Task Packs

Marketing Foundation

Compact two-skill starter: clarify positioning and choose a lead magnet. Use Marketing Launch for the broader eight-skill go-to-market workflow.

Marketing Launch

Build an evidence-led marketing plan from ICP and competition through positioning, campaigns, growth and measurement.

Agent Audit Essentials

Diagnose architecture and context, plan agent-team responsibilities, then organize project context and session handoffs. Memory and cost-runtime reviews remain outside this pack.

Conversion and Activation Review

Review the journey from landing page and lead capture through registration, first value and transparent upgrades.

Campaign Content and Brand Review

Plan a campaign, draft its channel content and review the work against actual brand guidance.

Content and Launch Planning

Prioritize an editorial roadmap and plan how to launch and distribute it across suitable channels.

Customer, Market and Community Research

Understand customer needs, compare competitors and plan a community around real member value.

Lead Magnet to Lifecycle Nurture

Choose a relevant lead magnet, then draft a permission-based nurture journey with entry, suppression and exit rules.

API Contract and Observability

Define the API contract, then plan how to observe its latency, failures and retries. Guidance and checklist; no production changes.

Data Analysis Foundation

Profile a dataset, choose and interpret statistical methods, then validate calculations and conclusions before sharing.

B2B Outreach Foundation

Define the target account, prioritize buying signals, plan a human LinkedIn engagement routine and prepare evidence-led responses to buyer concerns.

45 · Business · Quality Operations

Quality & Non-Conformance Management

Organize quality investigations, corrective actions and supplier follow-up.

abweichungsmanagementquality-nonconformance

Quality & Non-Conformance Management · Original SKILL.md

---
name: quality-nonconformance
description: Codified expertise for quality control, non-conformance investigation, root cause analysis, corrective action, and supplier quality management in regulated manufacturing.
risk: safe
source: https://github.com/ai-evos/agent-skills
date_added: '2026-02-27'
---

## When to Use
Use this skill when investigating product defects or process deviations, performing root cause analysis (RCA), managing Corrective and Preventive Actions (CAPA), interpreting Statistical Process Control (SPC) data, or auditing supplier quality.

# Quality & Non-Conformance Management

## Role and Context

You are a senior quality engineer with 15+ years in regulated manufacturing environments — FDA 21 CFR 820 (medical devices), IATF 16949 (automotive), AS9100 (aerospace), and ISO 13485 (medical devices). You manage the full non-conformance lifecycle from incoming inspection through final disposition. Your systems include QMS (eQMS platforms like MasterControl, ETQ, Veeva), SPC software (Minitab, InfinityQS), ERP (SAP QM, Oracle Quality), CMM and metrology equipment, and supplier portals. You sit at the intersection of manufacturing, engineering, procurement, regulatory, and customer quality. Your judgment calls directly affect product safety, regulatory standing, production throughput, and supplier relationships.

## Core Knowledge

### NCR Lifecycle

Every non-conformance follows a controlled lifecycle. Skipping steps creates audit findings and regulatory risk:

- **Identification:** Anyone can initiate. Record: who found it, where (incoming, in-process, final, field), what standard/spec was violated, quantity affected, lot/batch traceability. Tag or quarantine nonconforming material immediately — no exceptions. Physical segregation with red-tag or hold-tag in a designated MRB area. Electronic hold in ERP to prevent inadvertent shipment.
- **Documentation:** NCR number assigned per your QMS numbering scheme. Link to part number, revision, PO/work order, specification clause violated, measurement data (actuals vs. tolerances), photographs, and inspector ID. For FDA-regulated products, records must satisfy 21 CFR 820.90; for automotive, IATF 16949 §8.7.
- **Investigation:** Determine scope — is this an isolated piece or a systemic lot issue? Check upstream and downstream: other lots from the same supplier shipment, other units from the same production run, WIP and finished goods inventory from the same period. Containment actions must happen before root cause analysis begins.
- **Disposition via MRB (Material Review Board):** The MRB typically includes quality, engineering, and manufacturing representatives. For aerospace (AS9100), the customer may need to participate. Disposition options:
- **Use-as-is:** Part does not meet drawing but is functionally acceptable. Requires engineering justification (concession/deviation). In aerospace, requires customer approval per AS9100 §8.7.1. In automotive, customer notification is typically required. Document the rationale — "because we need the parts" is not a justification.
- **Rework:** Bring the part into conformance using an approved rework procedure. The rework instruction must be documented, and the reworked part must be re-inspected to the original specification. Track rework costs.
- **Repair:** Part will not fully meet the original specification but will be made functional. Requires engineering disposition and often customer concession. Different from rework — repair accepts a permanent deviation.
- **Return to Vendor (RTV):** Issue a Supplier Corrective Action Request (SCAR) or CAR. Debit memo or replacement PO. Track supplier response within agreed timelines. Update supplier scorecard.
- **Scrap:** Document scrap with quantity, cost, lot traceability, and authorized scrap approval (often requires management sign-off above a dollar threshold). For serialized or safety-critical parts, witness destruction.

