Production Quality Hold Investigation

Inspection template for investigating production quality holds, documenting containment, root cause, disposition, and customer notification actions.

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
  Identify the specific product and traceability scope placed on hold.
• Non-conformance description documented
  Describe the observed defect, deviation, or complaint that triggered the hold.
• Hold reason classified
  Select the primary reason for the hold.
• Quantity affected and quantity on hand recorded
  Enter the affected quantity and current inventory quantity under hold.
• Containment owner assigned
  Identify the responsible owner for immediate containment and coordination.

Containment Actions

• Affected inventory physically segregated and labeled HOLD
  Verify the product is clearly segregated from conforming inventory and marked to prevent use or shipment.
• Shipping and release controls applied
  Confirm release systems, shipping, and ERP/MES controls prevent unintended disposition or shipment.
• In-process and finished goods screened for escape risk
  Confirm related WIP, finished goods, and adjacent lots were reviewed for potential impact.
• Customer and internal stakeholders notified of containment status
  Verify notifications were sent to the appropriate internal functions and, if needed, the customer.
• Containment actions documented with date/time
  Record when containment actions were completed.
• 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
  Select the evidence sources used to determine cause.
• Root cause identified
  Confirm whether a validated root cause has been determined.
• Root cause statement
  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
  Choose the final disposition for the held material.
• Disposition approved by authorized role
  Confirm the disposition was approved by the required quality or management authority.
• Disposition rationale documented
  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
  Record the quantity released, reworked, scrapped, or otherwise dispositioned.

Customer Notification and Closure

• Customer notification required
  Confirm whether the customer must be notified based on contractual, regulatory, or risk requirements.
• Customer notification completed
  Verify the customer was notified when required.
• Notification date/time and contact method recorded
  Capture when the customer was notified and how communication was sent.
• Corrective action or CAPA opened
  Confirm whether a corrective action, CAPA, or preventive action has been initiated.
• Closure approval and signature
  Inspector or authorized approver signs to confirm the investigation is complete and accurate.