Compass Health SOP: Inspection Equipment Control

Study Notes

Purpose: To establish a system and instructions for maintaining key process equipment/machines and support systems, ensuring conformity to product requirements.
Scope: Applies to all inspection, measuring, and test equipment/machines needing calibration/maintenance and used in validation, production, and/or servicing at Compass Health.
Applicable Standards: FDA QSR § 820.72, ISO 13485:2016 Section 7.6, and TG(MD)R Sch3 P1 1.4(5)e.
Reference Documents:
- 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 Equipment/machine Maintenance Log (QMS-SOP-0024, QMS-LOG-0004)

Operations: Responsible for equipment certification, identifying key equipment/machines for maintenance programs, maintaining logs, and approving records regarding manufacture and procurement.
Quality Assurance-Regulatory Affairs (QA-RA): Responsible for planning and conducting maintenance audits, documenting investigation results, and initiating certifications/preventative maintenance actions (CPARs).

New equipment is identified in the Production Plan, along with maintenance plans for the log.
The log includes equipment/machine name, manufacturer, serial number/model, maintenance requirements/frequency, section, location, last certification, person/facility who performed certification, due date, and status (Available/Stopped).
Equipment needing no maintenance/calibration is marked.
Equipment needing maintenance shall be labelled with calibration/certification dates.
Manufacturer certification papers shall be available and used to set subsequent certification dates.

Certification includes calibrating, certifying, validating, performing preventive maintenance, or verifying inspection, measuring, or test equipment/machine.

Low: Minimal impact on QMS and device development, production.
Medium: Equipment has an impact on device development but is not entirely dependent on it, minimal impact on critical QMS processes.
High: Critical equipment used in device development and maintenance, non-functional equipment impedes critical QMS processes (no alternatives).

Engineering equipment/machines are subject to procedure requirements.
Equipment use in validation or production is logged, with validation dates and marked as "Certification Not Required."

Custom equipment is documented consistently with company policies and commensurate with associated risks.
Documentation includes specs, test plan, validation results, instructions for use, certification/maintenance procedures, and storage/handling requirements.

Measuring equipment must be calibrated, verified against standards traceable to international standards, and adjusted/re-adjusted.
Equipment identification for calibration status is required.
Safeguards against invalidating measurements are crucial.

When equipment is retired, the log is updated to show status, with a memo in the equipment file (retained equipment marked "Stopped").
Re-activation requires re-certification.

Maintenance activities are inspected according to applicable schedules and SOP: Quality System Audits. QA-RA plans and conducts equipment and log audits.

Equipment/Machine Maintenance Log: Records equipment repair/maintenance activities
Calibration and Certification Records: Documentation associated with the certification, validation, and verification of inspection, measurement, or test equipment.