Master’s in Audit Engineering, Change Control, Recalls, Post-Market Surveillance.
Online master's programme of 1,900 hours in audits, change control, recalls and post-market surveillance engineering: 12 modules covering the regulatory product life cycle, technical and system audits, engineering change control, post-market surveillance, product risk assessment, recall management, defect investigation, North American, EU and Asian requirements, and field analytics, with an assigned technical tutor.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Apply market surveillance and manufacturer requirements.
Carry out product and compliance audits.
Manage engineering changes with regulatory impact analysis.
Detect risk signals in field data.
Assess product risks using official methodologies.
Plan and execute multi-region recalls.
Implement auditable product safety systems.
Who it's for
- Product safety officers responsible for post-market decisions.
- Recall managers coordinating campaigns with authorities and dealer networks.
- Field quality engineers analysing warranty data and returned parts.
- Compliance auditors working on product, process or CSMS/SUMS audits.
- Post-market surveillance analysts monitoring field signals and trends.
- Change control engineers assessing the regulatory impact of design changes.
- Engineering or science graduates looking to enter the automotive sector.
What you'll work with
- Regulation (EU) 2019/1020 (market surveillance and compliance of products)
- 49 CFR Part 573 (defect and noncompliance responsibility and reports)
- Regulation (EU) 2018/858 (approval and market surveillance of motor vehicles)
- ISO 19011 (guidelines for auditing management systems)
- Regulation (EU) 2023/988 (General Product Safety Regulation)
- IATF 16949 (automotive quality management systems)
- 49 CFR Part 579 (reporting of information about potential defects, EWR)
- ISO 10393 (consumer product recall guidelines for suppliers)
- Siemens Teamcenter
- SAP QM
- Tableau
- Python
- Sparta TrackWise
12 modules · 1900 h
1.1From development to withdrawal from the market1.2Manufacturer obligations after type approval1.3Market surveillance in the EU1.4Regulation (EU) 2019/10201.5Responsibilities of importers and distributors1.6General product safety1.7Post-market risk management1.8Interaction with authorities1.9Compliance culture1.10Case study: obligations of an importer
2.1ISO 19011 auditing principles2.2Product versus process audits2.3First-, second- and third-party audits2.4Risk-based planning2.5Interview and sampling techniques2.6Auditing regulatory requirements2.7CSMS cybersecurity audits2.8SUMS software audits2.9Audit reporting and follow-up2.10Workshop: product audit of a component
3.1Change request and change order process3.2Regulatory impact analysis3.3Classification of minor and major changes3.4Type-approval extensions and revisions3.5Software changes and RxSWIN3.6Supplier and process changes3.7Communication with the technical service3.8Management in PLM systems3.9Auditing the change process3.10Practical exercise: impact analysis of a design change
4.1Sources of field information4.2Warranty claims4.3Dealer and workshop data4.4Social media and customer complaints4.5Fleet telematics data4.6Authority databases4.7Failure trend analysis4.8Early risk detection4.9Periodic safety reports4.10Lab: signal detection in warranty data
5.1RAPEX methodology and Safety Gate5.2EU risk assessment guidelines5.3Severity and probability of harm5.4Consideration of vulnerable populations5.5Serious risk and required measures5.6Safety decision committees5.7Documenting the decision5.8Review of previous decisions5.9Risk assessment in software5.10Case study: risk assessment of a defect
6.1Safety campaign decision6.2Notification to authorities in the EU6.3The NHTSA recall process and Part 5736.4Recalls in China with SAMR6.5Communication with owners6.6Parts and workshop logistics6.7Recalls via OTA updates6.8Monitoring the completion rate6.9Closing the recall6.10Workshop: multi-region recall plan
7.1Analysis of returned parts7.2Failure reproduction tests7.3Technical root cause analysis7.4Analysis of affected batches7.5Determining the scope of the population7.6Confirmatory laboratory tests7.7Coordination with suppliers7.8Documentation for authorities7.9Design lessons learned7.10Case study: investigation of an airbag failure
8.1The US Vehicle Safety Act8.2The TREAD Act and Early Warning Reporting8.349 CFR Parts 573 and 5778.4NHTSA ODI investigations8.5Civil penalties and consent orders8.6Transport Canada and recalls8.7Emissions defects with the EPA8.8Record retention8.9Product liability litigation8.10Practical exercise: quarterly EWR report
9.1Regulation (EU) 2018/858 and surveillance9.2Safety Gate and notifications9.3Recalls in Japan and the MLIT9.4Korea and KATRI9.5China: product defect regulations9.6India and its voluntary recall policy9.7Australia and the ACCC9.8Coordination of global recalls9.9Differences in deadlines and formats9.10Case study: recall in the EU, Japan and China
10.1Integration into IATF 1694910.2Product safety procedures10.3The product safety officer10.4Document management and retention10.5Evidence for authorities and courts10.6Field quality indicators10.7Internal compliance audits10.8Staff training10.9Continuous improvement of the system10.10Workshop: product safety procedure
11.1Text mining of complaints11.2Field reliability models11.3Failure prediction with machine learning11.4Connected vehicle data11.5Surveillance dashboards11.6Integration of heterogeneous sources11.7Data quality and governance11.8Automation of regulatory reports11.9Bias risks in analytics11.10Lab: predictive model of complaints
12.1Selection of a product or case12.2Diagnosis of post-market processes12.3Design of a surveillance system12.4Change control procedure12.5Recall management plan12.6Indicators and analytics12.7Assessment of residual risks12.8Improvement recommendations12.9Master's Thesis report12.10Master's Thesis: defence before a panel
How you'll learn
The programme is delivered 100% online on SEIUM's campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, so it fits around your job.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Siemens Teamcenter, SAP QM, Tableau, Python and Sparta TrackWise, in free, academic or evaluation versions. Testing is studied through real procedures: analysis of parts returned from the field, in-plant product audits and defect investigations. Assessment is continuous, module by module, plus the final Master's Thesis.
Standards covered: Regulation (EU) 2019/1020, 49 CFR Part 573, Regulation (EU) 2018/858, ISO 19011, Regulation (EU) 2023/988, IATF 16949, 49 CFR Part 579, ISO 10393.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Where this takes you
Requirements
- A university degree in engineering, science or architecture, or equivalent demonstrable professional experience.
- An internet connection and a computer capable of running the programme's software.
- English sufficient to read technical standards.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 1,900 hours over 12–14 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.
You work with Siemens Teamcenter, SAP QM, Tableau, Python and Sparta TrackWise, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.
A SEIUM Institute diploma, awarded on passing the continuous assessment and the Master's Thesis. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the higher programme. Ask about the recognition policy when you enrol.
A university degree in engineering, science or architecture (or equivalent professional experience), a computer able to run the programme's software and English sufficient to read technical standards.
Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.
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