Manufacturing

PRACTICAL GUIDANCE

The starting point

Follow the product from order and design through purchasing, production and release. Audit the controls that prevent recurrence, preserve traceability and manage the environmental and safety risks of the actual process.

Priorities to examine

• Customers need confidence that specifications and changes are controlled across the supply chain.
• Scrap, rework, rejects or recurring defects show where process evidence needs closer attention.
• New equipment, materials, shifts or outsourced operations alter risks and competence needs.
• Environmental performance and worker safety depend on controls that remain effective under normal production pressures.

Standards to investigate

Evidence to consider

• Order and specification reviews, drawings and controlled engineering changes.
• Incoming material checks, supplier performance and outsourced-process records.
• Production instructions, traceability and product release records.
• Measurement-equipment status and evidence that acceptance decisions use suitable methods.
• Nonconforming output, concession, root-cause and effectiveness-check records.
• Environmental and occupational safety assessments linked to actual equipment, materials and work patterns.

Questions for your scope

• Does the scope include design responsibility, manufacturing only, assembly or servicing?
• Which product families and process variants need representative sampling?
• How is a changed specification prevented from being lost between purchasing and production?
• What happens when equipment, materials or output fall outside acceptable conditions?
• Do the products need sector-specific standards or regulatory assurance beyond a general management-system review?

Related guidance and practical next steps