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- Pharmaceuticals QMS
- 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
-
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
-
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
-
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
-
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
-
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
-
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
Who does what
Roles and permissions- 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.