Page 216 - Safety Risk Management for Medical Devices

Production and Postproduction Monitoring 195

Risk management is applied to the entire product lifecycle, but it is very different
in the preproduction versus production and postproduction. In the preproduction
phase, risk management is a predictive tool. It forecasts what Hazards will manifest
and what risks the medical device will present. After the product is produced and
released for use, risk management is a retrospective tool, intended to protect the
public from discovered risks.
Production monitoring aims to detect and prevent release of nonconforming
products whose safety characteristics may have been adversely affected. Process data
monitoring and trending, and quality control are some of the proactive ways in which
production of nonconforming products is prevented, or their release avoided. If
production monitoring indicates that nonconforming products with the potential to
cause safety risks have escaped, then postmarket risk management activities should be
initiated (see Section 24.1 for more details).
Postproduction monitoring is intended to evaluate the performance of the product
in the field. A data monitoring plan should be established that stipulates sources of
information and frequency of data collection and trending. Trending of data may
show that a particular signal has been increasing and may have exceeded its threshold.
Even though no patient Harm may have happened, this may indicate the potential for
a future adverse event. Such a signal may necessitate the creation of a Corrective and
Preventive Actions (CAPA) to initiate a root-cause analysis, determine preventive and
corrective actions, and plan for verification of effectiveness of said actions. Sources
that should be included in postproduction monitoring are:

• nonconformance reports
• CAPAs with potential for safety risk to patients
• complaint trending signals
• signals from returned product investigation, and service
• reports of new Hazards in competitor products
• published information
• postmarket clinical follow-ups
• surveillance registries
• reports of injuries and death that are attributable to the product

If postproduction monitoring indicates reported or potential Harm from released
products, postmarket risk management activities should be initiated (see Section 24.1
for more details).
Postmarket-detected issues that have a potential safety impact must be addressed
within certain time limits (e.g., 30 days) to limit the exposure of patients.
Sometimes root-cause analysis could identify a supplier of the manufacturer as the
source of a Hazard. In that case, CAPA would reflect back to the supplier. The CAPA
may also impact the incoming inspection procedures at the manufacturer.