Stop routing paper ECRs through your office

Engineering change management (ECM) is the structured process of requesting, evaluating, approving, and implementing changes to products, processes, or documentation in manufacturing. ISO 9001:2015 clauses 8.3.6 (design changes) and 8.5.6 (control of changes) require manufacturers to maintain documented evidence of change reviews, impact assessments, approvals, and actions taken.

An Engineering Change Request (ECR) initiates the change process by documenting what needs to change and why. An Engineering Change Order (ECO) is the approved instruction to implement the change, including impact assessment, affected parts, and implementation plan. An Engineering Change Notice (ECN) communicates the approved change to all affected departments and stakeholders.

ISO 9001:2015 requires organisations to identify and control changes to production or service provision (clause 8.5.6) and to control changes to the design of products and services (clause 8.3.6). This includes retaining documented evidence of the results of change reviews, the persons authorising the change, and any necessary actions arising from the review. Auditors specifically check for this evidence during surveillance audits.

A Change Control Board (CCB) is a cross-functional group that reviews and approves engineering changes. Typically it includes representatives from engineering, production, quality, and purchasing. The CCB evaluates each ECR for impact on cost, schedule, quality, and regulatory compliance, then decides whether to approve, reject, or defer the change. For SME manufacturers, the CCB may be as small as 2-3 people who meet weekly.

A non-conformance report (NCR) documents a product, process, or material that does not meet specified requirements. NCRs often trigger engineering changes — if a non-conformance is systemic, a corrective action (CAPA) may lead to a design or process change via an ECR. ISO auditors specifically check the traceability from NCR to CAPA to ECO to verify that root causes are addressed through documented changes.

Spreadsheets can track basic change logs and status, but they cannot provide structured multi-department approval routing with digital signatures, automatic impact assessment distribution, tamper-evident audit trails with timestamps, or exportable evidence packs. Most ISO auditors accept spreadsheet-based evidence, but the manual effort to collate it is significant — typically 30 or more minutes per ECO for evidence pack preparation.

Enterprise PLM tools with ECM modules cost between £7,000 and £100,000 per year. The cheapest mid-market options with proper ECR to ECO workflow start at approximately $49 per user per month and are typically US-based. ChangeRoute is designed for UK SME manufacturers who need proper engineering change workflow at a fraction of these costs. Join the waitlist for early-bird pricing.

ChangeRoute is built by Crocker Digital Ltd (Company No. 17008789), a UK software company focused on compliance and quality management tools for small and medium enterprises. The product is purpose-built for UK manufacturers, not a repackaged enterprise platform.