When it comes to both quality and safety, a commitment to planning and preparation is often what sets leaders apart. Areas of life sciences manufacturing where planning and preparation are most critical include:
Document Control: Policies, work instructions and specifications can easily get out of hand without a way to manage them, ultimately leading to versioning issues and mistakes. Sending out the wrong specification could lead to huge production delays and losses in the millions of dollars.
Change Control: One of the central goals of change management is being able to pursue new opportunities in a way that reduces risk. Identifying and assessing risks associated with planned changes ensures that all changes made to the product will be effective and will not introduce risk.
Employee Training: Too many companies let training programs become stale or outdated, or allow people to get behind on required trainings. Rather than looking at training as another box to check, companies need to proactively track compliance, regularly refresh materials and evaluate training effectiveness.
Risk Management: Risk Management software tools like Failure Modes and Effects Analysis (FMEA), the risk matrix and bowtie risk assessment improve safety and quality, allowing you to look at processes holistically, utilizing historical information and anticipate problems. Tracking all hazards in a centralized Risk Register is the only way to ensure you don’t have unmitigated risk hiding in your lab.
