Verification of Purchased Products SOP (Compass Health AI) PDF

Compass Health AI SOP: Verification of Purchased Products Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin...

Compass Health AI SOP: Verification of Purchased Products Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin COO Document# QMS-SOP-0019 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document# QMS-SOP-0019 1 Introduction The purpose of this procedure is to provide a system and instructions and to assign responsibilities for verification of purchased products, and for performing inspections of incoming new materials or products. 1.1 Scope This procedure applies to on-site verification of purchased materials and products at Compass HealthAI Inc. (“Compass”) for all items intended to be part of, or which may affect the quality of, the finished, packaged, and labeled Compass products. Note: Compass does not have any planned arrangements for the verification of products off of its premises nor does Compass support the customer/OEM to perform verification activities on Compass’s or the supplier’s premises. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: FDA QSR § 820.50 Purchasing Controls ISO 13485:2016 Section 7.4. Purchasing 2.2 Reference Documents Document Title Document # Document# QMS-SOP-0019  Engineering Change Order Form QMS-FRM-0002 SOP: Control of Records QMS-SOP-0003 SOP: Control of Non-Conforming Product QMS-SOP-0024 3 Acronyms and Definitions Table 1: Acronyms Acronym Meaning SOP Standard Operating Procedure QMS Quality Management System QA-RA Quality Assurance Regulatory Affairs FAI First Article Inspections Table 2: Definitions Term Description Class-I Materials Standard materials and hardware, not designed by or for Compass, which some require incoming inspection. These materials do not Document# QMS-SOP-0019  affect the quality of Compass products or services. Examples: tripod, wound phantom. Non-standard materials and/or active components, usually designed by or for Compass, which may require incoming Class-II Materials inspection. These materials may affect the quality of Compass products or services. Non-standard materials and/or active components designed by or Critical Materials for Compass, which are critical to the safety and effectiveness of the medical device, and require 100% incoming inspection. 4 Process Roles Role Description Responsible for spot checking purchasing activities periodically, QA-RA and reviewing Personnel designated as qualified to perform incoming inspection of Operations a given material. Personnel with specialized knowledge relating to the inspection of Engineering specific materials. Personnel with responsibility for marketing materials generated in Marketing support of a Compass product or service. 5 Verification Process All product received by Compass shall be identified by Operations to determine whether an incoming inspection is required (e.g. by material class), and whether specific inspection Document# QMS-SOP-0019 work instructions exist. All products received must be logged in the Purchasing and Receiving Log [ QMS-REC-5000]. Immediately upon receiving the product/part, a Receiving label (see Figure 1) must be placed on them. Figure 1: Receiving Label 5.1 Incoming Inspection Acceptance Requirements Designated Operations personnel shall perform all incoming material inspections, unless otherwise called out in the relevant work instruction. Certain tests and evaluations may be required to be performed or reviewed by Engineering. Such requirements shall be specified in the relevant work instruction. Document# QMS-SOP-0019 All new incoming products/materials requiring inspection shall be inspected at the production station. All such products are first inspected for outward signs of damage or mishandling. If product or material cannot be inspected at the time of arrival, they shall be labelled as HOLD (Yellow label) and placed in segregated HOLD storage, not for use or sale. Special incoming inspection requirements for all Critical and some Class-II materials shall be outlined in the relevant component/part verification plan, contained in the Device Master Record for medical devices, and steps for performing such special required inspections shall be documented in the corresponding inspection work instructions for the specific component or material. Inspection shall be performed under adequate lighting and at the designated inspection station. If additional environmental controls are required for inspection of a particular part, the relevant incoming inspection work instruction shall outline the requirements. Materials passing inspection and found to be conforming are labelled as CLEAR (Green label), and shall be placed in the “Raw Materials/Parts - Tested" storage locker to be packaged or assembled for sale. Materials failing inspection and found to be non- conforming are handled according to SOP: Control of Non-Conforming Product. If Compass Health becomes aware of any changes to the purchased product, Compass will determine whether these changes will affect the product realization process or the medical device. If Compass or its customer intends to perform verification at the supplier’s premises, Compass will define and provide the intended verification activities and methods of product release in the purchasing information provided as per SOP: Purchasing. The following sections outline the inspection requirements for each component class. The component class shall be specified in the corresponding part/component specification. 