2019 HPRCT Conference

In 2014 there were very few people at our contract pharmaceutical sterile filling site who believed that effective investigations would be the key to unlocking the performance potential of our site. Support for investigation processes is a regulatory requirement in the pharmaceutical industry, and our level of support was sufficient to meet the requirement, but quality had to drive and pull teams to meet the standard. Today our site and culture are different. Our investigations are considered “best in class” in our contract manufacturing network and we have received this feedback from FDA, ANVISA, Russian Ministry of Health, EMEA, and other regulatory authorities. Leading the team that drove these improvements has been the highlight of my career and our success can be attributed to deep cultural support more than any other factor. This support was challenging to generate and has even been withdrawn at times.   We faced multiple complex problems generating and maintaining buy in to do investigations well even though our process was obviously improved. From 2014-2018 we have had double digit year on year reduction in deviations. We have had investigation cycle time decrease from over 150 days to less than 30 while improving the quality. We have gone from identifying causes in <50% of deviations to 98%. We have gone from human errors being assigned as the cause in 75% of deviations to <10%.  We also went from 30 average days to close back up to 70 and then back down again. We had to identify the causes of shifting support and put processes in place to prevent them in the future. My hope is that others can benefit if I share some very challenging problems and our solutions.  
• How do you get organizational leaders excited support for investigations?
• How do you ensure that stakeholders in each investigation are engaged, honest, and effective?
• How do you motivate a team that has to solve the hardest problems the company faces?
• How do you promote a culture where ownership and accountability?
• How do you recover from the support that led to your success being withdrawn?
• How do you complete investigations quickly without compromising the content?
• How do you facilitate operators and technical teams in finding the most efficient solutions?
• How do you translate quality metrics to financial ones?

It is a complicated and challenging task to get teams excited about investigations. If you love investigating, you are just a little bit of a unique snowflake! It is also so rewarding and satisfying to part of a quality centered organization that embraces change and data driven solutions. Our experience can be used in any industry or environment, because once the case for quality is made in an effective way, support and engagement is the natural response.