The Mike Risk: When Quality Depends on One Person

The Mike Problem: When Expertise Turns Into Operational Risk

“Just ask Mike, he knows it.”

A sentence heard every day in laboratories, production halls and QC/QA offices.
A sentence that solves problems fast.
A sentence that feels efficient.
And from a quality perspective, one of the most dangerous sentences in any organisation.

We all know a “Mike”:

• 20–30 years of experience
• Knows every quirk of every machine
• Remembers every special approval Customer XY ever needed
• Knows the full history of materials that haven’t been used in years

We call these people top performers. But in reality, they are often risk carriers.

Because when Mike retires, gets sick, or resigns, something critical leaves with him:

Not just a colleague. The process knowledge itself.  And suddenly, quality stops, not because the system broke, but because the system never existed.

In many mid-sized manufacturing and pharmaceutical environments, what we call processes” are actually head monopolies. And as long as knowledge lives only in individual minds, quality becomes a matter of luck.

Why This Is a Quality Problem

When critical knowledge is undocumented, informal and person-dependent, quality is:

• not reproducible
• not scalable
• not audit-proof
• not resilient
  
  

This means: Every day is stable, until Mike is absent.

This is not Quality Management. This is Quality by Presence.

Real Quality Excellence does not diminish the value of experts. It protects their knowledge so the organisation can operate without dependency risks.

That means moving:

• from “private know-how” → to standardised instructions
• from verbal shortcuts → to documented logic
• from heroic troubleshooting → to structured learning
• from individual ownership → to team capability

A process is only truly stable when it still works on the days when Mike is not there.

How q_alizer Eliminates the “Mike Risk”

q_alizer is built to solve exactly this problem: make knowledge visible, make decisions consistent, and make processes resilient.

1. Knowledge becomes structured instead of hidden

q_alizer captures and organises the operational and quality knowledge usually stored only in people’s heads:

• decision criteria
• historical context
• exceptions and special approvals
• method knowledge
• line behaviour
• CAPA learnings
• customer-specific requirements

This builds a central Data Channel where expertise becomes accessible and scalable.

2. Decisions become reproducible

Instead of “Ask Mike,” teams follow:

• transparent workflows
• standardised logic
• unified decision pathways

q_alizer ensures that decisions follow the same rules every time, no matter who performs them.

3. New team members get productive faster

With mental models and processes made explicit:

• onboarding accelerates
• training becomes consistent
• knowledge transfer no longer relies on shadowing a single expert

Your next generation of staff doesn’t inherit Mike, they inherit the system he helped create.

4. Quality becomes resilient

With q_alizer, processes remain stable even when:

• someone is sick
• someone is on holiday
• someone leaves the organisation

This transforms quality from person-dependent to system-dependent—and systems scale, experts do not.

The Hard Question

How many of your processes would stop tomorrow if your most experienced expert didn’t walk through the door?

With q_alizer, that question becomes much less frightening - because knowledge stops being a personal asset and becomes an organisational capability.

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