Managing design verification regression testing of design changes

#1
Hi,
Just curious how others manage regression testing for design changes relative to their original design verification protocol/report.

For example, a design change is assessed to affect tests #1, 2, 3 on DVT protocol so we want to repeat those tests to document the results following design change. Do you leave protocol as-is (no revision) and revise test report with new results? If so do you maintain the original results in addition to the new results? And where do you document some background on the design change?

Alternatively I've seen use of addendum reports (keep original report as-is, add standalone addendum report to document new results) as well as entirely new protocol/report to describe the change and subset of testing to be performed/results. To me it seems each has its upside and downside so curious to know how others manage this and what they've found to be best.
Thanks
 
Elsmar Forum Sponsor

ECHO

Involved In Discussions
#2
I feel like regression testing is one of those topics where if you asked a 100 people, you should get a 100 answers. It is also difficult to say since I don't know anything about your product or your Quality System.

That said, I won't approach it your way. When you make a design change, every requirement pertaining to your system should be tested. If you happen to have a previously executed Verification Report and if that result is sufficient for your testing purposes, that's great! Reference the Verification Report and document your justification.
As for the tests that were re-executed, this depends on your doc control system. I have seen all the methods you mentioned above. My advice is think of what your trace matrix would look like once you are done.

All that said, if you are complying to IEC 62304, Section 5.6.6 Conduct Regression tests is for integration testing and not Verification testing. Note 1 for Section 5.1.5 does say integration testing and system testing can be combined so again, reference your procedure.

I recommend taking a look at Appendix B.5.7 of IEC 62304.

Lastly, the background on the design change should be documented in the DDP.
 
Thread starter Similar threads Forum Replies Date
J Design Verification - Managing Changes Design and Development of Products and Processes 4
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
qualprod Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
A Managing overseas travel risks to food handlers Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
M Medical Device News DHS – Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients Medical Device and FDA Regulations and Standards News 0
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
Jane's You may or may not have the same person managing Operations and QA ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Managing Internal/External RNC and Complaints in same Format ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L Managing Finance Processes - Identification of Sub Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Microbiology Testing - Managing a Microbiology Process Hospitals, Clinics & other Health Care Providers 2
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
G Managing Ongoing Compliance to Standards when they are Changed Misc. Quality Assurance and Business Systems Related Topics 3
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Need ideas on managing Shelf Life Studies within an organization ISO 13485:2016 - Medical Device Quality Management Systems 1
I Any recommendations on software for managing the APQP, PPAP, PFMEA, Control Plan etc? Quality Assurance and Compliance Software Tools and Solutions 2
R Managing Tooling Condition at Suppliers Supplier Quality Assurance and other Supplier Issues 6
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Looking for Practical Advice in Managing Measurement Uncertainties Measurement Uncertainty (MU) 3
L Managing ITP with an ERP system Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Form for Managing Coating Process Parameter Changes during Production Document Control Systems, Procedures, Forms and Templates 2
S Managing a Significant Number of Outstanding Non-Conformities Nonconformance and Corrective Action 6
A Software Tools for managing a QMS (Quality Management System) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing Inspection Records with a Database and Destroying Paper Records Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Process for Managing Documents which are Overdue for Review Document Control Systems, Procedures, Forms and Templates 20
S Q1 Manufacturing Site Assessment - Managing Post-Job 1 Changes Procedure Manufacturing and Related Processes 1
B Are there any Standards related to Managing an Airport Various Other Specifications, Standards, and related Requirements 3
Q Managing Internal and Client Complaints ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Industry Best Practices for managing outside Engineering Consultants Design and Development of Products and Processes 3
Q Process or Departments - Document Content and Managing the Process Approach ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Filtering ECR/ECO by quality management? Managing Engineering Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Managing the Unexpected - Book Recommendation Book, Video, Blog and Web Site Reviews and Recommendations 1
T Internal Conflict of Interest in Managing Suppliers Supplier Quality Assurance and other Supplier Issues 2
L Managing Certificates of Analysis or Conformance for Products Quality Assurance and Compliance Software Tools and Solutions 4
T Managing Audit Reports and Schedules General Auditing Discussions 3
M Managing Changes to an SFDA Registered Device China Medical Device Regulations 6
F Who manages QI projects? Quality or PMO? Managing Six Sigma and Lean Projects Six Sigma 2
Hami812 Attribute Data Gage R&R - Managing Data Sets - Minitab Using Minitab Software 2
E Nonconformity on managing documents for Electric Arc Furnace Manufacturing and Related Processes 4
D Managing an Employee Suggestion Program Quality Manager and Management Related Issues 4
K Managing Prerequisite Programme Activities Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Non Normal Data Managing - Clements Method to get Process Characteristics Statistical Analysis Tools, Techniques and SPC 8
J Managing New and Revised Electronic Documents (Procedures) - Share Point Document Control Systems, Procedures, Forms and Templates 8
N Managing Subcontracting Process - Material Traceability from Warehouse to Processing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Should ISO/QMS policy be signed by the Managing Director or anyone from Top Mgt? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom