Calibration/Verification Records - IATF 16949 section 7.1.5.2.1 (i)

Reference clause 7.1.5.2.1 i of IATF which requires that the records of verification of production related software used for Product and process control needs to be maintained, can you please suggest how the same can be demonstrated for a Cold Rolling Mill and Annealing Furnaces. Since all the production processes are controlled by software, how can I demonstrate compliance.

 

I work mostly in medical devices but we have similar requirements so I'll share my perspective.

If the software just comes with the system then there's just not a whole lot you can do. If you do any kind of system validation, you can cite that to show the software is meeting its intended use.

If you implement any specifics, say, security, that can be an area that should be addressed in validation. For example, if the system enables unique logins for all users and your company sets things up with a single, generic login, that's probably not the best practice. Maybe there are different privilege levels like operator, administrator, maintenance. Showing those are appropriately allocated is a good exercise.

The equipment manufacturer may provide software updates so one thing to check is whether you're up to date or not.

The equipment manufacturer may also maintain a list of known issues. Looking at that and considering if your implementation could be affected can be an eye-opener. You may find you should be doing things differently to avoid such issues.

If you layer on specific workflows then you can assess whether those are constructed within the framework the equipment manufacturer intended. You also may need to walk through the workflows if the system qualification doesn't cover everything.

Edge cases (error handling) and safety are always good to look at. Does the software handle error conditions and detect and respond appropriately to unsafe conditions?

If there is a remote client; i.e., you can operate the system remotely from a stand-alone PC, you'll want to consider if the PC it runs on is appropriate (memory, OS, speed, etc.). And a number of the above considerations (esp. security) can also be appropriate.

Hope that helps.