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4M change management - every change controlled, every audit answered
A new operator, a repaired tool, a changed parameter, an alternate material - each one can send a defect to your customer. Raise every Man, Machine, Method and Material change, review the risk with your CFT, approve, trial and verify it, and hand the auditor a complete record in seconds.
- Built for IATF 16949 & ISO 9001 audits
- CFT risk review & open points
- Cloud or on-premise
What is Qubha's 4M Change Management software?
It is change-control software for the four inputs of every manufacturing process - Man, Machine, Method and Material. Anyone can raise a 4M change request. The 4M coordinator checks it, a cross-functional team (CFT) records the risks and actions, plant approvers sign off in order, and the change is trialled with first-off inspection - and customer approval where needed - before it is verified and closed. Nothing is closed while an action point is still open.
It is built around IATF 16949 clause 8.5.6 (control of changes), which also matches ISO 9001 clause 8.5.6, so the evidence your certification and customer auditors ask for is already in one place. Built by Qubha Infotech, Chennai, for automotive and engineering plants in India; runs in the cloud or on your own server. Works with ECN Management for drawing and design changes.
What the auditor asks for - already on the record
In an IATF 16949 or customer audit, the auditor picks a recent change and follows it end to end. Here is where each answer lives.
| The auditor asks | Where Qubha 4M answers it |
|---|---|
| "Show me your changes this year." | Every change in one register, filtered by category, line, department or status, exported to Excel. |
| "Was the risk assessed before the change?" | CFT risk register: process step, failure mode, risk level, action and owner - signed off by each member. |
| "Who approved it, and when?" | Append-only workflow history - every review, approval, return and rejection with name, role and time. |
| "Were the PFMEA and control plan updated?" | Documents to revise are listed on the change, and the related action stays open until it is done and verified. |
| "How did you validate the first parts?" | Implementation record: trial lot and quantity, first-off inspection, traceability marking and evidence files. |
| "Did the customer approve it?" | Customer and PPAP level on the change; implementation is blocked until the customer approval date and reference are entered. |
| "Was it effective?" | Effectiveness verification with date and remarks before closure. |
| "What about temporary deviations?" | Deviation period, quantity and rollback plan recorded on every temporary change. |
From change request to verified closure
Each step has a time limit, so slow changes show up as overdue instead of being forgotten.
- Step 1
Raise
Category, part, line, before and after, reason, containment.
- Step 2
Review
Coordinator checks documents and calls the CFT.
- Step 3
Assess risk
CFT records risks and actions, then signs off.
- Step 4
Approve
Plant approvers sign in sequence.
- Step 5
Act & implement
Actions closed with evidence; trial lot and first-off.
- Step 6
Verify & close
Effectiveness checked, everyone informed.
Most "sudden" defects start with an uncontrolled change
4M changes on paper and e-mail
- A new operator or alternate material goes into production without anyone reviewing the risk.
- CFT actions agreed in a meeting are never followed up.
- PFMEA and control plan are not updated after the change.
- Temporary deviations quietly become permanent.
- Before the audit, the team spends days rebuilding the file.
With Qubha 4M Change Management
- Risk reviewed first - CFT risk register and sign-off before approval.
- Open points tracked - owners, target dates, evidence and verification.
- Documents listed - PFD, PFMEA, control plan, work instruction, drawing.
- Deviations controlled - period, quantity and rollback plan recorded.
- Audit-ready every day - the full history of every change, one click away.
Everything your quality team, CFT and plant head need
4M change request
The whole change, in one form.
- Man, Machine, Method, MaterialOne or more categories per change
- Temporary or permanentInternal, customer or supplier scope
- Before and afterExisting condition, proposed change and reason
- Containment & impactInitial containment, customer, safety and regulatory impact
CFT risk review
Every function, on record.
- Coordinator reviewDocuments verified; send to CFT, skip, return or reject
- Risk registerProcess step, impact area, failure mode, risk level
- ActionsRecommended action, owner, dependency and lead time
- CFT sign-offEach member signs off their review
Plant approval
The right people, in the right order.
- Sequential approvalApprover levels you set in flow settings
- Approve, return, rejectWith remarks, at every level
- Stage time limitsOverdue changes flagged automatically
- My queueEach approver sees only what is waiting for them
Open-point tracker
No action left behind.
- Owner & target dateCommitted by the person who does the work
- EvidenceProgress, closing action and files for each point
- Verified by coordinatorDone is not closed until checked
- On track, at risk, overdueAgeing and top owners at a glance
Implement & verify
Proof from the first parts.
- Trial lotLot number, quantity and actual date
- First-off inspectionDone and recorded before regular production
- Customer & PPAPPPAP level 1-5; approval required before implementation
- Effectiveness checkVerified before closure
Dashboard & reports
Every change, every plant, live.
- 4M dashboardOpen, overdue, high-risk, cycle time, on-time closure
- TrendsBy category, department, change type and risk
- Daily e-mailOpen changes and overdue steps every morning
- PDF & Excel4M form in your customer's format; register to Excel
Risk assessed by every function, before anyone approves
Production, quality, maintenance and engineering each write down what could go wrong with this change, how serious it is and who will act. The plant head approves knowing the risk - and the auditor can see it.
