Handling in-Process Defect Repairs

[malasuerte]

And that would definitely represent a departure from the original design. A weldment can lead to defects such as cracks, corrosion, deformation, etc....

But that doesn't always make it a design change. Again, I am going off my past and current experience. The 'weld' would already be an approved process for repair and not go back and design a weld brand new. The very first time maybe - but I expect most/some of the time the repair would have already been designed in the design process. At least in my world it is - we very very rarely go back and design something new after it was in Prod.

 

[cferrer]

All my experience at any level is reworks can not be undocumented.

Thanks a lot malasuerte. I hear you and I do have a hard time with the argument of undocumented, "risk-based" rework but I wanted to hear other opinions. Maybe there will be some more iput from other non-certified companies.

 

[John Broomfield]

Thanks a lot malasuerte. I hear you and I do have a hard time with the argument of undocumented, "risk-based" rework but I wanted to hear other opinions. Maybe there will be some more input from other non-certified companies.

Are there any other parts of ISO 9001 that do not reflect what is widely accepted as good practice?

 

[Alan_DB]

Depends if the repair is repeating the already established / documented manufacturing process. E.g. Visual inspection step detects parts that need to be re-processed, they loop back into the manufacturing stream. I wouldn't call this a non-conformity or re-work especially if the product is not finished at this point.

My interpretation of 'rework' is taking non-conforming finished product and performing some level action on it to make it conforming. Would normally be the result of a non-conformity and be fully documented etc.

 

[cferrer]

Interesting. This scenario was actually part of my question, hence the name "in-process". This is where the gray area is most prominent. Depending on the context and specifics of the process, there are coincievable circumstances in which stoping to document every single re-processing (or reworking) of "work-in-progress" in a given subprocess would not be sensible or reasonable.

 

[Alan_DB]

Interesting. This scenario was actually part of my question, hence the name "in-process". This is where the gray area is most prominent. Depending on the context and specifics of the process, there are coincievable circumstances in which stoping to document every single re-processing (or reworking) of "work-in-progress" in a given subprocess would not be sensible or reasonable.

Build in re-processing to your existing documented process (allowable under certain circumstances or certain defects or whatever controls you deem necessary), have a impact assessment documented as to why it is acceptable. Without knowing exact industry / product / process its hard to comment on what level of documentation would be advisable.

Re-work in my experience tends to need specific / one off instructions in order to bring the product to a state of conformity, must only be done with prior approval and of course if it is in scope of the management system!

 

[John Broomfield]

Interesting. This scenario was actually part of my question, hence the name "in-process". This is where the gray area is most prominent. Depending on the context and specifics of the process, there are coincievable circumstances in which stoping to document every single re-processing (or reworking) of "work-in-progress" in a given subprocess would not be sensible or reasonable.

Agreed.

Imagine asking a potter to keep rework records.

But if the pot cracks in the kiln, that would be recorded and the records used to improve the firing part of the process.

 

[Ed Panek]

I worked at a medical printer company. The final approval step was to print a medical breast exam on film and it either passes or fails the visual test. There was also a densitometry and scaling test but the final test was using it as the user would.

Once a number of faulty units accumulated we created a work order with a list of serial numbers and failure symptoms. A senior production tech would go through each printer to find what was faulty. That data was used for suppliers feedback or training improvements.

 

[John C. Abnet]

Agreed.

Imagine asking a potter to keep rework records.

But if the pot cracks in the kiln, that would be recorded and the records used to improve the firing part of the process.

Great example @John Broomfield

 

[mattador78]

Agreed.

Imagine asking a potter to keep rework records.

But if the pot cracks in the kiln, that would be recorded and the records used to improve the firing part of the process.

Good analogy and i speak as some one raised in the Potteries, even down to batches of clay mixed it cant be traced as all old off cut's of clay before firing are mixed back into "fresh clay" in slip rooms to be repurposed with minimal waste so what was fresh on a Monday could be back in a new mix on Wednesday and Friday before being back again the following Monday. Extra points if some one could tell me what a Sagger makers bottom knocker is without googling it.