Fawn Parke

Do not underestimate the power of benchmarking both internally and externally in your respective industry. Identify a specific area in which the team would benefit seeing how another team approached a similar challenge and found success. Bring home the best practices and encourage the team to take a bit of calculated risk as well. Regroup after the benchmarking trip/activity to clearly identify short and long term actions with due dates to drive immediate improvement.

I believe the most important first step is to motivate the team. You must show them what is possible if they build a continuous improvement culture. Possibilities are endless! Drive excitement by sharing examples of other teams or within the industry and paint a picture of the future. Then begin sharing tools, methodologies and ways they can start small and continue building a continuous improvement culture.

Coach your team to always be "audit ready". Do this by keeping documents up to date and easily accessible. Create an internal SOP outlining how and what to do when an auditor arrives at the door. Practice going through an audit at least annually. Prepping in this way will not only ensure higher success by discovering and correcting potential gaps but will also give confidence to the team when the actual audit comes.

The small 'c' in front of cGMP stands for 'Current' good manufacturing practices. Read up to ensure you are following the up to date CURRENT cGMP's.

Take pause after you've planned your full approach to implementing a change. Reflect on the anticipated question(s) each group is likely to have. Finally, go back and incorporate into the roll-out plan along with associated solutions. Once you are confident you've addressed the majority of major concerns, then you may proceed confidently.

Given the team is remote, I would have regular and frequent team meetings to work through the major milestones together. I would also recommend individual meetings to effectively hear each person given the remoteness of the team and to ensure everybody has a voice.