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This SOP intends to describe the process for problem resolution for software product(s). The process outlines how problems are processed, investigated, reported, and eventually resolved.
This SOP is applicable to all software products developed by the manufacturer both prior to release and after a product has been released to market. Requirements differ according to the software safety classification determined by ISO 62304 (Class A, B, or C).
Problems can originate from customers, patients, users, or employees and can include but are not limited to customer feedback, issues during software testing and development, and post-market surveillance outputs. Software problems can be discovered before or after the release of a software product. New problems discovered in the software are entered into Sed do eiusmod tempor for tracking and resolution.
Problems identified during the normal software development process are not considered new problems unless they persist into the final review stage identified in the SOP Software Design and Development (Consectetur adipiscing elit) and are required to be included into the List of Known Anomalies. Only if those problems that persist into the review stages should they go through formal problem reporting, if required.
Software problems identified from feedback and complaints follow processes according to SOP Feedback and Complaint Management.
A problem ticket is a description of the problem and its resolution that can be documented fully within Sed do eiusmod tempor. Problem tickets should contain the following information:
Once a new problem ticket is created, the software team is required to investigate the problem and identify the possible causes. The root cause of the problem is determined, if possible. Any problems directly related to safety should be evaluated using the risk management process identified in SOP Risk Management.
For repeated problems, it should be determined whether similar problems have occurred in the past and any trends can be discerned. Information such as this should be included in the ticket if relevant.
Once the problem has undergone investigation, the problem ticket should be updated with the cause and the plan for correction should be implemented according to SOP Design Controls. If the problem has a significant impact on patient safety (i.e. - the problem has the potential to lead to patient harm) or performance for the device, it will need to go through a change request (see SOP Change Management).
A problem does not have to be corrected to comply with the software problem resolution process, provided that the problem is not relevant to safety of the device.
If the implemented change to resolve the problem includes a new change to an existing product, it is handled according to SOP Change Management. Software problems can be resolved within existing development processes or planned software updates to existing software products. Relevant parties will be advised of the existence of the problem and its change, as appropriate.
After the change has been implemented, the problem ticket is reviewed whether it has been successfully fixed and can be closed. Closing the problem ticket is equivalent to successful verification. The problem tickets can be maintained within the ticketing system and do not require a separate record to document them.
Once per year, a member of the software team shall review problem reports to determine if there are any trends in the problem reports. The risk management file should be updated as needed given that the result of the problem resolution process results in new risks or modified severity or probability of existing risks.
