United States

Pharmaceutical Case Study: Janssen-Ortho

Implementation: Organizing Information to Meet Business Needs

In the pharmaceutical industry, the penalties for deficient recordkeeping can be extremely harsh, for the simple reason that people’s lives are at stake. This makes ensuring compliance a full time occupation for Goldwyn Chan and Karen Connell at Janssen-Ortho.

Anticipating a mandatory records management policy review by their parent company, Chan, Connell and their Quality Systems group launched an internal audit of all departments. They discovered a
number of opportunities, especially around electronic documents and shared drives, where the retention and classification system developed for Janssen-Ortho’s Regulatory group could be used, so Chan and Connell decided to roll it out company wide.

Changing Culture: The People Factor

Chan and Connell knew overcoming the challenge of getting buy-in from frontline users was essential, because without it any RM program amounts to little more than binders sitting on a shelf. They needed a dynamic education and training program that would engage their people, and they called TAB.

A Natural Partnership
Both Chan, as Manager, Quality Systems, and Connell as Records Specialist had worked with Colleen Moretti and the TAB team to develop the classification and retention system used by the Regulatory group. TAB had also recently updated the program, so their knowledge of Janssen-Ortho’s business practices and records requirements was accurate and current. Because TAB had been instrumental in creating the records management program, TAB therefore seemed an obvious choice to help Janssen-Ortho take it enterprise wide.

Lesson Plan

TAB’s involvement with education and training programs at many different companies had taught them the best way to engage people was to present the information as a story relevant to their corporate culture.

The TAB team had interviewed a number of key stakeholders and front-line personnel during the initial records management program development. They knew that Janssen-Ortho used the Six Sigma methodology, and were very geared to measurement, analysis and metrics. They also recognized
that the employees thrived on achievement and competition.

So Moretti and her team went back and reviewed the classification and retention system, combining this with what they knew about the culture to create a learning environment best suited to Janssen-Ortho personnel.

Going to School

TAB developed an entire road show-style training package for different departments which Janssen-Ortho could continue to roll out as needed in the future. The program focused on the importance of records management, explaining why Janssen-Ortho was committed to it and how the new system would help make everyone’s job easier.

The training program consisted of a one-day session, with half a day spent in the classroom learning the classification and retention system, and half a day spent on the floor applying what they had learned. TAB personnel supported and mentored employees, walking them through the TAB SMART process, including a review and purge of paper and electronic records. Together they went through the steps of applying classification to files and shared drives, as well as organizing records on their servers. In the process they also covered the dangers of keeping multiple copies, hard vs. soft copies, the correct way to handle emails and more.

The emphasis was on making the process fun and engaging. To foster friendly competition, different groups had timelines and targets set for cleaning up and organizing their files. Incentives included “TAB Bucks” that employees could collect for good questions, correct answers and goals met, redeeming them for rewards.

After initial training, TAB continued to work one on one with individual groups to ensure that everyone was up to speed.

A Prescription for Compliance

For both Janssen-Ortho and TAB, the project was a learning experience and a success. A good illustration of this can be found in how concerns around the shared drives were alleviated. Through the training process, a common language and structure on shared drives was implemented,
regardless of topic, group or ownership. It went from being an unstructured catch-all to a structured, tiered design, making the retrieval process easier, and putting Janssen-Ortho in a
position to implement a document management system.

As Chan puts it “Over the past year, we’ve worked with TAB to develop a classification scheme, retention schedule, and implementation plan for our organization. I think a lot of our success has come from the quality of the training program. Usually the education process is dry and it makes buy-in all the more difficult, but TAB really excelled at making it fun and engaging for everyone. The SMART concept has been well received by our personnel. Our thanks to TAB for being great business partners.”

TAB shares this view, and according to Moretti, “Working with Janssen-Ortho was an excellent professional experience. For us, pharma is the Everest of records management. TAB’s strength is the knowledge we have, our practical experience. We know how to tell the story of records management and make it relevant to the people that actually use it. This is why we have had so much success as educators and facilitators in the implementation phase. This project gave us a chance to use every tool and all the approaches we have been developing. Both Goldwyn Chan and Karen Connell as well as their entire team were very good at helping us do what we do best.”

Both sides continue to work together on emerging priority areas and refining the existing system.

Download a PDF of this case study here.

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