1. Pharmaceuticals QMS
  2. Process
  3. Out of specification review
Process · Out of specification review

Out of specification review

Capture a batch test exception against an inspection and follow laboratory and manufacturing review.

Step by step

  1. Select operational record Inspector

    Inspector chooses the Inspection that supplies the quality context for the batch test.

    • Identifies source inspection and responsible person
    • Updates Inspections, People
  2. Capture case Inspector

    Inspector enters batch number, test name, observed value, specification and opened date with source evidence.

    • Records batch, test and measured result
    • Updates Out of specification cases
  3. Validate submission Inspector

    The capture flow checks the linked Inspection, responsible People identity and case details before saving the attributed record.

    • Saves a case with valid source context
    • Updates Out of specification cases, Inspections
  4. Laboratory review Laboratory Reviewer

    Laboratory Reviewer examines the reported result and source context as the case enters laboratory review.

    • Advances case review
    • Updates Out of specification cases
  5. Manufacturing review Manufacturing Reviewer

    Manufacturing Reviewer examines the same case after laboratory work and records the next review state.

    • Continues review on the same case
    • Updates Out of specification cases
  6. Close case Manufacturing Reviewer

    The responsible review team closes the case after the required investigation of the reported result.

    • Marks reviewed case closed
    • Updates Out of specification cases
Inspector
Submits the case; Laboratory Reviewer and Manufacturing Reviewer conduct the staged review; Quality Reviewer coordinates related inspection work.

Set up Pharmaceuticals QMS your way.

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

How to get started