Quality Control

Why it matters

Quality failures found by a customer cost an order of magnitude more than the same failure found in process, and in regulated industries they carry consequences beyond cost.

• Cost rises with lateness: In process, at inspection, at customer — each step multiplies.
• It is evidence: Regulated products need the record, batch by batch, for years.
• It enables traceability: Recall scope is determined by how well batches and lots were tracked.

The workflow

1. 01

   Inspection planning

   What is inspected, at which point, against which characteristics and at what sample size.

2. 02

   Quality inspection

   Executed and recorded against the batch or lot, with results retained.

3. 03

   Non-conformance handling

   Material quarantined, dispositioned and the cause investigated rather than just the item fixed.

4. 04

   Quality reporting

   Trends by product, supplier and cause, used to change the process.

Disposition and root cause are different activities. Reworking the failed unit closes the non-conformance; only the cause analysis stops the next one, and it is the step most often skipped when the line is waiting.

What you need in place

• Inspection plans as data: Attached to the material and the operation, not to a person's knowledge.
• Quarantine that actually holds: Non-conforming stock physically and systemically unavailable.
• Batch and lot traceability: Forward to customer and backward to supplier.
• Root cause discipline: With a method, and an owner for the corrective action.
• Supplier quality feedback: Non-conformance attributed to the supplier who caused it.
• Retention periods: Records kept for the regulated or contractual period.

Questions to ask

Metrics and KPIs to track