We were acting as the owner’s agent for a client without an internal automation team. Identified the original quote was missing a GMP package and worked with the vendor to provide site acceptance testing. The field technician installed the equipment, ran the scripted tests, and handed us a completed SAT with no deviations.

The equipment still had a serious liquid integrity issue that had no corresponding test. From the field team’s perspective, every checkbox was complete. My client still did not have a working unit.

That is what it looks like when the process becomes the project. The paperwork proves that every required step was completed, but the outcome those steps were intended to protect has been lost.

Process is necessary, but it is only a tool

Quality processes are the backbone of automation projects, especially in GMP life sciences. They create consistency, minimize gaps, engage the right decision makers and allow projects to scale without dropping quality.

But over time, the “why” and original intent get pushed aside by the words on the paper. People follow the process because that is how it has always been done, or because following the written steps feels safer than owning an exception or making a decision. This is the creep we have all seen: the tipping point where the project begins to support the process rather than the process serving the project goal.

Quality process unlocks scale

Processes provide the means to scale, but scale itself is not the enemy. The resulting distance from the outcome is. 

As the people responsible for a process become more specialized, they grow further from the people doing the work and accountable for the final outcome. new requirements get created that make sense within the context of the process itself. 

Specialization itself is a good thing, particularly with the speed and complexity of modern automation technology. 

The problem comes when each person sees only one narrow view of the project. Their metrics may be control modules deployed, documents submitted or deviations resolved. That is what they are asked to optimize, but those optimizations may not align with the overall project goal. Completing an assigned step might not actually advance the project. 

Someone needs to retain the wider view, feed the consequences of individual decisions back into the process and be empowered to make a decision when the individual parts do not align with the overall outcome

Warning signs, tips for recognition

Project work doesn’t reward effort alone. Every project team member can work hard and perform their assignment correctly, but it means little if no one is accountable for the complete outcome.

We’ve all seen warning signs. An SOP that has been around since the facility broke ground, but the people doing the work rarely follow it because it is disconnected from the actual work. In its place, a shadow workaround for decisions and approvals has organically formed because it just works better.

Employees know them viscerally. Integrators clock them as red-flags because they have seen them before: too many reviewers, conflicting comments and no decision maker empowered to pick a path. Other signs include outdated design standards, best practices inconsistently applied, or finding that only one person actually understands the quality system workflow.

It happens on the integrator side, too. Efforts to drive costs down can produce internal processes that favor company templates, scheduling tools, quality systems, and file-storage methods. Over time, the processes begin to control scope to the letter rather than to the intent of delivering a functioning system.

When both situations come together, you get a self-reinforcing system where the process becomes the deliverable at the expense of project budget and schedule.

A network approval process, a real-life workaround 

Another real life example involved a client with a formal process for adding network.

The goal intent was great: verify that the device was compatible with the existing system and document the as-built state. The form captured the MAC, IP settings, and port assignment. The workflow included pre-approval, execution of the work, and post-approval of the as-built record.

On paper, it appeared thorough. The problem was that the pre-approval reviewer did not have the tools to discover conflicts. The reviewer could only confirm the documentation was complete, but could not reliably identify IP conflicts, routing issues or port-assignment conflicts.

It turns out everyone used a workaround. They sent one person in IT a spreadsheet of switches, ports and IP addresses, then called when they were ready to connect. The field installer configured the switch while IT monitored the work, and together they resolved network segmentation, routing, IP and port-assignment issues. They captured the final configuration, completed the form as-built and sent it back through the review process.

Many hours were wasted tracking down information spread across engineering standards, drawings and online IT databases. The as-built configuration was the real deliverable, not the effort spent generating documentation for a technical review that never happened.

The red flag was the organically grown workaround required to get the actual work done. The documentation requirement was not unreasonable. The problem was that the procedure did not support the way the work was actually executed

Informal workarounds are evidence of process failure

One of the best ways to judge how unwieldy a process has become is to count the workarounds and determine how institutionalized they are. When formal processes are too slow or disconnected from the work, capable employees create alternate methods. These may be unofficial trackers, spreadsheets, verbal agreements or personal notes that become the actual source of truth.

Do not confuse these with avoiding responsibility. Workarounds are typically created by people trying to protect the project. They keep tasks moving, but at the potential cost of lost traceability, inconsistent records and tribal knowledge concentrated in one individual.

The solution is not simply to codify the workaround. It is to reevaluate the existing procedure so it aligns with both the original intent and the practical lessons contained in the workaround.

A review is not a decision

The only thing that has outpaced inflation is the number of people added to document reviews. Reviewer lists are often used as FYI notices or a way to spread responsibility. What they actually do is increase costs and extend schedules.

This can be improved by identifying or empowering a decision maker. The review should include the minimum number of people necessary: a decision maker and representatives from the departments actually affected by the decision.

The decision maker consolidates and reconciles conflicting comments. That saves review cycles and working meetings while allowing broad input without losing accountability.

For every review, approval or form, ask three questions: What risk is this step intended to control? What decision or evidence should it produce? Does the reviewer have the tools and authority to act? If those answers are unclear, the step needs to be redesigned.

Why integrators can see the gap

Smaller integrators often remain closer to the complete project outcome. It is not so much that they have fewer quality procedures, but that they remain involved through the entire process: proposal and design documentation through implementation and commissioning.

Accountability is also critical. Often, the next project is determined by performance on the current one. That accountability gets built into the way the engineer approaches every decision. Smaller firms cannot rely on organizational scale or a large sales pipeline to overcome consistently poor execution.

Small is not automatically better. A small integrator without disciplined engineering standards, peer review, document control and testing is simply undercontrolled. The advantage comes from combining mature processes with close proximity to the outcome.

Large organizations can preserve the same advantage by keeping outcome ownership close to the people designing, building and testing the system.

A client understands its own facility, quality system and organizational requirements better than an outside contractor but integrators have a responsibility to bring their experience to show clients where processes might be streamlined or strengthened.

The right tone is, “This is how we have seen this work successfully in the past.” It should be offered as a valuable outside perspective, not as a way to disparage existing procedures.

Quality without losing sight of the goal

This is not about reducing controls to meet a metric. Faster execution at the expense of quality is not acceptable, nor is allowing contractors to bypass the client’s quality system.

On your next project, look for the unofficial spreadsheet everyone relies on, the approval no one can clearly explain, or the repeated review that produces comments but no decision. Ask what risk the step controls, what outcome it produces, and who has the authority to act. That is where improvement should begin.

Good process is a guardrail that helps the team reach its deliverables safely and consistently.  The quality process should protect the project, not replace it.