Compass Health AI Production SOP PDF

Compass Health AI SOP: Production Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author +BO Yangzom QA/RA James Approver...

Compass Health AI SOP: Production Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author +BO Yangzom QA/RA James Approver +BO +BO Baskin COO ,FWJO Approver +BO )FBE
PG
,FOOFEZ &OHJOFFSJOH Document# QMS-SOP-0012 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document# QMS-SOP-0012 1 Introduction The purpose of this procedure is to provide a system and instructions for production of Compass Health AI Inc’s (“Compass”) medical device products (hardware and software), and to assign responsibilities for all production processes and relevant quality planning activities. 1.1 Scope This procedure applies to receiving of purchased product, product (software and hardware) and process verification and validation activities, labeling, inventory management, packaging and shipping. It can also apply to post verification software lifecycle phases as per contractual obligations. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure:  FDA QSR § 820.70 Production and Process Controls  ISO 13485:2016 Section 7.5 Production and Service Provision  TG (MD)R Sch3 P1 Cl1.4(5)(d)&(e) 2.2 Reference Documents Document Title Document # Purchasing and Receiving Log QMS-REC-5000 Document# QMS-SOP-0012  Purchase Order Form QMS-FRM-0006 Process Deviation Form QMS-FRM-0093 Approved Suppliers List CLR-REC-2000 SOP: Contract Review and Order Management QMS-SOP-0006 SOP: Change Control QMS-SOP-0014 SOP: Purchasing QMS-SOP-0015 SOP: Labeling and Packaging QMS-SOP-0018 SOP: Verification of Purchased Product QMS-SOP-0019 SOP: Control of Non-Conforming Product QMS-SOP-0024 WI: Facility Controls QMS-WI-0001 3 Acronyms and Definitions Table 1: Acronyms Acronym Meaning PDP Product Development Process RMA Return Merchandise Authorization Document# QMS-SOP-0012  FCE Functional Capacity Evaluation DMR Device Master Record QC Quality Control Table 2: Definitions Term Meaning Design History File An index of records that describe the design history of a finished Index (DHFI) device. The DMRI shall contain links to the following information, as applicable to the product: a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate Device Master Record equipment specifications, production methods, production Index (DMRI) procedures, work instructions, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and Document# QMS-SOP-0012  (e) Installation, maintenance, and servicing procedures and methods. (f) Production Plan. (From QSR 820.181 Device master record) Inventory Log List of currently available items in inventory, with volumes. Record of the production history of a lot, where a “lot” means one or more components that consist of a single type, model, Lot History Record class, size, composition or software version that are (LHR) manufactured under essentially the same conditions that are intended to have uniform characteristics and quality within specified limits Document which contains:  Reference to work order, product/part configuration, Device History Record device master record version (DHR)  Device specific production information  Results of in-process testing and final testing for a device See Section 2.3 4 Process Roles Role Description of Responsibilities  Oversees all production and quality planning processes/sub-processes, phase transitions and Operations ensures alignment with project, contract and company Lead/Project Manager objectives.  Creates the Product Development Plan, Work Breakdown Structure (WBS), Project Schedule Document# QMS-SOP-0012   Ultimately responsible for product design transfer to production, receipt and verification of purchased product, quality planning  Specifying production processes and their interrelationships.  Ensuring risk management best practices are aligned with the most recent version of ISO 14971. Note: This role can be expanded into 2 resources based on the complexity of the project. Responsible for documenting:  The quality plan (included in the Production Plan),  Creation/revision of risk analysis Quality  The development, execution and recording of evidence Assurance/Regulatory supporting all verification and validation activities as they (QA/RA) relate to incoming hardware product and/or internal software products.  Quality Assurance also performs incoming approval for Critical and Class II parts, and some Class I parts. Responsible for following and implementing the procedure for the various aspects of the production processes:  Performs incoming inspection for Critical and Class II Operations parts, and some Class I parts. Representative  Shipping Process  Testing/Calibrating products  Secure Product Storage  Production procedure Document# QMS-SOP-0012 5 Production Process 5.1 General Production and quality planning are carried out by a multidisciplinary team. The team includes the Operations Lead, QA-RA, and Project Manager and/or other representatives as appropriate per project. In the production planning phase, the team is led by the Operations Lead, who is responsible for design transfer to production. In the phase of quality planning, the Project Manager and QA-RA representative take the lead and responsibility for cooperatively establishing a quality plan as part of the Production Plan. Work Instructions will be performed as directed by the governing Production Plan, and/or other work orders. Any deviations from this process, for example, for software only products, will be outlined in the product-specific PDP, and reflected in the DMR. For production processes where the resulting output cannot be or is not verified by subsequent monitoring and measuring shall be validated as per SOP: Process Validation. 