Control Of Inspection Measuring Test Equipment PDF

Compass Health AI SOP: Control of Inspection, Measuring, and Test Equipment Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver...

Compass Health AI SOP: Control of Inspection, Measuring, and Test Equipment 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 03-Jan- Initial Release 2024 1 Introduction 1.1 Purpose The purpose of this procedure is to provide a system and instructions. It also assigns responsibilities for the maintenance of key process equipment/machine and support systems needed to achieve conformity to product requirements. 1.2 Scope This procedure applies to all inspection, measuring and test equipment/machines requiring calibration/maintenance and used in validation, production and/or servicing at Compass HealthAI Inc. (“Compass”). 2 Applicable Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: FDA QSR § 820.72 Inspection, measuring, and test equipment ISO 13485:2016 Section 7.6. Control of Monitoring and Measuring Devices TG(MD)R Sch3 P1 1.4(5)e 2.2 Reference Documents Document Document Title Number SOP: Control of Records QMS-SOP-0003 SOP: Quality System Audits QMS-SOP-0023 SOP: Product Development QMS-SOP-0007 SOP: Change Control QMS-SOP-0014 SOP: Control of Non-Conforming Product QMS-SOP-0024 Equipment/machine Maintenance log QMS-LOG-0004 3 Acronyms and Definitions Term Meaning Any apparatus which is required in order to perform some Production Equipment form of measurement, functional test, inspection, or assist in the production of devices intended for sale or distribution. Engineering Equipment Any non-production equipment/machine used for test or measurement purposes on devices, which are being  designed or developed for release to production, or for clinical evaluation. For the purpose of this procedure, certification is the act of calibrating, certifying, validating, performing preventive Certification maintenance, or verifying all inspection, measurement, or test equipment/machine. Equipment/Machine A log of all equipment used in inspection, testing and Maintenance Log production. It is maintained by Operations. 4 Process Roles Role Description Responsible for certification activities and the identification of key process equipment, machines, and systems to be included in a formal, planned preventive manufacturing Operations and procurement engineering program. Additionally, responsible for maintaining the equipment log and approving the maintenance records by manufacturing and procurement engineer. Responsible for planning and carrying out the audits for maintenance activities and adherence to applicable maintenance schedules Quality Assurance- Document the result of the investigation and place the Regulatory Affairs report in the equipment file (QA-RA) Make the final determination of Corrections and Removals and initiate a CPAR (Certification and/or Preventative Maintenance Requirements) when necessary 5 Procedure 5.1 New Equipment/machine New equipment/machine required for validation, production, or service is identified in the product’s Production Plan, along with the validation and maintenance plan for the equipment/machine. Once validated, the equipment/machine is added to the equipment/machine maintenance Log. The equipment/machine maintenance Log shall include, at a minimum, the: Equipment/machine name Manufacturer/Vendor Serial Number/Model Maintenance Requirements (frequency, reference to maintenance work instructions if appropriate) Section: Quality/ Operational/ Production/R&D/Non Production Equipment Location Last certification Person or facility who performed the certification Due date of next certification Status – one of “Available, “ or “Stopped All equipment/machine not requiring maintenance or calibration will be clearly marked in the log. Each piece of equipment/machine requiring maintenance shall be labeled with the last date certified/calibrated and the next due date where practical (at minimum, the equipment/machine shall be labeled with the last certified/next due date logged in the equipment/machine records). All manufacturers of test equipment/machine requiring calibration and purchased or rented by Compass must supply a certificate of certification (or equivalent data), which shall include the original certification date. This date is used as the starting point for all subsequent required certification dates. Should the certification not be available, the equipment/machine shall be certified according to acceptable standards before being placed into service, and the certification results will be reviewed and approved by QA/RA before introducing new equipment into production. Any certification results are reviewed and approved by QA/RA prior to moving new equipment into production and added to Approval Suppliers (ASL). 