Compass Health SOP: Process Validation

Study Notes

Compass Health SOP: Process Validation

Document title: Compass Health AI SOP: Process Validation
Document number: QMS-SOP-0017
Version 1.0, initial release date 03 Jan 2024

Approvals

Tenzin Yangzom, Head of QA/RA, author, 02 Jan 2024
James Baskin, COO, approver, 02 Jan 2024

Revision History

Version 1.0, initial release date 03 Jan 2024

1 Introduction

Procedure for validating and controlling production processes, and computer software used in production and quality control.
Applies to all general and special processes related to Compass Health's medical devices, whether in-house or external.
Covers processes using computer software.

2 Applicable and Reference Documents

Standards: ISO 13485:2016 7.5.6 (Validation of processes), ISO 13485:2016 7.6 (Control of monitoring), TG(MD)R Sch3 P1 1.4(5)(e), TG(MD)R Sch1 P1 2(1)
Reference Document: SOP: Verification and Validation, QMS-SOP-0009

3 Acronyms and Definitions

Process Validation: Establishing consistent production of documented, safe, and effective products meeting predetermined performance specifications.
Special Processes: Production processes where output can't be verified through subsequent measurement and monitoring but instead rely on validation data (e.g., temperature control). Examples include joining, molding, coating, or treating materials.

4 Process Roles

Engineering: Responsible for validation method selection, execution, and documentation for both general and special processes.
QA-RA: Responsible for identifying general and special processes, collaborating with departments, demonstrating control over processes, and facilitating 3rd party testing, if applicable.

5 Process Validation Procedure

5.1 General Processes
- 5.1.1 Identification of General Processes: QA-RA identifies general processes needing validation (e.g., computer software, automated processes).
- 5.1.1.1 Assign Risk Level: Risk levels (low, medium, high) are assigned to general processes based on their impact on Compass Health's QMS, device development, and production. Low impact processes do not require full validation reports.
- 5.1.2 Validation of General Processes: QA-RA validates those general processes determined to have high or medium risk levels. Validation includes establishing protocols, validation protocols, reviewing results, and adherence to specified criteria on production processes and QC inspection software.
5.1.3 Revalidation of General Processes: If general processes change (higher revision level), QA-RA evaluates if/what revalidation is necessary. Revalidation follows a risk-based approach similar to initial validation.
5.1.4 Control of General Processes: Ensures processes meet specified conditions through methods, operator training, and monitoring of parameters (e.g., temperature, pressure).
5.2 Special Processes
- 5.2.1 Identification of Special Processes: QA identifies special processes requiring validation through a designated process identified in the production plan. Special processes include processes such as joining or molding materials.
- 5.2.2 Validation of Special Processes: Engineering performs validation through a variety of testing (e.g., specific validation methods), documents results, and Quality Assurance supports as appropriate.
- 5.2.3 Special Process Validation Report: A validation report is created and includes process identification, characteristics, validation method, acceptance criteria, results and approval from QA.
- 5.2.4 Control of Special Processes: Monitoring, validation and use of specific methods are used to control these processes

6 Quality Records

Special Process Validation Records: Validation reports for special processes.
General Process Validation Records: Validation reports for general processes. Records also include documented monitoring of processes.