Run Production Quality Hold Investigation — Free

Hold Identification

Hold record ID and date/time initiated

Record the unique hold identifier and the date/time the hold was initiated.

Affected product, lot, batch, or work order identified critical (required)

Identify the specific product and traceability scope placed on hold.

Non-conformance description documented critical (required)

Describe the observed defect, deviation, or complaint that triggered the hold.

Hold reason classified critical (required)

Select the primary reason for the hold.

Quantity affected and quantity on hand recorded critical (required)

Enter the affected quantity and current inventory quantity under hold.

Note (optional)

Containment owner assigned

Identify the responsible owner for immediate containment and coordination.

Containment Actions

Affected inventory physically segregated and labeled HOLD critical (required)

Verify the product is clearly segregated from conforming inventory and marked to prevent use or shipment.

Yes No N/A

Shipping and release controls applied critical (required)

Confirm release systems, shipping, and ERP/MES controls prevent unintended disposition or shipment.

Yes No N/A

In-process and finished goods screened for escape risk critical (required)

Confirm related WIP, finished goods, and adjacent lots were reviewed for potential impact.

Yes No N/A

Customer and internal stakeholders notified of containment status critical (required)

Verify notifications were sent to the appropriate internal functions and, if needed, the customer.

Yes No N/A

Containment actions documented with date/time

Record when containment actions were completed.

Note (optional)

Evidence of containment attached

Attach photos or other evidence showing hold labels, segregation, or system controls if available.

Investigation and Root Cause

Investigation team and roles identified

List the people involved in the investigation and their responsibilities.

Evidence reviewed critical (required)

Select the evidence sources used to determine cause.

Root cause identified critical (required)

Confirm whether a validated root cause has been determined.

Yes No N/A

Root cause statement critical (required)

Describe the validated root cause using specific, evidence-based language.

Contributing factors identified

Select any contributing factors that helped create or allow the issue.

Reference to applicable SOP or control plan

Document the governing procedure, work instruction, or control plan used in the investigation.

Disposition Decision

Disposition selected critical (required)

Choose the final disposition for the held material.

Disposition approved by authorized role critical (required)

Confirm the disposition was approved by the required quality or management authority.

Yes No N/A

Disposition rationale documented critical (required)

Explain why the selected disposition is appropriate based on risk, evidence, and customer requirements.

Rework or sort instructions defined

If applicable, document the exact rework, sort, or inspection steps required before release.

Affected quantity dispositioned critical (required)

Record the quantity released, reworked, scrapped, or otherwise dispositioned.

Note (optional)

Customer Notification and Closure

Customer notification required

Confirm whether the customer must be notified based on contractual, regulatory, or risk requirements.

Yes No N/A

Customer notification completed critical (required)

Verify the customer was notified when required.

Yes No N/A

Notification date/time and contact method recorded

Capture when the customer was notified and how communication was sent.

Note (optional)

Corrective action or CAPA opened critical (required)

Confirm whether a corrective action, CAPA, or preventive action has been initiated.

Yes No N/A

Closure approval and signature critical (required)

Inspector or authorized approver signs to confirm the investigation is complete and accurate.

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Run: Production Quality Hold Investigation

Hold Identification

Containment Actions

Investigation and Root Cause

Disposition Decision

Customer Notification and Closure

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