How to Manage Manufacturing Deviations.
Identify • Contain • Assess • Authorise • Verify
Control the change before the change controls the product.
- Baseline (Released) — Released PCB Baseline — Approved design, BOM, process requirements and drawings.
- No Silent Changes — Proposed / Actual Departure — Change to design, process, material or specification.
- Manufacturing Deviation — A controlled departure from a product, process or procurement requirement for a defined scope.
Why Formal Control Matters
| # | Heading | Caption |
|---|---|---|
| 1 | Protects configuration baseline | Maintains a trusted reference for what was approved. |
| 2 | Prevents unapproved CAM, material or process changes | Ensures changes follow the right path and approvals. |
| 3 | Assesses risk before shipment | Quality, reliability, schedule and cost impacts understood before decisions. |
| 4 | Preserves what was actually built | Accurate records enable traceability and learning. |
| 5 | Prevents temporary exceptions becoming permanent | Time-box, review and re-validate or revert to baseline. |
| 6 | Supports audits, investigations and corrective action | Evidence-based decisions that drive improvement. |
Terminology at a Glance
| Term | Definition |
|---|---|
| Deviation | Authorised departure from a requirement for a defined scope. |
| NCR | Requirement not fulfilled. |
| Concession | Authorised use of nonconforming product. |
| Rework | Returns product to full conformity to all original requirements. |
| Repair | Makes product usable but may not restore original conformity. |
| Use-AS-is | Accepts known condition with defined impact and controls. |
| Scrap | Prevents unintended use of nonconforming product. |
| Engineering change | Formally revises the baseline (released data, documents). |
Three Situations
| # | Situation | Statement | Bullets | Rule |
|---|---|---|---|---|
| 1 | Normal process adjustment | Small, routine adjustments within approved limits. | Within process window; No impact on fit, form, function; Managed by standard work/instructions | Document and monitor. |
| 2 | Supplier-proposed DFM change | Change to released data or process to improve manufacturability. | Must be proposed and documented; Requires formal evaluation; Approval before implementation | Do not implement without approval. |
| 3 | Actual nonconformance | Product already fails a requirement. | Stop, contain and evaluate; Record facts and impact; Disposition with authorisation | Control and close the loop. |
No deviation is implemented merely because the supplier believes it is harmless.
Contain, Define and Assess.
Stop Work • Identify Scope • Collect Evidence • Review Risk
- Identify — deviation/ proposed change
- Stop — affected work
- Contain — boards, panels, lots
- Cite — exact requirement
- Quantify — actual condition
- Collect — objective evidence
- Assess — technical and quality risk
- Identify — approval authority
- Select — disposition
- Obtain — written approval
- Implement — exactly
- Inspect / Test
- Update — CoC / NCR / traveler
- Close — corrective action and trend
- Stop shipment. Do not release or ship any affected product.
- Segregate physical product. Clearly label and segregate all affected boards, panels, and lots.
- Identify work orders / lots. Record WO, lot number, quantity, location, process step, and operator.
- Assess earlier shipments. Identify customer shipments and quantities already delivered.
- Freeze processing. Hold at current step; do not continue processing or rework.
- Preserve coupons / data. Retain panels, coupons, photos, and process data for analysis.
- Notify engineering / quality. Escalate immediately per procedure.
- Block ERP / MES release. Place holds to prevent movement or further processing.
- Record time / person. Document when, by whom, and what was contained.
- Drawing & revision. Refer to the latest released drawing and revision.
- Fabrication note. Applicable fabrication note and revision.
- Manufacturing dataset revision. CAM, drill, etch, route files and revision level.
- Stack-up. Layer build-up, material and thickness requirements.
- PO clause. Purchase order clause or special requirements.
- IPC standard / revision / class / paragraph. Exact IPC requirement and section.
- Customer quality specification. Customer specification and revision.
- Approved DFM & supplier qualification condition. DFM guidelines and supplier qualification status at time of order.
- Specified vs measured value. Exact requirement compared to actual measurement.
- Affected quantity. How many boards/panels/lots are affected.
- Lot / work order / date code. Traceability identifiers.
- Layer / feature / location. Where on the board and in which layer/feature.
- Photos / micrographs. High-resolution, scaled, and documented.
- Microsection. Cross-section with measurements and callouts.
- Et / impedance / material / process records. Test data and process parameters.
