Temporary Change of Process Control as per IATF 16949 |Complete Guide

In automotive manufacturing, production processes are designed with defined controls to ensure consistent product quality. However, situations may arise where the primary process control becomes unavailable or ineffective due to equipment failure, tool damage, gauge breakdown, manpower issues, or other unexpected conditions.

In such cases, organizations must implement a controlled temporary solution to maintain product conformity. This requirement is defined under IATF 16949 Clause 8.5.6.1.1 — Temporary Change of Process Controls.

Failure to properly manage temporary controls can lead to nonconforming product, customer complaints, line stoppages, and major audit nonconformities.

What is Temporary Change of Process Control?

A Temporary Change of Process Control is the replacement or modification of an established process control with an alternate control for a limited period when the original control cannot be applied.

This change is not permanent and must be documented, approved, monitored, and reverted once normal conditions are restored.

Key characteristics:

• Used only when primary control is unavailable
• Applied for a defined period
• Requires risk assessment
• Must maintain product quality
• Requires management approval
• Customer approval may be required
• Must be traceable

IATF 16949 Clause 8.5.6.1.1 — Requirement Summary

The standard requires organizations to:

• Maintain a list of primary process controls and approved alternate controls
• Identify situations where temporary changes are allowed
• Obtain authorization before implementation
• Perform risk assessment
• Ensure traceability of affected products
• Define time limits for the temporary control
• Implement additional monitoring if necessary
• Restore the original control as soon as possible
• Inform customers when required

This clause is frequently checked during IATF audits because temporary controls often introduce significant risk to product quality.

When is Temporary Process Control Required?

Temporary controls are typically required when normal production safeguards fail. Common situations include:

• Poka-yoke or error-proofing device failure
• Automated inspection system breakdown
• Measurement equipment malfunction
• Tool wear or tool breakage
• Fixture damage
• Shortage of approved gauges
• Machine malfunction
• Software issues in control systems
• Power failure affecting automated controls
• Operator shortage or skill mismatch

Organizations must plan for such contingencies in advance.

Examples of Temporary Change of Process Control

Example 1: Poka-Yoke Failure

Original Control: Sensor detects missing component automatically
Temporary Control: 100% manual visual inspection by trained operator

Additional Actions:

• Supervisor verification
• Inspection checklist
• Increased sampling frequency
• Traceability marking

Example 2: Gauge Breakdown

Original Control: Digital gauge for critical dimension
Temporary Control: Approved alternate calibrated gauge

Additional Actions:

• Verification of gauge accuracy
• Increased inspection frequency
• Recording of results

Example 3: Vision System Failure

Original Control: Automated camera inspection
Temporary Control: Manual inspection using master samples

Additional Actions:

• Dual operator confirmation
• Periodic supervisor audit
• Temporary work instruction

Example 4: Tool Wear or Damage

Original Control: Tool life monitoring system
Temporary Control: Reduced batch size with frequent checks

Additional Actions:

• SPC monitoring
• Increased first-off inspections
• Tool replacement planning

Step-by-Step Procedure to Implement Temporary Control

A robust procedure should include the following steps:

1. Identification of Need

Detect failure or unavailability of primary control.

2. Immediate Containment

Prevent nonconforming product from reaching the customer.

3. Risk Assessment

Evaluate the impact on:

• Product safety
• Critical characteristics
• Process capability
• Customer requirements

4. Selection of Alternate Control

Choose an approved method capable of maintaining quality.

5. Authorization and Approval

Approval levels typically include:

• Production Manager
• Quality Head
• Engineering
• Customer (if required)

6. Update of Control Plan

Temporary control must be documented in the control plan.

7. Operator Training

Personnel must be trained on the temporary method.

8. Identification and Traceability

Products produced under temporary control should be traceable.

9. Monitoring Effectiveness

Verify that the alternate control prevents defects.

10. Restoration of Normal Control

Reinstate original process as soon as feasible.

11. Documentation and Closure

Record actions taken, duration, approvals, and results.

