Four Things CIOs Need to Know about Quality

Matthew Lowe, Executive Vice President, MasterControl
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Matthew Lowe, Executive Vice President, MasterControl

In highly regulated companies, the CIO plays a critical role in ensuring that an organization’s IT environment, infrastructure, and applications are all in conformance with industry standards and regulatory quality guidelines. Under the auspices of the FDA and other analogous international regulatory bodies, regulated companies – particularly those in the life sciences–are required to implement a quality management system (QMS). The most common means of implementing such a system is an enterprise software tool. When it comes time to implement a QMS, the following four tips are insights every CIO should embrace.

Understand Validation

The first aspect of QMS implementation CIOs should be aware of is that full software validation of a computerized system is required for systems critical to production and quality (enterprise resource planning, quality management, etc.). It is critical to understand how the validation process impacts project timeframes and what kinds of skill-sets are needed on staff. If a CIO is coming into a highly regulated company for the first time, there is often a steep learning curve when coming up to speed on what validation is and how it is executed. It is critical that the CIO understands the primary objective of validation: to produce documented evidence that provides a high level of assurance that the software application has been installed properly and that it functions as indicated and meets user requirements.

‚Äč  Companies with a quality-first mindset are able to proactively bypass roadblocks and ensure that all operations run as smoothly as possible 

No software can be guaranteed by its manufacturer to be perfect. The more complex the software is, the more likely it is to contain errors. Therefore, it behooves QMS software vendors to prove to customers that the computer systems do what they are intended to do both functionally and operationally. This is the fundamental basis for computer system validation and should be of chief concern to CIOs.

The different readiness tests that must be performed in order to confirm the validation of an automated system are segmented into three different classifications of qualification: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). IQ shows that the system has been installed correctly. Once IQ has commenced, the system and infrastructure should be under formal change control. IQ considerations include: hardware and software installation, safety features, software and hardware documentation, security aspects, and so on. OQ tests the automated system’s processes and operating parameters to ensure that it meets the defined user requirements under all anticipated conditions of operation, including worst-case scenario testing. PQ demonstrates that the computerized processes will consistently produce acceptable outputs under normal operating conditions.

Choose the Right Solution for Quality Management

Input from an informed CIO can ensure that the company will make an investment in a comprehensive, integrated platform that can be configured to meet the organization’s needs, as opposed to purchasing one-off or piecemeal products for each separate element of the quality system. This is a critical component of effective quality management and long-term scalability.

Consider a software platform where every quality process is seamlessly connected versus a homegrown or hybrid electronic/paper system that uses one solution for document management, another disconnected application for training, another for quality events, and so on. Trying to get disparate systems to work together harmoniously and according to regulatory standards is a herculean effort that is altogether unnecessary when using an integrated system constructed on a purpose-built QMS platform.

Consider Analytics Capabilities

One of the main benefits an integrated platform provides is the ability to more cohesively and comprehensively leverage data. In a connected QMS, data is collected in a single repository, meaning there is a “single source of truth” for all critical documentation. The CIO must ensure the QMS’ analytics tool is robust and flexible enough to give users everything they need to do their jobs according to regulatory guidelines without overburdening the IT department. A well-suited QMS should feature comprehensive data gathering, processing, searching, and reporting capabilities. The analytics tool should also provide the ability to generate a broad variety of report types as well as customizable report variations users can create themselves. For example, the system under consideration should be able to produce reports for quality events, completed training records, pending training records, audits, approved vendor lists (AVLs), bills of materials (BOMs), or any other type of quality process required for the organization to meet industry or regulatory standards.

Real-time dashboards can help management view relationships between multiple trends by consolidating trend charts onto a single page. A quality trends dashboard can display a variety of useful types of information, such as: the number of non-conformances over the past year; the number of corrective and preventive actions (CAPAs) grouped by department; the number of CAPAs grouped by root cause; or the number of customer complaints by product trended over a particular time period.

Promote a Culture of Quality throughout the Enterprise

Even in the earliest days of the formal development of quality management as a discipline, pioneers such as W. Edwards Deming preached quality as a company-wide initiative that is not solely the responsibility of the quality department. The concept of total quality and quality management implementation experienced an awakening during the quality movement in post WWII Japan, led by Deming, who became a world-famous champion of quality control. He was a proponent of concentrating on the improvement of all processes at their most fundamental level from inception, rather than reacting to and correcting problems at the end of the manufacturing process. In every industry, this practice of incorporating quality excellence into every level of manufacturing is a main differentiator between market leaders and the rest of the pack.

Oncea company-wide quality perspective is internalized, companies not only have an easier time maintaining compliance with quality regulations, but they are even able to leverage quality as a business accelerator. Companies that adopt a culture of quality can make dramatic improvements in a variety of areas, such as reduced scrap rates, accelerated time to market, increased yields, and the elimination production disruptions that arise due to the continual emergence of quality events. Companies with a quality-first mindset are able to proactively bypass roadblocks and ensure that all operations run as smoothly as possible.

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