1. Pharma ERP
  2. Process
  3. Quality hold and corrective action
Process · Quality hold and corrective action

Quality hold and corrective action

Contain a finding, record the disposition and verify corrective work independently.

Step by step

  1. Record the finding Quality Inspector

    Quality Inspector records nonconformance reports with the product, quantity and raised date. Attach the available Lot, supplier, work order and quality inspection references. Inspection, customer complaint, floor observation and supplier issue distinguish the source without assigning a new meaning to the physical stock balance.

    • Finding linked to affected source
    • Updates Non conformance reports, Quality inspections
  2. Contain affected work Quality Inspector

    Quality Inspector places quality holds on the lot, receipt or work-order operation. Retain placed by, placed date and the nonconformance report link. An on hold restriction must block the affected issue, shipment or completion commands while the team investigates.

    • Affected use restricted
    • Updates Quality holds, Lots, Work orders
  3. Decide the disposition Quality Inspector

    Quality Inspector reviews the inspection evidence and records the supported hold disposition. Accept, Rework, Reject, return to vendor and use as is need a reviewed operating policy. Release attribution belongs to released by and released date; Scrapped or Returned stock must not be treated as ordinary released inventory.

    • Reviewed release or other outcome
    • Updates Quality holds, Inspection results
    ApprovalA person approves before the work moves on.
  4. Investigate the cause Quality Inspector

    Quality Inspector records root cause method and root cause in nonconformance reports where required. Corrective actions link each action back to that finding and retain owner, description and due date. Completing the task is separate from establishing that its result addresses the cause.

    • Owner and due work assigned
    • Updates Non conformance reports, Corrective actions
  5. Verify corrective work Quality Inspector

    A permitted Quality Inspector distinct from owner reviews the completed action and records the verifier and verification date. Corrective actions progress from Completed to Verified before closure under the agreed policy. A self-verification attempt must fail through the decision route.

    • Independent verification retained
    • Updates Corrective actions
    ApprovalA person approves before the work moves on.
  6. Close and review affected evidence Quality Inspector

    Quality Inspector checks that the finding, hold outcome and action result remain consistent before closing the investigation. If an instrument becomes Overdue, review the historical inspection results that selected it without overwriting their original instrument attribution.

    • Closure and historical review preserved
    • Updates Non conformance reports, Instruments, Inspection results

Where it usually breaks

And how to keep it from happening.

  • A hold records a finding but its restriction is not enforced by movement commands.
  • Completed corrective work is treated as independently verified without a separate actor.
  • Updating instrument status erases the identity used on earlier inspection results.
Quality Inspector
, Shop Floor Supervisor, Buyer, Operator.

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