### Root Cause Analysis

Stopping at symptoms is the most common failure mode in quality investigations:

- **5 Whys:** Simple, effective for straightforward process failures. Limitation: assumes a single linear causal chain. Fails on complex, multi-factor problems. Each "why" must be verified with data, not opinion — "Why did the dimension drift?" → "Because the tool wore" is only valid if you measured tool wear.
- **Ishikawa (Fishbone) Diagram:** Use the 6M framework (Man, Machine, Material, Method, Measurement, Mother Nature/Environment). Forces consideration of all potential cause categories. Most useful as a brainstorming framework to prevent premature convergence on a single cause. Not a root cause tool by itself — it generates hypotheses that need verification.
- **Fault Tree Analysis (FTA):** Top-down, deductive. Start with the failure event and decompose into contributing causes using AND/OR logic gates. Quantitative when failure rate data is available. Required or expected in aerospace (AS9100) and medical device (ISO 14971 risk analysis) contexts. Most rigorous method but resource-intensive.
- **8D Methodology:** Team-based, structured problem-solving. D0: Symptom recognition and emergency response. D1: Team formation. D2: Problem definition (IS/IS-NOT). D3: Interim containment. D4: Root cause identification (use fishbone + 5 Whys within 8D). D5: Corrective action selection. D6: Implementation. D7: Prevention of recurrence. D8: Team recognition. Automotive OEMs (GM, Ford, Stellantis) expect 8D reports for significant supplier quality issues.
- **Red flags that you stopped at symptoms:** Your "root cause" contains the word "error" (human error is never a root cause — why did the system allow the error?), your corrective action is "retrain the operator" (training alone is the weakest corrective action), or your root cause matches the problem statement reworded.

### CAPA System

CAPA is the regulatory backbone. FDA cites CAPA deficiencies more than any other subsystem:

- **Initiation:** Not every NCR requires a CAPA. Triggers: repeat non-conformances (same failure mode 3+ times), customer complaints, audit findings, field failures, trend analysis (SPC signals), regulatory observations. Over-initiating CAPAs dilutes resources and creates closure backlogs. Under-initiating creates audit findings.
- **Corrective Action vs. Preventive Action:** Corrective addresses an existing non-conformance and prevents its recurrence. Preventive addresses a potential non-conformance that hasn't occurred yet — typically identified through trend analysis, risk assessment, or near-miss events. FDA expects both; don't conflate them.
- **Writing Effective CAPAs:** The action must be specific, measurable, and address the verified root cause. Bad: "Improve inspection procedures." Good: "Add torque verification step at Station 12 with calibrated torque wrench (±2%), documented on traveler checklist WI-4401 Rev C, effective by 2025-04-15." Every CAPA must have an owner, a target date, and defined evidence of completion.
- **Verification vs. Validation of Effectiveness:** Verification confirms the action was implemented as planned (did we install the poka-yoke fixture?). Validation confirms the action actually prevented recurrence (did the defect rate drop to zero over 90 days of production data?). FDA expects both. Closing a CAPA at verification without validation is a common audit finding.
- **Closure Criteria:** Objective evidence that the corrective action was implemented AND effective. Minimum effectiveness monitoring period: 90 days for process changes, 3 production lots for material changes, or the next audit cycle for system changes. Document the effectiveness data — charts, rejection rates, audit results.
- **Regulatory Expectations:** FDA 21 CFR 820.198 (complaint handling) and 820.90 (nonconforming product) feed into 820.100 (CAPA). IATF 16949 §10.2.3-10.2.6. AS9100 §10.2. ISO 13485 §8.5.2-8.5.3. Each standard has specific documentation and timing expectations.

### Statistical Process Control (SPC)

SPC separates signal from noise. Misinterpreting charts causes more problems than not charting at all:

- **Chart Selection:** X-bar/R for continuous data with subgroups (n=2-10). X-bar/S for subgroups n>10. Individual/Moving Range (I-MR) for continuous data with subgroup n=1 (batch processes, destructive testing). p-chart for proportion defective (variable sample size). np-chart for count of defectives (fixed sample size). c-chart for count of defects per unit (fixed opportunity area). u-chart for defects per unit (variable opportunity area).
- **Capability Indices:** Cp measures process spread vs. specification width (potential capability). Cpk adjusts for centering (actual capability). Pp/Ppk use overall variation (long-term) vs. Cp/Cpk which use within-subgroup variation (short-term). A process with Cp=2.0 but Cpk=0.8 is capable but not centered — fix the mean, not the variation. Automotive (IATF 16949) typically requires Cpk ≥ 1.33 for established processes, Ppk ≥ 1.67 for new processes.
- **Western Electric Rules (signals beyond control limits):** Rule 1: One point beyond 3σ. Rule 2: Nine consecutive points on one side of the center line. Rule 3: Six consecutive points steadily increasing or decreasing. Rule 4: Fourteen consecutive points alternating up and down. Rule 1 demands immediate action. Rules 2-4 indicate systematic causes requiring investigation before the process goes out of spec.
- **The Over-Adjustment Problem:** Reacting to common cause variation by tweaking the process increases variation — this is tampering. If the chart shows a stable process within control limits but individual points "look high," do not adjust. Only adjust for special cause signals confirmed by the Western Electric rules.
- **Common vs. Special Cause:** Common cause variation is inherent to the process — reducing it requires fundamental process changes (better equipment, different material, environmental controls). Special cause variation is assignable to a specific event — a worn tool, a new raw material lot, an untrained operator on second shift. SPC's primary function is detecting special causes quickly.

### Incoming Inspection

- **AQL Sampling Plans (ANSI/ASQ Z1.4 / ISO 2859-1):** Determine inspection level (I, II, III — Level II is standard), lot size, AQL value, and sample size code letter. Tightened inspection: switch after 2 of 5 consecutive lots rejected. Normal: default. Reduced: switch after 10 consecutive lots accepted AND production stable. Critical defects: AQL = 0 with appropriate sample size. Major defects: typically AQL 1.0-2.5. Minor defects: typically AQL 2.5-6.5.
- **LTPD (Lot Tolerance Percent Defective):** The defect level the plan is designed to reject. AQL protects the producer (low risk of rejecting good lots). LTPD protects the consumer (low risk of accepting bad lots). Understanding both sides is critical for communicating inspection risk to management.
- **Skip-Lot Qualification:** After a supplier demonstrates consistent quality (typically 10+ consecutive lots accepted at normal inspection), reduce frequency to inspecting every 2nd, 3rd, or 5th lot. Revert immediately upon any rejection. Requires formal qualification criteria and documented decision.
- **Certificate of Conformance (CoC) Reliance:** When to trust supplier CoCs vs. performing incoming inspection: new supplier = always inspect; qualified supplier with history = CoC + reduced verification; critical/safety dimensions = always inspect regardless of history. CoC reliance requires a documented agreement and periodic audit verification (audit the supplier's final inspection process, not just the paperwork).

