Generic Product Development Documents that need Analysis in a Complaint Investigation

K

krishna007

#1
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
 
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Stijloor

Staff member
Super Moderator
#2
Re: Generic Product Development Documents that need Analysis in a Complaint Investiga

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
Any comments?

Thank you very much.

Stijloor.
 

yodon

Staff member
Super Moderator
#3
Re: Generic Product Development Documents that need Analysis in a Complaint Investiga

COULD you do it? I suppose. But I believe you would be adding no-value-added activities to the process. Your investigator should know / have available all the resources necessary - so I can see where maybe an index might be helpful, especially if there are a lot of documents. But to have to go through each document on the checklist just because your process said you have to seems like wasted effort.

Take a specific (hypothetical) example. Suppose you have a device that illuminates an LED when you turn it on. You get a bunch of complaints that the LED is not on when the device is turned on. You do a root cause analysis and find that you got a batch of LEDs that malfunction after being illuminated 3 times. What good would a required review of the service manual or functional requirements do in this case?

The investigator needs to take sufficient time to thoroughly investigate and identify the root cause(s). I think having any pre-defined activities just increases the potential for adding unnecessary burden.
 
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