What happens when a design change doesn’t reach the right people? An engineer updates a part, but the purchasing team orders the old version. Production stops, deadlines slip, and costs go up.
This happens often in manufacturing.
The engineering change control process tracks each change from request to approval, so nothing gets missed. Products evolve, and every update needs review, signoff, and proper records.
This guide covers the engineering change control process step by step, from request to validation, and shows how to manage changes properly.
TL;DR
- The engineering change control process outlines how companies review, approve, and implement changes.
- Key steps include change request, evaluation, approval, communication, and validation.
- Common challenges include missed approvals, inconsistent documentation, and delayed updates.
- TLM manages engineering change requests, approvals, documentation, and audit records in one system.
What Is the Engineering Change Control Process?
The engineering change control process is the method by which companies review and approve changes to a product, part, document, or manufacturing process.
Each proposed change follows a defined workflow from request to release, with review, approval, and records captured at every step.
In manufacturing, changes happen all the time. Parts get updated, specifications shift, and issues come up during production. Each change needs review and documentation, so teams use the correct version during execution.
Without a formal process, updates move through email or spreadsheets. Teams use outdated versions, order the wrong parts, and run into production issues.
A documented workflow keeps a full record of who requested the change, who reviewed it, and what was updated.
Engineering Change Control vs Engineering Change Management
Engineering change control deals with the change itself. It covers the request, review, approval, engineering change order, and release of updated product data or documents.
Engineering change management covers the full product lifecycle. It tracks how changes move over time, including planning, records, and communication between the people involved.
After approval, an engineering change notice shares the update with the right people. It states what changed, when it took effect, and what needs to be updated.
Benefits of an Effective Engineering Change Control Process
According to L2L, facilities lose an average of 360 hours of production each year to downtime. Most of that lost time comes from unplanned stoppages, and 6 in 10 leaders say those disruptions cost more than $250,000 each year.
A well-run engineering change process helps prevent those losses before they reach the floor.
It keeps approval workflows, work instructions, and product data aligned so employees act on the correct information.
It also gives relevant stakeholders a real-time view of each proposed change. A project manager, engineer, buyer, or quality lead can review the description, priority level, resources required, and approval status in one place.
That record also matters in heavily regulated industries like medical device manufacturing. A complete audit trail, change log, and documentation history help decision makers answer audit questions and trace issues back to their source.
Key Steps in the Engineering Change Control Process
Below are the core components of the engineering change control process. Each step handles a specific part of how a change gets reviewed, approved, and carried out.
1. Engineering Change Request
An engineering change request (ECR) records the issue or update before anyone makes changes. A problem report, customer complaint, or design update usually triggers it.
A useful ECR includes a clear description, the parts or documents involved, the priority level, and the expected impact.
For example, if a part cracks during use, the request should list the affected stock keeping units (SKUs), where the issue showed up, and any risk to customers.
If the request lacks detail, the review slows down. People have to go back and ask for missing information.
2. Change Evaluation and Impact Analysis
The project team reviews the request and checks what the change will affect. They look at design, cost, timing, and how it will run in production.
Different roles weigh in here. Engineering reviews the design, quality checks risk, and operations look at execution. This helps catch issues before approval.
For instance, a material change may fix a defect but increase lead time. The team needs that tradeoff before making a decision.
3. Engineering Change Order
An engineering change order (ECO) formalizes the approved change. It outlines required updates, responsible roles, and timing. A change control board reviews and signs off before release.
It also includes affected parts, updated documents, and instructions for work in progress. A change control board reviews the order and signs off before release.
4. Engineering Change Notice
An engineering change notice (ECN) sends the approved change to the right people. It states what changed, the effective date, and what needs updating.
It often links to updated drawings, work instructions, or other related files, so no one uses outdated information.
5. Implementation and Validation
Engineers and production leads update product data after approval. This includes bills of materials, drawings, and work instructions.
Quality teams then validate the change. They run tests, inspect parts, or review results to confirm the update works as planned. For example, a design change may require a first article inspection before full release.
Once validation is complete, the change closes with a record of what was done and verified.
