Specifications and testing

Quality specifications records the requirement for a product test. Each record identifies the product, specification code, type, test parameter and acceptance criteria. Lower and upper limits, unit of measure, effective date and version label give the QC Analyst context for a numeric result. The analyst should be able to see which requirement applies before recording an outcome for a batch.

Test results captures the observed value or text, test date, performer, instrument code, analyst note and outcome. Its batch reference identifies the lot under review. Its specification reference ties the test back to the applicable requirement when used. A Pass, Fail, Pass With Deviation, Invalid or Pending outcome says how the result is classified; the numeric or text result and note carry the detail needed for a later review.

• Product requirement. Admin maintains a named specification and its acceptance criteria for the product.
• Batch test. QC Analyst records the result against the lot and chooses the actual outcome.
• Exception review. QA Manager examines failures and results with deviations alongside the batch’s other quality records.

Choose a naming convention for specifications and decide how version labels and effective dates are maintained. Settle which test types apply to each product and how results arriving from a laboratory system are entered. The laboratory connection, if used, needs a clear source for result values and analyst identity. Agree when a pending result may be completed and who may mark an invalid run.

The team should also agree what evidence accompanies a result with a deviation. A short analyst note can describe the observation, while a separate deviation record holds the investigation and root cause. QA Manager must see the relationship to the lot before weighing a release decision.

Take a product with a Finished Product specification for a named test parameter. Record the acceptance criteria and any numeric limits. QC Analyst enters a result for one lot, with the test date and instrument code, then marks the outcome Pass. A second result for the same lot is marked Pass With Deviation and carries an analyst note. QA Manager opens a deviation for that batch and reviews the two outcomes during quality review.

Now compare the product on the specification with the product on the batch. The pairing must be deliberate. A result without the intended specification reference can still name the batch, but it cannot communicate which acceptance criterion was applied. In the pilot, verify that the analyst and reviewer can trace this relationship from the result screen.

• Tests needing results — Pending test records that still need a recorded outcome.
• Failed or exception tests — Failures, invalid tests and results marked with a deviation.
• Batches awaiting quality review — Lots whose test outcomes need to be considered with other quality evidence.

See testing and exceptions for the result handoff and batch quality to release for the wider lot path.