- Isolated or systemic. Single event or recurring pattern.
Risk Assessment (Consider All Impacts
| Segment | Caption |
|---|---|
| Electrical | Function, impedance, isolation, crosstalk |
| Thermal | Heat dissipation, Tg, CTE mismatch |
| Material | Laminate, copper, resin, finish |
| Compliance | Regulatory, safety, environmental |
| Mechanical | Strength, stress, vibration, handling |
| Reliability | Life, failure modes, field performance |
| Manufacturing margin | Process capability, variation sensitivity |
| Configuration | Design intent, fit, form, function |
| Traceability | Data integrity, end-to-end trace |
| Programme / qualification | Customer programme, qualification status |
“The board still works” is not a high-reliability risk assessment.
Contain first, debate second. Facts before opinions. Document before decisions.
Choose the Correct Disposition.
Rework • Repair • Use-AS-Is • Scrap • Remake
- Can Full Conformity Be Restored? — Yes → controlled rework / no → next question
- Controlled Rework — Return to original requirement.
- Can Known Condition Be Justified by Authorised Design/quality? — Yes → repair or use-AS-is / no → scrap / remake
- Repair or Use-AS-Is — Under approval.
- Scrap / Remake — Product cannot be justified or corrected.
| Disposition | Definition | Conditions |
|---|---|---|
| Rework | Returns to original requirement. | Approved instruction or process.; Extra exposure or intervention assessed for side effects.; Reinspect/retest 100% as required by plan.; Traceability and acceptance recorded. |
| Repair | Makes product usable but not necessarily fully conforming. | Approved repair method.; Evaluated for reliability impact.; Customer or design authority where required.; Post-repair evidence and disclosure. |
| Use-AS-is / concession | Requirement remains unmet. | Exact condition and rationale documented.; Limited to specific lot/quantity.; Usage restrictions and limitations defined.; Authorised approval obtained.; Referenced in shipment records.; Does not change future drawing automatically. |
| Scrap / remake | When risk cannot be justified or conformity restored. | Physically control scrap to prevent unintended use.; Preserve analysis samples as required.; Correct process before remake. |
Approval Authority Matrix – Who Can Authorise?
| Situation | Examples | Typical Authority |
|---|---|---|
| Process setting within approved window | Laminate cycle time, drill speed, plating current within limits | Supplier manufacturing / quality |
| Noncritical DFM feature | Nonfunctional copper balancing, fiducial count, tooling marks | PCB / design engineering |
| Impedance / geometry feature | Trace width/spacing within impedance tolerance, length match | PCB + si / design authority |
| Material substitution | Laminate, prepreg, copper foil substitution | Materials / PCB engineering + customer quality (AS required) |
| IPC acceptance departure, repair or use-AS-is | IPC-6012 / 6013 acceptance, use-as-is concession | Authorised mrb / design / customer authority |
| Site / source change | New supplier, alternate site, new equipment line | Supply chain + quality + engineering / requalification |
Disposition = what happens to this product. ≠ corrective action = why it happened and how recurrence is prevented.
Schedule pressure never justifies an unsafe disposition.
Assess PCB-Specific Deviations.
Stack-up • Material • Impedance • Vias • Finish
Every deviation must be reviewed, measured, and approved.
