Employees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Risk-based employee training is essential to bridging the awareness gap.
Since the adoption of ISO 13485:2016, life sciences manufacturers have continued to step up their risk-based training requirements. How does your organization currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process.
For life sciences manufacturers, the product design and the development of the manufacturing process will yield critical steps that need to be defined because they impact the quality of the process and/or the safety and performance of the product.
Determining Training Requirements
When determining the training requirements for these process steps, you will benefit from analyzing:
- Type of training
- Training content
- Competency evaluations required
- Method of tracking results
Training requirements and effectiveness checks should be proportionate to the risk associated with the work.
Risk at Various Levels
Does your business associate the risk for both role-level training and for job-specific requirements?
The answer would be “it depends.” If someone has the role of a “Qualified Person,” who is signing off on a batch release, or if a Quality Manager is signing off as a CAPA approver, these roles have a risk associated with their job activities.
How is that risk accounted for in the respective training requirements?
A specific lab test that a lab technician needs to run for a product may have a unique risk depending on the specific product and/or process criticality; therefore, a specific training document or lab procedure may be linked to a critical characteristic that has a specific risk value.
Getting it Documented
Finally, how will your organization capture this information and link it to objective evidence required for the competency of each role and/or requirement? Consider seeking a training management system that includes data capture capabilities and dashboards to provide you enterprise-wide visibility into training gaps, completion, and history.
Meeting the Challenge
Risk-based quality processes and training requirements are key elements within ISO 13485:2016. So, how can you keep both new and long-time employees up to date on product liability issues and make sure they understand that risk management and regulatory compliance are everyone’s responsibility? If you don’t have a plan for this, now is the time to act.
Risk-based Quality Processes
Adopt an automated training management system along with other internal continuing education efforts to ensure a skilled and compliant workforce, enabling you to increase productivity, reduce job quality issues, and maintain compliance with industry regulations. SmartSolve® QMS from IQVIA contains out-of-the-box best practices for:
- Audit Management – Captures auditee risk as a part of the audit planning process.
- CAPA Management – Provides a guided process to implement risk-based corrective actions quickly.
- Nonconformance Management – Enables the capture, resolution, and tracking of product and process nonconformances.
- Change Management – Allows specific cross-functional teams and business process workflows to be dynamically managed based on the significance of each proposed change.
- Document Management – Controls standard operating procedures and other documentation throughout their lifecycle.
- Supplier Management – Provides tools to perform supplier evaluation, selection, and maintenance.
- Training Management – Manages certifications for both role-related and job-related training requirements.