/> – Assess risks based on:
– Severity of the impact on product quality or safety.
– Likelihood of occurrence.
– Detectability of the hazard.
– Categorize risks as high, medium, or low, and prioritize them for control.

4.2 Selecting and Implementing Risk Control Measures
4.2.1 Types of Risk Controls
– Evaluate and select appropriate risk control measures, including:
– Inherent design changes (e.g., automating manual processes to reduce human error).
– Engineering controls (e.g., machine guards, alarms).
– Administrative controls (e.g., SOPs, training programs).
– Personal protective equipment (PPE) for operators.

4.2.2 Risk Control Implementation
– Integrate selected risk control measures into the manufacturing process, including:
– Equipment upgrades or modifications.
– Process adjustments, such as adding in-line quality checks.
– Establishing controlled environments (e.g., cleanrooms).
– Validate implemented measures through testing and pilot runs.

4.3 Monitoring Risk Control Measures
4.3.1 Continuous Monitoring
– Monitor the effectiveness of risk controls using:
– Real-time data collection systems.
– Regular inspections and audits.
– Feedback from operators and quality teams.
– Document findings in the Risk Control Monitoring Log.

4.3.2 Performance Metrics
– Define and track performance metrics for risk controls, such as:
– Frequency of incidents.
– Time between failures.
– Non-conformance rates.

4.4 Verifying and Validating Risk Controls
4.4.1 Verification Activities
– Verify that risk control measures are implemented correctly and operate as intended through:
– Equipment calibration records.
– Test reports from process validation activities.

4.4.2 Validation Testing
– Conduct validation testing for critical controls to ensure they mitigate identified risks effectively.
– Use methods like:
– Process validation studies.
– Environmental monitoring tests.
– Biocompatibility testing for materials.
– Record validation results in the Risk Control Validation Log.

4.5 Managing Changes and Updates
4.5.1 Change Management
– Review and update risk control measures whenever:
– New risks are identified.
– Process or equipment changes are introduced.
– Feedback from audits or inspections indicates gaps in control measures.
– Document changes in the Change Control Log.

4.5.2 Training and Awareness
– Train manufacturing personnel on updated risk controls and ensure understanding of their responsibilities.
– Record training sessions in the Training Log.

4.6 Documentation and Record Keeping
4.6.1 Risk Management File
– Maintain a comprehensive risk management file that includes:
– Risk assessments and categorization.
– Details of implemented control measures.
– Validation and monitoring records.
– Change control documentation.

4.6.2 Regulatory Compliance
– Ensure all risk control activities and records comply with:
– FDA Quality System Regulation (21 CFR Part 820).
– ISO 13485 requirements.
– EU MDR General Safety and Performance Requirements.

5) Abbreviations

– PFMEA: Process Failure Mode and Effects Analysis
– QA: Quality Assurance
– FDA: Food and Drug Administration
– EU MDR: European Medical Device Regulation
– PPE: Personal Protective Equipment
– SOP: Standard Operating Procedure

6) Documents

– Risk Control Monitoring Log
– Risk Control Validation Log
– Change Control Log
– Training Log
– Risk Management File
– Process Validation Reports

7) Reference

– ISO 14971: Application of Risk Management to Medical Devices
– FDA CFR Title 21, Part 820: Quality System Regulation
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements
– ISO 13485: Medical Devices – Quality Management Systems

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: Risk Control Monitoring Log Template

Date	Risk Control Measure	Monitoring Activity	Results	Responsible Team
DD/MM/YYYY	Temperature Monitoring System	Daily Temperature Check	Within Limits	QA Team

Annexure 2: Risk Control Validation Log Template

Date	Risk Control Measure	Validation Method	Results	Approved By
DD/MM/YYYY	Machine Guard Installation	Safety Test	Pass	QA Manager