Nonconforming Product SOP Template

1.Purpose

To make sure nonconforming product is identified, contained and dispositioned consistently, so defective product does not reach the customer and the root cause is addressed to prevent recurrence.

2.Scope

Applies to product identified as nonconforming during inspection, in production, or after a customer complaint. Routine sampling and inspection activity itself is covered by the quality inspection SOP.

Definitions

NCR

Nonconformance report. The record documenting a nonconforming condition, its containment and its disposition.

Material review board (MRB)

The cross-functional group that decides how nonconforming product is dispositioned.

Disposition

The decision made for nonconforming product: rework, scrap, use-as-is, or return to supplier.

Containment

Action taken to stop suspect nonconforming product from moving further into production or to the customer.

3.Responsibilities

Quality Inspector

Identifies nonconforming product, tags and segregates it, and opens the NCR.

Production Operator

Stops producing suspect product when notified and assists in checking upstream and downstream product.

Material Review Board

Reviews the NCR, determines the root cause, and decides the disposition of the nonconforming product.

Production Supervisor

Coordinates containment on the floor and ensures corrective action is communicated to the shift.

RACI matrix

R = Responsible, A = Accountable, C = Consulted, I = Informed

4.Materials and PPE

Materials, tools and systems

• →Nonconformance report (NCR) log or QMS
• →Quarantine area and tags
• →Root cause analysis form
• →Material review board meeting record
• →Specification and control plan for the affected part

Personal protective equipment

• →Safety glasses
• →Gloves appropriate to the product material

5.Procedure

1. 5.1

   Stop production of suspect product

   Production Operator

   Inspector or operator who identifies a suspect nonconforming condition stops production of the affected part immediately and notifies the production supervisor.

2. 5.2

   Tag and segregate the nonconforming material

   Quality Inspector

   Inspector tags the nonconforming product clearly and moves it to the quarantine area, physically separated from conforming product.

   Warning: Do not leave tagged nonconforming product mixed with conforming stock, even temporarily.

3. 5.3

   Open the nonconformance report

   Quality Inspector

   Inspector opens an NCR in the log or QMS describing the part, quantity, defect found, and where and when it was discovered.

4. 5.4

   Notify quality and production supervisor

   Quality Inspector

   Inspector notifies the quality manager and production supervisor of the nonconformance so containment can be coordinated across the affected shift or area.

5. 5.5

   Contain upstream and downstream product

   Production Supervisor

   Inspector and operator check product made before and after the suspect part was found, including any already moved to the next process or into finished goods, and quarantine anything at risk.

   Checkpoint: All product made between the last known good check and the point of discovery is located and checked.

6. 5.6

   Perform root cause analysis

   Quality Inspector

   Quality inspector leads a root cause analysis using the NCR details, process records and, where relevant, the operator's account of the process conditions.

7. 5.7

   Convene the material review board

   Material Review Board

   Material review board reviews the NCR, root cause findings and quantity affected, and decides whether to rework, scrap, use-as-is or return the product to the supplier.

   Checkpoint: Disposition decision is documented on the NCR with the reasoning before any product is released or scrapped.

8. 5.8

   Execute the disposition

   Quality Inspector

   The assigned team executes the disposition decided by the material review board, such as performing the rework, scrapping the material, or returning it to the supplier with documentation.

9. 5.9

   Verify reworked product meets specification

   Quality Inspector

   Inspector re-inspects any reworked product against the full specification before it is released back into the production flow.

10. 5.10

    Update and close the NCR

    Quality Inspector

    Quality inspector updates the NCR with the final disposition, quantities reworked or scrapped, and closes the record once all actions are complete.

11. 5.11

    Communicate corrective action to production

    Production Supervisor

    Production supervisor communicates the root cause and any process change to the affected shift so the same nonconformance is less likely to recur.

12. 5.12

    Track nonconformance trends

    Material Review Board

    Quality manager reviews NCR trends by part number, defect type and root cause monthly to identify recurring issues needing a broader corrective action.

6.Quality checks

• →Every nonconforming lot has a documented containment check of upstream and downstream product.
• →No disposition is executed before the material review board decision is documented on the NCR.
• →Reworked product is re-inspected against the full specification before release.
• →NCR trends are reviewed monthly for recurring root causes.

7.Records

• →Nonconformance reports (NCRs)
• →Root cause analysis documentation
• →Material review board decisions
• →Rework, scrap and supplier return records

8.KPIs

• →Number of NCRs opened per period
• →Average time to close an NCR
• →Percentage of nonconformances with a completed root cause analysis
• →Repeat nonconformances by part number or root cause

9.Common mistakes

• →Reworking product before the material review board decides the disposition.
• →Not checking downstream product already moved past the point of discovery.
• →Closing an NCR without a documented root cause.
• →Leaving quarantined material unlabeled or in a shared staging area.
• →Skipping re-inspection of reworked product before release.

10.Revision history