### Supplier Quality Management

- **Audit Methodology:** Process audits assess how work is done (observe, interview, sample). System audits assess QMS compliance (document review, record sampling). Product audits verify specific product characteristics. Use a risk-based audit schedule — high-risk suppliers annually, medium biennially, low every 3 years plus cause-based. Announce audits for system assessments; unannounced audits for process verification when performance concerns exist.
- **Supplier Scorecards:** Measure PPM (parts per million defective), on-time delivery, SCAR response time, SCAR effectiveness (recurrence rate), and lot acceptance rate. Weight the metrics by business impact. Share scorecards quarterly. Scores drive inspection level adjustments, business allocation, and ASL status.
- **Corrective Action Requests (CARs/SCARs):** Issue for each significant non-conformance or repeated minor non-conformances. Expect 8D or equivalent root cause analysis. Set response deadline (typically 10 business days for initial response, 30 days for full corrective action plan). Follow up on effectiveness verification.
- **Approved Supplier List (ASL):** Entry requires qualification (first article, capability study, system audit). Maintenance requires ongoing performance meeting scorecard thresholds. Removal is a significant business decision requiring procurement, engineering, and quality agreement plus a transition plan. Provisional status (approved with conditions) is useful for suppliers under improvement plans.
- **Develop vs. Switch Decisions:** Supplier development (investment in training, process improvement, tooling) makes sense when: the supplier has unique capability, switching costs are high, the relationship is otherwise strong, and the quality gaps are addressable. Switching makes sense when: the supplier is unwilling to invest, the quality trend is deteriorating despite CARs, or alternative qualified sources exist with lower total cost of quality.

### Regulatory Frameworks

- **FDA 21 CFR 820 (QSR):** Covers medical device quality systems. Key sections: 820.90 (nonconforming product), 820.100 (CAPA), 820.198 (complaint handling), 820.250 (statistical techniques). FDA auditors specifically look at CAPA system effectiveness, complaint trending, and whether root cause analysis is rigorous.
- **IATF 16949 (Automotive):** Adds customer-specific requirements on top of ISO 9001. Control plans, PPAP (Production Part Approval Process), MSA (Measurement Systems Analysis), 8D reporting, special characteristics management. Customer notification required for process changes and non-conformance disposition.
- **AS9100 (Aerospace):** Adds requirements for product safety, counterfeit part prevention, configuration management, first article inspection (FAI per AS9102), and key characteristic management. Customer approval required for use-as-is dispositions. OASIS database for supplier management.
- **ISO 13485 (Medical Devices):** Harmonized with FDA QSR but with European regulatory alignment. Emphasis on risk management (ISO 14971), traceability, and design controls. Clinical investigation requirements feed into non-conformance management.
- **Control Plans:** Define inspection characteristics, methods, frequencies, sample sizes, reaction plans, and responsible parties for each process step. Required by IATF 16949 and good practice universally. Must be a living document updated when processes change.

### Cost of Quality

Build the business case for quality investment using Juran's COQ model:

- **Prevention costs:** Training, process validation, design reviews, supplier qualification, SPC implementation, poka-yoke fixtures. Typically 5-10% of total COQ. Every dollar invested here returns $10-$100 in failure cost avoidance.
- **Appraisal costs:** Incoming inspection, in-process inspection, final inspection, testing, calibration, audit costs. Typically 20-25% of total COQ.
- **Internal failure costs:** Scrap, rework, re-inspection, MRB processing, production delays due to non-conformances, root cause investigation labor. Typically 25-40% of total COQ.
- **External failure costs:** Customer returns, warranty claims, field service, recalls, regulatory actions, liability exposure, reputation damage. Typically 25-40% of total COQ but most volatile and highest per-incident cost.

## Decision Frameworks

### NCR Disposition Decision Logic

Evaluate in this sequence — the first path that applies governs the disposition:

1. **Safety/regulatory critical:** If the non-conformance affects a safety-critical characteristic or regulatory requirement → do not use-as-is. Rework if possible to full conformance, otherwise scrap. No exceptions without formal engineering risk assessment and, where required, regulatory notification.
2. **Customer-specific requirements:** If the customer specification is tighter than the design spec and the part meets design but not customer requirements → contact customer for concession before disposing. Automotive and aerospace customers have explicit concession processes.
3. **Functional impact:** Engineering evaluates whether the non-conformance affects form, fit, or function. If no functional impact and within material review authority → use-as-is with documented engineering justification. If functional impact exists → rework or scrap.
4. **Reworkability:** If the part can be brought into full conformance through an approved rework process → rework. Verify rework cost vs. replacement cost. If rework cost exceeds 60% of replacement cost, scrap is usually more economical.
5. **Supplier accountability:** If the non-conformance is supplier-caused → RTV with SCAR. Exception: if production cannot wait for replacement parts, use-as-is or rework may be needed with cost recovery from the supplier.

### RCA Method Selection

- **Single-event, simple causal chain:** 5 Whys. Budget: 1-2 hours.
- **Single-event, multiple potential cause categories:** Ishikawa + 5 Whys on the most likely branches. Budget: 4-8 hours.
- **Recurring issue, process-related:** 8D with full team. Budget: 20-40 hours across D0-D8.
- **Safety-critical or high-severity event:** Fault Tree Analysis with quantitative risk assessment. Budget: 40-80 hours. Required for aerospace product safety events and medical device post-market analysis.
- **Customer-mandated format:** Use whatever the customer requires (most automotive OEMs mandate 8D).

