

Sample Template: Training Record Form:  **make into actual form

Training Topics Covered:

Trainer Comments:
(Optional notes on performance, strengths, or areas needing improvement)

Employee Acknowledgement:
I acknowledge that I have received the above training and understand the procedures required for non-sterile compounding.

Sample Template for Skills Assessment:  **make into actual form

Practical Skills Assessment:

(✔ Check if satisfactorily demonstrated, ❌ if not)

Overall Assessment:

• ⬜ Competent — no retraining required
• ⬜ Competency Gaps Identified — retraining required

Assessor’s Notes:
(Areas of excellence or need for improvement)

Employee Acknowledgement:
I acknowledge that my skills assessment was conducted and results have been reviewed with me.

These forms should be stored in personnel files.  If deficiencies are found, create a Corrective Action Plan such as:

Sample Template 3: Corrective Action Plan (CAP) for Compounding Personnel  **make into actual form 

Identified Deficiencies:

(List each skill or knowledge area where the employee did not meet standards)

Corrective Actions Required:

(Outline the specific actions needed to correct each issue.)

Reassessment Plan:

• Date for follow-up skills assessment: ___________________
• Responsible assessor: ___________________

Method of reassessment (e.g., direct observation, written test, practical demonstration):

Monitoring and Documentation:

(How compliance will be monitored and documented after reassessment.)

Employee Acknowledgement:
I acknowledge that this Corrective Action Plan has been explained to me and that I am responsible for completing the required actions within the agreed timelines.

A well-defined and consistently applied training and skills assessment program is foundational to a pharmacy’s compounding quality assurance system. It ensures that all personnel are competent, confident, and capable of performing their roles safely and in accordance with the most current standards. By developing comprehensive policies, maintaining accurate documentation, and conducting routine reassessments, pharmacies can mitigate risk, maintain regulatory compliance, and continually improve their compounding practices. Effective communication, supervision, and a proactive approach to performance management help create a culture of excellence and accountability in non-sterile compounding environments.