Process Risk Management Procedure
SKU: SOP 7-031
The ISO 14971 Process Risk Management Procedure governs production related risks. The ISO 14971 Process Risk Management Procedure is made part of the overall medical device risk management system.
- ISO 14971:2012 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word and Excel Formats
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Process Risk Management Procedure
The ISO 14971 Process Risk Management Procedure defines the process for identifying and mitigating risks associated with the manufacturing processes used to manufacture of medical devices. The ISO 14971 Process Risk Management Procedure is written in accordance with the requirements noted in ISO 14971:2012.
Process Risk Management Procedure Overview
The production risk management process should be conducted on every medical device. The production risk assessment will include the entire manufacturing process, including each operation in the process whether the manufacturing is conducted “in-house” or sub-contracted.
Review every operation step of the manufacturing process. Including all steps referenced on the manufacturing flow chart.
Assessment of Risks
Assess the risk for each hazardous situation.
Preliminary Risk Level (Acceptable / ALARP/ High)
Enter the risk level determined by the combination of the severity of harm and the probability of occurrence of harm using the Product Risk Acceptance Matrix
Risk Control Measures
Risk control measures can reduce the “severity of harm” or reduce the “probability of occurrence of harm” or both.
Re-estimation of Risks after Implementation of Risk Control Measures
After risk control measures have been implemented, the risks shall be re-evaluated.
Review of Production Risk Management during Post Market Surveillance
As market feedback becomes available, such as customer feedback, product complaints, product related CAPA’s, etc., the risk estimation should be reviewed to determine if there are any risks not previously identified or to assess the continued validity of the severity or probability of occurrence of harm.
ISO 14971 Process Risk Management Procedure Compliance
The ISO 14971 Process Risk Management Procedure is ISO 14971:2012, FDA QSR and ISO 13485:2016 compliant.
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