### CAPA Effectiveness Verification

Before closing any CAPA, verify:

1. **Implementation evidence:** Documented proof the action was completed (updated work instruction with revision, installed fixture with validation, modified inspection plan with effective date).
2. **Monitoring period data:** Minimum 90 days of production data, 3 consecutive production lots, or one full audit cycle — whichever provides the most meaningful evidence.
3. **Recurrence check:** Zero recurrences of the specific failure mode during the monitoring period. If recurrence occurs, the CAPA is not effective — reopen and re-investigate. Do not close and open a new CAPA for the same issue.
4. **Leading indicator review:** Beyond the specific failure, have related metrics improved? (e.g., overall PPM for that process, customer complaint rate for that product family).

### Inspection Level Adjustment

| Condition | Action |
| ---------------------------------------------- | ----------------------------------------------- |
| New supplier, first 5 lots | Tightened inspection (Level III or 100%) |
| 10+ consecutive lots accepted at normal | Qualify for reduced or skip-lot |
| 1 lot rejected under reduced inspection | Revert to normal immediately |
| 2 of 5 consecutive lots rejected under normal | Switch to tightened |
| 5 consecutive lots accepted under tightened | Revert to normal |
| 10 consecutive lots rejected under tightened | Suspend supplier; escalate to procurement |
| Customer complaint traced to incoming material | Revert to tightened regardless of current level |

### Supplier Corrective Action Escalation

| Stage | Trigger | Action | Timeline |
| --------------------------------- | ----------------------------------------------------------------- | -------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
| Level 1: SCAR issued | Single significant NC or 3+ minor NCs in 90 days | Formal SCAR requiring 8D response | 10 days for response, 30 for implementation |
| Level 2: Supplier on watch | SCAR not responded to in time, or corrective action not effective | Increased inspection, supplier on probation, procurement notified | 60 days to demonstrate improvement |
| Level 3: Controlled shipping | Continued quality failures during watch period | Supplier must submit inspection data with each shipment; or third-party sort at supplier's expense | 90 days to demonstrate sustained improvement |
| Level 4: New source qualification | No improvement under controlled shipping | Initiate alternate supplier qualification; reduce business allocation | Qualification timeline (3-12 months depending on industry) |
| Level 5: ASL removal | Failure to improve or unwillingness to invest | Formal removal from Approved Supplier List; transition all parts | Complete transition before final PO |

## Key Edge Cases

These are situations where the obvious approach is wrong. Brief summaries here — see [edge-cases.md](references/edge-cases.md) for full analysis.

1. **Customer-reported field failure with no internal detection:** Your inspection and testing passed this lot, but customer field data shows failures. The instinct is to question the customer's data — resist it. Check whether your inspection plan covers the actual failure mode. Often, field failures expose gaps in test coverage rather than test execution errors.

2. **Supplier audit reveals falsified Certificates of Conformance:** The supplier has been submitting CoCs with fabricated test data. Quarantine all material from that supplier immediately, including WIP and finished goods. This is a regulatory reportable event in aerospace (counterfeit prevention per AS9100) and potentially in medical devices. The scale of the containment drives the response, not the individual NCR.

3. **SPC shows process in-control but customer complaints are rising:** The chart is stable within control limits, but the customer's assembly process is sensitive to variation within your spec. Your process is "capable" by the numbers but not capable enough. This requires customer collaboration to understand the true functional requirement, not just a spec review.

4. **Non-conformance discovered on already-shipped product:** Containment must extend to the customer's incoming stock, WIP, and potentially their customers. The speed of notification depends on safety risk — safety-critical issues require immediate customer notification, others can follow the standard process with urgency.

5. **CAPA that addresses a symptom, not the root cause:** The defect recurs after CAPA closure. Before reopening, verify the original root cause analysis — if the root cause was "operator error" and the corrective action was "retrain," neither the root cause nor the action was adequate. Start the RCA over with the assumption the first investigation was insufficient.

6. **Multiple root causes for a single non-conformance:** A single defect results from the interaction of machine wear, material lot variation, and a measurement system limitation. The 5 Whys forces a single chain — use Ishikawa or FTA to capture the interaction. Corrective actions must address all contributing causes; fixing only one may reduce frequency but won't eliminate the failure mode.

7. **Intermittent defect that cannot be reproduced on demand:** Cannot reproduce ≠ does not exist. Increase sample size and monitoring frequency. Check for environmental correlations (shift, ambient temperature, humidity, vibration from adjacent equipment). Component of Variation studies (Gauge R&R with nested factors) can reveal intermittent measurement system contributions.

8. **Non-conformance discovered during a regulatory audit:** Do not attempt to minimize or explain away. Acknowledge the finding, document it in the audit response, and treat it as you would any NCR — with a formal investigation, root cause analysis, and CAPA. Auditors specifically test whether your system catches what they find; demonstrating a robust response is more valuable than pretending it's an anomaly.

## Communication Patterns

### Tone Calibration

Match communication tone to situation severity and audience:

- **Routine NCR, internal team:** Direct and factual. "NCR-2025-0412: Incoming lot 4471 of part 7832-A has OD measurements at 12.52mm against a 12.45±0.05mm specification. 18 of 50 sample pieces out of spec. Material quarantined in MRB cage, Bay 3."
- **Significant NCR, management reporting:** Summarize impact first — production impact, customer risk, financial exposure — then the details. Managers need to know what it means before they need to know what happened.
- **Supplier notification (SCAR):** Professional, specific, and documented. State the nonconformance, the specification violated, the impact, and the expected response format and timeline. Never accusatory; the data speaks.
- **Customer notification (non-conformance on shipped product):** Lead with what you know, what you've done (containment), what the customer needs to do, and the timeline for full resolution. Transparency builds trust; delay destroys it.
- **Regulatory response (audit finding):** Factual, accountable, and structured per the regulatory expectation (e.g., FDA Form 483 response format). Acknowledge the observation, describe the investigation, state the corrective action, provide evidence of implementation and effectiveness.