5.2 Facility Controls Operations is responsible for ensuring that proper environment is maintained in production, packaging and storage areas. The level of environmental control required is based on the type of medical device. Compass Health does not produce products which are distributed in sterilized state. Basic operational controls for maintaining proper environment in all areas where products are held or processed include good housekeeping practices, regular cleaning and trash removal, and pest control. The Production Plan identifies any additional requirements for the environment, which are documented in WI: Facility Controls (QMS-WI-0001). Document# QMS-SOP-0012 5.3 Change Controls Production process changes are controlled by SOP: Change Control. An Engineering Change Order (ECO) form is used to implement the change. An assessment of the impact on risk assessment, production plan, production processes, training, stock, and facilities is done (see Form: Engineering Change Order for the complete list of effects which are evaluated). The “Release Implementation Authorization” in the ECO form must be completed prior to implementation of the production changes. A temporary change to a documented production process may be implemented using a Process Deviation process (see Process Deviation Form [QMS-FRM-0093]). All affected parts and documents are listed on the Process Deviation Form [QMS-FRM-0093], where the regulatory impact, risk assessment impact, and impact on design, verification and validation are evaluated. The criteria for closing the deviation and a cross-reference to the products affected by the deviation are also recorded. The Operations Lead and QA-RA shall approve the Process Deviation form. The Operations Lead is responsible for ensuring any required training is completed prior to the implementation of the deviation. 5.4 Part Ordering & Receiving 5.4.1 Lot Work Order A lot order is an order to produce a part or batch of parts which will be placed in inventory. The Operations Lead creates a work order for a “lot production” in the form of a complete list of the product part to produce (part number), the volume, and the date the lot should be produced. For each lot to be produced, a lot report is created to track the status of the work order, and record the results of in-process testing. The report is updated throughout the order fulfillment process. Once the lot is produced and stored in inventory, the lot report form is stored in the LHR and the Inventory Log is updated. The Operations Lead determines the product component and volume to order based on supply demand and orders received. For Compass’s hardware products, parts are ordered in bulk form from the particular supplier selected from the Approved Supplier List and subsequently on an ad-hoc basis. The Operations Lead generates a Purchase Order by completing a Purchase Order Form (QMS-FRM-0005) to formally order the parts and components from the Supplier. The Supplier then confirms the shipment of the items Document# QMS-SOP-0012 ordered by sending an Order Confirmation notice. The Purchase Order details are logged in the Purchasing and Receiving Log (QMS-REC-5000) 5.4.2 Receiving Shipments When the ordered product first arrives at Compass, a visual verification of the box is made to identify any overt signs of damage, such as missing components or incomplete documents. If the received product has a unique serial/control number, inspection of the label occurs upon receipt of the product and the serial number is matched to the packing list. The Purchasing and Receiving Log (QMS-REC-0066 and/or SIN-REC-2162) is updated. If this receiving inspection fails, or if the product is a returned product from a customer, the product is a non-conforming product, SOP: Control of Non-Conforming Product shall be followed. The process for receiving purchased product is illustrated in Figure 1. Once received, a HOLD (yellow) label shall be placed on the box and the component/part shall be placed in the “Pre-QC Raw Materials/Parts” storage locker until the Acceptance Test can be performed. 5.4.3 Acceptance Test Acceptance tests are performed on purchased products per the SOP: Verification of Purchased Product, and per the relevant work instruction and/or Acceptance Test Record Form. If an Acceptance test is required and the Acceptance test fails, the product is non- conforming and the SOP: Control of Non-Conforming Product shall be followed. The Acceptance test results are documented in the Supplier Non-Conformance Report Form (QMS-FRM-0006). If the Acceptance Test passes, a green label is placed on the box and the component/part is placed in “Raw Materials/Parts - Passed” storage locker, ready to be assembled. The component label with the correct Lot# and quantity shall also be affixed on PASSED component. Document# QMS-SOP-0012 5.5 Assembly and Device QC Devices are assembled per device specific Assembly Work Instruction. Production team member shall only retrieve component/parts (per the quantity specified in the product specific Bill of Materials or Work Instruction) from the “Raw Materials/Parts - Passed” storage locker for assembly. Lot # and other pertinent information will be captured to ensure full lot traceability for the assembled device. Once device has been assembled per the Work Instruction, the device shall be placed in the "Pre-QC Assembled devices" Storage locker. A Device History Record is established for the product once assembly is complete. All hardware devices shall be QC'd before it can be packaged and ready to ship. The QC individual must be different from the assembler, Once devices have been QC'd per device specific Work Instruction or QC Test plan, it shall be moved from the "Pre-QC Assembled devices" storage locker to the "Post-QC Assembled devices" storage locker. From the "Post-QC Assembled devices" storage locker, the devices are ready to be packaged. 