Compass Health AI Purchasing SOP PDF

Compass Health AI SOP: Purchasing 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 Revi...

Compass Health AI SOP: Purchasing 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 Revision History Version Date Description 1.0 3-Jan- Initial Release 2024 1 Introduction This procedure is intended to establish controls for acquisition of products, materials, and services so that the quality, safety, and effectiveness of Compass Health Inc.’s (“Compass’s”) products and services are maintained. These controls help ensure purchased products and services conform to specifications. 1.1 Scope This procedure is intended to be applied to products and services that may affect the quality, safety, and effectiveness of Compass’s products and services. It does not extend to standard or commodity items such as office supplies, furniture, airfare, or other items not affecting quality at Compass. 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 TG(MD)R Sch1 P1 2, Sch3 P1 Cl1.4(5)(d)(ii) 2.2 Reference Documents Document Title Document # Supplier Evaluation Form QMS-FRM-0060  Purchasing and Receiving Log QMS-REC-0066 Purchase Order Form QMS-FRM-0067 Approved Suppliers List QMS-REC-0045 SOP: Document Controls QMS-SOP-0002 SOP: Control of Records QMS-SOP-0003 SOP: Software Development Process QMS-SOP-0008 SOP: Risk Management QMS-SOP-0013 3 Acronyms and Definitions Table 1: Acronyms Acronym Description QA-RA Quality Assurance-Regulatory Affairs SOP Standard Operating Procedure QMS Quality Management System PO Purchase Order 4 Process Roles Role Description The individual initiating the purchasing process. Responsible for: Originator Originating the purchase request Compiling purchase requirements with input from other personnel deemed appropriate. Responsible for spot-checking purchasing activities and QA-RA periodically monitoring purchasing activities at Compass to ensure purchases are conducted according to this process Responsible for reviewing the adequacy and sufficiency of Management documentation, appropriateness of the expenditure, and supplier selection 5 Purchasing 5.1 Purchasing Process The purchasing process follows, at a high level, the flow outlined in Figure 1. Compass Health Inc. (“Compass”) evaluates its suppliers, and purchases only from those who can satisfy quality requirements SOP: Supplier Evaluation and Monitoring. Figure 1: Purchasing High Level Process Flow (Gray Elements Covered by Other SOPs) Purchasing begins with identification by the Originator of a need within the company for a Product. With a need identified, if a decision is taken to purchase the needed Product, the nature of the Product is documented. If the nature of the Product is one which requires specifications or purchase requirements to be defined by Compass, such specifications shall be determined to the extent possible prior to evaluation of suppliers. Specifications shall include, as appropriate: any required design parameters such as material and performance description of quantity (units, length, weight, etc.) requirements for approval of product, procedures, processes, and equipment any required sampling plan, if sampling is to be performed by supplier, or if sampling by Compass may be used to accept or reject Product. requirements for qualification of personnel at the Supplier quality management system requirements any clauses that shall survive to subcontracted Product. Review of purchase specifications shall be conducted to ensure their adequacy prior to communication to the supplier. Such review may include input from potential suppliers. When applicable, Compass shall require suppliers to notify of changes in the purchased product prior to implementation of any changes that affect the specified purchase requirements. This will be documented in a written agreement or to be included as a purchase requirement. 5.2 Purchasing Information Potential suppliers are identified and evaluated per SOP: Supplier Evaluation and Monitoring (QMS-SOP-0025). Documentation of the nature of the product, including any known purchase specifications, is captured in a Purchase Order Form (QMS-FRM-0067). 5.3 Supplier Evaluation Supplier Evaluation is conducted according to criteria and procedures outlined under section 5.2 Evaluation of the SOP: Supplier Evaluation and Monitoring. 5.4 Conducting a Purchase 5.4.1 Product Purchase Purchases may be made by Purchase Order Form (QMS-FRM-0067) or by corporate credit card as appropriate or required by the Supplier. Purchase orders are documented in the Purchasing and Receiving Log (QMS-REC-0066) with a unique PO number. Purchases made by an employee using his or her personal credit card shall be filed as an expense to Compass's Travel and Expense Policy. 5.4.2 Service Purchase There are no defined limits on what services may be purchased by Compass personnel. Service requirements shall be communicated to the supplier and discussed with the supplier to ensure they have been thoroughly understood. Any training required to be provided to the supplier regarding internal processes or external regulations shall be indicated in the service requirements. The conducting of such training shall be documented. 5.4.3 Classification of Products/Services Classification of products and services is determined during the verification of the supplier. Classification is determined by QA-RA and all necessary stakeholders Classification of products/services is: 5.4.3.1 Class I Class-I products/ services are those that are deemed to have very low risk or no risk of affecting the quality of Compass Health’s products. 5.4.3.2 Class II Class II products/services are those that are deemed to have a medium risk of potentially affecting the quality of Compass Health’s products or services. 5.4.3.3 Critical Critical products/services are those which possess a high risk of affecting the quality of Compass products or services and the failure of which to meet specified requirements could cause significant degradation in the performance of Compass’s products. In the case of Class-II or Critical products/services which require provision of purchase requirements and specifications to the supplier, these specifications shall be communicated to the supplier prior to purchase, and the purchaser shall ensure the requirements or specifications have been thoroughly understood. This may be conducted through discussion with the supplier. In the case of Class II or Critical products/services purchased off the shelf, without provision of specifications or custom requirements beyond quantities or similar measures, purchases may be made without prior communication with the supplier. 5.5 Verification of Purchased Product Verification of purchased product is conducted according to SOP: Verification of Purchased Product. 6 Process Monitoring QA shall periodically monitor purchasing activities at Compass to ensure purchases are conducted according to this process. Non-fulfilment of purchasing requirements shall be addressed with the supplier proportionate to the risk associated with the purchased product and compliance with regulatory requirements. Results of such monitoring activities shall be made available to management at each Management Quality Review. 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 Purchase and A list of all the Purchase and Receiving orders requested by Receiving Log Compass personnel Purchase Order Completed Purchase Order forms Records