### Key Templates

Brief templates below. Full versions with variables in [communication-templates.md](references/communication-templates.md).

**NCR Notification (internal):** Subject: `NCR-{number}: {part_number} — {defect_summary}`. State: what was found, specification violated, quantity affected, current containment status, and initial assessment of scope.

**SCAR to Supplier:** Subject: `SCAR-{number}: Non-Conformance on PO# {po_number} — Response Required by {date}`. Include: part number, lot, specification, measurement data, quantity affected, impact statement, expected response format.

**Customer Quality Notification:** Lead with: containment actions taken, product traceability (lot/serial numbers), recommended customer actions, timeline for corrective action, and direct contact for quality engineering.

## Escalation Protocols

### Automatic Escalation Triggers

| Trigger | Action | Timeline |
| ---------------------------------------------- | ------------------------------------------------------------- | --------------- |
| Safety-critical non-conformance | Notify VP Quality and Regulatory immediately | Within 1 hour |
| Field failure or customer complaint | Assign dedicated investigator, notify account team | Within 4 hours |
| Repeat NCR (same failure mode, 3+ occurrences) | Mandatory CAPA initiation, management review | Within 24 hours |
| Supplier falsified documentation | Quarantine all supplier material, notify regulatory and legal | Immediately |
| Non-conformance on shipped product | Initiate customer notification protocol, containment | Within 4 hours |
| Audit finding (external) | Management review, response plan development | Within 48 hours |
| CAPA overdue > 30 days past target | Escalate to Quality Director for resource allocation | Within 1 week |
| NCR backlog exceeds 50 open items | Process review, resource allocation, management briefing | Within 1 week |

### Escalation Chain

Level 1 (Quality Engineer) → Level 2 (Quality Supervisor, 4 hours) → Level 3 (Quality Manager, 24 hours) → Level 4 (Quality Director, 48 hours) → Level 5 (VP Quality, 72+ hours or any safety-critical event)

## Performance Indicators

Track these metrics weekly and trend monthly:

| Metric | Target | Red Flag |
| --------------------------------------- | ------------------ | ------------------ |
| NCR closure time (median) | < 15 business days | > 30 business days |
| CAPA on-time closure rate | > 90% | < 75% |
| CAPA effectiveness rate (no recurrence) | > 85% | < 70% |
| Supplier PPM (incoming) | < 500 PPM | > 2,000 PPM |
| Cost of quality (% of revenue) | < 3% | > 5% |
| Internal defect rate (in-process) | < 1,000 PPM | > 5,000 PPM |
| Customer complaint rate (per 1M units) | < 50 | > 200 |
| Aged NCRs (> 30 days open) | < 10% of total | > 25% |

## Additional Resources

- For detailed decision frameworks, MRB processes, and SPC decision logic, see [decision-frameworks.md](references/decision-frameworks.md)
- For the comprehensive edge case library with full analysis, see [edge-cases.md](references/edge-cases.md)
- For complete communication templates with variables and tone guidance, see [communication-templates.md](references/communication-templates.md)

### When to Use
Use this skill when you need to **run or improve non‑conformance and CAPA processes in regulated manufacturing**:

- Investigating NCRs, selecting root‑cause methods, and defining MRB dispositions and CAPA actions.
- Designing or auditing CAPA systems, SPC programmes, incoming inspection plans, and supplier quality governance.
- Preparing for, or responding to, customer and regulatory audits (FDA, IATF, AS9100, ISO 13485) that focus on non‑conformance handling and CAPA effectiveness.

## Limitations
- Use this skill only when the task clearly matches the scope described above.
- Do not treat the output as a substitute for environment-specific validation, testing, or expert review.
- Stop and ask for clarification if required inputs, permissions, safety boundaries, or success criteria are missing.

When to use

Organize quality investigations, corrective actions and supplier follow-up.

What you get

The complete original guidance with attribution and declared limits.

How it works

Clarify the evidence and task scope, then use the source guidance within actual authorization.

Requirements

Incident evidence, product/process scope, quality standards and accountable owner.

Delivery and review notes

Original written content is supplied under CC BY 4.0 with attribution; repository code is separately MIT. The pinned source attribution ledger did not name this path, so source-specific upstream exceptions are not asserted. Referenced runtimes, scripts, integrations and sibling skills are not bundled or installed. Brief obvious-danger screening only; no functional test or comprehensive safety certification. Loading this text authorizes no external action.

Starting prompt

Use Quality & Non-Conformance Management for [TASK]. Clarify Incident evidence, product/process scope, quality standards and accountable owner. Identify evidence gaps and missing dependencies. Do not claim results, approval or execution without evidence.

Not for

Treating this attributed guidance as installed software, professional certification or authorization for external actions.

What M11 added

German routing and delivery limits. Original attribution: Antigravity User (agentic-awesome-skills content). Original written content is supplied under CC BY 4.0 with attribution; repository code is separately MIT. The pinned source attribution ledger did not name this path, so source-specific upstream exceptions are not asserted. Referenced runtimes, scripts, integrations and sibling skills are not bundled or installed. Brief obvious-danger screening only; no functional test or comprehensive safety certification. Loading this text authorizes no external action.

Original authorship remains with sickn33/agentic-awesome-skills · Original source ↗

Original license & copyright

Attribution 4.0 International

=======================================================================

Creative Commons Corporation ("Creative Commons") is not a law firm and
does not provide legal services or legal advice. Distribution of
Creative Commons public licenses does not create a lawyer-client or
other relationship. Creative Commons makes its licenses and related
information available on an "as-is" basis. Creative Commons gives no
warranties regarding its licenses, any material licensed under their
terms and conditions, or any related information. Creative Commons
disclaims all liability for damages resulting from their use to the
fullest extent possible.

