Out Of Specification

An Out Of Specification Case records a batch number, test name, observed value, specification, opened date and status. It points to an Inspection as its operational record. This link gives the case a quality context: the reviewer can move from a batch test exception to the inspection and its checks. The numeric observed value and the specification text should be read together. The record is a case for review, with a visible progression through open, laboratory review, manufacturing review and closed states.

The capture flow starts when an authorized Inspector submits a case against a selected inspection. It resolves the linked operational record and the responsible person through People. It validates case data and source evidence before saving the attributed case. The permitted path then gives Laboratory Reviewer and Manufacturing Reviewer clear handoffs. For a batch with a test outside its stated specification, those people can inspect the same case instead of passing a loose result by email.

• Case capture. Associate the batch and test result with the correct operational inspection.
• Laboratory review. Examine the submitted value, stated specification and source context.
• Manufacturing review. Continue the same case after laboratory work before the final close decision.

Agree the batch number format, the exact source of the test name and how the specification should be written. Decide how an Inspector finds the operational inspection before submitting. A linked inspection is required for the case to make sense across teams. Name the Laboratory Reviewer and Manufacturing Reviewer for each product area, and settle what evidence each handoff needs. If the laboratory result originates elsewhere, establish how its source evidence is brought into the case without changing the observed result.

A case’s status shows where it is in the review path. The team should also agree when an out of specification case requires a linked nonconformance. That decision belongs in the operating procedure and must refer to the source inspection; the case alone does not replace the nonconformance and corrective action records.

Choose a real inspection reference and a sample batch. Have the Inspector submit a case with test name, observed value and specification. Try the wrong inspection link and incomplete source evidence so the capture step can reject them. Then use a valid case and follow it from open through laboratory and manufacturing review. At each step, ask the next reviewer to identify the batch, original observed value and operational inspection without asking the prior reviewer for missing context. Keep the case open until the responsible review is finished.

• Out of specification review — Open cases and those moving between laboratory and manufacturing review.
• Inspection queue — The source quality work associated with each operational record.

See out of specification review and the linked inspection execution.