5.1.1 Class-I Some incoming inspection is required for Class-I products. Document# QMS-SOP-0019 5.1.2 Class-II All Class-II components shall be inspected. For Packaging and Labelling: One item per lot is required for visual inspection. The item shall be verified for correct revision, missing pages or elements, no break in text, no smeared letters, and all images are clear and readable. For Mass-quantity or Lot-based Products: A sampling plan shall be determined and recorded with justification within the relevant component verification plan. Inspection shall be carried out according to such sampling plan. Other Class-II Materials: At minimum, a single sample per month shall be inspected visually or if frequency of receiving is less than once per month, inspect a single sample per shipment per the relevant work instructions. The frequency of inspection may be increased at the discretion of Operations or QA-RA. 5.1.3 Critical Critical materials will be 100% inspected and/or tested unless otherwise specified in the component specification. For clarity, 100% inspection of a mass-quantity or lot-based material means inspection of 100% of shipments according to a documented sampling plan, as with Class-II lot-based materials. For Mass-quantity or Lot-based Products: A sampling plan shall be determined and recorded with justification within the relevant component verification plan. Inspection shall be carried out according to such sampling plan. Note: Sampling methods shall be adequate for their intended use and ensure that when changes occur, sampling plans are reviewed accordingly. 5.2 First Article Inspection (FAI) A FAI is performed for all first receipts of Class-II and Critical components. 5.2.1 FAI on Parts For new or revised parts, check the latest Engineering Change Order (ECO) form for the part to verify whether a first article inspection is required before proceeding. Engineering may choose the type of inspection. Document# QMS-SOP-0019 The sample size for a FAI is one sample. However, depending on the criticality and complexity of the component, this may be modified at the discretion of Operations or QA- RA. The FAI shall include all appropriate physical characteristics of the component, workmanship, completeness, and correctness of the required documentation. 5.2.2 FAI of Artwork on Labeling and Printed Material First Article inspection of all labeling and printed materials, non-Marketing, will be performed by the QA-RA or Engineering. Marketing printed material shall be inspected by personnel with Marketing responsibilities for the product. 5.3 Inspection Documentation All incoming inspections results shall be recorded in the Purchasing and Receiving Log (QMS-REC-5000). Such records shall be retained according to SOP: Control of Records. Results of the inspection shall include: Part Number / ID / Name Part Revision PO/Invoice Number: Quantity Received: Part Description (if needed) Supplier Name Inspection Date Name of Inspector Reference to the component spec, if any Any measured values, if applicable Identification of any measurement equipment used Disposition (pass or fail) of inspection 5.4 Acceptance Test (AT) Acceptance test shall be performed on all core components/parts of a product received. The sampling plan shall be determined based on the classification of the supplier/material Document# QMS-SOP-0019 as per the Approved Supplier List (ASL) QMS-REC-0045 or as determined on part specific work instruction or Acceptance test plan. Acceptance Test Results shall include, at minimum: Quantity Received Lot# Sampling plan & Sample size Pass/Fail Criteria Disposition of Pass/Fail Reference to C of C (where applicable) Equipment / Tools Required PO # Reference Documents (ie. work instructions, component specifications etc..) QA/RA Approval Once the Acceptance test has been completed and responsibilities approval by QA/RA, an Acceptance Test label (see Figures 2) shall be affixed on the parts tested. Document# QMS-SOP-0019 Figure 2: Acceptance Test label. Document# QMS-SOP-0019 6 Process Monitoring QA-RA shall periodically monitor incoming inspection activities, including spot checks of documentation, and witnessing of inspection activities as appropriate. All critical product inspections shall be witnessed to the extent possible. Results of QA-RA monitoring shall be made available to Management at Management Quality Review meetings. 7 Quality Records Record type Description Purchasing and All incoming inspection results shall be recorded in the Purchasing Receiving Log and Receiving Log (QMS-REC-5000). Approved List of suppliers who have met all the requirements and have been Supplier List approved by selected members of top management. (ASL) Document# QMS-SOP-0019