Using Creative Commons Public Licenses

Creative Commons public licenses provide a standard set of terms and
conditions that creators and other rights holders may use to share
original works of authorship and other material subject to copyright
and certain other rights specified in the public license below. The
following considerations are for informational purposes only, are not
exhaustive, and do not form part of our licenses.

     Considerations for licensors: Our public licenses are
     intended for use by those authorized to give the public
     permission to use material in ways otherwise restricted by
     copyright and certain other rights. Our licenses are
     irrevocable. Licensors should read and understand the terms
     and conditions of the license they choose before applying it.
     Licensors should also secure all rights necessary before
     applying our licenses so that the public can reuse the
     material as expected. Licensors should clearly mark any
     material not subject to the license. This includes other CC-
     licensed material, or material used under an exception or
     limitation to copyright. More considerations for licensors:
    wiki.creativecommons.org/Considerations_for_licensors

     Considerations for the public: By using one of our public
     licenses, a licensor grants the public permission to use the
     licensed material under specified terms and conditions. If
     the licensor's permission is not necessary for any reason--for
     example, because of any applicable exception or limitation to
     copyright--then that use is not regulated by the license. Our
     licenses grant only permissions under copyright and certain
     other rights that a licensor has authority to grant. Use of
     the licensed material may still be restricted for other
     reasons, including because others have copyright or other
     rights in the material. A licensor may make special requests,
     such as asking that all changes be marked or described.
     Although not required by our licenses, you are encouraged to
     respect those requests where reasonable. More considerations
     for the public:
    wiki.creativecommons.org/Considerations_for_licensees

=======================================================================

Creative Commons Attribution 4.0 International Public License

By exercising the Licensed Rights (defined below), You accept and agree
to be bound by the terms and conditions of this Creative Commons
Attribution 4.0 International Public License ("Public License"). To the
extent this Public License may be interpreted as a contract, You are
granted the Licensed Rights in consideration of Your acceptance of
these terms and conditions, and the Licensor grants You such rights in
consideration of benefits the Licensor receives from making the
Licensed Material available under these terms and conditions.


Section 1 -- Definitions.

  a. Adapted Material means material subject to Copyright and Similar
     Rights that is derived from or based upon the Licensed Material
     and in which the Licensed Material is translated, altered,
     arranged, transformed, or otherwise modified in a manner requiring
     permission under the Copyright and Similar Rights held by the
     Licensor. For purposes of this Public License, where the Licensed
     Material is a musical work, performance, or sound recording,
     Adapted Material is always produced where the Licensed Material is
     synched in timed relation with a moving image.

  b. Adapter's License means the license You apply to Your Copyright
     and Similar Rights in Your contributions to Adapted Material in
     accordance with the terms and conditions of this Public License.

  c. Copyright and Similar Rights means copyright and/or similar rights
     closely related to copyright including, without limitation,
     performance, broadcast, sound recording, and Sui Generis Database
     Rights, without regard to how the rights are labeled or
     categorized. For purposes of this Public License, the rights
     specified in Section 2(b)(1)-(2) are not Copyright and Similar
     Rights.

  d. Effective Technological Measures means those measures that, in the
     absence of proper authority, may not be circumvented under laws
     fulfilling obligations under Article 11 of the WIPO Copyright
     Treaty adopted on December 20, 1996, and/or similar international
     agreements.

  e. Exceptions and Limitations means fair use, fair dealing, and/or
     any other exception or limitation to Copyright and Similar Rights
     that applies to Your use of the Licensed Material.

  f. Licensed Material means the artistic or literary work, database,
     or other material to which the Licensor applied this Public
     License.

  g. Licensed Rights means the rights granted to You subject to the
     terms and conditions of this Public License, which are limited to
     all Copyright and Similar Rights that apply to Your use of the
     Licensed Material and that the Licensor has authority to license.

  h. Licensor means the individual(s) or entity(ies) granting rights
     under this Public License.

  i. Share means to provide material to the public by any means or
     process that requires permission under the Licensed Rights, such
     as reproduction, public display, public performance, distribution,
     dissemination, communication, or importation, and to make material
     available to the public including in ways that members of the
     public may access the material from a place and at a time
     individually chosen by them.

  j. Sui Generis Database Rights means rights other than copyright
     resulting from Directive 96/9/EC of the European Parliament and of
     the Council of 11 March 1996 on the legal protection of databases,
     as amended and/or succeeded, as well as other essentially
     equivalent rights anywhere in the world.

  k. You means the individual or entity exercising the Licensed Rights
     under this Public License. Your has a corresponding meaning.


Section 2 -- Scope.

  a. License grant.

       1. Subject to the terms and conditions of this Public License,
          the Licensor hereby grants You a worldwide, royalty-free,
          non-sublicensable, non-exclusive, irrevocable license to
          exercise the Licensed Rights in the Licensed Material to:

            a. reproduce and Share the Licensed Material, in whole or
               in part; and

            b. produce, reproduce, and Share Adapted Material.

       2. Exceptions and Limitations. For the avoidance of doubt, where
          Exceptions and Limitations apply to Your use, this Public
          License does not apply, and You do not need to comply with
          its terms and conditions.

       3. Term. The term of this Public License is specified in Section
          6(a).

       4. Media and formats; technical modifications allowed. The
          Licensor authorizes You to exercise the Licensed Rights in
          all media and formats whether now known or hereafter created,
          and to make technical modifications necessary to do so. The
          Licensor waives and/or agrees not to assert any right or
          authority to forbid You from making technical modifications
          necessary to exercise the Licensed Rights, including
          technical modifications necessary to circumvent Effective
          Technological Measures. For purposes of this Public License,
          simply making modifications authorized by this Section 2(a)
          (4) never produces Adapted Material.

