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What to Do When Optimization Conflicts With Process Needs


Image of life sciences quality management professionals discussion QMS process optimization.

The goal is to optimize each part of your business, but what happens when the best practice in one area interferes with the best practices of another? When considering digital transformation in quality management, how do you keep abreast of problems which are not strictly in any particular area, but are rather a product of the interaction between, for instance, security restrictions and quality management system process needs? Do you have a process for discovering places where these problems are occurring and how do you weigh the relative importance of conflicts they bring to light?

Let’s discuss some ways we can bring smarter optimizations and improve current processes.

Optimizing Your Quality Management System Process

Upon reviewing optimization opportunities as they arise in enterprise quality management, the first step is to begin with scope exploration and a thorough understanding of the current process needs, the people involved, and any parts of the process that cannot be interrupted. Consider these questions to begin the scoping process:

  • Who are the key process members at each step?
    These are the people that need to be involved in scope discussions, such as the remaining questions below, as they will be the best suited to notice where optimization may be impacting the current process.
  • What are the limitations and pain points of your current process?
    This is what we will aim to improve.
  • What are the most successful parts of your current process?
    These parts we will strive to keep the same.
  • What needs to be improved in your current process?
    These items are prioritized for process improvement.
  • What parts of the process cannot be disrupted, if any?
    These parts need to be considered during any optimization plan to ensure there are no interruptions in the current process.

Next Steps

The next step is to review options that prioritize the parts of the current process that needs to be improved, including pain points and limitations. Highlight options that work with and/or keep successful parts of your process intact and will not interrupt existing processes.

When options conflict with levels of impact, consider choosing the option that minimizes the impact to your current process, while addressing the top priority issues to be optimized in the quality management system process.

In Summary

While digital transformation in quality management is the goal, upon configuring a new process always stay open to the idea of evolving the existing process to remove steps/notifications/people that were involved because of the process environment. Ensure legacy steps are not included in the new process or QMS implementation to stay streamlined.

 

Melissa Leygan is the owner of eQMS Consulting LLC, specializing in eQMS administration, documentation, training, and support. Melissa has worked with MasterControl and other eQMS software since 2016, and she is known for her confidence, kindness, and efficiency. She graduated from the University of Maryland, College Park (Go Terps!) and balances her professional life with her roles as a wife and mother. Melissa's organized approach and clever problem-solving abilities have earned her a reputation as a trusted advisor in the industry. Through her work, she continues to make a significant impact, shaping the future of quality management systems for businesses worldwide.

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