5.6 Order Fulfillment 5.6.1 Sale Order A Sale order is an order placed to request for a finished product for shipment and the process flow for fulfilling a product work order is illustrated in Figure 2. The sale order shall include the product configuration (part number), and quantity required. For each product to be produced, the Customer Distribution List for the product is updated and used to track the status of the work order. The list is updated throughout the order fulfillment process, to when the product is packaged and shipped. The Customer Distribution List is stored part of the DHR. The process to place a sale order is specified in each relevant Work Instructions (WI). 5.6.2 Final Inspection Once the product is packaged, final inspection is performed on all hardware product as per the relevant Work Instructions. If the final inspection passes, the product is ready to ship. It is placed in the “Finished Good – Ready to Ship" inventory locker. Document# QMS-SOP-0012 If the final testing fails, the product is considered non-conforming and the SOP: Control of Non-Conforming Product is followed. The output of final testing and test results are stored in the production report. To maintain traceability of the Sale order, the amount manufactured and the amount approved for distribution shall be captured within the Device History Record (DHR). Operations lead shall verify and approve the record once the Sale order has been completed. 5.6.3 Shipment Packaging After a successful final testing of the assembled product, the shipment package for the sale order is prepared as per details outlined in the relevant Product Development Plan (PDP). Shipment packaging is only performed when fulfilling a sale order requested. Compass does not prepackage for shipment. The shipment packaging process shall consider the following considerations:  Degree of product sensitivity to temperature, pressure, humidity, light, jostling, fluctuations in environmental conditions during transport, etc.;  Method of transport (air, sea, land); and  Length of transport (time and distance)  Regulatory status  Destination country Once a shipping method has been selected, a shipping validation must be performed to ensure the selected method does not adversely affect the characteristics and performance of the medical device, taking into account the manufacturer’s instructions and information for transport and storage. The Shipping Validation Report must include at minimum:  Product name  Lot #  Serial Number (if applicable)  Method of shipment (must match method of shipment selected during Product Development Planning and Production Planning)  Package Ship and Receive date Document# QMS-SOP-0012   Acceptance criteria for Pass/Fail  Package Condition Upon receipt (with photos where possible)  Personnel performing the Validation  Disposition (Pass/Fail) Refer also to SOP: Labeling and Packaging. 5.6.4 Shipping Product is shipped to the customer indicated on the Sale order. The Customer Distribution List is updated. Compass team member who is in contact with the client shall provide customers with tracking number of the shipment upon request. 5.7 Distribution Records 5.7.1 Software Distribution Record Compass’s Engineering and Customer Success teams shall create and maintain clear and up-to-date distribution records for each device that is provisioned to facilitate an efficient response to notification of a defective unit and, in turn, help expedite the recall process. The distribution records for software medical devices shall provide detailed information, including: 1. Device name 2. Device identifier 3. App Version Installed 4. Control/ Part/Product Number(s) (If applicable) 5. Installation date 6. Name of company/ person supplied with the device(s) 7. Name and address of consignee(s) 5.7.2 Hardware Distribution Record Document# QMS-SOP-0012 Similarly, the Operations Representative shall create and maintain clear and up-to-date distribution records for the hardware medical devices. The distribution records for hardware devices shall provide detailed information about each product, including: 8. Sales Order Number 9. Name and Address of consignee(s) 10. Lot number or Serial Number of the device 11. Shipment date 12. Quantity shipped 13. Additional control number(s) (if applicable) Distribution records are maintained per the SOP: Control of Records (QMS-SOP-0003) 6 Process Monitoring The Operations Lead shall review all controlled documents printed in the production area to ensure good documentation practice on all quality records, as well as to confirm proper safeguarding of these printed controlled documents. The QA-RA personnel shall also monitor the purchase order process. QA-RA shall perform monthly spot checks to ensure that all the logs within section 7 Quality records are updated accordingly. 7 Quality Records Record type Description Used to formally order parts and components from suppliers. This Purchase Order captures the nature of the product, including any known purchase Form specifications Document# QMS-SOP-0012  All Purchase Order and All parts products received details are logged Purchasing and in the Purchasing and Receiving Log (QMS-REC-5000 and SIN-REC- Receiving Log 2162). Inventory Log Log to keep track of all the inventories of Compass Products Distribution Detailed records of all products and lots shipped to Record customers/clients Device History Records that describe the design history of a finished device. Record (DHR) Lot History Record of the production history of a lot Record (LHR) Created to track the status of the work order, and record the results of in-process testing. The report is updated throughout the order Lot Report Form fulfillment process. Once the lot is produced and stored in inventory, the lot report form is stored in the LHR For each product to be produced, this list is updated to track the Customer status of the work order. The report is updated throughout the order Distribution List fulfillment process, to when the product is packaged and shipped. This list is part of the DHR. Process Used when proposing and implementing a temporary change to a Deviation form documented production process Appendix A Document# QMS-SOP-0012 Figure 1: Process flow for incoming products Document# QMS-SOP-0012 Figure 2: Process flow for product work order Document# QMS-SOP-0012