5.1.1 Assign Risk level Risk Level Impact No/minimal impact on QMS Low No direct impact on the development and production of device Equipment has a direct impact on the device Development of product is not dependent on the Medium equipment/machine If equipment/machine is nonfunctional, minimal impact on Device. Critical QMS processes would still be functional Critical equipment/machine used in the development and maintenance of the Device High If equipment/machine is nonfunctional, Critical QMS processes would be impeded and no workarounds available (alternatives) 5.2 Engineering equipment/machine All Engineering equipment/machines used for validation or production purposes shall be subject to the requirements in this procedure. If any equipment/machine used during the validation process does not require Re-Certification or Preventive Maintenance, it will have the Validation Date only in the equipment/machine maintenance Log and be marked as “Certification Not Required.” Any component used for raw material acceptance testing shall be labelled as a master component and considered as an equipment/machine. Master component shall go through the Master Component Acceptance Test as per Master Component Acceptance Test Form and the completed record must be approved by Hardware engineer and QA-RA, at minimum. Once approved, Master Components shall be added to the equipment/machine log and maintained as per this SOP. 5.3 Custom Production Equipment Custom production equipment/machine will be documented in a manner consistent with company’s document control policies and commensurate with the risk associated with the equipment/machine. Custom equipment will include, where appropriate, the following: Specification Test Plan Validation Results Instructions for use Certification and/or Preventative Maintenance Requirements (CPAR) and procedures Storage and Handling Requirements Custom production equipment/machine will be formally released via the Change Control procedure prior to use in the production process, and will be listed in the equipment/machine maintenance Log. 5.4 Measuring Equipment Measuring equipment is considered production equipment to ensure valid results of measuring equipment/machine, the equipment shall: 1. Be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international measurement standards and when no standard is available, the method of calibration used shall be recorded. 2. Be adjusted or re-adjusted as necessary. All adjustments shall be recorded. 3. Have identification in order to determine its calibration status. 4. Be safeguarded from adjustments that would invalidate the measurement results.  5. Be protected from damage and deterioration during activities such as handling, maintenance, and storage. 5.5 Retirement of Equipment If the decision is made to retire a piece of equipment/machine, the equipment/machine maintenance Log shall be updated with that status, a memo stating the equipment is no longer in use shall be placed in the equipment file and, if the equipment is retained, it shall be marked as “Stopped”. In the event of a decision to re-activate the equipment, the log file and equipment/machine shall be updated accordingly. The equipment/machine must be re-certified prior to use. 5.6 Impact on material due to non-compliant equipment/machine If a piece of equipment/machine that requires certification is found to be out of tolerance, it must be tagged “Out of Certification - Do Not Use”. The Operations personnel shall notify the QA-RA immediately and an investigation shall be conducted in order to determine the following: No action to be taken – no action would be taken if the out of certification condition does not impact the results of any tests or QA-RA procedures. QA-RA shall document the result of the investigation and place the report in the equipment file. The equipment shall be repaired and re-certified, labeled with its limitation of use, or discarded. Re-test and/or re-certification of systems – if a piece of test equipment’s failure mode is such that the quality or reliability of any shipped product is in question, that product will be handled as non-conforming material. A report shall be created of all product built with the out of certification equipment/machine, including the product location. All products in the installed base and in the factory which must be re-tested will be identified if any. QA-RA shall make the final determination of Corrections and Removals and initiate a CAPA when necessary. The equipment shall be repaired and re-certified or labeled with its limitations of use, or discarded. Operations shall assess and record the validity of the previous measuring results when the equipment is found not to conform with the requirements. 5.7 Inspection of Maintenance Activities Maintenance activities and adherence to applicable maintenance schedules are inspected within the framework of internal audits of the quality system (refer to SOP: Quality System Audits). QA-RA is responsible for planning and carrying out the audits in the Equipment and Maintenance log. 6 Quality Records Record type Description Equipment/Machine Record of equipment repair and/or maintenance activities Maintenance Log Documented records of certification after calibrating, certifying, Certification and validating, performing preventive maintenance, or verifying all Calibration Records inspection, measurement, or test equipment.