Design Qualification is not a document. It's a conversation.

Last week I found myself in a familiar discussion.

The project was already well underway. Rooms had been designed. Equipment had been selected. Utilities had been defined. Drawings looked mature. Everyone was focused on the next milestone.

Then someone asked a seemingly innocent question.

“Can we still change this?”

It wasn't the first time I had heard that question.

And it probably won't be the last.

Design Qualification is not a document to complete

Design Qualification is often treated as something that simply has to be done.

A required step. A document to prepare. A box to tick before the project can move forward.

The template is opened. Requirements are listed. References are added. Approvals are collected.

And somewhere along the way, the real purpose can quietly disappear.

To me, Design Qualification is the moment where a team pauses and asks whether it is still solving the right problem.

Not only whether the design complies, or whether every requirement has been traced or document is completed.

But whether the decisions being made today will still make sense when operators, engineers, Quality, Maintenance, Microbiology and Production have to live with them every single day. Because once concrete is poured, stainless steel is welded into place and equipment has been ordered, every answer becomes more expensive.

What happens when Design Qualification comes too late

Years ago I joined a project that was already well underway.

By the time I became involved, the facility had been built. The layouts had been agreed. Equipment had been selected. Utilities had been routed. Countless design decisions had already been made.

Then I was asked to perform the Design Qualification. I remember looking around and thinking,

“What exactly am I qualifying?”

Not because the team had done a poor job. Quite the opposite. They had worked incredibly hard and delivered a facility they were proud of. But a Design Qualification is meant to influence a design while it can still be influenced.

At that stage the design already existed. The conversations that mattered had already taken place, major decisions had already been made.

And yet the Design Qualification still identified real issues.

There were opportunities to improve the design, things that could have worked better. But changing them was no longer straightforward. What could once have been changed on a drawing had now become a modification to finished rooms, installed systems or purchased equipment. The improvements were still possible. They simply became slower and more disruptive. And significantly more expensive.

That project taught me something I have never forgotten. A Design Qualification is not valuable because it produces a document, but because it creates the right conversation while meaningful choices are still available.

Once those choices have narrowed, even the best Design Qualification cannot undo the consequences of asking the questions too late.

Bring the perspectives together before design freeze

This week I found myself in a completely different project.

• Different people.
• Different technology.
• Different organisation.

Yet, once again, someone asked,

“Can we still change this?”

It reminded me that the value of Design Qualification has very little to do with the document itself. Its value lies in bringing the right people together before decisions become difficult to reverse.

• Quality sees different risks than Engineering.
• Engineering sees different opportunities than Operations.
• Operations notices things Maintenance never will.
• Radiation Protection sees constraints Quality may not immediately recognise.
• Microbiology notices details automation specialists might overlook.

None of them are wrong. They are simply looking at the same design from different perspectives.

Design Qualification creates the opportunity to bring those perspectives together before they become expensive lessons.

Interestingly, the upcoming revision of EU GMP Annex 15 is once again drawing attention to Design Qualification.

Some will see another regulatory expectation. I see something different.

Not a reminder to write a better Design Qualification, but a reminder to use it for the purpose it was always meant to serve.

Validation has never really started with Installation Qualification. Or OQ. Or PQ.

It starts much earlier, namely with a conversation.

Keep the original purpose visible

Whenever a process starts to feel like something we simply have to do, I try to ask myself one question.

What was the original purpose of this activity?

And then another.

Are we still doing it in a way that allows it to fulfil that purpose?

Because once we lose sight of the purpose, we start optimising the activity instead.

• We complete the document.
• We hold the meeting.
• We tick the box.

Yet we quietly miss the opportunity those activities were created to give us.

Perhaps that's the question worth asking, not only for Design Qualification, but for every process we follow.

What purpose have we stopped seeing?

Because that...

might just be what I am missing.