News

Outsourcing Quality Assurance in Supply Chains

News

Outsourcing Quality Assurance in Supply Chains

Article

April 04, 2019

Quality Assurance – core or commodity?

Ensuring product quality throughout the supply chain, from sourcing of components to manufacturing and distribution to customers, is becoming a key success factor for any producing / trading company. This holds true in particular for the life science industry, where any deviation on product quality can not only impact cost or reputation but at worst being a matter of life or death. Not surprising that companies first reaction to the question most likely is something along the lines of “Yes, of course, quality assurance (QA) is key to our business, from both a customer and a regulatory perspective!” However, looking at the QA function in more detail and understanding the underlying processes, leads to a more differentiated answer, exposing hidden opportunities for efficiency gains.

Untangling the Quality Assurance function in supply chains

Quality assurance is a broad topic, typically being driven by a central QA function with most required elements being covered by other functions within a company. This can become quite a headache to manage, in particular when multiple internal or external parties cover key roles within the supply chain and stringent regulatory requirements require detailed Standard Operating Procedures (SOPs). This is especially true for the pharmaceutical industry, which has one of the most complex as well as most regulated supply chains existing today. Nevertheless, in our view the QA function is essentially built from three areas: Strategy & Process Definition, Review & Decision-Making, and Process Execution.

Defining a company’s QA strategy and implementing it within the organization through appropriate processes and related controls is something that needs to be driven by a company’s leadership in order to ensure the change sticks. As such, companies normally still want to be in control of defining quality goals, metrics and SOPs, and rightfully so.

The review of both process effectiveness as well as process output, as well as apt decision-making, should also be owned and driven internally in order for a company to live up to its promise of accountability towards regulators, customers and shareholders. A few examples for decision-making are changes to organizational structures, processes or to provide approvals as part of a toll-gate function.

When it comes to day-to-day execution of QA processes on the other hand, we see a lot of potential for optimization through outsourcing, in particular in the supply chain. Taking temperature monitoring as one example, most companies evaluate, implement and manage monitoring systems as well as related hardware assets such as data loggers themselves, although this could be done by outside of the company as a service.

Based on discussions with customers, their need is to have direct access to easily digestible information that enables responsible persons, such as Quality Managers, to make decisions quickly and based on sound evidence. This is performed by a new third party role, the Quality-Assurance-as-a-Service (QAaaS) provider, who collects and aggregates data according to defined client SOPs from various sources, storing the information in a form required for audits and providing means of disseminating information in a secure manner between authorized external and internal stakeholders. In addition, a QAaaS service provider can enable process efficiency through automation and optimization based on today's available advanced data analytics.

 

Modum’s approach to QAaaS

At Modum, we recognize that companies want to focus their efforts on what counts most: making impactful decisions based on relevant information. Pharma manufacturers, for example, should outsource the temperature monitoring of their shipments, reducing the interaction with the distributor to the access and evaluation of data through a single interface, ideally incorporated into existing and familiar tools. A distributor of the products, on the other hand, takes over the role as QAaaS service provider, responsible for assessing and implementing monitoring solutions, dealing with any physical monitoring assets, supporting system validation assessments, and other logistic processes. This is a win-win situation: the pharma manufacturer reduces his process execution effort, enabling him to focus on quality control and remediation, whereas the distributor can grow his business by providing more rounded and comprehensive offerings to their clients.

Our current commercially available and certified solution MODsense for temperature-controlled logistics, enables many of these QAaaS aspects. MODsense covers monitoring and control of temperature-sensitive goods providing Quality Managers direct and immediate access to relevant measurement data linked to the physical shipment, as well as audit-ready reports, irrespective of location or logger handler. MODsense can be used stand-alone for quick adoption, but can also be integrated into common ERP systems, such as SAP, enabling a user to continue to work in a known environment. Logger handling itself is literally child’s play – both shipment preparation as well as data read-out is just a matter of seconds via several options depending on the level of integration, thereby supporting deployment as a service.

Additionally, due to the flexibility of MODsense’s account management, external parties such as auditors, can be provided with controlled and time-boxed access to relevant shipment evidence. We believe this will not only reduce audit preparation efforts, but also strengthen the relationship with the regulatory body by demonstrating transparency and helpfulness.

The fact that data integrity is ensured by using blockchain technology, creating an immutable and unique signature of the data measurement, introduces a new level of trust to the system. This level of trust in the underlying data opens the door for blockchain powered process automation of simple operational processes, such as shipment redelivery, payment settlement or initiation of Corrective and Preventive Action (CAPA) items.

 

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