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Manufacturing Quality (ISO 9001 / SPC)

free

Validate process capability, measurement systems, nonconformances, CAPA records, and BOM data for manufacturing quality.

11 rules 2476 downloads4.8 avg (228)
manufacturingiso-9001spccpkiatf-16949capabomipc
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About this pack

Data quality rules for manufacturing organizations pursuing ISO 9001, IATF 16949, or Six Sigma compliance. Covers: - SPC: Process capability (Cpk) thresholds, Gage R&R acceptance criteria - ISO 9001: Nonconformance severity, CAPA status lifecycle - Electronics: IPC reference designator format validation - BOM: Bill of Materials quantity validation Applicable to discrete manufacturing, electronics, automotive suppliers, and process industries.

Sources & References

IATF 16949 — IATF 16949:2016 Section 8.5.1.2

Process capability must be maintained at Cpk >= 1.33 for stable processes in automotive manufacturing

ISO 9001 — ISO 9001:2015 Section 9.1.3

Organizations shall analyze and evaluate data to assess process performance and identify improvement opportunities

IATF 16949 — IATF 16949:2016 Section 7.1.5.1.1

Statistical studies shall be conducted to analyze variation in measurement system results per AIAG MSA reference manual

AIAG — AIAG MSA Reference Manual 4th Edition

Gage R&R study results categorize measurement system acceptability: <=10% acceptable, 10-30% conditional, >30% unacceptable

ISO 9001 — ISO 9001:2015 Section 10.2

Organizations must react to nonconformities, evaluate the need for corrective action, and classify by severity

ISO 19011 — ISO 19011:2018 Section 6.4.8

Audit findings shall be classified by significance including major/minor nonconformity and observations

FDA — 21 CFR 820.90 - Nonconforming Product

CAPA procedures must be established for investigating, correcting, and preventing quality problems

IPC — IPC-2612 Sectional Requirements for Electronic Diagramming Documentation

Reference designators must follow standard letter class designations per IPC/ANSI standards

IEEE — IEEE 315 - Graphic Symbols for Electrical and Electronics Diagrams

Standard reference designator letter codes for electronic components

ISO 9001 — ISO 9001:2015 Section 8.5.1

Production and service provision must be under controlled conditions including documented information defining product characteristics

IPC — IPC-2581 Generic Requirements for Printed Board Assembly Products Manufacturing Description Data

BOM data must accurately represent component quantities required for assembly

What's included

4range rules
3format rules
2completeness rules
1uniqueness rules
1consistency rules

Checks included (11)

Process Capability Index (Cpk) Threshold(cpk)

Validates that process capability index (Cpk) values meet the minimum acceptable threshold. A Cpk of 1.33 or higher indicates a capable process where the spread of measured values falls well within specification limits. Values below 1.33 indicate the process may produce out-of-specification parts and should be flagged for investigation.

Gage R&R Percentage Threshold(grr)

Validates that Gage R&R (Repeatability and Reproducibility) percentage values are within acceptable limits. Per AIAG MSA guidelines: values <= 10% are acceptable, 10-30% may be conditionally acceptable, and values > 30% indicate the measurement system is unacceptable and needs improvement. This rule flags values exceeding 30% as failures.

Bill of Materials Quantity Positive(quantity)

Validates that Bill of Materials (BOM) quantity values are strictly positive (greater than zero). Every component in a BOM must have a quantity of at least 0.001 to be meaningful. Zero or negative quantities indicate data entry errors or improperly maintained BOM records that can lead to incorrect procurement, costing, and manufacturing planning.

Non-Negative Values

Validates that a numeric column contains no negative values. Common for quantities, counts, amounts, durations, and other measures that should never be negative.

Nonconformance Severity Classification(nc_severity)

Validates that nonconformance (NC) severity values conform to standard quality management classifications. Nonconformances are categorized as Critical (safety/regulatory impact), Major (significant quality impact), Minor (limited impact), or Observation (potential improvement area). These classifications drive the urgency and type of corrective action required.

Corrective Action (CAPA) Status(capa_status)

Validates that Corrective and Preventive Action (CAPA) status values conform to standard quality management lifecycle states. Valid statuses track CAPA items from initial creation through investigation, verification, and closure. The Overdue status flags items that have exceeded their target completion date.

Electronics Reference Designator Format(ref_designator)

Validates that electronics reference designators conform to IPC standard format. A reference designator consists of 1-3 uppercase letter prefix identifying the component type (e.g., R for resistor, C for capacitor, U for integrated circuit, J for connector) followed by 1-5 digits for the sequential number.

Column Not Null

Asserts that a specified column contains no null values. This is the most fundamental completeness check — every row must have a value present in the target column.

Column Completeness Threshold

Asserts that a column meets a minimum completeness threshold, measured as the percentage of non-null values. Useful when some nulls are acceptable but the overall population rate must stay above a defined level (e.g., 95%).

Column Unique

Validates that all non-null values in a specified column are unique. Useful for natural keys, email addresses, identifiers, and any column where duplicates indicate a data quality issue.

Enum Value Valid

Asserts that all values in a column belong to a predefined set of allowed values. Catches typos, unexpected category values, or upstream system changes that introduce new enum variants without coordination.