Laboratory change control process flowchart

What the laboratory change control process is

A change request is not ready for technical review until its rationale, affected work and stakeholders are clear. The first decision in this workflow returns vague proposals for detail rather than letting an approval group infer what will change.

The impact review considers methods, data and training before a team decides whether evaluation or qualification is needed. After implementation, a separate decision tests whether the available evidence supports the intended use and routes an unsupported outcome back to reassessment.

Adapt the approval authorities, assessment records, validation activities and communication steps to local governance. This template does not prescribe which changes require a particular level of review.

What this flowchart covers

In this template

• A change owner documents the rationale and affected laboratory work before assessment.
• An incomplete proposal returns for details and stakeholder input instead of advancing by assumption.
• Technical and quality roles decide whether an evaluation or qualification activity is required.
• Implementation evidence either supports an updated status or returns for correction and impact reassessment.

When to use this template

• You need to control a change to a method, instrument, software configuration, material, record or working practice.
• Technical reviewers and Quality need a shared view of when proposed changes require more evidence before use.
• You want change implementation and post-change review to remain connected to the original rationale.

How it works

1. Define change categories

   Replace the broad proposal with the categories and triggers your laboratory recognizes, and identify who can request each type of change.

2. Set impact prompts

   Add the method, data, equipment, training, documentation and stakeholder questions your reviewers use to make a proportionate evaluation decision.

3. Connect implementation evidence

   Link the implementation decision to the records that demonstrate the approved change was performed and communicated at your site.

Frequently asked questions

What does a laboratory change control process flowchart cover?

It covers defining a proposed change, clarifying missing information, assessing impact, deciding on evaluation, implementing approved work, reviewing the outcome and recording the resulting status.

Why include a post-implementation decision?

An approved plan does not by itself show that the implemented change supports its intended use. A post-implementation review connects the planned work to the available evidence and an accountable outcome.

Does every laboratory change need qualification or validation?

No. The appropriate evaluation depends on the change and its potential impact. The template provides a decision point so teams can apply their local process rather than assume one activity fits every change.