Massimo Franza, Senior Director of Software Development, Pilgrim Quality Solutions
As my colleague Kevin Lee says in his blog, The Pursuit of Zero Waste: Continuous Improvement to Drive Quality:
“The Pursuit of Zero Waste requires that an organization continuously improves its current products, processes, and people involved in making the perfect device, the perfect item or the perfect process to yield zero waste.”
So he really talks about how continuous improvement is the key to remain successful and to keep your organization growing.
In today’s post, we’ll discuss the relationship between change management and continuous improvement.
The Relationship Between Change Management and Continuous Improvement
To improve anything, it is not only essential to measure everything (identify deviations, nonconformances, out-of-specifications) and perform investigations (and identify the root cause of each problem), but it is equally essential to embrace change within your organization to implement the necessary corrections and improvements to your products and processes.
Change Management and Compliance
Change needs to be planned and controlled for it not to lead to confusion and chaos. It is no surprise, in fact, that inadequate change control procedures are frequently identified in the top 10 reasons for FDA warning letters to Medical Device firms. The FDA expects each company to have a system in place that carefully evaluates the impact of any change, and that changes to products and processes are controlled. This means that each change should be recorded, reviewed, and approved by the quality control unit.
So we realize you have a need. The need to grow, the need to lead your organization closer toward perfection through continuous improvement, and the need to manage change as an enabler for continuous improvement, while remaining compliant.
An automated change management solution is your enabler to controlled changes, as it provides a tool that you can use to organize, monitor, assign, review, and approve all of the tasks needed to implement changes throughout your organization.
What to Look For in a Change Management Solution
Here are the top 10 capabilities to look for in an automated change management solution. A compliance-focused change management solution should:
- Provide a centralized queue to manage and confirm incoming change requests.
- Capture any kind of change including changes in manufacturing, documentation, IT systems, facilities, equipment, validation procedures, packaging and labeling, laboratory operations, and design.
- Record all impacted areas, assign tasks, and propose change plans.
- Organize the change process to handle complex changes when necessary. This should include multi-level action plans so that larger changes can be broken into smaller tasks to be completed throughout your organization. You should have the option to run change tasks and plans sequentially or in parallel so that changes can be implemented in a timely manner.
- Enable one or multiple assessments to allow experts to evaluate the impacts of a change, accounting for results of impact assessments before routing for approval.
- Enforce formal sign-offs from a change control board and quality assurance to ensure compliance.
- Track and manage action plans as they are implemented and verified.
- Enable you to perform a quality check to ensure the effectiveness of each change.
- Integrate with other areas of the quality system to designate changes to documents as part of your heterogeneous action plans, including creation of new documents, new revisions, expirations and deviations, and, from there, additional trainings and certifications.
- Enforce electronic signatures during impact assessment, review, approval, and other critical signoff steps within the change process to help maintain 21 CFR Part 11 compliance.
Continuous Innovation Leads to Continuous Improvement
To summarize, this is the reason why Pilgrim has invested in building a complete Change Management solution. Not only is controlled change a regulatory requirement that you need to be compliant with, but we believe that it is also an enabler for your continuous improvement strategy that is key for your organization to continue to succeed in the highly competitive Life Sciences industry.
Pilgrim’s investment in continuous innovation translates into your organization’s continuous improvement.
Change Management Data Sheet
SmartSolve® Change Management enables you to develop a harmonized and efficient change control process. Download this data sheet to learn how Change Management can help your organization manage change effectively.