Eliminating rework loops by aligning decision quality

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The Situation

Deviation handling in regulated pharma must be rigorous and compliant.
But when deviation lead time drifts, it directly undermines release stability and operational focus.

The issue was clear:

• Deviation closure times were long
• The majority of deviations were overdue

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The Assumption (Tested)

A common belief was that delays were driven by a central function (often assumed to be QC).

Before changing anything, we tested this.
Data showed no meaningful correlation between QC response time and total deviation lead time.

The constraint was elsewhere.

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What Was Really Driving Delay

The dominant driver was iteration, not investigation complexity.

We found:

• Misalignment between Production and QA supporters on what a “good” deviation looked like
• Inconsistent expectations within QA
• High variability in submission quality
• Frequent returns for rework — in some cases up to 8 returns

Critical mechanism:
👉 Each return added ~1 week on average to total deviation lead time.

The system was not blocked.
It was looping.

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The Intervention

We did not “push people to work faster.”
We redesigned the deviation system to reduce rework and stabilise decision quality.

1. Defined “What Good Looks Like”

Aligned Production and QA on clear expectations for deviation quality, evidence, and completeness.

2. Reduced Return Loops (Right-First-Time)

Improved initial submission quality to prevent repeated back-and-forth.
The goal was simple: fewer returns, fewer weeks lost.

3. Made Rework and Aging Visible

Introduced KPIs to track:

• Deviation lead time
• Overdue rate
• Return frequency (rework loops)
• Aging by stage / owner

This shifted discussions from opinions to facts — and surfaced loop behavior early.

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Results

• Overdue deviations reduced from ~95% to ~20%
• Deviation lead time became shorter and more predictable
• Rework cycles dropped significantly, removing the “hidden week” losses
• Improved release stability without compromising compliance

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Key Insight

In regulated environments, long deviation lead times are often caused by unclear decision standards — not slow reviewers.

When expectations are misaligned, rework becomes normalised.
And if each return costs a week, iteration quickly becomes the real bottleneck.

Compliance ensures correctness.
Alignment ensures flow.