🚧 When a Process Becomes a Project: The Dark Side of Automation! 🚧

[Erkan Teskancan]

🤔 Process or Outcome?​

Have you ever considered what happens when processes themselves take precedence over the project in an automation project? For one of our clients, lacking an automation team, we encountered a proposal missing a GMP package. Working with the vendor, we provided site acceptance tests (SAT). The technician installed the equipment, performed the tests, and presented us with a flawless SAT report. However, the equipment had a serious liquid integrity issue, which was not covered in the tests. Every box was checked, but the client still didn't have a working unit. This is a case where the process became the project itself.

⚙️ Process is a Tool, Not the Goal!​

Quality processes are vital, especially in GMP life sciences automation projects. They ensure consistency, minimize gaps, and allow projects to scale without compromising quality. But over time, the "why" and the original purpose get lost behind the words on paper. People follow the process because "it's always been done this way" or because following written steps feels safer than owning an exception or making a decision. This is a situation where the project starts supporting the process, and the process no longer serves the project's objective.

🎯 Specialization and the Big Picture​

Processes enable scaling, but scaling itself is not the enemy. The real problem is moving away from the outcome. As those responsible for the process specialize, they become detached from those doing the work and responsible for the final outcome. Problems arise when everyone sees only a narrow view of the project. Their metrics might be deployed control modules, submitted documents, or resolved deviations. They are asked to optimize these, but these optimizations may not align with the overall project goal. Completing one step may not actually advance the project.

Someone needs to maintain a broader perspective, feed the results of individual decisions back into the process, and have the authority to make decisions when individual parts are not aligned with the overall outcome.

🚨 Warning Signs and Solutions​

• Shadow Workarounds: A SOP (Standard Operating Procedure) has existed since the facility was built, but employees rarely follow it because it's disconnected from the actual work. Instead, a shadow workaround has organically formed for decisions and approvals.
  
• Excessive Review and Indecision: Too many reviewers, conflicting comments, and no decision-maker with the authority to choose a path.
  
• Outdated Standards: Design standards that are not current or best practices inconsistently applied.
  
• Single Point of Knowledge: Only one person understands the quality system workflow.
  

These situations create a self-reinforcing system where the process becomes a deliverable at the expense of the project's budget and timeline.

💡 Informal Solutions are Proof of Process Failure​

One of the best ways to understand how cumbersome a process has become is to count the informal solutions and determine how institutionalized they are. When formal processes are too slow or disconnected from the work, skilled employees create alternative methods. These might be unofficial trackers, spreadsheets, verbal agreements, or personal notes that become the true source of information.

These situations should not be confused with avoiding responsibility. Informal solutions are often created by individuals trying to protect the project. They advance tasks, but with the potential cost of loss of traceability, inconsistent records, and tribal knowledge concentrated in a single person.

The solution is not just to codify the informal solution. It is to re-evaluate the existing procedure, aligning it with both the original intent and the practical lessons embedded in the informal solution.

✅ Review is Not a Decision!​

The number of people added to document reviews has outpaced even inflation. Reviewer lists are often used as notifications for informational purposes or as a way to spread responsibility. What they actually do is increase costs and extend timelines.

This situation can be improved by designating or empowering a decision-maker. The review should include a minimum number of people: a decision-maker and representatives from departments truly affected by the decision.

For every review, approval, or form, ask these three questions: What risk is this step intended to control? What decision or evidence should it produce? Does the reviewer have the necessary tools and authority to act? If these answers are not clear, the step needs to be redesigned.