Compass Health SOP: Production Overview

Study Notes

This document is a Standard Operating Procedure (SOP) for Compass Health Al Inc, covering the production of medical devices (hardware and software).
The document outlines procedures for receiving purchased products, product verification/validation, labeling, inventory management, packaging, and shipping.
It also covers post-verification software lifecycle phases as per contractual obligations.
The SOP refers to applicable standards like FDA QSR § 820.70, ISO 13485:2016 Section 7.5, and TG (MD)R Sch3 P1 Cl1.4(5)(d)&(e).
The SOP details reference documents, including "Purchasing and Receiving Log" (QMS-REC-5000).

The document lists approvals from key personnel with roles (Head of QA/RA, COO, Head of Engineering) and dates (02-Jan-2024).
The document details a revision history with the initial release date (03-Jan-2024) and version 1.0

The SOP aims to provide a system and instructions for Compass's medical device product production.
It outlines the procedures and responsibilities for all production processes.
It also encompasses quality planning activities.

Included a table defining acronyms like PDP (Product Development Process) and RMA (Return Merchandise Authorization).
This provides important context and understanding of the abbreviations used in the document.

Provides a table defining key terms such as "Design History File Index (DHFI)" and "Device Master Record Index (DMRI)".
These terms are critical for accurate interpretation of procedures in the SOP.

Defines roles within production process including responsibilities (Operations, Lead/Project Manager).
This section clarifies responsibilities for different operational roles and duties.

Production and quality planning is a collaborative effort from Operations Lead, QA (Quality Assurance), and Project Manager (and other representatives as needed).
The Operations Lead manages production transfer, while the Project Manager and QA/RA oversee quality planning.
Work instructions are defined by the Production Plan and/or work orders.
Deviation from standard procedures, such as for software-only products, will be outlined in the product-specific PDP (Product Development Plan).
Validation procedures for processes not verifiable by subsequent monitoring should be described in an SOP.

Change implementation involves an engineering change order (ECO) form.
Temporary changes to production processes may be implemented through a process deviation form.

Lot orders are for producing parts (batches) to be stocked.
The operations team creates a work order for each lot, listing details like part numbers, volumes, and dates.
Reports track work order status, in-process testing, and inventory updates.
Orders are often placed for individual components/parts from suppliers based on demand and received order requests

Visual verification, inspection of labels and component matching is done after receipt.
A non-conformance logging process is described, referring to the Non-Conforming product SOP.
Recording procedures when receiving purchased items are explained in detail, including use of "Hold" labels for pre-inspection storage.

Procedures for performing acceptance tests on purchased items are detailed.
Non-conforming products trigger a separate non-conformance procedure.
The results are documented.
Green labels are used for passing items, while non-conforming items use appropriate forms and reports.

Assembly procedures are process-driven using assembly work instructions (as per device-specific instructions or DMRs) for handling components.
Assembled items go in a specific staging area ("Pre-QC Assembled devices" storage) before final checks.
QC procedures are detailed.
Items pass through QC and a quality check before final packaging.

A sale order triggers product work orders for finished product creation and shipment.
Data like product configuration, quantity, and Customer Distribution List, are updated and tracked.
Order fulfillment processes, packaging, and shipment procedures are listed.

Hardware products are inspected before packaging and shipment.
The final inspection process is described in detail, and the location of approved storage is noted (“Finished Good – Ready to Ship" inventory locker).

Packaging for shipment is defined by product requirements and safety (e.g., environmental conditions during transit).
Procedures for verifying package suitability and final acceptance.

Software and hardware distribution records are maintained.
These records provide detailed information about each product.
Steps of the process from order, installation date, and consignee records are outlined.

A table outlines record types and their descriptions, including items like the Purchase Order Form and examples.

Flowcharts help to visualize risk management steps when products arrive for inspection.
These products are either accepted or rejected based on inspections.