- Failure mode and risk level - low, medium or high for each process step.
- Action, owner and lead time - and which action has to finish first.
- Signed off - each CFT member closes their review on record.
The actions that make a change safe - actually done
Every CFT action shows up in its owner's list with a target date. Owners upload evidence, the coordinator verifies it, and the change cannot be closed until every point is done.
- At risk before overdue - actions due within 7 days are flagged early.
- Ageing and top owners - see where actions get stuck.
- Evidence attached - photos, reports and revised documents on each point.
Your customer's 4M form, filled in automatically
Each change prints as a 4M change request form - basic information, risk analysis and actions, review and approval, and closure - with your format number, revision and customer name. No retyping for the customer or the audit file.
- Format number and revision - set per plant, as your QMS requires.
- Workflow history - who reviewed, approved, returned or closed, and when.
- Mail at every stage - editable templates, plus a daily summary e-mail.
Every kind of change on your shop floor
Man
New or replaced operator, skill change, shift change on a critical process.
Machine
New or relocated machine, major repair, tool, die, fixture or gauge change.
Method
Process parameters, sequence, work instruction, inspection or packing method.
Material
New supplier, alternate material, sub-supplier or raw-material grade change.
Temporary deviations
Limited period and quantity, with a rollback plan.
Customer-notified changes
Customer approval and PPAP level recorded before implementation.
4M software vs Excel tracker vs paper 4M forms
| What matters | Qubha 4M | Excel tracker | Paper 4M forms |
|---|---|---|---|
| Risk review | CFT risk register with sign-off | A column, often empty | Signatures, no detail |
| Approvals | Sequential, with return and reject | E-mail threads | Walk the form around |
| Open points | Owner, date, evidence, verification | Manual follow-up | Lost after the meeting |
| Customer & PPAP | Implementation blocked until approved | Not enforced | Not enforced |
| History | Append-only, who and when | Overwritten | In a file somewhere |
| Audit preparation | Ready every day | Days of clean-up | Days of searching |
4M change management questions
What is 4M change management?
4M change management is the control of any change to the four inputs of a manufacturing process: Man (operator), Machine (equipment, tooling), Method (process, parameters, work instruction) and Material (part, supplier, raw material). Each change is assessed for risk, approved, verified on the first parts and recorded before it reaches regular production, so a change does not create a defect the customer finds.
Why do IATF 16949 auditors ask for 4M change records?
IATF 16949 clause 8.5.6 (control of changes) requires you to review, verify, validate and approve changes that affect production before they are implemented, to assess their risk, to keep documented evidence and, where the customer requires it, to get customer approval. Auditors pick recent changes and ask for that evidence. Qubha 4M keeps the risk review, approvals, trial and first-off results, customer approval and closure for every change in one record.
What does a 4M change request record?
The category, temporary or permanent change, plant, line, department and process, part and supplier, existing condition and proposed change, reason, initial containment, customer and safety impact, customer approval and PPAP level, documents to revise such as PFMEA and control plan, risk areas and extra process controls, planned date and attachments. Temporary changes also record the deviation period, quantity and rollback plan.
How does the approval workflow work?
The 4M coordinator verifies the documents and sends the change to a cross-functional team (CFT), or skips CFT for simple changes. Each CFT member records risks and actions and signs off. Plant approvers then approve in sequence. After the actions are done and verified, the change is implemented with trial and first-off results, its effectiveness is verified, and it is closed. Any stage can return or reject the change with a reason.
How are open points tracked?
Every CFT action has an owner, target date and lead time. Owners update progress and upload evidence; the coordinator verifies it. The open-point tracker shows actions on track, at risk, overdue and on hold, with ageing and top owners, and a change cannot be closed while any action is open.
Does it handle customer approval and PPAP?
Yes. A change can be marked as needing customer approval with the customer and PPAP level 1 to 5. The implementation step cannot be saved until the customer approval date and reference are recorded.
Can we print the 4M form in our customer's format?
Yes. Each change prints as a 4M change request form with basic information, risk analysis and actions, review and approval, and closure, with your format number, revision and customer name.
How does it help solve internal quality issues?
Many internal rejections and customer complaints trace back to a change nobody controlled: a new operator, a repaired tool, a changed parameter or an alternate material. With every change raised, risk-reviewed, trialled and verified, and a dashboard of open and overdue changes, problems are caught at the first parts instead of at the customer.
Can it run on our own server?
Yes, in the cloud or on your own Windows server with SQL Server. It works in any web browser on desktop, tablet or phone.
Who makes it?
Qubha Infotech Pvt Ltd, Chennai, Tamil Nadu, India - the same team builds, installs and supports it.
Part of the Qubha shop-floor platform
Change control alongside your other quality systems.
Walk into your next IATF audit ready
See a 4M change go from request to CFT risk review, approval, first-off and closure in a 30-minute demo.