Ensuring compliance - The Functional Point of Contact (FPOC) story

As has been widely acknowledged, one of the most meaningful steps a business can take is to establish a single point of contact that permits one set of communications, with the whole of a client’s history to hand, instead of multiple strands of information scattered and held separately across disparate, siloed individuals or teams. A critical organisational way to facilitate prompt response and accurate information recall is also best practice for ensuring non-compliance events are documented and reported with expedience.

Here, two experts from Advanced Clinical – Senior Operations Quality Manager, Lisa Zinkevich, and Compliance and Quality Manager, Fauziyah Akhtar – share insights on the central role of the FPOC in the compliance process.

The FPOC: Reducing future non-compliance events

A functional point of contact (FPOC) is a dedicated liaison in each functional area responsible for evaluating and documenting non-compliance events and, ultimately, helping to reduce the likelihood of similar events occurring within their department via trending, awareness, and long-term corrective actions.

“The FPOC has the ideal understanding of the Standard Operating Procedures (SOPs) and workflows specific to their functional area, putting them in the most efficient position to investigate, evaluate, and document the non-compliant event,” explains Zinkevich. “As a leader, the FPOC role ensures visibility of Quality trends and issues within the functional area.”

“Essentially, an FPOC is a Subject Matter Expert (SME),” adds Akhtar. “They have the knowledge at the department level and can bridge the understanding between Quality and the Operations team. Having an auxiliary person not only supports the process, but provides valuable insight that may not be obvious to an ‘independent’ Quality person, or to a ‘Quality person independent of the operational activity’.”

For Advanced Clinical, the aim is to streamline its processes using technology, so that appropriate functional area leaders are notified of non-compliances within their department, while managing and ensuring that the proper investigation, communication, and documentation of the non-compliance takes place within the required timelines. This results in a more quality-compliant, efficient, and cost-effective process for addressing non-compliances, including capturing what action(s) was taken to address the issue, as well as what action has been taken to prevent those non-compliances recurring in the future.

“Timelines are critical, since they are subject to scrutiny in client audits and regulatory inspections,” says Akhtar. “Completing tasks and actions in a timely manner demonstrates a well-controlled and well-oiled quality system.”

“In accordance with our SOPs and Work Instructions, Advanced Clinical is committed to timely reporting, addressing, correcting, and preventing non-compliant events,” asserts Zinkevich. “The FPOC role provides this important layer of oversight between the Compliance & Quality team and the individual team members involved with the non-compliances.”

A Case Study

Advanced Clinical uses Veeva’s eQMS, and non-compliances are submitted via the Quality Issue Module and reviewed via the Operations Quality triage team; if deemed non-compliant, they will notify the FPOC to perform an evaluation. If reportable, the non-compliance would progress to a Quality Event in the eQMS managed by the FPOC.

At Advanced Clinical, a training non-compliance was identified. A team member from the Operations department reported this non-compliant event to the Quality Issue Module within Veeva eQMS, providing a description and details of the event in accordance with Advanced Clinical SOPs.

Upon receiving the submitted non-compliance, the Operations Quality team notified the FPOC from the applicable functional area by tasking them within the Veeva eQMS. Once the FPOC received notification of the non-compliance, they worked with the Reporter from Operations to ensure the event was reported accurately and completely. The FPOC then completed a risk assessment of the event within the Quality Issue Module to determine the impact.

After the impact of this event was evaluated as significant, the FPOC opened a non-compliance report with Veeva eQMS, and closed the Quality Issue Module record of submission, referencing the non-compliance report ID within the Quality Issue Module to effectively link the records.

The Quality Event (non-compliance) report includes key event documentation such as the description, impact, root cause, and corrective and preventive actions (CAPAs). The FPOC worked with the impacted department, the event reporter, and applicable functional leads to assess the situation and provide visibility on solutioning as part of the CAPA plan.

The report, including the determined CAPAs, was reviewed and approved by Compliance and Quality Management and routed for implementation. Once CAPA implementation was completed, the Quality Event was closed.

With growth, an increased focus on risk management

In order to scale, Advanced Clinical will align with ICH GCP E6 (R3), where the focus is on risk management. The non-compliance evaluation performed by the FPOC allows the company to concentrate its efforts on those deviations that have an impact or pose a risk to the data integrity and/or trial participant safety on a study, rather than less significant events that by definition are deviations.

“The FPOC role allows Advanced Clinical to manage and trend our non-compliant events more efficiently and identify where corrective and preventive actions are needed,” comments Zinkevich.

Compliance and Quality meet with the FPOCs frequently to actively manage this process, assess feedback, and ensure continued collaboration between Quality and Operations.

“Without the FPOC role, the process of investigating, evaluating, and documenting non-compliant events becomes very inefficient, due to a lack of necessary information or misinformation reported by staff to the Compliance and Quality team,” she continues. “The FPOC role streamlines the required details necessary for the appropriate non-compliance evaluation and documentation.”

What is also potentially lost is the “asset” of valuable information for the study or department, which may not be obvious to the Quality team and, therefore, not adequately captured in the non-compliance, according to Akhtar.

Having an FPOC for each department additionally builds transparency and insight into quality data that functional leaders need for improved compliance. As it continually improves this process, Advanced Clinical’s aim is to provide oversight for the leaders to assess/view any gaps and support them with process improvements and trend any potential issues that could be major, which were not previously identifiable through former processes.

The benefits of implementing an FPOC

1. Ensures non-compliances are identified, documented, tracked, and resolved in a timely manner.
2. Streamlines processes for better time management across the organisation.
3. Better visibility into non-compliance data at a functional level, which enables functions to be more aware of their process gaps and empowers them to be responsible and accountable for resolving and solutioning.
4. Enables a risk-based approach for reportable non-compliances that would have an impact on study and organisational activities that aligns with the direction ICH E6 (R3).
5. More quality-compliant, efficient, and cost-effective process.

“The FPOC is best positioned as the appropriate resource for their functional area team during the investigation, evaluation, and documentation of the non-compliant event,” says Zinkevich. “With direct and immediate involvement in the process, the FPOC role is kept aware of process gaps and quality concerns within the functional area, which allows them to ensure staff adhere to reporting timelines, and ultimately drive improved processes and compliance within their functional area and the organisation.”

“The FPOC role is a developing role; their insight, valuable knowledge, and active contributions support a well-written and meaningful non-compliance and CAPA plan,” adds Akhtar. “The FPOC not only supports the non-compliance process, but they also help their departments with improvements, trending, and identify common themes before they become a bigger issue, or identified at a regulatory inspection. The FPOC also catches cross-functional trends to allow for more widespread learning and improvements across other functions and departments.”

About Advanced Clinical

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. Visit our website to learn more: www.advancedclinical.com.

About Lisa Zinkevich

Lisa Zinkevich is a Senior Operations Quality Manager within the Operations Quality Department at Advanced Clinical. She has over 20 years experience in the clinical research and health science industry and has held varying roles within clinical operations, training & development, and quality management at pharmaceutical, CRO, and biotech companies.

About Fauziyah Akhtar

Fauziyah Akhtar is Manager of Compliance and Quality at Advanced Clinical. She has over 10 years of experience in compliance and quality ranging across different GxP such as Good Clinical Practice, Good Pharmacovigilance Practice, and Good Manufacturing Practice. She has been in quality management positions for the last six years and is an SME in non-compliance and CAPA management processes in clinical and post market activities. Akhtar's other areas of experience in quality include management of audits and inspections, vendors, QMS, training, and global client quality, to list some.