For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
Using Digital Advances to Evolve the SOP
For any company on the receiving end of an FDA 483 or warning letter, standard operating procedures (SOPs) represent an opportunity to simultaneously achieve compliance and improve operational efficiency. When properly managed and monitored, SOPs equip employers with a clear view of existing knowledge gaps and potential inefficiencies caused by inadequate training.
But are SOPs dynamic enough to keep the pace with natural improvements to working practice that occur through regular use by an organization’s employees? Using conventional SOP formats to capture and redistribute acquired employee value for positive effect is potentially challenging. The rapid advance and deployment of digital technology applications in organizations will further challenge the value of conventional SOPs for employees. Acknowledging these challenges and limitations should drive a reform of the traditional SOP format.
A Living, Workable Document
SOPs are a snapshot in time, capturing a moment in the continual evolution of a process. As such, their value is best realized when employees contribute their knowledge on an ongoing basis. Waiting for the traditional two- to three-year SOP revision cycle risks the loss of valuable knowledge acquired by frequent use and on-the-job improvements to processes. Moreover, employees who leave in between the revision cycles take valuable knowledge with them, which must be relearned as new employees test the SOPs anew.
The consequence of failing to capture the gained value and update the SOP accordingly could lead to observations of noncompliance, leading to 483s or the issuance of a warning letter. To ensure the capture of practical learnings, it is essential to include employees who have applied the SOPs in a real-world setting when SOPs revisions occur.
In short, SOPS should be living, workable documents that add value to the organization, when in reality they are often relegated to secondary or tertiary place by employees who have learned more efficient processes or established other sources of more accurate process detail as a result of frequent use experience.
A Way Forward
To incorporate newly acquired process knowledge, one solution is to build into each process SOP a revision activity for the document. Simply put, the SOP gets updated each time the process is executed, to reinvest the knowledge gained during the previous execution and thus “improve” the process for the next employee who uses the process.
In practice this would present significant challenges, such as frequent changes to process while in use, resource availability and cost. Overall, this could negatively impact employees and business success.
A more practical solution would be to deploy Process Management methodology as set out by TransCelerate Biopharma INC, whereby a difference is established between the SOP (controlled document) and managed information. Defined in TranCelerates’ paper1, Guidance to Successful Implementation of Processes in Clinical Development, “Managed information provides important information and knowledge required to perform the process right the first time. Managed information/documentation is described as the tacit (experience and insight) knowledge that is not managed in a traditional SOP, but ensures staff has the right information and knowledge needed to execute the process. An example of this may include materials such as lessons learned that are kept on common company-shared platforms for sharing across study teams.”
Deploy Process Management
Careful and considered process design would establish the mandatory tasks and any required task order that cannot / should not be frequently altered, and which should be followed without deviation or alteration. Simply put, it would identify those tasks that would not be permitted to naturally evolve and would only be changed through a formal change process.
To address SOP limitations, “how to” knowledge outside of the mandatory tasks would become what is known as “managed information.” As managed information does not define the process execution tasks, it can be structured to provide employees with continually updated information of practical value, driven by user and process owner experience, so that all employees using a process benefit from continual improvements and efficiency gains.
Managed Information can take the form of work instructions, job aids and other process-supporting formats created using appropriate technology—one that automatically creates a change history and content archive to allow frequent or continual content updates. The managed information content would be directly linked to process activities (tasks), allowing users to easily navigate to applicable “how to” knowledge for a specific activity.
The process owner and employees would maintain responsibility for updating managed information content rather than the central SOP administration. Importantly, changes to managed information should not require user retraining or notification but should be intuitive to all process users, since the objective is to improve the “how” rather than the “what.”
The impact of technology on SOPs
The digital age has revolutionized many aspects of global society: Online shopping, banking and electronic document signing are automated, and the user is guided through the various process steps, with critical data fields prepopulated to expedite the process and ensure accuracy. The result is high customer satisfaction, compliance and first-time quality. This technology is now moving into clinical trials. The use of workflow is not new—eSignatures are a simple and familiar example of workflow. As workflow begins to be deployed on a larger scale, the process that was once defined in an SOP will be defined initially by a Business Process Model & Notation (BPMN) process diagram. That BPMN diagram is then used to build workflows which form part of an integrated system solution used to conduct a clinical trial, from study start-up through to study close. This technical revolution is occurring, and early adopters may achieve a competitive advantage allowing market share gains. A system-defined process will not require a “written” SOP. However, control over the system-defined process will be required to ensure change is appropriate and managed. System defined process changes will require appropriate control and approval for changes in order to meet regulatory requirements.
Managed Information in a Technical Solution
While clinical trials follow a defined series of regulatory required steps, they are still considered experimental science. System-defined processes will require a degree of study-specific configuration, and study-specific details will not be known to the overall system process. Study teams will require study-specific knowledge, which could be presented using the managed information technology. Configuring a technology-based, end-to-end process for a specific trial would enable study-specific details and knowledge to be available only to the study team. The configuration would ensure the study team had far fewer process-related decisions and choices compared to today’s use of generic process SOPs, which attempt to cater to all study possibilities. Workflow would automate elements of the process, especially where compliance is critical to first-time quality and fiscal success. Users would have easy and direct access to appropriate study and process information at point of use via a study dashboard, thus reducing or eliminating the need for study teams to have specific system expertise.
Ensuring Quality Management & Regulatory compliance
In theory, a well-designed and effectively integrated technology platform would improve procedural compliance as well as yield significant process transaction data, which would drive further process optimization. Such systems may offer a platform upon which to deploy artificial intelligence, whereby the process is able to self-optimize based upon data collected during the execution of the process and contributions made by employee users. Utilizing this technology can reduce the need for additional FTEs and thereby reduce overall costs to the organization.
In addition, a well-designed- digitally-enabled technology platform allows employers to recruit from geographically dispersed populations to increase availability of potential workforce. Once onboarded, employees can utilize the technology to achieve greater efficiency and reduce errors due to study configured processes, effective use of workflow, and fully integrated study and process knowledge management databases.
The technologies required to achieve the outcomes described are already in existence. Known as Business Process Management (BPM) systems, they provide both content management databases and workflow engines. An important consideration when selecting any BPM technology is to ensure in-house staff can acquire the skills to configure and adapt the solution without relying upon external parties. CROs that invest the time and capital to build a digitally-enabled, fully-integrated platform have the potential to significantly enhance the clinical trial process through greater efficiency, data integrity and cost savings.
1 Guidance to Successful Implementation of Processes in Clinical Development by: Michael Edward Husovich, BS, Ruzica Zadro, MD, Lora Lee Zoller-Neuner, BSN, Griet Vangheel, MS, Odette Anyangwe, RN, BSc, MPH, MSC, Diane Puglia Ryan, MS, Beata Rygiel-Zbikowska, MD, MBA. First Published January 30, 2019 https://journals.sagepub.com/doi/full/10.1177/2168479018817751
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