Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions
Social networks, outsourcing, mobile apps, expiring patents, mergers and acquisitions, are but a few landmarks in the last 10 years that have changed the way business is conducted forever. If nothing else, industries have acknowledged that they must embrace change to remain competitive and protect market share. As such, regulated industries such as life sciences, must adopt a proactive and systematic method to integrate new technologies and efficiencies while preserving the quality, safety and efficacy of their products and services.
ICH Q10 Pharmaceutical Quality Systems outlines the goals of change management to include (1) achievement of product realization, (2) establishment and maintenance of a state of control and (3) facilitation of continual improvement. These objectives are obviously translatable to any business model. The principle of change management, previously phrased as change control, is incorporated into several industry standards including ISO 9001, Sarbanes-Oxley, ITIL, CMMI and numerous others. Whereas the key steps of change management remain the same, similar process weaknesses can be identified across industries.
The Weakest Links
The most common issues found in a lackluster change management program are the absence of documentation, deviations from the process, inadequate testing and poor notification of affected areas. Many times the excuse for such non-compliance is that the process is cumbersome and negatively affects response time. Admittedly there is an administrative burden to documenting changes. However, change management activities should be scaled based on product/system complexity, staff knowledge, and level of risk. In all instances, proposed changes should be evaluated by a change control board (CCB) consisting of, at minimum, the system owner (business knowledge), a subject matter expert (technical knowledge), and quality assurance (process and regulatory knowledge).
While the CCB role is that of due diligence to prevent unauthorized modifications to a validated system, another valuable activity of the CCB is the refinement of the process by assigning change categories. Through period assessment of cumulative changes to the system, routine changes can be identified and directed through an abbreviated path for change control (i.e., preapproval with predefined action plans). As the process matures, the pool of what is considered an “unplanned” change should shrink.
Mastering the Art of Change
Technology has even affected the art of managing change itself. Automation has become the game changer for efficient change control. Enterprise-wide change management systems deployed based on a solid manual process yield a quick return on the initial investment by reducing the time and cost of collaboration across geographic and functional barriers. Further these systems drive compliance with embedded business rules and workflows. Consequently, moving from manual to electronic coordination of efforts is a logical next step for progressive companies.
Overall, change occurs throughout the life cycle (development, technology transfer, production, retirement) of any product or service. When improperly managed, it can lead to product failures, recalls, poor reputation, regulatory sanctions and even injury. Therefore, sufficient time and energy must be devoted to understanding and promoting the importance of change management as an integral part of the quality system. The risk of not doing so is just too high.