"production -related software verification..." (7.1.5.2.1-i)

Good day all-
We would like some input from this group in regards to interpretation of this specific clause line item.

Here our current TWO interpretations...

1- This applies when, within a manufacturing organization ("production-related")
that organization verifies software ("...software verification...") as part product and/or process control.

In other-words, IF the organization is verifying software.


2- This applies when, within a manufacturing organization ("production-related") software is used to verify product and/or process control (e.g. on a press, the software that provides "thermostat" to control and record melt temperatures; the software that interprets a laser being used for length monitoring, etc... )

In other-words, this applies to the software on most automated pieces of direct manufacturing equipment in a modern facility and the organization must arrange "calibration/verification" of all equipment controllers, which are governed by software.

Thanks in advance for your feedback regarding this topic.

 

Temperature control system
1. Hardware - thermocouple
We know temperature and confirm thermocouple output voltage.
2. Software - steering program of PLC
We know input voltage and confirm PLC output signal steering heater.
Program has criteria telling PLC software how to handle certain input values.
Of course PLC is a piece of hardware too, but without program telling its software what to do it's a total zero.

 

Thanks for the feedback "serious man". Can I assume the "steering program" and "thermocouple" are items you produce for sale? (or are these items that verify inputs and/or outputs?)

I'd be curious if others have thoughts/examples on this as well.

Thank you.

 

Greatly appreciate your feedback Andy-glad you jumped in.

Based on your past experience, let me provide a specific example...
e.g. A plastic injection molding press has a built in controller, which verifies...
- Pressure
- Dwell (hold pressure time)
- Barrel temperature
- Cavity Temperature
- Injection velocity
- Clamp force
- Screw speed
....etc..etc...

Is this clause implying that the software used by this controller needs verified? This seems unreasonable/not feasible.

I'd appreciate your thoughts on this example.

Thank you.

 

I meant, it is example of complete control system included in control plan for manufacturing process where temperature is a process parameter, e.g. melting.
System consisting of hardware and software elements, which both have to be verified independently.

 

Seems to be a sound and viable approach. Sincere thanks for your input on this topic.

Is it safe to assume then, that our interpretation "1" (as follows) is the intent of the clause?...
1- This applies when, within a manufacturing organization ("production-related"),
that organization verifies software ("...software verification...") as part product and/or process control.

In other-words, IF the organization is verifying software.

 

Maybe a different example -

A cnc program to control a waterjet machine generated from a dxf drawing. Is the part cut by the waterjet the correct size? How do you know? Many factors come into play here, cutting nozzle offset, height, taper, etc. We conduct an FPI on the first part to determine that yes, the dxf is correct and the programming produced the part we want. I then call the "program", which is the entire cutting process, "validated" for that particular setup and part.

 

Requirement is very simple - keep in mind that not only hardware can mislead you, but software too.
So if hardware needs verification/calibration using master, software needs it too.

So what is a software master?
It is set of input data combined with output result.
Software calibration is procedure of running software on "master input data" and comparing achieved result to "master output result".

Do not mix here later activities like product/process validation, PPAP, anything related to process output.
You have to have reliable control tools in our hand to start thinking about product/process validation.