Compass Health SOP Verification Procedures

Study Notes

This document outlines the verification procedure for purchased materials and products at Compass HealthAl Inc.
The procedure covers on-site verification of all items intended for Compass products.
Compass does not verify products off-site or support customer/OEM verification at their premises.
The procedure adheres to FDA QSR § 820.50 Purchasing Controls and ISO 13485:2016 Section 7.4. Purchasing.

This procedure applies to the verification of materials and products for Compass Health products.
Included are all items that may affect Compass product quality (finished, packaged, and labeled).

Procedures adhere to FDA QSR § 820.50 Purchasing Controls and ISO 13485:2016 Section 7.4. Purchasing.

SOP: Standard Operating Procedure
QMS: Quality Management System
QA-RA: Quality Assurance Regulatory Affairs
FAI: First Article Inspections
Class-I Materials: Standard materials or hardware, not designed by Compass, some require inspection. These do not affect product quality
Class-II Materials: Non-standard materials designed by Compass. Some may require inspection; materials can affect product quality
Critical Materials: Non-standard materials critical to safety and effectiveness of the medical device, require 100% inspection.

QA-RA: Responsible for checking purchasing activities, and reviewing periodically.
Operations: Qualified personnel for incoming inspection of specific materials.
Engineering: Personnel with specialized knowledge related to material inspection.
Marketing: Personnel responsible for Compass product marketing materials.

All incoming products/materials are identified and labeled; a receiving label is placed on the products.
Incoming material shall be inspected at production based on if inspection is needed.
Damage or mishandling observed in product prior to inspection is noted.
Damaged/mishandled materials are stored in a segregated hold area until inspection procedures can be performed.

Incoming inspections are performed as per work instructions, with some material classes needing more verification.
Class-I: Minimal inspection needed.
Class-II: Single sample per month or more frequent inspections for materials received less than monthly; appropriate sampling plans are determined.
Critical: 100% inspection.

FAIs are performed on all initial receipts of Class-II and critical components.
The FAI results include component characteristics, documentation, workmanship, completeness, and correctness.

All inspection results are documented in the Purchasing and Receiving Log (QMS-REC-5000).
Log includes: Part number, part revision, PO/invoice number, quantity received, part description, supplier name, date, inspector name, reference to components, and measured values.
Results/disposition (pass or fail) are clearly noted.

Acceptance testing (AT) is performed on all product components.
Sampling plans are developed based on the supplier/material classification.
Acceptance test results shall include quantity, lot number, sampling plans, sample sizes, pass/fail criteria, disposition of pass/fail, and the reference to Certificate of Conformance (if applicable)
Accepted materials receive an acceptance test label, and are affixed to the parts tested.

Incoming inspection results are documented/recorded in the Purchasing and Receiving Log (QMS-REC-5000).
A list of approved suppliers (ASL) is maintained.