If a Picture is Worth a Thousand Words, What is a Video Worth?

According to YouTube, they have over a billion users, almost one-third of all people on the Internet, and every day people watch hundreds of millions of hours of YouTube videos, generating billions of views. It’s also been reported that videos increase people’s understanding by 74% (1). If a photo is worth a thousand words, a video is worth 1.8 million words per minute (Figure 1) (2).

Figure 1 Videos vs. Pictures (www.idearocketanimation.com)

In early 2015, Amgen’s quality leadership team identified a pressing need to improve adherence to procedures on the manufacturing floor. The quality leadership team saw this as an opportunity to look at the company’s document structure and evaluate whether or not procedures were truly written for the benefit of those working on the floor. The company had already provided iPads to manufacturing staff so they could access documents in real-time. In addition, Amgen’s leadership had led efforts to simplify SOPs, encouraging those maintaining and updating the documents to insert symbols and pictures. But was this enough? Amgen’s then Chief Quality Officer Martin VanTrieste challenged the status quo and felt “it was unacceptable that we don’t provide the tools necessary for frontline employees to be successful.” He wanted a disruptive/transformational approach to enable frontline professionals to be successful, not frustrated, when it came to using SOPs.

Around the same time, VanTrieste realized that the taillight on his car was not working. As an avid DIYer, he went enthusiastically and confidently into his garage to replace the light, only to become frustrated after 20 minutes of trial and error. In hopes of avoiding an expensive trip to the dealer, he resorted to an Internet search which, to his surprise, immediately pulled up a link to a short video demonstrating how to properly fix a taillight. Five minutes later, the repair was complete and VanTrieste quickly realized the power video could bring beyond home projects. Not long after, he initiated a project to bring video capabilities to Amgen’s SOPs.

After a successful pilot in one of its manufacturing plants, Amgen collaborated with Google to develop a YouTube-based platform, compliant with 21 CFR Part 11, that allows for the storage and linking of videos directly into controlled documents.

This has enabled Amgen to improve overall quality and facilitate “right first time,” as manufacturing personnel have access to short visual demonstrations of key process steps. A strong team composed of expert information systems, quality assurance, and validation leads launched the SOP video platform, known as “mySOP,” in May 2016.

What Exactly is mySOP?

The mySOP platform consists of short, focused video segments that demonstrate particular steps. It complements—but does not replace—existing written SOPs.

“Video clips should be short stories for critical tasks, not two-hour Hollywood movies representing complex 100-page SOPs,” VanTrieste said.

The platform leverages the existing document review and approval process. Although it initially covered only SOPs, mySOP could be used for any type of GMP document. It is a cloud-based system, using the Google Cloud Platform, that has no restrictions on number of users or total file size, and videos are version- and access-controlled with full user activity-tracking available.

But videos are not added haphazardly to the system. If an owner or operator wants to add a video to the mySOP system, they first have to complete an assessment that addresses at least two of the following:

1. A focused deviation analysis to determine if there are steps that consistently result in error
2. Consideration of what operators feel would improve their right first time operations
3. A deep understanding of process step complexity and criticality (i.e., the higher the complexity and/or criticality, the more likely a video is warranted)
4. Assessment of usage frequency (i.e., in a high mix/low volume manufacturing line, the processes that are not used frequently would benefit from an additional video demonstration)
5. Training difficulty and duration (e.g., if a step is particularly complex or intricate, a trainer may be required to watch or “shadow” a newly trained associate multiple times before feeling confident they can complete the task on their own; videos could be added to the procedures so that the trainee could complete the required training and refer to the video instead of relying on the trainer)

Once assessments are completed, the owner finalizes details about the video, such as what, if any, narration will be included, which point of view (e.g., operator vs. observer) would be best, and when the video can be recorded.

Once the specific what, how, and when has been decided, the video can be created using any recording device, such as an iPhone, iPad or GoPro. Simple video editing is usually required to clean up the start and finish of the video, but editing is generally minimal.

Expected Benefits of mySOP

The use of GMP videos in SOPs is expected to significantly benefit operations at Amgen. Seeing a video demonstration in real time can reduce length of training, improve the end user’s understanding of steps to be performed, diminish deviations, increase adherence to procedure, allow for further simplification of documents, and increase the company’s ability to consistently supply drug products to patients. Manufacturing personnel are able to focus on flawless execution instead of SOP interpretation. The quality leadership team will continue to evaluate monthly deviation rates and potentially conduct an assessment of the personnel using these videos to determine their actual benefit.

Looking to the Future

While the initial rollout focused on Amgen’s largest manufacturing location in Puerto Rico, mySOP provides the company’s entire operations staff another tool to enable further simplification of procedures and processes. Numerous departments within the company, such as supply chain, cybersecurity, commercial marketing and R&D, have reached out in pursuit of leveraging this new, exciting capability. This video platform has the potential to make a significant impact on the business and, ultimately, the patient.

References

1. Young Entrepreneur Council. “Why A Video Elevator Pitch Will Improve Your Market Share.” Forbes (Oct. 10, 2013)
2. Idea Rocket. “A Video is Worth 1.8 Million Words…Interesting Stats.” Idea Rocket. (May 16, 2014)