Process Validation SOP (Compass Health AI) PDF

Compass Health AI SOP: Process Validation 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: Process Validation 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-0017 Revision History Version Date Description 1.0 03 Jan 2024 Initial Release Document #: QMS-SOP-0017 1 Introduction This procedure provides for a system and instructions — and assigns responsibilities for — the validation and control of production processes, and validation of computer software used in production and quality control. 1.1 Scope This procedure applies to all general and special processes related to Compass Health’s medical devices, whether these activities are performed in-house or externally at an Approved Supplier site; and to processes using computer software. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 7.5.6 Validation of processes for production and service provision ISO 13485:2016 7.6 Control of monitoring and measuring equipment TG(MD)R Sch3 P1 1.4(5)(e) TG(MD)R Sch1 P1 2(1) 2.2 Reference Documents Document Title Document # SOP: Verification and Validation QMS-SOP-0009 Document #: QMS-SOP-0017  SOP: Production QMS-SOP-0012 SOP: Risk Management QMS-SOP-0013 SOP: Purchasing QMS-SOP-0015 SOP: Supplier Evaluation and Monitoring QMS-SOP-0016 Form: Process Validation Report QMS-FRM-0302 3 Acronyms and Definitions Term Definition Establishing objective and documented evidence that a process Process Validation consistently produces a result or product that meets its predetermined performance and safety specifications. Those processes where the resulting output cannot be verified by subsequent measurement or monitoring (must rely on validation data [e.g. temperature control] gathered during the production process itself to provide assurances that the quality of the product Special Processes is intact). Examples of special processes are: joining of materials by welding, soldering, splicing, or gluing; molding and casing of metals, plastics or cements; coating with paints, epoxies, metals, plastics or other materials; heat, radiation or chemical treatment of materials; etc. Document #: QMS-SOP-0017  General processes can include but are not limited to: Computer General Processes Software and Automated processes used in the quality management system 4 Process Roles Role Description For General or Special processes performed, Engineering is responsible for selecting a suitable validation method, performing the validation, Engineering and documenting its results. Engineering may call on QA-RA to assist, as required In addition to ensuring adherence to this procedure, QA-RA is responsible for identifying General and Special processes with the assistance from appropriate departments, as required, in all areas of QA-RA the production process, (see this procedure for details). QA-RA is responsible for demonstrating control over the processes, whether by in-house process validation testing and/ or facilitating 3rd party testing of the final product, as appropriate. 5 Process Validation Procedure 5.1 General Processes 5.1.1 Identification of General Process QA-RA is responsible for reviewing all manufacturing processes to identify those that need to be designated as general processes that require Process Validation prior to adoption and use. General processes can include but are not limited to: Computer Software and Automated processes used throughout the product life cycle. QA-RA shall use a risk-based Document #: QMS-SOP-0017 approach to determine the need for Process Validation, as well as the need for revalidation after changes to such processes or its application. Any relevant member of the Engineering Team may be called upon to assist with this review. The specific approach and activities associated with Process Validation and Revalidation shall be proportionate to the risk associated with the use of the process; including its impact on the quality of Compass’ product. A risk level for the general process considered is assigned upon evaluation. 5.1.1.1 Assign Risk level Risk Level Impact No/minimal impact on QMS Low No direct impact on the development and production of device Process/Software has direct impact on the device Development of product is not dependent on the Medium process/software If process/software is nonfunctional, minimal impact on Device. Critical QMS processes would still be functional Critical process/software used in the development and maintenance of the Device High If process/software is nonfunctional, Critical QMS processes would be impeded and no workarounds available (alternatives) General processes assigned a LOW risk level does not require a Process Validation Report to be completed prior to initial use. With Processes assigned a MEDIUM and/or HIGH risk level, more diligence is required and consequently, completion of the Process Validation Report as outlined in section 5.1.2 below is required. QA-RA shall assign the appropriate department or personnel to complete the Process Validation Report. The assigned personnel shall create a Process Validation test plan, Document #: QMS-SOP-0017 which shall be reviewed and approved by the Department Lead prior to commencement of the validation testing. Upon approval, the Process validation test shall be performed and all results shall be recorded. General Processes with HIGH risk level shall have at the minimum two different individuals from the department performing the Process Validation Test, given the Validation Test plan. The validation test results gathered shall be reviewed and compared to evaluate the inter-rater reliability and consistency of the process/software of interest. If major inconsistencies and poor inter-rater reliability are determined, an alternative process shall be considered. Final approval for the Process Validation Report shall include, at the minimum: QA-RA and the Department Lead. 5.1.2 Validation of General processes General processes that control production process and used for monitoring and measurement of requirements, and where malfunctioning of the general process could result in product nonconformity, is validated prior to initial use. This applies also to software that is used in Quality Control (QC) inspection equipment. For production process software, Engineering is responsible for establishing validation protocols, performing the validation, and documenting its results (Engineering may request QA-RA’s assistance). For QC inspection software, Quality Assurance is responsible for these activities. Production process or QC inspection software developed and supplied under contract is validated either by the contractor, in accordance with acceptance procedures specified in the contract, or by QA-RA. Software validation and its results are documented in a dedicated computer software validation report, using the Process Validation Report Form [QMS-FRM-0302]. At a minimum, the report includes the following information: Identification of the validated software, including its version/revision level, and the processes and/or equipment controlled by the process; Functions, modules, peripherals, sensors, alarms, etc. to be validated; Validation methods, simulation techniques, etc. used; Defined criteria for approval of the process; Validation results with objective evidence; Document #: QMS-SOP-0017  Dates and signature of the individual approving the validation report (QA-RA). 