ISO 13485 change in process

[FuzzyD]

All I work for a small machine job shop that does many one and two piece runs, Occasionally we have to change manufacturing methods mid process do to various reasons. What is the best way to handle these changes with product realization? Should we complete a new product realization each time the process is changed or is there an alternative?

Thanks in advance!!

 

[yodon]

Are these pieces intended for finished devices? Do you do 100% inspection on the outputs? Do you have a Quality Agreement (or similar) in place with your customers that require you notify them of any changes?

Sorry for all the questions but it can get complicated.

 

[FuzzyD]

Are these pieces intended for finished devices? Do you do 100% inspection on the outputs? Do you have a Quality Agreement (or similar) in place with your customers that require you notify them of any changes?

Sorry for all the questions but it can get complicated.

The quality agreement does not state we need to notify them of changes. Most product is only made once or twice at the most and is not validated.

 

[Zero_yield]

I think it would be best to clarify with your customers what the intended use of the product is. I'm thinking of the parts that we occasionally outsource to a machine shop.

1). A one-time mounting bracket / tool holder for a piece of production equipment or a 5S / process flow improvement
-This likely wouldn't be a problem if there was some slight tweak, as long as all the materials stayed the same.

2). A validated/qualified fixture for processing product through some piece of equipment.
-As long as the final output matches the drawing, it likely wouldn't be a problem. However, I would definitely notify the customer if it's being manufactured in a different method than originally agreed to so that they could assess the risk to their process and product.

3). A piece of an actual medical device.
-This is where it gets really hairy, as yodon alluded to.