1.6 Engineering Queries, ECO and Deviation Control
Informal agreements via instant messaging, email threads, or verbal confirmations are non-existent during a liability dispute. Ambiguity in the Golden Data Pack leads to production stops, scrap, or latent field failures. A formal Engineering Query (EQ) process converts ambiguity into a traceable, contractual manufacturing specification and ensures the "As-Built" configuration matches the "As-Approved" documentation.
The EQ Workflow
The Engineering Query is the primary mechanism to resolve discrepancies between the documentation (BOM, Gerbers, Assembly Drawings) and the physical reality of manufacturing.
1. Initiation & Definition
Do not raise open-ended questions. An EQ must drive a decision.
- Problem Statement: Clearly identify the discrepancy. Reference specific component designators (e.g., R45), file names, and revision levels.
- Evidence: Attach screen captures, photos of physical fitment issues, or conflicting datasheet excerpts.
- Proposed Disposition: Engineering must propose a technical solution based on DFM analysis. Do not ask "What should we do?"; ask "Is X acceptable to resolve Y?"
2. Disposition Logic
Categorize the resolution based on impact to form, fit, function, and longevity.
- If the query resolves an ambiguity in documentation without changing the physical product (e.g., clarifying text orientation), Then disposition is Clarification / Update Documentation.
- If the material is non-compliant but functionally acceptable for a specific quantity (e.g., alternative capacitor brand due to shortage), Then disposition is Deviation (Concession).
- If the product requires additional processing to meet the specification (e.g., manual soldering of a lifted pad), Then disposition is Rework.
- If the design is fundamentally flawed and requires a permanent change to the Golden Data Pack (e.g., wrong footprint for a connector), Then disposition is Engineering Change Order (ECO).
- If the issue poses a safety risk or unrecoverable functional failure, Then disposition is Stop-Build.
Pro-Tip: Always include a specific "Effective From" date or Serial Number range in the disposition. An open-ended approval implies a permanent design change, which requires an ECO, not just an EQ.
ECO vs. Deviation Control
Distinguish between temporary allowances and permanent changes to maintain configuration control.
Deviation (Temporary)
Use a Deviation to authorize a departure from the established requirements for a specific number of units or a specific time period.
- Scope: Limited to a specific Batch ID or Date Code.
- Expiration: The authorization automatically expires once the limit is reached.
- Traceability: The deviation number must be recorded in the device history record of affected units.
Engineering Change Order (Permanent)
Use an ECO to permanently alter the Golden Data Pack.
- Scope: Applies to all future production builds until the next revision.
- Requirement: Requires a revision roll of the top-level assembly or affected sub-assemblies.
- Implementation: Must define cut-in strategy (e.g., "Scrap old stock," "Rework old stock," or "Running change").
Final Checklist
Control Point | Critical Requirement |
EQ Syntax | Must include: Current State + Evidence + Proposed Solution. |
Approval Channel | Reject approvals via Chat/Email. Use the PLM/ERP system only. |
Deviation Limit | Define strict quantity or timebox (e.g., "Batch #204 only"). |
ECO Cut-In | Explicitly state disposition of existing inventory (Scrap vs. Rework). |
Closure | EQ is closed only when the decision is implemented in the build instructions. |
Response Time | Define SLA (e.g., ≤ 24 hours) to prevent line-down situations. |