5.1.3 Revalidation of General processes When general processes are changed internally and issued on a higher revision level, the QA-RA evaluates whether the software needs to be revalidated, and if so, what should be the extent and scope of the revalidation. Revalidation of the software shall follow a risk- based approach, where the impacts due to the changes made to the software shall be evaluated and assigned a risk level, similar to the risk evaluation performed during the initial validation of the software. After the revalidation is concluded, the QA-RA reviews and approves the validation report. If revalidation is not necessary (e.g., changes do not affect those modules or functions of the software that could cause product nonconformity), the QA-RA retrieves the previous validation report and extends its approval to cover also the new revision of the software. All Process Validation Reports shall be maintained and submitted into the Document Management System as Quality records. The Process Validation Report Initiator must be subscribed to change notification to software/process that requires process validation. If there is no subscription option, it is the Process Validation Report Initiator's responsibility to contact the supplier to explore other options for notification of any changes to the supplier. QA-RA shall review that all supplier that requires process validation have been subscribed to software change/update notification for the purpose of assessing the requirement for revalidation. QA-RA shall keep track of change notification subscription for all suppliers (where applicable) on the Approved Supplier List (ASL). 5.1.4 Control of General Processes In addition to validation, general processes shall be controlled and monitored to ensure that the specified conditions continue to be met. The process control and monitoring program includes, as appropriate: Use of specific methods and procedures; Training and qualification of process operators; and Monitoring and recording process parameters and equipment qualification (e.g. temperature, pressure, speed, tool wear, etc.); Document #: QMS-SOP-0017 Records of process monitoring and control for General Processes include documentation of the monitoring method, data, date performed, and identification of the individual performing the process (or operating the monitored equipment). 5.2 Special Processes 5.2.1 Identification of Special Processes QA is responsible for reviewing all manufacturing processes to identify those that need to be designated as special processes. These are documented in the Production Plan. Any relevant member of the Engineering Team may be called upon to assist with this review. The following types of processes are automatically designated as special processes, unless a proven method is implemented to inspect their results: Joining of materials by welding, soldering, splicing, or gluing; Molding and casting of metals, plastics or cements; Coating with paints, epoxies, metals, plastics or other materials; and Heat, radiation or chemical treatment of materials. In addition to processes covered by the definition of a special process and the list in Section 5.2.1, Quality Assurance may designate any manufacturing process to be a special process. This designation may be assigned on the basis of the importance of the process and/or a history of problems with controlling the process. Special processes are identified in the given product’s validation plan as part of the production planning process. Refer to SOP: Verification and Validation, SOP: Production, and SOP: Risk Management for details. 5.2.2 Validation of Special Processes If and when special processes are identified in the in-house manufacture/ assembly process, each process designated as a special process is formally validated to demonstrate its ability to achieve planned results. Engineering is responsible for selecting a suitable validation method, performing the validation, and documenting its results. Quality Assurance may be called upon to assist with these activities. Following completion of the manufacture/ assembly process and prior to product release, Compass Health-product featuring hardware components, regardless of whether the given product was subjected to special processes in-house, are tested by an accredited third Document #: QMS-SOP-0017 party testing house, from whom a test report is received demonstrating product conformity to expected performance and safety specifications. QA is responsible for choosing an appropriate testing facility. 5.2.3 Special Process Validation Report If and when special processes are identified in the manufacture/ assembly process. Validation shall demonstrate the ability of these processes to achieve planned results consistently. The process validation and its results shall be documented in the given product’s validation report. At a minimum, a section of the report shall be dedicated to process validation and include the following information: Identification of the validated process and/or equipment; Characteristics of the process and/or the processed product to be validated; Use of specific validation methods, procedures and acceptance criteria Defined criteria for review and approval of the process; Statistical techniques with rationale for sample sizes, as appropriate; Validation results; Required revalidation frequency; Dates and signature of the individual approving the validation report. When there is a process change that could impact process performance are made to a special process such as a material change, the process is revalidated and re-approved. The revalidation report shall include reason for revalidation. When product is validated by an accredited third party test house, the testing report supplied by the chosen test house shall be attached to the validation report. Refer to SOP: Verification and Validation for a more detailed overview of required verification and validation activities. 5.2.4 Control of Special Processes In addition to validation, special processes shall be controlled and monitored to ensure that the specified conditions continue to be met. The process control and monitoring program includes, as appropriate: Document #: QMS-SOP-0017  Use of specific methods and procedures; Training and qualification of process operators; and Monitoring and recording process parameters (e.g. temperature, pressure, speed, tool wear, etc.); Records of process monitoring and control for special processes include documentation of the monitoring method, data, date performed, and identification of the individual performing the process (or operating the monitored equipment). These records are maintained in the Device History Record (DHR). 6 Quality Records Record type Description Special Process Validation reports for special processes (part of the given Validation Records product’s overall validation report). General Process Validation reports for general processes used in production Validation Records processes and product verification. Document #: QMS-SOP-0017