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- Quality Management System
- Data model
The tables behind Quality Management System
Quality Management System ships with 27 tables, grouped here by the feature that uses them. Every record your team works with lives in one of them, and you can add fields and tables in Proto.
- Tables
- 27
- Features
- 7
- Change it
- Add fields and tables in Proto
How the model is organised
Inspection planning:
Products, quality standards, Specifications, inspection types, inspection plans and sample plans establish what to check.
Execution:
Inspections, inspection results, defect instances and Defects preserve observations and outcomes.
Issue control:
Non conformance reports, NCR defects, NCR affected serials and Containment identify affected material and decisions.
Corrective work:
CAP as, CAPA tasks, root cause analysis, five whys steps and fishbone categories track cause and action.
Audit and people:
Audits, audit checklists, audit findings, calibration records, Trainings and Users retain responsible work and evidence.
Supplier quality:
Suppliers and supplier quality scores connect incoming cases with period review.
Every table, by feature
- Inspection planning7
- Inspection execution7
- Nonconformance7
- CAPA and root cause7
- Audits6
- Calibration and training7
- Supplier quality7
- Products
Items and materials subject to inspection, specification and quality reporting.
- Quality standards
Applicable quality standards and frameworks driving audit scope and specification references.
- Specifications
Per-item specification sheet, one row per item per spec parameter.
Linked to Products, Quality standards - Inspection types
Catalog of inspection stages bound to inspection plans and inspections.
- Inspection plans
Per-item per-stage inspection configuration binding specifications and a sample plan.
Linked to Products, Inspection types, Sample plans, Users - Sample plans
ANSI Z1.4 / AQL sample plans resolving lot size and level to sample and accept numbers.
Linked to Quality standards - Inspections
Inspection event header with status and rolled-up pass/fail outcome.
Linked to Inspection plans, Inspection types, Products, Sample plans
- Inspections
Inspection event header with status and rolled-up pass/fail outcome.
Linked to Inspection plans, Inspection types, Products, Sample plans - Inspection results
Per-specification measurement recorded during an inspection.
Linked to Inspections, Specifications, Users - Defect instances
Per-defect-code occurrences found in an inspection.
Linked to Inspections, Defects - Defects
Defect catalog with severity and category cited by defect instances and NCR defects.
- Specifications
Per-item specification sheet, one row per item per spec parameter.
Linked to Products, Quality standards - Calibration records
Calibration log for measurement equipment used in inspections.
- Non conformance reports
Non conformance report header driving containment, disposition and CAPA.
Linked to Inspections, Products, Suppliers, Users
- Non conformance reports
Non conformance report header driving containment, disposition and CAPA.
Linked to Inspections, Products, Suppliers, Users - Containment
Containment actions applied to a non conformance report.
Linked to Non conformance reports, Users - NCR defects
Defects cited on a non conformance report.
Linked to Non conformance reports, Defects - NCR affected serials
Serials affected by a non conformance report.
Linked to Non conformance reports, Defect instances - Defects
Defect catalog with severity and category cited by defect instances and NCR defects.
- Inspections
Inspection event header with status and rolled-up pass/fail outcome.
Linked to Inspection plans, Inspection types, Products, Sample plans - CAP as
Corrective and preventive action header routed from major or critical issues.
Linked to Non conformance reports, Audit findings, Users
- CAP as
Corrective and preventive action header routed from major or critical issues.
Linked to Non conformance reports, Audit findings, Users - CAPA tasks
Investigation, corrective, preventive, verification and effectiveness tasks on a CAPA.
Linked to CAP as, Users - Root cause analysis
Root cause analysis exercise on a CAPA using Five Whys, Fishbone or other methods.
Linked to CAP as, Users - Five whys steps
One row per why in a five whys exercise.
Linked to Root cause analysis - Fishbone categories
One row per fishbone category cause cluster.
Linked to Root cause analysis - Non conformance reports
Non conformance report header driving containment, disposition and CAPA.
Linked to Inspections, Products, Suppliers, Users - Audit findings
Issues found during audits; major findings route into CAP as.
Linked to Audits, Users
- Audits
Internal or external audit cycle header.
Linked to Quality standards, Users - Audit checklists
Per-clause checklist row instantiated onto an audit.
Linked to Audits, Quality standards - Audit findings
Issues found during audits; major findings route into CAP as.
Linked to Audits, Users - Quality standards
Applicable quality standards and frameworks driving audit scope and specification references.
- CAP as
Corrective and preventive action header routed from major or critical issues.
Linked to Non conformance reports, Audit findings, Users - Users
Users
Linked to Users
- Calibration records
Calibration log for measurement equipment used in inspections.
- Inspections
Inspection event header with status and rolled-up pass/fail outcome.
Linked to Inspection plans, Inspection types, Products, Sample plans - Inspection results
Per-specification measurement recorded during an inspection.
Linked to Inspections, Specifications, Users - Trainings
Training records assigned to operators and inspectors, often as a corrective action.
Linked to Non conformance reports, CAP as, Quality standards, Users - Non conformance reports
Non conformance report header driving containment, disposition and CAPA.
Linked to Inspections, Products, Suppliers, Users - Specifications
Per-item specification sheet, one row per item per spec parameter.
Linked to Products, Quality standards - Quality standards
Applicable quality standards and frameworks driving audit scope and specification references.
- Suppliers
Supplier master for incoming quality, supplier NC rs and supplier scorecards.
- Supplier quality scores
Periodic per-supplier quality rollup with score and grade.
Linked to Suppliers, Users - Inspections
Inspection event header with status and rolled-up pass/fail outcome.
Linked to Inspection plans, Inspection types, Products, Sample plans - Non conformance reports
Non conformance report header driving containment, disposition and CAPA.
Linked to Inspections, Products, Suppliers, Users - Containment
Containment actions applied to a non conformance report.
Linked to Non conformance reports, Users - Audits
Internal or external audit cycle header.
Linked to Quality standards, Users - Audit findings
Issues found during audits; major findings route into CAP as.
Linked to Audits, Users
Keys and references
Inspection results and defect instances refer to their Inspections record. A non conformance reports record can refer to a source inspection and affected product. CAP as can refer to a nonconformance report or audit finding. Tasks and root cause analyses refer to the CAPA. Audit findings and checklists refer to an audit. Supplier quality scores refer to a supplier. Users references identify inspectors, owners, auditors, assignees and reviewers.
Migration order
- Enter Users, Products, Suppliers and quality standards with their identifiers.
- Add Defects, sample plans, inspection types and Specifications.
- Add inspection plans, calibration records and planned Audits.
- Import Inspections with results and defect instances, then nonconformance and containment records.
- Add audit findings, CAP as, tasks, analyses, training and supplier period scores after their parent links exist.
Set up Quality Management System your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.