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  3. Defect Observations
Feature · Defect Observations

Defect Observations

Record defect codes, severity and affected units against production inspection lots.

OverviewDefect Observations
Manufacturing QMS · Defect Observations

Defect Observations

Defect observations

New
LotDefect codeSeverityDefective unitsObserved at
PIL-35739DC-662Minor82004 Oct
PIL-35794DC-420Major79003 Oct
PIL-80976DC-520Critical9003 Oct
PIL-29137DC-416Minor17017 Oct
PIL-84764DC-697Major17015 Oct
6 of 6 records
DC-662Defect observations · DO-88031
Minor
LotPIL-35739
Defective units820
Observed at04 Oct
Example screen with sample data

What you can do

Attribute the defect to the sampled lot

A defect observation records what the inspector saw on a Production Inspection Lot. It keeps the defect code, severity, number of defective units and observation date beside a reference to that lot. The lot carries the work order reference, product code and lot number, so the quality team can follow the observation back to the inspected production scope.

The capture workflow validates the selected lot and each observation value before saving. Inspectors should make the defect code specific enough for another person to recognize the same condition. Severity is recorded as Minor, Major or Critical. The defective-unit value describes the affected units in that observation; it should be checked against the lot’s sample context during review.

How the work is organized

  • Choose the lot. The inspector starts from a saved Production Inspection Lot and confirms that its inspection link and identifiers match the sampled work.
  • Describe the observation. The inspector enters a defect code, severity, affected units and the date observed.
  • Review the context. The reviewer reads the observation with the lot and the linked inspection checks when deciding what scope passed or failed.

A saved observation is evidence about the lot. It does not itself change an inspection’s status. The inspection review workflow makes the acceptance or rejection decision from the required check results, and creates linked containment work for failures. Keeping these actions distinct prevents a defect count from being mistaken for a completed review.

What to agree during setup

Agree a controlled set of defect codes that inspectors can apply consistently across shifts. The record accepts text, so your team should maintain its working convention and examples. Decide how inspectors count defective units when several defect types appear on the same sampled piece. Also agree when a date should reflect the actual observation rather than a later entry time.

Rehearse a case with the production and quality teams together. Give them the lot identity and expected sample size, then ask an inspector to enter the observation. A reviewer should be able to tell what was found, how severe it was and which inspected scope was affected without asking the inspector to reconstruct the context.

Check the handoff on an actual case

An inspector finds a major defect in a sampled lot tied to an in-process inspection. The inspector chooses that lot, enters the defect code, marks the severity Major, records the defective units and observed date, and saves. The reviewer opens Defect Observations, follows the lot reference and checks the work order reference, product code and sample size before reviewing the linked inspection.

Try the case again without a lot or a defect code. The capture should require the missing information. Then use a second observation on the same lot. The team should be able to read both entries under the one production identity while keeping their separate severities and affected-unit values.

What your team sees

  • Defect Observations — Recorded defects with lot, severity, affected units and observation date.
  • Production Inspection Lots — Production and sample context for the observation.

Follow the work through

Start with lot and defect capture, then use inspection review for the acceptance decision.

What it keeps track of

Data model
Defect observations
Defect Observations records for QMS for Manufacturing.
Production inspection lots
Production Inspection Lots records for QMS for Manufacturing.
Inspections
Inspections records for QMS for Manufacturing.
Inspection checks
Inspection Checks records for QMS for Manufacturing.

Who uses it

Permissions
Inspector
Captures observations.
Reviewer
Uses them while considering inspection results.
Quality Manager
Follows recurring lot issues and related nonconformances.

Set up Manufacturing QMS your way.

Start free, then use Proto to change fields, steps and approvals before your team goes live.

How to get started