Enterprise platforms · Manufacturing
Quality management system for manufacturers
We build custom quality management systems for manufacturers: inspection plans and in-process checks, statistical process control, non-conformance records, corrective and preventive action, supplier quality, audits and calibration, linked to the work order, lot and machine. Quality data is captured where it arises and available where decisions are made, and you own the code.
Requirements template · Manufacturing
Manufacturing systems requirements template
A requirements template for a manufacturing execution system or manufacturing operations layer, organised around ISA-95: orders, scheduling, shop-floor data, traceability, quality, equipment and integration.- 01Eight requirement areas written as testable statements.
- 02The fields a machine signal list needs before you connect equipment.
- 03Integration points with the ERP and the plant network.
- 04Seven questions to put to any vendor or development partner.
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What the system does, module by module.
- 01
Inspection plans and characteristics
Plans per product and operation listing characteristics, limits, methods, gauges and sample sizes, versioned and linked to the control plan. - 02
In-process and final inspection
Measurements entered at a terminal or captured directly from gauges and machines, with immediate pass, warn or fail feedback. - 03
Statistical process control
Control charts, capability indices and run rules calculated on live data, with alerts when a process drifts before it makes bad parts. - 04
Non-conformance management
Records of defects with containment, disposition and cost, linked to lots and operations so affected product is found quickly. - 05
Corrective and preventive action
Root cause analysis, 8D reports, actions with owners and due dates, effectiveness checks and closure with evidence. - 06
Supplier quality
Incoming inspection, supplier non-conformance and corrective action requests, scorecards and approved supplier lists. - 07
Audits and findings
Internal, supplier and customer audit planning, checklists, findings and follow-up through to closure. - 08
Calibration and gauge management
Calibration schedules, certificates, out-of-tolerance impact assessment and the list of measurements made with a gauge that later failed. - 09
Documents, FMEA and customer reporting
Controlled procedures, FMEAs and control plans, and the customer-specific reports that quality teams build by hand today.
Reference architecture.
Standards and interfaces
What we design against.
- ISO 9001
- The general quality management system standard, with clauses on control of nonconforming outputs, corrective action and monitoring and measurement.
- IATF 16949, AS9100 and ISO 13485
- Sector standards for automotive, aerospace and medical devices, with additional traceability, control plan and validation requirements.
- AIAG core tools
- APQP, PPAP, FMEA and statistical process control practice used in automotive supply chains.
- ISO 10012 and calibration practice
- Measurement management systems and the control of monitoring and measuring equipment.
- 21 CFR Part 11 and Annex 11
- Electronic records and signatures for regulated products.
- Customer-specific requirements
- Reporting and notification rules that customers require from their suppliers.
Data model
The core entities.
- Inspection plan and characteristic
- Product, operation, characteristic, limits, method, gauge and sample plan.
- Measurement and result
- Value, unit, time, operator or device, order, lot and pass or fail.
- Control chart and capability
- Subgroup data, limits, run-rule violations and capability indices.
- Non-conformance
- Defect, quantity, lot, containment, disposition, cost and links to the action.
- Corrective action
- Problem statement, root cause, actions, owners, due dates and effectiveness check.
- Supplier issue
- Supplier, part, defect, request, response and scorecard effect.
- Gauge and calibration
- Instrument, interval, certificate, result and affected measurements.
When custom development is the right call.
Controls designed in, not added later.
Electronic records
Audit trail, signatures and permissions that meet the requirements of the products you make.Controlled documents
Only approved versions of plans and procedures are visible on the line, and superseded versions are withdrawn.Role-based access
Inspectors, engineers, supplier quality and auditors have separate roles, and approvals cannot be self-granted.Data integrity
Measurements captured from gauges are stored as received, with edits recorded and justified.Offline capture
Terminals continue to record during a network fault and synchronise afterwards.
From discovery to a system you run.
- 01
Quality process review
We follow how defects, inspections and corrective actions are handled today, with quality, production and supplier teams. - 02
Plans and workflows design
Inspection plans, SPC rules, non-conformance and CAPA workflows are agreed, together with the certification requirements. - 03
Build on one line
Inspection capture, SPC and non-conformance go live on one line, linked to its orders and lots. - 04
Add CAPA, supplier quality and audits
CAPA, supplier issues, audits and calibration are added and used by the quality team. - 05
Roll out and extend
More lines and plants follow, and customer reports are generated from the data.
Relevant work
Where to see our work.
Common questions.
- Can the system collect measurements straight from gauges and machines?
- Yes, through digital gauge interfaces, machine signals or connected instruments, with manual entry for what cannot be connected. Measurements are stored as received.
- How does it help find affected product after a defect?
- Every measurement and non-conformance is linked to the order, lot, machine and material, so a query returns the affected lots, products and customers.
- Does it support automotive or medical device requirements?
- Yes. Control plans, FMEA links, PPAP evidence, electronic records and audit trails are designed in where the sector standard calls for them, with validation planned with your quality team.
- Can it connect to our existing ERP and MES?
- Yes. Orders, lots and holds are exchanged with the ERP and MES through their interfaces.
- Who owns the code?
- You do. The code, the plans and the data stay yours.