Compass Health SOP: Non-Conforming Products

Compass Health SOP: Control of Non-conforming Products

• Purpose: Ensures safety and effectiveness of products by controlling non-conforming products throughout the production process. A key aspect is identifying non-conforming products early.

• Scope: Covers non-conforming products produced by Compass, received by Compass (for input or testing), impacting product quality.

• Applicable Standards:

  • ISO 13485:2016 Section 8.3 Control of Nonconforming Product
  • FDA QSR § 820.90 Nonconforming product
  • TG(MD)R Sch1 P1 2, Sch3 P1 1.4(3)(a),(b),(5)(b)(iii), (f)

Reference Documents

• Non-Conformance Form: QMS-FRM-0014
• Supplier Non-Conformance Report: QMS-FRM-0015
• SOP: Control of Records: QMS-SOP-0003
• SOP: Supplier Evaluation and Monitoring: QMS-SOP-0016

Acronyms and Definitions

• WIP: Work In Progress
• MRB: Material Review Board
• DHR: Device History Record
• LHR: Lot History Record
• QA-RA: Quality Assurance-Regulatory Affairs

Definitions

• Concession Request: A request to accept a product that doesn't meet strict specifications but still conforms to customer specifications.
• Non-conforming product: A product that doesn't meet a specified requirement.
• Quarantine Area: A designated area for isolating non-conforming products.
• Rework: Actions taken to correct non-conforming products to meet specifications before distribution.

Process Roles

• QA-RA: Performs initial product conformance evaluation, and recommends disposition for management approval, reports active concessions & non-conformances.

Control of Non-Conforming Product

• Identification: Suspect, non-conforming, or contaminated product is removed from work in progress (WIP), labeled with a "HOLD" label (yellow) and placed in the Quarantine Area.
• Disposition: An MRB (Material Review Board) meeting is held to determine the appropriate disposition of the non-conforming product. Dispositions include:
  • Rework
  • Scrap
  • Return to supplier
  • Accept by Concession
  • Further Investigation

Rework

• Responsible Manager approves the rework method with QA-RA and documents in a work instruction.
• Product is re-inspected by QA-RA and the Responsible Manager for compliance with specifications.
• If conforming, product is labeled "CLEAR" (green) and returned to inventory.

Scrap

• Non-conforming product to be scrapped is labeled "SCRAP" (red).
• All scrap operations are documented, including the quantity, methods used, and personnel involved.

Return to Supplier

• If product rejection is against the supplier's standards, a Supplier Non-Conformance Report is generated.
• Some quality issues require a supplier visit to confirm corrective actions.

Acceptance by Concession

• Products outside specifications are accepted if it performs as intended, is safe and conforms to regulations.
• Internal requests are reviewed by QA/RA and the manager. The validity needs approval before implementation.
• QA-RA notifies the customer/supplier of impact to concessions.

Returned Medical Devices

• Devices returned from customers are held and not released.
• Returned Devices are reviewed by QA-RA, may need Medical Device Reporting, and investigations.

Process Monitoring

• QA-RA reports on open non-conformances and active concessions in scheduled Quality System Management Reviews.

Quality Records

• Rework Operations Documents Document rework quantity, personnel, and dates.
• Concession Request Documentation Details of the Concession, period, and quantities.
• Supplier Non-conformance Records Created if rejecting against supplier.
• Scrap Operations Documents Information on any product scrapping.
• Non-Conformance Log: Tracks all non-conformance records.

This quiz focuses on the Standard Operating Procedure (SOP) for controlling non-conforming products at Compass Health. It emphasizes the importance of early identification of these products to ensure safety and efficacy during the production process. The quiz also addresses relevant standards and reference documents related to non-conformance.