| # | Card | Checklist items | Diagram labels |
|---|---|---|---|
| 1 | Stack-up change | Core / prepreg thickness; Board thickness (finished); Glass style / material family; Dk / Df at frequency; Impedance recalculation; Resin fill content; Aspect ratio (lamination); Dielectric spacing; Sequential lamination impact; Approved revision level | Top, L1, pp, L2, core, L3, pp, L4, bottom; Core thickness; Pp thickness; Board thickness |
| 2 | Material substitution | Exact manufacturer / grade; Tg (dsc) / Td; Z-axis CTE; Dk / Df at frequency; Moisture absorption; CAF resistance; UL recognition; Reflow compatibility; Matching prepregs / cores; Prior qualification data; Impact on signal loss | |
| 3 | Controlled impedance | Required value / tolerance; Original geometry (W/H); Proposed geometry (W/H); Actual dielectric (Er); Model used & assumptions; Coupon correlation data; Production measurement; SI / crosstalk review; Design approval before copper change | W; H; Er |
| 4 | Hole / via | Finished hole vs production drill; Aspect ratio (depth / dia.); Plating allowance; Annular ring (min / target); Press-fit / interference; Backdrill (depth / method); Current / thermal rating; Microsection verification; Assembly fit (connectors, pins); Impact to IPC Class 3 product | Ø finished hole; Drill diameter |
| 5 | Annular ring / registration | Layer / feature location; Remaining land / breakout; Acceptance criteria (min / target); Drill-to-copper and layer trend; Isolated vs systemic issue; Plating connection integrity; Process capability / margin | Annular ring; Registration offset |
| 6 | Copper thickness / plating | Base copper (weight / thickness); Finished copper PTH (min / target); Finished copper surface (min / target); Local vs average thickness; HAR distribution & uniformity; Current capacity & reliability impact; Representative microsection; Plating bath control records | Base copper (foil); Finished copper (after plating) |
| 7 | Microvias | Diameter / depth (target / capture); Stacked vs staggered; Target / capture geometry; Via fill (filled / capped / tented); Interface plating integrity; Lamination cycle compatibility; Microsection verification; Thermal / reliability evidence; Qualified HDI process scope | Stacked; Staggered |
| 8 | Surface finish / mask / dimensions / backdrill | Finish type / thickness and functional interface; Mask registration / web / creepage; Board thickness / profile / slots / bow; Target layer for backdrill; Residual stub (min / target); Backdrill depth tolerance; Registration checks; SI verification after backdrill | Finish; Mask; Dimensions; Backdrill |
- Marked Drawing
- Measurements
- Microsection
- Et / Impedance
- Material Data — Dk / Df; Tg / Td
- Process Capability — Cp; Cpk
- Reliability Results
- Risk Assessment
“Equivalent” material or “standard factory change” is not technical approval.
Control the Record and Prevent Recurrence.
Approval • Configuration • COC • Corrective Action • Trending
Explicit Approval Record
| Item | Detail |
|---|---|
| Deviation ID | Unique identifier for traceability. |
| Part / revision | Exact part number and revision. |
| PO / lot / quantity | Purchase order, lot number and quantity impacted. |
| Exact requirement | Cited drawing, specification or standard. |
| Actual condition | Observed condition and measured results. |
| Supporting evidence | Photos, reports, measurements, test data. |
| Disposition | Use as-is, rework, sort, scrap or other. |
| Limitations / conditions | How and where the product may be used. |
| One-time or permanent | Indicate one-time concession or permanent change. |
| Required inspection / test | Additional inspection, testing or 100% screen as required. |
| Approver name / function / date | Qualified approver with role and date. |
| Document changes | All document or record updates required. |
Temporary Deviation vs Permanent Engineering Change
| Temporary Deviation | Permanent Engineering Change |
|---|---|
| Defined lot, quantity and time scope. | Changes the product definition. |
| Requirement remains unchanged. | New revision baseline established. |
| Future lots must revert to requirement. | Future lots follow ECN / ECO. |
| Exception record with explicit approval. | Controlled design update. |
VS
Configuration Control Flow
- Released Baseline — (Requirement)
- Approved Lot-Specific Departure — (Concession)
- AS-Built Record / CoC — (Disposition, Evidence, Limits, Tests)
- One Time Only — Future lots revert to baseline requirement.
- Released Baseline — (Requirement)
- ECN / ECO — (Change Control Process)
- New Released Baseline — (New Revision)
- Permanent Change — Future lots follow new revision.
- State exact part number, revision and lot.
- Include concession ID where required.
- Include statement consistent with disposition.
- Reference all applicable NCRs (retrievable).
- Confirm no carryover to future lots.
- Disclose repair or rework where required.
