Comprehensive Guide to In-Process Quality Control Checks in Medical Device Manufacturing
1) Purpose
The purpose of this SOP is to establish a systematic procedure for performing in-process quality control (IPQC) checks during the manufacturing of medical devices. These checks ensure that products meet specified standards and regulatory requirements at each stage of production, preventing defects and ensuring consistent quality.
2) Scope
This SOP applies to all stages of the manufacturing process for medical devices, from raw material preparation to final assembly and packaging. It is intended for quality control personnel, production operators, and supervisors involved in monitoring and maintaining process integrity.
3) Responsibilities
– Quality Control (QC) Team: Conducts in-process inspections and records findings in the IPQC log.
– Production Operators: Support QC personnel by providing access to production areas and ensuring compliance with inspection requirements.
– Supervisors: Oversee the execution of IPQC activities and address any issues identified during checks.
– Quality Assurance (QA): Verifies and approves IPQC findings and ensures corrective actions are implemented for deviations.
4) Procedure
4.1 Preparation for In-Process Checks
4.1.1 Inspection Plan
– Develop an IPQC plan outlining critical control points (CCPs), inspection parameters, and testing methods.
– Include frequency and sample size requirements based on statistical
4.1.2 Equipment and Tools
– Ensure inspection equipment (e.g., calipers, micrometers, force testers) is calibrated and in proper working condition.
– Prepare test materials and reference samples for visual and functional comparisons.
4.1.3 Documentation
– Use pre-approved IPQC forms to record inspection results, including product name, batch/lot number, inspection criteria, and observations.
4.2 Execution of In-Process Checks
4.2.1 Raw Material Checks
– Verify the quality of raw materials during preparation and ensure they meet the specifications outlined in the material specification sheet.
– Record findings, including any deviations, in the raw material IPQC log.
4.2.2 Dimensional and Physical Checks
– Measure critical dimensions using precision instruments and compare them to design specifications.
– Inspect physical attributes, such as surface finish, color, and texture, for conformity.
4.2.3 Functional Testing
– Conduct functional tests on semi-finished products to ensure they meet performance requirements.
– Examples include load testing, electrical conductivity checks, and pressure resistance testing.
4.2.4 Assembly Line Checks
– Monitor assembly processes to ensure components are correctly positioned, secured, and aligned.
– Check for defects such as loose parts, misalignments, or incorrect connections.
4.2.5 Environmental Monitoring
– Verify that environmental conditions, such as temperature, humidity, and particulate levels, remain within acceptable ranges.
– Document any deviations and implement corrective actions promptly.
4.3 Sampling and Frequency
4.3.1 Sampling Methods
– Follow statistically valid sampling plans, such as ANSI/ASQ Z1.4 or ISO 2859, to determine sample sizes for each inspection stage.
– Collect samples at predefined intervals to ensure comprehensive process monitoring.
4.3.2 Inspection Frequency
– Perform in-process checks at regular intervals based on production volume and process criticality.
– Increase inspection frequency during process changes, equipment malfunctions, or when deviations are observed.
4.4 Handling Non-Conformities
4.4.1 Identification and Segregation
– Immediately identify and segregate non-conforming items to prevent them from proceeding to the next production stage.
– Tag non-conforming items with labels specifying the nature of the defect, batch/lot number, and date.
4.4.2 Reporting and Documentation
– Record all non-conformities in the IPQC log and notify the production supervisor.
– Complete a Non-Conformance Report (NCR) detailing the root cause, corrective actions, and disposition.
4.4.3 Corrective Actions
– Implement corrective actions, such as process adjustments, equipment recalibration, or retraining operators, to address identified issues.
– Document actions taken and verify their effectiveness in subsequent checks.
4.5 Documentation and Record Keeping
4.5.1 IPQC Log
– Maintain a detailed IPQC log for each batch, including inspection results, non-conformities, and corrective actions.
– Ensure records are signed by the inspector and approved by the supervisor.
4.5.2 Traceability
– Link IPQC records to batch/lot numbers for traceability throughout the production lifecycle.
– Retain records for at least five years or as required by regulatory authorities.
4.6 Review and Continuous Improvement
4.6.1 Post-Production Review
– Conduct a post-production review to assess the effectiveness of in-process checks and identify areas for improvement.
– Analyze trends in non-conformities to detect recurring issues.
4.6.2 Process Optimization
– Use findings from IPQC activities to optimize production processes and improve product quality.
– Implement lean manufacturing principles to reduce defects and enhance efficiency.
4.6.3 Audits
– Perform regular internal audits to ensure compliance with this SOP and regulatory standards.
– Address audit findings through corrective actions and process updates.
5) Abbreviations
– IPQC: In-Process Quality Control
– CCP: Critical Control Point
– QC: Quality Control
– QA: Quality Assurance
– NCR: Non-Conformance Report
6) Documents
– IPQC Log
– Non-Conformance Report (NCR)
– Material Specification Sheets
– Calibration Certificates for Inspection Tools
– Post-Production Review Reports
7) Reference
– ISO 13485: Medical devices – Quality management systems
– ISO 2859: Sampling procedures for inspection
– FDA CFR Title 21, Part 820: Quality System Regulation
8) SOP Version
– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]
Annexure
Annexure 1: IPQC Log Template
| Date | Batch/Lot Number | Inspection Stage | Parameter Checked | Result | Inspector |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch ID | Stage Name | Parameter Details | Pass/Fail | Inspector Name |
Annexure 2: Non-Conformance Report Template
| Date | Batch/Lot Number | Description of Non-Conformance | Root Cause | Corrective Action | Approved By |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch ID | Defect Description | Root Cause Details | Action Taken | QA Name |