Life science product development is all about process: to ensure safety and effectiveness of your product, processes must be in place to maintain high quality in your design and development work. In smaller organizations, these processes and procedures can be fairly easy to control and manage. However, as your business grows, so do the scope and complexity of your development activities. To maintain and improve your life science product development processes, there are a handful of methods your organization can undertake.
1. Thoroughly define roles & responsibilities
Product development teams need to be sure they are doing what they’re supposed to do. Consider reviewing the current roles and responsibilities you have in place to confirm that these are adequately assigned and communicated.
2. Write out SOPs and Work Instructions
FDA regulations and international standards require your life science organization to have documented evidence of your development processes. The most effective documents for this are standard operating procedures (SOPs) and Work Instructions (WIs). Make sure all SOPs/WIs are written, accessible to team members, and available for review during appropriate regulatory activities.
3. Review processes for clarity
Ensuring clarity in your development processes is about both language and sequence. Ambiguous phrasing or grammar that could leave a work step open to interpretation is far more likely to result in human error; likewise, neglecting to certify that the sequence of a given procedure is logical and each step builds off the other can be error-prone.
4. Get feedback from your development teams
To improve your development processes, it’s important to talk to the people who are performing them as part of their day-to-day work. Asking for this feedback can help you identify where potential breakdowns can occur, what processes and procedures are not working for your personnel, and where improvements can be made.
5. Associate your processes with regulations and standards
With so many procedures involved in the development of life science products, it can sometimes be hard to manage which are the most necessary for regulatory compliance. By linking processes and procedures to regulations and standards, it’s far easier to make sure the work steps of each result in outputs align with regulatory requirements.
6. Conduct training
Personnel training is essential to establishing that proper procedures are followed during the development process. These trainings should be conducted regularly for both new and established team members, and should include any improvements made as projects and your quality system mature.
7. Identify all your process outputs
It’s crucial to understand what the outputs of a given process are and what they look like. If you have procedures in place for your design review process, for example, the output could be some type of documentation that details what was reviewed, areas for improvement, and so on. Having these process outputs clearly identified leads to less confusion during development and simpler management of your development activities.
8. Look for opportunities to streamline processes
Waste is a concern in all quality systems, so eliminating or reducing it is vital to long-term organizational stability and growth. This means your development processes; wherever redundancies can be eliminated and work can be optimized without impacting the safety and effectiveness of either your quality system or the product is worthwhile.
9. Analyze all processes for risk
Certain development processes are more risk-prone than others. In prototyping phases, for example, certain procedures may expose team members to specific hazards, hazardous situations, and harms. These process risks can impact the safety of your development teams, but can also have an effect on users and patients down the line. Taking time to analyze your processes and procedures for risk can identify optimal methods for controlling development activities while continuing to promote safety and effectiveness.