- Contain
- Define
- Occurrence Root Cause
- Escape Root Cause
- Systemic Contributors
- Action
- Verify Effectiveness
- Review Similar Products
Weak vs Strong Response
| Response | Detail |
|---|---|
| Weak (symptom only) | Operator error / retrained. No objective evidence of effectiveness. |
| Strong (system solution) | System change prevents recurrence. Objective effectiveness evidence provided (data, metrics, audit). |
Deviation Log Fields
| Field | Description |
|---|---|
| Supplier | Supplier name and location. |
| Category | Plating, drilling, lamination, finish, etc. |
| Repeated part family | Part family / platform identified. |
| Unauthorised vs approved-before-build | Unauthorised deviation or approved concession before build. |
| Material substitutions | Material changes, supplier, grade. |
| Impedance / plating / registration | Technical performance categories. |
| Customer escapes | Escaped to customer (Yes/No, details). |
| Approval turnaround | Time from submission to approval. |
| Recurrence indicator | Repeat deviation (Yes/No, count). |
Trend Dashboard (What to Watch
| Metric | Unit | Direction arrow |
|---|---|---|
| Total deviations | (# per period) | down (green) |
| Repeat deviations | (% of total) | up (red) |
| Customer escapes | (# per period) | up (red) |
| Material substitutions | (% of total) | flat (amber) |
| Approval turnaround | (Avg days) | flat (amber) |
| Recurrence rate | (% within 90 days) | up (red) |
Supplier-Status Impact Ladder
| # | Status | Meaning |
|---|---|---|
| 1 | Monitor | Meets expectations. Continue standard oversight. |
| 2 | Capability-margin review | Minor issues or tight margins. Review capability and plans. |
| 3 | Corrective action / increased inspection | Issues identified. CAPA required. Increase oversight and inspection. |
| 4 | Restrict | Performance not acceptable. Restrict new business / volume. |
| 5 | Suspend / requalify | Severe or repeated issues. Suspend until requalified. |
A one-lot concession must never become the supplier’s new standard process.
Control Every Departure Before Release.
Managed Workflow • Review Checklist • Red Flags • Final Control
- Manufacturer — raises DFM/ deviation before implementation.
- Novatronic — checks completeness and evidence.
- Classify — process-only / DFM change / nonconformance / supplier change.
- PCB Manufacturing Risk Review — assess impact to function, yield, reliability, cost and schedule.
- Customer / Design Authority — receives focused decision package with facts and recommendation.
- Approve / Reject — decision and conditions are documented.
- Manufacturer — implements exact disposition as authorised.
- Evidence Verified — before shipment or release.
- Link to CoC and Lot — deviation linked to Certificate of Conformance and lot record.
- Supplier History — add event to supplier history. Recurring events trigger CAR or qualification review.
- Deviation ID / Reference
- Supplier / Site
- Part Number / Revision Level
- Purchase Order / Lot / Quantity
- Exact Requirement (spec, drawing, IPC, contract)
- Actual Condition (quantified)
- Evidence Attached (photos, reports, data)
- Scope Contained (lot, panels, areas)
- Previous Shipments Assessed (same condition? impact?)
- Impact Assessment Completed
- Electrical
- Mechanical
- Reliability
- Material
- Compliance
- Configuration
- Qualification
- Proposed Disposition (rework, use-as-is, concession, scrap)
- Decision Authority (name / role / company)
- Customer / Design Authority Approval
- Controlled Rework / Repair Instructions (if any)
- Verification / Test Plan and Results
- Certificate of Conformance Updated
- Corrective Action Required (CAR / Preventive Action)
- Deviation Logged (system / log) and AVL / Scorecard Updated
- Retention Period Confirmed
No deviation is complete without documented approval, verification, linkage to the lot and retention.
- Already changed because “it is our factory standard.”
- “Equivalent” material used — no approval needed.
- Automatic impedance / trace adjustment without notification.
- Electrical test used to dismiss a plating / finish issue.
- “We will update the drawing after shipment.”
- Cosmetic claim without evidence or quantified impact.
- “Class 3 allows it” — requirement not verified.
- No lot / quantity identified or scope not defined.
- Blanket permanent approval after only one production run.
- Repeated concessions on the same requirement.
- NCR issued without root cause or corrective action.
- Certificate of Conformance that hides a known exception.
- Lot and quantity match the approved deviation.
- Required rework / test complete and recorded.
- Board markings / date code verified.
- CoC reference and deviation ID present.
- Affected characteristic inspected or tested per approval.
- No additional, unapproved departures.
- Deviation record archived with receiving record.
- Identify Exactly — Define the exact requirement and the actual condition. No assumptions.
- Contain Completely — Limit scope to what is affected. Stop spread. Protect the customer and the process.
- Assess Objectively — Evaluate risk to function, yield, reliability, cost and delivery.
- Authorise Correctly — Obtain the right authority. Document the decision and any conditions clearly.
- Verify and Retain — Verify results. Link to CoC and lot. Retain records for the required period.
No silent changes — Every controlled departure is traceable to authority, lot and evidence.