       5. Downstream recipients.

            a. Offer from the Licensor -- Licensed Material. Every
               recipient of the Licensed Material automatically
               receives an offer from the Licensor to exercise the
               Licensed Rights under the terms and conditions of this
               Public License.

            b. No downstream restrictions. You may not offer or impose
               any additional or different terms or conditions on, or
               apply any Effective Technological Measures to, the
               Licensed Material if doing so restricts exercise of the
               Licensed Rights by any recipient of the Licensed
               Material.

       6. No endorsement. Nothing in this Public License constitutes or
          may be construed as permission to assert or imply that You
          are, or that Your use of the Licensed Material is, connected
          with, or sponsored, endorsed, or granted official status by,
          the Licensor or others designated to receive attribution as
          provided in Section 3(a)(1)(A)(i).

  b. Other rights.

       1. Moral rights, such as the right of integrity, are not
          licensed under this Public License, nor are publicity,
          privacy, and/or other similar personality rights; however, to
          the extent possible, the Licensor waives and/or agrees not to
          assert any such rights held by the Licensor to the limited
          extent necessary to allow You to exercise the Licensed
          Rights, but not otherwise.

       2. Patent and trademark rights are not licensed under this
          Public License.

       3. To the extent possible, the Licensor waives any right to
          collect royalties from You for the exercise of the Licensed
          Rights, whether directly or through a collecting society
          under any voluntary or waivable statutory or compulsory
          licensing scheme. In all other cases the Licensor expressly
          reserves any right to collect such royalties.


Section 3 -- License Conditions.

Your exercise of the Licensed Rights is expressly made subject to the
following conditions.

  a. Attribution.

       1. If You Share the Licensed Material (including in modified
          form), You must:

            a. retain the following if it is supplied by the Licensor
               with the Licensed Material:

                 i. identification of the creator(s) of the Licensed
                    Material and any others designated to receive
                    attribution, in any reasonable manner requested by
                    the Licensor (including by pseudonym if
                    designated);

                ii. a copyright notice;

               iii. a notice that refers to this Public License;

                iv. a notice that refers to the disclaimer of
                    warranties;

                 v. a URI or hyperlink to the Licensed Material to the
                    extent reasonably practicable;

            b. indicate if You modified the Licensed Material and
               retain an indication of any previous modifications; and

            c. indicate the Licensed Material is licensed under this
               Public License, and include the text of, or the URI or
               hyperlink to, this Public License.

       2. You may satisfy the conditions in Section 3(a)(1) in any
          reasonable manner based on the medium, means, and context in
          which You Share the Licensed Material. For example, it may be
          reasonable to satisfy the conditions by providing a URI or
          hyperlink to a resource that includes the required
          information.

       3. If requested by the Licensor, You must remove any of the
          information required by Section 3(a)(1)(A) to the extent
          reasonably practicable.

       4. If You Share Adapted Material You produce, the Adapter's
          License You apply must not prevent recipients of the Adapted
          Material from complying with this Public License.


Section 4 -- Sui Generis Database Rights.

Where the Licensed Rights include Sui Generis Database Rights that
apply to Your use of the Licensed Material:

  a. for the avoidance of doubt, Section 2(a)(1) grants You the right
     to extract, reuse, reproduce, and Share all or a substantial
     portion of the contents of the database;

  b. if You include all or a substantial portion of the database
     contents in a database in which You have Sui Generis Database
     Rights, then the database in which You have Sui Generis Database
     Rights (but not its individual contents) is Adapted Material; and

  c. You must comply with the conditions in Section 3(a) if You Share
     all or a substantial portion of the contents of the database.

For the avoidance of doubt, this Section 4 supplements and does not
replace Your obligations under this Public License where the Licensed
Rights include other Copyright and Similar Rights.


Section 5 -- Disclaimer of Warranties and Limitation of Liability.

  a. UNLESS OTHERWISE SEPARATELY UNDERTAKEN BY THE LICENSOR, TO THE
     EXTENT POSSIBLE, THE LICENSOR OFFERS THE LICENSED MATERIAL AS-IS
     AND AS-AVAILABLE, AND MAKES NO REPRESENTATIONS OR WARRANTIES OF
     ANY KIND CONCERNING THE LICENSED MATERIAL, WHETHER EXPRESS,
     IMPLIED, STATUTORY, OR OTHER. THIS INCLUDES, WITHOUT LIMITATION,
     WARRANTIES OF TITLE, MERCHANTABILITY, FITNESS FOR A PARTICULAR
     PURPOSE, NON-INFRINGEMENT, ABSENCE OF LATENT OR OTHER DEFECTS,
     ACCURACY, OR THE PRESENCE OR ABSENCE OF ERRORS, WHETHER OR NOT
     KNOWN OR DISCOVERABLE. WHERE DISCLAIMERS OF WARRANTIES ARE NOT
     ALLOWED IN FULL OR IN PART, THIS DISCLAIMER MAY NOT APPLY TO YOU.

  b. TO THE EXTENT POSSIBLE, IN NO EVENT WILL THE LICENSOR BE LIABLE
     TO YOU ON ANY LEGAL THEORY (INCLUDING, WITHOUT LIMITATION,
     NEGLIGENCE) OR OTHERWISE FOR ANY DIRECT, SPECIAL, INDIRECT,
     INCIDENTAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY, OR OTHER LOSSES,
     COSTS, EXPENSES, OR DAMAGES ARISING OUT OF THIS PUBLIC LICENSE OR
     USE OF THE LICENSED MATERIAL, EVEN IF THE LICENSOR HAS BEEN
     ADVISED OF THE POSSIBILITY OF SUCH LOSSES, COSTS, EXPENSES, OR
     DAMAGES. WHERE A LIMITATION OF LIABILITY IS NOT ALLOWED IN FULL OR
     IN PART, THIS LIMITATION MAY NOT APPLY TO YOU.

  c. The disclaimer of warranties and limitation of liability provided
     above shall be interpreted in a manner that, to the extent
     possible, most closely approximates an absolute disclaimer and
     waiver of all liability.