Documents and Records Required

Typical documentation includes:

• Temporary Change Approval Form
• Risk Assessment Report
• Updated Control Plan
• PFMEA review (if required)
• Work Instruction for temporary method
• Operator training record
• Inspection records
• Traceability records
• Customer approval (when applicable)
• Closure report

Maintaining proper records is essential for audit compliance.

Traceability Requirements

All products manufactured during the temporary control period must be identifiable. This allows organizations to:

• Perform recalls if necessary
• Investigate quality issues
• Provide evidence to customers
• Demonstrate control during audits

Traceability methods may include:

• Batch marking
• Production date coding
• Separate storage
• ERP tagging

Risks of Poor Temporary Control Management

Improperly managed temporary changes can result in:

• Shipment of defective products
• Safety risks
• Customer complaints
• Production disruptions
• Cost of rework or recall
• Loss of customer trust
• Major or critical audit findings

Many automotive recalls have originated from uncontrolled temporary processes.

Best Practices for Effective Implementation

Organizations should adopt preventive strategies such as:

• Maintain a pre-approved list of alternate controls
• Conduct periodic drills or simulations
• Train operators on contingency procedures
• Keep spare gauges and tools available
• Implement layered process audits
• Define clear approval hierarchy
• Use digital tracking systems

Proactive planning significantly reduces risk during emergencies.

Temporary Change vs 4M Change vs Engineering Change

Understanding the difference is important:

Temporary Change of Process Control
Short-term alternate control due to failure of primary control

4M Change (Man, Machine, Method, Material)
Any planned change affecting process inputs

Engineering Change
Design or product specification change

Temporary control focuses specifically on maintaining product quality when existing safeguards are disrupted.

Frequently Asked Questions (FAQ)

Is customer approval mandatory for temporary process control?
Customer approval is required when the change may affect product characteristics, safety, or contractual requirements.

How long can a temporary control remain in place?
Only for the shortest possible duration until the original control is restored.

Is PFMEA update required?
If the risk level changes significantly, PFMEA review and update should be performed.

Can manual inspection replace automated inspection temporarily?
Yes, provided it is validated, approved, and effective in detecting defects.

Is traceability mandatory?
Yes, products manufactured under temporary control must be identifiable.

Procedure :

Temporary Process Control List :

Head QA maintains the approved temporary process control list to be applied to various processes. Input can be taken from the control plan to prepare the temporary process control list. It includes inspection, measuring, testing and error-proofing devices (Poka Yoke) etc.

Temporary Change of Process Control Approval :

When any temporary process control is applied in the process due to failure of primary process control. Then request for the same is raised by the concerned department to the QA Head. Where required customer approval will be obtained before implementing an alternate process control method. Also before dispatching a product that was inspected or tested using the alternate control method, if required the organization shall take approval from the customer.

Work Instruction and Training :

All the temporary process controls are implemented as per the respective work instructions/operation standard. All the concerned operators have been given proper training before implementing the temporary process control.

Identification &Traceability :

All the products that are manufactured/Inspected/Assembled/Tested are identified with a traceability system so that they can be traced back if any problem is observed. Also do verification and retention of the first piece and last piece from every shift.

Temporary Process Control Audit :

All the temporary processes are audited ( Layered Audit as applicable) daily by Q.A. & result of the audit is discussed in the Daily Morning Meeting with the Plant Head.

Primary Process Control :

The Primary Process controls which are not being implemented in the shop are reviewed daily for progress with the intent to implement the same as soon as possible on the shop floor.

Conclusion

Temporary Change of Process Control is a critical requirement under IATF 16949 for ensuring product conformity during abnormal production conditions. Organizations must implement a structured, documented, and risk-based approach to manage such changes effectively.

Proper planning, approval, monitoring, and traceability are essential to prevent defects and maintain customer confidence. Companies that proactively prepare contingency controls are better equipped to handle unexpected process disruptions without compromising quality.

For automotive suppliers, robust temporary control management is not only a compliance requirement but also a key element of operational resilience and customer satisfaction.