Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company
Being competitive takes skill. Remaining competitive takes continuous effort. It’s what every enterprise strives for, so organizations would do well to heed wise words from the father of business management, Peter Drucker: “The only sustainable competitive advantage is an organization’s ability to learn faster than the competition. Your organization may be getting a run for your money, quite literally, by not investing in a solid learning strategy.”
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.
Regulatory requirements such as ISO 13485:2016 are increasingly driving home the criticality of managing standard processes from a risk-based perspective. With the adoption of ISO 13485:2016, medical device manufacturers have stepped up their risk management training requirements. The current regulation, like its predecessor, ISO 13485: 2003, “requires the manufacturer to determine the necessary competence for people who perform work that affects product quality.”
ISO 13485:2016 adds additional requirements:
- Document the process for establishing competence
- Document the process for providing needed training
- Provide training or take other action to achieve or maintain the competence needs
- Develop a methodology to check effectiveness that is proportionate to the risk associated with the work performed
Training Requirements and Risk
Naturally, every organization strives to remain compliant with these requirements and the myriad industry and regulatory requirements regarding qualified personnel. So how does your organization currently define training requirements? Training requirements and effectiveness checks should be proportionate to the risk associated with the work. If you’re not considering risk as you define them, you will need to add this consideration into your process.
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.
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
Risk at Various Levels
Does your business associate the risk for both role-level training and for job-specific requirements?
Of course 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? Seek 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
How can a company 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.
SmartSolve® Training Management, from Pilgrim Quality Solutions, an IQVIA company, helps you manage training and certification for a qualified, competent workforce, thereby enabling you to increase productivity, reduce job quality issues, and maintain compliance with industry regulations.
SmartSolve® Training Management
SmartSolve® Training Management is a comprehensive solution for ensuring employee job quality and compliance. Watch this video to learn how Training Management can help your organization.