{"id":96,"date":"2017-07-21T15:12:34","date_gmt":"2017-07-21T15:12:34","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=96"},"modified":"2023-07-17T05:36:13","modified_gmt":"2023-07-17T05:36:13","slug":"mdsap-audit-approach","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/mdsap-audit-approach\/","title":{"rendered":"MDSAP’s Process-Based Audit Approach & Sequence"},"content":{"rendered":"

Short-Term Pain = Long-Term Gain<\/h3>\n

The MDSAP audit model uses a process-based approach and defines the required audit sequence, nonconformity grading, scoring mechanism, and time requirements per process. In addition, the auditors must examine regulatory requirements from multiple countries. While the MDSAP audit may be more difficult at first, the payoff is big: A single audit satisfies multiple regulatory authorities.<\/p>\n

MDSAPs Process-Based Audit Approach<\/h3>\n

MDSAP’s process-based approach is different from the traditional checklist-style audit that reviews documentation and conformance to standard requirements and procedures but it’s not new. FDAs QSIT (Quality Systems Inspection Technique) and effective auditing to the ISO 13485:2016 requirements also employ a process-based approach.<\/p>\n

Auditors using a process-based approach assess the conformance of a process to regulatory requirements as well as the effectiveness of the process in producing the desired results. This approach not only reviews individual processes but also examines the interrelationships and connections between them, which allows organizations to understand both their level of conformance and the effectiveness of their quality management system (QMS).<\/p>\n

During an MDSAP audit, the auditing organization (AO) will review procedures, map the process, and then ask auditees about the process to determine if their responses align with the procedure and if the process is effective in achieving desired results. The AO will analyze process performance against targets (e.g., nonconforming parts, product defects, product quality, and reliability targets) and planned results. They will also evaluate the handling of process\/product nonconformities and effectiveness of the resulting corrective and preventive actions.Audit time for an MDSAP audit is based on tasks, not employee count, with an average of 15 minutes per task. This timed audit duration means that organizations need to articulate processes and interrelationships quickly and coherently.<\/p>\n

The MDSAP Audit Sequence<\/h3>\n

When an AO performs an MDSAP audit, they follow a defined sequence. The purpose of the sequence is to provide a logical, efficient roadmap for the AO and ensure consistency across auditors.<\/strong><\/p>\n

The audit sequence contains four primary processes <\/strong>(Management; Measurement, Analysis, and Improvement; Design and Development; and Production and Service Controls), an enabling process<\/strong> (Purchasing), and two supporting processes<\/strong> (Device Marketing Authorization and Facility Registration, appearing in two spots below, and Medical Device Adverse Events and Advisory Notice Reporting). The primary processes are built on a foundation of risk management requirements.<\/p>\n

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Adapted from MDSAP Audit Model | 2017-01-06 MDSAP AU P0002.004<\/figcaption><\/figure>\n

Each MDSAP process area includes audit objectives and a series of tasks that auditors use to determine compliance with ISO 13485 and the applicable regulatory requirements of the countries participating in the program (Australia, Brazil, Canada, Japan, and the US).<\/p>\n

As the AOs navigate the audit sequence, they:<\/p>\n