Roles and Responsibilities in Engineering Change Control
Engineering reviews the technical side of the request. Engineers check the proposed revision, update drawings or specifications, and confirm the change can proceed.
Quality reviews requirements, risk, and inspection needs. They check whether the revision affects validation, testing, or compliance records.
Manufacturing reviews how the revision will work in the plant. They look at routing, tooling, labor steps, and any updates needed in the work area before release.
Procurement reviews supplier and material issues. They check whether vendors need new specs, new quotes, or replacement parts.
The change control board (CCB) makes the final decision. This group reviews the full request in context, weighs cost, timing, and risk, and decides whether the company should approve, reject, or hold the change.
Engineering Change Control Process Best Practices
An engineering change control process works best when everyone follows the same steps and uses the same records. These practices help keep changes organized and easy to track.
- Record every engineering change in detail. Include the reason, affected parts, and outcome, so you have a complete audit trail in one place.
- Use a standard workflow for each request. Keep the approval process consistent so decision makers can review and approve changes right away.
- Share updates early with the right people. Cross-functional collaboration between engineering, production, quality, and procurement keeps work in sync.
- Set priority levels for each request. Focus on critical updates first so high-impact changes don’t get delayed.
- Keep related resources linked to each change. Drawings, work instructions, and product design updates should stay connected in a single source.
- Review past changes to spot repeat issues. This helps teams fix root problems instead of repeating the same mistakes.
Even with these practices in place, many teams still run into common challenges that slow the process down.
Common Challenges in Engineering Change Control
Many companies still track engineering changes in spreadsheets or email threads. That setup makes it hard to keep a reliable record. Approvals get missed, and people end up working from outdated information.
Documentation can also be inconsistent. One request includes full context, while another leaves out key details. That makes reviews slower and leaves room for mistakes.
Approvals often stall when no system routes them to the right people. Requests sit unanswered, and release dates start to slip.
Conflicting changes add another issue. Two updates may affect the same part or document, but no one spots the overlap until late in the process.
Product data errors cause problems, too. An outdated drawing or missed bill of materials revision can delay production and increase costs.
How Software Solves Engineering Change Control Issues
Manual engineering change control breaks down as the number of parts, revisions, and requests increases. Tracking approvals and records manually isn’t ideal anymore.
Software keeps everything in one system. It routes requests to the right people, records each approval, and keeps product data and documents connected to the same change.
Look for software that moves requests through the approval process, stores records in one system, and shows the current status without switching between files.
Dashboards show open requests, pending approvals, and completed changes at a glance. Audit logs record who reviewed and approved each step, along with dates and updates.
Without this setup, the process becomes harder to manage as the change volume increases. This is where a quality management system (QMS) like TLM comes in.
Standardize Engineering Change Control With TLM
TLM manages engineering change requests (ECRs) for parts, products, and documents, along with process and people-related changes.
It uses the ADKAR model to guide change adoption:
- Awareness
- Desire
- Knowledge
- Ability
- Reinforcement
TLM supports each stage with surveys, communication tracking, training records, and follow-up reviews.
TLM connects change control with document control, document type specific checklists, training, risk data, surveys, customer relationship management (CRM), and inventory systems.
Users can check the change status in real time. Dashboards show open tasks and approvals. Electronic signatures record decisions, and automated emails notify users when action is needed.
TLM supports International Organization for Standardization (ISO) and Food and Drug Administration (FDA) requirements through structured workflows and complete records.
Run your current change control process in TLM with a 30-day free trial.
FAQs About the Engineering Change Control Process
Who approves engineering change requests?
Approval usually comes from a change control board or a set of decision makers. This often includes leaders from engineering, quality, manufacturing, and procurement who review the request and determine if it should move forward.
What should be included in an engineering change request?
An engineering change request should explain what’s changing and why. It should list the affected parts or documents, the priority, and any expected impact so reviewers can understand the full picture before approving it.
What industries require strict change control processes?
Industries with strict regulations rely heavily on change control. This includes medical devices, aerospace, automotive, and food manufacturing, where companies need to maintain clear records for audits and regulatory compliance.
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