Quality is the adherence to a defined set of attributes and criteria or customer requirements; the product or service should be free of deficiencies. While quality is widely recognized as being relevant for sustainable business across industries, the corresponding efforts to ensure quality are mostly seen as a burden.
This is even more prominent in regulated industries where organizations must prove through extensive documentation that their products/services comply with the specifications. In addition, all involved processes and systems must be validated. The related activities are seen as business value added at best – but are still not seen as adding value to the actual product or process.
The New Paradigm
The recent times of crisis might have changed this. Consumers and patients are going through times of uncertainty and demand a much higher level of reliability, certainty – and quality. For manufacturers this means that the quality of their products becomes more important than ever before – it is business critical. Brand reputation and competitiveness depend on the quality companies deliver. How can an organization support this paradigm?
Additionally, many product-manufacturing processes have changed. Staff must keep social distancing of 1.5 to 2 m, making it difficult to collaborate in narrow spaces. Complying with sanitation rules and wearing masks during work are standard requirements for protecting others. And work is done in more shifts of smaller teams to avoid exposure to larger groups of people. This has two major effects:
- Procedures have had to change and new ones are introduced
- Working remotely and sharing information electronically is part of the “new normal”
This means organizations have to deal with the increased burden of more and more complex processes and create/adapt the related documentation. They must also move into a “less physical” world while ensuring optimized product quality delivered to patients with no delay.
The way to respond to this challenge is digitalization, which is not simply going electronic – although that is the first step. Handling processes on paper is no longer an option. In order to ensure business continuity, companies need to adapt to the “new normal” of more/different processes and increased physical distance.
With an electronic document management system (EDMS), organizations can minimize physical contact when it comes to documentation. It makes data, information and documents available to all individuals involved — independently of their location, whether onsite, remote or global, and it supports collaborative document development. EDMS also makes it easier to change, update and manage any processes and standard operating procedures (SOPs), as well as to create new ones.
Quality processes become the object of focus in times of crisis – and they should be, due to the increased scrutiny and quality expectations. Corrective Action and Preventive Action (CAPA), Change Control, Deviation and Complaint Management or Audits are processes demanded by the authorities like the US FDA (US Food and Drug Administration) and established by organizations to ensure product quality and patient safety. Companies can only efficiently manage the surging process changes encountered during times of crisis with electronic systems. Internal as well as external audits are now more cumbersome. Easy access to information through an electronic system reduces the need for physical presence while also shortening and streamlining inspections.
And what about trainings? With many new procedures in place, personnel need to receive the appropriate trainings (e.g., when, where and how to wear face masks and gloves, wash hands, disinfect, etc.). In the past, education was easily done by gathering people in a room, training them and handing over the procedures on paper, which is not an option anymore. So again, an electronic system like a Learning Management System (LMS), supported by online/video will help manage the process.
With the increased complexity described above, corrective and preventive actions are no longer enough. Organizations must anticipate new situations arising from our changed environment. This requires access to quality-related data that reside in different electronic systems. Connectivity becomes critical.
When EDMS, EQMS and LMS are integrated, ideally through a platform, employees can access and leverage the data for pro-active quality. Connected Quality drives data integrity, reliability and overall quality. At the same time, it supports deeper insight into and understanding of quality processes and the effect of deviations on macro-processes. It improves data-driven risk assessment and decisions.
Digitalized, connected Quality can help to ensure overall quality – of data, processes and ultimately of products. It can improve competitiveness and business continuity. Most importantly, it can help to keep people safe in times of crisis.
Learn more about how BIOVIA can help you manage and leverage Quality in times of crisis.