Dr. Chitra Lele, Chief Scientific Officer, Sciformix

Operational Excellence, Outsourcing and Oversight in Quality Management Systems

Dr. Chitra Lele Ph.D.

[This post is the third part in a series that will focus on achieving operational excellence with an effective quality management system.]

Until about 2009, compliance to reporting timelines of expedited reports by the marketing authorization holder (MAH) was the only valid metric of the effectiveness of an AE processing operation evaluated by global health authorities. Driven by the public focus on drug safety led by recalls of a few prominent drugs, the regulators began to look closely at the way the pharmaceutical companies were classifying cases.

Suspected unexpected serious adverse reactions (SUSARs) are reportable under existing guidelines, whereas AEs listed on a drug label are normally not reported individually but are compiled into aggregate periodic reports. There were some findings from US FDA inspections of questionable criteria being used to ‘downgrade’ reportable SUSARs. As a consequence regulators started looking closely at ‘case quality’.

Collection, processing and reporting of ICSRs is often outsourced since it is resource-intensive, primarily process driven and largely operational in nature. MAH oversight of outsourced processes is increasingly coming under regulatory scrutiny.

Increased complexity of drug safety monitoring, increased volumes and greater regulatory and public scrutiny, along with the ensuing need to outsource parts of the process have enhanced the focus on operational excellence. It is critical to outline the systems, processes and other tools and controls which the MAH will use to achieve operational excellence, thereby ensuring quality and compliance.

Irrespective of whether pharmacovigilance is done in-house or is outsourced, description of such systems, process and tools is an integral part of the quality management system (QMS). When parts of the process are outsourced, measures taken to achieve operational excellence are often outlined as part of the oversight plan of the MAH. Thus specification of how the oversight will be provided, the tools and controls that will be used, has become an important component of the QMS.

Relevant details of the processes, measures and controls are included in a quality agreement and/or a quality management plan (QMP) and an oversight and/or governance document signed by the MAH and its PV partner. These include the KPIs which will be used to monitor performance, how they will be measured, what are the thresholds, for example. The oversight/governance document mentions how operational and management teams from both organizations will monitor the performance of the PV system, the escalation and resolution mechanism, the communication channels and individual roles, responsibilities and accountability. There may be an oversight SOP in some cases.

Some of the KPIs used to monitor performance of the outsourced operations and which constitute service level agreements (SLAs) are:

  1. Regulatory reporting compliance (per cent cases submitted to regulators on time;
  2. Case quality metrics;
  3. Case turnaround time (internal case processing timelines);
  4. Number of daily case closures.

The QMS, through the quality agreement or QMP, outlines the process for documentation and evidence of monitoring of KPIs and may also include aspects of governance and escalation mechanisms. It should also contain some description of how the MAH will oversee other aspects of the outsourced operations on a day-to-day basis, for example, ensuring that adequately qualified and experienced individuals are recruited, required training is conducted and documented, individuals are signed-off on the project based on pre-defined criteria, ensuring adequacy of infrastructure and facilities of the service provider.

The QMP may also include details of any process improvements/enhancements which may be applied for attaining operational excellence and ensuring compliance. These details may include six-sigma or lean methodology applied to improve the process, automation of parts of the process to minimize the risk of errors and misses, additional quality gates and any templates, tools, checklists, that may be deployed. The QMP thus drives operational excellence and also enables effectiveness measurements.

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