Why have the MDSAP RAs imposed an initial response period of 15 calendar days?
MDSAP RAs have established the requirements in documents MDSAP AU P0027 in order to ensure that AOs can submit their audit reports in a timeframe that is compatible with the RAs' own obligations to review, process and make regulatory decisions based on audit reports.
Note that this response time applies to the manufacturer's investigation of any identified Nonconformity (NC) and the proposed actions to resolve it. This timeframe does not require the manufacturer to provide evidence of implementation of these actions.
The same consideration applies to the 30-calendar days to submit evidence of implementation for any NC graded as 4 or 5. In this case, the timeframe is justified by the criticality of the NC and, if the audit report meets the criteria for an early awareness notification (5-day notice), by the associated need to share the report within 45 days.
Important notes:
- Some corrections and corrective actions might need more that 30 days to implement; however, the AO should move forward with its review and decision process using the information obtained from the manufacturer within these 30 days, even if this information is partial, rather than delay the sharing the audit report with the RA. Therefore, it is always in the manufacturer's best interest to respond swiftly to audit nonconformities.
- In comparison, other RAs, such as the FDA, may offer only a 15-working-day timeframe to respond to their observations. Any information received after this timeframe will typically not be considered in their review process.