K
Dear Fellow Covers
being thankful for your informative and insightful discussion, i would like to ask you on your comments/suggestions and insights and as well checklists (if available) on the following topic:
Overview:
- whether is it possible to generically define (like a checklist) to say that a particular set of R&D documents could always be analysed during a root cause analysis/failure investigation
Situation:
- Let us say a particular product complaint/failure is because of root cause like a manufacturing defect/process change where validation was inadequate/design flaw etc
- offcos you execute a 5-why analysis, cause-effect diagram in a complaint/failure investigation team,
- still you do analyse the relevant product development documents like the FMEA, specification documents (both component & system) etc
Questions:
- as i have already cited in the overview, can we define a checklist that contains list of documents that would be analysed in a failure investigation
- spec docs - system/component/process
- FMEAs - Process & Design & System
- (design & process) validation reports/protcols
- test plans/procedures/instructions used in manufacturing
- incoming inspection checklists to check material/product from suppliers
- usability plans/reports
- User manuals
- Service manuals
etc..
Working in the medical device industry, i believe any defined process and also a supportive checklist would do a great job in doing a full-fledged investigation and also to track change control.
Please also advice with your critics as well, whether any such thought would be encouraged.
Eager to see your discussion and guidance.
thank you
krishna
being thankful for your informative and insightful discussion, i would like to ask you on your comments/suggestions and insights and as well checklists (if available) on the following topic:
Overview:
- whether is it possible to generically define (like a checklist) to say that a particular set of R&D documents could always be analysed during a root cause analysis/failure investigation
Situation:
- Let us say a particular product complaint/failure is because of root cause like a manufacturing defect/process change where validation was inadequate/design flaw etc
- offcos you execute a 5-why analysis, cause-effect diagram in a complaint/failure investigation team,
- still you do analyse the relevant product development documents like the FMEA, specification documents (both component & system) etc
Questions:
- as i have already cited in the overview, can we define a checklist that contains list of documents that would be analysed in a failure investigation
- spec docs - system/component/process
- FMEAs - Process & Design & System
- (design & process) validation reports/protcols
- test plans/procedures/instructions used in manufacturing
- incoming inspection checklists to check material/product from suppliers
- usability plans/reports
- User manuals
- Service manuals
etc..
Working in the medical device industry, i believe any defined process and also a supportive checklist would do a great job in doing a full-fledged investigation and also to track change control.
Please also advice with your critics as well, whether any such thought would be encouraged.
Eager to see your discussion and guidance.
thank you
krishna