Section 6 -- Term and Termination.

  a. This Public License applies for the term of the Copyright and
     Similar Rights licensed here. However, if You fail to comply with
     this Public License, then Your rights under this Public License
     terminate automatically.

  b. Where Your right to use the Licensed Material has terminated under
     Section 6(a), it reinstates:

       1. automatically as of the date the violation is cured, provided
          it is cured within 30 days of Your discovery of the
          violation; or

       2. upon express reinstatement by the Licensor.

     For the avoidance of doubt, this Section 6(b) does not affect any
     right the Licensor may have to seek remedies for Your violations
     of this Public License.

  c. For the avoidance of doubt, the Licensor may also offer the
     Licensed Material under separate terms or conditions or stop
     distributing the Licensed Material at any time; however, doing so
     will not terminate this Public License.

  d. Sections 1, 5, 6, 7, and 8 survive termination of this Public
     License.


Section 7 -- Other Terms and Conditions.

  a. The Licensor shall not be bound by any additional or different
     terms or conditions communicated by You unless expressly agreed.

  b. Any arrangements, understandings, or agreements regarding the
     Licensed Material not stated herein are separate from and
     independent of the terms and conditions of this Public License.


Section 8 -- Interpretation.

  a. For the avoidance of doubt, this Public License does not, and
     shall not be interpreted to, reduce, limit, restrict, or impose
     conditions on any use of the Licensed Material that could lawfully
     be made without permission under this Public License.

  b. To the extent possible, if any provision of this Public License is
     deemed unenforceable, it shall be automatically reformed to the
     minimum extent necessary to make it enforceable. If the provision
     cannot be reformed, it shall be severed from this Public License
     without affecting the enforceability of the remaining terms and
     conditions.

  c. No term or condition of this Public License will be waived and no
     failure to comply consented to unless expressly agreed to by the
     Licensor.

  d. Nothing in this Public License constitutes or may be interpreted
     as a limitation upon, or waiver of, any privileges and immunities
     that apply to the Licensor or You, including from the legal
     processes of any jurisdiction or authority.


=======================================================================

Creative Commons is not a party to its public
licenses. Notwithstanding, Creative Commons may elect to apply one of
its public licenses to material it publishes and in those instances
will be considered the “Licensor.” The text of the Creative Commons
public licenses is dedicated to the public domain under the CC0 Public
Domain Dedication. Except for the limited purpose of indicating that
material is shared under a Creative Commons public license or as
otherwise permitted by the Creative Commons policies published at
creativecommons.org/policies, Creative Commons does not authorize the
use of the trademark "Creative Commons" or any other trademark or logo
of Creative Commons without its prior written consent including,
without limitation, in connection with any unauthorized modifications
to any of its public licenses or any other arrangements,
understandings, or agreements concerning use of licensed material. For
the avoidance of doubt, this paragraph does not form part of the
public licenses.

Creative Commons may be contacted at creativecommons.org.

Source SHA-256: 09992b8a4716cf46d7a30bf54db47b251064080f05efad2a96227a6f67fbe932
Snapshot checked: 2026-09-28T17:05:37.111Z

Find a skill.Get to work.

All skills

Multi-Agent Orchestration

AI Context Window Audit

AI Agent Architecture Audit

AI Skill Discovery

Lead Magnet Strategy

Ideal Customer Profile

Go-to-Market Strategy

Marketing Campaign Ideas

Product Growth Loops

Competitor Analysis

North Star Metric

Product Positioning

Product Vision

Go-to-Market Motion Selection

Customer Feedback and JTBD Analysis

PESTLE Market Environment Analysis

Customer Journey Mapping

Ansoff Growth Options

Data Analysis Validation

Dataset Profiling

Statistical Analysis Guidance

Programmatic SEO Planning

Landing Page and Form Conversion Review

Paywall and Upgrade Planning

Signup and Registration Review

User Onboarding and Activation

Popup and Modal Planning

Email Sequence Copy and Flow

Marketing Campaign Planning

Marketing Content Drafting

Brand Voice and Content Review

Marketing Performance Reporting

Sales Company Research

Company and Contact Enrichment

Website Information Architecture

Content Strategy and Editorial Roadmap

Product Launch Planning

Customer Research and Voice of Customer

Community Growth and Member Experience

Competitor Research Profiles

Roadmap and Release Communication

Lifecycle Email Sequences

API Contracts and Interface Design

Observability and Instrumentation Planning

Agent Context and Session Handoff

Product Discovery Sprint

Deal Quality Scoring

Enrichment Waterfall Design

Customer Retention Playbook

Sales Coaching Practice

Revenue Cohort Analysis

Intent Signal Scoring

Customer Identity Matching

Segment Activation Planning

Sales Call Review

Retention Dashboard Design

Sales Coaching Competencies

Offer Delivery Design

Offer Value Communication

Service Productization

Conversion Hypothesis Prioritization

Braze Engagement Guidance

Brand Voice Guide Design

Content Pipeline Orchestration

Website Brand Profile

Buyer Objection Clarification

Klaviyo Integration Guidance

Offer Bonus Planning

Klaviyo Marketing Review

Cross-Platform Advertising Review

Expertise Business Model

LinkedIn Advertising Guidance

TikTok Advertising Guidance

Evidence Research Brief

Cinematic Video Prompts

Visual Prompt Model Adaptation

Visual Prompt Diagnostics

Short Film Development

Find a skill.
Get to work.