When Quality Gets Lost in Translation

A few years ago, I was facilitating a global design control workshop for a MedTech company with teams spread across the U.S., Europe, and India. Same company. Same QMS. Same SOP.

Three groups. Three interpretations. Zero alignment.

Each team believed they were following the procedure. But when we mapped out how they documented design inputs and verified traceability, it was clear we weren’t just speaking different languages - we were living in different realities.

“We don’t have a quality problem,” someone said. “We have a translation problem.”

That moment stuck with me. Because it perfectly captured one of the most persistent, yet underestimated, challenges in regulated industries:

When quality gets lost in translation, clarity becomes the true currency of compliance.

The Hidden Cost of Misunderstood Quality

Let us be honest: no one sets out to do the wrong thing. But in global MedTech environments, it is dangerously easy to assume alignment where none exists.

I have seen teams:

• Use outdated templates without realising it
• Follow SOPs to the letter, but misinterpret their intent
• Miss critical traceability steps because they misunderstood what “linkage” actually means

What is worse? These errors rarely show up until something goes wrong:

• A missing verification output during an audit
• A CAPA triggered by inconsistent risk documentation
• A regulatory submission delay because the design history file can’t be reliably reconstructed

These aren’t just mistakes – they are symptoms of a deeper issue: quality knowledge is not consistently understood, accessed, or applied across teams.

And in an industry where patient safety, market access, and public trust are on the line, that is a risk we can’t afford.

Why This Matters — Globally and Strategically

As MedTech companies expand globally, cross-functional collaboration becomes the norm - not the exception. Engineering may be in Boston. Manufacturing in Singapore. Regulatory in Zurich. Clinical in Sydney.

That is a strength - but also a complexity trap.

Procedures written with local assumptions don’t translate globally. Terms like “review,” “approval,” or even “risk” mean different things to different functions, regions, and roles.

The consequences?

• Redundant efforts as teams duplicate work they don’t know already exists
• Delays in innovation as people wait for clarification, rework, or escalation
• Audit failures due to inconsistent documentation practices

Regulators are watching. The FDA’s push toward harmonised QMS requirements, the EU MDR’s traceability demands, and ISO 13485:2016’s call for role clarity all reflect one reality:

Misalignment is no longer a local issue. It is a systemic threat.

The Reframe: From SOPs to Shared Understanding

The traditional QMS mindset focuses on creating documents - SOPs, WIs, forms. But in global environments, the document isn’t the destination - understanding is.

We need to stop asking, “Do we have a procedure?” and start asking, “Do people know how to apply it - correctly, consistently, and confidently?”

That means:

• Designing processes for comprehension, not just compliance
• Writing procedures like tools, not like legal disclaimers
• Valuing clarity over complexity

Five Strategies to Reconnect Quality Across Borders

1. Simplify the Language of Quality: Ditch jargon. Use plain language. Define key terms. I have seen a single unclear word (“mitigate” vs. “eliminate”) spark months of confusion. Make your SOPs readable by humans, not just passable for auditors.
2. Visualise the Process, Don’t Just Describe It: Flowcharts, swim lanes, decision trees - these aren’t decorations. They are essential tools to convey structure across cultures and learning styles. A visual that shows how design inputs feed into risk analysis speaks louder than three pages of text.
3. Global Onboarding, Local Anchoring: When rolling out new QMS procedures, involve local teams in contextualising them. Don’t just translate the words - translate the intent. Provide examples from their product, market, and role.
4. Peer-Led Quality Conversations: Create forums where cross-functional teams walk through how they interpret and apply key SOPs. These “translation workshops” surface blind spots and build shared ownership.
5. Embed Feedback Loops in the System: Don’t wait for audits to find misalignment. Build systems that surface variation in real time: analytics on how templates are used, review comments across sites, metrics on cycle times by geography.

From Confusion to Clarity: Real-World Shifts

In one organisation I supported, replaced a 14-page procedure with a 4-page visual guide, reinforced through interactive workshops tailored to different teams. The result? Training time cut in half, deviation rate dropped, and teams started asking better questions - not just ticking boxes.

In another case, a design control SOP was rolled out globally, but with region-specific onboarding sessions. Local leaders walked through the process using their actual projects. Adoption soared. Errors dropped. The SOP became a living tool, not a static artifact.

The key wasn’t more documentation. It was better translation of meaning, not just language.

What About You?

So, here is my challenge:

When was the last time you read your own SOP and thought: “This could confuse someone smart”?

Or better yet: “If I had to explain this to a new hire in a different country, how would I do it?”

Quality doesn’t fail because people don’t care.

It fails when people don’t understand and don’t feel safe admitting they don’t.

So, let us build systems where clarity is the default, not the luxury.

Because in global quality systems, it is not the absence of procedures that breaks trust – it is the absence of shared understanding. Clarity isn’t just a communication tool. It is a patient safety strategy.